Vaccines and medicines for the world's poorest
BMJ 2000; 320 doi: https://doi.org/10.1136/bmj.320.7240.952 (Published 08 April 2000) Cite this as: BMJ 2000;320:952
Data supplement
- Creating Global Markets for Orphan Drugs and Vaccines:
A Challenge for Public/Private PartnershipPRELIMINARY
CONSENSUS PAPERglobal health forum I
Quail Lodge
Carmel Valley, California
18 – 21 February 2000
PRESENTED BY:
GLOBAL FORUM FOR HEALTH RESEARCH
INSTITUTE FOR GLOBAL HEALTH
WITH SUPPORT FROM:
MEDICINES FOR MALARIA VENTURE
THE WORLD BANK
WORLD HEALTH ORGANIZATION
Preliminary Consensus Paper
Global Health Forum I:
Creating Global Markets for Orphan Drugs and Vaccines
Key Points
- Unprecedented Need and Opportunity. Investing in improved health is essential for global economic development. The epidemic of HIV/AIDS, and other "neglected" diseases of poorer countries such as TB and malaria, undermine efforts to educate populations, build infrastructure, and strengthen economies. Improved delivery of existing vaccines could save the lives of three million children annually. Development and delivery of new vaccines and affordable drugs for HIV/AIDS, malaria and TB could bring these devastating epidemics under control and save five million additional lives every year.
- Need for Global Partnership. The public and private sectors must work in partnership, recognizing their particular strengths. Industry has a legitimate expectation to recoup its investments and make a reasonable profit but also a responsibility to work with the public sector to address global health problems. Both OECD and non-OECD countries have responsibilities. There are no "first world solutions" to "third world problems."
- Need for Comprehensive Approach. Accelerating drug and vaccine development and delivery requires tailored interventions at every step in the process, including subsidizing the costs of research ("push") and establishing viable markets ("pull"). Public-private partnerships have a demonstrated capacity to accelerate development of specific products. Creation of functioning markets in middle-income and large low-income countries could ultimately attract new investments into currently neglected diseases.
- Make Health a Top International Priority. Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principal goal of international health and development organizations.
- Consensus in Support of Presidential Efforts. The efforts of President Clinton and US Congressional leaders to enact policy and achieve new funding to accelerate development and delivery of drugs and vaccines targeted at neglected diseases must be endorsed as critical first steps. The leaders of the European Union member countries, Japan, and multi-lateral organizations must take further steps to promote their own approaches. Continued Presidential leadership is necessary to pass legislation in the US and build international momentum to accomplish sustained policy changes.
- Global Health Forum Reaches Consensus and Agrees on Next Steps. A group of 45 leaders from industry, government, multilateral organizations, and research institutions met over President’s Day weekend at Quail Lodge in Carmel Valley, California to discuss mechanisms to accelerate the development and delivery of vaccines and therapeutic drugs needed in the developing world. The Forum was organized by the Institute for Global Health (UC San Francisco and UC Berkeley) and the Geneva-based Global Forum for Health Research. The findings and recommendations of this Forum are summarized in this preliminary consensus statement.
- Presidential leadership in the United States. The US President has made several promising proposals to fight disease in poorer countries and improve incentives for priority research and development. His fiscal year 2001 budget proposal includes a $50 million US contribution to the Global Alliance for Vaccines and Immunization (GAVI), increased funding from the World Bank and other multilateral development banks for low interest loans to expand immunization, a significant increase in the National Institutes of Health funding for basic research on diseases affecting developing nations, and a tax credit for sales of vaccines for malaria, TB and HIV, up to a value of $1 billion. The President has also supported $200 million in fiscal year 2001 funding for the LIFE Initiative, which helps sub-Saharan African countries and India provide HIV/AIDS prevention and treatment services, including some therapeutic drugs.
- Proposals in the US Congress. Several members of Congress have also proposed promising legislation. Senator John Kerry has recently introduced a comprehensive package of incentives for R&D on vaccines for malaria, TB, and HIV/AIDS. Senator Kerry and Rep. Nancy Pelosi have proposed a tax credit on R&D costs for vaccines targeting these three major infectious disease killers. Rep. Barbara Lee has introduced the AIDS Marshall Plan Fund for Africa Act that would provide funds for HIV/AIDS-related research, prevention, and treatment activities. Rep. James Leach and Senator John Kerry have introduced the World Bank Trust Fund Act to pay for AIDS education, prevention, treatment and vaccine development efforts targeting the world’s poorest countries. Senator Barbara Boxer has proposed the Global AIDS Prevention Act, which would authorize up to $2 billion through 2005 to fight AIDS abroad, particularly in Africa. Rep. Joseph Crowley will introduce legislation to increase the US investment in international health priorities.
- Japanese consortium on malaria.Twelve Japanese pharmaceutical companies working with the World Health Organization and Japan’s Ministry of Health and Welfare have launched a collaboration to identify potential drugs against malaria.
- African discussion of joint efforts. Countries in Southern Africa are studying how bulk purchasing and harmonization of product licensing in the region can accelerate and expand product delivery.
- New incentives in Europe. The European Union has recently passed Orphan Drug legislation. Modifications of this legislation in Europe and other countries could provide incentives for research on priority products for LMICs. Political leaders in France, the Netherlands and the United Kingdom (for example) have shown commitment to the global battle against HIV and other major killers.
- Expected increased focus from industrialized nations. The approaching meeting of the G8 in Japan is expected to include selected world health issues on its agenda, including HIV/AIDS and malaria.
- World Bank IDA fund: The World Bank is seriously considering creation of a $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, and other poverty-oriented, basic health measures.
- WHO/IFPMA Round Table: The World Health Organization and leaders of the global research-based pharmaceutical industry have formed a "Round Table" for discussions focused on improving medical treatment, including access to needed medicines and global health care delivery. At a January, 2000 Round Table meeting the group agreed on several points, including the need for both "push" and "pull" incentives (described below); the usefulness of a modified orphan drug act for neglected diseases (including tax breaks for research, market exclusivity guarantees, and a tax credit on product delivery); the importance of the Medicines for Malaria Venture; the need for incentives for both medicines and vaccines; and creation of a single fund for product purchase in order build credibility and provide both short and long term incentives for product development.
- WHO Commission on Macro-Economics and Health: The World Health Organization Commission on Macroeconomics and Health Working Group II brings together participants from industry, the World Bank, WHO, and research institutions to discuss the economics of incentives for new vaccine and product development. The group has developed a workplan and recognizes that advances in health are necessary to drive economic growth in the developing world. Working Group II has agreed on the need to focus on neglected products needing attention including vaccines for rotavirus, pneumonia, malaria, TB, and HIV/AIDS. Several incentives to generate new private sector commitment were identified, and include better epidemiological data, disease burden and market analysis, basic research and discovery efforts, a "sliding" fund for product procurement, purchase pre-commitments, and loans and credits.
- Research capacity building. The WHO-UNAIDS HIV Vaccine Advisory Committee is launching an initiative to strengthen research capacity in developing countries to work on HIV vaccines.
- Public Private Partnerships (PPPs). Several partnerships of public and private sector players have been formed and show promise for spurring research on neglected products. The Global Forum for Health Research in Geneva has begun a project to identify all significant PPPs and to map their origins, participants, aims, governance structures, degree of success, constraints, and difficulties. The goals of this work are to facilitate the exchange of information among potential partners and promote the development of new partnerships.
- For each priority disease, a unique set of incentives is needed to combat different sets of problems.
