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Maternal Healthcare in the Developing World

January 11th, 2010

Maternal healthcare in the developing world

By:

Derick Stace-Naughton, Jess McCamy, George Roche, and Cara Swantek

Section 1: Summary

When researching the vast health inequities between the developed and developing world, one of the most glaring and unmistakable differences is in maternal healthcare–the care provided to a woman during pregnancy, childbirth and the postpartum period. Undeniably, developed countries have nearly eliminated their maternal mortality while developing nations are left with little help to save dying mothers.  Every year, 537,000 women die due to complications of pregnancy, and 99% of those are in developing countries. While the number may be viewed as small in comparison to other death tolls, its impact cannot be underestimated. In his May 2009 statement on the Global Health Initiative, President Obama said the following: “I also recognize that we will not be successful in our efforts to end deaths from AIDS, malaria, and tuberculosis unless we do more to improve health systems around the world, focus our efforts on child and maternal health, and ensure that best practices drive the funding for these programs.”

The solution we have developed in order to address maternal mortality in developing nations is a Global Fund for Maternal Health. The Fund will be similar in function to the Global Fund for Tuberculosis, Malaria, and AIDS in that it will act solely as a financing instrument, and not a program implementing entity. It will seek donations from governmental agencies as well as private institutions in order to fund grants awarded to program proposals.  Separate programs will be developed by individual countries and their designated Country Coordinating Mechanisms, consisting of healthcare professionals.

While the Global Fund for Maternal Health would not develop programs itself, the experts have seen extensive progress made by a few particular approaches.  In fact, these efforts have shown such great success that the Fund will set their results as a benchmark for other programs.  The use of certain drugs, specifically expanded distribution of hemorrhagic drugs, has proven to alleviate their respective complications. In addition, the increased presence of skilled birth attendants has drastically decreased the number of maternal deaths in particular countries. Thus while the Fund does not require the use of these mechanisms in any program proposed by a country, it shall require the demonstration of enhanced results effecting maternal mortality – better than those seen with these drugs and skilled birth attendants.

­­Section 2: Conceptual Map

maternal_healthcare_conceptual_map

As we examined various issues in Global health, it was clear that the maladies affecting industrialized nations were vastly estranged from the basic health needs in the developing world. Then as we were looking at those diseases which were preventable, that we could therefore have an impact on, we encountered variances between populations. It seemed that the health issues adversely effecting individuals largely depended on sex and age. Then finally as we were researching women’s health issues, we found the UN’s Millennium Development Goals and number 5 was to reduce by three-quarters maternal mortality ratios (defined below).  We knew that if the UN had assigned high importance to this matter then it was certainly an issue which demanded viable solutions.

Section 3: The Maternal Healthcare Problem

Substantial

Every minute, a woman dies from pregnancy related complications, which are almost always avoidable with proper care.  Although over 500,000 women dying each year as a result of pregnancy-related complications, the maternal healthcare problem can extends to an additional 15 to 20 million women who suffer debilitating consequences of pregnancy each year.[1] Furthermore, deficiencies in maternal healthcare and the resulting deaths create hundreds of thousands of new orphans annually.  In addition, approximately 8 million babies die during the week before or after childbirth as a result of insufficient maternal healthcare.[2] This overall number of annual deaths due to insufficient maternal healthcare is staggering, and indicative of what a substantial global problem maternal healthcare is.

Urgent

Maternal deaths are almost always preventable and, as a result, maternal mortality rates are exceptionally low in the developed world.  The overwhelming number of preventable deaths has led the United Nations to make maternal healthcare the fifth Millennium Development Goals (MDG) for 2015.  The MDG has set a goal for global leaders to lessen the maternal mortality ratio by three-fourths by 2015, but current data indicates that completion of this goal remains extremely unlikely.  In the fifteen years between 1990 and 2005, maternal mortality rates were reduced a mere 5%.[3] Noeleen Heyzer, the top UN offical for the Asia-Pacific region, recently described the situation by stating, “Maternal health and child mortality are areas where progress has been extremely slow and where urgent action is needed.”[4] As a result of this slow progress in maternal care improvements, many countries, including most of sub-Saharan Africa and Afghanistan, still experience well over 1,000 deaths for every 100,000 births.[5]

Global

maternal_healthcare_figure_1

While many poor nations suffer from these excessive maternal death rates, the Millennium Development Goal Tracker shows that most developing countries have a ratio of less than 25 deaths per 100,000 births.  Figure 1 illustrates the maternal mortality ratio, via a color-based key, for every nation on earth.  The darker regions, indicative of greater maternal mortality rates, correspond with under-developed geographic areas. This discrepancy between ratios in developing and developed countries is so drastic that as a result maternal mortality ratios are often used to determine whether a country is developed, and as a marker for government instability.[6] Overall, the average number of deaths per 100,000 births in a developing country is 450, whereas the average for developed nations is just 9 deaths per 100,000 births.[7]

Ineffective Efforts

The WHO recommends that a woman receive care throughout her pregnancy and up to a month after childbirth.  Yet in Africa and Asia, roughly half of all pregnant women do not receive any antenatal care.  Lack of maternal healthcare has been recognized as a serious problem, which is why it is one of eight Millennium Development Goals established by the UN.  According to the UN Children’s fund, more than one-quarter of all adult women in developing countries suffer from pregnancy-related illnesses [8] In addition to a lack of care throughout pregnancy, the delivery itself only occurs in the presence of a skilled attendant 53% of the time in developing countries.[9] Such practices are even more dangerous than a lack of care during pregnancy, as delivery is the most dangerous aspect of having a child.  Despite the knowledge of the dangers of lack of care, and the well-documented lack of care in developing countries, little progress has been made.  With only a 5% decrease in maternal mortality ratios from 1990 to 2005, it is clear that current efforts are falling flat.  The WHO has been working on this issue since 1987, and while they have been successful in drawing attention to the program, their efforts to reduce maternal mortality through the promotion of clinical guidance is ineffective.  Many women in developing countries either do not have access to a clinic, or are prevented by cultural barriers from seeking help at a clinic.  As such, it is important that future efforts to reduce maternal mortality be more sensitive to the circumstances and cultural issues a pregnant woman in a developing country may face.

maternal_healthcare_figure_2

Figure 2: Percentage breakdown of major causes of maternal death.

Leading Causes

The most common causes of maternal mortality are all preventable through either drug treatments or the care of a skilled attendant.  The leading cause of death each year is hemorrhage, or massive blood loss, which is responsible for 31% of maternal deaths.  Hemorrhagic deaths can be prevented with appropriately administered drugs, or by suturing by skilled attendants.  Sepsis and hypertensive disorders, which often lead to eclampsia and seizures, are other common causes of death that can be prevented through medication and skilled care.  The proportion of deaths that various causes are responsible for can be seen in Figure 2.

Section 4: Medical Systems Interventions

Drugs to treat post-partum hemorrhaging

Hundreds of thousands of hemorrhage-related maternal deaths occur annually, simply because effective hemorrhagic treatment regimens are unavailable in much of the developing world.  The World Health Organization consistently lists post-partum hemorrhage as the single greatest cause of maternal death; hemorrhage-oriented health interventions have a vital role in the improvement of maternal healthcare outcomes.  Both due to the prevalence of this often fatal complication of pregnancy and because it is treatable with routine medicines, post-partum hemorrhage is an ideal target for health intervention programs.  The charitable augmentation of maternal healthcare options in developing nations depends upon the consistent, reliable availability the medications used to treat post-partum hemorrhage.

In order to increase the availability of hemorrhagic drugs, intervention programs must first identify the most effective option from a range of hemorrhagic medications offered by pharmaceutical companies.  Research and experience has led global health organizations to accept misoprostol and oxytocin as the most useful drugs in the treatment of post-partum hemorrhage worldwide[10].

Misoprostol

Misoprostol, which has been available for purchase since 1985, functions biologically as an E1 prostaglandin analoguein.  Prostaglandin is an endogenously produced compound with physiological functions including contraction and relaxation of smooth muscle.  The drug has current uses ranging from prevention of gastric ulcers, to a variety of obstetric applications; one of these ancillary benefits of misoprostol is its ability to induce labor.  Like other drugs which work to start the labor process, misoprostol causes the ripening of the cervix.  The cervix typically remains firm, keeping the baby in the uterus.  The baby can only be delivered when the cervix thins, as in women taking misoprostol.  Most cases of post-partum hemorrhage are related to uterine atony which is that loss of uterine muscle contraction.  The muscle contractions augment coagulation and aid in bleeding prevention.  Misoprostol causes uterine contractions, which both induce labor and help prevent bleeding[11].

Advantages of Misoprostol

85 nations have approved the medical use of misoprostol[12],[13].  This widespread acceptance facilitates the use of misoprostol in international aid programs.  Furthermore, researchers have categorized misoprostol as a “heat-stable drug,” meaning that it remains medically effective even after exposed to high temperatures.[14] Because international transportation, the temperate climates of much of the developing world, and a lack of easily accessible cooling devices in very poor nations, misoprostol’s heat-stable property is a vital qualifier for use in aid-based healthcare interventions.  In addition to misoprostol’s ability to tolerate heat, this drug’s method of administration enhances its appeal to third-world healthcare workers.  Patients take misoprostol in tablet form.[15] Because the medication can be taken orally, as a pill, intervention programs need not cope with the complications and challenges of sanitary intravenous delivery.  Administration of misoprostol does not require the presence of somebody familiar with the process and hygienic requirements of intravenous shots.  Effective delivery and increased accessibility of this drug in resource-deprived regions is therefore far more feasible than with medications dispensed in shot form.

Disadvantages of misoprostol

Misoprostol, significantly more than oxytocin, causes side effects such as shivering and pyrexia, or fever[16].   This shivering is not physically damaging, and typically persists for fewer than 24 hours.  However, physicians recognize pyrexia as a troubling, medically significant side effect of misoprostol.  The risk of pyrexia causes many doctors to hesitate to endorse misoprostol for use in the absence of a medical professional.  Although misoprostol-induced fevers do eventually dissipate, trained health workers should be present to monitor pyrexia[17].

Due to misoprostol’s published health side effects, the drug’s manufacturer and patent-holder, Pfizer, hesitates to market misoprostol for use in the treatment of post-partum hemorrhage.  Pfizer believes the drug is outdated for obstetric and gynecological purposes.  Consequently, in 2006, Pfizerceased selling Cytotec (a branded version of misoprostol) in Germany[18].  Pfizer’s cautious approach to misoprostol may also stem from the drug’s decreasing profitability.  As market values of the drug have declined, the OB/GYN medication manufacturers have also assumed greater liability for their products.  Pfizer recently decided not to even apply for licenses that would allow the sale and use of misoprostol for maternal health problems.  That decision is indicative of perceived barriers, both economic and medical in nature, to the increased production of the drug[19].

Oxytocin

Despite misoprostol’s acceptance and widespread use in healthcare intervention programming, it is not universally recognized as the best treatment of post-partum hemorrhage. As recently as 2009, the WHO stated publicly its belief that oxytocin—not misoprostol—acts as the most effective post-partum hemorrhage medication[20].  Clinical research has documented oxytocin’s potential to reduce post-partum hemorrhage rates by up to 50%, with negligible side effects4.  However, although it may reduce post-partum hemorrhage more than misoprostol when both are effectively administered, oxytocin has a unique set of challenges to delivery that make it a much less viable option for use in international aid programs.

Disadvantages of oxytocin

The current best-practices medical guidelines for administration of oxytocin state that a trained healthcare professional must be present at treatment, using sterilized syringes for injection of the medication4.  The requirement for some type of healthcare worker adept at administering intravenous medication immediately hinders use in poor, rural areas where the maternal health problem is most prevalent.  Healthcare intervention programs could try to address this problem through administration of oxytocin at a central, regional clinic with an experienced healthcare worker.  However, since post-partum hemorrhage is an immediately life-threatening situation for mothers, transportation to a hospital or clinic facility after the onset of hemorrhage is seldom a viable option.  Just during unanticipated, short-distance transportation, mothers can lose enough blood to die.  Post-partum hemorrhage medications must be administered quickly, but the intravenous nature of oxytocin severely impedes sterile, appropriately dosed, timely administration of this drug in the developing world.

Furthermore, injectable uterotonics such as oxytocin are unstable in high temperatures, and require cold-chain storage. [21] Because oxytocin requires refrigeration during transport and administration, administration can be particularly challenging in areas with little infrastructure.  For instance, according to a study published by the Derman Lab, oxytocin—despite its clinical success—is not a feasible treatment for post-partum hemorrhage in resource-poor areas, where a significant portion of births occur in individual homes[22].  Oxytocin is therefore least effective as a treatment for post-partum hemorrhage in the regions that need it most.  The use of oxytocin is not yet feasible in much of the developing world, where deliveries still take place in rural areas without the wealth for refrigeration capacity or the knowledge base for effective use of intravenous syringes.

Which hemorrhagic drug is best for healthcare intervention programs?

Misoprostol does not suffer from the problems associated with oxytocin.  Studies have been conducted to show the success misoprostol in regards to post-partum hemorrhage, demonstrating oral misoprostol’s ability to reduce acute hemorrhaging by as much as 50%, and acute-severe hemorrhaing by as much as 80%, equivalent in effectiveness to oxytocin[23].  The cost of misoprostol is very low, making it particularly attractive for health ministries.  It is possible to manufacture misoprostol for as little as 4 cents a tablet.  In many developing nations a three tablet dose can go for as little as 1 USD[24].

Given the advantages and disadvantages of both oxytocin and misoprostol there is an inherent difficulty in stating the best possible course of treatment.  However, keeping current research and doctor recommendations in mind, oxytocin should remain the gold standard for addressing post-partum hemorrhage.  Due to its lack of side effects, success rate comparable to that of misoprostol, and low cost, oxytocin should be used where the existence of cold-storage infrastructure permits.  However, the current limitations in terms of distribution and administration of oxytocin, misoprostol should be used in rural areas and areas inaccessible to skilled birth attendants.  Misoprostol can serve as a near term solution to mitigate the deaths occurring in these regions until further health systems strengthening occurs.

Addressing professional guidelines

Professional guidelines often suggest that only trained medical staff handle the allocation of proper drug doses4.  Of course, these professional medical recommendations are created by and for healthcare professionals in developed countries.  The weak, or even nonexistent, health systems of underdeveloped countries lack the human resources associated with these standards.  It would simply be unrealistic to expect that professionals with the knowledge and training of, for instance, American nurses, allocate and administer all hemorrhagic drugs in third world nations.  Developing countries must thus use first world medical guidelines as a goal, but not a prerequisite, for post-partum hemorrhagic drug administration.

As stated by Lilly Kak of USAID, the World Health Organization’s current guidelines do not recommend the administration of misoprostol by local health workers.  According to these recommendations, misoprostol should only be taken under the supervision of a trained birthing attendant or the trained workers at health facilities.  Even with sufficient supplies of misoprostol pills, these guidelines would inhibit the accessibility of misoprostol in resource-deprived locations, where doctors and skilled birth attendants are seldom available. Many maternal deaths occur with pregnancies in rural homes, beyond the reach of WHO-approved health officials.  There is thus a need for delivery of drugs by persons on site in the rural areas.

Future change to the WHO guidelines on misoprostol is on the horizon.  According to Lilly Kak of USAID there has been a call for randomized sampling studies proving the proficiency of community health workers in regard to giving proper dosage and timing of misoprostol.  Studies have been published showing potential safety of distribution at the local health worker level.  However, there is a dearth of studies conducted using random sampling methods to scientifically prove the workers effectiveness.  As such, the WHO remains hesitant to change their guidelines for distribution until data proving local health work proficiency is conducted.  When this research is published, the WHO would likely change its guidelines for distribution allowing broader scale access to misoprostol and therefore alleviating the bottleneck for distribution.

Further work needs to be done to address the problems with current distribution outlets and methods for oxytocin and misoprostol.  It is imperative to have these drugs, which are vital to saving lives, be readily available to mothers in need.  As a health system strengthening occurs and more skilled birthing attendants can work with mothers, the accessibility of post-partum hemorrhage drugs to these workers is crucial.  Additionally, skilled birthing attendants, who can work with mothers in their homes, should have access to supplies and proper equipment in order to lower at-home death rates.   Similar measures need to be taken with oxytocin because it requires intravenous administration and refrigeration which is not always possible.

Should proper equipment, such as sterile hypodermic needles and refrigeration, be accessible, misoprostol is not the best choice of drug.   Oxytocin, because of its lack of side effects and comparable affect on hemorrhage, is an ideal treatment.  Misoporostol, however, may also be identified by Global Fund proposals as an appropriate choice, since misoprostol can easily be transported and taken orally to treat post-partum hemorrhage.  However, under current guidelines and given the side effects of use, misoprostol should be taken with care and under the guidance of a SBA.  Shivering and fever are both dangerous and, if uncontrolled, can have serious consequences.  Only if a given Global Fund proposal demonstrates that local health workers are proficient in distribution of misoprostol and the handling of side effects, should supplies be readily accessible to these local workers.  One of the main dilemmas with addressing the problem of post-partum hemorrhage is the inaccessibility of treatment to remote, resource-poor regions.  If distribution of misoprostol in these places areas then post-partum hemorrhage prevalence with decrease accordingly.

Skilled Birth Attendants

What are birth attendants?

Increasing both the portion of births attended by a skilled professional and the quality of training for these workers is, along with increasing hemorrhagic drug use, one of the most effective maternal healthcare interventions.  A skilled birth attendant (SBA) is “an accredited health professional–such as a midwife, doctor or nurse–who has been educated and trained to…manage normal…pregnancies, childbirth and immediate postnatal period” (4).  Although doctors and nurses technically qualify as SBAs, in the developing world these attendants are most often narrowly trained around the experience of childbirth.  The exact duties of SBAs vary widely with region, but typically include delivering of infants during childbirth, counseling and training new mothers to breast feed, and caring for newborn children immediately following birth.  Despite the myriad health risks associated with labor and delivery, a full third of births worldwide take place in private homes, without the assistance of SBAs (1).  Periodic prenatal check-ups with a skilled healthcare professional, as well as the presence of a skilled birth professional during delivery, would provide women in the developing world with a much safer maternal experience.

The vast majority of human communities, whether or not they are within or strongly connected to the developed world, are familiar with the concept of birth attendants.  Even regions without substantial healthcare infrastructure as well as communities that have a traditional reluctance towards formal healthcare typically recognize the value of SBAs.  Consequently, in these developing areas where the maternal health problems are particularly prevalent and new healthcare delivery systems are particularly challenging, preexisting SBA networks represent a unique, well-positioned option for healthcare improvements.  Unfortunately, although SBAs provide a valuable service for pregnant women and new mothers, these existing SBA networks often lack the medical resources and knowledge necessary to truly maximize potential SBA impact maternal health outcomes.  Birth attendants in under-developed countries can, ideally, mediate between outdated local health practices and the scope of current medical knowledge and procedures.  Existing SBA frameworks have unique potential to enhance maternal healthcare outcomes.

How do skilled birth attendants impact maternal mortality?

According to Joy Phumaphi, Assistant Director-General of Family and Community Health at WHO, “Life-threatening complications occur in 15% of all births…[and] a skilled birth attendant can make the difference between life and death.”[25] In response to the immense potential of expanded skilled birth attendant networks to reduce maternal mortality, the United Nations Millennium Declaration included the strengthening of SBA networks as a core aspect of its maternal healthcare Millennium Development Goal (MDG).  In particular, the MDG specifies that 90% of births should occur in the presence of a skilled attendant by 2015.[26] Ideally, skilled birth attendants should have the knowledge to identify pregnancy-related medical conditions as they develop, the resources to address those issues, and the ability to spend time with mothers periodically throughout pregnancy and for at least several hours after birth.  In a joint statement, the World Health Organization, International Midwife Coalition, and International Federation of Gynecology and Obstetrics expressed the importance of an “enabling environment” that provides these conditions necessary to the success of skilled birth attendants . [27] A high-functioning, robust network of SBAs can not only “recognize and prevent medical crises on the spot, but…can refer women for life-saving care when complications arise”. [28]

maternal_healthcare_figure3

Figure 3: Maternal mortality in Thailand, Sri Lanka and Malasia by year with increasing midwife prevalence.

It has been shown that increased prevalence of skilled birth attendants at childbirth greatly decreases maternal mortality.[29] Industrialized nations experienced this impact in the early twentieth century when they halved their maternal mortality ratios by providing professional midwifery care at childbirth.[30] This effect has also been seen in developing countries. Malaysia, Sri Lanka and Thailand all halved their maternal mortality ratios within ten years in the 1960s and 1970s.  The dominant health systems intervention in each of these cases was a vast increase in the number of midwives, and each of these nations attributed their improvements in maternal care to the increases in SBA availability.  The association between enhanced SBA availability and decreased maternal mortality is illustrated in Figure 3. As the graph indicates, the number of hospital beds needed decreased as the number of SBAs increased, because their presence decreased the need for emergency care. Egypt provides another example of drastic maternal death reductions via SBA system improvements.  During the years 1983 through 2000, Egypt both doubled its proportion of deliveries assisted by skilled birth attendants and reduced its maternal mortality ratio by fifty percent.[31]

Quality of SBAs through training programs

SBA-related health intervention programs should both increase the portion of births attended by SBAs, and the knowledge with which these SBAs handle the atypical pregnancy and childbirth scenarios that cause maternal deaths.  In particular, SBAs must be able to quickly identify a problem which would require referral to a health facility.  The World Health Organization’s SBA instruction model addresses maternal health complications most effectively, and should serve as a template for subsequent SBA-related health programs.  The WHO provides 6 modules for midwifery education, with the assumption that students already have the basic abilities to monitor blood pressure, conduct a normal delivery, and infection prevention.[32]

The first module is considered the foundation, and outlines economic and cultural as well as medical factors that put a woman at risk of having a complicated pregnancy. In addition, it discusses the dangers in delaying seeking medical care, and outlines ways to reduce a woman’s risk factors.  In the second module, students focus on post-partum hemorrhage, which is a severe loss of blood. It first details the physiology of the entire third stage of labor and when it is most likely to occur.  Students learn what hemorrhage is, risk factors for it, how to identify it, and basic steps to control it.  The focus is on prevention of postpartum hemorrhage through active management of the third stage of labor which includes massaging the uterus, basic suturing, as well as drug treatments.  The third module focuses on prolonged and obstructed labor, and begins by reviewing the anatomy and physiology related to such occurrences. In addition to being able to identify major risk factors, the third module teaches how to assess both the pelvic and baby positions, and how to perform vacuum extractions in the case of an emergency.

The WHO education program for midwives then moves onto the fourth module which addresses puerperal sepsis, a severe uterine infection after childbirth.  It explains how to identify this condition as well as how to differentiate it from other infections.  There is also a focus on proper procedures to lessen exposure to potential infections, as well as a discussion on how to provide the proper drugs should sepsis occur.  This module also contains a small chapter devoted to minimizing mother-to-child HIV transmission. The fifth module teaches how to manage eclampsia, or non-neurological seizures in pregnant women. It discusses the pre-eclampsia and eclampsia conditions and how to identify them.  A strong focus is placed on prevention and identification of risk factors, however the proper approach to caring for someone during a seizure is included as well.  The sixth module is related to abortion and how it affects maternal mortality.  The module explains abortion and the various types and stages.  However, it also discusses stress the laws and regulations related to abortion, and explores social and religious opinions on abortion.  In addition, means of preventing unwanted pregnancy are detailed so that the midwives can help women from wanting an abortion in the first place.  However, emergency abortion procedures are detailed so as to preserve the mother’s life.

While the WHO’s training program does not leave the midwife equipped to independently handle any emergency, it does enable the midwife to prevent a majority of the most common complications, and control the problems that lead to preventable maternal deaths.  This training module encompasses the major complications without overestimating the medical knowledge of the midwives, and countries implementing training programs should be encouraged to utilize it, or create a similar program. Ideally the program would be taught by midwives, possibly centralized at the nearest health clinic, who would be accredited by the WHO to provide the course. An apprenticeship program which would complement the coursework could be highly beneficial to inexperienced students and should be considered by CCMs. As the WHO modules and texts have already been created after careful study and are readily accessible, organizations creating training programs could use these to more rapidly begin training rather than devote resources to creating new education modules. However, the Global Fund would not require the usage of the WHO modules, as it is important to leave room for creativity and cultural sensitivity in both training and implementation.  In addition, evaluation of the modules has found that while they were developed for in-service education, they can also be utilized in pre-service education programs.[33] However, the outcome of an attendant who is skilled in preventing and identifying major complications, would still be desired.

Quantity of SBAs through Community Health Organizations

There is currently a 50% shortfall of the estimated 700,000 midwives needed to ensure universal coverage of maternal care.[34] On a broader scale, there are 4.3 million health workers lacking worldwide.[35] Thus, not only must SBAs receive more thorough training in maternal healthcare, they must be employed more efficiently, to provide services at more births.  SBA networks must also be increased in size.  It is imperative that resources be dedicated to recruitment, training, and retention of professionals with midwifery skills.         Of course, the services of a SBA are less costly than maternal health services provided through a regional clinic or hospital.  For instance, in Berega, Tanzania, a birthing attendant’s services cost about $2 USD per birth. At an area hospital, an uncomplicated birth would cost $6 USD, while an emergency Caesarean procedure costs $15 USD.[36] A Global Fund for Maternal Health would pay SBAs through regional grant programs, making SBA care much more affordable for impoverished populations, and incentivizing both the training and use (through those lower costs) of the use of birth attendants.

This new Global Fund could also fund proposals designed to support increasing the establishment of small, formal schools dedicated to providing midwifery education, thereby increasing the chance that a person could attend such a program. It could not only act as an opportunity to those already interested, but as an attractive agent to those who may not have considered the option previously. The fund strongly suggests incorporating and enticing individuals from a community in need. By keeping individuals near or within their own communities, more mothers are guaranteed skilled maternal care.  These professionals will have the personal incentive to remain within their own communities and provide the necessary extended care to women who have given birth.  So often is the case that birth attendants cannot monitor the vulnerable period following childbirth, and some complications go undetected

One Organization which has shown immense success with enticing participants is Rural Expansion of Afghanistan’s Community-Based Healthcare, or REACH. REACH, funded in part by USAID, offers an 18-month midwife training program, which had 20 applicants for 20 available spots in 2003; however, due to improved living arrangements during the course and the potential for a vastly increased salary after graduation, by 2006 there were 1300 applicants.[37] The responsiveness of the program to the needs of women for better living arrangements so that their families would permit them to attend, as well as the spread of their enthusiasm about the benefits of being a midwife contributed to the success of the program.  Afghanistan has also approached the issue through an increase in the number of Community Health Organizations, which are efforts at the village level to improve post-natal and basic care[38]. As these organizations do not deal with delivery itself, workers require less skilled training. The program could then produce a larger volume of these community health workers and a greater percentage of mothers would receive the necessary extended postnatal care.  In addition, a community-based program gives a sense of ownership over maternal healthcare, which helps ensure continuing participation in programs aimed at decreasing maternal mortality.

Importance of providing resources for SBA to perform duties

Skilled birth attendants must be able to act upon the solutions and preventions they identify.  As such, the full efficacy of increasing the number of skilled birth attendants will not be reached until there is an increase in the number of well-equipped health centers, primarily for referral in an emergency.  To complement the knowledge being applied, pharmaceutical drugs as well as tools should be accessible to the attendants.  Every country should also have a national system in place for licensure and accreditation.  Uniform standards for knowledge and protocol ensure the safety and reliability of someone who is properly referred to as a skilled birth attendant. Continuing education as well as performance auditing protocols should also be considered.

Section 5: Advantages and Disadvantages

Please find Section 5 throughout Sections 4 and 6.

Year Amount
1985 132.2
1986 155.6
1987 184.5
1988 172.6
1989 203.3
1990 185.6
1991 251.1
1992 269.0
1993 281.5
1994 240.3
1995 296.8
996 360.9
1997 338.3
1998 380.9
1999 363.0
2001 361.1
2002 391.7
2003 389.7
2004 442.9
2005 458.7

Section 6: Addendum

Addendum 1: The Structure of a solution

USAID and Maternal Care

About one half of one percent of America’s annual federal budget is spent by the United States Agency for International Development (USAID), the government’s primary mechanism for foreign assistance.[39] USAID disburses American aid, in the form of financial assets, material goods, and human resources, in support of a variety of international causes.  Although the Secretary of State ultimately dictates USAID’s priorities and policies, USAID consistently promotes such causes as agricultural and economic development, global health, and humanitarian relief.  Both through its own global health programming, and via some collaboration with international, national, governmental, and private sector partners, USAID works to improve maternal healthcare around the world.  USAID health interventions can take a range of different forms, from community-level interventions to broad health-systems strengthening.  USAID’s maternal care programs focus on a set of interventions designed to target specific, high-mortality complications of pregnancy and birth.  Those target complications coincide with Figure 2, and include post-partum hemorrhage, hypertension and eclampsia, and infections, among others.  USAID also directs some of its work on maternal healthcare improvements directly to improving the prevalence and quality of SBA-attended births.

Disadvantages of USAID work on maternal health

Although USAID recognizes the potential to enhance maternal health through programs that improve healthcare options throughout both pregnancy and the post-partum period, its programs have not fully addressed the maternal healthcare problem.

As depicted in Table 1, USAID has spent more than $6 billion on global child survival and maternal health efforts since 1989.  Despite these efforts, the global maternal mortality count has remained for years at about 500,000 deaths annually.  Due to global population growth, the consistent 500,000 maternal death count does represent a progressively smaller portion of annual births, and therefore some slight degree of improvement in maternal healthcare over the past two decades.  This constancy of the global maternal death count does not render USAID intervention programs unsuccessful, but it does mean that USAID efforts can absolutely not be treated as a sufficient response to maternal healthcare deficiencies.

USAID is clearly committed to improving maternal healthcare, but it seems to view this problem primarily through the lens of child death.  For instance, when USAID describes and motivates the maternal health problem on its website, it claims that to “combat illness in children and create a safer future for the world, USAID has to care for newborns [and] train midwives.” (CITE).  This statement, though completely accurate, is indicative of USAID’s approach to maternal care as a means to improved child survival rates, rather than a worthwhile end in itself.  Indeed, the expenditures that USAID characterizes as investments in child survival/maternal health are in large part geared towards child programs.  Though USAID’s approach to the maternal health improvements principally in terms of their potential to enhance child health is not necessarily inappropriate, the maternal healthcare problem would benefit from the efforts of an organization focused specifically on the health of mothers.

The Global Fund to Fight TB Malaria and AIDS

Three other global health problems have been approached successfully via a different method of intervention program development and aid disbursement.  Since 2002 the Global Fund for Tuberculosis, Malaria, and AIDS has effectively combated these three contagious diseases.   As a funding—but not an implementation—mechanism, the Global Fund’s purpose is to collect and appropriately distribute monetary assets in a way that most reduces the burden and prevalence of tuberculosis, malaria, and AIDS.  The Global Fund structure takes the form of an international partnership between a number of public and private organizations, both donating and receiving the financial resources of the Global Fund.  Thus, the Global Fund works with national governments, private corporations and individuals, non-governmental organizations, and civil society to raise money and facilitate health intervention programs.  This organization was originally designed “to serve as a catalyst for the generation of additional funds, and to complement already existing sources.”[40] When the Global Fund entered the arena of charitable, international health intervention programming, it was meant to attract new financial contributions, and not to detract from organizations and funding sources with similar goals.  The Global Fund model has proven itself successful; since 2002, Global Fund staff have raised and spent US$ 18.7 billion on 572 different programs.  In addition to bringing supplemental resources to its target issues, the Global Fund has made investments in tuberculosis, malaria, and AIDS interventions more effective, by helping unify and focus the efforts of its many partner organizations.

The Global Fund does not directly implement the healthcare programs that it funds, but instead relies on a Country Coordinating Mechanisms (CCMs) to supply the knowledge and will to develop healthcare solutions.  CCMs that have conceived and developed health intervention program ideas may propose these interventions to the Global Fund administrators.  The Global Fund uses a comprehensive review system to select and enhance promising proposals, and then provides the proposing CCM with a grant to implement its intervention concept.  By leaving program design and implementation to CCMs, the Global Fund model allows recipient organizations and countries to act on their own healthcare priorities, and makes certain that all funded programs are designed with an awareness and acknowledgement of the unique concerns of the beneficiary population. Because of its emphasis on centralized funding and local program design, the Global Fund’s grant program represents a new way of responding to international healthcare challenges.

USAID vs. Global Fund for Maternal Care

The establishment of a Global Fund for Maternal Health is the best way to address the maternal healthcare crisis.  The Global Fund for Tuberculosis, Malaria, and Aids has undergone several periodic evaluations since its inception, and independent evaluations of the Global Fund have consistently articulated the unique strengths and advantages of the Global Fund’s approach to healthcare improvements.  These strengths in large part stem from the structure of the Global Fund, not from the particular details of tuberculosis, malaria, or AIDS interventions.  Many of the existing Global Fund’s advantages would thus extend to a new Global Fund for Maternal Health.  One of those advantages involves the Global Fund’s ability to bring completely new funding sources to international efforts to control tuberculosis, malaria, and AIDS.  For instance, David Wilkinson’s appraisal of Cambodia’s Global Fund CCM notes that “The Global Fund, through the establishment of the CCM, has provided new opportunities for a range of stakeholders to work together more effectively.”[41] Steve Radelet’s independent evaluation of the Global Fund’s progress in 2004 corroborates this perspective, and also points out that the Global Fund “has successfully raised global awareness about the three diseases.”  [42] Of course, the Global Fund structure has a number of other benefits, beyond its ability to increase participation in the fight against its three target diseases.

The use of CCMs to carry out the conception and implementation of programs, as opposed to USAID’s practice of conceiving, funding, and implementing its own disease-based health interventions, provides important benefits for the Global Fund structure.  Different regional populations have unique religious perspective, cultural values, and traditions that sometimes affect the type of healthcare interventions needed to improve maternal care.  For instance, most Afghan mothers may seek out medical attention only “with the permission of their families (husbands, but often parents-in-law, and sometimes village religious leaders as well).”[43] Afghan women must also receive treatment only from female health workers.  In other cases, the influence of culture on healthcare intervention effectiveness is more subtle, but the situation of Afghan women demonstrates a typical type of barrier to maternal health improvements.

The locality of program development and implementation would strengthen the cultural sensitivity of Global Fund interventions, ensuring that programs are built with an awareness of a given region’s social norms.  Any given Global Fund program would be designed and administered, at least in part, by individuals native to the region targeted by that program.  All project will therefore be designed with an understanding and acknowledge of those ideological practices which would traditionally act as barriers to health systems improvements.  Regional CCM project administrators will not propose projects which they know to conflict heavily with social values in their respective areas.  Because the Global Fund supports local projects, cultural awareness is built into health interventions.

The political situation of USAID also contributes to the selection of a Global Fund structure for support of SBA system strengthening, increased hemorrhagic drug use, and other intervention programs targeting maternal health.  USAID core goals and missions are ultimately subject to the foreign policy agenda of the Secretary of State and, by extension, the ideological perspective of the President of the United States.  While it seems fitting that the leader elected by the American people dictates the use of American tax dollars overseas, this model can interfere with the otherwise effective programs of aid workers.  Each change of administration—and each shift in one given administration’s approach to foreign policy—can emphasize or devalue certain global challenges, and certain types of programs.  Long term planning and development programs are particularly challenging for organizations, like USAID, that do not know what their own, exact goals will be in just a few years’ time.  Even changes within Congress, occurring every two years, can alter USAID’s expectations for funding reauthorization.  Because Congress must, presumably, justify its appropriations to the American people, so must USAID justify its expenditures to Congress.  USAID’s position within the federal government of the United States forces it to think, and act, in the short-term.

Given USAID’s necessary focus on verifiable short-range problem solving, it is not surprising that this organization favors output-based, rather than outcome-based, metrics of success.  Output-based metrics, although easier to measure than outcome-based metrics, are less indicative of the actual health improvements of intervention programs.  A measure of a program’s success (or failure) in output metrics will provide quantitative information about the degree to which financial resources were able to create possibilities for healthcare improvements.  Outcome-based measurement will instead provide information regarding the extent to which healthcare interventions actually improved the overall health of a population.

