HOSTED JOINTLY BY THE CONGRESSIONAL HUMAN RIGHTS CAUCUS AND THE CONGRESSIONAL BLACK CAUCUS HEALTH BRAIN TRUST Testimony of Nicolas de Torrente, Executive Director, MSF-USA
Testimony of Nicolas de Torrente, Executive Director, MSF-USA before the Congressional Human Rights Caucus and the Congressional Black Caucus Health Brain Trust on access to medicines.
Good afternoon, and thank you very much for allowing Doctors Without Borders/Médecins Sans Frontières (MSF) the opportunity to provide members of Congress with information about a critically important but forgotten crisis, which our medical teams are faced with every day in the course of their work in the field.
As many of you know, MSF is an independent international medical humanitarian organization that delivers emergency aid to victims of armed conflict, epidemics, and natural and man-made disasters, and to others who lack health care due to social or geographical isolation in over 80 countries throughout the world. MSF was awarded the 1999 Nobel Peace Prize, and that same year launched an international Access to Essential Medicines Campaign, which grew directly out of the frustration of MSF doctors and nurses who were increasingly unable to treat their patients because the medicines they needed were too expensive, no longer produced, increasingly ineffective, or simply did not exist. Over the past four years, we have contributed to focusing serious political and public attention on the overwhelming lack of access to existing therapies in developing countries, most tragically illustrated by the lack of access to antiretroviral (ARV) therapy for the treatment of HIV/AIDS in developing countries. As you all know, 95% of the 42 million people living with HIV/AIDS worldwide do not have access to ARVs, and over three million people die of HIV-related causes every year - that's approximately 8,500 every day.
MSF has responded to this crisis in two fundamental ways: First, we are on the frontlines, actually providing ARV treatment in resource-limited settings in Africa, Asia, Latin America, and Eastern Europe. Today, we are treating approximately 3,500 patients with ARVs in 12 countries, demonstrating the feasibility of providing ARV treatment using affordable quality generics in severely resource-constrained environments. Second, we are continuing to fight for the sort of political response to the AIDS pandemic-the greatest global health crisis of modern times-that will be required to scale-up treatment for all those who need it. That means demanding increased resources and pro-public health interpretations of international trade agreements from donor countries like the United States, greater political commitment to national programs that include ARV treatment from national governments in developing countries, and greater technical resources from specialized United Nations agencies like the World Health Organization (WHO), UNAIDS, and UNICEF. We will not give up the fight for access to AIDS treatment until those political responsibilities have been properly assumed and until a credible international response, proportionate to the magnitude of the AIDS pandemic, has been mounted.
The AIDS crisis shows vividly how existing medicines must urgently be made available to those who need them. But there is another less visible dimension to the access to medicines crisis, the other side of the coin, so to speak: the crisis in research and development (R&D) for neglected diseases. There is an urgent need to ensure a robust research pipeline full of newer, more effective, easier-to-use medicines, but so far this critical need has failed to capture the attention of policy-makers and the media. Millions are suffering and dying needlessly as a result, and it is crisis to which I would like to draw your attention today.
As part of MSF's Access to Essential Medicines Campaign, we have developed a traveling public education exhibit, the Access to Essential Medicines EXPO, which uses photographs, sound, text, and interaction with MSF field volunteers to educate visitors about the access to medicines crisis, and highlights the lack of R&D for neglected diseases. The U.S. tour was launched in March 2002 at MSF's international conference on "The Crisis of Neglected Diseases" in New York and has since visited 25 U.S. cities.
Today, the Access EXPO is just a few steps away from you on the National Mall, and we are here because we want to deliver a very clear message to policy-makers: the current system of research and development is failing our patients, it is failing the poor-with huge consequences in human terms-and we must change course dramatically if we hope to turn the tide against infectious diseases that claim millions of lives every year. To do that, we need government action and global cooperation.