- The distribution of cost and risk across the research and development processes differ for vaccines and medicines.
- Small biotech companies and large pharmaceuticals must both be involved in the development of new therapies, but different types of incentives will motivate them.
- Increased funding for research on neglected diseases. Large government funded research institutions, such as the US National Institutes of Health, play a vital role by financing upstream research. They can focus more of their efforts on diseases of poorer countries. Governments can also provide support for clinical trials of priority vaccines and drugs. Middle income countries have growing research capability and industrialized countries could help foster this expertise through direct funding and technology transfer.
- Tax credits on research and development. By providing credits on research and development, the cost of R&D is lowered. In one proposal, tax credits could also be passed on to equity investors in smaller companies, helping these companies raise capital for priority (but high investment risk) research.
- Social venture capital funds. These arrangements allow the public sector, and perhaps interested private investors, to buy equity positions in research on priority products. The investments provide funding to companies to do needed research, and investors retain certain rights, including ability to influence research priorities and product pricing and delivery agreements.
- Harmonization of licensing processes. The multiplicity of product licensing procedures in countries creates an obstacle for accelerated delivery of products. More uniform licensing processes and standards would give industry a clearer picture of the kinds of products that are likely to win approval. The first step in this process would be the standardization of application requirements and administrative procedures.
- Expedited approval of drug and vaccine products.Commitments to quicken the drug approval process for priority drugs will accelerate delivery of these products and give industry confidence that new products will be used. Delays in approval of drugs and vaccines are of particular concern to industry given the time-limited value of intellectual property rights.
- Purchase funds. Drug and vaccine purchase funds provide a credible market for products and thus incentivise R&D and secure delivery of products once licensed. Purchase funds are among the top priority for industry as they provide tangible ability to purchase and deliver their products. As noted above, the WHO/IFPMA round table has recommended creation of a single fund so that products now available can be delivered, as well as those in the early research stages. Other efforts are focused on creating funds for single products, such as HIV vaccines. Purchase funds present special political challenges. Governments may find it difficult to appropriate monies to a purchase fund in advance of a product to purchase. International organizations, using developed country and foundation funding, may be best suited to creating credible purchase funds. An alternative to purchase funds are requisitions or promises to buy particular products. Under these schemes, governments would commit to purchase products meeting certain specifications, but would not be required to appropriate funds until the product was licensed. It is unclear whether such a plan would be sufficiently credible to industry.
- Tax credit on sales.US President Clinton and Senator John Kerry have proposed legislative packages that include tax credits on the sale of vaccines for malaria, TB or HIV/AIDS. Companies would receive a 100% credit on the value of their sale to qualified organizations. Tax credits on sales would increase company revenue from sale of a product destined for low-income countries, thus making these markets more attractive. The credit proposal is politically palatable because it does not require appropriations in the current year. These credits do not assure that a market exists, however. The GAVI, World Bank, and purchase fund proposals work towards filling this demand gap. Participants at the Forum also cautioned that these credits should be designed so that they do not create an incentive to inflate the unit price of products for developing countries. Some Forum participants stressed that a tax credit on salesshould also apply to currently available, or soon to be available, priority vaccines and drugs. The credit proposed by Clinton would have a $1 billion cap, so expanding the number of products eligible for the credit could have the effect of substantially reducing credits available for the eventual sale of malaria, TB and HIV/AIDS vaccines.
- Wider delivery of currently available vaccines. It typically takes ten years or more for a vaccine to reach populations in poorer countries after it has been licensed for use in the OECD countries. Wider purchasing and delivery of existing or soon to be available vaccines would give credibility to other multi-lateral efforts in the eyes of industry, and would have an immediate impact on the public health of communities around the world. (Haemophilus influenzae type b (Hib) and hepatitis B vaccines are already licensed but not yet widely available in many countries. In the near future, pneumococcus, rotavirus, dengue, and Japanese B encephilitis vaccines will be ready for use.) The proposal now being considered by the World Bank to create a $1 billion "replenishing fund" for vaccine purchase, delivery and infrastructure development would help improve product delivery. Forum participants noted that this plan alone is not sufficient, particularly since there are substantial unused IDA funds already available for these purposes and IDA funds would not benefit the poorer communities in middle-income countries such as China and Indonesia.
- The Global Alliance for Vaccines and Immunization (GAVI), through the Global Children’s Vaccine Fund, funded by the Bill and Melinda Gates Foundation and others, is a collaborative effort to purchase and deliver vaccines and encourage development of priority vaccines.
- The International AIDS Vaccine Initiative and the South African AIDS Vaccine Initiative, promote development and accessibility of HIV vaccines useful in the developing world
- The Medicines for Malaria Venture is stimulating research and development on new drugs for malaria
- The International Trachoma Initiative fosters expanded use of antibiotics and other interventions to fight this major cause of blindness.
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Preliminary Consensus PaperGlobal Health Forum I:
Creating Global Markets for Orphan Drugs and Vaccines
Forty-five leaders from private industry, government, representatives of multi-lateral and bilateral organizations, and health policy researchers came together February 18 – 21, 2000, at Quail Lodge in Carmel Valley, California to discuss mechanisms to accelerate the development and delivery of vaccines and therapeutics desperately needed in the developing world.
Participants (listed in Appendix 1) included representatives from the World Health Organization, World Bank and World Trade Organization, executives from biopharmaceutical companies including Aventis Pasteur, Cadila Pharmaceuticals, Chiron, Glaxo-Wellcome, Hong Kong Institute of Biotechnology and SmithKline Beecham, health officials and corporate leaders from Canada, China, France, India, Indonesia, South Africa, and the United Kingdom, staff from the White House and the US Congress, and academics with expertise in global health.
The first Global Health Forum was organized by the Geneva-based Global Forum for Health Research and the Institute for Global Health of the University of California, San Francisco and UC Berkeley, with support from the Medicines for Malaria Venture, the World Bank and the World Health Organization.
Infectious Disease Killing Millions and Undermining Economic Development
The past three decades have seen great advances in immunization and health care in many low- and middle-income countries (LMICs). Approximately 3 million lives are saved each year, and 750,000 children avoid becoming disabled, because of immunization. This year, 74% of children in the world will receive the standard immunizations recommended by the World Health Organization. Even people at war have recognized the primacy of fighting disease. In some areas, when polio eradication teams arrived with batches of vaccine, fighting halted so communities could be immunized.
Yet for all this progress, the health divide between the "haves" and "have nots" in the world is steadily growing. Three million children perish each year -- six children every minute -- from diseases that can be prevented with existing vaccines. The vaccine for hepatitis B, licensed in the United States in the early 1980s, could save 900,000 lives per year if widely used. The cost would be under $20 for each year of healthy life saved.
Other major diseases of the developing world, including malaria, TB, and HIV/AIDS, are potentially vaccine preventable in the longer term and treatable with new medicines in the medium term. In fact, widely available vaccines for these three killers could save more than five million people each year. However, scientific obstacles, economic disincentives, and failed leadership have resulted in under-investment in medical research for new vaccines and medicines targeted at these diseases.
Industry and governments worldwide must work together to meet the health needs of LMICs, thereby employing the ever expanding pool of scientific and technical knowledge to narrow the health quality gap between the rich and poor in the world. Unfortunately, current practices are moving in the opposite direction: less than 10% of all public and private health research and development investments are devoted to addressing the primary health problems of 90% of the world’s population.