For instance, a program designed to reduce hemorrhagic deaths may measure output in terms of the number of misoprostol tablets distributed in a given area.  However, outcome-based metric would provide data regarding how many of those pills were actually received—at the right time and in the appropriate dose—to women in labor, and how many maternal deaths the drug prevented.  Health outcomes clearly function as a better indicator of a given program’s value.  Unfortunately, outcome-based metrics of success take longer and are more challenging to obtain than output data.  Organizations oriented towards annual goals and in need of data justifying their programming, such as USAID, consequently favor output-based measurements.  A Global Fund for Maternal Health, because it would be less dependent on any one source of funding, could thus enjoy a greater degree of political and financial consistency than USAID.  This ultimately makes a Global Fund structure more capable of long-term planning and improvements, and would allow a Global Fund for Maternal Health to place greater value on outcome-based data.

Global Fund Guiding Principles

Like the Global Fund for Tuberculosis, Malaria, and AIDS, the Global Fund for Maternal Health would attract, manage and disburse resources to improve maternal healthcare.  It will act solely as a financial instrument and not an implementing entity.  The Global Fund for Maternal Health would seek out donations from the same types of national governments and private firms which have historically donated to the Maternal Fund for TB, Malaria, and AIDS.  Our approach to obtaining donations will be outlined below, in the section titled ‘Shaping Public Opinion.’ Disbursement of funds would take place in the form of a grant program.  Maternal healthcare intervention grant proposals will be conceived, developed and submitted by the Country Coordinating Mechanisms (CCM) of individual countries. Proposals will be evaluated through independent review processes, designed to identify proposals which would most effectively and efficiently address unmet maternal healthcare needs.

CCMs would typically be composed of representatives from the private and public sectors, such as governments, bilateral and multilateral agencies, non-governmental organizations, academic institutions, private businesses and people working in the country’s healthcare system.  A given CCM, having developed an intervention concept, may formally propose that project to the Global Fund at any time.  Following approval, each program will be operating locally, administered, potentially revised, and monitored almost exclusively by the CCM.  Local involvement in both decision-making and decision-implementation fosters a sense of empowerment and ownership of Global Fund projects.  The CCM structure is also necessary because unique cultural outlooks, often stemming from religious perspective, can detract from the ability of American-designed programs to flourish in developing countries.  For areas, such as Afghanistan, with particularly challenging cultural barriers to maternal care, the Global Fund for Maternal Health’s administrators would require grant proposals to outline and address popular attitudes towards maternal health.  The Global Fund would only fund grant proposals that both recognize these barriers, and pinpoint a means of overcoming them.

The Maternal fund will ensure effectiveness through performance based funding. All CCMs will have project goals, developed in conjunction with the Global Fund administrators, to measure project success and identify shortcomings.  Time-based and results-based goals will be set at the outset of each newly funded program.  In evaluating the goals, the Maternal Fund will prioritize metrics measuring outcome over those measuring output.  The Global Fund’s use of an independent Technical Review Panel ensures that limited resources are invested in technically sound programs with the greatest chances of success. The panel includes disease experts, as well as experts in the field of development who are able to assess how proposed programs complement ongoing health and poverty reduction efforts at the country level.  Because it leaves project implementation to CCMs, the Global Fund need only to monitor these feedback mechanisms in order to make funding decisions during periodic reauthorization processes.  Every program must be able to account for their use and dispersal of resources granted by the Maternal Fund.

Funding priority will be given to interventions that have demonstrated scientific and technical merit, as determined by the panel of experts in the field of medicine, business administration, economics, public health policy, and others.  For instance, (as discussed above) two specific medical systems interventions have been identified as particularly effective ways to reduce a region’s maternal mortality rate.  Distribution of hemorrhagic drugs and antibiotics, as well as the strengthening of skilled birthing attendant systems, set a benchmark of maternal mortality rate reduction.  Funding decisions will therefore favor these types of projects, unless a grant proposal can demonstrate equivalent or greater potential success for a different intervention.  Potential success may be demonstrated through historical data on a given intervention (preferably data which employs outcome, not output-based metrics) or intervention outcome modeling algorithms.  Projects not focused on either skilled birthing attendants or drugs distribution will be started small and, potentially, scaled up.

Addendum 2: Shaping Public Opinion

A Global Fund for Maternal Health can only function as long as national governments and large private donors choose to contribute financially to the organization.  Founders of a Global Fund must thus consider popular attitudes, particularly in rich nations, towards maternal health.  Unfortunately, because wealthy countries already have highly effective maternal healthcare systems, these potential donor countries tend not to appreciate the extent of the global maternal healthcare problem.  The nature of the maternal health crisis as an issue unique to the developing world heightens the challenge of altering public perspective in developed areas of the world.  Here, we will briefly discuss ways in which proponents of the Global Fund may shape the American public’s opinion towards maternal health improvements.

The United States has pledged almost US$6 billion to the Global Fund for Tuberculosis, Malaria, and AIDS.  These three diseases do have both a significantly greater affected global population and a more explicit link to international security concerns than the maternal health problem.  Consequently, a United States contribution to the Global Fund for Maternal Health would not—and need not—reach as high as US$6 billion.  Still, advocates of this new Global Fund would ultimately shape public opinion in order to secure as much funding as possible.  Thus, the ultimate purpose of altering opinions towards maternal healthcare is not necessarily to inform average Americans on the topic, but rather to secure  an appropriation, from Congress, for this new Global Fund.  Advocates need only make average Americans value global maternal care improvements enough to leverage support from federal officials.

Several different approaches to the maternal healthcare issue will help convince specific American Members of Congress (MCs) to support a substantial contribution to the Global Fund for Maternal Health.  For instance, Global Fund advocates may target MCs who represent stake-holding Congressional districts.  Congressman Rodney Frelinghuysen, of New Jersey’s 11th Congressional district, represents many employees of pharmaceutical companies, which could potentially benefit for an increased demand for maternal healthcare medications.  That aspect of his constituency would, for example, hopefully make Representative Frelinghuysen empathetic to a Global Fund appropriate. By identifying and utilizing these types of relationships between MCs and the maternal healthcare issue, advocates can increase support for a large American donation to the Global Fund.

The attitudes of MCs towards the Global Fund for Maternal Health can also be shaped simply through case-appropriate framings of the maternal care issue.  Again, this discussion will provide only examples of the types of reasoning that Global Fund advocates can use.  With liberal and progressive CMs, Global Fund supporters may frame maternal health as a women’s rights issue.  When shaping the opinions of more conservative CMs, advocates may have more success by explaining the way in which maternal care improvements can prevent unnecessary abortions worldwide.  Of course, these are both broad generalizations.  The point is that the maternal healthcare message can—and should—change with the message’s audience.

Although many altruistic individuals may value maternal health improvements as a worthy humanistic cause, a treatment of maternal health problems as a global security threat has the potential to affect even more Americans.  A country of orphans will not grow into a stable government; by emphasizing the relationship between maternal mortality and governmental instability, Global Fund advocates can transform expenditures on maternal healthcare improvements into an investment in America’s safety.

Use of a ‘simple truth’ in conversations with MCs, or in communications targeted towards the entire American public, will also help strengthen American support of a Global Fund for Maternal Health.  For instance, the statement, “It costs less than one dollar to save a mother’s life,” although based on a number of assumptions made by the Commission for Macroeconomics and Health regarding appropriate maternal healthcare interventions, succinctly juxtaposes a small requisite investment with a large, compelling outcome.  Global Fund advocates must learn to transform dense facts into convincing statements.

National publicity efforts on the maternal healthcare issue and on the Global Fund for Maternal Health should note that America only spends approximately 1% of its annual federal budget on foreign assistance.  Recognition of this fact could help preempt suggestions that America’s aid costs are already too high.  Intensive efforts to shape public opinion in America should also take place near Mother’s Day, in order to utilize the sentiments and values expounded by this holiday.


[1] USAID. “Saving the Lives of Women and Children. (http://www.usaid.gov/our_work/global_health/mch/mh/index.html, accessed 8 December 2009).

[2] UNICEF. “Improve Maternal Health.” (http://www.unicef.org/mdg/maternal.html, accessed 8 December 2009).

[3] “Maternal Care”. World Health Organization.. (http://www.who.int/topics/maternal_health/en/, accessed 19 September 2009).

[4] “UN Urges Greater Investment in Maternal, Child Health in Asia-Pacific Region”

Voice of America 16 September 2009.
[5] Millenium Development Goal Monitor. (http://www.mdgmonitor.org/map.cfm?goal=4&indicator=0&cd=, accessed 20 September 2009).

[6] Cole, Elizabeth.  “Maternal Health in Afghanistan: A Security Issue?”  2008.

[7] “Maternal Care”. World Health Organization.. (http://www.who.int/topics/maternal_health/en/, accessed 19 September 2009).

[8] [8] UNICEF. “Improve Maternal Health.” (http://www.unicef.org/mdg/maternal.html, accessed 8 December 2009).

[9] “Reduction of Maternal Mortality.” A Joint WHO/UNFPA/UNICEF/World Bank Statement. 1999.

[10] Villar J, Gulmezoglu AM, Hofmeyr J, Forna F. Systematic review of randomized controlled trials of misoprostol to prevent postpartum hemorrhage. Obstet Gynecol. 2002;100:1301-1312.

[11] Weeks, Andrew. “Misoprostol in Obstetrics and Gynaecology”. November 30, 2009 <http://www.misoprostol.org/>.

[12] Weeks, Andrew. “Misoprostol in Obstetrics and Gynaecology”. November 30, 2009 <http://www.misoprostol.org/>.

[13] Reproducitve Health Supplies Coaliton, http://www.path.org/files/RH_caucus_new_underused_med-abort_br.pdf

[14] Pagel, C., Lewycka, S., Colbourn, T., Mwansambo, C., Meguid, T., Chiudzu, G., Utley, M., and Costello, A. Estimation of potential effects on improving community-based drug provision, to augment health-facility strengthening, on maternal mortality due to post-partum haemorrhage and sepsis in sub-Saharan Africa: an equity-effectiveness  model. The Lancet 2009. 374: 1441-1448

[15] Ibid.

[16] Hoj, L., Cardoso, P., Bruun, B., Hvidman, L., Nielsen, J., Aaby, P. Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial. BMJ 2005: 331: 723.

[17] Hoj, L., Cardoso, P., Bruun, B., Hvidman, L., Nielsen, J., Aaby, P. Effect of sublingual misoprostol on severe postpartum haemorrhage in a primary health centre in Guinea-Bissau: randomised double blind clinical trial. BMJ 2005: 331: 723.

[18] Weeks, Andrew. “Misoprostol in Obstetrics and Gynaecology”. November 30, 2009 <http://www.misoprostol.org/>.

[19] Weeks, A., Fiala, C., Safar, P. Misoprostol and the debate over off-label drug use. BJOG 2005: 112: 269-272.

[20] Villar J, Gulmezoglu AM, Hofmeyr J, Forna F. Systematic review of randomized controlled trials of misoprostol to prevent postpartum hemorrhage. Obstet Gynecol. 2002;100:1301-1312.

[21] Derman, R., Kodkany, B., Goudar, S., Geller, S., Naik, V., Bellad, M.B., Patted, S., Patel, A., Edlavitch, S., Hatwell, T., Chakraborty, H., Moss, N. Oral misoprostol in preventing postpartum haemorrhage in resource-poor communities: a randomised controlled trial. The Lancet 2006: 368: 1248-1253.

[22] Ibid.

[23] Ibid.

[24] Grossman, Amy. “A Birth Pill”. The New York Times 05/09/09: 10.

[25] Skilled attendants vital to saving lives of mothers and newborns. World Health Organization. 15 November 2004. (http://www.who.int/mediacentre/news/notes/2004/np23/en/)

[26] Millenium Development Goal 5. World Health Organization. (http://www.who.int/making_pregnancy_safer/topics/mdg/en/index.html

[27] Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO. Geneva, World Health Organization, 2004

[28] Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO. Geneva, World Health Organization, 2004

[29] Making pregnancy safer: the critical role of the skilled attendant. A joint statement by WHO, ICM and FIGO. Geneva, World Health Organization, 2004

[30] Skilled attendants vital to saving lives of mothers and newborns. World Health Organization. 15 November 2004. (http://www.who.int/mediacentre/news/notes/2004/np23/en/)

[31] The world health report 2005 – Make every mother and child count. Geneva, World Health Organization, 2005 (http://www.who.int/whr/2005/en, accessed 2 December 2009).

[32] Midwifery Education Modules. The World Health Organization, 2006. (http://www.who.int/making_pregnancy_safer/documents/9241546662/en/index.html, accessed 8 December 2009).

[33] Prevention of Postpartum Hemorrhage Initiative. “Evaluation of the Training Strategies for the Management of Third Stage of Labor.” 2007.

[34] The world health report 2005 – Make every mother and child count. Geneva, World Health Organization, 2005 (http://www.who.int/whr/2005/en, accessed 2 December 2009).

[35] The world health report 2006 – Working together for health. Geneva, World Health Organization, 2006 (http://www.who.int/whr/2006/en, accessed 14 August 2008).

[36] Grady, Denise. “Where Life’s Start is a Deadly Risk.” The New York Times. (http://www.nytimes.com/2009/05/24/health/24birth.html?_r=2&sq=May, accessed 2 December 2008).

[37] Cole, Elizabeth. “Maternal Mortality in Afghanistan as a Security Issue?” 2008

[38] Ibid.

[39] Offical USAID Website, http://www.usaid.gov/about_usaid/

[40] DR. Anne Peterson, ACVFA Briefing on Global Fund, October 9th, 2002.

[41] Wilkinson, David.  A Case Study on Cambodia CCM.  February 2004.

[42] Steven Radelet’s (Center for Global Development) June 2004 report on The Global Fund to Fight AIDS, Tuberculosis and Malaria: Progress, Potential, and Challenges for the Future

[43] Cole, Elizabeth  “Maternal care in Afghanistan”  2008.

Global Health, Global Health Projects


Draft Speech for Janet Napolitano

January 11th, 2010

Bio-Deterrence:

Elimination of Anthrax as a Threat

Christa Johnson, Shana Rakowsky, Vania Reyes

Science & Society: Global Challenges

14 December, 2009

Appendix 3 – Speech presented by Janet Napolitano

“Good morning and thank you very much. I would like to thank Vania Reyes, Shana Rakowsky, and Christa Johnson for their kind introductions.

I greatly appreciate the Center for Disease Control and Prevention hosting us here today. The efforts of the CDC have helped us make this solution viable, and we are deeply appreciative.

The topic we are discussing today presents great challenges to our national security. Because of this, it is of crucial importance that the department be made aware of what the Department of Homeland Security is doing to meet those challenges.

As you know, the Commission on the Prevention of WMD, Proliferation, and Terrorism stated that “It is more likely than not that a weapon of mass destruction will be used somewhere in the world by the end of 2013.” The internal anthrax attack of 2001 revealed the flaw of the United States in dealing with the threat of biological weapons, a problem that is both international and domestic.

The legislation created by President Obama to defend against such acts of biological terrorism has been very definite in setting the bar for what we as a country need to do to protect our nation.

So today I will reveal to you a novel approach to eliminating the threat. There is an urgent need to refocus our counter attack approach, to adapt strategies that were successful in the past and apply them in innovative ways to the problems that continue to plague our great nation.

The challenge is not to just figure out better ways to strengthen our guards and gates or to increase the responsibility placed on our scientific personnel. Rather, the challenge is to find a way to completely eliminate a problem, a way that renders an attack ineffective.

A wise approach to protecting our nation from a biological attack would be to highlight one of the greatness strengths of our country – our ability to innovate, to create, to modify, to make more efficient. The United States has employed extremely innovative ways to defend our country in the past, and has never been too proud to look into our history and evaluate where we were most effective and where our attempts fell short.

This problem of bioterrorism calls for us to re-evaluate our efforts. It calls for our scientists, our legislators, to think beyond the typical approaches, to look into our past and see where we succeeded.  It calls for us to modify those successes in such a way so that they are applicable to the problem of bioweapons in the 21st century.

Currently the United States has a list of the ten most dangerous pathogens. These pathogens, due to their abilities to cause great fatalities and instill public fear, require our immediate attention. We cannot allow ourselves, as members of a great and powerful nation, to be susceptible to attacks by these pathogens by rogue nations, organizations, or anyone.

Current efforts focus on dealing with the overall threat of bioweapons. And while these efforts are necessary, the Department also realizes it must address each pathogen individually. These pathogens are living, multiplying, and unique. Through the hard work of our Department, the United States has found a way to make the response of our nation safe from, arguably, the most dangerous of these pathogens – anthrax.

The past has shown the ability of anthrax to cause death and public fear. Following the 2001 attacks, the safety and integrity of our postal system was threatened. Our people were scared. Of the 22 that were infected, 5 died. Our new approach will ensure that attack by anthrax will never again cause death or fear. We will ensure that the United States is fully prepared to effectively respond in such a way that the appeal of anthrax as a WMD will be completely eliminated.

Let me stress – we have the ability to render an anthrax attack against the United States completely ineffective.

The consequences of living in a state of fear rather than a state of preparedness are enormous. A report by the World Health Organization, Clinical and Epidemiologic Principles of Anthrax, explicated the magnanimity of the impacts an effective anthrax attack would cause. Following the 2001 attack, the United States was not as prepared as it should have been. Lack of preparation is a risk that the United States is no longer willing to take.

So how do we propose to counter this problem? During the terrifying days of the Cold War, the United States remained in a nuclear standoff with the Soviet Union by having the ability to retaliate against a nuclear attack. Today we have the ability to retaliate against and anthrax attack, not with anthrax itself, but with the means to treat and protect the entire United States population. The hard work and dedication of our nation’s scientists and researchers have developed and tested the efficacy of treatments that will protect and cure any citizen who is infected with anthrax.

We propose to continue furthering the government action that has already been taken. Currently, all members of the military as well as susceptible populations receive the anthrax vaccine. The current vaccine has a high protection rate and a low rate of side effects. We plan to stockpile this vaccine in such a quantity that every man, woman, and child of the United States will be able to receive the regimen following an anthrax attack.

Research has shown that a combination therapy of the vaccine and antibiotics is the best therapy to save those infected by anthrax – it proved to be 100% effective. It is imperative that this vaccine is readily made available to the public to not only protect those who were not yet exposed to the pathogen, but to most effectively treat and save those who showed symptoms.

We will stockpile this vaccine in the Strategic National Stockpile. This stockpile already exists and is in operation. The stockpile is organized for flexible response, and contains 12-Hour Push Packs that can be delivered anywhere in the United States within 12 hours. Each state and locality already has a plan by which they can deliver the medicine they receive to every citizen in their locality.

In Chesapeake County, VA, a method of home delivery was employed. Using school buses, every citizen successfully received their vaccination within 48 hours. In Lake County, IL, the voting sites were used to deliver the vaccines to the citizens. A mock simulation proved their method effective – all households will be able to receive their vaccinations in the allotted time slot.

The government has already invested $6 billion to defend against bioweapons via Project Bioshield, and about $500 million into increasing the number of vaccine doses in the stockpile. We plan to immediately increase the number of vaccines in the stockpile.

The symptoms of anthrax worsen over an approximately ten-day period. Beginning with prodromal stage symptoms, they worsen to fulminant stage before death results. Due to the highly effective distribution of medication via the Strategic National Stockpile, we will be able to reach every U.S. citizen with vaccination within a maximum of four days – before the symptoms ever reach the fulminant level.

The 2001 attacks proved that infected citizens will seek medical attention while they are still in the prodromal phase. A problem that resulted at that time was that the medical community was not fully aware of the symptoms of anthrax infection, and so some cases were not properly diagnosed until it was too late. In order to address this issue, the government and the medical community have made joint efforts to ensure that all emergency personnel and medical caregivers are fully aware.

New classes, such as the WMD Awareness-Level Training Course, provides students of the course with a thorough knowledge of the strategies to prevent WMD attacks and ways to deal with attacks when they happen. Over 60,000 personnel in all 50 states have already received WMD training, and the program aims to soon be an ally of all premier medical institutions in the United States.

Highly accredited medical journals, such as the Journal of the American Medical Association and the Annals of Emergency Medicine, has increased the prevalence of publications pertaining to WMD. These journals can be found in every medical school and are received by the majority of doctors. They also are readily available for viewing on the internet.

New diagnostic tests further improve the speed and efficacy of a doctor’s diagnosis. A culture and sensitivity test of the blood, spinal fluid, skin sores, or respiratory fluids reveal the presence of the bacteria from which anthrax is weaponized, bacillus anthracis. The Anthrax Quick ELISA test has been approved for diagnostic use by the U.S. Food and Drug Administration, and can be completed much more quickly than any previous test. Upon the positive diagnosis of one case of anthrax infection, the vaccine stockpile in the SNS would be immediately deployed. Within 4 days, the entire United States population would be effectively and irrevocably treated and protected from the current attack and any future attack.

The attack will result in minimal to no fatalities. Public fear will not ensue, because the citizens are now aware that we have a plausible, effective, and efficient way to address the problem. The anthrax attack will have been entirely ineffective.

The novel proposal of the Department can be split into two parts – the implementation of pre-attack precautions and the definition of post-attack strategy. By ensuring both parts are in place, our enemies will be deterred from using anthrax in an attack. The efficiency of our response will ensure that no citizen will be left unprotected following an anthrax attack. Anthrax as a biological weapon of mass destruction will cease to cause mass destruction. Anthrax as a weapon will be rendered ineffective.”

*Modeled off of: “DHS: Remarks by Secretary Napolitano at the Council on Foreign Relations.” Department of Homeland Security | Preserving our Freedoms, Protecting America. Web. 23 Nov. 2009. <http://www.dhs.gov/ynews/speeches/sp_1248891649195.shtm>.

Security, Security Projects


Bio-Deterrence: Elimination of Anthrax as a Threat

January 11th, 2010

Bio-Deterrence:

Elimination of Anthrax as a Threat

Christa Johnson, Shana Rakowsky, Vania Reyes

Science & Society: Global Challenges

14 December, 2009

Section 1

Biological weapons are microorganisms that can be utilized to cause mass destruction. Recent commissions have predicted that one of these weapons will be used somewhere in the world in the near future. The United States has designated ten pathogens on their Select Agent List as the most dangerous, and current responses to the threat have been initiated. However, these responses address the threat posed by bioweapons as a whole. The living nature of these pathogens makes each unique, and so each poses different security challenges. Anthrax is one of the designated most dangerous pathogens due to its widespread availability, its ability to cause public fear, and the high fatality rate associated with infection.

We propose to employ a theory of bio-deterrence in order to render an anthrax attack against the United States ineffective. Bio-deterrence is a defensive strategy that can be understood as deterrence by denial. If an enemy uses anthrax as a weapon against the United States, the nation will ensure such a rapid, efficient response that the normally deadly, fear-inspiring effects will be non-apparent. The appeal of anthrax as WMD will be eliminated.

In order to create deterrence, we recommend the United States to stockpile 330 million doses of the current anthrax vaccine, Biothrax, within the Strategic National Stockpile while continuing to fund research of an improved vaccine. The timeline of anthrax symptomology is approximately 9 days from beginning symptoms to death, and our timeline of dispensal ensures all citizens will be treated or protected within 4 days.

The entirety of our proposal can be split into two parts – implementing pre-attack precautions and defining post-attack strategy. By ensuring both parts are in place, enemies will be deterred from using anthrax and an entire class of weapons will be rendered ineffective.

Section 2

Following the disastrous attacks of September 11, 2001, the population of the United States became painfully aware of the danger posed to their country by terrorists. Using mechanical means, the terrorists wreaked havoc not just on the targeted area, but on the entire nation, generating mass fear and forcing the government to take immediate action to prevent another attack. Since this attack, the government has implemented the Patriot Act, the FBI Intelligence Reform, the Intelligence Reform and Terrorism Prevention Act (P.L. 108-458), and the Homeland Security Appropriations Act, 2007 (P.L. 109-295, Title VI, Subtitle D). However, physical attacks are not the most dangerous weapon in the arsenal of terrorists. The potential for terrorist usage of biological weapons, also known as bioweapons, creates another problem of security for the United States that requires immediate attention.

The Commission on the Prevention of Weapons of Mass Destruction, Proliferation, and Terrorism in December of 2008 stated that “it is more likely than not that a weapon of mass destruction will be used in a terrorist attack somewhere in the world by the end of 2013.”[1] Bioweapons are defined as microorganisms that are employed with the intent to kill, incapacitate, or seriously impair a person, group of people, or even an entire population.[2] These pathogens can be transported to a susceptible population through food, air, water, and/or living organisms and, if properly released, can kill on a massive scale. These weapons are possible to produce without government support since the equipment it takes to develop them is found in universities, hospitals, and pharmaceutical plants, among other places. The effectiveness of a biological weapon greatly determines its ability to harm people; the more effective that it is the more damage it can cause. Currently, over twenty countries have the means (the technology and/or facilities) to plan and execute a bioweapon attack in the near future. Of these countries, nine have offensive bioweapon projects, meaning that almost half of the countries that have the technology could potentially use them against another state/nation/continent.[3] Most of the bioweapon programs in existence are remnants of programs that have existed since WWII and many of the facilities in Eastern Europe do not have the proper infrastructure to safely work with and secure the pathogens.[4]

The committee describes the susceptibility of the United States to an act of biological terror, stating,

“The United States still wields enormous power of the traditional kind, but traditional power is less effective than it used to be. In today’s world, individuals anywhere on the planet connect instantly with one another and with information…. Weapons of tremendous destructive capability can be developed or acquired by those without access to an industrial base or even an economic base of any kind, and those weapons can be used to kill thousands of people and disrupt vital financial, communications, and transportation systems, which are easy to attack and hard to defend. All these factors have made nation-states less powerful and more vulnerable relative to the terrorists, who have no national base to defend and who therefore cannot be deterred through traditional means.” [5]

Due to the obvious threat posed to the United States, government agencies have been focusing on creating and passing bills to both prevent and prepare for an attack. The threat posed by bioweapons is real, and to counter the threat NGOs have continued their research on bioweapons while the public sector has begun to take action.

Bill S.1649, The Weapons of Mass Destruction Prevention and Preparedness Act of 2009, sponsored by Senators Lieberman and Collins, is one such action. The bill addresses a vast array of problems posed to the United States by bioweapons.  When introducing the bill to Congress, Sen. Collins stated “the bill implements many of the recommendations of the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism.”[6] Bob Graham and Jim Talent of The Hill’s Congress Blog have said, “This bill is a giant step in the right direction.”[7]

The WMD Act contains five titles that attempt to regulate bioweapons on a domestic and foreign scale – I. Enhanced Biosecurity, II. Response to a Weapon of Mass Destruction Attack, III. International Measures to Prevent Biological Terrorism, IV. Government Organization, and V. Emergency Management and Citizen Engagement.[8] Sen. Collins stressed the importance of introducing such a bill, elucidating the draw of terrorists to these weapons. “In contrast to nuclear weapons, the technological hurdle is lower to develop and disseminate bioweapons, access to pathogens is more widespread, and pathogens are harder to contain. The spread of biotechnology, the difficulty of detecting such pathogens, and terrorists’ known interest in bioterrorism combine to produce an even greater menace”[9] The bill defines bioweapons using a tiered approach, designating the most dangerous pathogens as Tier 1 agents by the following criteria;

‘(i) whether the agent or toxin has significant potential to be used effectively in a biological attack;

‘(ii) whether the risk posed by the agent or toxin requires additional biosecurity measures, beyond those required under subsection (b), to prevent misuse domestically or abroad;

‘(iii) information available from any biological or bioterrorism risk assessments conducted by the Department of Homeland Security or other relevant assessments by other departments or the intelligence community; and

‘(iv) such other criteria and information that the Secretary determines appropriate and relevant.[10]

Graham and Talent said that the “tiered approach ensures that U.S. laboratories can focus on innovation and not paperwork.”[11] The United States currently has a Select Agent List of 82 virus and bacteria, and the new bill designates 10 of these as Tier One agents.[12]

The legislation provides guidelines for increasing the security of domestic biological laboratories that handle dangerous pathogens and requires the registration of labs that handle less strictly controlled, but still dangerous, pathogens. It authorizes a grant program at $50 million for each of the next four years in order to help fund the security enhancements at the highest-risk biolabs and avoid diverting research funding to security upgrades. The bill provides a method to improve the government’s ability to distribute medical countermeasures and increases the cooperation between different government agencies by requiring actions to improve communications with the public before and during a biological attack. In order to ensure communication between agencies concerning foreign laboratories, the bill advises for the Director of National Intelligence to report on countries that have facilities with the highest-risk pathogens and the security measures in place at these facilities. The bill also allots for the Secretary of State to provide assistance to enhance security at laboratories with dangerous pathogens worldwide and to use exchange programs to train foreign nationals in proper handling of these pathogens. The overall goal of the bill is to ensure that the United States is prepared for a biological attack.[13]

Although the bill attempts to attend to all of the issues posed by bioweapons, there are many criticisms. The American Society for Microbiology (ASM), an agency of over 40,000 members that are involved in basic and applied research as well as clinical laboratory testing and public health activities, commented on each section of the bill.[14] The main criticism of the ASM was the language of the bill was very vague and broad, especially pertaining to the designation of Tier 1 agents and which laboratories should be included in the databases. The ASM felt that Tier 1 agents were not properly identified, and it was “difficult to understand the scope and impact of the potential enhanced classification of certain agents as Tier I agents.” The ASM did not agree that the authority for rulemaking concerning bioweapons should be given to the Department of Homeland Security, but recommended that the authority be given “jointly [to the] Department of Health and Human Services in coordination with the Department of Agriculture.”[15]

The Global Security Newswire also posted an article commenting on the WMD Act. The American Association for the Advancement of Science is concerned with how the bill would affect scientists that are currently working in laboratories. They feel as though the bill would hinder the ability of labs to do research due to the amount of time that would be required to be spent on guarding the facilities. This puts a strain on the scientific community and pressure on the personnel of the laboratories to enforce security measures.[16] The ASM and the AAAS are just two of many committees to find flaws with the WMD Prevention and Preparedness Act of 2009.  Their criticisms highlight that this bill is not sufficient alone to eliminate the threat posed to the United States by bioweapons.

In 2002, the G8 Global Partnership against the Spread of Weapons and Materials of Mass Destruction instructed numerous countries to contribute money to eradicating the threat of bioweapons. To further carry out this mission, the Canadian government decided in mid-2009 to build a bio-security lab in Kyrgyzstan. Canada has pledged to invest $30 million into this lab, hoping to prevent terrorist access to these weapons. Previously, the Soviet Union boasted a massive bioweapons program that produced immense volumes of dangerous pathogens. Since the fall of the Soviet Union, the labs that housed these agents, as well as the scientists that worked with them, have been neglected. The poor condition of the labs adds to the danger posed to the scientists. The labs consist of “doors with broken locks….fences that have fallen down, windows with no bars and no glass, and trees that have overgrown.” “Scientists toil in conditions that are dangerous to them, as well, lacking the airtight boxes and spacesuit-like equipment used by Westerners working with such diseases”. Moreover, the scientists are paid extremely low wages, sometimes as low as $1 per day.[17]

The lack of security implemented in the actual laboratories, as well as the vulnerability of the scientists to terrorist bribes, are international security concerns. The Canadian government, following the lead of the United States which accomplished similar projects in other former Soviet Union countries, plans to strengthen these sites by turning them into secure research facilities. Because many of the dangerous pathogens are still endemic to the region it is important for research to continue. With their financial and instructional support, Canada hopes to ensure this research is conducted safely without risk of external or internal threats.[18]

While Canada’s efforts will strengthen physical lab security, namely the “guards and gates,” and may help increase the well-being of the scientists, it is not enough. Its critical flaw, one that affects many other actions against bioweapons, is that it fails to take into account determined insiders that want to obtain these weapons. Dr. Julie Fischer of the Stimson Center agrees, saying “You can put up guards and gates and you can engage scientists, but if one does decide to go rogue these actions will do little to stop them.” [19]

Recognizing the danger of solely relying on guards and gates to protect these pathogens, the National Academy of Sciences has released a report that focuses on personnel reliability. The report, Responsible Research with Biological Select Agents and Toxins, underlines the importance of the physical protocols already in place in bio-labs, but presents novel recommendations that are focused on strengthening personnel relations, making the scientists realize that they have a responsibility to prevent the misuse of bioweapons.[20]

Fundamentally, the report demands that specific actions be taken by laboratory scientists when dealing with Biological Select Agents and Toxins (BSAT) as opposed to other pathogens. The report contains nine key recommendations to augment security of BSATs.[21] On a broader scale, the recommendations call for increased training in scientific ethics as well as shared knowledge of how to conduct proper research with BSAT materials. They propose the creation of an additional oversight committee of the Select Agent Program, in order to:

Promulgate guidance on the implementation of the Select Agent Program; facilitate exchange of information across institutions and sectors; promote sharing of successful practices across institutions and sectors; Provide oversight for evaluation of the Select Agent Program; provide advice on the composition/stratification of the list of select agents and toxins; convene regular meetings of key constituency groups; and promote harmonization of regulatory policies and practices. [22]

The problems pertaining to laboratory security and how to properly identify pathogens as select agents are more specifically addressed in the third, fourth, and sixth recommendations. The eighth recommendation advises that inspectors of BSAT research facilities receive special training and boast years of experience working in similar labs in order to recognize secure labs.[23]

Although the report reiterates the necessity of maintaining the strength of current lab security, the novelty of the report’s recommendation lies in its focus on personnel reliability. The current screening process, the Security Risk Assessment, was deemed sufficient, with the minor addition of an appeals process. However, the report stresses that even though an individual may pass the SRA when they are hired his/her position or personal life may change, thus affecting his/her decisions while working in the lab. Therefore, the report heavily emphasizes the need for colleagues to monitor each other, being conscious of changes in behavior and/or mood.[24]

However, this report contains two main flaws. First, it advises the establishment of cross sector committees and collaboration, but does not provide sufficient detail of which departments should be responsible for funding, management, or leadership in the endeavors. Since BSATs are used for medical and scientific research as well bioweapons, they are important to numerous governmental organizations. Thus, collaboration and information sharing is a valid problem and while the NAS addresses the matter, it fails in identifying a plausible solution. Secondly, the NAS’s support for personnel reliability is an important novel stance but it rests on many assumptions. Similar to Canada paying Kyrgyzstani scientists higher wages and hoping they will less likely to take bribes, NAS’s report rests on the hope that scientists will be able to correctly identify lifestyle and behavioral changes.

The most current response to biological WMDs was the Obama administration’s response to biological threats issued on December 9, 2009. The National Strategy for Countering Biological Threats combines many of the recommendations of the NRC and the Commission on WMDs. It contains seven key objectives:

To promote global health security; to reinforce norms of safe and responsible conduct; to obtain timely and accurate insight on current and emerging risks; to take reasonable steps to reduce the potential for exploitation; to expand our capability to prevent, attribute, and apprehend; to communicate effectively with all stakeholders; and to transform the international dialogue on biological threats.[25]

Primarily, the Strategy underlines the Biological Weapons Convention and facilitates its implementation. The response addresses fundamental problems with the way the government formerly addressed the issue. In the past, biological threats, both domestic and abroad, were dealt with throughout the government in many different sectors. This dispersion caused a severe lack of discussion among experts. The Strategy aims to centralize the issue with the creation of the World Health Organization Collaborating Center under the CDC for the implementation of International Health Regulations.[26] Moreover, the report recognizes the unique problems of biological pathogens and therefore underlines the need for international collaboration to produce transparency in scientific research.

While this report solves many of the intricacies involved in addressing bioweapons, it still relies heavily on trusting scientists to act in an ethical manner. The report also establishes “that confidence in BWC compliance should be promoted by enhanced transparency about activities and pursuing compliance diplomacy to address concerns,” rather than by verification. Thus, the report contains many of the same weaknesses previously discussed.[27] It fails to guarantee prevention of a biological attack because of the fear of inhibiting scientific research and the inability to verify compliance.

While these government actions attempt to decrease the threat of a bio-attack, each has inherent flaws. The WMD Act hinders the freedom of scientific research. The Canadian response focuses solely on physical protection, while neglecting the living properties of biological pathogens. The NAS the Obama administration focus on personnel reliability, providing no absolute guarantees. Biological weapons prove a complicated threat to handle because the pathogens can be utilized as a diverse group of weapons. These pathogens are alive; they grow, spread, and develop on their own. This living quality makes each pathogen unique, and thus each presents unique challenges. Characteristics that are important to addressing a threat, such as level of contagiousness, fatality rate, and treatment, differ depending on the pathogen that is weaponized. Thus, in order to address the overall solution to the problem of bioweapons, each pathogen must be addressed individually.