Yesterday, we delivered petitions to President Bush and the Pharmaceutical Research and Manufacturers of America (PhRMA) calling for the adoption of appropriate policies and the commitment of the financial and human resources necessary to develop new medicines for neglected diseases. The petitions were signed by tens of thousands of people from every U.S. state and territory as well as organizations representing millions of Americans. Supporters include over 30 deans of U.S. medical schools and schools of public health, former U.S. Surgeon General David Satcher, MD, former FDA Commissioner David Kessler, MD, the National Council of Churches, the American Society of Tropical Medicine and Hygiene, and Kids for World Health.
We believe we speak for them when we say that we hope you will join us on the Mall this week to experience for just 15 minutes what it is like to walk in the shoes of one of our patients living with a neglected disease for which treatment options are severely limited or non-existent. And we hope we can count on your support to search for appropriate public policy solutions to the crisis in R&D for neglected diseases.
Bearing Witness to the Crisis in Research and Development for Neglected Diseases
According to the World Health Organization, 14 million people die each year from communicable diseases such as malaria, TB, sleeping sickness, and kala azar. An estimated 97 percent of deaths from infectious diseases occur in developing countries, with the poorest people in those nations disproportionately affected. In its 30 years of working in some of the world's poorest regions, Doctors Without Borders/Médecins Sans Frontières (MSF) has witnessed the loss of countless lives due to the lack of access to medicines. Though we acknowledge that there are many factors that contribute to inadequate access to health care in developing countries-poverty; lack of trained personnel; quality of diagnosis; accurate prescribing, selection, distribution and dispensing of medicines; drug quality; capacities of health systems; and scarce health budgets-the lack of access to medicines constitutes a serious barrier, which is worsening every day. Old diseases are reappearing and drug resistance is spreading rapidly, rendering useless medicines that were once effective. Some of the medicines used today were invented decades ago and are highly toxic. For some diseases, existing medicines are simply too expensive, and for others still there is no treatment to offer whatsoever: no effective medicine has been found and nobody is looking for new possibilities.
In the past several months, we have witnessed unprecedented international cooperation and a tremendous marshalling of financial, scientific, and political resources to respond to outbreaks of severe acute respiratory syndrome (SARS). In a matter of weeks, scientists have sequenced the coronavirus, thought to be the cause of SARS. Governments around the world, the World Health Organization, and private firms are mobilizing resources to strengthen public health systems to cope with this new threat and to search for a cure. This mobilization represents everything that is right about the current system-and everything that is wrong with it. It tells us clearly that where there is a will, there is a way.
To date, approximately 400 people have died of SARS. It is a serious new disease, which warrants our serious attention. Today alone, 19,000 people will die from HIV/AIDS, tuberculosis, malaria, sleeping sickness and kala azar-one child in Africa dies of malaria every 30 seconds. So why is so little done, relatively speaking, for people with these diseases? Because, unlike SARS, these neglected diseases overwhelmingly affect poor people in developing countries, and, unlike SARS, they occur in places of little consequence to the global economy. Surely, the international community-and the United States in particular-can meet the medical, scientific, and political challenges posed by these diseases, which overwhelmingly claim the lives of people in poor countries, with at least the same level of urgency.
DEFINING THE CRISIS
Over the past several decades, unprecedented medical advances have led to the creation of innovative treatments for everything from cardiovascular diseases and cancer to baldness and impotence. But this "health revolution," which has resulted in considerable gains in life expectancy and improvements in health in some parts of the world, has left most of the world's population behind. Millions continue to die of preventable and treatable diseases, such as HIV/AIDS, malaria and tuberculosis, and one category of diseases that has been all but forgotten by drug developers.