Investing in improved health is essential for global economic development. Today, diseases of poorer countries undermine efforts to improve life expectancy, educate populations, expand infrastructure, and build economies. The HIV/AIDS epidemic has already set back development in some African countries by three decades. The fact is, even modest progress on health could lead to significant economic advances. Every year of increase in the national average life expectancy is significantly correlated with a 1% increase in GDP 15 years later. Better delivery of existing vaccines and the development of new ones would increase life expectancy and improve childhood development and labor productivity.
Time is running out. Failure to tackle the problem of under-investment in priority vaccines and therapeutic drugs will come at great social and economic cost. Malaria may soon become untreatable as a consequence of pervasive resistance to existing drugs. The number of cases of multi-drug resistant tuberculosis is growing alarmingly. The AIDS pandemic will soon cause the same level of devastation in Asia as it already has in Africa. A growing number of drug-resistant microbes are leaving health care workers with few tools to fight established, formidable and common bacteria.
Drug and vaccine donation programs of pharmaceutical companies have made important contributions to public health in less developed countries and have provided lessons for strengthening delivery systems. But donations of drugs and vaccines are not a solution to the fundamental problem of under-investment in research and delivery of needed health care technology. Donations should only be one part of a comprehensive package of measures.
Achieving more equitable distribution of health technology is well within the reach of the international community. It has been estimated that delivery of approved vaccines to children in the world would cost $3 billion to $5 billion annually. Developing a new vaccine for one of the major infectious disease killers would cost $500 million to $1 billion. According to the Global Alliance for Vaccines and Immunizations, "even if the cost of a routine immunization program incorporating new vaccines were US $2 billion per year to reach out to all children in low income countries, that would still represent only about US $0.35 for every person on earth and less than 0.1% of what the world spends on health."
A Challenge to Governments and Industry Around the World
Participants at the Global Health Forum challenged leaders in government, industry, international organizations, and affected communities to harness the potential of vaccines and therapeutics to fight disease and save millions of lives.
Neither the public sector nor the private sector can achieve this vision alone. They must work in partnership, recognizing their particular strengths. The private sector has a legitimate expectation to recoup its investments and make a reasonable profit, and a responsibility to work with the public sector to address health problems of global concern. The public sector has a responsibility to provide the funding and incentives to ensure the development and more equitable distribution of lifesaving vaccines and drugs.
A global approach must be taken. There are no "first world solutions" to "third world problems." OECD countries and LMICs have a shared responsibility to ensure improved development and delivery of health care technology. LMICs must be at the table as international initiatives are planned.
The current lack of patent protection in several countries is an important problem that requires leadership and consensus. In part, concerns over the loss of intellectual property rights are responsible for industry reluctance to invest in products that would chiefly be used in the developingworld. New treaties promise to standardize patent law and provide industry with assurances that its products will not be stolen. But these agreements are not sufficient for meeting the challenges of neglected diseases and are only sustainable if there is a system in place to assure access of lower income country populations to needed drugs and vaccines. Patents confer property rights. With those rights also come responsibilities.
Unique Opportunity for Progress
As we enter the "age of biology," there is a growing opportunity to prevent and treat infectious diseases that take the lives of millions of people annually. Rapidly expanding scientific capacity means policy changes can leverage significant results for international public health. Growing international awareness of the personal, social and economic costs of disease in LMICs, and of the rapid global spread of new and more virulent infections, is leading to increased public support for efforts to expand the fight against diseases of less developed countries.
International economics has changed as well as science. Countries in the world can no longer be easily divided between rich and poor, developed and developing. Middle income countries are establishing markets that can demand neglected vaccines and drugs and these countries are developing pharmaceutical research and development capabilities that are increasingly directed at priority local diseases. The pharmaceutical and biotech industries are changing too, with much innovation in the biotech sector and big pharma increasingly relying on the biotechs for research and innovation.
Very significantly, there is also a building political momentum. A short list of current national and international efforts to accelerate development and delivery of priority drugs and vaccines for poorer countries includes:
- Presidential leadership in the United States. The US President has made several promising proposals to fight disease in poorer countries and improve incentives for priority research and development. His fiscal year 2001 budget proposal includes a $50 million US contribution to the Global Alliance for Vaccines and Immunization (GAVI), increased funding from the World Bank and other multilateral development banks for low interest loans to expand immunization, a significant increase in the National Institutes of Health funding for basic research on diseases affecting developing nations, and a tax credit for sales of vaccines for malaria, TB and HIV, up to a value of $1 billion. The President has also supported $200 million in fiscal year 2001 funding for the LIFE Initiative, which helps sub-Saharan African countries and India provide HIV/AIDS prevention and treatment services, including some therapeutic drugs.
- Proposals in the US Congress. Several members of Congress have also proposed promising legislation. Senator John Kerry has recently introduced a comprehensive package of incentives for R&D on vaccines for malaria, TB, and HIV/AIDS. Senator Kerry and Rep. Nancy Pelosi have proposed a tax credit on R&D costs for vaccines targeting these three major infectious disease killers. Rep. Barbara Lee has introduced the AIDS Marshall Plan Fund for Africa Act that would provide funds for HIV/AIDS-related research, prevention, and treatment activities. Rep. James Leach and Senator John Kerry have introduced the World Bank Trust Fund Act to pay for AIDS education, prevention, treatment and vaccine development efforts targeting the world’s poorest countries. Senator Barbara Boxer has proposed the Global AIDS Prevention Act, which would authorize up to $2 billion through 2005 to fight AIDS abroad, particularly in Africa. Rep. Joseph Crowley will introduce legislation to increase the US investment in international health priorities.
- Japanese consortium on malaria.Twelve Japanese pharmaceutical companies working with the World Health Organization and Japan’s Ministry of Health and Welfare have launched a collaboration to identify potential drugs against malaria.
- African discussion of joint efforts. Countries in Southern Africa are studying how bulk purchasing and harmonization of product licensing in the region can accelerate and expand product delivery.
- New incentives in Europe. The European Union has recently passed Orphan Drug legislation. Modifications of this legislation in Europe and other countries could provide incentives for research on priority products for LMICs. Political leaders in France, the Netherlands and the United Kingdom (for example) have shown commitment to the global battle against HIV and other major killers.
- Expected increased focus from industrialized nations. The approaching meeting of the G8 in Japan is expected to include selected world health issues on its agenda, including HIV/AIDS and malaria.
- World Bank IDA fund: The World Bank is seriously considering creation of a $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, and other poverty-oriented, basic health measures.
- WHO/IFPMA Round Table: The World Health Organization and leaders of the global research-based pharmaceutical industry have formed a "Round Table" for discussions focused on improving medical treatment, including access to needed medicines and global health care delivery. At a January, 2000 Round Table meeting the group agreed on several points, including the need for both "push" and "pull" incentives (described below); the usefulness of a modified orphan drug act for neglected diseases (including tax breaks for research, market exclusivity guarantees, and a tax credit on product delivery); the importance of the Medicines for Malaria Venture; the need for incentives for both medicines and vaccines; and creation of a single fund for product purchase in order build credibility and provide both short and long term incentives for product development.
- WHO Commission on Macro-Economics and Health: The World Health Organization Commission on Macroeconomics and Health Working Group II brings together participants from industry, the World Bank, WHO, and research institutions to discuss the economics of incentives for new vaccine and product development. The group has developed a workplan and recognizes that advances in health are necessary to drive economic growth in the developing world. Working Group II has agreed on the need to focus on neglected products needing attention including vaccines for rotavirus, pneumonia, malaria, TB, and HIV/AIDS. Several incentives to generate new private sector commitment were identified, and include better epidemiological data, disease burden and market analysis, basic research and discovery efforts, a "sliding" fund for product procurement, purchase pre-commitments, and loans and credits.