Section 3

Anthrax is one such pathogen whose unique threats cannot be eliminated by a general solution. Stan Bedlington, a retired CIA analyst at the agency’s Counterterrorism Center, said, “… you could take a small plane and sprinkle anthrax over New York City and wipe out half the population.”[28] The described attack would require properly weaponized anthrax as well as a successful dispersion tool. Nonetheless, the risk and consequences are significant. A report titled, Clinical and Epidemiologic Principles of Anthrax, published by the World Health Organization in 1993, also described the risk posed by anthrax. The report quantified the danger by explicating a plausible attack scenario, “that if a city of 500,000 people was attacked by 50kg anthrax, approximately 125,000 infections would occur. Of the 125,000 infected people, 95,000 would die.” The predicted number of deaths from an anthrax attack, when compared to similar scenarios following the release of other bioweapons, is substantially higher.[29] The danger is heightened by the availability of the pathogen. Numerous countries’ arsenals contain stockpiles of anthrax. For example, Iraq’s stockpile possessed enough anthrax in 1995 to kill the entire world 2500 times over.[30] Due to the substantial risk posed by this pathogen, its elimination as a viable weapon would be significant in reducing the overall threat of bioweapons.

Anthrax results from the weaponization of the bacterium, bacillus anthracis. A typical anthrax spore is roughly 1 micron in diameter and weighs approximately one trillionth of a gram. Bacillus anthracis thrives in soil and has the ability to remain dormant for long periods of time, up to 40 years, before being activated. These spores are extremely resilient, and are resistant to boiling, freezing, and suspension in alcohol. Activation occurs when the bacterium comes into the right environment – one that is rich in amino acids, nucleosides and glucose. One such environment is human blood.[31]

This agent as a bioweapon exists in three forms – cutaneous, gastrointestinal, and inhalation. In cutaneous anthrax, the spores enter into a host through an open cut or scrape. This form of anthrax is the most common, accounting for about 95% of observed cases worldwide, and has a fatality rate of 20%.  Symptoms begin to appear after about 12 days. The germination of the bacteria results in local swelling of the skin, and a small papule (bump) will appear. The following day the bump will enlarge into an ulcer and begin discharging a clear fluid. Then, a painless, depressed, black scab will form, dry, and fall off within one to two weeks. The second form, gastrointestinal anthrax, is the rarest form of infection. This form affects its hosts after they eat infected undercooked meat or drink unchlorinated water. Causing death in 25-60% of the cases, the beginning symptoms are similar to the flu. After approximately one week, the symptoms intensify to nausea, vomiting blood, abdominal pain, bloody diarrhea, and extreme weakness. The third form, which is the most deadly, is inhalation anthrax. In order for an infection to occur, a host must inhale at least 2500 spores. The deadliness of the spores is increased by the fact that they are colorless, tasteless, and odorless. Symptoms begin to appear after about 7 to 10 days. This first stage may last anywhere from a few hours to a few days. The stage includes symptoms of fever, cough, headache, vomiting, chills, weakness, abdominal pain, shortness of breath and chest pain. Then, there may be a brief break in symptoms or the infection can progress into the next stage. The second, and final, stage of the disease can last anywhere from two to four days. The symptoms include fever, difficulty breathing, sweating, a bluish discoloration of the skin, shock, and, ultimately, death.[32]

Because the beginning symptoms of anthrax infection are similar to many other ailments, it can be difficult to realize that a patient is suffering from this particular agent before it is too late. However, if anthrax is suspected as a cause, a series of tests are performed to identify the strain of anthrax. Because multiple strains exist, such as the Vollum, Ames, and Sterne strains, it is important to figure out which the patient is infected with.[33] A complete test begins with the culturing of a blood sample that is taken from the patient, which takes 6 to 24 hours. Then a Gram stain, which highlights the bacterium, is performed, taking 10-15 minutes. Finally, a biochemical test is performed, in which the stain is sent out to the national reference lab for comparison. This step takes approximately 24 hours.[34] A new method of diagnosis, a direct patient blood test, is now available. This test is much quicker because it eliminates the need to send the sample to the national reference lab and does not require specialized equipment or trained personnel.[35]

Currently, patients suffering from anthrax infection are treated with a 60 day regimen of twice daily antibiotics. The most commonly used antibiotics are penicillin, doxycycline and ciprofloxacin. Even with antibiotic therapy, the prognosis of inhalation anthrax once it reaches the second stage is poor. Up to 90% of cases in the second stage result in death.[36]

Fatalities occur due to anthrax’s ability to attack the body in a calculated, precise manner. When anthrax enters the body, it is activated from its dormant state into its active state due to the environment of the blood. The active bacterium moves into the lymph nodes producing a toxin that attacks human cells. This toxin is formed by the combination of three proteins – the protective antigen, the edema factor, and the lethal factor. Separately, these proteins pose no threat to the host, but, in combination, can be deadly. When these proteins are released, the protective antigen binds to the cell surface and forms a type of channel in the cell membrane that allows the edema factor and lethal factor to enter the cell. The edema factor, when combined with the protective antigen, forms a toxin known as the edema toxin. The lethal factor, when combined with the protective antigen, forms a toxin known as the lethal toxin. It is the lethal toxin that does the most damage within the cell.[37]

In order to make anthrax from the spores, one must undergo a refining process containing five difficult steps. For a microbiologist, growing bacillus anthracis in the laboratory and causing it to form spores is an easy task. However, converting a culture containing millions of these spores into an effective weapon is not easy. The first step, which can be performed by any trained microbiologist, is germination, or causing the seed spores to develop into living germs. The next step is vegetation, in which one grows sufficient anthrax germs to provide what is needed. The third step is sporulation, in which one causes the anthrax germs to create spores. The fourth step, separation, purifies the anthrax spores by freeing spores from dead “mother germs” and other debris. The fifth, and most difficult step, is weaponization. Weaponization involves drying the spores into a superfine powder and is extremely difficult to perform correctly.[38] Each of these steps has as many as 50 sub-steps, all of which could be carried out in hundreds of different ways. For example, Bill Patrick, a scientist who used to make anthrax weaponry for the United States, patented a secret process for weaponization. His process involves freeze-drying the spores, milling the resulting anthrax ‘cake’ to yield particles of the proper diameter, and then coating them with a special mixture to dampen electrostatic charges that cause clumping. Patrick calls this making the particles ‘slippery.’[39] If one manages to carry out these five steps efficiently, the anthrax will be ready for use as a bioweapon.

Since WWII and the beginning extensive research on bioweaponry, anthrax has posed a great threat. In 1993, the religious cult Aum Shinikyo released a liquid suspension of Bacillus anthracis off of the top of an eight-story building in Tokyo. The event had the potential to cause hundreds, or even thousands, of human fatalities. However, the cult failed to generate spores that would produce inhalation anthrax from the attenuated B. anthracis strain used to vaccinate livestock. Due to the improper weaponization of the bacteria, the occurrence resulted in few symptoms and no fatalities.[40] The United States anthrax attack of 2001, in which letters containing anthrax spores were mailed to various news media offices as well as U.S. Senators, was more successful. The attack resulted in five fatalities, and panic and fear swept through the public. The FBI has since concluded that former employee, Bruce Ivins, of governmental biodefense labs in Fort Dietrick, Maryland likely carried out the attacks. However, Ivins committed suicide before any legal action could be taken.[41]

The anthrax attack of 2001 highlights the lack of detection by the medical community. For example, Case #15, a 55 year old male who most likely inhaled anthrax from a mailed letter, first entered the emergency room on October 18, 2001 complaining of progressive fatigue, myaligias, and fever. He was discharged later that day, but returned to the hospital on October 21st with significantly worse symptoms, including chills, tightness in his chest, and a high temperature. He died later that night. Case #16, a 47 year old male, was also improperly diagnosed. After his first visit to the emergency room on October 21, 2001 prompted by fatigue, nausea, vomiting, and diarrhea, he was discharged. He returned to the emergency room on October 22nd in respiratory distress, and died six hours after re-entering the hospital. If the hospitals had properly diagnosed the cases during the first stage of symptoms, these two victims would have had significantly increased chances of survival.[42]

Section 4

Anthrax is a highly deadly, fast-acting pathogen. It is available throughout the world and has proven to be appealing to both enemy states as well as rogue organizations. The technology exists to weaponize it from bacteria into an effective biological weapon of mass destruction. Because of the immense threat, we propose to employ a theory of bio-deterrence in order to render an anthrax attack against the United States ineffective. Bio-deterrence is an evolution of the traditional deterrence theory that was used during the Cold War. Instead of employing the theory in the offensive manner of mutually assured destruction, bio-deterrence can be better understood as deterrence by denial. This angle of the theory uses deterrence as a defensive measure, “ultimately aiming to decrease terrorist motivation by fortifying targets of attack.”[43] By ensuring a rapid, efficient response to an anthrax attack, which would serve to treat and protect the entire United States population from the deadly effects of weaponized anthrax, the appeal of anthrax as a biological weapon of mass destruction would be eliminated.

Deterrence theory is a strategy employed by a country to prevent domestic attack. The theory was popularized by the United States and Soviet Union governments during the Cold War. In this theory, one country prevents attack by another country by flaunting their power and making it publicly known that they have the means to and will attack the other if there is any sign that they are about to take action. In the case of the Cold War, stockpiles of nuclear weapons served as the deterrents. The United States threatened drastic retaliation on the Soviet Union if they considered using nuclear warfare.[44] David Krieger of the Nuclear Age Peace Foundation summarizes the situation as follows:

“Country A [the United States] tells country B [the Soviet Union] that if B does X, A will attack it with nuclear weapons. The theory is that country B will be deterred from doing X by fear of nuclear attack by country A. For deterrence to work, the leaders of country B must also believe that country A has nuclear weapons and will use them. Nuclear deterrence theory holds that even if country A might not have nuclear weapons, so long as the leaders of country B believed that it did they would be deterred.” [45]

Deterrence theory is a viable choice for security as long as Country B believes that Country A can carry out the retaliation they promise or that Country A is protected by a country that can.

The United States cites this theory as a reason to maintain their stockpile of nuclear weapons, claiming its arsenal is necessary to deter aggression. In the case of the Cold War, a “balance of terror” was achieved between the United States and the Soviet Union through the military doctrine of Mutually Assured Destruction.[46] The doctrine supports the idea that the population could best be protected by leaving it vulnerable so long as the other side faced comparable vulnerabilities. Both countries maintained their stockpiles of nuclear weapons with a mutual understanding that if they engaged their weapons first the other country would retaliate on a massive scale and would not hesitate to cause mutual destruction.

While this doctrine maintained an uneasy standoff in the Cold War, it could potentially fail if one side was able to destroy the other’s stockpile in the first strike. In order to prevent this, the United States has attempted to makes its nuclear weapons invulnerable to attack, placing “weapons on land in hardened silos, while those in the oceans on submarines that were difficult to locate underwater.”[47]

Our employment of the deterrence theory modifies the strategy from an offensive perspective, guaranteeing mutually assured destruction, to a defensive perspective. Deterrence of an anthrax attack can best be understood as deterrence by denial.[48] Deterrence by denial eliminates the threat of attack by negating the effectiveness of a weapon. The goal of the denial theory is not based on the threat of retaliation by retaining equivalent weapons of response; rather, the United States will be equipped to so effectively respond to an attack that anthrax as a weapon will cease to be appealing. We plan to implement pre-attack precautions and define post-attack strategy in order to ensure the United States has the ability to respond to an anthrax attack in such a way that fatalities are minimized and public fear is diminished. The key infrastructure of our pre-attack strategy is the Strategic National Stockpile.

The Strategic National Stockpile is designed to supplement and resupply state and local public health agencies in the event of a national emergency anywhere, and at anytime, within the United States or its territories. Authorized by Congress in 1998, this stockpile was originally titled the National Pharmaceutical Stockpile and operated under the Department of Health and Human Services. After a few exchanges of control of the stockpile, the signing of the BioShield legislation reaffirmed the role of the HHS as the overseer for the program. The HHS manages federal agencies, namely the Center for Disease Control and Prevention, which are responsible for maintenance and delivery of SNS assets.  The stockpile contains a national repository of antibiotics, chemical antidotes, antitoxins, life-support medications, IV administration, airway maintenance supplies, and medical/surgical items and is located in secure, environmentally controlled areas throughout the United States. The composition of the SNS Program assets are determined by the HHS and CDC after considering many factors, such as current biological and/or chemical threats, the availability of medical materiel, and the ease of dissemination of pharmaceuticals. The most significant factor considered is the medical vulnerability of the U.S. civilian population.[49]

The majority of the inventory is made up of vaccines, ventilators, and antitoxins which are managed by specific vendors or manufacturers. The fast-response inventory, which makes up less than 5%, is known as 12-Hour Push Packs. These Push Packs contain broad-spectrum oral and intravenous antibiotics, IV fluids and fluid administration kits, airway equipment, such as ET tubes, stylettes, oropharyngeal airways, Ambu-Bags, and CO2 detectors, and bandages. The SNS maintains ownership of the inventory and is responsible for storing, monitoring, and maintaining the inventory. All medicine in the SNS is free for everyone.[50]

Although the SNS is not a first response tool, it is organized for flexible response. The inventory of the SNS would be made available following a direct request from affected state’s governor’s office to the CDC or HHS. The stockpile would be accessed post-emergency, when local public health resources would likely be or have already been overwhelmed by the magnitude of the medical emergency, such as following a natural disaster or terrorist event. The stockpile could also be accessed pre-emergency, following actionable intelligence, analysis of data derived from syndromic or epidemiologic surveillance, or a sentinel event, such as a single case of smallpox. The 12-Hour Push Packs can be delivered anywhere in the United States or its territories within 12 hours of a federal decision to deploy. The Push Packs are configured to be immediately loaded onto either trucks or commercial cargo aircraft for the most rapid transportation and, simultaneously, the SNS program will deploy its Technical Advisory Response Unit (TARU) to coordinate with state and local officials so the SNS assets can be efficiently received and distributed upon arrival at the site.[51]

State and local authorities must plan to receive, store, stage, distribute, and dispense the assets. In order to aid local distributors, the SNS project has developed practical references defining methods of dispensing that are useful for local health departments to follow. The guidelines are defined in the Cities Readiness Initiative (CRI). The CRI is a pilot program to aid cities in increasing their capacity to deliver medicines and medical supplies during a large-scale public health emergency. Funding for CRI is provided through CDC’s Public Health Emergency Preparedness (PHEP) Cooperative Agreement, and cities that receive this funding are designated based on their population, geographical location, and potential vulnerability to a bioterrorism threat. Within each designated city, points of distribution (PODs) are chosen. A POD is a location that will be converted to a medical dispensing site in an emergency. However, because the dynamic of each area is so different, the CRI has provided examples of some of the most innovative and effective ways that communities are planning to distribute their supplies.[52]

For some communities, home delivery is a viable option. One example is a method employed by Chesapeake County, Virginia known as “push distribution.” This community plans to deliver door-to-door life saving countermeasures via public school buses, with Medical Reserve Corps volunteers and City employees dispensing the medication. The community tested the feasibility in of their method in 2007, by engaging in an exercise titled “Special Delivery.” The timed test began during kit assembly, in which 1000 kits were assembled. Each kit consisted of a drawstring bag containing four bottles of a 10-day antibiotic regimen, two information sheets describing the mock anthrax bioterrorism attack being exercised, and an 8-page newspaper-size insert with teaching information about anthrax as well as instructions describing the medication being distributed and recommended treatment regimen. The kits were delivered to the door knobs of 934 residents by one bus driver and four volunteers on public school buses which followed pre-determined GIS-mapped routes. The results of the exercise were based on the assumptions that 900 City staff and volunteers from the Medical Reserve Corps will be available and show up in an event and the 196 buses that will be needed for transport will be maintained and available for use. This plan is feasible for this area due to their ability to close down roads and have access to the supplies of the community.[53]

In Palm Beach, Florida, the dynamics of the community are very different from Chesapeak County, Virginia and so require a different method. This community decided their most effective distribution would be based on a hybrid plan of involving public and closed PODs. The community decided to solidify partnerships with gated residential communities. A lease agreement was signed between the community and the private locations, which circumvents potential legal and liability challenges. In this agreement, during an emergency, the private location agrees to temporarily donate a portion of their property to the health department. This donation of real property as a service allows the residential board to register with the county and become classified as a Florida Statute 110 Volunteer. Under Florida Statute 110, all volunteers are provided state liability protections and workers compensation. Palm Beach contains a large number of retirement communities with residents 65 years of age and older, so this method of dispensing is most effective for them. [54]

For other communities, the best method is to use sites that are already well known to their citizens. In Lake County, Illinois, the PODs are the voting sites. A lot of responsibility is placed on each municipality and each has identified public works personnel and their own security to pick up and deliver the medications and supplies to each of the activated polling places. The method was originally tested in 2007 using one polling site. Lake County activated the plan from the point of the county drop site to a single polling site located several miles from the drop site, which was then opened and actively operated for 2 hours. With scenario cards in hand, 70 volunteer “mock” patients repeatedly went through the dispensing site. Projections of time data collected during the exercise demonstrated that all heads of households in Lake County could receive medication for their household well within the 48-hour time frame required by the CDC. In July, 2008 the community repeated the test run with two polling sites and a 15% efficiency increase was noted.[55]

As of 2009, the government had allotted $600 million in order to increase the amount of anthrax vaccines in the SNS. The current goal of the government is to increase the number of vaccines in the stockpile by 25 million doses.[56]

The only current licensed vaccine for anthrax infections is BioThrax® (Anthrax Vaccine Adsorbed). It is produced and manufactured by Emergent Biosolutions, a company based in Rockville, Maryland. The vaccine stimulates the body to produce protective antibodies against the protective antigen, therefore preventing PA from interacting with the other factors in anthrax that make it lethal. The vaccine is considered “inactivated” because it does not contain whole live or dead bacteria, and is made from a strain of the anthrax bacteria that cannot cause anthrax infection.[57] A number of components make up the vaccine, including aluminum, benzethonium chloride, and formaldehyde. The aluminum acts as an adjuvant, helping to increase the body’s immune response by attracting white blood cells and acting as a storage depot to slow the release of PA in one’s system. The benzethonium chloride functions as an antimicrobial preservative in the vaccine, preventing contamination in multi-dose vials. Formaldehyde acts as a stabilizer and helps to increase the shelf life of the vaccine to approximately four years.[58] The vaccine regimen is made up of five doses taken over 18 months supported by an annual booster shot. After the full vaccination series, the individual is considered protected. “One of the studies used to support the original marketing approval of BioThrax constituted a controlled field study in which the BioThrax predecessor vaccine was calculated to be 92.5% effective in preventing inhalational and cutaneous anthrax.” Currently, BioThrax is only licensed for prophylactic use among high risk persons, including military personnel, laboratory workers, or postal workers. To date, 2.1 million individuals have been vaccinated. [59]

While the protective capacity of the BioThrax vaccine is relatively high, the current vaccine does have many criticisms. One major con is that the vaccine is only fully protective for one to two years, and requires an annual booster shot to maintain its efficacy. This demanding vaccination schedule results in an increase in the number of people who do not complete the full series. If the series is not completed, that person is not fully protected. Another con to the vaccine is the incidence of side effects. In clinical studies, greater than 10% of participants reported injection-site reactions, including tenderness, pain, erythema, and limitation of arm motion. Systemic adverse reactions were also observed in approximately 5% of participants, including muscle aches, fatigue, and headaches.  In post-marketing surveillance, more severe side effects were observed, including serious allergic reactions.[60] Due to the difficulty for the public to weigh the probability of experiencing a side effect versus the probability of an anthrax attack, many people do not feel it is necessary for them to get vaccinated.

In order to address these criticisms, a second-generation vaccine is currently under development by Emergent Biosolutions as well as Pharmathene. Both companies are pursuing recombinant protective antigen vaccines, which vary slightly, but should result in a lesser dosage vaccination series that causes fewer side effects. Studies on a new vaccine have been on-going for years. A study performed by Welsh School of Pharmacy, Cardiff University concluded that after “Almost two decades and millions of dollars, we still do not have a replacement vaccine and some argue that the spectrum of protection that [the new vaccine] confers will not be as broad as the vaccine it replaces.”[61] To deal with this issue, Department of Health and Human Services awarded both Emergent and Pharmathene funds for research and development in order to stimulate the process. Whichever company is able to construct a quality vaccine first will secure an exclusive contract with the government to manufacture the new vaccine in bulk.[62]

Regardless of the motivation to produce a new vaccine, the research and development process still takes time. As stated by the WMD Commission of 2008, the threat of an attack by a biological weapon is imminent – it will likely occur within the next 5 years.[63] Because of this pressing threat, our proposal requires action. We recommend the immediate augmentation of the Strategic National Stockpile with 330 million doses of the current Biothrax vaccine, at the cost of approximately $3.3 billion.

The Stockpile must be increased to 330 million doses to be able to protect and treat the entire United States population. The U.S. Census of 2000 determined the population of the United States to be approximately 300 million people (See Appendix 1).[64] The number of doses of vaccination in the stockpile would be sufficient to provide every member of the United States with their first dose of the vaccination regimen. Although every member would not be fully protected, vaccination of adults with the licensed vaccine induced an immune response measured by indirect hemagglutination in 83% of vaccinees 2 weeks after the first dose.[65]

The additional 30 million doses are recommended to be stockpiled in order to immediately treat the affected population in the areas which were attacked. Supposing the worst, if the nation’s two largest cities, New York and Los Angeles, were to be simultaneously attacked, approximately 13 million people would be exposed to anthrax. Current research proves that the most cost-effective and successful treatment of exposed persons is combination prophylaxis, antibiotic and vaccine therapy. The shortened vaccine regimen consists of 3 doses, one at 0, 2, and 4 weeks, in combination with 14 days of ciprofloxacin.[66] The additional 30 million doses would ensure that the entire populations of New York and Los Angeles could receive this treatment in full.

Thus, our proposal also recommends that the FDA immediately license BioThrax for post-exposure prophylaxis. The Division of Bacteriology at the United States Army Medical Research Institute of Infectious Diseases in Fort Detrick, MD conducted a study following the 2001 attacks in which two groups of ten macaques were exposed to inhalation anthrax. The first group was treated with only ciprofloxacin twice daily for 14 days. The second group received this same treatment in combination with three doses of the anthrax vaccine absorbed. Out of the ciprofloxacin-only group, four monkeys survived. In the combination therapy group, all ten survived. The study concluded that “postexposure vaccination can shorten the duration of antibiotic prophylaxis required to protect against inhalational anthrax.”[67]

Ciprofloxacin, although a critical part of effective treatment, does not need to be further stockpiled as per our proposal. The SNS already contains a sufficient amount of the antibiotic, and, due to its numerous FDA approved uses, is readily available at pharmacies nationwide.

Section 5

The strength of our proposal lies in the ability to quickly and effectively distribute the vaccine via the SNS. The timeline of symptoms of inhalation anthrax occurs over an approximately 9 day period (See Appendix 2).[68] On Day 1, an affected person would present with prodromal phase symptoms, such as sore throat, fever, and muscle aches. These symptoms would increase in severity over the next four days before reaching the fulminant phase, in which patients experience difficulty breathing, shock, and meningitis. After someone enters the fulminant phase, they have a 90% chance of death even with treatment within two days.[69] Our deployment of treatment via the SNS enables all citizens to be reached within a four day period.

The timeline relies heavily on the ability of doctors and emergency personnel to properly diagnose a patient. Two preventable deaths that occurred following the 2001 attacks highlighted the need to instruct the medical community about weapons of mass destruction. To respond to this gap in knowledge, the government and the medical community have made efforts to increase the awareness of doctors and emergency personnel. The government responded by creating the National Domestic Preparedness Consortium, sponsored by the Department of Defense. The mission of the consortium is to

Enhance the preparedness of federal, state, local, and tribal emergency responders/first receivers and teams, including non-governmental organizations and the private sector, to reduce the Nation’s vulnerability to incidents involving weapons of mass destruction, terrorism, and all-hazard high-consequence events by developing, delivering, and assessing plans, training, technical assistance, and exercises[70]

The vision of the consortium is to eventually be recognized as an ally of the premier institutions of medicine. The program has conducted training programs in all 50 states, and has already trained 60,000 emergency responders and state, local, and tribal government employees. The program offers many courses to increase WMD awareness, both online and in classroom settings.[71] One example of a class offered is the WMD Awareness-Level Training Course. The objectives of this six-hour training program are to provide students with a working knowledge of the current prevention and deterrence strategies, to help them identify indicators of potential terrorist acts, and to allow them to understand recognition, avoidance, isolation, and notification techniques of chemical agents, toxic industrial chemicals and materials, biological materials, radiological and nuclear materials, and explosive devices when used as WMD.  Students will receive awareness-level instruction covering the ways to deal with these hazards. At the end of the course, students receive an ODP certificate of completion.[72]

The medical community has responded by increasing the prevalence of WMD information in their major publications. Respected journals such as the Journal of the American Medical Association and the Annals of Emergency Medicine have published articles depicting symptoms, treatments, and case studies of those affected by WMD. One such article is “Bioterrorism and weapons of mass destruction 2004: Physicians as first responders” by Robin B. McFee DO, MPH. She cites the 2001 attack to show doctors the consequences of their lack of awareness, stating “Physicians who do not know the common signs of deadly, albeit uncommon illnesses, will lose lives.” The article provides symptoms, pictures, medical management, and treatment options for multiple WMD, ensuring that doctors have a training guide which to refer.[73] The medical community has also improved their methods for diagnosing anthrax. In June, 2004, the FDA approved a test for anthrax known as the Immunetics Test. This is the first anthrax test to directly test a patient’s blood specimen, and can be used by any public or private laboratory without the need for specialized equipment or trained personnel. The test was shown to detect 100% of the anthrax patients tested in clinical trials, with less than a 1% chance of false positive results by detecting the presence of the lethal factor in the blood.[74]

Another strength of our solution is the cost-effectiveness of the recommended combination therapy over the antibiotic therapy alone. The full 60 day regimen of Ciprofloxacin costs approximately $204.[75] Three doses of the vaccine combined with the 14 day shortened antibiotic regimen equates to $126 per person.[76] Thus, combination treatment saves $78 per infected person.

Our proposal recommends that the United States incurs a great cost. Each dose of the current anthrax vaccine is $10, and to stockpile the SNS as recommended by our proposal requires the government to spend approximately $3.3 billion.[77] While this number may seem excessive, the solution is actually the most cost-effective method for eliminating anthrax as a biological threat. If the entire nation were to be pre-vaccinated, every citizen would require 5 doses to complete the initial regimen plus an annual booster shot.[78] The cost of pre-vaccination would be at least $18 billion. By stockpiling only the first dose of the vaccine and enough to treat those affected with the short-regimen, the United States has a great enough number of doses to eliminate the threat of anthrax without investing in vaccinations, that under the deterrence theory, will never be necessary.

In addition to being less cost-effective, pre-vaccination can be deemed as implausible as shown by past government attempts. In 2003, an attempt was made to vaccinate the U.S. population against small pox, another Select agent, with a newly developed vaccine. The CDC proposed to vaccinate 500,000 doctors, nurses and other health workers in a 3 month period. They then proposed to be ready to vaccinate up to 10 million others. At the end of 3 months, only about six percent of the targeted workers had been vaccinated. Health-care workers refused to get the vaccine due to fear of risks to themselves and their families. Despite major efforts by the CDC to address these concerns, they were not able to overcome the hesitancy of the participants.[79] Currently, the United States has been dealing with the H1N1 flu epidemic. Although a vaccine is available to the public, the fear of extreme and rare side effects such as Guillain-Barre, has prevented many susceptible people from receiving the vaccine.[80]

Our proposal also relies on the ability of Emergent to quickly produce a great number of vaccines. Although Emergent is attempting to scale-up its Biothrax activities, its new facility is only capable of producing 60 million vaccines per annum.[81] Ideally, every citizen would be able to strictly follow the current vaccination regimen, meaning that one month after the attack they should receive their second dose of vaccine. Emergent does not currently have the capability to provide this many doses in the one-month time frame. We recommend the government put forth whatever funds are necessary to expand these capabilities to produce another cycle of 300 million doses in one month if an attack should occur.

Another weakness of our solution is that the current vaccine has a shelf-life of only four years.[82] Thus, the entire stockpile must be replaced in four years. However, as previously stated, both Emergent and Pharmathene are currently developing second generation vaccines that will require less doses. The SNS should contain the most up-to-date vaccine available, thus BioThrax expiring in four years allows the government to cycle in the newer vaccine that ideally will also have a longer shelf life. This process of perfecting the vaccine will continue until a single dose, cost-effective, 100% efficient vaccine is produced and stockpiled.

Our proposal attempts to address all of the elements of anthrax that make it a viable biological weapon. The entirety of our proposal can be split into two parts- implementing pre-attack precautions and defining post-attack strategy. By ensuring both parts are in place, all enemies of the United States will be deterred from using anthrax in an attack. The strategy of bio-deterrence will render an entire class of weapons ineffective.

Section 6

The Department of Homeland Security was created to protect the civilian sphere of the United States. This department oversees 22 government agencies, all of which focus on benefiting the citizens and protecting their civil liberties. Due to the domestic focus of the solution, the Department of Homeland Security is the most suitable department to support the proposal and publicly announce the strategy.[83]

The current secretary of the Department of Homeland Security, Janet Napolitano, would relay the biodeterrence proposal through a national address. As the secretary of a position that was created in response to the attacks of September 11, 2001, her main responsibilities are to help the nation respond to terrorist attacks and natural disasters. Napolitano has spoken on issues such as border security, securing Americans against cyber attacks, and the preparedness of the Red Cross.[84]

Napolitano’s speeches function to relay any updates to national security or any new strategies that are currently being implemented or have already been established to the public. These addresses are nationally and globally broadcasted in order to make them available to both national and international audiences. This enables the address to reach a broader audience and guarantees the documentation and support of the solution by the U.S. government.

As a means to further national security, the solution would need to be made known to all citizens, civilian and military personnel. The most efficient way to do so is through a national address from a prominent political figure. The speech would create deterrence because it solidifies the plan as a current strategy of the United States to global leaders. The audience for such a speech will be the some of the major players in the global community. By stating the proposal publically they will have the opportunity to know what the United States is doing to protect itself (See Appendix 3).

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Wright, Robert.”Why a real war on terrorism brings out the best in us. (8) – By Robert Wright -.” Slate Magazine. Web. 18 Sep. 2009. <http://www.slate.com/id/2070210/entry/2070799/>.

Appendix 1 – Population Density Map of the United States

Figure 1″USA 2000 Population Density.” Map. Boston University School of Theology Library Archives. Boston University, 10 Sept. 2007. Web. 14 Oct. 2009. <http://sthweb.bu.edu/archives/index.php?option=com_awiki&view=mediawiki&article=File:USA-2000-population-density.gif>.

Description: 2000 U.S. population density in persons per sq. mile (contiguous U.S. only). Averaged on a per-county basis.

Legend, light to dark (white to dark blue):

  • 0-1 (white)
  • 1-4 (yellow)
  • 5-9 (yellow-green)
  • 10-24 (green)
  • 25-49 (teal)
  • 50-99 (dark teal)
  • 100-249 (blue)
  • 250-66,995 (dark blue)

Appendix 2 – Timelines


[1] “Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Congress must act to prevent WMD attack.” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Home. Web. 8 Oct. 2009. <http://www.preventwmd.gov/congress_must_act_to_prevent_wmd_attack/>.

[2] “Biological weapons – definition of Biological weapons in the Medical dictionary – by the Free Online , Thesaurus and Encyclopedia.” Medical Dictionary. Web. 15 Sept. 2009. <http://medical-dictionary.thefreedictionary.com/Biological+weapons>.

[3] “NOVA Online | Bioterror | Global Guide to Bioweapons (Flash).” PBS. Web. 17 Sep. 2009. <http://www.pbs.org/wgbh/nova/bioterror/glob_flash.html>.

[4] “Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Congress must act to prevent WMD attack.” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Home. Web. 8 Oct. 2009. <http://www.preventwmd.gov/congress_must_act_to_prevent_wmd_attack/>.

[5] “Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Congress must act to prevent WMD attack.” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Home. Web. 8 Oct. 2009. <http://www.preventwmd.gov/congress_must_act_to_prevent_wmd_attack/>.

[6] “Introduction of the WMD Prevention and Preparedness Act of 2009 (S.1649).” Federation of American Scientists. Web. 13 Sep. 2009. <http://www.fas.org/irp/congress/2009_cr/s1649.html>.

[7] Graham, Bob, and Jim Talent. “Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism :: Bioterrorism: Redefining Prevention.” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism :: Home. Web. 18 Sept. 2009. <http://www.preventwmd.gov/6_09/>.

[8] Weapons of Mass Destruction Act of 2009, S. 1649, 111 Cong., United States Senate Committee on Homeland Security and Government Affairs: Press 3 (2009). Print.

[9]“Introduction of the WMD Prevention and Preparedness Act of 2009 (S.1649).” Federation of American Scientists. Web. 13 Sep. 2009. <http://www.fas.org/irp/congress/2009_cr/s1649.html>.

[10] Weapons of Mass Destruction Act of 2009, S. 1649, 111 Cong., United States Senate Committee on Homeland Security and Government Affairs: Press 3 (2009). Print.

[11] Graham, Bob, and Jim Talent. “Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism :: Bioterrorism: Redefining Prevention.” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism :: Home. Web. 18 Sept. 2009. <http://www.preventwmd.gov/6_09/>.

[12] Weapons of Mass Destruction Act of 2009, S. 1649, 111 Cong., United States Senate Committee on Homeland Security and Government Affairs: Press 3 (2009). Print.

[13] Weapons of Mass Destruction Act of 2009, S. 1649, 111 Cong., United States Senate Committee on Homeland Security and Government Affairs: Press 3 (2009). Print.

[14] “ASM Comments on the Weapons of Mass Destruction Prevention and Preparedness Act of 2009.” Microbiology — The American Society For Microbiology. Web. 5 Oct. 2009. <http://www.asm.org/index.php?option=com_content&view=article&id=91066&title=ASM+Comments+on+the+Weapons+of+Mass+Destruction+Prevention+and+Preparedness+Act+of+2009&Itemid=349>.

[15] “ASM Comments on the Weapons of Mass Destruction Prevention and Preparedness Act of 2009.” Microbiology — The American Society For Microbiology. Web. 5 Oct. 2009. <http://www.asm.org/index.php?option=com_content&view=article&id=91066&title=ASM+Comments+on+the+Weapons+of+Mass+Destruction+Prevention+and+Preparedness+Act+of+2009&Itemid=349>.

[16] Matishak, Martin. “NTI: Global Security Newswire – Group Warns Biosecurity Bill

Could Burden Scientific Research.” NTI – Global Security Newswire. 19 Nov. 2009. Web. 5 Dec. 2009. <http://www.globalsecuritynewswire.org/gsn/nw_20091119_7367.php>.

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[19] Fischer, Dr. Julie. “Interview with Dr. Fischer.” Personal interview. 30 Oct. 2009.

[20] Responsible Research with Biological Select Agents and Toxins. Washington: The National Academies, 2009. Print.

[21] Responsible Research with Biological Select Agents and Toxins. Washington: The National Academies, 2009. Print.

[22] Responsible Research with Biological Select Agents and Toxins. Washington: The National Academies, 2009. Print.

[23] Responsible Research with Biological Select Agents and Toxins. Washington: The National Academies, 2009. Print.

[24] Responsible Research with Biological Select Agents and Toxins. Washington: The National Academies, 2009. Print.

[25] United States of America. National Secutiy Council. Executive Office of the President. National Strategy for Countering Biological Threats. National Security Council, 9 Dec. 2009. Web. 9Dec. 2009. <http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Countering_BioThreats.pdf>.

[26] “Preventing Biological Weapons Proliferation and Bioterrorism.” U.S. Department of State. Web. 10 Dec., 2009. <http://www.state.gov/t/us/133335.htm#>.

[27] United States of America. National Secutiy Council. Executive Office of the President. National Strategy for Countering Biological Threats. National Security Council, 9 Dec. 2009. Web. 9 Dec. 2009. <http://www.whitehouse.gov/sites/default/files/National_Strategy_for_Countering_BioThreats.pdf>.

[28] Eisner, Peter, and Delthia Ricks. “Experts divided on odds of germ attack — chicagotribune.com.” Chicago Tribune breaking news, sports, weather and traffic in Chicago – chicagotribune.com. 13 Sept. 2001. Web. 28 Sept. 2009. <http://www.chicagotribune.com/news/nationworld/chi-0109130352sep13,0,4909373.story>.

[29] Cieslak, Theodore J., and Edward M. Eitzen. “Clinical and Epidemiologic Principles of Anthrax.” Centers for Disease Control and Prevention. Web. 2 Nov. 2009. <http://www.cdc.gov/ncidod/EID/vol5no4/cieslak.htm>.

