Joan Amondi, Jean-Hervé Bradol, Vanja Kovacic & Elisabeth Szumilin
Joan Amondi graduated in Literature (Moï University, Eldoret, Kenya). She has worked for MSF-Crash as an interpreter, a translator and a research assistant.
Medical doctor, specialized in tropical medicine, emergency medicine and epidemiology. In 1989 he went on mission with Médecins sans Frontières for the first time, and undertook long-term missions in Uganda, Somalia and Thailand. He returned to the Paris headquarters in 1994 as a programs director. Between 1996 and 1998, he served as the director of communications, and later as director of operations until May 2000 when he was elected president of the French section of Médecins sans Frontières. He was re-elected in May 2003 and in May 2006. From 2000 to 2008, he was a member of the International Council of MSF and a member of the Board of MSF USA. He is the co-editor of "Medical innovations in humanitarian situations" (MSF, 2009) and Humanitarian Aid, Genocide and Mass Killings: Médecins Sans Frontiéres, The Rwandan Experience, 1982–97 (Manchester University Press, 2017).
Vanja Kovačič is a Medical Anthropologist. After having worked for several years as a researcher at the Crash, she is now working for the Manson Unit in MSF UK.
Jean-Hervé Bradol and Elisabeth Szumilin
By the late 1990s the mortality rate for the human immunodeficiency virus (HIV) had been brought under control in high-income countries, thanks to the combination of several antiretroviral drugs. Yet there was no plan for administering the treatment in the world’s largest foci of infection. Sub-Saharan Africa in particular, the most seriously affected region, was not benefiting from therapeutic advances. Refusing to accept this situation required innovative efforts on two fronts: medical and political. In 2008, 140,000 people, ten thousand of them children, received free generic antiretroviral drugs in projects supported by MSF. After a limited number of laboratory tests, patients are prescribed fixed-dose combination treatments (in a single tablet) by non-specialist doctors or nurses. If there are no complications, the prescriptions can sometimes be renewed by public health technicians.As compared with France, where fewer than ninety thousand people receive Affection de longue durée (long-term illness) health insurance for AIDS and only specialist physicians can prescribe antiretroviral therapy. See www.sante-sports.gouv.fr/IMG//pdf/03_Epidemiologie.pdf (in French)
Treatment of opportunistic infections is available wherever possible, and treatment for tuberculosis, the leading cause of death among AIDS patients in Africa, is integrated with HIV treatment. During the first few years of treatment, survival rates are similar to those obtained in North America and Western Europe. Does this qualify as a success? Only a sustained reduction in the number of deaths and the number of people carrying the virus in the hardest-hit regions will show the true effect of the changes that have occurred in recent years. This article presents the circumstances and reasons which led MSF to treat patients who would not otherwise have access to new and costly treatments.
THE RIGHT CIRCUMSTANCES, AND A CERTAIN INDIFFERENCE
According to the World Health Organization (WHO), “The human immunodeficiency virus (HIV) is a retrovirus that infects cells of the human immune system, destroying or impairing their function. In the early stages of infection, the person has no symptoms. However, as the infection progresses, the immune system becomes weaker, and the person becomes more susceptible to opportunistic infections. The most advanced stage of HIV infection is acquired immunodeficiency syndrome (AIDS). It can take ten to fifteen years for an HIV infected person to develop AIDS. Antiretroviral drugs can slow down the process even further. HIV is transmitted through unprotected sexual intercourse (anal or vaginal), transfusion of contaminated blood, sharing of contaminated needles, and between a mother and her infant during pregnancy, childbirth, and breastfeeding.”http://www.who.int/topics/hiv_aids/en/index.html.
