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September 19, 2000 Meeting Minutes

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service
National Institutes of Health
John E. Fogarty International Center
for Advanced Study in the Health Sciences

Minutes of the Advisory Board
Forty-sixth Meeting

 

Table of Contents

Attendance
1. Call to Order
2. Consideration of Minutes of Previous Meeting
3. Review of Requirements for Confidentiality and Conflict of Interest Procedures
4. Future Meeting Dates
5. Report of the Director
6. Update on International Activities at NIH
7. Intellectual Property Rights: The State Department Role
8. IPR and Global Public Good: The View From the Commission on Macroeconomics and Health
9. Federally Funded Health R&D: Implications for Access to New Products in the Developing World
10. Closed Portion of the Meeting
11. Review of Application
12. Adjournment

The meeting of the Advisory Board of the John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) was convened on Tuesday, September 19, 2000, at 8:40 a.m., in the Conference Room of the Lawton Chiles International House, National Institutes of Health (NIH), Bethesda, Maryland. The meeting was open to the public from 8:40 a.m. to 1:02 p.m., followed by the closed session for consideration of grant applications until adjournment at 3:00 p.m. Dr. Gerald T. Keusch presided as Chair.

Board Members Present:

Dr. Barry R. Bloom
Dr. Margaret A. Chesney
Dr. Thomas W. Cole, Jr.
Dr. Ezekiel J. Emanuel
Dr. Mary Claire King
Dr. Cora B. Marrett
Dr. Patricia Marshall
Mr. Thomas J. McAndrew
Dr. Donald O. Nutter
Dr. Theodore Reich
Dr. Catherine M. Wilfert

Board Members Absent:

Dr. Cutberto Garza
Dr. Steven E. Hyman

Members of the Public Present:

Ms. Stephanie Bursenos, former Deputy Director, FIC
Dr. Phyllis Freeman, University of Massachusetts, Boston
Dr. Jean O. Lanjouw, Yale University, New Haven, Connecticut
Ms. Pamela Moore, Capitol Publications
Ms. Georgia Persinos, Washington Insight
Dr. David Rothman, Columbia University, New York, New York
Dr. Jeffrey Sachs, Harvard University, Boston, Massachusetts
Dr. Philip E. Schambra, former Director, FIC
Ms. Angela Sharpe, Consortium of Social Science Associations, Washington, D.C.

Federal Employees Present:

Mr. Amar Bhat, FIC/NIH
Dr. Richard Krause, FIC/NIH
Dr. David E. Barmes, NIDCR/NIH
Ms. Judith Levin, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Jeanne McDermott, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Ms. Silvia Mandes, FIC/NIH
Ambassador Kenneth Brill, DOS
Dr. Kathleen Michels, FIC/NIH
Ms. Jennifer Cabe, FIC/NIH
Dr. Mark Miller, FIC/NIH
Ms. Nancy Coulter, FIC/NIH
Mr. Richard Miller, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Dr. Norman Neuriter, DOS
Mr. Robert Eiss, FIC/NIH
Dr. Thomas Novotny, DHHS
Dr. Maria Freire, OD/NIH
Ms. Rachel Park, FIC/NIH
Ms. Lee Ann Gschwind, FIC/NIH
Dr. Joshua Rosenthal, FIC/NIH
Ms. Wendy Hall, OSTP
Dr. Luis A. Salicrup, FIC/NIH
Ms. Anne Hill, FIC/NIH
Ms. Rita Singer, FIC/NIH
Dr. Sharon Hrynkow, FIC/NIH
Ms. Janice Solomon, FIC/NIH
Dr. Gerald T. Keusch, FIC/NIH
Dr. Sandy Warren, CSR/NIH
Dr. Ruth Kirschstein, OD/NIH
Ms. Helen Wegman, NHLBI/NIH

OPEN PORTION OF THE MEETING

I. CALL TO ORDER

Dr. Gerald T. Keusch, Director, FIC, called the open session of the Advisory Board meeting to order at 8:40 a.m. on Tuesday, September 19, 2000. He introduced Dr. Sharon Hemond Hrynkow as the new Deputy Director for FIC. A press release announcing her appointment on September 6 was provided to the Board. Dr. Hrynkow joined the FIC in 1995 and has served in a number of capacities at the Center since that time.

Dr. Keusch noted that two Board members are retiring from the Board: Dr. Thomas Cole and Dr. Donald O. Nutter. He thanked each of them for their service and contributions and presented them with certificates of appreciation. Dr. Keusch announced that Dr. Robert Shope, University of Texas at Galveston, will be joining the Board in February as a new member. The appointments of two additional individuals are pending confirmation. In addition, Dr. Keusch thanked Dr. Cora B. Marrett for extending her service on the Board.