[30] Geddes, Alasdair. “Infection in the twenty-first century: predictions and postulates — Geddes 46 (6): 873 — Journal of Antimicrobial Chemotherapy.” Oxford Journals | Medicine | Journal of Antimicrobial Chemotherapy. 1999. Web. 26 Oct. 2009. <http://jac.oxfordjournals.org/cgi/content/full/46/6/873>.

[31] “HowStuffWorks “How Anthrax Works”” Howstuffworks “Science” Web. 24 Sep. 2009. <http://science.howstuffworks.com/anthrax.htm>.

[32] “Anthrax.” Manbir Online … for Health & Fitness. Web. 25 Sep. 2009. <http://www.manbir-online.com/diseases/anthrax-2.htm>.

[33] “ASA Newsletter – Anthrax Toxin.” ASA Inc – Topics In Chemical And Biological Warfare And Bio Terrorism. Web. 2 Oct. 2009. <http://www.asanltr.com/newsletter/03-3/articles/Anthrax.htm>.

[34] “HowStuffWorks “How Anthrax Works”” Howstuffworks “Science” Web. 24 Sep. 2009. <http://science.howstuffworks.com/anthrax.htm>.

[35] “FDA Approves First Blood Test for Anthrax; Boston Based Company Test Shown to be Accurate for Anthrax Diagnosis. – Free Online Library.” News, Magazines, Newspapers, Journals, Reference Articles and Classic Books – Free Online Library. Web. 3 Dec. 2009.

[36] “Inhalation Anthrax.”Medline Plus Web. 2 Dec. 2009. <http://www.nlm.nih.gov/medlineplus/ency/article/000641.htm.>

[37] “HowStuffWorks “How Anthrax Works”” Howstuffworks “Science” Web. 24 Sep. 2009. <http://science.howstuffworks.com/anthrax.htm>.

[38] “Analysis of the US anthrax cases.” Analyzing The Anthrax Attacks – 2009 edition. Web. 22 Sep. 2009. <http://www.anthraxinvestigation.com/index.html#refining>.

[39] “Analysis of the US anthrax cases.” Analyzing The Anthrax Attacks – 2009 edition. Web. 22 Sep. 2009. <http://www.anthraxinvestigation.com/index.html#refining>.

[40] Takahashi H, Keim P, Kaufmann AF, Keys C, Smith KL, Taniguchi K, et al. Bacillus anthracis incident, Kameido, Tokyo, 1993. Emerg Infect Dis [serial online] 2004 Jan [date cited]. Available <http://www.cdc.gov/ncidod/EID/vol10no1/03-0238.htm>

[41] “The Case Against Bruce Ivins – washingtonpost.com.” Washingtonpost.com – nation, world, technology and Washington area news and headlines. Web. 22 Oct. 2009. <http://www.washingtonpost.com/wp-dyn/content/article/2008/08/06/AR2008080602794.html>.

[42] “American Anthrax Outbreak of 2001.” UCLA Department of Epidemiology: School of Public Health. 28, Oct.2009.

<http://www.ph.ucla.edu/epi/bioter/detect/antdetect_list.html.>

[43] Kosal, Margaret E., Terron, Ann, and Lange, Katherine. 2009. Bioterrorism Deterrence:

the Role of Public Health in Security. Atlanta, Georgia: Sam Nunn School of International Affairs Publications.(PDF document downloaded 21 Nov 2009)

[44]“Nuclear Deterrence, Missile Defenses and Global Instability, by David Krieger, April 2001.” Nuclear Age Peace Foundation. Web. 1 Nov. 2009. <http://www.wagingpeace.org/articles/2001/04/00_krieger_nuclear-deterrence.htm>.

[45] “Nuclear Deterrence, Missile Defenses and Global Instability, by David Krieger, April 2001.” Nuclear Age Peace Foundation. Web. 1 Nov. 2009. <http://www.wagingpeace.org/articles/2001/04/00_krieger_nuclear-deterrence.htm>.

[46] Wright, Robert.”Why a real war on terrorism brings out the best in us. (8) – By Robert Wright -.” Slate Magazine. Web. 18 Sep. 2009. <http://www.slate.com/id/2070210/entry/2070799/>.

[47] Kleiman, Mark, and Beau Kilmer. The Dynamics of Deterrence. Publication. University of California in Los Angeles, 15 June 2009. Web. 25 Oct. 2009. <http://www.spa.ucla.edu/faculty/kleiman/Dynamics%20of%20Deterrence%20PNAS%202009[1].pdf>.

[48]Kosal, Margaret E., Terron, Ann, and Lange, Katherine. 2009. Bioterrorism Deterrence:

the Role of Public Health in Security. Atlanta, Georgia: Sam Nunn School of International Affairs Publications.(PDF document downloaded 21 Nov 2009)

[49] “CDC | Strategic National Stockpile.” CDC Emergency Preparedness & Response Site. Web. 5 Oct. 2009. <http://www.bt.cdc.gov/stockpile/>.

[50] “CDC | Strategic National Stockpile.” CDC Emergency Preparedness & Response Site. Web. 5 Oct. 2009. <http://www.bt.cdc.gov/stockpile/>.

[51]“CDC | Strategic National Stockpile.” CDC Emergency Preparedness & Response Site. Web. 5 Oct. 2009. <http://www.bt.cdc.gov/stockpile/>.

[52] “Strategic National Stockpile | NACCHO.” National Connection for Local Public Health | NACCHO. Web. 23 Oct. 2009. <http://www.naccho.org/topics/emergency/SNS/>.

[53] “Strategic National Stockpile | NACCHO.” National Connection for Local Public Health | NACCHO. Web. 23 Oct. 2009. <http://www.naccho.org/topics/emergency/SNS/>.

[54] “Strategic National Stockpile | NACCHO.” National Connection for Local Public Health | NACCHO. Web. 23 Oct. 2009. <http://www.naccho.org/topics/emergency/SNS/>.

[55] “Strategic National Stockpile | NACCHO.” National Connection for Local Public Health | NACCHO. Web. 23 Oct. 2009. <http://www.naccho.org/topics/emergency/SNS/>.

[56] “CIDRAP HHS evaluates proposals for new anthrax vaccine.” CIDRAP Center for Infectious Disease Research and Policy. Web. 12 Nov. 2009. <http://www.cidrap.umn.edu/cidrap/content/bt/bioprep/news/aug1208vaccine-jw.html>.

[57] “Anthrax Vaccine Immunization Program.” The Official DoD Anthrax Information Web Site. Web. 4 Nov. 2009. <http://www.anthrax.osd.mil/>.

[58] “Anthrax Vaccine Immunization Program.” The Official DoD Anthrax Information Web Site. Web. 4 Nov. 2009. <http://www.anthrax.osd.mil/>.

[59]“Emergent BioSolutions-BioThrax.” Emergent Biosolutions. Web. 3 Oct. 2009. <http://www.emergentbiosolutions.com/html/biothrax.aspx>.

[60] “Anthrax Vaccine Immunization Program.” The Official DoD Anthrax Information Web Site. Web. 4 Nov. 2009. <http://www.anthrax.osd.mil/>.

[61]“Is new always better than old?: The development of… [Hum Vaccin. 2009] – PubMed result.” National Center for Biotechnology Information. Web. 27 Oct. 2009. <http://www.ncbi.nlm.nih.gov/pubmed/19786839>.

[62] “Emergent BioSolutions-BioThrax.” Emergent Biosolutions. Web. 3 Oct. 2009. <http://www.emergentbiosolutions.com/html/biothrax.aspx>.

[63] “Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Congress must act to prevent WMD attack.” Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism: Home. Web. 8 Oct. 2009. <http://www.preventwmd.gov/congress_must_act_to_prevent_wmd_attack>.

[64] “USA 2000 Population Density.” Map. Boston University School of Theology Library Archives. Boston University, 10 Sept. 2007. Web. 14 Oct. 2009. <http://sthweb.bu.edu/archives/index.php?option=com_awiki&view=mediawiki&article=File:USA-2000-population-density.gif>.

[65] “Use of Anthrax Vaccine in the United States.” Centers for Disease Control and Prevention. 15 Dec. 2000. Web. 25 Oct. 2009. <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>.

[66] “Use of Anthrax Vaccine in the United States.” Centers for Disease Control and Prevention. 15 Dec. 2000. Web. 25 Oct. 2009. <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>.

[67] “Use of Anthrax Vaccine in the United States.” Centers for Disease Control and Prevention. 15 Dec. 2000. Web. 25 Oct. 2009. <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>.

[68] “Anthrax.” Manbir Online … for Health & Fitness. Web. 25 Sep. 2009. <http://www.manbir-online.com/diseases/anthrax-2.htm>.

[69] “Inhalation Anthrax.”Medline Plus Web. 2 Dec. 2009. <http://www.nlm.nih.gov/medlineplus/ency/article/000641.htm.>

[70] Welcome to NDPC. Web. 3 Dec. 2009. <http://www.ndpc.us/>

[71] “Homeland Security Training Program homepage.” Wyoming Law Enforcement Academy. Web. 8 Dec. 2009. <http://www.wleacademy.com/HLS/index.htm>.

[72] “Homeland Security Training Program homepage.” Wyoming Law Enforcement Academy. Web. 8 Dec. 2009. <http://www.wleacademy.com/HLS/index.htm>.

[73]McFee, Robin B. 2004. Bioterrorism and weapons of mass destruction 2004:

Physicians as first responders. Wynnewood, PA: American Academy of Clinical Toxicology.(PDF document downloaded 3 Dec 2009)

[74] “FDA Approves First Blood Test for Anthrax; Boston Based Company Test Shown to be Accurate for Anthrax Diagnosis. – Free Online Library.” News, Magazines, Newspapers, Journals, Reference Articles and Classic Books – Free Online Library. Web. 3 Dec. 2009. <http://www.thefreelibrary.com/FDA+Approves+First+Blood+Test+for+Anthrax;+Boston+Based+Company+Test+…-a0117874737>.

[75] “Use of Anthrax Vaccine in the United States.” Centers for Disease Control and Prevention. 15 Dec. 2000. Web. 25 Oct. 2009. <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>.

[76] “Use of Anthrax Vaccine in the United States.” Centers for Disease Control and Prevention. 15 Dec. 2000. Web. 25 Oct. 2009. <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>.\

[77] “Use of Anthrax Vaccine in the United States.” Centers for Disease Control and Prevention. 15 Dec. 2000. Web. 25 Oct. 2009. <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr4915a1.htm>.

[78] “Emergent BioSolutions-BioThrax.” Emergent Biosolutions. Web. 3 Oct. 2009. <http://www.emergentbiosolutions.com/html/biothrax.aspx>.

[79] “Report: Smallpox Program Too Slow to Evaluate.” Vaccination News. Web. 13 Dec. 2009. <http://www.vaccinationnews.com/DailyNews/2003/May/03/ReportSmallpox3.htm>.

[80] Fritsky, Lauren. “Why I Won’t Get the H1N1 Vaccine -.” Lemondrop.com. Web. 5 Dec. 2009. <http://www.lemondrop.com/2009/11/05/why-i-wont-get-the-h1n1-vaccine/>.

[81] “HHS Cancels RFP for rPA Procurement and Modifies Their Approach in Favor of BAA for Development of rPA Vaccines: Business Wire Business News – MSN Money.” News: Business, Financial and Investing News – MSN Money. Web. 13 Dec. 2009. <http://news.moneycentral.msn.com/provider/providerarticle.aspx?feed=BW&date=20091207&id=10844410>.

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Security, Security Projects


Proposed Bleeding Disorder Bill

January 11th, 2010

Open Questions:

1) What would be the most effective, politically feasible form for a bill implementing the von Willebrand’s screening recommendations of H.Con.Res.147?

2) Will any new, substantial additions to the healthcare reform package be made over the next month?  If so, how feasible would it be for a Member to include this bill as an amendment?  If not, I’m looking for other moving bills, to which this bleeding disorder bill could be attached.

*****
Please read the Discussion Draft of the bill below, or click on this link to view a PDF of the Discussion Draft:  Bleeding Disorders – Discussion Draft[1].
*****

A BILL

To authorize the Secretary of Health and Human Services to conduct programs to screen adolescents, and educate health professionals, with respect to bleeding disorders.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

This Act may be cited as the ‘‘[ ] Act of 2009’’.

SEC. 2. FINDINGS.

The Congress finds as follows: [TBA]

SEC. 3. ADOLESCENT SCREENING PROGRAMS.

(a) IN GENERAL.—The Secretary of Health and Human Services (in this Act referred to as the ‘‘Secretary’’), directly or through the award of grants or contracts to States, political subdivisions of States, or other public or nonprofit private entities, shall carry out the following activities:

(1) Development of a verbal screening tool to use in the
diagnosis of bleeding disorders in adolescents.

(2) As widely as possible in adolescent populations—

(A) use of the verbal screening tool developed under
paragraph (1) and other screening tools relevant to the
diagnosis of bleeding orders in adolescents;

(B) if screening suggests the possibility of a bleeding
disorder, provision of further laboratory-based diagnostic
testing; and

(C) provision of referrals for medical services regarding
bleeding disorders.

(b) PRIORITY.—In awarding any grant or contract under subsection (a), the Secretary shall give priority to applicants proposing to provide screening to high school or institution of higher education students.

(c) TECHNICAL ASSISTANCE.—The Secretary, directly or through grants or contracts, may provide recipients of grants or contracts under subsection (a) with technical assistance regarding the planning, development, and implementation of activities under such subsection.

(d) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there is authorized to be appropriated [to be determined]

SEC. 4. INCREASING AWARENESS AMONG HEALTH PROFESSIONALS.

(a) IN GENERAL.—The Secretary, directly or through the award of grants or contracts to States, political subdivisions of States, or other public or nonprofit private entities, shall conduct an education campaign to increase awareness about bleeding disorders among health professionals.

(b) PRIORITY.—In awarding any grant or contract under section (a), the Secretary shall give priority to applicants proposing to increase awareness about bleeding disorders among—

(1) health professionals, such as primary care physicians, who
commonly provide medical care for the adolescent population; or

(2) obstetricians and gynecologists.

(c) TECHNICAL ASSISTANCE.—The Secretary, directly or through the award of grants or contracts, may provide recipients of grants or contracts under subsection (a) with technical assistance regarding the planning, development, and implementation of activities under such subsection.

(d) AUTHORIZATION OF APPROPRIATIONS.—To carry out this section, there is authorized to be appropriated [to be determined]

SEC. 5. REPORT.

(a) IN GENERAL.—Not later than [ ] after the date of the enactment of this Act, the Secretary shall submit to the Congress a report on the results of activities under this Act.

(b) CONTENTS.—At a minimum, the report under subsection (a) shall—

(1) catalog, with respect to bleeding disorder screening and
health professional education—

(A) the activities of the Federal Government, including an
assessment of the progress achieved under this Act;

(B) the portion of students in United States high schools
and institutions of higher education who have received some
form of screening for bleeding disorders as a result of programs
under this Act; and

(C) the number of health professionals who have received
some form of bleeding disorder education as a result of
programs under this Act; and

(2) make recommendations for the future direction of bleeding
disorder activities, including—

(A) a description of how the Federal Government, as well
as recipients of grants and contracts under this Act, may
improve their screening and education programs to increase
bleeding disorder diagnostic rates, including the identification
of steps that may be taken to reduce—

(i) the prevalence of undiagnosed bleeding disorders;
and

(ii) the burden of bleeding disorders as a chronic
condition;

(B) an identification of organizations that have most
effectively and efficiently increased bleeding disorder screening
rates;

(C) an identification of programs and procedures that have
most effectively and efficiently increased bleeding disorder
screening rates, and steps that may be taken to expand such
programs and policies to benefit larger populations; and

(D) recommendations for future research and interventions.

*****
The bill has evolved from a concurrent resolution, H.Con.Res.147, introduced to Congress over the summer by Representative Carolyn McCarthy and included below.
*****

H. CON. RES. 147

    Expressing the sense of Congress regarding people in the United States with bleeding disorders.

IN THE HOUSE OF REPRESENTATIVES

June 11, 2009

Mrs. McCarthy of New York (for herself, Mr. Bishop of Georgia, Ms. Kilpatrick of Michigan, Mr. LoBiondo, Mr. Cummings, Ms. Baldwin, and Ms. Bordallo) submitted the following concurrent resolution; which was referred to the Committee on Energy and Commerce


CONCURRENT RESOLUTION

Expressing the sense of Congress regarding people in the United States with bleeding disorders.

    Whereas the lives of millions of people in the United States are impacted by both congenital and inherited bleeding disorders as patients, asymptomatic carriers, and caregivers;
    Whereas studies estimate that as many as 1 in 50 people in the United States suffer from von Willebrand’s disease, making it the most common inherited bleeding disorder in the United States;
    Whereas von Willebrand’s disease is characterized by frequent nosebleeds, recurrent bleeding from the mouth and gums often resulting in periodontal disease, swollen and painful joints, gastrointestinal bleeding, excessive bruising, postoperative bleeding, prolonged bleeding following minor injury, and menorrhagia (excessive menstrual bleeding);
    Whereas studies estimate that 13 to 20 percent of women in the United States diagnosed with menorrhagia suffer from von Willebrand’s disease;
    Whereas an accurate diagnosis of von Willebrand’s disease is sometimes difficult to obtain given current standard laboratory testing techniques, and, as a result, the majority of people in the United States who suffer from von Willebrand’s disease remain undiagnosed;
    Whereas failure to correctly diagnose von Willebrand’s disease in women may lead to unnecessary hysterectomies resulting in increased risk from bleeding at the time of surgery;
    Whereas effective medical treatments are available for von Willebrand’s disease when it is diagnosed properly;
    Whereas the onset of von Willebrand’s disease symptoms usually occurs during adolescence and the symptoms can remain undiagnosed for several years;
    Whereas programs designed to increase screening for von Willebrand’s disease in adolescents could greatly improve diagnosis;
    Whereas the Current Population Study estimates that 67 percent of high school graduates enroll in institutions of higher education;
    Whereas prior to entering institutions of higher education, students have to receive a physical examination and meet immunization requirements; and
    Whereas including a verbal screening tool for von Willebrand’s disease as part of the medical requirement for entrance into institutions of higher education would increase early diagnosis, improve treatment, and lead to better health outcomes: Now, therefore, be it

Resolved by the House of Representatives (the Senate concurring), That it is the sense of Congress that—

(1) the Federal Government has a responsibility to—

(A) further the research that is needed to identify a more accurate laboratory test for von Willebrand’s disease;

(B) increase funding for biomedical and psychosocial research on von Willebrand’s disease, rare blood disorders, and hemophilia;

(C) continue to improve access to treatment centers for all individuals with bleeding disorders;

(D) improve public education and awareness of bleeding disorders; and

(E) support screening for von Willebrand’s Disease as an aspect of the health requirements of all institutions of higher education;

(2) the Director of the National Institutes of Health should take a leadership role in the fight against bleeding disorders by acting through appropriate offices within the National Institutes of Health to provide Congress with a 5-year research plan for people with bleeding disorders;

(3) the Director of the Centers for Disease Control and Prevention should continue the critical role of the Centers in improving outreach about, treatment for, and prevention of the complications of people with bleeding disorders by facilitating an educational relationship between treatment centers, university health clinics, and undergraduate student populations;

(4) referral of a person with a bleeding disorder to a federally sponsored hemophilia treatment center is critical to comprehensive treatment of people with bleeding disorders;

(5) physicians should screen all women presenting with menorrhagia, especially severe menorrhagia, for von Willebrand’s disease;

(6) patient advocate organizations and medical specialty societies should continue to collaborate on public education campaigns to educate people about bleeding disorders; and

(7) physicians should screen all adolescents attending institutions of higher education for von Willebrand’s disease.


Global Health, Global Health Projects


Antibiotic Resistance: Conquering the Killer Within

January 11th, 2010

Section I: Summary

Antibiotic resistance has become a major hurdle in treating diseases. The rate of drug discovery is incomparable to the rate of drug resistant bacterial mutations. Although the treatment of many diseases has been impaired by this challenge, the treatment of tuberculosis, one of the top three infectious diseases, is by far the most impeded. Tuberculosis, which affects one third of the world’s population[1], is highly prevalent in the developing world. As a result, the treatment and prevention of this disease has been limited due to lack of funding, research, and established programs. The global emergence of multi drug resistant tuberculosis (MDR-TB) has quickly become a universal concern.  The lack of effective drugs to treat MDR-TB has drawn our attention to preventative measures to impede the possibility of global emergence.

Our strategy towards a preventive measure was inspired by successes seen in rebate programs applied in various contexts.  Rebates have infrequently been implemented in the health sector.  As premature termination of drugs is a major contributing factor to antibiotic resistance, instituting a rebate system in the health sector will motivate patients to comprehensively complete drug regimens because of the financial responsibility placed on them. The rebate system has great potential as it not only motivates patients, but also provides an incentive for pharmaceutical companies to provide the rebate. Patients are more likely to complete and thus receive greater amounts of the antibiotic if they have an incentive to finish their drug regimen. As a consequence, there will be greater demand for the antibiotic from the manufacturing pharmaceutical companies, causing increased revenue. If only a portion of this were to be redistributed in form of a rebate to the patients, this program would not only be self-sustainable, but also not require government funding. In conjunction with a national awareness campaign regarding the importance of drug completion and the potential for a financial rebate, the rebate system has great promise in areas without preexisting treatment programs.

In areas with existent treatment programs where drugs are provided to patients at no cost, rewards and contract programs can be used to entice patients to complete their drug regimen. Through this program, patients are reimbursed for transportation fees, and provided with food and hygiene products, after receiving treatments. Although this program is not self-sustainable, as it requires that a third party, such as the government, to provide funding for the rewards, case studies have indicated low costs associated with this program. Patients sign a binding contract stating that they will be financially responsible for the cost of treatment if they do not complete the drug regimen, further enticing them to comply with the regulations of the program. We believe that the implementation of these programs provide motivation for patients to complete prescribed drug regimens, diminishing the emergence of drug resistant tuberculosis due to selective pressure associated with early termination of drugs.

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Section III: Microbial Resistance

The development of antimicrobial agents to fight infectious diseases was a breakthrough in the scientific community. Antimicrobial agents have proven to be very effective in treating certain diseases; however, their effectiveness is only attainable when they are administered and used appropriately. Microbes can confer resistance as a result of natural mutations in their genetic code, though a more pressing concern is resistance attributed to human factors. Failure to adhere to drug regulations or drug regimens results in a microbe’s ability to survive in the presence of the particular drugs used. This microbial resistance is then passed on to the microbe’s progeny as it replicates and divides. The ease and rapidity at which microbes pass on genes conferring resistance pose a serious threat to our health and our ability to fight off infections, for which science and drugs simply cannot keep up. The avenue in which to best combat this issue lies in amending human factors, as they are a major cause of antimicrobial resistance[2].

Drugs rendered ineffective by antimicrobial resistance have serious implications for treating infectious diseases. If a microbe develops resistance to first-line drugs, second-line drugs are then issued which are typically more expensive. Treatment is usually much longer, less successful and tends to have more harmful side effects– all factors that increase the chance of resistance spreading. Seeing the potential for antimicrobial resistance to become an even larger concern, the World Health Organization (WHO) initiated the Global Strategy for Containment of Antimicrobial Resistance in 20011. As stated in the title of this project, antimicrobial resistance is a global issue; every country is susceptible to the phenomenon and thus every country must take action. All countries, developing or developed, need to collaborate in order to help stop the spread and emergence of antimicrobial resistance. Moreover, because of increased globalization and ease of transnational travel, the threat of resistance spreading across boarders is greatly increased.

Tuberculosis

One disease in particular that is subject to microbial resistance is tuberculosis (TB), which is a contagious airborne diseased caused by the bacterium Mycobaterium tuberculosis. TB is one of the top three deadliest infectious diseases, alongside HIV/AIDS and malaria[3]. One third of the world’s population is infected with M. tuberculosis, with 10% of them developing the active, transmissible form of TB, capable of infecting an average of 15 other individuals[4]. Clearly there is the potential for the spread of TB to grow if left unchecked. The number of global TB cases has increased from 6.6 million in 1990 to 9.27 million in 20074. Although TB is present in every country, the regions hit hardest with the disease are Asia and Africa, where 55% and 31% of the incident cases in 2007 were located, respectively[5]. As seen in Figure 1 (pg. 3), the number of TB cases has increased for both Asia and Africa, while the number of TB cases in other regions has remained roughly the same. This figure also shows that the rate of increase in Africa is greater than that of Asia, partly due to the higher rate of HIV in Africa2.

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Figure 1. The number of new TB cases per year for Asia, Africa, and other regions between 1990 and 200510

Several initiatives have been put in place to help stop the spread and emergence of TB, including the WHO-led DOTS (directly observed treatment, short-course), the Stop TB strategy, and the Green Light Committee. All three, in addition to other programs, have been successful in stopping TB’s prevalence in countries that strictly adopt their policies. In particular, DOTS has been able to produce cure rates of over 95% in countries that comprehensively adopt the program5. DOTS’ success stems from its insistence on directly observing patients take their medications. One of the biggest problems with TB treatment is that patients do not realize the importance of strictly adhering to their drug regimen. If throughout the course of treatment they begin to feel better, they may stop taking their medications because they believe they have been cured. Terminating treatment, however, has dire consequences, as it allows for those microbial strains to develop resistance to the drugs that were used. In the case of TB, developing resistance to both first-line drugs – isoniazid and rifampicin – results in multidrug-resistant TB (MDR-TB)[6].

Multi-drug Resistant Tuberculosis

A person can acquire MDR-TB either by catching it from another individual, or by developing resistance after failed attempts at treating drug-susceptible TB. Because MDR-TB is resistant to both first-line drugs, second-line drugs must be used, which tend to produce harmful side effects. These drugs are much more expensive as well, as they can be up to 1400 times more costly than first-line drugs7. Treatment is also much longer; drug-susceptible TB treatment lasts roughly six months, while MDR-TB treatment lasts up to two years. A 2007 study in Singapore found that the transmission rate of Beijing’s MDR-TB strains increased from 4.4% to 7.7%8. Additionally, the cure rate of MDR-TB decreased to 67% from a 95+% cure rate for drug-susceptible TB9. If MDR-TB is not properly treated, it can lead to extensively drug-resistant TB (XDR-TB), which has even more serious implications regarding treatment9. Seeing the complexity and difficulty of treating MDR-TB, our solution to this problem takes a preventative approach; it consists of implementing an initiative that targets drug-susceptible TB so that it does not develop into MDR-TB.

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Figure 2. The incidence rates of MDR-TB between 1994 and 2007 on a global scale66.

According to Figure 2, the areas in yellow correspond to countries with more than a 6% incident rate of MDR-TB among new TB cases. It is clear that the highest rates of MDR-TB are located in Eastern Europe, the Russian Federation and areas in Western Asia. It is estimated that the population-weighted mean of MDR-TB cases among all reported TB cases worldwide is 5.3%, with some areas reporting 0% and some areas reporting up to 35%6. Even though absolute numbers of TB cases are located largely in Asia and Africa, the occurrence of MDR-TB is greatest in India and China (who shoulder 50% of the cases), and the Russian Federation (who shoulders 7% of the cases)6.

The WHO report, Anti-tuberculosis drug resistance in the world, published in February 2008 recorded the highest rates of MDR-TB compared to all previous reports. It estimated that half a million new cases of MDR-TB emerge a year10. Even though it reported the highest rates worldwide, MDR-TB trends vary by region. In Peru, for example, MDR-TB is on the rise, while in the US, MDR-TB is declining6. Proportions of MDR-TB among all TB cases in Moldova, Ukraine, the Russian Federation, and Uzbekistan were all higher than the rates recorded in 2004. The country with the highest recorded rate was Eastern Europe’s Azerbaijan, where 22.3% of all TB cases were MDR-TB1010.

Targeting MDR-TB in Eastern Europe

Referring back to Figure 2, one of the regions with the highest percentage of MDR-TB among new TB cases is Eastern Europe, making it our region of interest in targeting MDR-TB. Table 1 shows the large disparity between Eastern Europe and the remaining regions regarding the percentage of MDR-TB. The proportion of MDR-TB in Eastern Europe is 22.6% for combined cases, 10.0% for new cases, and 33.7% for previously treated cases.

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Table 1. Incidence rates for MDR-TB per region among new cases6.

This is dramatically higher than rates in Central and Western Europe, where proportions of new, previously treated, and combined cases are 9%, 7.7%, and 1.5%, respectively6. As seen in Figure 3, the proportion of MDR-TB among TB cases is greatest in Azerbaijan, Moldova, and the Ukraine.

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Figure 3. Rates of MDR-TB among new cases in various countries6.

The high rates of MDR-TB in Eastern Europe are largely attributed to the fall of the Union of Soviet Socialist Republics in 1991. The Soviet prisons were breeding grounds for MDR-TB because of poor sanitation environments; when these prisoners were released in 1991, MDR-TB was no longer contained in prisons, but spread amongst the population.  The economic crisis that ensued affected the health care system, resulting in poor treatment of infectious diseases, including TB. This ultimately led to increased prevalence of drug-resistant TB throughout the region. Some countries were less affected, such as Georgia, which recorded proportions of resistance among new cases to be 6.8%6. Such countries have attributed their lower rates to strict adherence to WHO-led initiatives. Needless to say, failure to strictly adopt these policies can result in higher rates of drug-resistant TB, which has been the case in many countries3. For example, Figure 4 (below) shows the difference in MDR-TB rates between Chile and Estonia11. Poor handling of TB, along with a lack of DOTS in Estonia led to increased rates.  On the other hand, the very low rate of MDR-TB in Chile over the years is credited to the presence of the DOTS program, indicating the effectiveness of the program.

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Figure 4. MDR-TB rates in Chile and Estonia from 1991 to 199811.

Conclusions Regarding this Pressing Issue

From discussions about the issues associated with antimicrobial resistance, TB, and particularly MDR-TB in Eastern Europe, it is clear that further actions must be taken in order to tackle this rising problem. Despite increased surveillance and improvements in treating TB patients, drug-resistant TB is still prevalent, especially in the Eastern European region. Our solution to this issue recognizes the lack of TB-drug education among patients and the medical community, and also recognizes the need for an incentive for patients to complete their drug regimens to prevent the spread of resistant strains.

Section IV: Solutions

Providing a solution to prevent the spontaneous occurrence of antibiotic resistance in tuberculosis patients revolves around preventing the selective conditions for mutated resistant bacteria to form. There are two means of approaching a preventive solution to prevent resistance: through the healthcare providers, or patients.  Although regulating the prescription of drugs to patients is an important and essential part of preventing drug resistance, we decided to focus on implementing strategies to prevent this global challenge through the patients for several reasons. Educating physicians about carefully prescribing medications to patients can ensure that patients are given the correct antibiotics, but it cannot guarantee that they will complete their dosages. Enticing patients to take drugs responsibly by educating them and providing them with an incentive is the best approach to preventing the occurrence of antibiotic resistance.

Financial rebates have been useful in various facets of society including recycling programs, product sales, and the automobile industry; however, they have been underutilized in global health programs. Rebates have proven to be a powerful tool to entice the public when there is general reluctance. Tuberculosis programs that have incorporated material and financial incentives have shown to have great success. We propose financial rebates as a means to increase patient responsibility when taking anti-tuberculosis antibiotics, and thus prevent the outbreak of antibiotic resistance. The true novelty of this program is its self-sustainability and it’s funding which rests in the hands of the private sector rather than government funding and organizations.

Rebate Program: Involving the Public and Private Sectors

Often, tuberculosis patients discontinue treatments when symptoms cease to exist. Unfortunately, rather than confirming that they are cured of the disease with a medical examination and tests, patients terminate their treatments on their own. Due to the latency of the diseases, bacteria usually continue to exist within the patient, after symptoms have terminated. When antibiotics are terminated prematurely, patients discontinue purchasing the drug from pharmacies. If there is a financial incentive for patients to continue purchasing and taking the treatment to the end of the course, they will undoubtedly purchase more of the antibiotics. In turn, this increased demand will provide increased profit for pharmaceutical companies. If only a margin of these increased profits was redistributed in form of rebates to patients, patients would continue to buy the entire course of the antibiotic, thus creating a self-sustainable cyclic rebate system. There will undoubtedly be patients who do not receive the rebate because they did not follow the guidelines; we suggest that the rebate be distributed to responsible healthcare providers to encourage diagnosis and proper record keeping and drug prescription. This rebate system is based on a similar strategy enacted by the Bangladesh Rural Advancement Committee, in which patients made a deposit when beginning treatment, which was partially returned to them when the treatment was completed. [7]

In addition to the rebate system, we propose the implementation of a government funded advertisement campaign to promote antibiotic resistance awareness. The purpose of this campaign should be to make residents aware of the symptoms that are characteristic of tuberculosis, and the importance of finishing and not sharing prescribed antibiotics. Without proper education on the risks to patients’ families and themselves, patients may discontinue treatment when symptoms subside.[8] As a part of this program, hospitals should implement a tutorial for patients diagnosed with tuberculosis and physicians detecting and treating tuberculosis. When patients are prescribed antibiotics, they should be made aware of the importance of completing their drug regimen as well as the opportunity to receive financial reimbursement for completing the treatment and frequently getting retested. In combination with a rebate, this two-tiered program will not only educate patients on the importance and severity of multi drug resistant –tuberculosis, but also provide them with an incentive to complete the entire treatment.

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Figure 5. The Self-Sustaining Cycle of the Rebate System.

Successful Cases Supporting this Program

Although the financial aspect of the rebate program is dependent on pharmaceutical companies, enforcement or regulations by the government is essential to the success of the program. In the oblast (district) of Orel in Russia, a combination of patient incentives, and monitoring and enforcement by the tuberculosis facilities and legal systems led to a very high success rate; only 3% of those diagnosed with tuberculosis neglected to complete their treatments, a much higher rate than surrounding areas.[9] The key to successful tuberculosis treatment program is the strict monitoring; if patients fail to attend treatments for three consecutive days, the doctor is sent to their home to speak with the patient. If in-facility treatment cannot be arranged, outpatient treatments are available at the patient’s home. If the patient refuses to comply, a representative from the nearest TB program visits the patient to inform them of the danger due to the patient’s negligence. This is followed by a visit from the police and lastly, a court notice. The endangerment of those around the patient refusing treatment is grounds for breaking the law. This strict enforcement has decreased incidence by 26.5%, mortality by 48.3%, and prevalence by 44.5%[10]. This district has become a model for tuberculosis treatment and containment success.

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Figure 6. Successful TB treatment monitoring system in the District of Orel.

The DOTS program has had massive success in TB prevalent areas, as treatments are overseen by medical personal, volunteers, or family members, preventing irresponsible or inconsistent antibiotic use.  However, the success of this program comes at a cost, which is unaffordable to some. The cost of traveling to healthcare facilities, frequent tests, and drugs becomes high, and, as a result, patients from impoverished backgrounds are often unable to comply with the DOTS standards. By providing a rebate to the patient for the cost of the drugs, and thus removing obstacles preventing treatment completion, impoverished patients, who have higher rates of TB,[11] are more frequently able to overcome the disease.

Rather than basing the rebate on the treatment outcome, the issuing of rebates is dependent on the actions of patients; attendance to treatments and examinations are requirements for this program to be successful. In addition to it’s self sustainability, the rebate program has potential and is an attractive option because it requires patients to assume the financial cost of the treatment, enticing patients to comply with the regulations of the program. Although other incentive programs have been used in regulating and promoting the treatment of tuberculosis, we suggest this novel program, as it helps sustain the pharmaceutical company providing the drugs, as well as make the patient financially liable for a part of the cost. While aforementioned deposit programs may seem more attractive, as patients receive most or the entire sum of the deposit back after completion after treatment, these programs are dependent on government funding to provide the drug at low or no cost. Fluctuations in national budgets and the priorities of varying political parties can have devastating effects and cause regression.

Establishing Incentives with Preexisting Treatment Programs

In cases where there are already preexisting programs, which cover the cost of DOTS treatment, our rebate program is not an option. The foundation for our rebate program relies on the rebate being provided from the pharmaceutical companies, which comes from increased profit margins. In these situations, we propose a program that incorporates a rewards program as well as government awareness campaigns and legal enforcement.

The rewards program specifically targets the impoverished population, which shows the highest rates of TB prevalence. Through this program, in return for receiving treatments, patients are provided with transportation fees, food, and hygiene products – basic living necessities. The program providing the free antibiotics regulates and oversees patient treatments and visits. In addition, TB facilities and physicians oversee the program. Unlike the rebates program; however, this program is not self-sustainable, as it requires that government or a third party fund the rewards for this program.