Tropical diseases such as leishmaniasis, lymphatic filariasis, Chagas disease and schistosomiasis continue to cause significant morbidity and mortality. Other diseases such as dengue fever and human African trypanosomiasis are re-emerging. In the absence of new treatments, physicians are forced to continue using old tropical medicines that are less and less effective due to inevitable drug resistance. At the same time, the handful of new medicines relevant to tropical diseases and other diseases of the poor such as HIV/AIDS tend to be unaffordable and poorly adapted to those who need them. Together with tuberculosis, these disabling and/or life-threatening diseases represent an enduring unmet medical need. Collectively, they can be called "neglected diseases"-diseases for which treatment options are inadequate or do not exist at all, mainly because they affect patients with little or no purchasing power. Below are some examples of neglected diseases.
Sleeping sickness is a parasitic disease that affects 36 countries in sub-Saharan Africa. An estimated 300,000-500,000 people are currently infected, and this figure appears to be on the rise. If left untreated, sleeping sickness is 100% fatal, killing over 66,000 people each year. In many places, melarsoprol has been the only treatment available for second stage sleeping sickness. Developed in 1949, it is an arsenic derivative so toxic that it kills one in 20 patients. Production of eflornithine, a safer and far more effective medicine, was discontinued in 1995 because it was not considered profitable by its manufacturer (now Aventis). Production was restarted in 2001 after Bristol-Myers Squibb discovered that a topical ointment containing eflornithine as the active ingredient was useful in removing "unwanted facial hair" in women. BMS received approval to market the ointment for cosmetic use in 2000. Finally, after a great deal of advocacy directed toward BMS, Aventis, and WHO, in 2001, Aventis agreed to restart production and donate to WHO enough eflornithine to meet global need for the next five years, and committed to working with WHO to find a long-term solution. Eflornithine has yet to reach all the hospitals and clinics in Africa that desperately need it in order to begin treating people. Moreover, it is unlikely that a new drug for sleeping sickness will be available in the near future. As is the case for other diseases such as river blindness and leishmaniasis, the veterinary industry may be the only hope, since the private sector is researching a form of the disease that infects cattle. This work may prove useful, as some of the drugs developed for the animal form of the disease may be effective in humans. But no drugs have been approved for human use and it will take a long time to study their effectiveness and obtain authorization for use. Some public funding has been allocated for research into a shorter treatment course for melarsoprol, but this toxic drug is still far from adequate.
Every year, there are an estimated 300-500 million cases of malaria in more than 90 countries worldwide. Ninety percent of cases occur in Africa. One child dies every 30 seconds from malaria. Chloroquine, a medicine developed in 1934, continues to be the only treatment available for most people with malaria. Unfortunately, high resistance in many parts of the world has rendered it virtually useless-in some parts of Asia and Africa, the chloroquine resistance rate is up to 100%, and the parasite has now also developed resistance to some newer drugs, including sulfadoxine-pyrimethamine (SP) and mefloquine. Effective treatments exist, most notably combination therapies containing artemisinin, which is derived from a Chinese plant. While African countries are heeding the advice of world experts to switch from old failing single-drug treatments to combination treatments, they are being forced to switch to stop-gap, less expensive combinations because of a lack of donor resources. Meanwhile, there is very little R&D devoted to this major killer, making prospects for better medicines very dim.
Kala azar (visceral leishmaniasis)
Visceral leishmaniasis, known in India as kala azar, is endemic in 62 countries but the majority of cases occur in India, Bangladesh, Sudan, Brazil, and Nepal. An estimated 500 000 people are infected every year, and a total of 200 million people are at risk. If left untreated, kala azar is fatal. MSF started treating patients with kala-azar in 1988 and has since cared for over 60,000 patients in Sudan, Ethiopia, Uganda, Kenya and Somalia. The most recent epidemic started in Sudan in late 2002. MSF responded by increasing the number of treatment centers and stepping up its support to Sudanese health authorities and other NGOs. But efforts by MSF and others have been limited by a lack of affordable, available treatments, particularly in Africa. The most commonly used drug against in kala azar, sodium stibogluconate, was discovered more than 70 years ago. It has to be injected into the muscle or given intravenously and requires hospitalisation for one month. It is a metal derivative so toxic that it causes serious side effects in 10% of patients, killing some. There are more modern treatments, but they are not available to most patients in Africa. AmBisome Â®, dubbed as a "miracle drug," revives patients within hours of the first shot and has virtually no side effects. However, it is astronomically expensive at $850-1400 per treatment. The gross national income per capita in Sudan is $330 per year. So far the producer has not offered significant discounts for developing countries and no generic formulations are available. Access to kala azar drugs has been improved by the registration of a new oral drug, miltefosine, in India and by the use of generic sodium stibogluconate in some African countries. But real progress in tackling the disease will require additional sources of generic drugs and a substantial increase in public funding for R&D to discover or finish development of new, affordable drugs and diagnostics.