- Research capacity building. The WHO-UNAIDS HIV Vaccine Advisory Committee is launching an initiative to strengthen research capacity in developing countries to work on HIV vaccines.
- Public Private Partnerships (PPPs). Several partnerships of public and private sector players have been formed and show promise for spurring research on neglected products. The Global Forum for Health Research in Geneva has begun a project to identify all significant PPPs and to map their origins, participants, aims, governance structures, degree of success, constraints, and difficulties. The goals of this work are to facilitate the exchange of information among potential partners and promote the development of new partnerships.
- For each priority disease, a unique set of incentives is needed to combat different sets of problems.
- The distribution of cost and risk across the research and development processes differ for vaccines and medicines.
- Small biotech companies and large pharmaceuticals must both be involved in the development of new therapies, but different types of incentives will motivate them.
- Increased funding for research on neglected diseases. Large government funded research institutions, such as the US National Institutes of Health, play a vital role by financing upstream research. They can focus more of their efforts on diseases of poorer countries. Governments can also provide support for clinical trials of priority vaccines and drugs. Middle income countries have growing research capability and industrialized countries could help foster this expertise through direct funding and technology transfer.
- Tax credits on research and development. By providing credits on research and development, the cost of R&D is lowered. In one proposal, tax credits could also be passed on to equity investors in smaller companies, helping these companies raise capital for priority (but high investment risk) research.
- Social venture capital funds. These arrangements allow the public sector, and perhaps interested private investors, to buy equity positions in research on priority products. The investments provide funding to companies to do needed research, and investors retain certain rights, including ability to influence research priorities and product pricing and delivery agreements.
- Harmonization of licensing processes. The multiplicity of product licensing procedures in countries creates an obstacle for accelerated delivery of products. More uniform licensing processes and standards would give industry a clearer picture of the kinds of products that are likely to win approval. The first step in this process would be the standardization of application requirements and administrative procedures.
- Expedited approval of drug and vaccine products.Commitments to quicken the drug approval process for priority drugs will accelerate delivery of these products and give industry confidence that new products will be used. Delays in approval of drugs and vaccines are of particular concern to industry given the time-limited value of intellectual property rights.
- Purchase funds. Drug and vaccine purchase funds provide a credible market for products and thus incentivise R&D and secure delivery of products once licensed. Purchase funds are among the top priority for industry as they provide tangible ability to purchase and deliver their products. As noted above, the WHO/IFPMA round table has recommended creation of a single fund so that products now available can be delivered, as well as those in the early research stages. Other efforts are focused on creating funds for single products, such as HIV vaccines. Purchase funds present special political challenges. Governments may find it difficult to appropriate monies to a purchase fund in advance of a product to purchase. International organizations, using developed country and foundation funding, may be best suited to creating credible purchase funds. An alternative to purchase funds are requisitions or promises to buy particular products. Under these schemes, governments would commit to purchase products meeting certain specifications, but would not be required to appropriate funds until the product was licensed. It is unclear whether such a plan would be sufficiently credible to industry.
- Tax credit on sales.US President Clinton and Senator John Kerry have proposed legislative packages that include tax credits on the sale of vaccines for malaria, TB or HIV/AIDS. Companies would receive a 100% credit on the value of their sale to qualified organizations. Tax credits on sales would increase company revenue from sale of a product destined for low-income countries, thus making these markets more attractive. The credit proposal is politically palatable because it does not require appropriations in the current year. These credits do not assure that a market exists, however. The GAVI, World Bank, and purchase fund proposals work towards filling this demand gap. Participants at the Forum also cautioned that these credits should be designed so that they do not create an incentive to inflate the unit price of products for developing countries. Some Forum participants stressed that a tax credit on salesshould also apply to currently available, or soon to be available, priority vaccines and drugs. The credit proposed by Clinton would have a $1 billion cap, so expanding the number of products eligible for the credit could have the effect of substantially reducing credits available for the eventual sale of malaria, TB and HIV/AIDS vaccines.
- Wider delivery of currently available vaccines. It typically takes ten years or more for a vaccine to reach populations in poorer countries after it has been licensed for use in the OECD countries. Wider purchasing and delivery of existing or soon to be available vaccines would give credibility to other multi-lateral efforts in the eyes of industry, and would have an immediate impact on the public health of communities around the world. (Haemophilus influenzae type b (Hib) and hepatitis B vaccines are already licensed but not yet widely available in many countries. In the near future, pneumococcus, rotavirus, dengue, and Japanese B encephilitis vaccines will be ready for use.) The proposal now being considered by the World Bank to create a $1 billion "replenishing fund" for vaccine purchase, delivery and infrastructure development would help improve product delivery. Forum participants noted that this plan alone is not sufficient, particularly since there are substantial unused IDA funds already available for these purposes and IDA funds would not benefit the poorer communities in middle-income countries such as China and Indonesia.
- The Global Alliance for Vaccines and Immunization (GAVI), through the Global Children’s Vaccine Fund, funded by the Bill and Melinda Gates Foundation and others, is a collaborative effort to purchase and deliver vaccines and encourage development of priority vaccines.
- The International AIDS Vaccine Initiative and the South African AIDS Vaccine Initiative, promote development and accessibility of HIV vaccines useful in the developing world
- The Medicines for Malaria Venture is stimulating research and development on new drugs for malaria
- The International Trachoma Initiative fosters expanded use of antibiotics and other interventions to fight this major cause of blindness.
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Multiple Interventions – and Structural Change – Are NeededInterventions are needed all along the product development and delivery pipeline. No single model or incentive can solve the problem of under-investment in diseases of the poor. Many tools will be needed – and some of these tools will need to be individually targeted at specific diseases. The gaps in research and development efforts must be identified for each of the most needed products, and public and private sectors must work in concert to fill these gaps. Simply increasing foreign aid budgets will not rectify the structural problems with under- investment in diseases of less developed countries.
In planning policy incentives and interventions, it is important to take several factors into consideration:
- For each priority disease, a unique set of incentives is needed to combat different sets of problems.
- The distribution of cost and risk across the research and development processes differ for vaccines and medicines.
- Small biotech companies and large pharmaceuticals must both be involved in the development of new therapies, but different types of incentives will motivate them.
- Increased funding for research on neglected diseases. Large government funded research institutions, such as the US National Institutes of Health, play a vital role by financing upstream research. They can focus more of their efforts on diseases of poorer countries. Governments can also provide support for clinical trials of priority vaccines and drugs. Middle income countries have growing research capability and industrialized countries could help foster this expertise through direct funding and technology transfer.
- Tax credits on research and development. By providing credits on research and development, the cost of R&D is lowered. In one proposal, tax credits could also be passed on to equity investors in smaller companies, helping these companies raise capital for priority (but high investment risk) research.
- Social venture capital funds. These arrangements allow the public sector, and perhaps interested private investors, to buy equity positions in research on priority products. The investments provide funding to companies to do needed research, and investors retain certain rights, including ability to influence research priorities and product pricing and delivery agreements.
- Harmonization of licensing processes. The multiplicity of product licensing procedures in countries creates an obstacle for accelerated delivery of products. More uniform licensing processes and standards would give industry a clearer picture of the kinds of products that are likely to win approval. The first step in this process would be the standardization of application requirements and administrative procedures.