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Figure 7. Noncyclical Rewards System in areas with Preexisting Treatment Programs.

Alternatively, a contract program would entice patients to attend and receive treatment regularly in a similar way that the rebate program does, but is applicable in areas where patients receive free treatments. In this program, patients would sign a contract agreeing to complete their treatments or pay for the medications they received, prior to the treatments. Rather than paying a deposit fee, patients sign a contract making them legally responsible for the payment of the treatments if they fail to take antibiotics. Because the cost for breaking the contract is rather high for low-income patients, this program provides a financial incentive for patients to comply and receive treatments. Although this may seem unethical or unattractive to push treatments on patients by holding them financially responsible, it seems more unethical for patients to not receive free treatments and put those around them at serious risk. The Perkumpulan Pemeberantasan Tuberkulosis Indonesia- Jakarta program has used a similar contract method. [12]

Conclusions Regarding Solutions

When it comes to solving the problem of antibiotic resistance in tuberculosis, there is no silver bullet. Ideally, the rebate program would provide the best solution as it is self-sustainable and holds patients financially responsible for receiving treatments. However, in areas where free treatments are already available, this program is not useful. Rather, the rewards and contract programs are useful because both can be applied to incentivize patients to attend treatments. In conjunction with awareness campaigns organized by the regional or national governments, we believe that these programs will be successful based on effective models of similar TB programs.

Section V: Strengths and Weaknesses of Our Solution

The intrinsic nature of each program type allows for certain strengths and weakness. An understanding of the factors that lead to these differences is critical to understanding the distinguishing characteristics of each program. In this section, the rebate and rewards-based programs will be compared with the intention of emphasizing their perspective strengths and weaknesses that, in turn, determine their appropriateness for a specific region.

The Need for Third-Party Participation

As has previously been described, the Rebate Program and Rewards Program differ in their degree of self-sustainability. The Rebate Program’s simple two-party system requires participation from only those sectors that stand to immediately benefit, those patients who are – or at least believed to be – infected with M. tuberculosis and the associated private pharmaceutical corporations (PMCs). The patients will be incentivized to complete the appropriate drug regimen because of the financial rebate. Similarly, the PMCs will be incentivized to provide the financial rebate because patients who might otherwise prematurely terminate treatment will buy more drugs. Thus, both patients and PMCs have a financial incentive to participate in the Rebate Program.

The Rewards Program, on the other hand, requires participation by a third party that does not stand to immediately benefit or make a financial profit. To sustain the Rewards Program, local and/or federal government assistance in the form of funding is absolutely necessary because the funds will be used to provide the actual rewards. Though the rewards may change depending on the region and socioeconomic class targeted by the program, the rewards themselves are the principle component of the Rewards Program. Without them, patients will not be incentivized to seek treatment and the program may not be as successful.

The operational maintenance of the rebate and rewards-based programs is the major difference between them. The Rebate Program is self-sustaining because it does not require funding by a third party. Rather, both the patients and PMCs are financially motivated to participate. However, the Rewards Program is forced to compete with numerous other programs and organizations for scarce government or agency funding. Ultimately, the Rebate Program is self-sustaining while the Rewards Program is not self-sustaining.

The Superiority of the Rebate Program in Terms of Self-Sustainability

The financial self-sustaining nature of the Rebate Program is its major strength. In fact, a recent publication in the British Medical Journal argues that the development and implementation of sustainable measures to improve adherence to TB control programs is of critical importance1. Though multiple reports have been made on the types of intervention used by TB control programs such as DOTS2, a publication in Tropical Medicine and International Health states that “most of these interventions, however, depend heavily on additional inputs, including external funding, and their sustainability is highly questionable” 3.

The self-sustainability of the Rebate Program makes it a potential long-term strategy for TB control in Eastern Europe. While the continued operation of the Rewards Program is contingent upon a dependable stream of funding, the Rebate Program is not. Many unanticipated factors can end government – or even agency – funding. For example, the short-term horizon of governments and funding agencies in addition to short budget cycles during times of internal political pressures can have negative impacts on the necessary funding4.  This unpredictable source of funding compromises the sustainability of the Rewards Program. Clearly, termination of the Rewards Program in a specific region due to lack of funding is counterproductive if TB still occurs in the area. Because the Rebate Program does not face the possibility of termination due to lack of third-party funding, it is superior to the Rewards Program in terms of self-sustainability.

The dependency of the Rewards Program on external inputs, however, should not be misinterpreted as a crippling feature. Tuberculosis control programs such as DOTS that also require funding have proven to be “remarkably inexpensive and cost-effective”5. A study conducted in Thailand, for example, found that for every $1.00 invested by the government in tuberculosis control, the local community gained $50 over a 20-year period6. In some low-income countries such as India, in fact, the per capita costs of implementing DOTS are as low as $0.057. This is significant because it shows that despite the need of the Rewards Program for funding, it can still prove to be highly economically efficient.

The Potential for Black Markets

Preexisting market conditions in the target region dictate which program is appropriate. In a market system where the patient community must pay for drugs, the Rebate Program should be used. In a market system where the drugs are freely available, the Rewards Program must be used. The possible development of black markets to satisfy the demand for antibiotics must be considered for each program type.

Black Markets as a Possible Weakness in the Rebate Program

The Rebate Program will require PMCs to charge slightly higher than normal prices for antibiotics. Appropriate TB treatment will thus represent a greater financial burden for patients under the Rebate Program. It is important to note, however, that this will only be the case during the actual course of treatment when the drugs are being bought. Ultimately, upon completion of the drug regimen, the patients will benefit when they receive the financial rebate. Nevertheless, the temporary price inflation may drive some patients to seek the drugs in black markets.

Patients who believe that the extended TB drug regimen is unnecessary to treat the disease will be unwilling to pay the inflated prices. This is of particular concern in Eastern Europe where a direct correlation has been found between TB incidence and wealth inequality8. Because individuals of lower socioeconomic status may not be able to afford the complete treatment, they may seek temporary treatment by buying drugs in black markets. This will compromise the efficiency of the Rebate System to control the evolution of drug-resistant strains of TB.

The fall of the communist regime in Eastern Europe took with it many of the control systems for a healthy market economy. The absence of these control systems have allowed for the flourishing of black markets9. The development of black markets under the Rebate Program may signal a failure on part of the tutorial system. The tutorial must succeed in convincing patients that the full regimen has to be completed in order to clear their bodies of the mycobacterium.

The establishment of black markets in a specific region can be prevented in two ways: either the tutorial system can be improved and/or the underground demand for TB drugs can be monitored. Expansions or improvements to the tutorial system will come in the form of greater educational efforts. The monitoring of underground demand will require constant policing networks. The employment of personnel and organization of resources necessary to improve the tutorial system and/or police underground networks will be a financial burden on the Rebate Program – potentially compromising its self-sustainability.

The Non-Existence of Black Markets is a Strength of the Rewards Program

The emergence of black markets is unforeseen under the Rewards Program. The rewards-based program requires a market system in which drugs are free. There will be no underground demand because the drugs are freely available. This is a strength of the Rewards Program.

The Potential for Negative Reactions

In areas where treatment is free, contractual agreements will be made with all patients seeking antibiotics. The contracts will be signed by patients before receiving any drugs and will dictate a set of conditions by which, should the patient prematurely terminate the drug regimen, he or she will have to pay the full cost of all the drugs taken up until the point of default. This will further incentivize patients to complete the treatment.

Note that contracts demanding payment cannot be used under the Rebate Program because patients will already be paying for their own drugs.

Contracts in the Rewards Program

Implementation of the contract system represents a change in the established means of acquiring drugs. By requiring patients to pay for the drugs themselves if they do indeed default, the contract may induce a negative public perception and/or reaction towards the Rewards Program. This is of unique concern in Eastern Europe where incomplete treatment often leads to the development of bacterial resistance10. Patients may refuse to participate in the Rewards Program if they believe – for whatever reason – that they will have to default. The fear of having to pay for treatment may cause them to shun the program and continue with the current inappropriate forms of treatment.

Concluding Remarks on Strengths and Weaknesses

This section has described the strengths and weakness of the rebate and rewards-based programs. The Rebate Program is highly self-sustaining under ideal conditions because both patients and PMCs have economic incentives to participate. Also, the Rebate Program does not require participation from a third party. The Rewards Program, on the other hand, is not self-sustaining because it requires funding from the organizations or governments in order to provide the actual rewards that are necessary to its continued operation. The need for funding, though, does not seriously compromise the effectiveness of the Rewards Program.

Each program has unique difficulties that must be considered. The Rebate Program is threatened by potential black markets while the Rewards Program is threatened by the patient’s negative reaction to having to sign a contract. Nevertheless, both programs are novel approaches to incentivizing TB patients in Eastern Europe to complete the appropriate drug regimen and, thus, control the spread and development of resistance amongst TB strains.

Section VI: Role of USAID and Policy Proposal

The rebate program links the private sector directly to TB positive patients, negating political volatility from tempering with the effectiveness of our solution.  In order to see lasting results in our efforts to contain—and diminish—the prevalence of MDR-TB, the action plan must be long-term.  By taking politics out of the equation, the rebate program comes through as impartial, credible and independent.  These qualities are particularly important because it inherently guarantees that patients will be rebated at the end, should their tests yield smear-negative results.  Because the rebate program does not have to factor in the nature of governance structures, it can be applied to any and all countries and be equally effective in improving the TB situation in respective countries.

From the experts we have consulted, we have discovered USAID to be especially involved in health issues around the world.  Not only does USAID have regional experts who specialize in understanding the social, political and cultural aspects of each region, but they also assign TB experts to the areas that demand extra attention on the disease.  Carolyn Mohan, one of the experts we interviewed, is USAID’s TB specialist in Eastern Europe.  Because of her unique position, she plays an integral role in incorporating health problems in Eastern Europe with the other USAID strategies in the area.  In addition, USAID seeks to build partnerships with local organizations as well with international agencies.  Because of how USAID is orchestrated, we think it is the optimal organization to champion the rebate program in different regions.  These experts would be adept at sticking to the backbone of the rebate’s objectives while modifying it to cater to each region’s distinct characteristics.

Furthermore, it is important to highlight that the rebate program relies on the cooperation of the private sector.  Specifically, it is the pharmaceutical industry.  Since the main pharmaceutical corporations that produce TB drugs are from the United States, having a US-based organization would be best in securing their participation.  USAID realizes the importance of maintaining relationships with private enterprises, and “has working relationships with more than 3,500 American companies.”[13] The rebate program is contingent on the pharmaceutical industry’s cooperation; pharmaceuticals need to know that a reliable “middle man” will be in charge of this following through with details of the rebate program.  Rather than having an international organization head the rebate program, USAID is in an unrivaled position because of its special track record with the US pharmaceutical companies.

As mentioned before, the solution we think will be most effective in addressing MDR-TB is a preventative one, with a mandatory tutorial prior to treatment and a rebate program at the end for successful patients.  At the same time, however, we realize that the current TB strategies operating across regions are different and must be factored in.  Since TB drugs are presently free for patients in Eastern Europe, the rebate program would not take off simply because it is highly unlikely for patients to agree to pay for drugs (even if they are rebated) if drug availability is currently unconditional.  Therefore, our proposal for Eastern Europe—as well as all other regions where TB drugs are free—to implement and enforce the rewards program.  In regions where these drugs are not free, our proposal calls for the adoption of the rebate program because it is distinctively self-sustaining and not subject to political caprice.  The latter is detailed in USAID proposal format below.

USAID Proposal:  Tutorial and Rebate Program for Drug-Susceptible Tuberculosis Patients

  1. A. Program Goal

To implement a preventative action plan that will address the growing MDR-TB population, mainly in Eastern Europe and Asia.  This action plan hopes to contain—and diminish—the number of MDR-TB patients by proactively motivating drug-susceptible TB patients to fully complete their drug regime.

  1. B. Critical Assumptions
    1. Drugs that meet international standards will be readily available for patients in all regions.  These drugs can be purchased through the Global Drug Facility.
    2. Pharmacies are readily prepared with TB drugs and are at least located in all the main cities and towns
    3. Physicians and health care provider have the proper training and facilities to correctly diagnose patients displaying TB symptoms.  They are also well read in the drug regimen and treatment process
    4. Governments are supportive of the DOTS program and all efforts to decrease the TB population
    5. Drugs will remain free in Eastern Europe
  2. C. Objectives and Expected Results: focus on the health sector
    1. Objective 1: to increase citizen understanding of drug resistance TB through the mandatory tutorial prior to drug regimen.

i.  Expected Results: a population more aware of the effects of premature termination of drug regimen.

  1. Objective 2: to keep physicians aware of the accuracy of their diagnosis by providing them with data to show proportion of patients with smear-positive TB results at beginning of drug regime and upon completion.

i.  Expected Results: higher percentage of proper diagnosis than prior to rebate program.

  1. Objective 3: to motivate patients to complete the entire drug regime with the conditional rebate at end of drug treatment period.

i.  Expected Results: a larger number of Tb patients who thoroughly complete drug regimen than previous to rebate program.

  1. Objective 4: coordinate a timely rebate provided from pharmaceutical company to patient.

i.  Expected Results: pharmaceuticals will standardize a system of providing rebates to successful TB patients.

  1. Objective 5: to decrease the number of MDR-TB cases through containing the number of existing MDR-TB patients.  These patients will continue to undergo second-line drug treatment headed by the Green Light Committee.

i.  Expected Results: percentage increase of MDR-TB patients will reduce per year until there are no more new MDR-TB cases.

  1. Indicators and Performance Baseline Data
  2. D. Indicators and Performance Baseline Data: “Indicator” number correlates to “Objective” number in [C]
    1. Indicator 1: Number of patients coming in for diagnosis per month.  If the national population is becoming more aware of the symptoms of TB/MDR-TB, they should be more apt to come in for smear tests.
    2. Indicator 2: Number of TB diagnosed patients compared to the number of rebates granted upon end-of-regimen testing.
    3. Indicator 3: Percentage of Tb diagnosed patients who come back at the end of regimen for a test, and get approved for rebate upon smear negative results.
    4. Indicator 4: Average time for a) a rebate request to reach pharmaceutical companies and b) average time for a rebate to be received by patient.  Another indicator would be the number of complaints filed to pharmaceuticals regarding untimely receipt of rebate.
    5. Indicator 5: WHO’s periodic report on new TB/MDR-TB cases worldwide.
    6. Performance Baseline Data: number of patients coming in for diagnosis per month, estimated number of TB patients per region, estimates of new TB cases next year, and estimated of new MDR-TB cases will serve as baseline data.
  3. E. Implementation
    1. Since USAID’s role is to coordinate the linkage between patients and pharmaceuticals—and thus plays an indirect role in this humanitarian effort– stating a targeted number of beneficiaries is not applicable.  It is important to note, however, at the targeted demographic of this program would be all TB positive patients in respective regions.
    2. USAID will negotiate a standardized rebate amount that pharmaceuticals must adhere to.  There could be some variation that is dependent on the differences in drug costs in different countries.
    3. USAID will, through partnerships with indigenous organizations and health care providers, create a paperwork process that is both credible and easy to understand for patients to request rebates from pharmaceuticals.
    4. In the beginning stages, USAID will be evaluating the efficiency of the rebate program, as well as if there are any loopholes in execution.  Revisions will be made if necessary.

Monitoring Plan

  1. Number of patients coming in for diagnosis per month:  provided by governments and health care institutions.
  2. Number of TB diagnosed patients compared to the number of rebates granted upon end-of-regimen testing:  provided by health care institutions. Data from the DOTS program will be used to cross-check the information provided by these health care institutions.
  3. Percentage of TB diagnosed patients who come back at the end of regimen for a test, and get approved for rebate upon smear negative results: provided by health care institutions. This number will be cross-checked with the number of rebates sent to pharmaceutical companies for accuracy.
  4. Average time for a) a rebate request to reach pharmaceutical companies and b) average time for a rebate to be received by patient.  (A) is provided by pharmaceuticals.  (B) will be evaluated based on the number of patient complaints.

*The rebate program will be evaluated bi-monthly for the year, and then every three months as maintenance.

*USAID’s TB specialists will be in charge of gathering the data mentioned above from regional governments, health care institutions, indigenous organizations, pharmaceuticals and international health organizations every two months (for the first year) and three months (for the following years).  If the rebate system seems to be operating effectively, thorough evaluations can be reduced to a bi-annual basis.

Evaluations

  • Evaluation forms (each question answered with a 1-5 “not satisfied” to “very satisfied”) will be distributed to physicians and pharmacists on a bi-monthly basis (frequency will be reduced when rebate system becomes ingrained).
  • A rewards incentive (either in a free meal or coupons) will be given to patients who volunteer to fill out the evaluation form post-rebate.  Same evaluating format as above applies here.
  • Periodic debriefing with pharmaceuticals on rebate system.  Since these persons would be easier to contact, evaluations will be in the form of interview.
  1. F. Transition or Exit Strategy
    1. When rebate system appears to be seamlessly incorporated into each countries’ health structure, USAID will execute a phase out strategy.  This will mainly be done through reduced participation in the monitoring process.

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Anchorage, Alaska, 16 Sept. 2009. Web.

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/Nunn.ashx>.

10 “WHO | Antimicrobial resistance.” Jan. 2002. Web. 10 Dec. 2009. <http://www.who.int/mediacentre/factsheets/fs194/en/>.

10 “WHO | New survey finds highest rates of drug-resistant TB to date.” WHO. 26 Feb. 2008. Web. 10 Dec. 2009. <http://www.who.int/mediacentre/news/releases/2008/pr05/en/index.html>.

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[7]Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development. N.p., n.d. Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

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<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

[9] Zolotova, Elena. “Russian oblast is model in fight against TB.” World Health Organization. May 2007. Web. 14 Dec. 2009. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636654/>.

[10] Zolotova, Elena. “Russian oblast is model in fight against TB.” World Health Organization. May 2007. Web. 14 Dec. 2009. <http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2636654/>.

[11] Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development.Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

[12] Beith, Alexandra, Rena Eichler, and Diana Weil. “Worldwide: Incentives for Tuberculosis Diagnosis and Treatment.” Center for Global Development. N.p., n.d. Web. 1 Dec. 2009.

<http://www.cgdev.org/doc/books/PBI/12_CGD_Eichler_Levine-Ch12.pdf>.

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2 Volmink, Jimmy, Patrice Matchaba, and Paul Garner. “Directly observed therapy and treatment adherence.” Lancet 355.9212 (2000): 1345-350. Http://sciencedirect.com. Science Direct. Web. 10 Dec. 2009. <http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6T1B-4049VK9S&_user=655954&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_acct=C000035538&_version=1&_urlVersion=0&_userid=655954&md5=739eb5ba47cf174c410ff35717eee8e7>.

3 Liendhart, Christian, and Jessica A. Ogden. “Tuberculosis control in resource-poor countries: have we reached the limits of the universal paradigm?” Tropical Medicine and International Health 9.7 (2004): 833-41. Wiley InterScience. Web. 10 Dec. 2009. <http://www3.interscience.wiley.com/cgi-bin/fulltext/118806551/HTMLSTART>.

4 Shedica-Rizkallah, Mona C., and Lee R. Bone. “Planning for the sustainability of community-based health programs: conceptual frameworks and future directios for research, practice, and policy.” Health Education Research 13 (1998): 87-108.

5 Frieden, Thomas R., and Cynthia R. Driver. “Tuberculosis control: past 10 years and future progress.” ELSEVIER 83 (2003): 82-85.

6 Sowart, Holgart, Sukhontha Kongsin, Vallop Payanandan, Pasakorn Akarasewi, Paul P. Nunn, and Mario C. Raviglione. “Costs and benefits of improving tuberculosis control: The case of Thailand.” Social Science & Medicine 44.12 (1997): 1805-816. ScienceDirect. Web. 10 Dec. 2009. <http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6VBF-3SWXX70-4&_user=655954&_rdoc=1&_fmt=&_orig=search&_sort=d&_docanchor=&view=c&_searchStrId=1131350979&_rerunOrigin=google&_acct=C000035538&_version=1&_urlVersion=0&_userid=655954&md5=19052ac9fd16154ff96e2a7dcf372044>.

7 WHO. Joint program review: India. New Delhi: World Health Organization, 2000: WHO/SEA/TB/2000.224

8 Suk, Jonathan E., Davide Manissero, Guido Buscher, and Jan C. Semenza. “Wealth Inequality and Tuberculosis Elimination in Europe.” Center for Disease Control. Nov. 2009. Web. 10 Dec. 2009. <http://www.cdc.gov/eid/content/15/11/1812.htm>.

9 Paldam, Martin, and Gert T. Svendsen. “Missing social capital and the transition in Eastern Europe.” IDEAS: Economics and Finance Research. Web. 10 Dec. 2009. <http://ideas.repec.org/p/hhs/aareco/2000_005.html#abstract>.

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Global Health, Global Health Projects


AIDS, Africa, and ARVs: Domestic Production as the Solution to the Treatment Gap

January 11th, 2010

Olulomire Ogunye, Will Smith, Natalie Hays Stewart, and Kuna Malik Hamad

Download and Read Full PDF of Aids, Africa, and ARVS

Domestic-Production-as-a-Solution-to-the-Treatment-Gap-title


Abstract

Part I gives an overview of key terms, including ARVs, TRIPS, Global Fund and CHAI, which are necessary to understand before delving into the more complex issues within the treatment of HIV/AIDS. Part II investigates the weaknesses of the current system of ARV supply. The first section discusses the problems with brand-name production, while the second looks at challenges that current generic manufacturers face, which could restrain Africa’s access to their imported drugs- such as changes in patent laws and WHO recommendations, or decreased Global Fund budgets. Part III provides the solution of domestic production and then goes into the details of what has worked, what hasn’t worked in the past, and also what could work in the future, using five specific case studies of current generic pharmaceuticals in Africa as examples. Part IV addresses the main criticisms of the model of domestic production: comparative advantage, the infant industry argument, and opportunity cost, and then provides counterarguments for each of these points. Part V is a policy proposal to the World Bank suggesting that they grant a loan of $2 million to domestic manufacturers seeking WHO approval who apply and qualify. The paper also includes a mock press release that could be used by the World Bank to introduce the nature of the loan.


Introduction

“Most global health issues can truly be understood only within the larger context of the HIV/AIDS pandemic.” 1 This statement may seem exaggerated considering only 33 million out of six billion people in the world are infected with HIV/AIDS. However, when left out of control, AIDS weakens individuals and makes them more susceptible to other infectious diseases, such as TB.2 In addition, the economic burden of AIDS consumes entire public health systems in developing countries.3 Considering these factors, focusing on the AIDS epidemic can help to reduce the threat of global pandemics, and free up funding and space for other diseases to receive the attention and support they need.

Though investment in prevention is also important to mitigate the epidemic, without treatment, the current 33 million people infected with AIDS will be left to die. Anti-retrovirals have been proven to increase life expectancy of someone living on AIDs, and with generic manufacturing, they are now affordable to people in developing countries. Many organizations, such as Global Fund, PEPFAR, and the Clinton HIV/AIDS Initiative have donated significant money towards achieving their 2010 goal of universal access of ARVs. Despite these efforts, they expect to fall short of the 2010 goal, leaving many people without treatment4.

Sub-Saharan Africa has been the hardest hit by the epidemic. In 1993, 9 million (out of a worldwide 14 million infections) were in Sub-Saharan Africa. Today, 22.5 million (out of a global 33 million infections) are from Sub-Saharan Africa. To put things in perspective, Haiti is the country with the highest prevalence rate outside of Sub-Saharan Africa, with a prevalence rate of only 2.2%.5

arvs_figure_1

In terms of treatment, Sub-Saharan Africa uses almost four times the ARVs of the rest of the world combined. However, the current system of treatment for HIV/AIDs is still insufficient. According to the WHO/UNAID/UNICEF 2009 progress report “Towards Universal Access,” 66% of people who ARVs in Sub-Saharan Africa (around 6,700,000 people), are still not receiving treatment. Not to mention the 2,925,000 people who have already begun treatment, will need to continue receiving ARVs for the rest of their lives6. There is still a gap between what Donor organizations are able to provide and what is needed on the ground. The burden continues to expand as new people need treatment and old patients need to switch to even more expensive second-line drugs. Moreover, international donor funds have recently been more constrained, leaving African countries to find new resources to solve the demand for ARVs7.

Domestic Production of ARVs can help to reduce the cost of ARVs while lifting the entitlement burden off the shoulders of the United States and international donors. Many big pharmaceuticals have already begun to partner or invest in African generic pharmaceutical companies, in countries such as Ghana, Uganda, South Africa, and Mozambique. While each of them has applied for domestic or voluntary licensing to produce generic ARVs, this paper suggests that they consider working under the never-before invoked Article 6(i) of the Doha Declaration, which allows developing countries to bypass patent laws and produce and export to countries within their respective trade agreement regions, as long as more than half of them are least developed countries. In addition, the paper asks the World Bank to help secure a non- interest loan of $2 million dollars to allow African Pharmaceuticals to get WHO bioequivalency testing, and to be able to access wider markets for their drugs.


Part I. Terms

Anti-retroviral Treatment

Anti-retrovirals (ARVs) are not a cure for HIV/AIDs, but they can keep people from becoming ill if they take them everyday for the rest of their lives. Patients have to take a combination of drugs (drug cocktails) so that they do not develop resistance to the treatment. There are over 20 WHO approved drugs, but they vary in price, availability, and side effects. After as short as 4- 5 years of “first-line” drug therapy, 8doctors have to shift HIV-infected patients to “second-line” treatment. Most treatments consist of two NRTIs and one NNRTI. The most common anti-retroviral therapy (ART) was triamune, or triple combination therapy which consisted of stavudine, lamivudine and nevirapine (triomune) but a recommendation by the WHO on December 1 of this year, suggests the discontinued use of stavudine because of its negative side effects. Some improved first line combinations have been combined within a daily pill called a ‘fix dose combination.’ Also, in recent years, first-line drugs have ranged around $99 pp/year in least developed countries (LDCs), whereas second-line drugs start at around $700 pp/ year in LDCs.9 Second-line drugs are more complicated to manufacture, as well as have newer patents, therefore few generic producers have attempted to manufacture them. The focus of this paper will be on the domestic production of first-line ARVs.


TRIPS and Licensing

One of the greatest obstacles to keeping ARV prices low, is intellectual property rights also known as TRIPS (Trade Related Aspects of Intellectual Property Rights). TRIPS was introduced in 1995 to give pharmaceutical industries the right to patent their drugs for twenty years. This prohibits the production of generic drugs (i.e., identical copies or bio-equivalents of the patented brand-name drug). Therefore, no company can make, use, sell, offer to sell, or import the patented drug. The patents do not always benefit research and development, however, since Universities who create patented drugs often spend billions on R&D and are lucky to make only a few million on royalties.10 In any case, the majority of developing nations with high manufacturing capacity, were given a ten year transition period to bring their legislation in line with TRIPS; developing countries such as India were given until 2005, while least developed countries are allowed to disregard patents until 2016.

One way that a generic drug manufacturer can avoid patents is through applying for a voluntary or a compulsory license. Patent holders grant companies voluntary licenses, if they want to produce or import a generic version of the drug during a public health emergency. Governments grant compulsory licenses to companies who make a case that patent holders are abusing their rights and keeping prices unfairly high for potential consumers. Since 2001, compulsory licenses can be issued during a severe health emergency without having to pay royalties to the patent holder. Thankfully, the production of generic ARVs have provided affordable drugs on the market. To meet their new competition, many brand name producers dropped their prices right above generic prices. “The graph below illustrates the effect of generic competition on proprietary drug prices between 2000 and 2001.” 11

arvs_figure_2


Another way that a producer could avoid patent restrictions is specified in Article 6(i) of the Doha Declaration on the TRIPS Agreement and Public Health Decision of the General Council of 30 August 2003. This clause legally provides an opening for import or production of patented drugs. It allows the company to export to a group of countries party to a regional trade agreement, consisting of more than half Least Developed Countries, and sharing a similar health concern.12

” With a view to harnessing economies of scale for the purposes of enhancing purchasing power for, and facilitating the local production of, pharmaceutical products:

(i) where a developing or least-developed country WTO Member is a party to a regional  trade agreement within the meaning of Article XXIV of the GATT 1994 and the Decision of 28 November 1979 on Differential and More Favourable Treatment Reciprocity and  Fuller Participation of Developing Countries (L/4903), at least half of the current membership of which is made up of countries presently on the United Nations list of least  developed countries, the obligation of that Member under Article 31(f) of the TRIPS Agreement shall be waived to the extent necessary to enable a pharmaceutical product produced or imported under a compulsory license in that Member to be exported to the markets of those other developing or least developed country parties to the regional trade agreement that share the health problem in question. It is understood that this will not prejudice the territorial nature of the patent rights in question;13


ARV Provision Programs- Global Fund and Clinton HIV/AIDS Initiative (CHAI)

To acquire ARVs in Sub-Saharan Africa, a community can ask their Country Coordinating Mechanisms to send a grant proposal to the Global Fund. The Global Fund is a financing mechanism, which receives money from governments and private donors and then awards it to Principal Recipients, based on the technical quality of their applications. On average, the US is the biggest single donor to the Fund, making up about 33% of the total funds every year.14 Sixty-one percent of the Funds’ budget goes towards HIV/AIDS. More than half of its funds are allocated to Sub-Saharan Africa alone. Fourty-five percent of its total expenditures go towards the procurement of drugs, commodities and products.15 By November 30, 2009, the Global Fund supplied 2.5 million people worldwide with ARVs.16

In 2007, The Global Fund established the Voluntary Pooled Procurement (VPP) service so that countries with low procurement volumes of ARVs could pool their drug orders and benefit from more competitive pricing.17 The Fund also contracted The Clinton HIV/AIDS Initiative (CHAI) to provide technical support, help them to negotiate prices, and select suppliers for ARVs. The VPP also ensures that all ARVs comply with the Global Fund’s Quality Assurance Policy for Pharmaceutical Products. The Global Fund will only purchase from manufacturers who are pre-qualified by the WHO.18 Especially with ARVs, it is important that standards of quality are ensured so that the chance of resistance to the treatment is minimized.

Founded in 2002, The Clinton HIV/AIDS Initiative (CHAI) was designed to negotiate lower prices for ARVs. Since then it has “transformed the marketplace for HIV commodities from a low-volume, high-margin market to a high-volume, low margin market through simultaneous and intensive engagement on both the supply and demand sides of the market.” 19 Since CHAI combined their negotiating power with the purchasing power of UNITAID in 2006, the price of first line treatment has decreased by 50% and second line treatment by a cumulative 30% in low income countries. 20 More specifically, CHAI currently works with 8 suppliers, who offer some of the lowest prices on 40 formulations, simply by being able to sell and deliver in bulk. CHAI sends out a bid for new suppliers every year and selects based on three criteria: price, registration coverage in countries where UNITAID-CHAI have programs, and historical supply performance including adherence to delivery dates.21

Unlike Global Fund, The Presidents Emergency Plan for AIDS Relief focuses on direct funding from the US Government. A Global AIDS Coordinator, supplies money to government agencies who then supply the funds to prime partners in different countries. PEPFAR also uses a one-stop-shop for procurement of their ARVs. Since September 2008, they have supplied 2.1 million people with ARVs. PEPFAR also uses a “one-stop-shop” for procurement of their ARVs. In 2005, they contracted Partnership for Supply Chain Management (SCMS). In 2008, PEPFAR gave more money to SCMS ($84 million) than any of their other partners.22 Another criticism of PEPFAR is of particular concern; the Statement of the Ecumenical Pharmaceutical Network from Moshi, Tanzania argues that “PEPFAR disregards national drug regulations and local supply chain management systems, which could damage national health systems, especially the pharmaceutical sector.”23 According to the Institute of Medicine, the SCMS should support local and regional systems rather than simply support a “US-controlled system.”24


Part II. Problems with the current system of ARV supply

The current system of treatment of AIDS is insufficient because costs of ARVs are out of reach for many people in developing countries, where treatment is needed most. Donor organizations, like the Global Fund and PEPFAR, have a limited budget and can only afford to treat a small percentage of the people who are in need. To improve the current system, it is necessary to find ways to lower costs of treatment.

Known as Big Pharmaceuticals, Originators, Innovators or Brand name manufacturers, these firms have been notorious for keeping their drug prices high. One quarter of ARV drugs developed between 1988 and 2005 were patented by Universities and then eventually licensed to big pharmaceutical companies.25 In many cases, the Universities neglect to specify global access provisions. For example, Harvard “only included global access provisions in 5 out of 62 licenses over the past two years (2007- 2009).” Global Access provisions include tiered pricing, financial incentives, mandatory sub-licenses to generic manufacturers and non-patenting policies; these provisions are an attempt to enable poorer countries to have more access to the drugs they need.

In 2001, “a group of Yale students learned that d4T (stavudine), an HIV antiretroviral drug patented by Yale and licensed to Bristol-Myers Squibb, was being sold at outrageous prices overseas, blocking off access for HIV patients living in South Africa and other developing countries.”26 Withouttheprovisionsinplace,bigpharmaceuticalcompaniesoftenchoosetosell their brand name drugs primarily to developed countries. “PhRMA […] concedes that Africa comprised only 0.5% of sales in 2007” while “the U.S. represented 67.7% of 2007 world sales.” 27

However, global access provisions are not necessarily the best solution for creating more access for ARVs. First, provisions can remain secret or hidden within the patents; “the nature of the access provisions, the number of medical licenses, and even the identity of the drugs covered, remain opaque.” 28 Secondly, the provisions themselves can be incredibly hard to monitor. One provision, tiered pricing, which allows pharmaceuticals to change the prices of their ARVs for different countries, makes it incredibly hard for countries to compare prices or find the lowest cost supplier. In an article by the African Press International titled “Countries pay widely varying prices for ARVs” it states, “some nations are paying up to three times more for the life- prolonging medicines than others with similar HIV prevalence and income levels. In 2007 Nigeria paid US$334 per patient per year for a combination of first-line ARVs that cost Congo only US$95. Both are low-income countries, but Nigeria has a higher HIV prevalence of 3.1 percent, compared to Congo’s 1.2 percent.” 29 This discrepancy in pricing is due to global access provisions because “when originator companies apply discounted prices on ARVs, each has different eligibility criteria, which is a considerable source of confusion for purchasers”30 For example, according to Médecins Sans Frontières, Merck gives discounts to countries which are lowest on the Human Development Index and have >1% HIV prevalence rates, GlaxoSmithKline offers its lowest prices to Global Fund Grantees and Gilead has an entirely different list of eligible countries.31 Therefore, access to ARVs is not fair and those countries who need them most may have to pay more for them if they depend on the big pharmaceuticals to decide.

As a result many governments and donors have neglected to buy from brand producers and substituted their ARV supply with generic drugs instead. According to PEPFAR’s 2009 annual report to Congress, “In FY2007, 73 percent of antiretroviral drugs delivered through PEPFAR, and 93 percent delivered through SCMS, were generic formulations. By using generics, PEPFAR partners were able to save an estimated $64 million — a 46 percent reduction in cost if they had purchased only innovator drugs.”32 Generic production has indisputably contributed to lower costs of ARVs, and consequently increased access to AIDS treatment in poorer countries. Generic producers (specifically an Indian Pharmaceutical company) created a triple combination therapy in 2001 that was available for $295 per person bringing the price of treatment down from a whopping US $10,000-15000 in 1996. Today the most widely used drug treatment (d4T+3TC+NVP) is available for $US 88 per person per year.33

Generic Production may not be able to continue in the way it has in the past because of approaching patent blocks. Indian Pharmaceuticals skirted their 2005 WTO compliance deadline using the Indian Patents Act 2005, which, overrides the WTO patent regulations using an “automatic licensing system.” This automatic licensing allows the manufacturers to continue producing generic drugs that they were already producing, as long as the pay a reasonable royalty to the patent holder. Whether India or China will be able to apply for voluntary or compulsory licenses to produce new drugs (such as second-line ARVs) that will come out in the future is still in question. Since these companies often supply over 40% of the API to many countries, if they are blocked by new patents, ARV prices will again spike up creating a new price crisis. (Graph 4 and explanation34)

arvs_graph_4


33 Avert. 2009. AIDS, drug prices and generic drugs. 34 Médecins Sans Frontières. 2007.

Generic producers also depend on WHO regulations and guidelines to determine what drugs are in demand and which drugs should be created. First, if the WHO recommends a drug to be included in the first line therapy, that is still under patent, the cost of treatment could significantly rise. On December 1, 2009 the WHO recommended “that countries phase out the use of Stavudine, or d4T, because of its long-term, irreversible side-effects. Stavudine is still widely used in first-line therapy in developing countries due to its low cost and widespread availability. Zidovudine (AZT) or Tenofovir (TDF) are recommended as less toxic and equally effective alternatives.”35 Fortunately, the Clinton Foundation (CHAI) and UNITAID have been able to keep prices low by buying drugs in bulk. “These price reductions were made possible by the UNITAID Second-Line Project, which has increased and aggregated demand for tenofovir by supplying other tenofovir-based products for use in second-line treatment and also on an exceptional basis for first-line use in three countries. While the focus of this UNITAID project is on second-line price reductions, the increased tenofovir volumes have translated into a cumulative price reduction since 2007 of 62 percent for once-daily first-line HIV/AIDS treatment in low-income countries, further broadening the market impact of UNITAID support.” 36

In the same recommendation, the WHO pushed back their recommendation for when to begin treatment with ARVS. Whereas in 2006, the WHO had people begin treatment when they were typically showing symptoms, the “WHO is now recommending that ART be initiated at a higher CD4 threshold of 350 cells/mm3 for all HIV-positive patients, including pregnant women, regardless of symptoms.” 37 Now that AIDS treatment is recommended for patients at an earlier stage, there will be more of a demand for ARVs in the near future.