Dr. Keusch welcomed two special guests to the meeting: Dr. Philip E. Schambra, who served as Director, FIC, from 1988 to 1998, and Ms. Stephanie Bursenos, former Deputy Director, FIC. He invited them to participate in future Board meetings.

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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING

The minutes of the Advisory Board meeting of May 16, 2000, were considered and accepted unanimously.

III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES

Dr. Keusch thanked the Board members for providing their updated Confidential Financial Disclosure Reports to the FIC.

IV. FUTURE MEETING DATES

The following meeting dates were confirmed:

Tuesday, February 6, 2001
Tuesday, May 22, 2001
Tuesday, September 11, 2001

The proposed meeting dates for 2002 are:

Tuesday, February 5, 2002
Tuesday, May 21, 2002
Tuesday, September 10, 2002

Dr. Keusch asked Board members to inform Ms. Irene Edwards, Executive Secretary, of any scheduling conflicts they may have with the future dates. All subcommittees of the Board will meet on the Monday preceding each Board meeting.

V. REPORT OF THE DIRECTOR

Dr. Keusch reported on personnel changes within the Department of Health and Human Services (DHHS), NIH, and FIC and highlighted recent and future FIC activities. Mr. Richard Miller, Executive Officer, FIC, presented an update on the NIH and FIC budgets for Fiscal Year (FY) 2001. The written Report of the Director was distributed previously to Board members, was available at the meeting, Written Report of the Director.

Personnel Changes

Dr. Keusch reported that Dr. Edward Greg Koski was appointed the first Director of the newly created DHHS Office for Human Research Protection (OHRP) in the Office of the Assistant Secretary for Health. The OHRP replaces the NIH's Office for Protection from Research Risk. Dr. Keusch noted that the FIC has extended an invitation to meet with Dr. Koski at his earliest convenience.

Recent personnel changes at the NIH include the appointments of Dr. Raynard Kington as Associate Director for Behavioral and Social Sciences Research, effective October 8, and Dr. Lawrence Tabak as Director, National Institute of Dental and Craniofacial Research. Dr. Keusch noted that Dr. Jack Whitescarver is serving as Acting Director, Office of AIDS Research, replacing Dr. Neal Nathanson, who left NIH September 1 to return to the University of Pennsylvania. He also noted that Dr. Carl Kupfer has stepped down as Director of the National Eye Institute (NEI). Dr. Kupfer was the founding director of the NEI, the longest-serving director of any NIH institute, an ex officio member of the FIC Advisory Board, and, transiently, Acting Director of FIC in January-June 1988.

Within the FIC, Dr. Martin Alilio has come from the National Institute for Medical Research, Tanzania, to serve as FIC's Malaria Program Officer for the Multilateral Initiative on Malaria; Dr. Rachel Nugent is FIC's first Sheldon M. Wolff Fellow in International Health under the auspices of the Science and Diplomacy Program of the American Association for the Advancement of Science; and Ms. Jennifer Cabe is a new Communications Officer in FIC's Office of the Director.

FIC Budget

Mr. Miller reported that little action has been taken in Congress on the FY 2001 budget since the previous Board meeting. The President's Budget for FY 2001 requests $18.8 billion for the NIH, an increase of approximately 5.6 percent over FY 2000. The House of Representatives' bill, completed in May-June, reflects the President's Budget, but also includes language on the potential allocation of $20.5 billion. The Senate bill provides for $20.5 billion, an increase of approximately 15.2 percent over FY 2000.

For the FIC, the President's Budget requests $48 million, an increase of approximately $5 million over FY 2000. The House bill reflects the President's Budget and includes language on the potential allocation of $50.3 million. The Senate provides for $61.3 million. Mr. Miller noted that the percentage increases proposed in the President's Budget are greater for the FIC than they are for the NIH, reflecting Dr. Varmus' (former NIH Director) continued interest in international health research. The percentage increases in the House bill are approximately the same for the FIC and the NIH (16.1 percent and 15.2 percent, respectively), but the percentage increases in the Senate bill are greater for the FIC (41.4 percent and 15.2 percent, respectively). Mr. Miller noted that the Senate increase for the FIC is second only to that for the NIH's National Center for Complementary and Alternative Medicine, is far higher than for any other institute or center, and reflects the Senate's interest and concern about global health issues.

FIC's new initiatives for FY 2000 include the Ecology of Infectious Diseases Program, the Bioethics Program, and the Malaria Research Training Program. In FY 2001, the FIC anticipates launching seven new initiatives, for smoking prevention and cessation, health and economics, mental health disorders, molecular genetics and disorders, clinical investigation, international centers of research excellence, and an epidemiology program. Mr. Miller remarked that the available funding to support these initiatives will depend on the final appropriations process. A final budget is expected by the end of the current fiscal year on September 30. Dr. Keusch noted that the FIC will keep the Board informed.