A look at the advance in knowledge on HIV from the early 1980s to the mid-1990s shows that discoveries were made quickly (Grmek, 1990). Clinicians began to suspect the existence of a new disease in 1981. In 1982, transmission of the disease to hemophiliacs via blood products that, despite filtering, transmitted the infectious agent suggested a very small micro-organism: a virus. In 1983, HIV was classified as a member of the retrovirus family because of its mode of replication. It was cloned in 1984, and its genome was identified. The identification of HIV antigens led to a blood test that—within certain limits of sensitivity and specificity—could confirm or rule out the presence of HIV (1985), making it possible to prevent transmission through blood transfusions. The test identified those who carried the virus and those who did not. It then became possible to discern better how the virus spread within populations, and to identify the most seriously affected regions and the highest risk groups and behaviors. This helped define and measure the effect of the preventive actions that were being introduced in high-income countries in the late 1980s. Understanding the retroviral mode of replication led to the use of the first drug, Zidovudine, whose efficacy is relative and temporary (1987). Prevention of mother-to-child HIV transmission and administration of a treatment against the virus itself became possible. Knowing HIV’s genetic makeup also led to measurement of the viral load in the blood—a key laboratory indicator for monitoring treatment efficacy. Genetics also enabled identification of mutant viruses resistant to certain drugs, making it possible to avoid ineffective antiretrovirals right from the start of treatment. Understanding the virus’ predilection for certain blood cells involved in the immune response resulted in a test that could measure HIV’s effect on the body’s immune defenses, the T4 lymphocyte level (CD4 test). At the same time, different strains of the virus (HIV-1, HIV-2, etc.) were identified. Roughly fifteen years separated the first clinical diagnoses (1981) from the prescription of a treatment transforming an almost-always fatal disease into a chronic one (1996).
The 1983 International AIDS Conference in Denver saw the emergence of a political movement for people living with HIV. At the 1989 Montreal Conference, ACT UP and its Canadian counterpart, AIDS Action Now, manifested their presence as soon as the opening ceremony started. They demanded that research focus on patients’ needs rather than on pharmaceutical industry interests alone. In 1994 the principle that organizations of people living with HIV should have greater participation in the fight against AIDS was adopted by forty-two countries at a summit in Paris. In 2008 the Global Network of People living with HIV (GNP+) included more than a thousand member organizations. They demand participation in all institutional processes regarding the fight against AIDS, call for universal access to prevention and treatment programs, and emphasize prevention targeting those who are HIV-positive. They also call for more information on sexual and reproductive health, are opposed to criminalization of virus transmission, and defend the rights of people living with HIV.
In 1989 MSF-France’s Board of Directors approved a proposal to participate in the Montreal AIDS Conference, and MSF-Belgium opened a free, anonymous testing center in Brussels. The MSF delegate to the Montreal Conference declared that it was “unthinkable to him that Médecins Sans Frontières should not be involved in the response to AIDS.” He suggested possible approaches involving education, treatment, epidemiological surveys, and palliative care. He reported that treatments were being developed “based on very complex and very expensive combinations” and, among the avenues of research, he noted that there were “openings in Africa on mother-to-child transmission. … A long debate began between those who thought that Médecins Sans Frontières could and should conduct AIDS related activities, and those who thought it was not within the organization’s scope.”Report from the MSF-France Board of Directors meeting, June 30, 1989.The debate was lively and tense. Advocates of engagement emphasized the large number of deaths in certain social categories and certain areas of the world—Africa in particular. They spoke of possible prevention activities and treatment approaches. Those resistant to the proposal stressed that there were no drugs available, and that prevention activities relying primarily on persuading people to change their sexual behavior had very doubtful outcomes. In their view, MSF—a foreign organization with little mastery of the languages needed for disseminating information and a superficial approach to local culture—was not the institution best-suited to do work that was more social than medical. The first report on AIDS, written by EpicentreEpicentre is an MSF satellite organization that specializes in the epidemiology of intervention, research, and training.for MSF in 1990, concerned the situation in France: “MSF is frequently asked to intervene on AIDS in France. Yet no one in the organization is particularly responsible or expert in that area, and MSF has no policy on the subject.”Philippe Malfait, Mission MSF et sida en France, Epicentre, January 25, 1990.The requests were coming from patient organizations, researchers, and practitioners hoping that MSF would support their cause with its resources and reputation. A large diversity of opinions emerged among the governing bodies at MSF. Over the 1980s, these bodies had developed into a movement of different national sections (Belgium, Spain, Greece, Switzerland, Holland, etc.). The relative political indifference at the office in Paris was met with internal opposition that had a lot of support from other national sections.