As the WHO changes their recommendations to include newer drugs and start treatment at an earlier stage, organizations like the Global Fund, are struggling to meet the increase in demand. “The Fund’s 8th funding round, which closed in the Fall of 2008, was three times the size of Round 7. This was due to an increased number of higher quality and larger applications than in the past […] If Round 8 is funded at the recommended levels, very little money would be left for future rounds.” 38 To save money, grants Approved Grants have to take 10% efficiency cuts, phase II of existing and future grants will be cut by 25%, the number of rounds per year is reduced to 1 again and round 9 postponed 6 months and second round grants are capped at 140%. Uganda has been hard hit by cuts in the budget since 95% of their ART program is funded by PEPFAR or Global Fund.39 Milly Katana, an HIV activist, attributes ARV shortages in the country to lack of donor funds: “many donors like PEPFAR, the Global Fund and others, who had been providing ARVs, are reducing the assistance because of the current credit crunch.” 40 Dr. Michael Strong, the PEPFAR coordinator, announced “a blanket freeze on new patient enrollment” and asked partner organizations to try to postpone treatment and refocus on care.”41 All this to say, people who depend on ARVs and the goodwill of donor foundations such as the Global Fund may be at risk if budgets are constrained as demands and recommendations for treatment continue to expand. Domestic Production is a viable option for those countries who want to maintain their sovereignty and avoid being affected by the decisions of other countries.42


Part III. The Solution is Domestic Production

What has worked

There have been several attempts at domestic production in Africa: Zimbabwe (Varichem), Kenya (Cosmos), Ghana (Danadams), South Africa (Aspen), Uganda (Quality Chemicals Ind.), and most recently Mozambique. This section will look at what has worked for these case studies and then what hasn’t worked. As a preface to this section, domestic production can only be a solution to fill the gap of supply for ARVs in countries where the environment will not prove to be a barrier to production. For example, some countries, such as Zimbabwe experienced more challenges than others, such as South Africa because of their external environments. The economy and political system must be sufficiently stable to support this enterprise.

Four out of the five domestic producers offer prices that are competitive with the market. Improving access to HIV/AIDS medicines in Africa Trade-Related Aspects of Intellectual Property Rights (TRIPS) flexibilities utilization, a book published by the world bank in 2008 argues explicitly that Zimbabwe, Kenya and South Africa were able to offer prices below the current domestic prices. Before the expansion of Varichem to include ARVs, costs of treatment per person in Zimbabwe ranged from $30-$50 per month. However, Varichem’s generic versions of lamivudine-zidovudine would only cost about $15 per person.43 Kenya’s domestic producer Cosmos, was granted a voluntary license from pharmaceutical giants GSK and Boehringer Ingelheim (BI) for the production of lamivudine, nevirapine, and ziduvudine. Although Cosmos offered lower prices for their generic versions, GSK and BI cut their prices for these drugs in order to compete with the domestic producer. 44Although Cosmos did not retain the lowest cost for ARV supply, their entry into the market was significant because it cut the cost of brand name drugs and thus benefitted the population in need of ARVs. Lastly, Aspen commands a high portion of the local South African ARV market and its public sector prices, at R100 (US$10) per month per person, are highly competitive. These are partially offset through government purchase of production materials in a tradeoff for lower prices.45 “In another article, The African private sector steps in to fill the drug gap, Danadams prices are reported as extremely competitive. According to Sarah Perkins, Faculty of Law at the University of Toronto, “If Danadams could afford the bioequivalence tests to obtain WHO approval, it could be supplying even more of the country’s drug needs at prices on a par with or lower than those from India.” 46 Lastly, according to the WHO, Uganda imports most of its drugs, but that may be about to change: “The first batch of locally produced generic ARVs and antimalarial drugs are expected to be delivered to the health ministry this year in a move that will see the cost of these life-saving remedies dropping from between US$ 15 and US$ 9 to between US$ 9 and US$ 2 per patient per month, Ugandan officials say.”47 In sum, Zimbabwe, Kenya, South Africa, Ghana, and Uganda have all quoted prices that compete with the current generic ARV prices.

Domestic Producers have sometimes functioned as key suppliers in moments of drug shortage. For example, During a 2004 shortage of ARVs in Ghana caused by a change in patent laws and the issuance of a compulsory license to Danadams, Ghana was forced to find new sources of ARVs. From this situation Danadams received a one-time contract worth over $250,000, or a little over 5% of the ARV market in Ghana. The other 95% came largely from Indian generics manufacturers.48 An article entitled “Crisis of lack of antivirals in Uganda” reports that in the summer of 2009, “Ministry of Health facilities across the country have reported stock outs of ARVs which means people living with HIV stop taking the drugs or have their drug regimens (combinations) changed.”49” According to Dr. Michael Strong, the PEPFAR coordinator, “We expect that PEPFAR funding for Uganda will continue at its current level of around $280m annually through 2013. But this will still leave a gap between national treatment needs and the funds available. Uganda needs to identify other resources to fill this gap.”50 Since Uganda used to be 95% funded by PEPFAR and Global Fund, Uganda’s new domestic pharmaceuticals factory, which opened in October 2007 to manufacture ARVs and antimalarial drugs hopes to step in to fill the new gap with targets of 240,000 people on treatment by 2012 and 342,200 by 2020.51 South Africa is the domestic production success story. Originally established in Steven Saad’s suburban home in 1997, today Aspen is one of the top 20 manufacturers of generic medicines globally today, and secured nearly 50% of the local generic market share in 2007.52

What has not worked

First, many countries do not even look into domestic production as an option because they are intimidated by the paperwork and legalities. Few countries have tried to exercise the rights of flexibilities in TRIPS laws, “citing a lack of capacity and legal know-how to negotiate the complicated paperwork required, and political pressure from foreign governments.”53 The idea of licensing can be daunting, and compulsory licensing can sometimes result in a slap on the wrist from big pharmaceutical companies. For example, Thailand issued a compulsory license in 2007 to import and produce LPV/r, but the patent holder, Abbott retaliated by refusing to register new drugs in Thailand.54 Although Abbot has received condemnation in the global eye, their response has created fear within countries who might consider applying for licenses but do not want to risk their ability to access these life-saving drugs. An article from SouthAfrica.info titled SA’s pharmaceutical success story, attributes Steven Saad’s ability to make Aspen into South Africa’s leading pharmaceuticals producer, to his “foresight in securing voluntary licenses from multinational pharmaceutical companies for the manufacture of more affordable generic antiretrovirals.” 55 Without attempting to work within the TRIPS agreement, countries will always depend on foreign producers to make decisions about what drugs and what prices are best for them.

Many domestic manufacturers cite the high cost of bio-equivalency tests and API import costs as barriers to entry into the market.


“The prices of locally produced ARVs in Ghana, Kenya, and Zimbabwe do not include the extremely high cost of in vivo bio-equivalence tests. “Given that in vivo bio-equivalence is a prerequisite for the attainment of WHO pre-qualification, the current prices will most likely increase sharply should these countries attempt to meet this requirement.”56

In an interview, the chief executive of Danadams (Ghana) identified three major challenges:

(a) the high cost of bio-equivalence tests for each product that are required for the acquisition of WHO pre-qualification, (b) the high cost of APIs when purchased in relatively small quantities, and (c) the inadequate market share and lack of economies of scale that result from an inability to supply under the Global Fund arrangements (this in turn the result of the absence of WHO pre-qualification).57

Cosmos cited the same major obstacles quoting bio-equivalency tests at “$50,000 per ARV (and even higher for fixed-dose combinations), as well as the high cost of APIs, which accounted for an estimated 50 percent of the ex-works price of ARVs.” 58 ! Costs of bio-equivalency tests are only the tip of the iceberg, while the larger problem of achieving successful domestic production is breaking into the supply chain that is already well- established. Sarah Perkins, Faculty of Law at the University of Toronto, argues that:

Quality assurances are important for antiretrovirals, [and] obtaining WHO approval is expensive and daunting for burgeoning manufacturers. By linking Fund money to WHO approval, a monopoly has been created, ensuring that only well established manufacturers, such as those in the USA, Canada, Europe, and India, will be able to supply most of the world’s antiretrovirals. Unless something changes, manufacturers in developing countries will be left out from the potential financial boon in antiretrovirals created by the Fund and WHO.59

Dr. Rudolf V. Van Puymbroek, Senior Scholar at the O’Neill Institute for National & Global Health Law, advises any new domestic producers trying to break into the business to avoid producing the same drugs produced by CHAI manufacturers60. These contracts for large sums of ARVs keep their prices as low as possible and make it extremely hard for small start-ups to even have a chance at offering competitive prices when CHAI and UNITAID send out their yearly bids for the lowest prices. Kenya experienced a similar scenario when they first began producing ARVS in 2003. “It is pertinent to note that the moment Cosmos started manufacturing ARVs, GSK and BI lowered their prices for those ARVS below the prices offered by Cosmos, further endangering the viability of the Kenyan company’s ARV production plan.” 61 This case reveals how established firms with a large market share have an advantage of price flexibility over a start-up firms that might depend solely on independent or government contracts.

What could work

If a country feels that they want to begin domestic production of ARVs in their pharmaceutical industry, Sarah Perkins, suggests they look at Article 6(i) of the Doha, Declaration on the TRIPS Agreement and Public Health Decision of the General Council of 30 August 2003.62 Though the clause has never before been invoked, it allows domestic producers to bypass the complicated paperwork of applying for a voluntary license as well as the risks of applying for a compulsory license and accusing a patent-holder of unfair pricing, such as was the case with Thailand.63

Especially in Africa where 33/47 countries are LDCs, there are several groupings of countries which fit the description of Article 6(i) and belong to a regional trade agreement that consists of more than 50% LDCs. For example, Danadams in Ghana could produce and export to ECOWAS (the Economic Community of West African States) which consists of 9/13 LDCs. Cosmos in Kenya or Quality Chemical Industries in Uganda (a LDC) could export to the EAC (East African Community) which consists of 4/5 LDCs. Mozambique could export to the SADC (Southern African Development Community) which consists of 7/14 countries (with Madagascar’s recent suspension). Firstly, exportation to a regional grouping allows local producers to focus specifically on the gap between what donor countries are offering, and who still needs treatment in that region. If transportation is feasible between the countries in the region, they could benefit from lower transportation costs by importing the drug from a regional producer rather than importing it from a foreign one. Secondly, countries grouping together around a shared health concern would be positive for general regional integration purposes, as well as for African countries taking on the responsibility of solving the ballooning HIV/AIDS burden themselves.

Countries hoping to begin domestic production should select the drug cocktail they choose to produce very wisely. CHAI has done extensive research on how to get the lowest prices from its 8 generic manufacturers. These manufacturers already produce every drug product on the WHO list of recommended drugs. At the same time, these suppliers will not always have the upper-hand on incoming producers, because the list of recommended drugs keep changing. For domestic production, Dr. Rudolf V. Van Puymbroek suggests that producers avoid producing what CHAI does best (the standard first-line cocktail). Uganda made the mistake of getting into production of the wrong drug, Stavudine, which the WHO recently removed from its list of recommended drugs. “This has shuttered the hopes of PLHIV [People Living with HIV] who had hoped that now that the drugs being home-made, they will be more affordable and readily available to the Ugandan population.” 64

It is important that domestic producers are very strategic. If they choose to produce a drug that is already being manufactured by a CHAI producer, it might be advised that they look at drugs that are being produced by only 1/8 manufacturers and are still only offered at a high cost.


(Chart above65) For example, countries might want to focus on improved first line drugs, such as a daily pill that combines the drugs tenofovir, lamivudine and efavirenz (EFV) and abides by the new WHO recommendations. CHAI has negotiated pricing for this treatment to $210 pp/year down 37% from the average market price for low income countries, but only one generic drug company, Matrix, is producing it.66


Part IV. Counter arguments of domestic production

The most basic economics argument against domestic production is that Africa does not have comparative advantage in the pharmaceuticals industry. Few may believe that anyone could produce generics more cheaply than China or India. Dr. William McGreevey, Associate Professor in the Department of International Health at Georgetown University advises Africa to take China’s advice and find out what it can sell to developed countries, whether that be textiles or handicrafts.67 Economists fear that if Africa tries to take on an industry in which it does not have comparative advantage, it will fail miserably. In a personal correspondence, Dr. McGreevey cited the import substitution model – every country who adopted it in in the 50s and 60s failed to grow because they were trying to make domestically what could be more easily and more cheaply bought abroad68. McGreevey argues that, by allowing the market to do the work, countries can enjoy unexpected consequences. For example, skilled health professionals might board on a plane to the United States on the day of their graduation from medical school in Africa, but they will send money home, which will help their families and which could encourage their children and grandchildren pursue their education69.

The comparative advantage argument is sound in a perfect world, but it disregards countries’ desires for self-sovereignty. ARVs seem to be different than any other average commodity because of their emotional tug on the people.70 Countries may want the assurance that the lives of their own populations are somewhat in their control. Ghana-born Managing Director of Danadams Pharamceuticals Limited, Dr. Yaw Adu Gyamfi states:

The reason why we specifically focused on HIV and anti-malaria medication is that five years ago we identified these diseases as the ones that are having the greater impact upon the public as a whole….rather than producing over the counter medication, like pain killers, we decided to become focused in an area where we knew there was a market, while at the same time the social dimensions of our a work would have a greater impact on society.71


Gyamfi argues that Ghana should take responsibility. “Each country must solve its own problems,” he says. “For Ghana or Africa to make it, we have to make things happen ourselves.”72 If international donors or the US suddenly dropped the ball, people who could not afford drugs would die. Uganda has already experienced this crisis when the drugs stopped coming. Within 2 months of not receiving drugs, “Denis Mock, from ADFPHA Apac District forum of People living with HIV/AIDS, said 17 people [in Uganda] have died.”73 Domestic Production answers the call by PEPFAR to “identify other resources to fill [the] gap” between available funds and the needs of the people.74

The other evidence against the comparative advantage argument is that many big pharmaceuticals have chosen to partner with African local pharmaceuticals. In 2008, Chinese pharmaceutical company, Adams Pharmaceutical (Anhui) Co. Ltd agreed to a joint venture with Danpong Pharmaceuticals Ghana Ltd in the creation of Danadams;75 Indian Generic Pharmaceutical, Cipla works directly with Ugandan pharmaceutical importer Quality Chemical Industries Ind who manufactures an ARV combination therapy76; Brazil, a model in the fight against HIV/AIDS, is investing $23 million to build a factory in Mozambique in 2009;77 London-based GlaxosmithKline, the second largest drug maker by revenue, holds 81.7 million shares (or 19%) of Aspen, South Africa. 78 China, India, London, and Brazil have been the leading pharmaceutical manufacturers in the world, yet they see openings in Africa.

Many fear that domestic production in Africa is an attempt at the infant industry model which always fails. Economics has revealed that protection of a domestic industry using tariffs and trade barriers never benefits the consumers and decreases the net welfare of the country. If countries choose to protect a domestic industry by taxing imports of the same product to create a level playing field, the government and the producers will be pocketing the tax-payers money and the profits from an inefficient industry. People fear that this kind of protection will give corrupt officials more money, and therefore more leverage, hurting the economy and the growth of the country more than it would give it support. The market does a better job than the people. Domestic producers should have to bid for the lowest prices like any other company so that they are forced to be efficient.

This paper’s model for domestic production is not the infant industry argument model. First, domestic production under article 6(i) is legally written into the Doha Declaration as of 2003 and provides an opening for LDCs to ask for forgiveness of patent laws. Producing under this clause does not ask for any government tariffs against imported ARVs, which could cause complications or lead to corruption. Second, the infant industry model was designed for the sole purpose of benefitting the domestic economy, disregarding the current level of supply. However, in the case of domestic production of ARVs in Africa, gaps in the supply have been recognized and could be filled by the new manufacturers (which may in turn have positive consequences on the domestic economy).

Finally, opportunity cost is important to take into consideration. Some may argue that within the constrained budgets caused by the recent financial crisis, money should be used to find the cheapest drugs, and not reallocated to a risky venture of creating domestic industry. But, to view the world in terms of its current crises negates foward-looking attempts at preventing crises before they happen. Opportunity cost can also be thought of in a different way- what donors could fund now, versus what they would have to fund later. According to Dr. Mead Over, Senior Fellow at the Center for Global Development and former Lead Health Economist in the Development Research Group at the World Bank:

Escalating treatment costs coupled with neglected prevention measures threaten to squeeze out U.S. spending on other global health needs, even to the point of consuming half of the entire U.S. foreign assistance budget by 2016 […] The United States has unwittingly created a new global ‘entitlement’ to U.S.-funded AIDS treatment that currently costs about $2 billion per year and could grow to as much as $12 billion a year by 2016- more than half of what the United States spent on total overseas development assistance in 2006. “And the AIDS treatment entitlement would continue to grow, squeezing out spending on HIV prevention measures or on other critical development needs, all of which would be considered ‘discretionary’ by comparison.79

Domestic Production is the sustainable solution to the entitlement burden because by funding domestic production, investors will also be benefitting Africa’s healthcare system, and the health of Africans infected with other diseases. In countries such as Ghana, Nigeria, and Uganda, domestic production of anti-retrovirals significantly improves the procurement and distribution of drugs for other diseases such as tuberculosis and malaria80. In an October 2009 article, the chief financial officer of Uganda’s QCIL, Frederick Mutebi Kizito, confirmed that international investment in the distribution and production of ARVs contributes to a more efficient disease control mechanism and a substantial price reduction in ARVs and anti-malarial drugs. His facility, produces both anti-retrovirals and anti-malarial drugs81.

Studies also show that domestic production improves the skills of pharmacists and healthcare workers. Particularly, it has improved the skills of pharmacists to provide adherence counseling82. More and more pharmacy assistants and nurses have been trained to dispense anti- retrovirals as well as drugs for other chronic diseases83. According to a Lancet publication one reason for this is that:

The managerial skills needed to keep antiretroviral drugs in stock, to minimize diversion, to confirm that they are administered to those who can use them, and to monitor adherence and side- effects are the same types of skills needed to assure that other important programmes such as safe motherhood packages, malaria, tuberculosis, and sexually-transmitted disease control and diarrheal disease treatment are delivered effectively and consistently.84

Therefore, investing in the infrastructure needed to deliver ARVs will spill over into other collateral health benefits.

More specifically, in Mozambique, investment in domestic production has forced its pharmaceutical company and ARV national programs to adopt task shifting in which mid-level health care workers are trained with the skills of medical doctors to administer ARVs to HIV patients. Such an approach has been highly effective in a nation that once had merely eighty physicians for 10.6 million peoples. Even patients from rural and disadvantaged areas now have access to quality ART services. This method tripled the number of facilities providing medication within six months.85


Part V. Policy Proposal

Challenges

In order to fund the development necessary to achieve large scale domestic production of ARVs in Africa, several possible negative effects must be screened for and avoided. Some of these problems, such as corruption and rent seeking behaviors, are major political issues in several Sub-Saharan African nations. Others, such as heavy subsidies, are economic issues that can decrease the positive effects of development.

First of all, corruption is a considerable issue in many African governments. In 2006, it was estimated by those inside of African governments, that corruption cost African nations about 25% of government income each year86. Money and goods are stolen largely through bribes, political favoritism, and informal connections between politicians and the private sector87. This often makes investment in African countries and companies a risky venture, as it is possible that large amounts of the money may be skimmed off of the top or the project could become mired in political deal-making. Political nepotism may also cause governments to channel aid money and other funds to companies run by close relatives88. Should this happen, the best case is that the money may be given to a relatively inefficient company or industry. In the worst case, much of the aid money could simply be embezzled.


Widespread corruption may then lead to the even larger issue of rent seeking. This occurs when the political group in power has unprecedented access to further power and wealth and everyone outside of that limited group is left with almost nothing. Because all of the power is concentrated in the ruling group and opposition groups are left with no possible avenues, all of the groups in the system will seek to become in power. And, once in power, these groups will use their considerable benefits to stay in power rather than develop the country as a whole, simply because the greatest benefits are derived from staying in power89. Not only could this be caused through aid donations being dispersed amongst the leading class, but also the through development of an inefficient industry that is run by government officials or their relatives.

In order to effectively develop domestic production of ARVs in Africa these situations must be avoided. Corruption, of course, would be against the interests of such a development program. Bribes could increase operating costs and embezzlement would decrease the total amount of aid funds available for use. Funding a rent seeking class will only serve to add to the already numerous adversities facing certain countries.

Heavy subsidies given to the pharmaceutical industry are red flags that must be screened for by effective policy. Subsidies indicate that the industry is unable to be competitive without help from the government. While this may be economically viable if limited subsidies are needed, the costs of heavy subsidies often far outweigh the benefits that the industry can produce. This is especially true in Africa where heavy subsidies often mean that taxpayer money that could have gone to basic development (greater access to drinking water or primary education for example) is instead being spent to help prop up an inefficient industry.90 This puts a heavy burden on the state and, as a result, the taxpayers.

There have been a couple of examples of African ARV producers requiring subsidies in order to continue production; most notably in Zimbabwe where the state played a large role in both the development of the pharmaceutical industry and its maintenance91. While providing

funding to such an industry may lead to a decrease in the subsidies down the road as the industry develops, there has been little historical evidence that this will happen. Instead, these industries will often remain inefficient, as the protective subsidies and aid funding provide little incentive for the industry to streamline and become competitive92.


Policy

With these challenges in mind, we believe the most effective policy route to take in order to help develop domestic production of ARVs in Africa is through the creation of a loan. Such a loan would be provided through the World Bank International Development Agency (IDA), which gives low to no interest loans to developing nations, and given to the best proposal depending on a number of specific criteria.

First of all, the company must satisfy the requirements outlined under Article 6(i) of the 2003 Doha Declaration. At least 50% of the ARVs produced in the company must be designated for export only throughout the economic region. At least 50% of the region must be composed of Least Developed Countries, yet considering both ECOWAS and the East African Community are largely composed of LDCs, this will not be an issue for companies in these economic communities. In order for the World Bank to approve a loan for the production of goods involving intellectual property, patent rights must be agreed upon beforehand93. Through satisfying the Doha Agreements, however, these companies will be able to produce without patents and still be in accordance of World Bank policy94.

Secondly, the company must be compliant with international good manufacturing practices (GMP). These are international guidelines for management control and quality control in pharmaceutical production95. In order to acquire WHO qualification and the subsequent international recognition of quality, companies must be compliant with GMP guidelines96Auditors who specialize in GMPs may be brought in to assess the company’s facilities and systems to determine if they are in compliance97.

Companies must also be able to display the capacity to produce ARVs at a large scale in order to provide treatment, through aid agencies, to at least 25% of those who need it in their region. Considering that 25% of people requiring ARVs ranges from 225,000 in West Africa to 500,000 people in East Africa, these numbers are certainly within the capacity of current domestic producers.98 Connected to this, the company must also have a plan to eventually increase their capacity to reach all of the people who need ARVs in their region. This means that these companies will be able to start producing and providing ARVs to large portions of the region as soon as they upgrade facilities and pass quality tests. This ability, coupled with a detailed plan for future increases, would immediately help scale up current ARV provision programs.

The drugs being produced must be competitive on an international scale. This also includes a lack of heavy government subsidies, as the drugs must be competitive with limited government help. This, above all else, is one of the most important criteria. If these drugs are not competitive the money being spent on the development of the industry, subsidizing its costs, and purchasing its drugs could all be spent on a far more effective project.

Finally, both the rule of law and corruption ratings, measured annually by the World Bank through Worldwide Governance Indicators, are important indications of the strength, freedom, fairness, lack of violence, and corruption of governments in individual nations.99 This is especially important for aid projects as political instability or corruption could easily destroy projects and wipe out any gains made. Yet, the outlook for Africa is not entirely negative. In the 2008 ratings for control of corruption, West African nation Ghana scored better than both India and China and on a similar level to Italy100. Hopefully, these ratings can provide a way to predict and avoid countries where upheaval and corruption are likely.

Using these different methods of screening, the loan seeks to reward companies that have the greatest chance of succeeding in producing cost-effective ARVs to a large international market. By avoiding countries that are likely suspects of corruption and political violence or companies that require heavy government support, the loan also will avoid the challenges that were stated earlier. Instead, this proposed policy would simply provide enough start up capital, $2 million, for specific companies to reach economies of scale so that production can be streamlined and input costs reduced.

This $2 million figure comes from a combination of bio-equivalence costs and facility upgrades needed to reach higher capacity production. Considering that WHO bio-equivalency tests can run to $60,000 per drug produced and that production companies often try to produce between five and seven drugs in order to produce the necessary drug cocktails, costs can run upwards of $420,000 for these tests.101 Current domestic producers have also cited facility upgrade costs of $1 million-$2.5 million in order to reach higher capacity production102. Therefore, the loan would provide anywhere up to $1.5 million to upgrade facilities to increase capacity and efficiency and $500,000 in order to pass bioequivalency tests. This loan would not be too difficult for most companies to pay back, especially at a low or no interest rate. Ghana’s Danadams company, for example, had a turnover of $4.5 million in 2009 and has seen a steady increase profits since 2005.103 Also, considering the World Bank gave $297.2 million solely for Sub-Saharan African private sector development in 2009, this loan would be well within the means and the goals of the IDA104 .

Should several proposals score well on the screening, it is important that the funding go to the best prospects in each region. Given the Doha Agreement’s clause, a producer in an economic community composed of more than 50% least developed countries can produce without patents as long as more than 50% of the products are exported, the loan would be specifically looking for companies in West Africa and East Africa to satisfy the requirements. The top prospect from ECOWAS and the East African Community, should they satisfy all the requirements, would be awarded the loan. Should no company satisfy the requirements in either region, no money will be awarded and the companies can resubmit proposals each year until one company can satisfy all of the requirements.


Conclusion

Using the legal framework provided by Article 6(i) of the Doha Declaration on the TRIPS Agreement in 2003 coupled with a financial boost provided through the World Bank, African production of ARVs could increase dramatically in a very short period of time. Given the benefits of this possibility: decreased cost of the drugs produced domestically, sovereign control over a necessary product, increased regional integration and increased healthcare capacity, domestic production is something that is of great interest to countries currently crippled by the AIDS epidemic and those scrambling to meet the needs of treatment. And, while there are strong economic objections to the development of this industry, issues of dynamic comparative advantage and important social costs change the structure of this issue beyond a strictly classical economic interpretation.

The development of African domestic production could prove to be the force that changes the current issues with the inaccessibility of ARVs by reducing costs, providing a trusted source of the drugs, and increasing the confidence of people in the ability of their governments to be able to handle the challenges of HIV/AIDS. Only with a reliable plan set in place for the treatment of those with HIV/AIDS, can focus then be turned toward the necessary issue of prevention to finally bring the epidemic under control.

Global Health, Global Health Projects


Proposed Amendment to the Methane Capture Jobs and Security Act

January 11th, 2010

Claire McCarthy

Masako Chen

Maura Duffy

Victoria Stulgis


Section VI: The Amendment

Methane Capture Jobs and Security Act (Introduced in Senate)

________________________________

SEC. 101. GUARANTEED POWER PURCHASE AGREEMENTS.

Public Utilities Regulated Under the Clean Energy Jobs and American Power Act is amended by adding the following new section after section 101 (as added by this Act ):

`SEC. 101B. METHANE CAPTURE PAYMENTS.

`(a) Definitions- For the purposes of this section:

(1) METHANE CAPTURE FACILITIES:

`(A) methane collection at active underground coal mines;

`(B) methane collection at landfills;

`(C) non-landfill methane collection involving organic waste streams that would have otherwise emitted methane in the atmosphere, including manure management and biogas capture;

`(b) Methane Capture Payment Rules- Not later than 2 years after the date of enactment of the Renewable Energy Jobs and Security Act , the Commission shall prescribe, and from time-to-time thereafter revise, such rules as it determines necessary to encourage the purchase of electric energy by public utilities from methane capture sources. The rules shall require public utilities to offer to purchase electric energy from methane capture energy facilities in accordance with this section at uniform national rates established pursuant to this section. Each such public utility shall provide access to the grid and purchase electricity from methane capture energy facilities on a priority basis, and each transmitting utility (as defined in the Clean Energy Jobs and American Power Act) shall transmit such energy on a priority basis. Such rules shall be prescribed, after consideration of recommendations made in reports under section 101 of the Clean Energy Jobs and American Power Act, after consultation with representatives of State regulatory agencies having ratemaking authority for electric utilities, and after public notice and a reasonable opportunity for interested persons (and State agencies) to submit data, views, and arguments. Such rules may not authorize a methane capture energy facility to make any sale for purposes other than resale.

`(c) Effective Date- The rules under this section shall apply only to contracts for the purchase and sale of electric energy from methane capture energy facilities entered into after the effective date of such rules and before the date 20 years after such effective date.

`(d) Methane Capture Energy Payment Rates for Purchase of Power-

`(1) PURPOSES- The purposes of this subsection are to–

`(A) reduce methane emissions by methane capture and biogas generation to mitigate climate change

`(B) promote widespread (both local and industrial) use of methane capture technologies to generate electricity.

`(C) prevent excessive profits for methane capture generators;

`(D) prevent excessive profits for electricity suppliers;

`(E) prevent unnecessary costs to ratepayers.

`(2) UNIFORM NATIONAL RATES- Except as otherwise specified in this section, the rates paid for the purchase of electric energy from methane capture facilities under contracts entered into under this section shall be established on a uniform national basis by the Commission by rule. Such rates shall be–

`(A) fixed throughout the duration of a contract extending for a period of at least 20 years;

`(B) no less than the amount needed for development plus a reasonable profit, with consideration to–

`(i) the technology used;

`(ii) the year the installation is placed into service;

`(iii) the size of the methane capture facility;

`(iv) the industry from which the methane is derived. Such industries shall (1) exclude those facilitating the recapture of fugitive methane emissions from natural gas pipelines (2) shall include but shall not be limited to those involved in —

`(a) Animal Husbandry

`(b) Human and agricultural liquid waste

`(c) Landfill solid waste

`(d) Coalmine ventilation

`(3) RATES OF RETURN- Such rates shall be set to provide a nominal, post-tax project internal rate of return of not less than 10 percent after recovery of all operating and maintenance costs for projects sited in locations with favorable methane capture energy resource potential, consistent with the purposes of this subsection.

`(4) PERIODIC ADJUSTMENT- The Commission shall review the rates under this subsection every 2 years and adjust those rates applicable to prospective contracts in accordance with paragraph (2) and in a manner that is consistent with the purposes of this subsection.

`(5) DEGRESSION RATES- For new facilities commencing construction in each year after the first year for which tariffs under this section applied to any facility, the tariffs rates paid under this standard under this section may be reduced relative to the previous year in accordance with annual tariff degression rates. Such degression rate shall be specific to each technology and methane source.

`(6) PRIORITY- The rules under the standard under this subsection shall require each public utility to purchase and each transmitting utility to transmit electric energy from methane capture facilities on a priority basis. Such requirement shall not apply if the public utility or transmitting utility is already committed through long-term contracts to full capacity of its load and such utility has no ability to transmit any new generation from methane capture energy facilities to a neighboring utility.

`(e) Standard Contracts- The Commission shall approve a standard contract to be used in all power purchase agreements under this section that are subject to the jurisdiction of the Commission under this part. The contract shall include the prices paid for each kilowatt hour generated, the duration of the contract, and terms of access to the grid. The Commission shall provide public utilities subject to the jurisdiction of the Commission with standard contracts within 18 months of the date of enactment of this subsection.

`(f) Public Reporting Requirements- After enactment of this act, each public utility shall submit an annual public report to the Energy Information Administration the following information recorded during the previous calendar year:

`(2) The total quantity of electricity and the total amounts paid to methane capture facility operators in accordance with compliance with the rules under this section.

`(3) The total quantity of electricity delivered to by the public utility.

`(4) The total number of methane capture facilities in the area in which the public utility supplies electric energy.

`(5) For each technology and application, the amount of growth in capacity installed relative to the number of new interconnections in the area in which the public utility supplies electric energy.

`(6) The total amount of electricity (in kWh) generated by methane capture facilities in the area in which the public utility supplies electric energy.

`(7) The location of new renewable energy facility development relative to population density in the area in which the public utility supplies electric energy.

`(g) Reports by the Energy Information Administration- In each of the first 2 years and every 2 years thereafter after the enactment of this section, the Secretary of Energy, acting through the Energy Information Administration, shall make public and submit to Congress a report that shall include the number of new methane capture facilities in each State and the environmental benefits and effects of the addition of those generators. There are authorized to be appropriated to the Secretary of Energy such sums as may be necessary to carry out this subsection.

`(h) Federal Contracts- No contract between a Federal agency and any electric utility for the sale of electric energy by such Federal agency for resale which is entered into after the date of the enactment of this Act may contain any provision which will have the effect of preventing the implementation of any rule under this section with respect to such utility. Any provision in any such contract which has such effect shall be null and void.

Environment, Environment Projects


FiTing Methane into America’s Future

January 11th, 2010

Global Climate Change:

FiTing Methane into America’s Future

Claire McCarthy

Masako Chen

Maura Duffy

Victoria Stulgis

Section I: Abstract

Global climate change is one of the greatest threats to the global community.  Since 1750, atmospheric concentrations of greenhouse gases (GHGs) have increased dramatically as a result of human activity (IPCC).  GHGs trap heat in the earth’s atmosphere and the increase in concentration of these gases has warmed the earth’s average surface temperature 1.2-1.4° C in the past 100 years (EPA).

Though not the largest contributor to global warming, methane (CH4) has a greater global warming potential (GWP) and shorter atmospheric lifetime than carbon dioxide (CO2). Methane is also unique in that it is the only greenhouse gas that can be used as an energy source, as it is a primary constituent of natural gas.  Positive effects from reduction of atmospheric CH4 can be seen more immediately, allowing us to “buy time” while long-term solutions to mitigate climate change are innovated and implemented.

We propose an amendment to the Clean Energy Jobs and American Power Act (S.1733) that would enact Methane Capture Payments modeled after a feed-in tariff system for electricity generated from CH4 capture sources: coal mines, landfill solid waste, and human and agricultural liquid waste.  The legislation would guarantee access to the grid and mandate that utility companies pay a fixed rate for electricity from eligible sources.  The feed-in tariff will incentivize the investment in technologies for CH4 capture, so that companies have a timeline for recouping their initial investment.  A feed-in tariff for electricity from captured CH4 avoids excessive financial burden on energy consumers and taxpayers and levels the playing field for both local and industrial methane capture projects.  In addition to the primary environmental benefits of CH4 capture, the legislation provides several secondary economic benefits that incentivize CH4 mitigation.

Section II: Conceptual Map

methan_conceptual_map

Global Climate Change and Methane

“Warming of the climate system is unequivocal, as is now evident from observations of increases in global average air and ocean temperatures, widespread melting of snow and ice, and rising global average sea level.”    – Intergovernmental Panel on Climate Change, 2007

According to the 4th IPCC, anthropogenic global greenhouse gas (GHG) emissions have increased 70% between 1970 and 2004, continuing a marked rise since pre-industrial times.  (IPCC).  The increase in concentration of GHGs has warmed the earth’s average surface temperature 1.2-1.4° C in the past 100 years (EPA).  From 1995-2006, eleven of the twelve years ranked among the twelve warmest years in recording global surface temperature since 1850 (IPCC).  Specifically, average Arctic temperatures have increased at almost twice the global average rate in the past 100 years.