FIC Activities

Dr. Keusch reported on recent and upcoming initiatives, as follows.

International Bioethics Education and Career Development Award. At the present meeting, the Board will consider the first set of proposals for FIC's new award to create or enhance international bioethics training programs and to train participants from developing countries in bioethics. Dr. Keusch noted that this program is an important step forward in NIH's efforts to build capacity in bioethics in medical research globally.

Second Global Forum on Bioethics in Research. The series of global forum on bioethics is continuing, with the second global forum to be held in Bangkok, Thailand, in October. FIC assisted the World Health Organization (WHO) in planning the second forum and will help to organize the initial planning for the next three meetings. The lead organization for the third meeting, to be held in The Gambia, West Africa, in November 2001, is the United Kingdom's Medical Research Council; for the fourth, to be held in Latin America, the Pan American Health Organization, which will be celebrating its 100th anniversary in 2002; and for the fifth, to be held in Europe, the Wellcome Trust. Dr. Keusch noted that the FIC and the National Institute of Allergy and Infectious Diseases (NIAID) are the lead NIH components on a 3-year NIH grant to support the participation of individuals from developing countries at these forums.

Consultation on Medicine and the Media. On June 7, the FIC sponsored a meeting entitled "Biomedicine and the Media: An International Colloquium," which was attended by 24 medical editors, print journalists, and other communication specialists, including 6 from developing countries. The meeting was moderated by Dr. Drummond Rennie, of the Journal of the American Medical Association, and Dr. Jerome Kassirer, formerly of the New England Journal of Medicine. Dr. Catherine Wilfert represented the Board. The participants addressed the reliability, objectivity, and ethics of reporting in medical journals and the popular press and the needs for improved education and training in science for medical reporters. The main message conveyed was the need to establish a relationship of truth, trust, and respect between medical scientists and reporters. The FIC is considering the suggestions made and ways for the FIC to move forward on this issue.

Presidential Millennium Vaccine Challenge. Dr. Keusch noted that the FIC is working with the NIAID to plan a second conference in response to this presidential challenge. This conference, entitled "Enhancement of Pull/Demand Strategies for HIV/AIDS, Malaria, and Tuberculosis Vaccines: Addressing the Presidential Challenge," will be held at the NIH in early 2001. It follows on the first conference, which was at the NIH in May 2000, bringing together vaccine developers from academia, the public sector, and private industry to "push the agenda" for developing new vaccines. Dr. Barry Bloom led the discussion on tuberculosis vaccines at this meeting. The second conference will focus on broader issues of generating the economic and public "pull," or demand, for vaccines. Dr. Mark Miller, Associate Director for Research, FIC, is leading the planning for this conference.

International Tobacco Control Research and Training Initiative. The FIC has initiated an effort, which involves seven other NIH components, to address the impact of tobacco on health in the developing world. Staff are preparing a draft Request for Applications (RFA) for international research and training in tobacco and health, which will emphasize behavioral and social issues (e.g., messages from the tobacco industry) contributing to the initiation of smoking. The FIC is developing this initiative in coordination with the Centers for Disease Control and Prevention, which is responsible for the Government's global surveillance in tobacco, and the WHO, which has launched its Tobacco-Free Initiative. At the 10th World Conference on Tobacco or Health, recently held in Chicago, the FIC presented NIH's plans for the initiative and convened a focus group for scientists from developing countries.

Multilateral Initiative on Malaria (MIM). Dr. Keusch noted that MIM, for which the FIC serves as secretariat, is proceeding well. African colleagues have originated a proposal for a training program to develop skills in research management, and they are meeting with multiple potential donors and funders this week in September in the United Kingdom. In addition, a number of countries have indicated interest in participating in MIM and funding some activities. Dr. Keusch noted that MIM is potentially a model of a global public-sector alliance for addressing other health issues. Recently, the FIC had an opportunity to present MIM and the possibility of a similar alliance in HIV/AIDS to the heads of the major global biomedical research organizations, who met at the NIH at a meeting hosted by Dr. Ruth Kirschstein, Principal Acting Director, NIH.

Ecology of Infectious Diseases. Dr. Keusch noted that the response to the first RFA issued under FIC's Ecology of Infectious Diseases Program was spectacular. The purpose of the RFA was to broaden the current agenda for emerging and infectious diseases from surveillance and diagnostics to include research on the laws of nature governing emergence of disease and, ultimately, prediction and prevention of infectious diseases. The FIC was the lead NIH component on the RFA, which was issued in collaboration with the National Science Foundation (NSF). Seventy-nine applications were received, 75 were considered responsive to the RFA and reviewed by an NSF special emphasis panel, and approximately 20 were considered highly fundable. The FIC will be funding or co-funding 12 awards.