In missions outside France, the growing awareness of how health care facilities were responsible for the spread of AIDS led to a series of measures aimed at preventing virus transmission during medical procedures. In June 1993 the medical department at the Paris headquarters informed the Board of Directors that screening tests were being set up at sites where MSF was directly responsible for transfusions. While members of the Board are not directly in charge of sensitive activities (sterilizations, transfusions, injections, surgery, etc.), this work is nevertheless dependent on them. An unanticipated diagnosis before transfusion, coupled with the fear of stigmatization and discrimination and no offer of treatment, has sometimes meant that testing was delayed. Studies of serological prevalence among pregnant women (Uganda and Sudan) sparked a debate on the appropriateness of informing a woman that she is HIV-positive during a routine pre-natal consultation. “What should we do with someone whom we’ve informed, after our testing, that she is HIV-positive, or with a patient? We risk condemning people to a faster and more painful death, because that knowledge will get them ostracized from their community.”Report from the June 1989 Board of Directors meeting, Paris.
Antiretroviral drugs made their first appearance in an MSF HIV prevention kit in the mid-1990s, following an accidental occupational exposure to blood. Mutual aid was also discreetly provided to infected colleagues, friends, and lovers. MSF employees with opportunistic infections were given access on an individual basis to treatments that were unavailable, and often very expensive, in their own countries. Ad hoc networks sprang up to stay with dying friends and loved ones. Refusals to grant visas on the grounds of seropositivity were circumvented with the organization’s complicity. Later, when the first triple therapies appeared, they were sent “under the counter” to colleagues in countries where they were unavailable. Such actions were limited in number, but they highlighted the fact that MSF needed to get involved in treating the disease. One of the very first field projects (Surin, Thailand, 1995) that focused on treatment, rather than prevention, was started by an expatriate nurse who had spent several years supporting Thai friends in the terminal stage of the disease. From such individual acts, carried out in the belief that therapeutic solidarity was morally legitimate, emerged a sense of political affinity among those who strongly opposed an institutional position they considered overly timid, and who were willing to change MSF’s policy. Some members of MSF hoped for public advocacy and the large-scale use of antiretroviral drugs as a way to reconcile individual experience and institutional action.
The epidemic was particularly severe in places (eastern, southern, and central Africa) where MSF had developed its original, non-AIDS-related hospital activities. The medical teams were faced with a growing number of cases involving difficult-to-treat opportunistic infections and management-intensive terminal patients. The teams also had to deal with local staff who were not informed of how the virus was transmitted, and who refused to care for patients for fear of infection. MSF team members mobilized to improve patient welcome and disseminate basic knowledge on transmission and prevention with information and professional training sessions. Practical objectives included welcoming patients, treating opportunistic infections, and providing palliative care (pain, wounds, nutritional support, personal hygiene, psychological and social support). Antiretroviral drugs are therefore essential. Without them, treatment is difficult and ill adapted, and neither reduces the body’s viral load nor restores the immune system. This was an argument for their use.
Prevention activities in the field increased among specific groups, such as prostitutes and truck drivers in Mwanza, Malawi, despite the reluctance of some, who wanted to focus mainly on treatment. In late 1995 an editorial on the cover of MSF-France’s in-house magazine Messages asked, “MSF: a white, heterosexual, HIV-negative organization?” It was a provocative title designed to promote prevention activities and patient support, and fight against stigmatization and discrimination. Such activities were not widely adopted by MSF-France, but began to flourish among other sections. By 1998 MSF was able to claim “48 field projects in which AIDS is a major component.” Without an effective treatment, however, the fight against discrimination and in favor of prevention was not enough to make AIDS a core concern in MSF’s policy.
DRUG PRESCRIPTION: HESITATIONS AND AUDACITY
At the opening ceremony of the 1996 International AIDS Conference in Vancouver, the New York representative for ACT UP raised the issue of access to treatment for the hardest hit populations. “Yes, the preliminary results from these hugely expensive combination treatments look great. But we are a long way from a cure, even for the rich who can afford the treatments. And we are no closer to a cure for the majority of people living with AIDS on this planet than we were ten years ago. Most peoples living with AIDS can’t get aspirins.”http://www.actupny.org/Vancouver/sawyerspeech.html.