The effects of climate change pose a serious threat to the global community.  Thermal expansion of the ocean, melting of glaciers, icecaps and polar ice sheets have contributed to global rises in sea level: rising at an average rate of 1.8 mm per year over 1961 to 2003 and at an average rate of about 3.1 mm per year from 1993 to 2003 (IPCC).   The IPCC determines that there is “very high confidence” that recent warming is affecting earth’s biological ecosystems.  Effects of climate change have threatened some aspects of human health, such as excess heat-related mortality, and changes in infectious disease vectors.  Furthermore, rising sea levels coupled with human development are contributing to losses of coastal wetlands and mangroves, putting coastal regions at risk for increasing damage from coastal flooding  (IPCC).

“Anthropogenic warming could lead to some impacts that are abrupt or irreversible, depending upon the rate and magnitude of the climate change” (IPCC).

Given these significant anthropogenic changes to the environment, experts within the scientific community agree that climate change is approaching or has already reached a tipping point (Walker, 2006). The processes that lead to global warming will eventually reach a point when a positive feedback loop is established.  Melting of the expansive ice sheets at the earth’s poles contributes to this positive feedback loop (Walker 2006). As the sheets are highly reflective, the loss of these sheets results in more heat being absorbed by the earth, rather than being reflected back and escaping into the earth’s atmosphere.  Because of positive feedback loops such as this, once global temperatures rise to a certain degree, climate change will transcend the scope of human intervention.

The significant contributors to global warming include CO2, CH4, NO2, and fluorinated gases.  Currently, CO2 makes up 76.7% of the world’s anthropogenic GHG emissions, while CH4 contributes 14.3%.  Though CO2 emissions compose the largest percentage, CH4 has a higher global warming potential (GWP) than CO2.  GWP is a measure used to compare each GHG’s ability to trap heat in the atmosphere over a 100-year period; CH4 is 21[1] more times effective at trapping heat in the atmosphere than CO2 (EPA).  Additionally, CH4 has an atmospheric lifetime of 12 years in comparison to CO2 whose average lifespan is 50-100 years in the atmosphere (EPA).  The global atmospheric concentration of CH4 has increased from a pre-industrial value of 715 parts per billion (ppb) to 1774 ppb in 2005 (IPCC).  Specifically in the United States, CO2 emissions contribute 69.6% and CH4 emissions 22.9% to the total US GHG portfolio.  In 2007, 585.3 TgCO2eq (teragrams of CO2 equivalent) of CH4 was emitted in the United States (EPA). Amounts of non-CO2 GHGs are often reported in units of TgCO2eq, which is found by multiplying the mass of the GHG by its GWP[2].

Section III: The Methane Problem

Where does the approximate 585 TgCO2eq of CH4 emitted into the atmosphere per year in the US come from? The primary source is the digestion of organic matter in biological systems. Microbes that thrive in oxygen-depleted environments undergo anaerobic digestion, in which organic acids are broken down and into shorter organic molecules. Methane is released as a byproduct in a process called methanogenesis. The agriculture sector is the largest contributor to methanogenesis worldwide, as well as in the US. The EPA estimated that in 2007, 190 TgCO2eq of CH4 was emitted through enteric fermentation, animal waste, wetland rice cultivation, and burning of agricultural residues (EPA 2009).

Enteric fermentation occurs in the digestive tracts of ruminant animals, which include cattle, buffalo, sheep, and goats. Because of their unique digestive systems, ruminant animals have a fore-stomach or “rumen” which is a breeding ground for anaerobic bacteria. These microbes break down coarse plant material, and the CH4 generated as a byproduct is emitted into the atmosphere when the animal exhales or belches. Though all animals undergo enteric fermentation to a small extent in the large intestine, only ruminant animals have anaerobic microbes in appreciable amounts and generate significant quantities of CH4. In 2007, about 72% of CH4 from enteric fermentation came from beef cattle, about 23% from dairy cattle, and the rest from swine, sheep, horses, and goats (EPA 2009). In addition to the animal’s type of digestive tract, the amount of CH4 generated through this mechanism depends on feed quality and feed intake. In generally, lower feed quality results in higher CH4 emissions, and the more food consumed by the animal, the more CH4 it will emit (Lazarus 2008). Overall, 139.0 TgCO2eq came from enteric fermentation in 2007, accounting for about 24% of all US anthropogenic CH4 emissions (EPA 2009).

Animal waste management is another major CH4 source within the agricultural sector, accounting for 8% of total US anthropogenic CH4 emissions (about 44.0 TgCO2eq) in 2007 (EPA 2009). The waste of livestock, swine, and poultry when stored in liquid environments like lagoons, ponds, or tanks, creates favorable conditions for anaerobic decomposition. When manure is handled in solid systems like stacks or drylots, aerobic decomposition predominates, and minimal CH4 is released. Most large dairy and swine facilities in the US have liquid manure systems, and smaller farms are more likely to have solid manure systems. There was an estimated 45% increase of CH4 emissions from the animal waste sector between 1990 and 2007, which is attributed to the general trend of switching from smaller farming operations to larger farming operations (EPA 2009).

In addition to animal waste, municipal solid waste (MSW) contributes to rising atmospheric CH4 levels. In 2007, 132.9 TgCO2eq in the US came from landfills (EPA 2009). Waste, which includes paper, yard clippings, and food scraps, is buried in landfills where it is consumed aerobically until oxygen is depleted after about one year. Then, anaerobic bacteria consume the remains, breaking down organics into cellulose, amino acids, and sugars. These molecules are further fermented into gases and short-chain organic compounds, which provide optimal growing conditions for methanogenic bacteria. These bacteria convert short-chain organics into biogas, composed of half CH4 and half CO2. During its average lifetime of ten to sixty years, landfill waste releases biogas into the atmosphere. The amount of biogas produced depends on the composition of waste, size of landfill, and climate. Despite increased recycling efforts in the US, the total amount of MSW is expected to rise in the coming years as the country’s population grows (EPA 2009).

Methane also exists naturally deep within coal beds, but can be released to the atmosphere during coal mining processes and when vented. Methane is already required by the Mine Safety and Health Administration (MSHA) to be vented from operational coalmines because accumulation of gas underground in high concentrations can cause explosions. Most mines, both underground and surface mines, vent the 95% pure CH4 directly into the atmosphere (EPA 2006). The EPA estimates that in 2007, 57.7 TgCO2eq of CH4 came from coal mining, 85% of which came from venting, and 15% from post-mining processes (EPA 2009). CH4 can be emitted post-mining when CH4 retained in coal is exposed during processing, storage, and transport. In 2008 23% of US energy came from coal; as long as coal is a large part of the US energy portfolio, coal bed CH4 will be a climate change issue (EIA 2009).

Methane is the primary component of natural gas, which supplied 24% of the US’s energy in 2008 (EIA 2009). The US natural gas infrastructure is made up of hundreds of wells, hundreds of thousands of processing facilities, and over one million miles of pipelines (EPA 2009). CH4 is leaked to the atmosphere as uncombusted exhaust from turbines and natural gas engines, fugitive emissions from faulty pipelines and system components, and discharge during maintenance procedures. It is estimated that the natural gas sector emitted 104.7 TgCO2eq of CH4 in 2007 (EPA 2009). Because of improved technology, management practices, and new equipment, especially plastic piping, the amount of CH4 emissions decreased 19% from 1990 to 2007 (EPA 2009). However, as long as natural gas plays a large role in fulfilling the nation’s energy needs, fugitive CH4 will continue to be a problem.

A major difficulty that impedes policy solutions that target CH4 emissions is the impracticability of measuring and verifying CH4 across all sources. For example, enteric fermentation is the most significant source of atmospheric CH4, but currently the only way to directly measure it is by placing a mask over the cow or other ruminant animal and connecting it to a calorimeter chamber, a bulky device. Thus, the technical requirements for measuring the collective CH4 output of a herd of cows make it nearly impossible for farms to measure and report their enteric fermentation gas output. In hopes of remedying this quantification problem, the EPA has come out with guidelines called the Cattle Enteric Fermentation Model (CEFM) which involves a 16-variable equation including factors like light-weight, average weight-gain per day, fat content of milk, and slaughter rate to estimate the total CH4 output of a cattle herd. However, it is risky to rely on mathematical models that remain unchecked by direct verification.  Researchers are trying to develop more practical analytical methods, but even an accurate measurement of enteric fermentation would not remedy the verification issues. For example, if a dairy farmer added a special ingredient to cattle’s diet in hopes of mitigating enteric fermentation, comparing measurements of CH4 output before and after the additive would have many confounding variables. If the winter season of one year was colder than the next, and animals were under more stress, it would be difficult to prove that the change in CH4 emitted was the direct result of the diet additive (De la Chesnaye). The “measure and verify” problem is not unique to the agriculture sector because most major sources of CH4 are the result of small and scattered emissions including smaller farms, landfills, and scattered pipeline leakages.

Methane is unique as a GHG in that is the only one that can be used as an energy commodity since it is the main component of natural gas. Advanced technology exists that is able to not only prevent CH4 from diffusing into the atmosphere, but also to harness its energy potential. One successful and proven technology is the anaerobic digester. There are various types that collect and cover different forms of waste, creating favorable conditions for anaerobic microbes that produce biogas. The CH4 in the gas can then be directed into combustion engines, turbines, or fuel cells to generate electricity. The electricity can be used on-site or sold back to the grid. In 2007, there were about 111 farms that utilized anaerobic digesters that transformed manure from cattle, swine, and poultry into biogas, outputting approximately 215 million kilowatt-hours (kWh) of electricity (EPA 2009). On average, an anaerobic digester captures 85% of CH4 that would be emitted from liquid manure systems. In addition to the direction reduction of GHGs, anaerobic digesters have the indirect environmental benefit of saving energy that would be needed from non-renewable sources like coal. Other benefits for the farmer include odor control, ammonia control, improved water quality, and improved air quality (Lazarus 2008).

Landfills have been utilizing CH4 capture and electricity generation technology successfully for decades. Landfill gas capture is about 60-90% effective depending on the technology used (EPA 2006). Landfill gas can be extracted using a series of wells and a vacuum system, and then directed toward a central site where it is processed, treated, and generated into electricity. The benefits include: direct reduction in greenhouse gases emitted, indirect reduction of greenhouse gases by offsetting other non-renewable energy sources, reduction in landfill odor, and reduction in explosion hazard. According to the EPA’s Landfill Methane Outreach Program, in 2008, landfill gas energy projects saved about 23 TgCO2eq of GHGs from being emitted (EPA 2009). Viable CH4 mitigation opportunities also exist in the coalmining sector. Equipment can oxidize the ventilated CH4 into CO2 and heat, which may be used for on-site electricity generation. This technology has the capacity to prevent the emission of 97% of ventilation air methane. The EPA estimates that from 1994 to 2006, coalmine CH4 projects were responsible for the capture of 18 TgCO2eq per year (EPA 2009).

As demonstrated, CH4 capture projects have successfully reduced GHG emissions while providing financial benefits to the owners, but these technologies are not utilized to their full potential because of the current economic and political climate in the US. Methane capture projects are capital-intensive, since each one must be uniquely engineered to the specific site, and requires maintenance. A study of 38 farm-based anaerobic digesters in the US found that the startup costs for a digester ranged from $69,000 to $603,000 (Lazarus 2008). The maintenance cost for a small dairy farm with 125 cows is about $8,800 per year (Burke 2001).  Though much of this investment is returned when the electricity generated is sold, the current prices offered by utility companies for captured CH4 electricity are too low to justify the investment. The unpredictability of market prices for electricity makes it difficult for potential investors to calculate the timeframe of returns on a digester and arrange their finances (Lazarus 2008). Though the EPA sponsors voluntary CH4 capture programs like AgSTAR, Coalbed Methane Outreach Program, and Landfill Methane Outreach Program, the incentives offered are not enough to encourage investment in these technologies, particularly for smaller operations.

Section IV: A Feed-in Tariff to Incentivize Methane Capture

A feed-in tariff (FiT) is a policy mechanism designed to encourage renewable energy sources; whereas the Renewable Portfolio Standard (RPS) promotes price competition between renewable energy sources, the FiT mandates fixed prices above wholesale rate that utility companies must pay different renewable generators.  The FiT in Europe has been met with great success, and as of January 2007, eighteen European Union Countries as well as Brazil, Indonesia, Israel, South Korea, Nicaragua, Norway, Sri Lanka, Switzerland, and Turkey had adopted FiTs (Rickerson 2007). Around the world, FiTs have shown their capabilities to truly revolutionize different renewable energy markets.  In Germany, Denmark, and Spain, FiTs have promoted the generation of 31 gigawatts of wind electricity capacity, that is 53% of the world’s total wind energy generation from 1990-2005 (Rickerson 2007).  Just as the renewable energy FiT in Europe has been successful in promoting the wind and solar photovoltaic (PV) industries, the methane-capture FiT will encourage sources to capture CH4 from being emitted to the atmosphere.   The FiT will incentivize the investment in technologies for CH4 capture, so that companies have a set timeline for recouping their initial investment.  While we refer to the policy as a FiT throughout this paper, in the amendment to the Clean Energy Jobs and American Power Act, we will instead refer to this policy as “Methane Capture Payments.”  The word “tariff” or “tax” may be less acceptable to the American public and would limit support for the legislation.

The Methane Capture Jobs and Security Act Amendment establishes a national FiT regulatory program for electricity produced from CH4 captured from specified sources and may include but are not limited to individuals or corporate entities managing livestock, human and agricultural liquid waste, landfill solid waste, and coalmine ventilation. These methane capture entities exclude those capturing fugitive emissions from existing natural gas pipelines, because the policy should not incentivize inefficient pipelines.

Specified methane capture facilities will be guaranteed grid access; the utility companies must compensate these generators for every kWh of electricity produced and sent to the grid.  The amendment will determine a twenty-year contract between the CH4 capture sources and the utility companies.  Uniform national rates paid for electricity from CH4 capture sources will be fixed for twenty years, adjusted every two years, and calculated, based on the technology, capital investments, and maintenance costs, and market price for electricity.  There will be different prices for CH4 captured from different sources (livestock, human and agricultural liquid waste, landfill solid waste, and coalmine ventilation).  In twenty years, the FiT will be reevaluated to determine and set a phase out plan.  This will be evaluated based on the contribution of electricity generated from captured methane to the US Energy Portfolio.  The amendment also requires that each public utility administers an annual progress report that shall be submitted to the Energy Information Administration including the total amount of electricity in kWh generated from methane capture sources.

The purposes of the FiT, as defined by the amendment, are to reduce CH4 emissions by CH4 capture and electricity generation to mitigate climate change, to promote profitable development of CH4 capture facilities that use available commercialized technologies, and to prevent excessive profits for electricity generation facilities and methane capture facility operators and unnecessary costs to ratepayers.

In Germany, the FiT for renewable energy was introduced in 1991, and has since been adapted to provide a succinct and successful model for a US FiT for methane capture sources.  The Energy Feed-In Law (Stromeinspeinspeisungsgesetz) was enacted in 1991. The main drawback was that utility companies and grid operators were not required to permit free grid access to all electricity generators, so small-scale facilities were denied access to the grid.  As many renewable energy producers—wind, solar PV, hydro—are small-scale facilities and residential homes, the Act did not succeed in its ultimate goal.  The law was replaced in 2000 with the Renewable Energy Law (Erneuerbare-Energien-Gesetz, EEG), which among other logistical changes, required that grid operators guarantee free access to renewable energy suppliers, and mandated payment for said electricity fed into the grid.  Access is key to a successful FiT and will be imperative to the success of the Methane Capture Payments, as many smaller farms and landfills will be able to capture methane.  The Renewable Energy Sources Act (2009) further amended the EEG; rates per kWh for wind power were increased, while the price for solar PV was set to begin a phase out, degressing 8-10% in 2010 and 9% in 2011.  Stefan Dietrich, a spokesman for a German solar PV company Q-Cells states, “the FiT gives companies a good basis for planning but also makes them become more efficient and competitive. It is a win-win-win—for the industry, the government and individuals” (Seager 2007).

As the German model demonstrates, investors need to be assured that the capital and long-term investments are worth making.  Once the market is created for both the energy from CH4 and the technology, the prices will likely lower substantially, making the technology more affordable to smaller enterprises.  In 2006, of the 1,500 MW of solar energy produced in Germany, 240 MW were generated from residential homeowners, and 300 MW were fed into the grid from solar PV on barn roofs (Gipe 2006). In 2006, renewables accounted for 11.8% of total electricity consumption in Germany, and in 2005 they prevented the emission of 83 TgCO2 (Mendonca 2007).  As of 2007, the renewable energy industry in Germany employed 214,000 people, which was more than the number that the conventional energy sectors employed (Medonca 2007).  Germany paved the way for the US Methane Capture Payments: the FiT allows a revolutionary industry growth and development, allowing for capture of CH4, which would otherwise be emitted to the atmosphere.

The utility companies are required to pay more for the electricity per kWh, but they ultimately pass this cost to the end-use consumer.  The German Solar Energy Association estimates that the FiT in Germany currently adds $1.69 for a monthly residential bill.  The 2007 Department of Energy Data Book estimated that 31% of the average utility bill comes from heating (DOE); considering heating and air conditioning is seasonal, and energy bills can fluctuate substantially depending on the month and season, the slight increase in price is not likely to affect the consumer.

The FiT will stimulate industries that currently emit CH4 to capture and generate electricity, in hopes of reducing the 585.3 TgCO2eq that are emitted in the US each year. The EPA estimates of 2007 GHG emissions in the US were assumed to be good indicators of yearly CH4 emissions over the next twenty years, even though in reality yearly emissions are dynamic. The theoretical potential, meaning the hypothetical upper limit of emissions targeted is 264.6 TgCO2eq of CH4 per year, which is the sum of emissions that come from the specific sources in our amendment i.e. landfills, coalmines, animal manure, and wastewater treatment (IEA 2008). The technical potential encompasses the engineering constraints for CH4 capture and electricity generation technology in each sector (IEA 2008). Though hopefully the technical efficiency will be improved in the coming years, the current average technology efficiencies in terms of percent CH4 able to be captured out of total CH4 emitted was used in this calculation. The prediction also factors in the economic costs and benefits, planning constraints, and existing barriers to technology (de la Chesnaye). Based on European FiT models and US Department of Agriculture research, the estimate for participation rate, meaning the number of businesses that adopt CH4 capture technology out of the total number of businesses that contribute to that source, was assumed at worst 5% and at best 30%. The exception is abandoned coalmines, where the lower participation rate is 1% and the upper participation rate is 10%, since this CH4 source has significantly more boundaries due to questions of ownership issues. Encompassing all parameters, the realizable potential of the amendment is between 10.3 and 62.1 TgCO2eq per year by the time it is reevaluated in twenty years. These figures signify a reduction in US CH4 emissions by between 1.8 and 10.6%; this is roughly equivalent to the CO2 emissions from the gasoline used to power 2% to 10% of passenger cars in 2007 (EPA 2009). This calculation only includes direct reductions in CH4, and not the indirect benefit that the electricity generated will offset the GHGs from “dirty” energy sources.

Table 1. Theoretical, technical, and realizable potentials for CH4 mitigation.

Source

Theoretical Potential (TgCO2eq/year)

Technology Efficiency1

Technical Potential (TgCO2eq/year)

Lower Participation

Upper Participation

Lower Realizable Potential (TgCO2eq/ year)

Upper Realizable Potential (TgCO2eq/year)

Landfill

132.9

0.75

99.7

0.05

0.30

5.0

29.9

Coal

57.6

0.82

47.5

0.05

0.30

2.4

14.2

Coal Abandoned

5.7

0.97

5.5

0.01

0.10

0.06

0.6

Manure

44.0

0.85

37.4

0.05

0.30

1.9

11.2

Wastewater

24.4

0.85

20.7

0.05

0.30

1.0

6.2

TOTAL

264.6

210.8352

10.3

62.1

(1) Sources: EPA 2006, 2009

Realizable Potential = (Theoretical Potential) * (Technology Efficiency) * (Participation Estimate)

Section V: Policy Options Passed Over in Favor of the Feed-in Tariff

One possible approach to reducing CH4 emissions is the formation of an organization modeled after the CIA’s “In-Q-Tel” program. This organization would invest in the research and development of new technologies for CH4 emission reduction. The actual investment process would be outsourced to this organization within the private sector, rather than remaining under direct governmental observation. Since there is already a substantial amount of research in developing technologies to mitigate climate change, this option may not be the most expedient.  In 2007, the Advanced Research Projects Agency-Energy (ARPA-E) was established for this exact purpose and this agency has received $400 million under the American Recovery and Reinvestment Act. Furthermore, reliable technologies to capture CH4 from a variety of sources already exist (DOE 2009). Considering CH4 reduction has the potential to make a rapid impact due to its short half-life, we would be remiss not to focus on tapping into this potential as soon as possible using existing technology.

Another policy up for consideration is an outreach program that would focus on propagating technology for the reduction of fugitive emissions from natural gas pipelines abroad, specifically in the former Soviet Union, which has a massive but antiquated natural gas pipeline infrastructure. (Leliveld 2005). The US has the technology to make these pipelines more efficient. However, this policy lacks the scope of potential impact offered by the FiT. While fugitive pipeline emissions are substantial, a US FiT targets a number of different sources. Domestically, the sum of these emissions exceeds those that we anticipate would be immediately reduced through this outreach program, and thus it was passed over in efforts to produce the greatest immediate impact. The estimated amount of fugitive CH4 emissions in Russia in 2005 was 174.8 TgCO2eq, which is lower than the theoretical potential of the Methane Capture Payments amendment of 264.6 TgCO2eq, as discussed in the previous section (Methane-to-Markets 2008).

A CH4 tax is a potential policy mechanism for limiting methane emissions. This initially attractive option, however, is ultimately unfeasible due to the difficulty of monitoring CH4 emissions. While calculating the amount of energy produced from methane sources, as required by a FiT, is relatively simple, the actual amount of CH4 being emitted from a particular source is substantially more difficult to quantify. This difficulty is particularly egregious in the agricultural sector. Though animals can be isolated and monitored in order to calculate their emissions, there is no existing technology that would feasibly allow for real-time quantification of CH4 emissions from livestock on a large scale. Therefore a policy that consistently taxes all CH4 emissions would be extraordinarily difficult to carry out.

The difficulty of quantifying CH4 emissions also justifies the infeasibility of a required capture policy option. This policy would require that livestock operations, coalmines, and landfills would be monitored for CH4 emissions and mandate the capture of a certain percentage of these emissions. However, as with the CH4 tax option, the lack of mature CH4-monitoring technology is a significant hindrance. Additionally, because of the vast number of sources in the form of thousands of landfills, agricultural operations, and coalmines, administrative costs of regulating this policy would be substantial if not prohibitive for both the required capture and CH4 tax option. In contrast, a FiT requires significantly less direct supervision; technology for the regulation of electricity utilization and production is already in place in the US. Therefore the FiT does not require the investment in the enormous amount of additional infrastructure that would be required by a CH4 tax or a required capture policy.

Another mechanism that has been used to regulate emissions is a cap-and-trade. In this system, emissions are capped at a set level. If a particular business is unable to meet this cap and must go over, it can do so by purchasing either the rights from another business, or offsets from industries producing renewable energy.  However, this system has several flaws, particularly if the desired effect is to minimize CH4 emissions in particular. First of all, a cap-and-trade system that caps CH4 exclusively is infeasible because of the lack of technology for monitoring CH4 emissions. This still leaves the option of using CH4 sources as offsets in a CO2 based cap-and-trade system.  One of the downfalls of a cap-and-trade system is that because of its market-based approach, different renewable energy sources are put into competition against one another for use as credits. This system favors the cheapest renewable energy options; thus, though a cap-and-trade system increases utilization of some energy sources, it does not necessitate that CH4 in particular will be reduced. Furthermore, previous legislators have had difficulty passing cap-and-trade policies that set emission levels low enough to instigate the use of offsets. This has been an issue of concern in regards to the cap-and-trade system recently put into place by the European Union. For example, the US Government Accountability Office noted that in Germany, “electricity companies were supposed to receive 3 percent fewer permits than they needed to cover their total emissions between 2005 and 2007, which would have forced them to cut emissions. Instead, the companies got 3 percent more than needed…a windfall worth about $374 billion at the peak of the market.”(GAO, 2008). In short, possibly in part due to lobbyist pressure, the way that the cap-and-trade systems set emission levels and distributed permits resulted in less actual environmental impact than was originally intended.

Why the Feed-in Tariff for Methane is the Most Effective Policy

To implement our overall goal to mitigate CH4 emissions, we believe that a FiT is the most effective policy solution to increase investment in CH4-capture technologies from a wide array of CH4 emission sources and introduce CH4 into the market as an alternative energy source.

According to some industry experts, a FiT is a market distortion that may stagnate competition to improve energy efficiency, create windfall profits for generators, and increase costs for energy consumers. As will be demonstrated in the following section a FiT in actuality will promote competition and distinguish between different CH4 sources without imposing a significant financial burden on energy consumers.

To reduce global reliance on fossil fuels and mitigate global climate change, the two most popular policy solutions to encourage renewable energy development have been a FiT and a Renewable Portfolio Standard. (Lipp 2007). As explained in the previous sections, a FiT offers a fixed price for electricity generated from captured CH4. In other words, the governing body determines price, while the market dictates quantity of generation and consumption. Comparatively, in the RPS scheme, the quantity is set while the price fluctuates with the market. According to the proponents of RPS over FiT, “Renewable Energy technologies producing power at the lowest cost are purchased to meet the obligation, and least cost is typically achieved by large developers using well-established technologies” (Lipp 2007). Therefore, an RPS, in theory, promotes competition to drive the use of the cheapest and most efficient technologies to generate clean energy. However, this model does not take into account CH4’s high GWP and short atmospheric lifetime and these implications on global climate change.  An RPS scheme forces competition between all renewable energy sources: wind, solar, and biogas, while a FiT distinguishes between these technologies by accounting for the technological costs associated to each industry. Reiterating the data from Section 3, an anaerobic digester, for example, can cost anywhere from $69,000 to $603,000. Given the comparative cost to start these projects, CH4 capture will most likely be ignored, despite its environmental benefits. Economists may cringe at the idea of fixed prices (Connaughton, De la Chesnaye), but competition and innovation still exist within a FiT. However, the fixed price in a FiT targets CH4 capture by guaranteeing a reasonable rate of return on investments. Therefore, a FiT takes into account the urgency of CH4 emissions and the need for capture.

Secondly, the FiT still allows for competition to drive innovation and production of more efficient CH4 capture technologies. In the case of windpower under the FiT in Denmark, lower prices of wind turbines decreased windpower prices from 14 €-cents/kWh in 1985 to 4 €- cents/kWh in 2004 (Hvelplund 2005). Rather than pitting all renewable energy sources to compete against each other, the competition shifts to the technologies within each renewable energy source. Because the FiT price is set depending on the CH4 emission source and respective capturing technology, it accounts for all renewable energy sources to be utilized, including CH4. In addition, the price degression outlined within our Methane Capture Payments amendment accounts for improved efficiency and implementation of these CH4 capture technologies to prevent windfall profits for generators.

Finally, the fixed price and long term contract of at least 20 years encourages local CH4 capture projects. Under a RPS, the small local generators face competition from larger projects. Fixed prices under a FiT, however, “create a market certainty needed to attract investment and grow the industry” (Lipp 2007). Given that most CH4 emissions come from a range of local and industrial sources, this inclusion of both small and large projects maximizes CH4 capture. Under the FiT in Germany, one-third of the wind turbines are local landowners and residents. Similarly in Denmark, residential families own 80% of the country’s wind turbines.

Another argument against a FiT lies in its cost. A RPS in theory is thought to be the most cost effective, as competition creates a downward pressure on renewable energy prices. However, recent assessments have shown that a FiT is the more cost-effective compared to quota and trading systems. In fact, the European Commission has concluded, “well-adapted feed in tariff regimes are generally the most efficient and effective support schemes for promoting renewable electricity.”  Because a RPS entrusts a small number of utility companies to determine the price of electricity from captured CH4, price competition is still hindered. For example in the United Kingdom, there are only five or six, multi-nationally based electricity suppliers (Toke 2006).  Within this oligopoly, the few electrical suppliers force generators into “long term, relatively (or actually) fixed price contracts” (Toke 2006), without the benefits of a FiT for local and industrial CH4 capture projects. 

A comparison of United Kingdom’s Renewable Obligation system (RO), Germany’s Renewable Energy Feed-in Tariff (REFIT), and Denmark’s shift from a FiT to a RPS system establishes that a FiT is more effective than market-based systems. In the British RO, the quota for electricity generated from renewable energy sources was set to increase steadily from 10.4% by 2010 and 15% by 2015 (Toke 2006). Energy suppliers purchase Renewable Obligation Certificates (ROCs) from eligible energy generators, who receive ROCs for every kWh of renewable electricity they produce. Ideally, the competition created through this scheme will drive prices down, but it involves the price of certificates instead of electricity prices (Toke 2006).  Though the FiT is thought to be an expensive mechanism, analyses from the European Commission determined that the RO in UK and other quota systems produce electricity at a higher cost than FiT (EC 2005). Without any specifications as to what kind of renewable energy or the length of the contracts, the RO increased risk and investment uncertainty for renewable energy generators. With short-term contracts, these generators could not determine the volume or price of the energy they provided (Lipp 2007). As seen in Figure 8 below, the effectiveness indicator in 2005 for the UK quota system is significantly less than the countries that employed a feed-in tariff. In addition to its costs, renewable energy accounts for 3.9% of total energy in 2005 with the UK RO, falling short of its goal of 10.4% by 2010 (DTI 2006).

methane_figure_8

Despite the theoretical advantages of competition in a market-based system, the RO in the UK clearly demonstrated that in practice, quota systems like RPS result in higher costs, lower generation, and fail to achieve lower emissions.

Denmark’s shift from a successful FiT to a more market-based system caused significant declines after 1999 in electricity generated from wind power. Since the global oil crisis in 1973, Denmark immediately mobilized to establish renewable energy projects. To quote Hvelplund, “systematic public interference in the monopoly market broke its barrier to entry and opened the door for wind power technology.”  In 1993, Denmark’s FiT mandated utilities to purchase wind power electricity to be fixed at a rate of 85% of the consumer price for electricity (Hvelplund). As seen in Figure 3 below, ­from 1993, windpower grew from 500 MW to 3,000 MW, but has leveled off in 2004 when a new government shifted to a renewable portfolio standard. Therefore, Denmark’s FiT jumpstarted a widespread adaption of wind-power generation, but recently stagnated with its switch to a market-based system.

methane_figure_3

(Source: John Farrell, April 2009)

The most successful policy model for stimulating renewable energy generation has been the feed-in tariff in Germany. The FiT bill of 1990 required access to the grid and a fixed price for electricity from renewable energy sources of 65 to 90% of the consumer price (Lauber, Mez). The benefits were especially significant for stimulating adaptation of windpower technology, as summarized in Figure 4 below. In 2000, the German FiT was revised to include a long-term contract for 20 years, different prices between different renewable sources, and annual degression rates to account for improving technologies (Farrell).

methane_figure_4

(Source: John Farrell, April 2009)

Table 3 below summarizes the effectiveness of a FiT (Lipp 2007). As of 2006, Germany, through its FiT, has managed to most effectively reduce CO2 emissions by 215 TgCO2, of which renewable energy accounted for 58 TgCO2.  Though the United Kingdom has reduced CO2 emissions more than Denmark with 108.2 TgCO2 compared to 1.2 TgCO2, most of the reductions resulted from a switch from coal-fired to gas-fired electricity in the 1990’s (Lipp 2007).

methane_table_3

Conclusion

Global climate change poses a challenge to the global community and demands immediate action.  As a solution to mitigate climate change in the short term, we propose the Methane Capture Jobs and Security Act, an amendment to the Clean Energy Jobs and American Power Act.  Under this Act, fixed rates for methane captured from specified sources will revolutionize the methane capture to energy industry.  The Methane Capture Payments will incentivize and send the necessary market signals for livestock corporations, coalmines, and landfills to invest in the technology to capture methane and generate electricity.  The Methane Capture Payments is the best option in mitigating methane emissions specifically because of methane’s ability to generate electricity, and because regulating methane emissions is technologically difficult.  The feed-in tariff mandated in this Act requires annual reports, which will quantify the amount of electricity produced per kWh from methane, allowing us to measure how much methane has been captured.  Feed-in tariff models in Europe have proven that the policy is very successful in revolutionizing the renewable energy industries, especially on the small and local level.  This Act will effectively reduce CH4 emissions in the US by between 10.3 and 62.1 TgCO2eq per year by twenty years after its enactment. While not the ultimate solution, this Act creates a wedge, buying time for the global community to develop an all-encompassing solution to climate change.

Environment, Environment Projects


The ePET Program Energizing the Plastic Beverage Bottle Industry

January 8th, 2010

The ePET Program

Energizing the Plastic Beverage Bottle Industry

14 December 2009

Henry Fingerhut

Brian Fochtman

Caroline Lee

Allison O’Rourke

Section 1.  Summary

Background

With the growth of worldwide plastic use, public attention to and industry mitigation of the resources consumed in the production of plastic products is increasingly important. This necessary consciousness is especially true of plastic packaging, as approximately half of the plastic consumed annually is intended for single use. Specifically in the case of plastic bottles, plastic feedstock material and resin production processes command 7-8% of global petroleum use. While public campaigns to encourage conservation and recycling are prevalent in the United States, and many beverage producers advertise environmental attributes of their product, no credible and widely accepted standard exists to convey the energy intensity of plastic bottles over the life cycle. Ecolabeling programs worldwide vary in form and scope, and are critical tools in the effort to raise public awareness of environmental issues and drive industry toward more energy efficient practices. Successful U.S. certification programs, including Energy Star and LEED, tend only to address durables and industrial products. The establishment of an energy efficiency certification program for plastic bottles will more associate small-scale, single-use packaging with its cumulative energy effect in the public awareness.

Methods

We propose the establishment of a government certification program for the energy efficiency of plastic bottles. Qualifying bottles will earn a seal of energy efficiency, the ePET label, which will be awarded to market leaders who minimize energy costs of the Polyethylene terephthalate (PET) bottle over the entire bottle life cycle.  The ePET label energy threshold is set at an aggressive 20 gigajoule (GJ)/metric tonne of plastic, which is currently 20% of the market average.  Such a revolutionary figure will require the industry to develop innovative methods.  There will be few limits placed on companies to encourage greater development.  Applications for the label will be made on a voluntary basis by those companies that seek to differentiate their product based on energy conservation.  To ensure the long-term success of the program and to drive further industry improvement, the energy threshold will be revisited every 5 years and adjusted to maintain its innovative nature.

Section 2.  Global Challenge

epet_global_challenge_diagram

The ePET program addresses the energy crisis global challenge. The energy crisis can be considered from various angles, including the production of energy from natural resources, its procurement by consuming nations and industries, the consumption of energy by industrial and private sectors and the recycling and extraction of secondary energy after use.

ePET affects energy consumption by minimizing input resources in the plastic bottle industry. Energy consumption can be considered differently in the cases where a) energy is an intermediate good ancillary to the production of another and b) energy is the final good to be consumed privately, eg. as a utility or in transportation.

Two perspectives are equally integral to reduction efforts in energy consumption as an intermediate good. In the development of policy that is both broad enough to effect advancement but sufficiently focused to achieve practical success, these approaches should be taken independently. First, efficiency can be improved through process-constant policy, which considers a particular process across a series of affected industries, eg. by improving transportation systems for many products, the production of plastic resin to be used in many plastic products, or recycling processes. Or, industry-constant efficiency can be improved, addressing a single good over many processes within the life cycle. We chose this approach with hopes to attract attention to changes in plastic bottle production with effects across the life cycle to balance current public and industrial process-oriented awareness.
Section 3.  Particulars of the Problem

Global Energy Demand

The global demand for energy is increasing rapidly with increases in both global population and per capita energy consumption in developing nations.  The US Energy Information Administration estimates that from 2006-2030 the global energy demand will increase by 44%.[1] This increasing demand can only be met in two ways: attempting to curb it by increasing efficiency or by finding new sources of power.

Finding new sources of power is both problematic and costly.  Researchers at the University of Albany predict that the world is rapidly approaching peak oil production.[2] More sustainable sources of power are being adopted more slowly because of high infrastructure costs.[3] Secondary problems are associated with creating more energy to meet global demand.  Use of fossil fuels, which currently produce 87% of global energy, release carbon dioxide into the atmosphere and ultimately contribute to global climate change.4 This problem is not predicted to be resolved in the near future.  By 2030 fossil fuels are expected to produce 80% of the global energy supply.[4] Given the problems, logistically and environmental in meeting unrestrained global energy demand it is in the greater interest to use energy more efficiently.  One area that can be targeted is disposable products, such as plastic beverage bottles.