Despite progress made in both the basic knowledge of many infectious diseases and the process of drug discovery and development, drug R&D for such diseases is at a virtual standstill. Of the 1,393 new drugs approved between 1975 and 1999, only 16 (or just over 1%) were specifically developed for tropical diseases and tuberculosis, diseases that account for 11.4% of the global disease burden. It is now more than ten years since the Commission on Health Research for Development released its landmark 1990 report. It found that global spending on health research was grossly skewed, with only 5% of total R&D funds (then $30 billion in 1986) being spent on the health problems of 93% of the world's population. Since then, the WHO released its 1996 report, Investing in Health Research and Development, and in 1996 another new institution, the Global Forum For Health Research, was created with its central objective being to "help correct the 10/90 Gap." Even with this apparently intense focus at the international level, little has changed. Today the 10/90 Gap remains, so that now less than 5% of all global R&D spending is relevant to the health status of 90% of the world's people.
More is known about the molecular biology, biochemistry, cell biology, immunology and genetics of members of the kinetoplastidae family of parasitic protozoa than most other types of parasites. An active and vibrant area of basic research on these parasites receives continuous support from both public research institutions and private foundations. More recently, new information is being generated at an even more rapid rate through genome sequencing and the development of novel and sophisticated approaches to functional genomics. Yet little, if any, of this basic research is translated into applied work that leads to the development of new drugs for these neglected diseases. Given this body of basic research, it is ironic that the drugs currently used to treat kinetoplastid diseases were discovered empirically decades ago. With few exceptions, the wealth of basic research knowledge of these parasites is not being translated into practical applications.
THE FAILURE OF THE CURRENT SYSTEM
There is a widely held assertion that granting patent rights to protect pharmaceutical innovations is the best way to stimulate (private sector) investments in R&D. It is argued that by providing exclusive patent rights to inventors - a temporary monopoly - one creates financial incentives for R&D, which leads to innovation. Some even go further in characterizing the World Trade Organization Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS), which establishes a worldwide harmonization of intellectual property (IP) rules, as a major global policy instrument to stimulate R&D.
Patents that ensure intellectual property protection are part of a complex system that can motivate investment in R&D under certain circumstances, in particular when a profitable return on investment can be expected. However, patents as a tool to stimulate neglected diseases R&D is doubtful, precisely because the people who suffer from neglected diseases do not have substantive purchasing power, and thus cannot constitute a profitable market. Market driven patent protected drug development for neglected diseases will not increase no matter how strong the level of intellectual property protection. Also, the assertion that innovation will automatically follow when there is IP protection is questionable. Historically, protection of intellectual property has followed industrial development. One cannot argue that the reverse will also be the case.
In 2002, the UK government commissioned a report from an independent group of experts, the Commission on Intellectual Property Rights (CIPR). The CIPR Report, published in September 2002, concluded that "[a]ll the evidence we have examined suggests that [IP] hardly plays any role at all [in stimulating R&D], except for those diseases where there is a large market in the developed worldâ€¦The heart of the problem is the lack of market demand sufficient to induce the private sector to commit resources to R&D... [The] presence or absence of IP protection in developing countries is of at best secondary importance in generating incentives for research directed to diseases prevalent in developing countries."
Conceptually, the failure of the current system can be broken into two areas: market failure and public policy failure.