International Research Scientist Development Award (IRSDA). Dr. Keusch noted that the FIC is concerned that the response to the RFA for this new award was not as great as anticipated. This initiative is intended to help stimulate U.S. investigators' interests in international research. Staff will present possible changes to the Board to make the award more attractive.

Minority International Research and Training (MIRT) Program. Dr. Keusch noted that the FIC is working closely with NIH's Office of Research on Minority Health to continue the highly successful MIRT Program and has sponsored a MIRT working group meeting to discuss introducing ethics training into the Program.

Analysis of International Policies and Practices at NIH. Dr. David Rothman, Professor of Social Medicine and Director, Center for the Study of Society and Medicine, Columbia University College of Physicians and Surgeons, and Professor of History, Columbia University, New York, presented a brief update on his retrospective assessment of NIH's international commitments over the past 10 years. The assessment, which FIC is supporting for the NIH, is focused on four questions: (a) What impact has the NIH had on individual investigators who have come to the NIH to work in the intramural program? (b) What impact has the NIH collaboration had on the research capacity of developing countries? (c) What impact has the NIH collaboration had on advancement of scientific knowledge? (d) What have been the outcomes in terms of improved health status and advances in scientific knowledge? Dr. Rothman noted the extraordinary level of cooperation he has received from institute directors and staff in conducting this study.

Dr. Rothman reported on initial perspectives on the NIH relationship with China. He noted the large number of Chinese scientists who have trained in the intramural program over the years and the impact of collaboration in improving research methodologies and standards in China. These findings will be presented at the Second Global Forum on Bioethics in Research, in Bangkok, Thailand, October 2000. In closing, Dr. Rothman noted that American science is setting the standard for international science in dramatic ways.

Additional details on personnel changes, the FY 2001 budget, and FIC activities are provided in the Written Report of the Director.

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VI. UPDATE ON INTERNATIONAL ACTIVITIES AT NIH

Dr. Ruth Kirschstein presented the NIH perspective on international research. She began by thanking the Board members for their willingness to serve and advise the NIH. Dr. Kirschstein noted that the NIH has been involved in international health issues since its beginning in 1887 as a small Staten Island laboratory for infectious diseases. This international mandate was affirmed some 50 years later by President Franklin Roosevelt as he dedicated NIH's Building 1 in October 1940. He remarked, "NIH has been devoted throughout its long and distinguished history to furthering the health of all mankind, in which service it has recognized no limitations imposed by international boundaries and has recognized no distinctions of race, of creed, or of color."

NIH's strong commitment to international research continues and has expanded in scope and complexity during the past several years. As recently noted by President Clinton, the health of U.S. and other citizens around the world is a vital national security interest to the United States, and the "iron link between deprivation, disease, and war" must be confronted to create peace.

Dr. Kirschstein commented on the role of the FIC in international health research, highlighting several examples. She noted that the participation of the FIC and other NIH components in the Presidential Millennium Vaccine Challenge is highly appropriate and timely, as infectious diseases emerge and reemerge in more virulent and drug-resistant forms.

Similarly, NIH's new international scientific partnerships to combat chronic diseases and disorders are appropriate responses to new information on the global burden of disease. Dr. Kirschstein noted the FIC's important role in developing and arranging these partnerships in cooperation with other NIH components. Examples include the NCI's participation in the historic Middle East Cancer Consortium agreement in 1996 and the Memorandum of Understanding between the Republic of Ireland, Northern Ireland, and the United States to enhance cancer research and treatment in Ireland, where incidence and mortality rates for cancer are among the highest in the Western world; NHLBI's long-term agreements with the former Soviet Union and more recent agreements with international organizations and other countries to address hypertension in the Americas and in the Middle East; NEI's worldwide collaborations as the world's foremost research agency for the prevention of blindness and other eye disorders; the National Institute of Child Health and Human Development (NICHD) and NIAID's involvement in new research collaborations (e.g., in maternal and child health, HIV/AIDS) under the auspices of a new U.S.-India agreement in science and technology; and NICHD's completion of vaccine trials in Vietnam against typhoid.

Dr. Kirschstein emphasized that FIC's role in the training of foreign scientists is absolutely crucial. Forty to 60 percent of the scientists who work in countries other than the United States, particularly in developing countries, have received training in the United States, and much of this has been supported by the FIC. And, FIC's influence, largely beginning under the leadership of Dr. Schambra and Ms. Bursenos, encouraged the NIH to strengthen its efforts to train scientists from developing countries. The prime example of the success of these programs is FIC's AIDS International Training and Research Program, which now importantly includes re-entry grants for advanced in-country training. FIC's training programs complement the research efforts of the other NIH components and support foreign scientists in the NIH's Visiting Program.