Energy Costs of Bottled Beverages

Beverages bottled in polyethylene terephthalate (PET) are both energy intensive and in high demand.  Both of these factors make this industry an urgent piece of the energy security puzzle.  According to the National Association of PET Container Resources (NAPCOR) 2.4  million metric tonnes of PET were used for bottles in 2006.[5] The energy cost of producing these bottles from virgin resin, according to the Hopewell et. al., averaged 100 GJ/tonne for a total energy cost of 2.4 billion GJ, the energy equivalent of 393 million barrels of oil, at 6.1 GJ per barrel of oil.[6],[7] An explanation of this figure will be given below.  This amount of energy is highly significant given that global oil output is roughly 30 billion barrels a year.2 The energy cost of PET beverage bottles is incurred over the entire life cycle of the bottle and depends on the methods and materials employed.

The life cycle of a beverage bottle may be divided into three bins- production, transportation and recycling.  The production bin summarizes two steps: the creation of PET resin and the creation of the bottle from this resin (see Figure 1).  PET resin may be created from virgin or recycled sources.  Hopewell et al. have determined that the creation of this resin costs 83 GJ/metric tonne for virgin resin and 8-55GJ/metric tonne for recycled resin.6 Use of recycled resin instead of virgin resin results in an energy savings of 90 – 44%.  The use of recycled resin however depends on availability and cost.  Hopewell has also estimated a cost of 20 GJ/metric tonne to form the resin into bottles.  Hence 100 GJ/metric tonne to make a bottle from virgin resin.

epet_figure_1

Figure 1.  Energy cost in Gigajoules / metric tonne for bottles created with PET vs recycled PET (rPET).6

The second life cycle bin of a bottle is transportation.  The energy total for this category is equal to the sum of several events depending on company practices.  This category accounts for the transportation of resin to the factory in which bottles are created, the transportation of the bottles to the bottler where they are filled, and the shipment of the filled bottles to the consumer.  The transportation energy costs for an average bottle are difficult to calculate given the great variety of distances companies may need to ship their products or its components and the mode of travel used.  Gleick and Cooley estimated these costs for five different modes of transportation.  This data is summarized in Table 1.[8] Depending on the distance traveled these energy costs can be significant.

Table 1. The average cost per ton per kilometer of five common modes of shipping.  Please note that this table uses tons, while this paper uses metric tonnes as the standard unit of weight.8

Cargo ship/ocean (MJ t–1 km–1) Air cargo (MJ t–1 km–1) Rail (MJ t–1 km–1) Heavy truck (MJ t–1 km–1) Medium truck (MJ t–1 km–1)
0.37 15.9 0.23 3.5 6.8

The third category of energy costs is recycling.  Once a bottle is used it must be disposed of.  PET from used bottles may be recycled, or left in a landfill.  The energy cost of recycling is 1.5GJ/tonne.6 The energy cost is broken down further in Figure 2.

epet_figure_2

Figure 2.  The total cost of recycling a PET bottle.6

As seen in Figure 2 the majority of these costs come from the collection of to be recycled goods.  The part of this number that varies throughout the industry is the materials recovery, the cost of recovering 100% of the bottle, labels, and dyes included as reusable products.

Increasing Global Demand

The problem of high energy investments in plastic beverage bottles is pressing because global beverage bottle use is on the rise.  NAPCOR posits a 6.9% increase in market size for PET bottles in 2006 alone.1 Figure 3 shows that such high levels of market growth are common.[9] This growth is being realized largely in the bottled water markets.  The Bottled Water – Global Market Guide claims that the bottled water market grew 8.1% by volume in 2006, with over 50% of these global sales in Europe.[10]

epet_figure_3

Figure 3. Per Capita PET Beverage Bottle Wasting and Recycling Data for 1990-2006 is used to show the increase in demand for PET Beverage Bottles. Taken from the Container Recycling Intitute.9

Furthermore much of this global growth has been caused by great increases in the developing world.  Figure 4 shows the percent increase in bottled water in various markets throughout the world.[11] Charting growth in the bottled water sector is a sufficient marker of market growth as increases in bottled water use is the driving force behind the PET bottle market growth.  In an unpublished study it is claimed that the bottled water market in India rows by 50% every year.[12] The rapid growth in demand for PET beverage bottles coupled with their high energy costs makes decreasing the energy cost of PET bottles a relevant and important part of curbing global energy needs.

epet_figure_4

Figure 4. Percent increase in bottled water consumption from 1999-2001 in 8 distinct global markets.  Strong growth in demand for PET bottles is seen in Pacific and Asian regions.  Taken from Ferrier.11


Section 4.  Particulars of the Solution

Labeling Program and Its Administration and Process

The goal of the ePET program is to certify plastic beverage bottles that meet a certain threshold for the energy invested in the production, transportation, and recycling of the bottle.  The ePET program will be run by a specific governmental department, as specified by Congress.  This department will run the daily processes of the program

Individual beverage bottle companies will independently apply to the program.  The program will have auditors that assess the energy invested in the bottle.  The energy value determined by the auditors must be at or below the threshold set by the department.  Once this level is reached, the bottle now can display the ePET symbol on its label to show that it is certified as an energy efficient beverage bottle.  A continual audit process of every five years will ensure that the certified bottle still meets the energy investment standard.  The ePET program’s energy investment number will be revisited every five years by the governing department.  Therefore, any changes to the energy investment threshold will apply to the previously certified bottle and determine continued or revoked certification.

The ePET label can be used as a marketing tool by the beverage company whose bottle has been certified.  The government department heading the program will also establish a public awareness campaign to inform the public of the requirements of the program and its effects, thereby preventing any false advertising by certified or non-certified bottles.

Life Cycle Analysis

In assessing the energy investment of an individual plastic bottle, the life cycle of a bottle was assessed.  It was imperative to define the boundaries of the life cycle of the bottle so that any life cycle analysis performed on a specific bottle would be comparable to the life cycle analysis of any other bottle.  The earliest energy investment cited in the life cycle analysis is the production of the feedstock into resin.  The source can include materials such as petroleum or corn.  Therefore, the energy used to obtain the oil or grow the corn, for example, is not taken into account.  The final energy investment cited in the life cycle analysis is the recycling of the bottle, including dyes and labels, into reusable resin.  At this point in the life cycle, the bottle is no longer in existence, and has been reduced to its component materials.  Finally, the entire bottle must be recyclable or biodegradable.

The life cycle of a plastic bottle, now defined by its boundaries, can be divided into three categories: production, transportation, and recycling.  The production of the resin from the source, the production of the bottle from the resin, and the filling of the bottle with the beverage are the components of the production category.  The transportation of the resin to the bottle-making plant, the transportation of the bottle to the beverage plant, and the distribution of the bottled beverage to locations for purchase by the consumer are the components of the transportation category.  The recycling of the bottle into reusable resin, the recycling of the label and cap, and the recycling of the dye are the components of the recycling category.

The life cycle energy investment for plastic beverage bottles in the current industry was determined for the three categories.  The energy unit used for the life cycle analysis is GJ/metric tonne of plastic.  This unit is practical for industry use, as manufacturers use large amounts of energy, and buy their plastic in measurable weight.  As discussed before, the total energy investment in the plastic beverage bottle life cycle using virgin PET resin is about 100 GJ/metric tonne.  For rPET resin, the life cycle energy investment is around 80 GJ/metric tonne.  However, the production of resin value for rPET was given as a range of 8-55 GJ/metric tonne.  Therefore the maximum energy investment is about 80 GJ/metric tonne, where the minimum energy investment is about 25 GJ/metric tonne.

Choosing An Energy Number

In choosing a threshold for the program, the limit could be evolutionary or revolutionary.  An evolutionary goal would set an achievable threshold for the energy investment number.  In this case, current bottled beverage producers could be certified for the ePET program today, as shown by the current rPET values.  The main purpose for setting an evolutionary goal would be to eliminate any beverage bottle producers who are on the periphery of energy efficiency.  As more bottles are certified under the evolutionarily-set energy threshold, those without the certification would be marginalized in the beverage bottle market.[13]

On the other hand, a revolutionary goal would incite the market to update current practices to more energy-efficient practices in order to achieve the certification.  This way, only a few if any beverage companies in the current market could achieve the certification today.  The certification of a bottle that achieves the threshold will create a distinction among products in the market.  As more beverages are bottled in the energy efficient bottles, the direction of the industry will be controlled by the competition induced by the ePET program.

Therefore, a revolutionary threshold was set for the energy investment in the life cycle of a plastic bottle.  As previously mentioned, the lowest energy investment at this time is 25 GJ/ metric tonne, compared to the average of the industry, 100 GJ/metric tonne.  Therefore, a revolutionary threshold number was set to 20 GJ/metric tonne.  At this point, there is no evidence it can be reached, but current practices show it is nearly possible.  This number provides a goal for producers to achieve.

Working With Industry
Though the ePET program emerges from a critique of inefficiencies within the plastic bottle industry, a central facet to the program is the willingness of industry leaders to engage with program administrators. The ePET seal will establish an additional means of product differentiation for those producers that achieve the threshold figure. As a result, the program is advantageous not just for the producers who can already achieve the threshold, but also as a motivator for other leading producers to negate this advantage by increasing efficiency.

The program depends on public outreach, awareness and demand for holistic energy efficiency information. This is achievable with minimal government outreach, because the product differentiation offered by the seal is a marketable factor for qualifying products. As a distinction occurs within the industry between those with and without the seal, more efficient practices become standard and the industry as a whole advances.

How Can Industry Work Within This Structure to Reduce Their Number?

The purpose of the threshold is not to discourage producers from the goal of energy investment reduction, but rather to give producers the ultimate flexibility and decision-making capabilities in achieving the threshold number.  The program also seeks to acknowledge the efforts of the industry leaders in developing and stream-lining energy efficient practices.

Within the production category, the producer has various options.  Virgin resin can be substituted with rPET or another lower-energy resin source.  Naked JuiceTM has started to switch to 100% rPET bottles as of 2009.  Naked JuiceTM estimates that when their entire product line is fully recycled material in 2010, their company “will reduce virgin plastic consumption by 8.1 million pounds per year and will save 57,000 barrels of oil every year—the equivalent of taking 3,460 cars off the road.”[14] Coca-Cola has introduced a fully recyclable beverage bottle that is 20% bioplastic.  The amount of plastic used in the bottle can be varied as well.  Low density plastic bottles are currently on the market.  Nestle Pure-Life water bottles are now made with 30% less plastic than other 0.5 L water and carbonated beverage bottles.  Nestle accomplished this by reducing the plastic in the cap and making the bottle lighter and more flexible.[15] A change in the shape of the bottle would also result in the reduction in the amount of plastic used in a beverage bottle. Walmart currently has a milk bottle that is cubic in shape.  Such a shape, as shown below, holds more milk, uses less plastic, and is more easily packed, thereby reducing shipping costs.  These benefits translate into a 10-20 cent reduction in the price of milk.[16]

epet_figure_5

Figure 5. Impact of change in shape of milk bottle sold at Walmart. [17]

Within the transportation category, the manufacturer must balance the energy efficiency of its fleet while maintaining a distribution necessary for company survival.  One immediate change a producer could make would be to change the radius of distribution for their product.  A smaller radius would in most cases reduce the energy needed to transport the bottles from the bottling plant to the point of purchase, usually a supermarket.  In the same vein, the beverage company can acquire their resin from local sources.  This effort would be beneficial if linked to a local recycling plant.  Besides changing the radii of acquisition and distributions, the beverage company can modify their fleet of vehicles and air planes to more fuel efficient models.  Coca-Cola has the largest fleet of diesel-electric trucks in the United States.[18] Finally, a change in the shape or density of a bottle can affect the number of products that can be transported at any given time.  A lower density bottle is less rigid and therefore can be packed into a tighter space.  Bottles that are designed in interlocking shapes or bottles that are cubic or rectangular in shape are easier to pack closer together.

Within the recycling category, producers can affect the market for recycled PET and reduce the number of plastic bottles in landfills.  Producers can invest in local recycling industries in order to receive rPET from a nearby source, thus reducing transportation, and to keep costs of rPET low.  Another option in the recycling category is biodegradable bottles.  Biodegradable bottles can enter the landfill and compost into the earth.  Therefore, the producer incurs no energy requirement for such a bottle.

Comparison to FTC Guides for the Use of Environmental Marketing Claims

The ePET program is inspired by the 1992 Federal Trade Commission (FTC) Guides for the Use of Environmental Marketing Claims or “Green Guides”. These guidelines regulate the use of marketing statements or insignia that connote the environmental effect of a product or its packaging. The Green Guides “apply to any claim about the environmental attributes of a product, package or service in connection with the sale, offering for sale, or marketing of such product, package or service.” Though the holistic scope of the Green Guides covers any environmental claim marketed with respect to a given product, the guides fulfill the FTC responsibility to protect against “deceptive acts and practices” in marketing and commerce.[19] While the guides promote truth in environmental advertising and call attention to the accuracy of broad, qualitative claims, standardization of environmental claims to facilitate comparison between products are beyond the scope of the FTC program. Further, the FTC program is not designed to convey holistic information about a product’s environmental effect.  In fact in submitting the guidelines and their 1996 and 1998 revisions, the FTC “concluded that issuance of the Guides would not have a significant impact on the environment and that any such impact would be so uncertain that environmental analysis would be based on speculation.’”[20] The Green Guides are an International Organization for Standardization Type II label; though the Guides standardize certain terms, claims under the FTC Guides do not reference pre-determined criteria and address only single processes within the life cycle.[21] The International Standards Organization maintains template environmental labeling systems, ISO 14024 (Type I), 14021 (Type II), and 14025 (Type III) to represent information provided on an ecolabel to three distinct degrees. The Type I standard refers to a third-party label, certifying adherence to predefined criteria. Type II reflects first-party environmental claims. Type III governs the objective, third-party confirmed declaration of a standard set of environmental factors.[22][23]

The ePET program will expand upon the Green Guides to allow producers a holistic, objective standard against which to claim energy effect. Since the ePET standard reflects the life cycle energy investment of the bottle, qualifying producers that advertise their ePET compliance shift the energy marketing standard to more complete claims. Further, consumers who differentiate products based on environmental effect are provided a comprehensible and easily comparable governmental certification. This shift in marketing standard can minimize consumer dependence on process-oriented, often incomparable claims, including post-consumer material percentages or qualitative claims (such as “Eco-safe”, “Environmentally Friendly,” et al.), that may provide a false impression of overall environmental effect. ePET will be an ISO Type I label, offering “an indication of the overall environmental preferability” of comparable products throughout the life cycle.[24]

Public Engagement: Awareness Campaign, Industry Marketing, Degrees of Information, and Legitimization

Widespread public recognition and validation of a plastic bottle energy equivalence standard is essential to the program’s success in motivating industry efficiency improvement. In effect, the program works only to the extent that consumers demand objective information about these products, clearly understand its meaning and apply this information as a factor affecting consumption decisions. For this reason we propose a standardized and comprehensive system offering tiered degrees of information. This can take the form of a recognizable seal on the product label, certifying that the product reaches the efficiency threshold, comparisons between available products at the point of sale, and more detailed statistics underlying the certification, hosted on an agency website.

To affect the plastic bottle industry as a basis for consumers’ comparative decision-making, ePET fulfills requisite characteristics, set forth by Rotherham:

This information needs to be clearly presented (well defined terms, consistent format across a product category, logo or “ecomark” to summarize LCA-based approaches, simple figures for single-attributes), credible (criteria developed by credible authorities, third-party verification or government monitoring), and must address the particular environmental aspects that the consumer is most interested in (comprehensive information or single-attributes developed and defined in an open and inclusive process).[25]

As an ISO Type I, thresholded label with a supportive education program, ePET achieves Rotherham’s first criterion. The program is also dependent on consumers’ view of the government as a credible source of environmental information. To this end, the ePET program may benefit from partnership with leading non-governmental organizations, quickly increasing the program’s stake and credibility at low cost. Ecolabeling systems worldwide rely on “green consumerism,” and the education of consumers to differentiate products on specific environmental goals via the broad visibility of relevant labels.[26] This awareness is fostered first by sponsoring organizations and stakeholders to establish a consumer demand for reliable environmental information. Program success is then driven by producer competition, as producers communicate positive environmental attributes about their product.[27]

A common trend affecting ecolabel programs worldwide is that label recognition does not necessarily command consumer decisions. In a 1994 study in Singapore, for example, while 78% recognized the national GreenLabel, only 30% considered environmental attributes as a purchasing decision input.[28] However, in the ePET case, where it is expected that the incurred costs to achieve the ePET standard will not affect product retail price, the ePET label should positively affect purchase decisions for this market share. In this case, the resultant change in purchasing trends should be sufficient to drive a larger percentage of the market toward more efficient practices.

An exciting trend that potentially facilitates the ePET program is the rise of environmentally conscious retailers.[29] Partnership with this niche market can foster the promulgation of the ePET label as an arena in which environmentally preferable goods are standard. Especially in the program’s early stages, the opportunity for retailer ePET adoption and additional point of purchase information distribution offers an advantageous starting position for the program and immediate effect within at least a non-negligible market component.

Section 5.  Strengths and Weaknesses

An Evolutionary vs. Revolutionary Energy Requirement

To challenge the plastic bottle industry to substantially reduce energy use, the ePET label’s maximum energy investment will be set to 20 GJ/metric tonne. This value is 5 GJ/metric tonne lower than the industry minimum and represents an 80% reduction from the industry average of 100 GJ/metric tonne. This decision reflects a desire for an achievable yet rapid and significant change to the industry alongside an acknowledgment of the high upfront costs of acquiring energy reducing technology and capital. According to James Tansey, a chair in business ethics at the University of British Columbia: [30]

“In some cases, a strong business case exists for making the initial investment [in energy reduction technology]: an immediate savings on energy bills. In others, upgrades are much pricier and capital costs associated with those upgrades may only be recovered after five or ten years. Owners and developers may be unable or unwilling to assume this risk.”

Therefore, a revolutionary goal is advantageous because of the inherently high capital costs. To achieve the same effect through an evolutionary approach, participating companies incur substantial capital costs over the long term, adversely affecting involvement. Also, allowing for incremental change may not motivate substantive design innovation and thus can mitigate program effectiveness over the long term. However, caution must also be taken in establishing an energy goal that is too ambitious, as an overly aggressive energy threshold may require too much investment from the producer, and the potential benefits of the ePET label may be outweighed by its costs. Even in this scenario, the energy requirement for certification could potentially be revisited in order to establish an achievable goal.

Establishing a Mandate vs. Creating Incentives for Energy Reduction

Along with establishing a more challenging energy requirement, the ePET label is constructed as part of a voluntary, incentives-driven program, rather than a mandated energy cap that all bottlers must achieve. According to Tom Rotherham of the International Institute for Sustainable Development, “Sustainable development policies must, among other things, make caring for the environment a corporate priority. This can be achieved if profitability becomes more obviously linked to a company’s environmental performance.”[31] Working along with industry to make energy efficient products competitive in an incentives-based structure allows for technology and process innovation which can lead to an eventual improvement of the status quo. While a mandate is inherently designed to capture straggling bottlers, an incentives-based program does not compromise with a lower goal designed to encompass the whole industry. Rather, industry leaders with the initiative create an opportunity for themselves to distinguish their brand and set an example for the industry. Within this structure, the Environmental Protection Agency recognizes that “only a small percentage of products will qualify for the label, thus providing an incentive for all other product manufacturers to improve the environmental attributes of their products.”[32]

Additionally, a frequent criticism of a mandated labeling system is that such energy ceilings are of “protectionist intent.” With a compulsory energy value, potential barriers to entry of the market are created, particularly stifling foreign companies’ ability to compete within the domestic market.  However, by making the ePET program voluntary, the barriers are lowered and the label can be used as a distinguishing marketing tool.[33]

Potential Execution Issues

Alongside its virtues, obstacles in the execution of a life cycle assessment present themselves in evaluating the energy content of a plastic bottle. Labeling programs can be subject to weak oversight, lax auditing, and poorly defined practices, especially if the program expands in size or scope. These have the potential to debilitate necessary consumer confidence in the integrity of the label. Similar problems have recently plagued the Energy Star Program over some labeled products with dubious and unverifiable energy efficiencies.[34],[35] To prevent such occurrences, well-defined practices must be established; loopholes must be eliminated; and the oversight process must be rigorous and vigilant.

Despite these potential problems, a life cycle assessment is believed to be the most effective tool in determining an accurate and comprehensive measure of energy and bottle use. Measuring a bottle’s energy footprint based on petroleum content or energy used in production, transportation, or waste management alone provides an insufficient picture of bottle resource inputs, ruling out the effectiveness of a single or even multiple-attribute certification program, similar to the Energy Star Program.[36],[37] The success of other eco-labeling programs like Canada’s Eco-logo and the U.S.-based Green Seal in effectively evaluating its participants using a life cycle assessment lends confidence that careful administration and execution will allow the ePET label to become a reputable symbol of energy efficiency.[38]

Public Awareness and Willingness to Pay

The success of the ePET program is dependent on consumer awareness and recognition of the label as well as the premium that the public places on purchasing energy efficient items. While there is little evidence on whether similar programs have successfully been able to successfully penetrate the marketplace in the United States, it has been shown that the Nordic Swan label, similar to the proposed ePET label program, was able to increase the marginal willingness to pay for certified, environmentally friendly toilet paper by 13 to 18% of the price.[39] Thus, dissemination of information is key to the success of any labeling awareness campaign, and a government-sponsored program has the potential to establish significant legitimacy in the eyes of manufacturers and consumers.[40] Despite the limitations, there is substantial anecdotal evidence that with adequate marketing, prevalent brand acknowledgement is feasible: 68% of German households were familiar with the Blue Angel label in 1988; 78% of households recognized the GreenLabel in Singapore in a 1994 survey; and 54% of households in France were willing to pay up to 10% more for environmentally preferable products in 1996.[41] Thus, while common label recognition and support is possible, these are reliant on a well-educated public willing to pay for such items.

Simplification of Energy Content and Exclusion of Environmentally Beneficial Factors

One of the strengths and potential points of criticism of the ePET labeling program is its restrictively basic criteria of energy efficiency. Because this program focuses solely on energy reduction and not environmental impact, environmentally preferable technologies and practices used in bottle production, transportation, and recycling are not offered preference in the certification process. Such factors would include the use of bioplastics (although the energy invested to create bioplastic resin would be considered); the use of cleaner alternative energy sources (although the amount of energy used would be tallied in the energy content), or biodegradable bottles. It may be the case that adopting environmentally friendly technologies is both a cost and energy saving step for the bottler producer. However, with the contentious, complicated nature of evaluating other environmental effects like carbon footprint, excluding such considerations in defining a bottle’s energy content eliminates unnecessary processes and loopholes which could allow for the certification of non-energy efficient bottles, as was the case for some products under Energy Star.[42]

In the end, despite the significant liberties bottle makers are allowed under the ePET program, not all bottlers will be able to achieve the prescribed threshold. Such companies, particularly those whose bottled products have a fixed, energy intensive cost of transportation are inherently restricted marketing energy efficiency under the ePET program. However, the program will recognize those who do take the initiative to make significant cutbacks in the energy expended on producing bottles. This label allows the industry trendsetters who are leading the efforts to innovate bottle production and drive down the energy intensity of the industry a platform upon which they can build their brand.

Section 6.  Bill

A BILL

To motivate increased energy investment efficiency of the plastic beverage bottle industry through the establishment of a voluntary audit and certification program.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

Section 1.  SHORT TITLE

This Act may be cited as the “ePET Program Act”.

Section 2.  FINDINGS

Congress finds the following:

(1)  Petroleum used in the production of PET bottles comprises 7-8% of national petroleum consumption.  Decreased energy investment in plastic bottles would reduce petroleum dependence while providing an economic benefit to manufacturers.

(2)  Over 4 million tons of polyethylene terephthalate (PET) plastic is currently consumed in the production of plastic beverage bottles, comprising an annual energy investment of approximately 400 million gigajoules (GJ).

(3)  Recent industry efforts to conserve resources in production have been successful and well received; many companies have reduced their average bottle weight by one half from 38 g/L.

(4)  Established government and industry programs, including Energy Star and LEED, gauge, certify, and promulgate objective information about products’ energy efficiency and environmental impact. The widespread public adoption of these programs has positively influenced consumer behavior and drives their respective industries to more efficient practices.

Section 2.  ePET BOTTLE CERTIFICATION PROGRAM

(1)  Definitions- For the purposes of this section:

(a)   ePET BOTTLE- The term ‘ePET bottle’ means a beverage bottle produced with an overall energy investment not to exceed 20 GJ/tonne over the bottle life cycle.

(b)  BOTTLE LIFE-CYCLE – The bottle life cycle includes the production, transportation and recycling stages of the bottle.

(c)   PRODUCTION STAGE- The production stage shall include the manufacture of the plastic resin and composition of bottle from the plastic resin and all energy costs therein.

(d)  TRANSPORTATION STAGE- The transportation stage shall include movement of the plastic resin to the bottle manufacturing plant, the bottle to the beverage manufacturing plant, and filled bottles to the final point of purchase.

(e)   RECYCLING STAGE- The recycling state shall include processes necessary to convert the plastic beverage bottle and all constituent parts, including labels and dyes, to reusable plastic resin

(2)  Establishment- Congress shall initiate the ePET program to audit participating producers’ energy cost per bottle and certify qualifying plastic beverage bottles, beginning not later than 2 years after the date of enactment of this Act.  Qualifying beverage bottles certified under the ePET program may display an ePET label upon date of certification.

(3)  Study- In creating the program under this section, the Secretary of Energy shall study and provide recommendations to –

(a)   Improve the certification process cost-efficiency and accuracy for international and national beverage bottling companies

(b)  Improve the infrastructure at all three points in the life cycle of the plastic bottle

(c)   Increase recycling program availability and participation

(d)  Link local recycling plants to bottle production plants

(4)  Program Design- The program under this section shall be designed –

(a)   To set and keep technologically current minimum energy efficiency standards and to motivate industry-wide adherence to and advancement of such practices.

(b)  To standardize and promulgate environmental marketing claims within an objective, holistic context

(c)   To effectively and prominently label certified plastic beverage bottles with a recognizable ePET label.

(d)  To foster public awareness and adoption of consumer products’ energy cost by providing objective, comprehensible information via accessible outlets

(5) Public Engagement and Review Dissemination- The ePET program administration shall provide for the dissemination of public awareness about the ePET program, to include point of purchase informative materials and educational outreach. In addition, a website shall be established and regularly updated to provide ePET program information and to comprehensibly disclose energy investment data for each certified bottle.

(6)  Report to Congress on Program Design- not later than 2 years after the date of enactment of this act, the department head of the ePET program shall transmit to Congress a report setting forth the design of the enacted program.  Such report shall include an explanation of how each of the program design requirements under subsection (d) has been incorporated into the program.

(7)  Program Reevaluation- The department head of the ePET program shall transmit to Congress a report examining current industry levels for the three bottle life cycle stages, the current infrastructure standards and major industry innovations, and the percent of certification within the industry. This report is to be transmitted to Congress at the end of each 5 year period and is to include a recommended ePET-qualifying energy threshold for the upcoming 5 year period.  This new threshold will be adopted by the ePET program pending review by Congress.


[1] U.S. Energy Information Administration: International Energy Outlook 2009 http://www.eia.doe.gov/oiaf/ieo/world.html

[2] The Peak Global Oil Production in This Decade: http://www.albany.edu/geosciences/oilngas.html

[3] Wald, M. “Cost Works Against Alternative and Renewable Energy Sources in Time of Recession” New York Times 28-March-2009

[4] Twinker, S.W., Opinion: Global Energy- Build Bridges Not Walls http://www.utexas.edu/know/2009/10/12/global_energy_opinion/

[5] NAPCOR 2006 Report on Post Consumer PET Container Recycling Activity

[6] Hopewell, J. et al. Plastics Recycling: Challenges and Opportunities. Phil. Trans. R. Soc. B. 364 (2009) 2115-2126

[7] Bioenergy Conversion Factors:  http://bioenergy.ornl.gov/papers/misc/energy_conv.html

[8] Gleick, P.H. and Cooley, H.S. Energy Implications of Bottled Water.  Environ. Res. Lett. (2009) 4, 1-6

[9] The Container Recycling Institute: http://www.container-recycling.org/images/graphs/plastic/PETpercap-wasterec-96-06.gif

[10] Bottled Water-Global Industry Guide- New Research Report on Companies and Markets

[11] Ferrier, C. Bottled Water: Understanding the Social Phenomenon April 2001

[12] Jose, Raphel Bottled Water Entreprise in India 1998

[13] Richard Campbell, Congressional Research Service.  Interview.  16 November 2009.

[14] “Get to Know Us.” http://www.nakedjuice.com/?#GetToKnowUs/Details/Sustainability/Renewabottle/RenewabottleShell/QuickQA. Naked Juice.  2009.  Web.  17 October 2009.

[15] “Easier to hold, Easier to Live with.”  http://www.nestle-purelife.us/flavors/ecoshape.asp.  Nestle Waters North America Inc.  2009.  Web.  17 October 2009

[16] Rosenbloom, Stephanie.  “Solution, or Mess? A Milk Jug for a Green Earth.” The New York Times.  30 June 2008.  Web.

[17] Rosenbloom, Stephanie.

[18] “Refuel.”  http://www.thecoca-colacompany.com/citizenship/fleet_transportation.html.  The Coca-Cola Company.  2009.  20 October 2009.

[19] 16 C.F.R. Part 260 (1996)

[20] 16 C.F.R. Part 260 (1996) and 16 CFR 1.83(a).

[21] Rotherham 4

[22] European Commission. “Environmental Product Declarations (ISO 14025 Technical Report).” Summary of Discussions at the 2nd Integrated Product Policy Expert Workshop, May 16, 2001. Brussels: European Commission, 2001

[23] Rotherham 3

[24] Rotherham, Tom. “Selling Sustainable Development:Environmental Labeling and Certification Programs.”Meeting of Technical Specialists and Policy Experts on Environmentally-Sound Trade Expansion in the Americas, October 28-9, 1999. Miami: University of Miami, 1999.
[25] Rotherman 10

[26] United States. Environmental Protection Agency. Environmental Labeling Issues, Policies, and Practices Worldwide. Washington: December 1998

[27] EPA 51

[28] EPA 53

[29] EPA 55

[30] Tansey, James. “Carbon Offsets Then and Now.” Awareness Into Action. Web. 12 Dec. 2009. < http://www.awarenessintoaction.com/whitepapers/carbon-offsets-voluntary-market-offsetter-James-Tansey.html>

[31] Rotherham, Tom. “Selling Sustainable Development: Environmental Labeling and Certification Programs.” Meeting of Technical Specialists and Policy Experts on Environmentally-Sound Trade Expansion in the Americas. University of Miami, Oct. 28-29, 1999. Print.

[32] United States. Environmental Protection Agency. Environmental Labeling Issues, Policies, and Practices Worldwide. Washington: GPO, 1998. 32. Print.

[33] Rotherham, Tom.

[34] Wald, Matthew L. “Energy Star Appliances May Not All Be Efficient, Audit Finds.” New York Times. 18 Oct. 2009. Web. 12 Dec. 2009. < http://www.nytimes.com/2009/10/19/business/energy-environment/19star.html>

[35] “Energy Star Climate Change Claims Misleading, Audit Finds.” Environment News Service. 31 Dec. 2008. Web. 12 Dec. 2009. < http://www.ens-newswire.com/ens/dec2008/2008-12-31-092.asp>

[36] U.S. E.P.A., 6.

[37] Gleick, et al.

[38] U.S. E.P.A., 11.

[39] Bjoner, Thomas Bue, Lars Hansen, and Clifford S. Russell. “Environmental labeling and consumers’ choice—an empirical analysis of the effect of the Nordic Swan.” Journal of Environmental Economics and Management 47 (2004): 411-434. Print.

[40] U.S. E.P.A., 52.

[41] U.S. E.P.A., 53.

[42] Wald, Matthew L. “Energy Star Appliances May Not All Be Efficient, Audit Finds.” New York Times. 18 Oct. 2009. Web. 12 Dec. 2009. < http://www.nytimes.com/2009/10/19/business/energy-environment/19star.html>.

Energy, Energy Projects


Proposed ePET Legislation

January 8th, 2010

Henry Fingerhut, Brian Fochtman, Caroline Lee, Allison O’Rourke. Georgetown University

A BILL

To motivate increased energy investment efficiency of the plastic beverage bottle industry through the establishment of a voluntary audit and certification program.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled,

Section 1. SHORT TITLE

This Act may be cited as the “ePET Program Act”.

Section 2. FINDINGS

Congress finds the following:

(1) Petroleum used in the production of PET bottles comprises 7-8% of national petroleum consumption. Decreased energy investment in plastic bottles would reduce petroleum dependence while providing an economic benefit to manufacturers.

(2) Over 4 million tons of polyethylene terephthalate (PET) plastic is currently consumed in the production of plastic beverage bottles, comprising an annual energy investment of approximately 400 million gigajoules (GJ).

(3) Recent industry efforts to conserve resources in production have been successful and well received; many companies have reduced their average bottle weight by one half from 38 g/L.

(4) Established government and industry programs, including Energy Star and LEED, gauge, certify, and promulgate objective information about products’ energy efficiency and environmental impact. The widespread public adoption of these programs has positively influenced consumer behavior and drives their respective industries to more efficient practices.

Section 2. ePET BOTTLE CERTIFICATION PROGRAM

(1) Definitions- For the purposes of this section:

(a) ePET BOTTLE- The term ‘ePET bottle’ means a beverage bottle produced with an overall energy investment not to exceed 20 GJ/tonne over the bottle lifecycle.

(b) BOTTLE LIFE-CYCLE – The bottle lifecycle includes the production, transportation and recycling stages of the bottle.

(c) PRODUCTION STAGE- The production stage shall include the manufacture of the plastic resin and composition of bottle from the plastic resin and all energy costs therein.

(d) TRANSPORTATION STAGE- The transportation stage shall include movement of the plastic resin to the bottle manufacturing plant, the bottle to the beverage manufacturing plant, and filled bottles to the final point of purchase.

(e) RECYCLING STAGE- The recycling state shall include processes necessary to convert the plastic beverage bottle and all constituent parts, including labels and dyes, to reusable plastic resin

(2) Establishment- Congress shall initiate the ePET program to audit participating producers’ energy cost per bottle and certify qualifying plastic beverage bottles, beginning not later than 2 years after the date of enactment of this Act. Qualifying beverage bottles certified under the ePET program may display an ePET label upon date of certification.

(3) Study- In creating the program under this section, the Secretary of Energy shall study and provide recommendations to –

(a) Improve the certification process cost-efficiency and accuracy for international and national beverage bottling companies

(b) Improve the infrastructure at all three points in the lifecycle of the plastic bottle

(c) Increase recycling program availability and participation

(d) Link local recycling plants to bottle production plants

(4) Program Design- The program under this section shall be designed –

(a) To set and keep technologically current minimum energy efficiency standards and to motivate industry-wide adherence to and advancement of such practices.

(b) To standardize and promulgate environmental marketing claims within an objective, holistic context

(c) To effectively and prominently label certified plastic beverage bottles with a recognizable ePET label.

(d) To foster public awareness and adoption of consumer products’ energy cost by providing objective, comprehensible information via accessible outlets

(5) Public Engagement and Review Dissemination- The ePET program administration shall provide for the dissemination of public awareness about the ePET program, to include point of purchase informative materials and educational outreach. In addition, a website shall be established and regularly updated to provide ePET program information and to comprehensibly disclose energy investment data for each certified bottle.

(6) Report to Congress on Program Design- not later than 2 years after the date of enactment of this act, the department head of the ePET program shall transmit to Congress a report setting forth the design of the enacted program. Such report shall include an explanation of how each of the program design requirements under subsection (d) has been incorporated into the program.

(7) Program Reevaluation- The department head of the ePET program shall transmit to Congress a report examining current industry levels for the three bottle lifecycle stages, the current infrastructure standards and major industry innovations, and the percent of certification within the industry. This report is to be transmitted to Congress at the end of each 5 year period and is to include a recommended ePET-qualifying energy threshold for the upcoming 5 year period. This new threshold will be adopted by the ePET program pending review by Congress.

Energy, Energy Projects