- Expedited approval of drug and vaccine products.Commitments to quicken the drug approval process for priority drugs will accelerate delivery of these products and give industry confidence that new products will be used. Delays in approval of drugs and vaccines are of particular concern to industry given the time-limited value of intellectual property rights.
- Purchase funds. Drug and vaccine purchase funds provide a credible market for products and thus incentivise R&D and secure delivery of products once licensed. Purchase funds are among the top priority for industry as they provide tangible ability to purchase and deliver their products. As noted above, the WHO/IFPMA round table has recommended creation of a single fund so that products now available can be delivered, as well as those in the early research stages. Other efforts are focused on creating funds for single products, such as HIV vaccines. Purchase funds present special political challenges. Governments may find it difficult to appropriate monies to a purchase fund in advance of a product to purchase. International organizations, using developed country and foundation funding, may be best suited to creating credible purchase funds. An alternative to purchase funds are requisitions or promises to buy particular products. Under these schemes, governments would commit to purchase products meeting certain specifications, but would not be required to appropriate funds until the product was licensed. It is unclear whether such a plan would be sufficiently credible to industry.
- Tax credit on sales.US President Clinton and Senator John Kerry have proposed legislative packages that include tax credits on the sale of vaccines for malaria, TB or HIV/AIDS. Companies would receive a 100% credit on the value of their sale to qualified organizations. Tax credits on sales would increase company revenue from sale of a product destined for low-income countries, thus making these markets more attractive. The credit proposal is politically palatable because it does not require appropriations in the current year. These credits do not assure that a market exists, however. The GAVI, World Bank, and purchase fund proposals work towards filling this demand gap. Participants at the Forum also cautioned that these credits should be designed so that they do not create an incentive to inflate the unit price of products for developing countries. Some Forum participants stressed that a tax credit on salesshould also apply to currently available, or soon to be available, priority vaccines and drugs. The credit proposed by Clinton would have a $1 billion cap, so expanding the number of products eligible for the credit could have the effect of substantially reducing credits available for the eventual sale of malaria, TB and HIV/AIDS vaccines.
- Wider delivery of currently available vaccines. It typically takes ten years or more for a vaccine to reach populations in poorer countries after it has been licensed for use in the OECD countries. Wider purchasing and delivery of existing or soon to be available vaccines would give credibility to other multi-lateral efforts in the eyes of industry, and would have an immediate impact on the public health of communities around the world. (Haemophilus influenzae type b (Hib) and hepatitis B vaccines are already licensed but not yet widely available in many countries. In the near future, pneumococcus, rotavirus, dengue, and Japanese B encephilitis vaccines will be ready for use.) The proposal now being considered by the World Bank to create a $1 billion "replenishing fund" for vaccine purchase, delivery and infrastructure development would help improve product delivery. Forum participants noted that this plan alone is not sufficient, particularly since there are substantial unused IDA funds already available for these purposes and IDA funds would not benefit the poorer communities in middle-income countries such as China and Indonesia.
- The Global Alliance for Vaccines and Immunization (GAVI), through the Global Children’s Vaccine Fund, funded by the Bill and Melinda Gates Foundation and others, is a collaborative effort to purchase and deliver vaccines and encourage development of priority vaccines.
- The International AIDS Vaccine Initiative and the South African AIDS Vaccine Initiative, promote development and accessibility of HIV vaccines useful in the developing world
- The Medicines for Malaria Venture is stimulating research and development on new drugs for malaria
- The International Trachoma Initiative fosters expanded use of antibiotics and other interventions to fight this major cause of blindness.
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Four Primary ToolsA combination of "push," and "pull" interventions, PPPs, and development of functioning markets is needed to address under-investment in priority vaccines and drugs. The key challenge is to identify a combination of incentives and programs that governments will enact and to which industry will respond.
1. Push Interventions
Push interventions reduce the costs or risks of research and development. Such interventions are particularly important to biotech companies that are generally less well capitalized, more likely to rely on venture capital for financing, and more motivated to do innovative product development.
Priorities for push interventions identified by Forum participants include:
- Increased funding for research on neglected diseases. Large government funded research institutions, such as the US National Institutes of Health, play a vital role by financing upstream research. They can focus more of their efforts on diseases of poorer countries. Governments can also provide support for clinical trials of priority vaccines and drugs. Middle income countries have growing research capability and industrialized countries could help foster this expertise through direct funding and technology transfer.
- Tax credits on research and development. By providing credits on research and development, the cost of R&D is lowered. In one proposal, tax credits could also be passed on to equity investors in smaller companies, helping these companies raise capital for priority (but high investment risk) research.
- Social venture capital funds. These arrangements allow the public sector, and perhaps interested private investors, to buy equity positions in research on priority products. The investments provide funding to companies to do needed research, and investors retain certain rights, including ability to influence research priorities and product pricing and delivery agreements.
- Harmonization of licensing processes. The multiplicity of product licensing procedures in countries creates an obstacle for accelerated delivery of products. More uniform licensing processes and standards would give industry a clearer picture of the kinds of products that are likely to win approval. The first step in this process would be the standardization of application requirements and administrative procedures.
- Expedited approval of drug and vaccine products.Commitments to quicken the drug approval process for priority drugs will accelerate delivery of these products and give industry confidence that new products will be used. Delays in approval of drugs and vaccines are of particular concern to industry given the time-limited value of intellectual property rights.
- Purchase funds. Drug and vaccine purchase funds provide a credible market for products and thus incentivise R&D and secure delivery of products once licensed. Purchase funds are among the top priority for industry as they provide tangible ability to purchase and deliver their products. As noted above, the WHO/IFPMA round table has recommended creation of a single fund so that products now available can be delivered, as well as those in the early research stages. Other efforts are focused on creating funds for single products, such as HIV vaccines. Purchase funds present special political challenges. Governments may find it difficult to appropriate monies to a purchase fund in advance of a product to purchase. International organizations, using developed country and foundation funding, may be best suited to creating credible purchase funds. An alternative to purchase funds are requisitions or promises to buy particular products. Under these schemes, governments would commit to purchase products meeting certain specifications, but would not be required to appropriate funds until the product was licensed. It is unclear whether such a plan would be sufficiently credible to industry.
- Tax credit on sales.US President Clinton and Senator John Kerry have proposed legislative packages that include tax credits on the sale of vaccines for malaria, TB or HIV/AIDS. Companies would receive a 100% credit on the value of their sale to qualified organizations. Tax credits on sales would increase company revenue from sale of a product destined for low-income countries, thus making these markets more attractive. The credit proposal is politically palatable because it does not require appropriations in the current year. These credits do not assure that a market exists, however. The GAVI, World Bank, and purchase fund proposals work towards filling this demand gap. Participants at the Forum also cautioned that these credits should be designed so that they do not create an incentive to inflate the unit price of products for developing countries. Some Forum participants stressed that a tax credit on salesshould also apply to currently available, or soon to be available, priority vaccines and drugs. The credit proposed by Clinton would have a $1 billion cap, so expanding the number of products eligible for the credit could have the effect of substantially reducing credits available for the eventual sale of malaria, TB and HIV/AIDS vaccines.