Dr. Kirschstein complimented FIC's leadership in other areas as well, including the International Cooperative Biodiversity Group Program, the MIM, and global discussions of bioethics in research. She encouraged the FIC to accept the major challenge of identifying ways to interest and attract new U.S. scientists into research assignments in developing countries. Dr. Kirschstein noted that sabbaticals abroad were important and enriching experiences for previous generations of American scientists, but are less attractive currently because of the heightened competitiveness of U.S. science. She urged the FIC and the Board to address this problem.

Dr. Kirschstein highlighted NIH's international research on HIV/AIDS as a microcosm of the overall needs and concerns for international research. The NIH supports the largest single public investment in AIDS research in the world, and the NIH's Office of AIDS Research (OAR) is striving to assure that the research conducted with this support is relevant to the global pandemic. Dr. Kirschstein noted that the Congress strongly supports this international effort. Following on the XIII International Conference on AIDS, held in Durban, South Africa, in July 2000, the OAR is collaborating with the FIC and other NIH components to significantly increase the NIH's international AIDS research portfolio. The OAR has developed a separate strategic plan for international AIDS research, broadened its advisory council to include representatives from UN AIDS, and established an AIDS research collaborating committee that includes various organizations, including the World Bank. Recent examples of progress include an NIAID-sponsored clinical trial in Uganda, which demonstrated the cost-effectiveness of an antiretroviral drug to reduce mother-to-child transmission of HIV; elucidation of the biological determinants of infectiousness and susceptibility in studies of HIV transmission; continued research on an AIDS vaccine; and ongoing clinical trials.

Dr. Kirschstein noted that the FIC has contributed significantly to international research on AIDS and that the OAR has provided support to the FIC to expand its research training programs. She also highlighted the important contributions of Board members Dr. Catherine Wilfert and Dr. Barry Bloom.

In closing, Dr. Kirschstein said that the NIH has a very robust program of international activities. She challenged the Board to help the FIC and NIH continue its leadership in international health. She concluded with another quotation from President Roosevelt's dedication of Building 1, "We cannot be a strong nation unless we are a healthy nation, and so we must recruit not only men and materials, but also knowledge and science in the service of national strength."

Discussion

Commenting on the retrospective assessment of NIH's international commitment, the Board noted the need to also systematically address the impact on U.S. investigators, institutions, and research capacity and the barriers to taking full advantage of these opportunities. Dr. Kirschstein agreed that this review would be important and should be conducted with the broad participation of all NIH components and the extramural community. Dr. Keusch noted that the DHHS is discussing development of a global strategy for health and that the FIC is helping to organize a trans-NIH assessment and strategic planning process as part of this effort. One issue is that the NIH is traditionally a research organization, whereas many global health needs, particularly in developing countries, are for services and delivery of care. Other agencies within DHHS offer expertise in these areas and are conducting similar assessments.

Asked to comment on FIC's recognition of the importance of social and behavioral factors in health (e.g., in the tobacco and HIV/AIDS initiatives), Dr. Kirschstein agreed that this direction was appropriate and reflects national and international interests as well. The Board complimented the NIH for broadening its goals for research to include the transfer and application of research results. Dr. Kirschstein noted that the NIH has always been interested in these issues and that clarification of the (greater) opportunities and needs currently enables the NIH to exploit and export potential solutions. The Board noted that the NIH can have an important role in helping other nations, particularly developing nations, create successful research enterprises ("NIH transplants") in their own countries. The Board encouraged the NIH to address ways to strengthen the research capacity of institutions, as well as individuals, and to create linkages among the great universities worldwide. Dr. Kirschstein noted the importance of engaging all U.S. academic institutions in this effort, and she cited the Yale-China program as one example of a successful, long-term institutional linkage.

The Board also called for more sophistication in the NIH review process regarding the value placed on international research collaborations. Often, young scientists serving as grant reviewers do not appreciate the critical importance of collaborative research abroad and evaluate international research grant applications by the narrow standards of American expectations. Dr. Keusch said that the FIC has had initial discussions with the Director, Center for Scientific Review, NIH, about this issue and hopes to identify appropriate solutions in continuing discussions. In closing, he noted that "international" is part of the whole fabric of the NIH, more than ever before, and that budget support for international research has escalated in recognition of international needs.

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VII. INTELLECTUAL PROPERTY RIGHTS: THE STATE DEPARTMENT ROLE

Dr. Keusch introduced the main topic for the Board's meeting: intellectual property rights (IPR) and the translation of scientific discovery into health benefits. He noted that, although the opportunities for establishing new public and private partnerships are great, the obstacles to translating research findings into available and affordable products for populations worldwide are many.