At the 1997 Abidjan Conference, the French president and the minister of health called for “international therapeutic solidarity.” In June 1997, with support from a few multinational drug companies and the World Bank, the Joint United Nations Programme on HIV/AIDS (UNAIDS, created in 1995) launched the HIV Drug Access Initiative (UNAIDS-DAI). The DAI relied on some of the big pharmaceutical firms agreeing to differential pricing according to a country’s income level, whereas these firms previously asked a single price worldwide. In 1998 several countries (Uganda, Senegal, and Ivory Coast) began using triple therapy in their public programs. Its virological efficacy was established in the initial reports. These early experiences using triple therapies in resource-limited countries proved their feasibility and efficacy. Some of the practical aspects (the lack of generics; prices that were still too high; asking patients to contribute to the cost; the lack of fixed-dose combination of three antiretroviral drugs in a single pill; the significant clinical, laboratory, and psychosocial follow-up needed; etc.) were only compatible with cohorts of several hundred patients, however, at a time when tens of thousands of patients were waiting for the simplest, least expensive treatment.
The small number of patients treated by the UNAIDS accelerated-access initiative contrasted with the experience in Brazil, whose national program—using generics and free medications—rapidly treated nearly 100,000 patients (170,000 in 2008). In 1996 Brazil launched a public treatment program by presidential decree. Brazilian patent law allows for compulsory licensing (without the patent-holder’s consent) to produce generic drugs, so while the public pharmaceutical company Pharmanguinhos (Oswaldo Cruz Foundation) does not manufacture all antiretrovirals itself, the possibility of doing so—should a private firm’s price be considered too high—creates a credible threat of competition that lowers prices. Brazil stands out because it was the first low- or medium- income country to treat large numbers of patients, and remained the only one to do so until the mid-2000s. MSF reached an agreement with Brazil’s public institutions to export Brazilian antiretrovirals to South Africa. Apart from this agreement, Brazil has never supported the effort to treat patients in very poor countries by exporting generics,The World Trade Organization (WTO) has allowed countries to manufacture generic drugs legally for public health reasons, but the possibility of sending these generic drugs to other countries where they are covered by patents is unclear.though it does assist them in developing their own production.
The high cost of the triple therapies used by Brazil (about $3,000 per patient per year) made large-scale initiatives by other countries highly unlikely. In February 2000 the Indian pharmaceutical company Cipla Cipla’s creation in 1935 expressed the nationalism of its founder, Khwaja Abdul Hamied. The company was honored by a visit by Mahatma Gandhi in 1939.announced that it would be marketing a combination treatment, Triomune, for $350 per patient per year. Its components were chosen based on efficacy, the amount of time until certain side effects appeared, and, above all, the price of raw materials.Telephone interview with Dr. Yusuf Hamied, Cipla chairman and CEO, January 23, 2009.The aim at the time was to offer it at the lowest possible price: $650 per patient per year, as opposed to several thousand dollars. Cipla granted MSF an additional $300 discount, which was ultimately extended to all customers. It was not in the economic interest of the patent-holders of each individual drug to manufacture a single pill, so producing generics without a patent made it possible to produce the triple therapy. This was the first time patients throughout the world had access to such a simple treatment—three antiretroviral drugs in a single tablet, morning and evening. Triomune’s low price and ease of use opened the way for public health programs on a national scale.
At the same time, in Africa, private companies from various sectors (mining, energy, beverage, automotive, etc.) began funding access to antiretroviral drugs for their employees. Held in one of the most seriously affected countries, the July 2000 International AIDS Conference in Durban was a high point in improving access to treatment. It was at this venue that Merck, the pharmaceutical giant, and the Bill and Melinda Gates Foundation announced their $100 million donation for a treatment program in Botswana. The hype surrounding these philanthropic actions masked the essential fact that even the least expensive triple therapies, available through UNAIDS, were nevertheless still very costly (between $800 and $1,000). Information obtained from the pharmaceutical industry, and confirmed by a WHO expert, prompted MSF to publish the report HIV/AIDS Medicines Pricing (Perez-Casas, 2000), which showed that it would be possible to reduce the cost to under $200 per patient per year.