To date, drug development has been largely confined to the R&D-based pharmaceutical industry, which has grown into one of the most prosperous industrial sectors by focusing on the most lucrative medical markets. The reliance on market-based incentives and commercial actors to generate new medicines has transformed drugs into regular consumer goods. The limitation of this system is that market forces skew drug development investments toward diseases and patients that guarantee the highest financial returns. With North America, Europe and Japan accounting for 80% of the world pharmaceutical market, the health needs of the majority of the world's population are being sidelined by the proprietary pharmaceutical industry.
According to the United Nations Development Program, in the United States less than five per cent of the drugs introduced by the top 25 pharmaceutical companies represented true therapeutic advances. These so-called "me too" drugs do not contribute to improving health outcomes, but they do improve the profit margins of their producers. Moreover, in order to generate new markets among patients with significant purchasing power, lifestyle conditions (such as obsessive shopping) and normal lifecycle conditions (such as menopause, or male pattern baldness) are medicalized through carefully constructed marketing campaigns. Any overlap with genuine medical need is increasingly incidental.
According to a 2002 Harvard University School of Public Health survey of eleven top-grossing pharmaceutical companies, none reported having brought a drug to market in the last five years for three of the most neglected diseases-sleeping sickness, kala azar, and Chagas' disease-and there is nothing currently in the research pipeline for these diseases. Overall R&D budgets for the responding companies ranged from $500 million to greater than $1 billion per year.
A survey on new medicines in development conducted by the U.S. drug industry lobby group, PhRMA, reports that of the 137 medicines for infectious diseases in the pipeline during 2000, only one mentioned sleeping sickness as an indication, and only one mentioned malaria. There were no new medicines in the pipeline for tuberculosis or leishmaniasis. In contrast, PhRMA's 2000 "New Medicines in Development" list showed eight drugs in development for impotence and erectile dysfunction, seven for obesity, and four for sleep disorders.
While publicly financed research institutions are involved in the early phases of research and drug discovery, the expertise, infrastructure and management capacity for taking these findings through the drug development pipeline are almost entirely concentrated in the private commercial sector. Hence, while multimillion-dollar investments fund research aimed at developing highly profitable drugs for prosperous markets-including for non life-threatening conditions-drug R&D for neglected diseases is stifled. For neglected diseases, little knowledge or technology is transferred from the public to the private sector, in stark contrast to the dynamic flow of information regarding diseases that represent significant markets.
Public Policy Failure
This market failure has been compounded by a failure of public policy - both globally and within endemic countries - to ensure the development of drugs for neglected diseases. In neglected disease-endemic regions, the public sector has not adequately cultivated drug development expertise and capacity. In those countries with drug R&D potential, governments have been confronted with a lack of financial resources, and for the most part have not demonstrated political will to invest in long-term health development. They have also failed to implement public policy measures to establish viable domestic drug R&D industries.
Industrialized countries subsidize basic and discovery research at universities and public research institutes, and have developed a series of enabling incentives to foster private R&D investment in order to transform scientific advances into medical products. Such incentives include the patent system and various forms of public purchasing to pay for health tools, including national health care and insurance systems. This balance between public and private capacity, investments and interests has worked reasonably well to provide important health tools for the 15 percent of the world's population living in industrialized countries. But it has not been effective in providing new or adapted health tools that target diseases occurring almost exclusively in the developing world.
Despite considerable agreement on the nature of the challenge, governments have not developed meaningful and viable global policies that ensure needs-driven R&D for neglected diseases.
PARTIAL SOLUTIONS AND CURRENT INITIATIVES
In recent years, awareness of the lack of effective treatments for neglected diseases has been growing. While some novel approaches have emerged to stimulate R&D and produce health tools that are adapted to the needs of developing countries, these policy tools and initiatives are not situated within a larger- framework that guarantees sustainable, needs-driven health R&D.