Pertinent questions for discussion are noted in a September 6 press release from the Nuffield Council on Bioethics, which announced a series of meetings to examine ethical and legal issues associated with the patenting of DNA and proteins and the implications for health care. The key questions, similar to those being addressed by the NIH, include: "What is the proper balance between public and private sectors in these developments? Will broad patents covering important disease genes...restrict the development of a portable test? What is the role of patent offices?....Does the patent system actually encourage innovation in biomedical research?" Dr. Keusch noted an overriding concern: how to protect IPR and, yet, provide for the global public good, particularly from research sponsored by the public sector. The next three speakers were invited to open FIC's discussion of an international agenda for this area.

Ambassador Kenneth Brill, Principal Deputy Assistant Secretary of State, Bureau of Oceans and Environmental and Scientific Affairs, U.S. Department of State, commented on the importance of IPR and the role of the Department of State in this issue. He noted that IPR is a relatively new topic for diplomats and that their role, during the past decade and particularly overseas, has been not to create IPR, but to "police," or manage, the diplomatic and negotiating implications of IPR. In the current knowledge-based economy, IPR "drives" many economic issues in the United States and worldwide. American diplomats are very active in negotiating IPR in world trade discussions, bilateral science and technology agreements, multilateral environmental agreements, and the global marketplace (i.e., the "pirating" of U.S. pharmaceuticals, software, movies, etc.).

As a diplomatic issue, the U.S. position on IPR reflects national policies to advance the U.S.'s strategic interests and economy. An interagency process has been established for discussing and defining the U.S. position on IPR, which initially focused on protecting the IPR of commercial firms and has since expanded to include IPR as related to the broader public good (e.g., national security, technology transfer, capacity building). The Department of State has a unique role in this process, serving as both an activist policy organization and as the only cabinet agency that can synthesize across the Cabinet on international issues. In discussions of the global common good, the Department of State advances the U.S. position internationally.

Ambassador Brill noted that the intersection of the public good, the private good, and the need to maintain and support innovation is becoming an issue internationally. He noted that Rio Plus Ten, a planned global summit in 2002 to review progress since the Rio Earth Summit of 1992, may provide an opportunity to consider this complex of issues. At this conference, the international community will focus on issues of sustainable development, the environment, and related issues, among which health, specifically HIV/AIDS, is likely to be an important topic. The Department of State will play a key role in developing U.S. positions for this conference, but the interagency process has not yet begun.

Ambassador Brill noted that the FIC and the NIH are making important contributions to shaping U.S. Government attitudes and approaches regarding IPR questions, especially those pertaining to pharmaceuticals, HIV/AIDS, and vaccines. He highlighted, for example, NIH's recent influence on the Administration to adopt a flexible IPR approach for medicine and drugs for HIV/AIDS. He emphasized that the upcoming transition between administrations offers a special opportunity for engaging policymakers in discussions of appropriate and sustainable policies, domestically and internationally, that balance U.S. interests and the public good. Ambassador Brill commented that "pushes" from the NIH and the international health community have been useful in beginning the evolution of discussions, within the diplomatic community, of ways to provide low-cost medicines to people who cannot afford them. In interagency and international processes, the Department of State aims for sustainable, long-term approaches to such issues that advance U.S. interests and values and promote stability.

Discussion

The Board highlighted the emergency of infectious diseases (e.g., malaria, tuberculosis, HIV/AIDS, cholera, dysentery) worldwide and the irrelevance of IPR rules and debates for the people affected with these diseases. Noting the willingness of scientists in private companies who are desperate to make a contribution and the historical precedence of companies collaborating to meet national needs (e.g., for penicillin and malaria drugs during World War II), the Board urged the U.S. Government to issue a clarion call for a consortium of pharmaceutical companies, funded publicly and privately, to develop new and cost-appropriate treatments for these diseases. Dr. Keusch noted that the NIH and the Department of State, collaborating in a concerted effort, can move the agenda forward. A dialogue also has been established between DHHS and the U.S. Trade Representative.

Ambassador Brill emphasized the importance of FIC and NIH's efforts to encourage U.S. scientists to work abroad, even for limited periods, because U.S. science is held in extraordinarily high regard overseas and they can have tremendous impact, reinforcing the Department of State's efforts to build and sustain relationships bilaterally and multilaterally. He noted that the Department of State supports any efforts or new approaches to foster this interaction. Ambassador Brill also urged the FIC and NIH to continue to build support for increased international activities in the Congress and the new Administration. In closing, he indicated that the Department of State would be interested in participating in an interagency process to promote discussion, nationally and internationally, on the issue of patenting genes and other DNA materials.

VIII. IPR AND GLOBAL PUBLIC GOOD: THE VIEW FROM THE COMMISSION ON MACROECONOMICS AND HEALTH

Dr. Jeffrey Sachs, Director, Center for International Development and Galen L. Stone Professor of International Trade, Harvard University, Cambridge, Massachusetts, presented a macroeconomic view of IPR issues and the global public good. Dr. Sachs chairs the WHO Commission on Macroeconomics and Health. He summarized the goals of the Commission and the issues being addressed by one working group focused on IPR and the global public good surrounding health.