Procuring the drugs and getting them to the field meant clearing a dual pharmaceutical and legal hurdle (Boulet, 1999). No internationally recognized reference institution could guarantee the quality of the supply source alternatives to the pharmaceutical multinationals. Buyers were unlikely to be reassured by generic triple therapies from India, which were not marketed in either the US or Europe. MSF criticized the WHO for not taking responsibility; humanitarian pharmacists had to visit and validate manufacturing sites themselves in order to choose suppliers. In 2001 MSF began publishing an international guide to purchasing antiretroviral drugs for developing countries (the Campaign for Access to Essential Medicines, MSF, 2008). MSF-Logistique’s legal status as a pharmaceutical establishment facilitated transit through Europe and redistribution in several dozen countries. To manage the risks involved in purchasing, storing, importing, and exporting generic triple therapies, MSF recruited a team of lawyers and pharmacists specialized in intellectual property issues, administrative registration, supplier selection, and drug marketing.
Just because a treatment is available on the market does not mean that authorities will automatically approve—or medical teams support—its use. Obtaining official authorization and convincing medical teams of the benefits means that new products need to be incorporated into a treatment protocol that is realistic both in terms of the patients’ circumstances and the caregivers’ professional practice. How to simplify without sacrificing efficacy? That was the task of the staff at MSF’s medical departments, charged with providing technical support for field teams, with backup from experts at university medical centers. Some of the doctors who undertook this technical adaptation had continued to take short-term assignments in hospitals in Europe, Japan, Australia, or North America, and had been prescribing triple therapy for several years. With their experiences in resource-limited countries in mind, they were convinced that the protocols could be simplified without sacrificing the practices essential to therapeutic efficacy. Brazil had already proven that it was possible to prescribe antiretroviral drugs in middle-income countries, and others were following the same path, particularly Thailand. There were strong reservations, however, about sub-Saharan Africa, which, over the past decades, had suffered increasing poverty, political instability, and the collapse of public health institutions.
There were some parameters the medical team could control, such as prescription quality and drug management, but if patients didn’t take medication regularly, failure was inevitable. From an individual stand point, patients facing imminent death would have more to gain by trying a treatment that is risky; but a poorly controlled program and bad treatment compliance (creating resistant strains of the virus) would compromise the future of treatment for the population as a whole. For this reason, the patient’s ability to come for check-ups (distance, available transportation, and budget) was an essential criterion for acceptance into the group receiving triple therapy. A strict treatment protocol means more than just coming in for checkups, however. The patient must also understand, or at least accept, the medical reasons underlying the protocol. The MSF medical team decided to focus on providing information to the patients using specialized medical counselors, and a member of the patient’s social circle was chosen and trained to encourage daily adherence to treatment.
Lab testing was also a tricky issue. Existing knowledge suggested starting antiretroviral drugs when the immune response was markedly weakened, but lab tests were not readily accessible to MSF teams. Other tests to evaluate the function of potential target organs for side effects were also needed. Monitoring treatment efficacy would have required lab tests to measure viral replication in the body (the number of viruses per unit of blood, or viral load). In a professional setting dominated by the idea of evidence-based medicine which often relies on the measurement of biological markers, initiating treatment based on a marked deterioration in immune defenses, ensuring its efficacy, and preventing its toxicity without the help of lab tests seemed dangerously experimental.
Once the protocols were defined and administrative authorization obtained, there were still several concerns hindering prescription. Would the fact that there were only a small number of treatments available for a large number of patients lead to tensions, violence, or crime? Should priority be given to people who were needed to treat others (doctors, nurses, etc.), or even to those who performed essential societal functions (political leaders, teachers, etc.)? Decisions to launch field projects were based on several criteria: the local prevalence of AIDS, the attitude of public health officials (whether they were open to the use of antiretroviral drugs), and MSF’s institutional interests. Treatments were administered to patients who were already frequenting outpatient clinics and hospital services, with priority going to those whose condition was most critical. Medical staff would be among the first to receive treatment due to their proximity with those prescribing it. Tensions did exist, and MSF sometimes hesitated to treat its own staff. The impossibility of delegating the treatment of MSF personnel to specialized institutions, which were largely non-existent, was a convincing argument. Being able to prescribe such complicated-to-manage treatments simultaneously in the dozens of countries where MSF intervened was difficult. Some in MSF’s leadership feared that adopting an official resolution in favor of treating staff when there was no treatment mechanism in place might expose the organization to legal action by employees. Finally, in November 2002, the MSF International Council decided to guarantee MSF employees access to antiretroviral treatment.