UNDP/World Bank/WHO Special Program for Research and Training in Tropical Diseases (TDR) was established in 1975 in response to appeals from neglected disease-endemic countries. TDR addresses ten tropical diseases and has a two-fold mission, namely: developing new tools and methodologies to combat its target diseases, and developing research capacity in developing countries to enable them to better address their needs and contribute to sustainable long-term solutions. Its work includes support for drug discovery and development, advocacy, agenda-setting and professional training among other tasks. It has played a key leadership role in establishing GATB and MMV, which are intended to marshal significant new resources into tightly focused R&D programs on tuberculosis and malaria respectively. TDR has successfully contributed to the development of several new treatments for tropical diseases over the past 25 years and continues to be active in this area, but there remain significant unmet curative and preventive medical needs, particularly for the most neglected diseases.
"Market push and pull mechanisms" are various forms of financial and economic incentives designed to encourage the R&D-based pharmaceutical industry to develop drugs for otherwise neglected diseases. They work by lowering the costs and risks of companies' R&D efforts ("push" mechanisms such as R&D grants, tax reductions, access to public research funds and human resources) or by securing the profitability of the market ("pull" mechanisms, such as market exclusivity, patent extension, health insurance coverage). To date, these tools have primarily stimulated the development of drugs for "orphan diseases" - those that affect a small number of patients in wealthy countries. In the case of the most neglected diseases, both national governments in disease-endemic countries and patients have little ability to pay, and these mechanisms are therefore of limited use.
Philanthropic initiatives led by private foundations have notably been responsible for the single biggest change in funding for neglected diseases over the past few years - not private industry or the public sector. The Bill and Melinda Gates Foundation in particular has become a major force in neglected disease drug development. In the last few years, the Gates Foundation has given $25 million (over five years) to the Global Alliance for TB Drug Development (GATB) and the Medicines for Malaria Ventures (MMV) respectively, and another $15 million to vaccine research for leishmaniasis. But ensuring the development of life-saving medicines should not depend on charitable philanthropic endeavors. It is unwise and unsustainable to entrust global public health to system that relies on the wealth and goodwill of a handful of individuals, whose priorities can change without warning. As important as philanthropic efforts are, they are an untenable proposition in the long-term.
Public-private partnerships (PPPs) seek to foster R&D for neglected diseases by matching existing capacity, expertise and resources in both the public and the private sector on specific diseases, or even specific projects. Typically, these initiatives play a coordinating role in setting a disease-specific R&D agenda, raising funds and managing R&D projects. Examples include the Global Alliance for TB Drug Development (GATB), the Medicines for Malaria Venture (MMV), and the International AIDS Vaccine Initiative (IAVI). Generally, the PPP strategy relies on market-based mechanisms to stimulate the development of drugs for neglected diseases, providing public resources to compensate for the perceived market failure. They use the potential existence of a prosperous market in wealthy countries (e.g. people with HIV/AIDS and/or TB, or travelers to malarial regions) as a means to interest multinational pharmaceutical companies. At the same time, they provide funds to subsidize R&D in order to minimize risk to corporate partners. However important these initiatives are, none have yet or will likely yield sustainable long-term solutions to the crisis in R&D for neglected diseases for which there is no potential market in wealthy countries, and all suffer thus far from a dearth in substantive and long-term public and private sector funding.