- Wider delivery of currently available vaccines. It typically takes ten years or more for a vaccine to reach populations in poorer countries after it has been licensed for use in the OECD countries. Wider purchasing and delivery of existing or soon to be available vaccines would give credibility to other multi-lateral efforts in the eyes of industry, and would have an immediate impact on the public health of communities around the world. (Haemophilus influenzae type b (Hib) and hepatitis B vaccines are already licensed but not yet widely available in many countries. In the near future, pneumococcus, rotavirus, dengue, and Japanese B encephilitis vaccines will be ready for use.) The proposal now being considered by the World Bank to create a $1 billion "replenishing fund" for vaccine purchase, delivery and infrastructure development would help improve product delivery. Forum participants noted that this plan alone is not sufficient, particularly since there are substantial unused IDA funds already available for these purposes and IDA funds would not benefit the poorer communities in middle-income countries such as China and Indonesia.
- The Global Alliance for Vaccines and Immunization (GAVI), through the Global Children’s Vaccine Fund, funded by the Bill and Melinda Gates Foundation and others, is a collaborative effort to purchase and deliver vaccines and encourage development of priority vaccines.
- The International AIDS Vaccine Initiative and the South African AIDS Vaccine Initiative, promote development and accessibility of HIV vaccines useful in the developing world
- The Medicines for Malaria Venture is stimulating research and development on new drugs for malaria
- The International Trachoma Initiative fosters expanded use of antibiotics and other interventions to fight this major cause of blindness.
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
2. Pull Interventions"Pull" interventions provide support on the product delivery side, guarantee markets for products, or subsidize sales. These interventions are particularly important for larger pharmaceuticals, but may also incentivise activity at biotechs.
Priorities for pull interventions identified by Forum participants include:
- Purchase funds. Drug and vaccine purchase funds provide a credible market for products and thus incentivise R&D and secure delivery of products once licensed. Purchase funds are among the top priority for industry as they provide tangible ability to purchase and deliver their products. As noted above, the WHO/IFPMA round table has recommended creation of a single fund so that products now available can be delivered, as well as those in the early research stages. Other efforts are focused on creating funds for single products, such as HIV vaccines. Purchase funds present special political challenges. Governments may find it difficult to appropriate monies to a purchase fund in advance of a product to purchase. International organizations, using developed country and foundation funding, may be best suited to creating credible purchase funds. An alternative to purchase funds are requisitions or promises to buy particular products. Under these schemes, governments would commit to purchase products meeting certain specifications, but would not be required to appropriate funds until the product was licensed. It is unclear whether such a plan would be sufficiently credible to industry.
- Tax credit on sales.US President Clinton and Senator John Kerry have proposed legislative packages that include tax credits on the sale of vaccines for malaria, TB or HIV/AIDS. Companies would receive a 100% credit on the value of their sale to qualified organizations. Tax credits on sales would increase company revenue from sale of a product destined for low-income countries, thus making these markets more attractive. The credit proposal is politically palatable because it does not require appropriations in the current year. These credits do not assure that a market exists, however. The GAVI, World Bank, and purchase fund proposals work towards filling this demand gap. Participants at the Forum also cautioned that these credits should be designed so that they do not create an incentive to inflate the unit price of products for developing countries. Some Forum participants stressed that a tax credit on salesshould also apply to currently available, or soon to be available, priority vaccines and drugs. The credit proposed by Clinton would have a $1 billion cap, so expanding the number of products eligible for the credit could have the effect of substantially reducing credits available for the eventual sale of malaria, TB and HIV/AIDS vaccines.
- Wider delivery of currently available vaccines. It typically takes ten years or more for a vaccine to reach populations in poorer countries after it has been licensed for use in the OECD countries. Wider purchasing and delivery of existing or soon to be available vaccines would give credibility to other multi-lateral efforts in the eyes of industry, and would have an immediate impact on the public health of communities around the world. (Haemophilus influenzae type b (Hib) and hepatitis B vaccines are already licensed but not yet widely available in many countries. In the near future, pneumococcus, rotavirus, dengue, and Japanese B encephilitis vaccines will be ready for use.) The proposal now being considered by the World Bank to create a $1 billion "replenishing fund" for vaccine purchase, delivery and infrastructure development would help improve product delivery. Forum participants noted that this plan alone is not sufficient, particularly since there are substantial unused IDA funds already available for these purposes and IDA funds would not benefit the poorer communities in middle-income countries such as China and Indonesia.
- The Global Alliance for Vaccines and Immunization (GAVI), through the Global Children’s Vaccine Fund, funded by the Bill and Melinda Gates Foundation and others, is a collaborative effort to purchase and deliver vaccines and encourage development of priority vaccines.
- The International AIDS Vaccine Initiative and the South African AIDS Vaccine Initiative, promote development and accessibility of HIV vaccines useful in the developing world
- The Medicines for Malaria Venture is stimulating research and development on new drugs for malaria
- The International Trachoma Initiative fosters expanded use of antibiotics and other interventions to fight this major cause of blindness.
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
3. Public Private Partnerships (PPPs)PPPs can create "win-win" situations for the public and private sectors by combining resources from each to develop or deliver needed products. PPPs generally attempt to guarantee some intellectual property or other rights for the non-profit sponsor, and allow private sector partners to seek a return on their investment. Examples of currently operating PPPs include:
- The Global Alliance for Vaccines and Immunization (GAVI), through the Global Children’s Vaccine Fund, funded by the Bill and Melinda Gates Foundation and others, is a collaborative effort to purchase and deliver vaccines and encourage development of priority vaccines.
- The International AIDS Vaccine Initiative and the South African AIDS Vaccine Initiative, promote development and accessibility of HIV vaccines useful in the developing world
- The Medicines for Malaria Venture is stimulating research and development on new drugs for malaria
- The International Trachoma Initiative fosters expanded use of antibiotics and other interventions to fight this major cause of blindness.
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Commercial pharmaceutical companies have also joined with the public sector internationally and at the country level to combat some of the major diseases of the poor, such as onchocerciasis (River Blindness), leprosy, trachoma, drug-resistant malaria, and lymphatic filariasis (elephantiasis) through donations of drugs and by supporting the development of delivery systems.Forum participants discussed several issues relevant to design and management of PPPs. It was agreed that these partnerships work best when there is a common and highly focussed goal among participants, clearly defined leadership, accountability, trust between partners, and common management of day to day operations.
Forum participants felt these partnerships present political challenges and are not the answer to all under-investment issues. Participants concluded that creation of PPPs should remain on a disease-by-disease or product-by-product basis and that an overarching or "umbrella" PPP organization is not appropriate.
LMICs can play a role in PPPs by helping to select priority products (and the strains to be targeted by a product), and collaborating on ethical, scientific, regulatory and epidemiological issues, as well as clinical trials. Several Forum participants emphasized the importance of involving members of civil society in the design and management of PPP research and clinical trials in LMICs.
4. Creating Functioning Markets
Participants at the Forum noted that if both public and private demand in large low income and middle income countries was adequately expressed, a substantial new market incentive would be created. For example, if the governments of China, India and Indonesia took perfectly rational and well-informed decisions about public purchase of high priority drugs and vaccines for the poorer segments of their populations (in total at least 1.5 billion people), a substantial demand would be created. Similarly, the large and growing middle class in these countries could exert a substantial private demand if new products were available and their benefits widely known. In addition, in many middle income countries a sizable proportion of the population is covered by social insurance or private insurance. The policies of the insurers, and the benefit packages purchased by employers, have a large impact on demand for children’s vaccines and other products. Policy reform, better information, and improved performance of health care systems are necessary before these markets will become globally significant and play a major role in industry investment decisions.