By the early 1990s infectious diseases had again become a priority in international relations due to their potential economic and security repercussions. The emergence of new epidemics (Ebola and AIDS, in particular) and the fear of bioterrorism spurred governments to step up their disease related activities. Many institutions (national governments, international organizations, pharmaceutical firms, national and international private organizations, religious institutions, unions, political parties, etc.) were faced with the dilemma of how to respond to the AIDS pandemic. The Internet played a key role in relationships that transcended borders, spreading to the most peripheral players (patients, caregivers, citizens), and reaching the top of public health, economic, and political institutions. Until then, the issues of drug access had been examined behind closed doors, and were the exclusive domain of experts, manufacturers, and government representatives. Henceforth, the discussion enjoyed broad media exposure. AIDS organizations and medical organizations like MSF took their place at the negotiating table. The medical and political dynamics challenged interpretation according to institutional positions or individual opinions based on their own interests. The strong feelings around the disease changed the usual dividing lines between individuals and institutions. We can define three basic attitudes: realism, universalism, and caution.
The realists argued that the conditions necessary for increasing the number of people treated from a few hundred thousand to several million did not exist. Drug availability by itself could not make up for the patients’ lack of schooling, the shortage of qualified personnel and equipment, the meager budgets and inadequate management of health care institutions, or the poverty and instability of the hardest-hit countries. Why make a special effort for AIDS and not for other diseases that were just as prevalent, even more deadly, and far easier to treat? MSF, an emergency-oriented organization, would not have the expertise and constancy that were essential for a lifetime commitment to the patient. There was a serious risk that drugs would be used incorrectly and that mutant, antiretroviral resistant strains of the virus would rapidly emerge. Prescribing before conditions were right would compromise the ability to introduce treatment under more favorable circumstances in the future. Another perverse effect—a drop in prices, and, more importantly, a weakening of intellectual property rights—would discourage research and development funding for new drugs. The prospect of a return on investment would be undermined by black market imports of low-price generics competing with patented drugs in viable markets, and by an erosion of profit margins in emerging markets due to lower, differential pricing based on country income. Charitable donation was proposed as the only suitable method in the rare situations where conditions were right for using triple therapy. At the 2000 International AIDS Conference in Durban, Merck announced that it would supply two antiretroviral drugs free of charge for the national treatment program in Botswana. In that country, where one in four adults (fifteen to fifty years old) carried the virus, realism, faced with a potential demographic catastrophe, met its limits.
Universalists advocated making AIDS treatment accessible to everyone. Public health policies could not be restricted to priority groups dictated by disease statistics. Indeed, societies’ reactions to the pandemic, whether rational or not, would be an opportunity for poorly functioning health care systems to use the fight against AIDS as a starting point for recovery. Generally speaking, the universalists characterized any objection to making HIV treatment immediately accessible as an obstacle to be overcome. The MSF representative who participated in the parallel meetings at the 1999 WTO Ministerial Conference in Seattle declared that patients were dying not from AIDS, but from the unavailability of drugs due to the patent system. This reasoning, without limiting it to the realm of intellectual property alone, supposes a change in attitude by governments, the pharmaceutical industry, the medical profession, and patients.
Where the universalists saw obstacles to overcome, the cautious needed guarantees before taking action. Precautions had to be taken in order to satisfy not only the moral imperative to treat, but also the need to do no harm, and to avoid squandering available resources and compromising the future. So prescribing HIV treatment was considered, but on a smaller scale and in countries that already had some means (Brazil and Thailand, for example) and depending on the environment (patents, the policy of patient contribution, limited human and material resources, etc.). The first use of antiretroviral drugs in Africa on the initiative of UNAIDS, and the first MSF protocols, illustrate this cautious approach.
All three attitudes brought morality, medical science, public health, economic rationalism, and political will to bear in their arguments; all three wanted to be universal, realistic, and cautious at the same time. In practice, however, they were mutually contradictory. Compromise was essential, but finding the perfect balance was impossible. MSF was a good example of this dynamic plurality of opinions that changed as a function of many variables, some more heavily weighted than others: the emergence of triple therapy, the will of governments, social and political mobilization, the changing application of intellectual property rules, the drop in antiretroviral prices, the availability of public funding, the analysis of the early experiences in the field, scientific publications, public controversies, and each institution’s own interests.