Dr. Sachs noted that research by economists, epidemiologists, and others increasingly shows that the most important variables affecting a nation's economic growth and development relate to health (e.g., life expectancy), rather than to economic policies. Yet, despite the strong links between health and development, there is a "shocking under-investment" in health. For example, public health expenditures per individual per year amount to only $2.70 in India and $2.80 in Nigeria, and, although the international community invests about $3-4 billion a year in health, nutrition, and population programs, less than $1 billion is directed toward disease control. Dr. Sachs argued that, for many economies, particularly African economies, the number one developmental priority is the current health crisis (i.e., the burden of disease).

The aims of the Commission on Macroeconomics and Health are to amplify these themes, develop rigorous evidence for them, and make a case for the kinds of global investments needed in health. The Commission has established working groups and is convening meetings around the world to elaborate the themes and to develop a comprehensive view of the costs involved. An international report will be presented by the end of 2001. Dr. Sachs invited the Board members to provide input to the Commission's deliberations.

The working group on IPR and the global public good surrounding health is addressing three categories of issues: access to essential medicines, research and development (R&D) for diseases of poor people, and the appropriate scope of patenting. For each category of issues, IPR poses different problems. The first category of issues relates to the pricing of products, for diseases that affect both rich and poor countries, which is based on the markets of developed countries and makes them inaccessible to poor people. The second category relates to diseases which pharmaceutical companies do not address, or address only in a limited way, because they affect primarily poor countries and do not offer markets in rich countries. A good example is malaria, which accounts for about 2 percent of the world's burden of disease but receives only 0.001 percent of R&D monies. The third category relates to patents, an innovative and efficient economic institution that provides incentives for R&D, but creates a highly inequitable monopoly for the life of the patent. Dr. Sachs noted that the tradeoffs between incentives and inequality can be handled in developed countries, but are more difficult for poor countries where access to products (e.g., vaccines) determines life and death on a daily basis.

Dr. Sachs noted that the first category, access to essential medicines, needs to be approached from a broader view than IPR to include how to get available drugs to poor people and poor countries. He suggested three actions: identifying alternatives to patent-protected prices, supporting the infrastructure needed to deliver products, and conducting operational research on appropriate protocols and uses of products in local circumstances. Dr. Sachs proposed a two-pronged approach: direct segmentation of the markets (and prices) for poor versus rich countries, and greatly increased support from international donors. Possible options for making essential medicines accessible to poor countries include encouraging compulsory licensing for critical classes of drugs, negotiating for "deep discounts" by pharmaceutical companies, companies licensing others for production of medicines in poor countries, and Federal "buyouts" of rights for use in other markets. Dr. Sachs noted that rich countries can well afford these measures. He cautioned, however, that the sustainability of any efforts would need to be assessed and that the innovative and high-quality U.S. pharmaceutical industry must be maintained.

Dr. Sachs noted that R&D for diseases of poor people, the second category, has been much discussed, but little action taken. He suggested that both "push" and "pull" mechanisms are needed to develop the funds for the complex chain of R&D that would result in the delivery of products for these diseases. For example, the R&D process could be subsidized from the beginning, and companies could receive "purchase funds" or tax benefits and credits for the end-of-product R&D phase or final delivery. He commented that money is a strong incentive for companies and that no mechanisms such as these have been introduced for decades. Dr. Sachs also noted a desperate need for developing "standing" research capacity, both basic and applied, within developing countries. He proposed establishment of a major program, funded by several billion dollars over the next 10 years, to support, equally, 10-year grants to outstanding research and public health institutions and regular extramural research project grants to individuals.

Dr. Sachs noted that the third category, the appropriate scope of patenting, addresses the conceptual issue of what is patentable. He made two observations: (a) the idea of patenting genes is abhorrent and an economic and societal mistake, and (b) ownership of the human genome is a global issue, not a national issue, and should be debated internationally because U.S. patent law has worldwide implications.

In closing, Dr. Sachs commented on the appropriate forum for coordinating international efforts on IPR and public good issues. He urged that the WHO be used and strengthened for this purpose. He noted that, among existing organizations, the WHO can best serve as the global institution for health. Other organizations lack the necessary expertise and/or are dominated by the United States.

Discussion

The Board noted the importance of developing local research capacity in developing countries and of securing funds to support this effort (e.g., the costs of research supplies, equipment, personnel). Commenting on the appropriate scope of patenting, the Board voiced strong concern about companies' demand for "reach-through" patent agreements for reagents or medical equipment, which are a major disincentive for multilateral cooperation. The Board encouraged the Commission to consider this issue as well. Dr. Maria Freire, Director, Office of Technology Transfer, NIH, noted that the NIH continues to address the three categories of issues outlined by Dr. Sachs. Particular concerns for NIH's international activities include the continuation of price differentials after drugs are "off-patent," identifying incentives to assure testing of NIH-developed technologies (e.g., vaccines) for the "null set" of diseases in poor countries, and delineation of consistent policies on what is patentable.