Drugs for Neglected Diseases Initiative: An Innovative Model? MSF has helped to co-found a new model for developing drugs for neglected diseases: the Drugs for Neglected Diseases Initiative (DNDi). DNDi aims to improve the health and quality of life of people suffering from the most neglected diseases. To fulfill this aim, DNDi will use an alternative model to address unmet needs and develop new drugs or new formulations of existing drugs for neglected diseases. It will aim to secure a majority of funds for R&D projects from the public sector, and will utilize and build capacity in countries where neglected diseases are endemic and in doing so, contribute to R&D technology development. DNDi will build a needs-driven project portfolio based on modifications of existing drugs and compounds (short- and medium-term projects) and new lead compounds (long-term projects). It will initially focus mainly on kinetoplastids (human African trypanosomiasis, Chagas disease and visceral leishmaniasis). DNDi will not itself conduct research. Rather, it will stimulate and coordinate research activity and manage drug development projects. This virtual model of drug development is intended to minimize overhead costs and harness existing but fragmented capacity in the developing countries. Building on existing networks and creating new synergies, DNDi will collaborate with partners in both wealthy and developing countries, including research institutions, governments, pharmaceutical and biotech companies, NGOs, and foundations. DNDi will also work closely with other initiatives that aim to address neglected diseases, in particular TDR. Three Immediate Drug Development Projects (IDDPs) - using existing drugs or compounds - have already been started as DNDi pilot projects. DNDi will continue systematically to identify and/or develop new compounds so as to establish a balanced R&D portfolio of short, mid-term and long-term projects. It is estimated that, by 2014, DNDi will have registered six to eight new drugs and will have built an additional balanced portfolio containing a minimum of eight ongoing projects in its drug development pipeline. Still, although this new model may provide valuable lessons for policy-makers in developing innovative mechanisms to stimulate R&D for neglected diseases, it, like the other policy tools and initiatives described above, is not situated within a larger framework that guarantees sustainable, needs-driven health R&D.
THE ROAD FORWARD
Given the market and public policy failure to generate R&D for diseases of the poor, a new framework for stimulating R&D for neglected diseases is clearly needed. Redirecting today's knowledge and scientific expertise to address health needs will require a paradigm shift in the way life-saving or other essential health tools are valued, and how efforts are organized globally to ensure their development and widespread availability. Firm public leadership is required to develop alternate and complementary public sector and not-for-profit models that view health R&D for neglected diseases as a global public good. In a world of increasingly globalized trade and travel, the pursuit of neglected disease health R&D as a global public good is not charity, but an endeavor from which all nations stand to benefit.
To realize this required paradigm shift the public sector must embrace a global public goods framework that marshals scientific and technical expertise as well as financial resources to develop viable R&D capacity directed at neglected diseases. To this end, the Commission on Macroeconomics and Health concluded that an additional yearly investment of $3 billion is needed to reach an appropriate level of health R&D to meet the needs of the poor.
As the legally mandated intergovernmental agency responsible for global health, the World Health Organization must take on the challenge to work with its member states to develop a global treaty or framework convention on essential health technology R&D. The authority and legitimacy to play this role stems from Article 19 of the WHO constitution, which states that "the Health Assembly shall have authority to adopt conventions or agreements with respect to any matter within the competence of the Organization. A two-thirds vote of the Health Assembly shall be required for the adoption of such conventions or agreements, which shall come into force for each Member when accepted by it in accordance with its constitutional processes."
At this year's World Health Assembly, which takes place later this month in Geneva, MSF will be calling on WHO member states to initiate discussions on a global convention for health R&D, which would:
- Define a needs-driven international R&D priority agenda;
- Commit all countries to contribute to R&D for health;
- Outline an agreement and clear rationale for sharing the burden of the cost of this R&D;
- Define appropriate funding and incentive mechanisms for governments to fulfill their commitments to public sector involvement in R&D;
- Establish and strengthen international mechanisms for exchanging and transferring research results, knowledge, and technology;
- Ensure developing countries' central involvement in public sector R&D.
MSF will also bring this recommendation to the Group of Eight (G8) Summit in Evian, France, in early June.
This global agreement will only be possible with true international cooperation and public sector leadership. Because the overwhelming majority of global health R&D is conducted in public and private research institutions in the United States-and because the U.S. is the wealthiest and most powerful nation in the world-the U.S. government has a critical role to play in guaranteeing the leadership and cooperation required to ensure that advances in science and medicine will contribute to alleviating suffering and meeting the critical medical needs of the millions of people in the developing world.
Thank you once again for the opportunity to speak with you about this important crisis.