Governments, international organizations, pharmaceutical firms, and local associations were all involved in a national and international political dynamic that exposed their contradictions, obliged them to explain themselves publicly, and forced them to make decisions that, until previously, they had considered contrary to their intentions and their interests. In May 2000 President Clinton supported the countries of sub-Saharan Africa that wished to produce and import generic drugs (Executive Order 13155). In July 2000 at the United Nations (UN) Security Council meeting and the Group of Eight (G8) summit in Okinawa, two important commitments were made: “mobilizing additional resources” and “addressing the complex issue of access to medicines in developing countries, and assessing obstacles being faced by developing countries.”G8 communiqué, Okinawa, Japan, July 2000; www.g8.utoronto.ca/summit/2000okinawa/finalcom.htm.The terms “access” and “obstacles” in the final G8 resolution were borrowed from the vocabulary of nongovernmental organizations, including MSF, that were involved in preparing the Okinawa summit. Then UN Security Council Resolution 1308 (2000) stressed that “the HIV/AIDS pandemic, if unchecked, may pose a risk to stability and security.” The World Bank described AIDS as a “development crisis.”
After the failure of the WTO Ministerial Conference in Seattle (1999) there was strong pressure to ensure that the Doha Conference (2001) provide a solution to the crisis. The question of access to drugs seemed to offer the possibility of a positive outcome for at least one of the issues being negotiated internationally. The monopoly granted to patent holders for marketing their drugs was weighing heavily on prices; in the late 1990s, triple therapy cost between $10,000 and $15,000 a year. Therefore, what was needed was to make application of the Trade-related Aspects of Intellectual Property Rights (TRIPS, 1994) agreement more flexible, so that the management of patents would not conflict with the production and circulation of less expensive generic medications, considered essential to public health. Brazil, India, and Thailand led a group of about sixty countries in which Africa was heavily represented. They worked for access to generics, and were backed by several hundred national and international organizations, including Oxfam and MSF. For some countries with limited legal and pharmaceutical expertise, the alliance with advocacy organizations meant the possibility of receiving technical assistance. The organizations linked their technical assistance with lobbying for their political proposals. Countries concerned with defending intellectual property rights (the United States, Japan, and countries in the European Union, in particular) wavered between strengthening and softening the rules. They feared that by rejecting an agreement authorizing production and circulation of generic drugs, they would spark reactions jeopardizing the entire newly created TRIPS agreement. A few months before the Doha Conference, and in view of the Pretoria trial,In 1998 a coalition of about forty pharmaceutical firms filed suit in South Africa to try to prevent the application of a South African law, passed by Parliament in 1997, allowing the production of generic drugs. The cases were abandoned in 2001 under pressure from public opinion.US Trade Representative Robert B. Zoellick tried to get the pharmaceutical firms to see reason: “If they don’t get ahead of this issue, the hostility that generates could put at risk the whole intellectual property rights system” (Blustein, 2001). Not all manufacturers were on the defensive, however. Indian companies producing generics were poised to take over the large market expected to result from the change in WTO policy. At Doha, the Ministerial Conference affirmed the sovereign right of nations to take measures to protect public health. Among other things, the Doha Declaration made it possible for a country to manufacture drugs without the patent holder’s consent (compulsory licensing), providing royalties were paid (‘t Hoen, 2009). It authorized importation from a country where prices are lower (parallel imports) without the manufacturer’s or patent holder’s permission. It was another two years before the issue of parallel imports of generic drugs under compulsory license was addressed, on August 30, 2003, in Geneva, with the establishment of fairly restrictive procedures. Despite the limits of the measures adopted, and the pressures exerted to curtail their application, the competition created by the arrival of generics on the market brought a radical drop in prices, which fell 99% between 1999 and 2007.