Areas for Further Discussion
Participants identified a number of specific areas that require further discussion:
- The appropriate balance of "push" and "pull" mechanisms for various products, and the detailed design of these measures
- Expansion of the public sector capability in the area of product development and delivery
- Focusing capacity development efforts and policy reforms on a few middle income and large low-income countries in order to strengthen their role in R & D and create market demand that can drive development of products needed throughout the developing world
- Specific policies that will foster functioning markets and better delivery systems in low-income countries
- The relative usefulness of PPPs as compared to more "hands off" interventions, such as R&D and delivery incentives
- The credibility to industry of pre-commitments to purchase vaccines if governments are not willing to allocate funds before products are ready for purchase.
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Recommendations1. Make Markets for Orphan Drugs and Vaccines a Top International Priority
- Accelerated development and delivery of vaccines and drugs should be a priority issue at the upcoming G8 meeting in Japan and a principle goal of international health and development organizations.
- Forum participants challenged public and private sector leaders to build on existing international momentum to address under-investment in diseases of the poor. They encouraged more involvement from governments in the European Union, Japan and selected middle-income countries.
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
2. Support Existing ProposalsForum participants were united in their belief that several specific proposals hold great promise and deserve widespread support.
Promising proposals include:
- Clinton Administration package of funding, a tax credit, and other incentives to deliver existing drugs and vaccines and spur development of new vaccines
- World Bank consideration of $1 billion International Development Association (IDA) replenishing credit for purchase of drugs and vaccines in less developed countries, infrastructure development, and other poverty-oriented health measures
- Other legislative proposals now before the US Congress, including recently introduced legislation from Senator John Kerry, that would provide funding and incentives for vaccine research and development
- GAVI, IAVI, MMV and other partnerships aimed at specific products.
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Forum participants also emphasized that no one of these proposals will solve the problem on their own. As noted in the "push" and "pull" sections above, Forum participants raised several questions about the specifics of various proposals. As each effort is advanced, it should be analyzed and refined with a view to ensuring its political and economic feasibility and optimizing its impact on R & D investment in the private sector.Also needed is an assessment of the gaps in existing proposals to help future discussions devise more comprehensive plans. Needed incentives and interventions for specific diseases and products should be developed.
3. Support Public Private Partnerships (PPPs)
Several PPPs have already established their ability to bring public and private resources together on drug and vaccine development, and existing partnerships deserve increased international support. Public and private sector advocates should look for new opportunities to build successful partnerships to develop and deliver products.
4. Build Capacity in Developing Countries
- The international community should invest in strengthening research, product development, health care infrastructure, and regulatory capacity in LMICs.
- Reinforcement of the vaccine and drug delivery system and absorption capacity in LMICs is needed. All countries should assess and improve the efficiency of their systems for drug and vaccine distribution with a view to using resources most effectively and enhancing demand.
- The current and potential contribution of pharmaceutical and biotechnology companies in middle-income and large low-income countries should be assessed and their engagement on locally endemic diseases encouraged. Brazil, China, India, Indonesia, Thailand and South Africa were regarded as especially important in this regard.
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
5. Establish Indicators of PerformanceSuch a comprehensive and bold set of actions must be carefully monitored. A strong independent group is needed to measure the effectiveness of each of the proposed interventions. Criteria will focus on the proximal stimulation of product development and delivery as well as distal measures of health status improvement and economic benefit.
Ongoing Commitment of Forum Participants
- Participants of Global Health Forum I are committed to continue working towards increased funding, policy changes and legislation that can accelerate the development and delivery of priority drugs and vaccines. Participants urge other key players, including government leaders, international organizations, foundations, and affected communities to continue their efforts towards this goal.
- The recommendations of this meeting of the Global Health Forum will be carried forward by the WHO Commission on Macroeconomics and Health, the IFPMA/WHO Roundtable, the PPP project of the Global Forum for Health Research, and the Institute for Global Health of the University of California. The precise division of roles and responsibilities will be clarified in the near future.
Appendix I:Participant List
Creating Global Markets for Orphan Drugs & Vaccines:
A Challenge for Public/Private Partnership
Quail Lodge, Carmel Valley, California
February 18 - 21, 2000
Invited Participants
Dr. Dyna Arhin-Tenkorang
Lecturer in Health Economics and Finance
Health Policy Unit
London School of Hygiene and Tropical Medicine
Keppel Street
London WC1E 7HT
United Kingdom
Tel: +44 171 927 2176
dyarhin{at}yahoo.comDr. Luis Barreto
Vice President, Public Policy Canada
Director, International Public Health Affairs
Aventis Pasteur
1755 Steeles Avenue West
Toronto, Ontario
M2R 3T4
Canada
Tel: +1 (416) 667-2738
Fax: +1 (416) 667-2865
Luis.Barreto{at}aventis.comDr. Seth Berkley
President
International AIDS Vaccine Initiative
810 Seventh Avenue
New York, NY 10019-5818
USA
Tel: +1 (212) 655-0201
Fax: +1 (212) 843-0480
Sberkeley{at}iavi.orgDr. Kenneth W. Bernard
Special Advisor, International Health Affairs
National Security Council
Old Executive Office Building
17th Street and Pennsylvania Avenue, NW
Washington, DC 20504
USA
Tel: +1 (202) 456-9394
Fax: +1 (202) 456-9390
Kbernard{at}NSC.eop.govDr. Sunil Chacko
Senior Pharma/Biotech Industry Analyst
New Info Solutions Llc.
1642 Besley Road
Vienna, VA 22182
USA
Tel: +1 (703) 585-3234
Fax: +1 (703) 255-3234
schacko{at}erols.comDr. Albert Y. Chang
Managing Director (Retired)
Hong Kong Institute of Biotechnology, Ltd.
380 Urbano Drive
San Francisco, CA 94127
USA
Tel: +1 (415) 337-2176
Fax: +1 (415) 337-2075
alberty_chang{at}yahoo.comDr. Joseph Cook
Executive Director
International Trachoma Initiative
6 East 45th Street
New York, NY 10017-2414
USA
Tel: +1 (212) 490-6460
Fax: +1 (212) 490-6461
jcook{at}trachoma.orgProfessor Dean Jamison
Director, Economic Advisory Service
World Health Organization
Room 3074
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 3922
Fax: +41 22 791 3111
Jamisond{at}who.ch
Alternate Tel (UCLA): +1 (310) 206-0223
djamison{at}isop.ucla.eduMr. Jim Jones
Office of Senator John Kerry
United States Senate
304 Russell Building
Washington, DC 20510-2102
USA
Tel: +1 202-224-2742
Fax: +1 202-224-8525
Jim.jones{at}Kerry.senate.govDr. Hannah E. Kettler
Office of Health Economics
12 Whitehall
London SW1 A2DY
UK
Tel: +44 20 7930 9203 ext. 1464
Fax: +44 20 7747 1419
hkettler{at}abpi.org.ukDr. Gerald Keusch
Director, Fogarty International Center
National Institutes of Health
Building 31, Room B2C02
31 Center Drive
Bethesda, MD 20892
USA
Tel: +1 (301) 496-1415
Fax: +1 (301) 402-2173
keuschg{at}nih.govProfessor Michael Kremer
Harvard University
Department of Economics
Littauer Center 207
Cambridge, MA 02138
USA
Tel: +1 (617) 495-9145
Fax: +1 (617) 495-7730
mkremer{at}fas.harvard.eduMr. Sean P. Lance
Chairman and CEO
Chiron Corporation
4560 Horton Street
Emeryville, CA 94608-2916
USA
Tel: +1 (510) 655-3100
Fax: +1 (510) 655-9910
sean_lance{at}cc.chiron.comDr. Julian Lob-Levyt
Chief Advisor, Health & Population
Department for International Development
94 Victoria Street
London SW1E 5JL
UK
Tel: +44 171 917 0107
Fax: +44 171 917 0174
j-lob-levyt{at}dfid.gov.ukDr. Christopher Lovelace
Director, Health, Nutrition & Population
The World Bank
1818 H Street, NW
Room G 3021
Washington, DC 20433
USA
Tel: +1 (202) 458-5520
Fax: +1 (202) 522-3234
clovelace{at}worldbank.orgDr. Ian W. Marceau
U.S. Advisor to the Minister of State for Research & Technology
BPPT Building 2, 5th Floor
Jl MH Thamrin No. 8
Jakarta 10340
Indonesia
Tel: +62 21 391 2340
Fax: +62 21 316-9720
Usadvid{at}attglobal.net
marsupial{at}erols.comDr. Jacques-Francois Martin
Chairman and CEO
PARTEUROP S.A.