The organizations advocating universal access to antiretroviral drugs timidly began prescribing them. By November 2001, 650 patients were receiving antiretroviral drugs in all MSF projects combined. The evolution from prevention to treatment met with so much internal resistance that, in November 2002, the MSF International Council adopted a resolution prohibiting AIDS projects that were limited to prevention and did not include the use of antiretroviral drugs. Due to caution, treatment protocols were so restrictive they drastically limited the number of patients treated. MSF then relied on the experience of other prescribers (the Burundian Association Nationale de Soutien aux Séropositifs et Sidéens, and Paul Farmer’s teams in Haiti) to increase rapidly the number of patients treated. From 2003 to 2004, MSF doubled the number of patients receiving antiretroviral drugs in its projects, from five thousand to eleven thousand.
In June 2001 a special session of the UN General Assembly recommended the creation of an international fund to finance the fight against the AIDS pandemic. The Global Fund to Fight AIDS, Tuberculosis and Malaria was created in 2002, awarding its initial funding to thirty-six countries. That same year, the WHO added antiretroviral drugs to its list of essential medicines. The “3 by 5 Initiative” (three million patients on antiretroviral drugs by 2005), launched in 2003 by the WHO and UNAIDS, was a major step toward providing access to AIDS treatment. Though pleased by these developments, MSF voiced some reservations regarding the absence of what it considered essential recommendations. Many in the organization believed that the use of generic drugs was not being promoted, despite the fact that generics would allow many more patients to be kept alive for the same amount of money. Some members also pushed for generics containing several drugs in one tablet, which simplified the treatment regimen for the patient, thus ensuring better treatment adherence and efficacy. MSF was also critical of the fact that the “3 by 5 Initiative” did not advocate either free treatment for patients or the right for nurses to prescribe drugs, when the limited number of practicing doctors made it impossible to treat several million patients.
In 2003, the US President’s Emergency Plan for AIDS Relief (PEPFAR) was launched. The plan included the dispensing of antiretroviral drugs, which the US administration had, until recently, considered impracticable in Africa. In an article in the Boston Globe on June 7, 2001, Andrew Natsios, administrator of the United States Agency for International Development (USAID), was quoted as saying that “many Africans don’t know what Western time is. You have to take these [AIDS] drugs a certain number of hours each day, or they don’t work. Many people in Africa have never seen a clock or a watch their entire lives.” Scientific arguments were needed to make the case, so Epicentre created a database (FUCHIA) of all patients treated by MSF for HIV infection. Beside their usefulness in guiding actions, the analyses produced from the database have enabled MSF to publish in scientific journals, thus legitimizing its contribution to the public debate. The international mobilization and the publication of early results on survival rates among African patients on antiretroviral drugs The early results were made public during an oral presentation at the International AIDS Conference in Barcelona (summer 2002).dismissed the Bush administration’s initial reluctance (Kasper et al., 2003; Ferradini et al., 2006). At a meeting with MSF representatives, Randall L. Tobias, coordinator for the president’s AIDS initiative, maintained that the results obtained by several teams, including MSF’s, made inclusion of antiretroviral funding inevitable in the president’s plan.Report from the January 7, 2004, meeting with Randall L. Tobias, MSF archives.
The number of people receiving antiretroviral treatment in low- and middle-income countries increased from three hundred thousand in 2002 to three million in 2007. Yet only a third of patients needing treatment were receiving it in 2007. That same year, 2.5 million people were newly infected, and more than two million died of AIDS. The specific needs of children—in terms of both prevention and treatment—are still only poorly covered. The treatment available today is complicated, has severe side effects, and must be taken for life. In addition, the data on the efficacy of national treatment programs is fragmentary. Globally, 18% of treatment sites that provided information have experienced at least one inventory shortage of antiretroviral drugs (WHO, UNAIDS, UNICEF, 2007, p.4). The lab test that helps assess treatment adherence and efficacy is rarely available for individual monitoring. A few epidemiological surveys make up, in part, for the lack of information on the success rates of treatment programs in precarious settings.
Today, due to their toxicity and limited efficacy, the antiretroviral combinations in use in middle- and low-income countries are no longer prescribed in high-income countries. The flexibility in intellectual property rules that made a first-generation treatment possible in resource-limited countries in no way guarantees that these countries will get new drugs, the need for which is already being felt. Nor is there any guarantee that the funding available for fighting AIDS will continue. Therefore, roughly twenty years after discussions began, voices are once again being raised, both within MSF and elsewhere, urging innovation rather than resignation.
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