36, Quai Fulchiron
F-69005 Lyon
France
Tel: +33 4 78 42 63 71
Fax: +33 4 78 42 34 24
Parteurop{at}aol.comMr. Ryan McCormick
Office of Senator John Kerry
304 Russell Senate Office Building
Washington, DC 20510
USA
Tel: +1 (202) 224-2742 or 224-4030
Fax: +1 (202) 224-8525
Ryan_mccormick{at}kerry.senate.govDr. Rajiv Modi
Director
Cadila Pharmaceuticals, Ltd.
IRM House
C.G. Road, Navrangpura
Ahmedabad 380 009
India
Tel: +91 79 656 2615
Fax: +91 79 642 5741
rajivimodi{at}aol.comMr. Adrian Otten
Director, Intellectual Property Division
World Trade Organization
154 rue de Lausanne
1211 Geneva 21
Switzerland
Tel: +41 22 739 5115
Fax: +41 22 731 4206
adrian.otten{at}wto.orgDr. Ariel Pablos-Mendez
Rockefeller Foundation
420 Fifth Avenue
New York, NY 10018
USA
Tel: +1 (212) 852-8348
Fax: +1 (212) 852-8279
Ap39{at}columbia.edu
apablos-mendez{at}rockfound.orgMs. Stefani Pashman
White House Office of Management and Budget
Room 7001
725 17th Street, NW
Washington, DC 20503
Tel: +1 (202) 395-4929
Fax: +1 (202) 395-3910
Stefani_J._Pashman{at}omb.eop.govDr. Walter Prozesky
Coordinator, South African AIDS Vaccine Initiative
Medical Research Council
Box 19070
Tygerberg 7505
South Africa
Tel: +27 21-938-0211
Fax: +27 21-938-0201
walter.prozesky{at}mrc.ac.zaDr. Regina Rabinovich
Director, Malaria Vaccine Initiative
6290 Montrose Road
Rockville, MD
USA
Tel: +1 (301) 770-5377
Fax: +1 (301) 770-5322
rrabinovich{at}path-dc.orgDr. Robert Ridley
Director, Medicines for Malaria Venture
c/o World Health Organization
20, Avenue Appia
1211 Geneva 27
Switzerland
Tel: +41 22 791 3715
Fax: +41 22 791 4854
ridleyr{at}who.chDr. Jose Roesma
Vice-Chairman, BPPT
BPPT Building 2, 5th Floor
Jl MH Thamrin No. 8
Jakarta 10340
Indonesia
Tel: +62 21 316-9706
Fax: +62 21 316-9720
Usadvid{at}attglobal.netDr. Michael Scholtz
Executive Director
Health Technology and Pharmaceuticals
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 4798
Fax: +41 22 791 4889
Scholtzm{at}who.chMr. William Schuerch
Deputy Assistant Secretary for International Development, Debt and Environment
U.S. Department of the Treasury
1500 Pennsylvania Avenue, NW
Washington, DC 20220
USA
Tel: +1 202-622-5300
Fax: +1 202 622-2536
William.Schuerch{at}do.treas.govDr. Richard Smith
Editor, British Medical Journal
BMJ House
Tavistock Square
London WC1J 9JR
UK
Fax: +44 171 383 6418
Rsmith{at}bmj.comDr. Sally Stansfield
Program Officer
The Bill and Melinda Gates Foundation
1551 Eastlake Avenue East, Suite 100
Seattle, WA 98102
USA
Tel: +1 (206) 709-3100
Fax: +1 (206) 709-3180
sally{at}gatesfoundation.orgProfessor Joseph E. Stiglitz
Senior Vice President and Chief Economist
The World Bank
1818 H Street, NW Room MC4-315
Washington, DC 20433
USA
Tel: +1 (202) 473-3774
Fax: +1 (202) 522-1158
jstiglitz{at}worldbank.orgMr. Walter Vandersmissen
Director, Government Affairs
SmithKline Beecham Biologicals
Rue de l’Institut 89
1330 Rixensart
Belgium
Tel: +32 2 656 83 70
Fax: +32 2 656 81 45
walter.vandersmissen{at}sbbio.beDr. David Webber
Senior Public Policy Manager
GlaxoWellcome plc
Glaxo Wellcome House
Berkeley Avenue
Greenford
Middlesex UB6 ONN
UK
Tel: +44 (0) 208 966 8257
Fax: +44 (0) 208 966 5981
dw30539{at}glaxowellcome.co.ukDr. Humphrey Zokufa
Ministry of Health
Government of South Africa
Civitas Building
Room 2027
cor Andries and Struben Streets
Pretoria 0002
South Africa
Tel: +27 12 328 4773
Fax: +27 12 325 5526
Zokufa{at}hltrsa.pwv.gov.za
Secretariat
Ms. Ann Carollo-Taylor
Associate Director
Corporate and Foundation Relations, UCSF
44 Montgomery Street, Suite 2200
San Francisco, CA 94104
USA
Tel: +1 (415) 502-2404
Fax: +1 (415) 476-1590
acarollo{at}dismail.ucsf.eduMr. Christopher Collins
Consultant, Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 647-5585
Fax: +1 (415) 647-5027
ChrisCSF{at}aol.comMr. Louis J. Currat
Executive Secretary
Global Forum for Health Research
c/o World Health Organization
20, Avenue Appia
1211 Geneva 27
Switzerland
Tel: +41 22 791 4260
Fax: +41 22 791 4394
curratl{at}who.chDr. Richard Feachem
Director, Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 597-8200
Fax: +1 (415) 597-8299
rfeachem{at}psg.ucsf.eduMs. Marsha Mathews
Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 597-8208
Fax: +1 (415) 597-8299
Mmathews{at}psg.ucsf.eduDr. John Peabody
Deputy Director, Health Policy
Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 597-8202
Fax: +1 (415) 597-8299
Jpeabody{at}psg.ucsf.eduMs. Suzanne Scheele
Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 597-8210
Fax: +1 (415) 597-8299
Sscheele{at}psg.ucsf.eduMs. Elizabeth Stoller
Deputy Director, Administration
Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 597-8203
Fax: +1 (415) 597-8299
estoller{at}psg.ucsf.eduDr. Julia Walsh
Acting Head, Vaccinology & Immunization
Institute for Global Health
74 New Montgomery Street, Suite 508
San Francisco, CA 94105
USA
Tel: +1 (415) 597-8200
Fax: +1 (415) 597-8299
jwalsh{at}socrates.berkeley.eduDr. Roy Widdus
World Health Organization
20, Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 4369 (or +41 22 791 4791)
Fax: +41 22 791 3111
Widdusr{at}who.ch
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