In response to a question from the Board, Dr. Sachs noted that, except in the Middle East, U.S. developmental assistance has essentially collapsed, especially for poor countries. He suggested that the U.S. public could be motivated to support foreign aid by a strong Government policy and Presidential commitment which conveys the human benefits of small per capita contributions from the United States and strategically links aid to the solution of health problems through application of U.S. science and technology. Dr. Sachs also noted that pharmaceutical companies would be receptive to the segmentation of markets if the benefits of this approach were communicated effectively to the U.S. public and their domestic position were not undermined. In closing, he emphasized the need for a serious policy that addresses the reality of HIV/AIDS in developing countries and that would include provision of the lowest-cost antiretroviral drugs with local protocols.

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IX. FEDERALLY FUNDED HEALTH R&D: IMPLICATIONS FOR ACCESS TO NEW PRODUCTS IN THE DEVELOPING WORLD

Dr. Jean O. Lanjouw, Associate Professor, Department of Economics, Yale University, New Haven, Connecticut, and Visiting Fellow, Brookings Institution, Washington, D.C., addressed the question: How can the NIH increase the contribution of its extramural R&D funding to the creation of new drugs for developing countries and the availability of new drugs in these countries at prices that make them widely accessible? Focusing on IPR and patenting issues and on potential research areas for the FIC, she considered three hypothetical policy changes to achieve these ends: (a) no longer allow patenting and make all basic research from federally funded R&D publicly available; (b) continue to allow patenting of federally funded research results, but maintain ownership of the patents with the NIH, rather than with universities; and (c) continue to allow patenting, with current patent owners, but attach conditions to the use of patents in specific circumstances. For simplicity, Dr. Lanjouw identified three "actors" in these scenarios: the NIH, the firm, and the university.

Dr. Lanjouw argued that the first possible policy change reverts to the situation two decades previously. She noted that firms are profit-making entities and may be unwilling to commercialize products without a patent or nonexclusive license. A series of legislation beginning in the early 1980s (e.g., the Stevenson-Wydler Technology Innovation Act, the Bayh-Dole Act) substantially enhanced the rights of researchers to patent results derived from federally funded projects. Two questions to consider in weighing whether the current rights to exclusivity are too strong are: How much is gained in the development of new products as a result of these new patenting rights, and how much is lost in higher prices and reduced access. Dr. Lanjouw noted that the answers in this old debate are unknown, that neither view about whether they are appropriate is empirically grounded, and gains and losses are hard to measure.

Dr. Lanjouw also argued that it is also unclear whether the second possible policy change would be effective. She noted that the research motivations of the NIH are different from those of universities and that, while university licensing receipts are small relative to R&D funding, they are growing rapidly and are already large relative to current NIH spending on tropical diseases, for example. On the other hand, there are many issues to consider, including whether the NIH has the same incentive as universities to seek licensing opportunities, where licensing receipts would be deposited (e.g., would they be taken from research into university or Government general funds), whether possibilities for profitable research would distort research priorities in universities or the NIH, and whether licensing firms view the NIH and universities as equivalent. Regarding the latter, Dr. Lanjouw suggested that, despite the benefits of the more-structured Cooperative Research and Development Agreements (CRADAs), firms are likely to view contracting with the Government as more uncertain and vulnerable to political interference.

Dr. Lanjouw suggested that the third possible policy change could effectively enable the NIH to enhance the creation, availability, and accessibility of new drugs for developing countries. She noted that patent rights are awarded per country and that conditions could be attached for their use in specific circumstances. This policy would be especially relevant for patents on drugs to treat some categories of infectious diseases (e.g., HIV/AIDS) and chronic diseases (e.g., cancer, cardiovascular disease, diabetes), which are prevalent in both developed and developing countries. Dr. Lanjouw demonstrated that because most of the market for drugs to treat these diseases is in rich countries, exclusive licensing of patents in poor countries contributes minimally to a firm's profits and research incentives. At the same time, any rise in prices for these drugs in poor countries has a very large effect on the accessibility of the drugs to the people in these countries.

Dr. Lanjouw proposed the following condition on the use of patents: On innovations that result from federally funded R&D and relate to a specified set of diseases, the patents in a specified set of poor countries must be made available on a nonexclusive basis; use of patents on these innovations elsewhere remains unrestricted. Such a policy change would lower prices of patented drugs in poor countries, speed the introduction of drugs in these countries, not increase uncertainty, potentially reduce any NIH subsidies for R&D, and require no change in patent ownership. Issues to consider include identification of the applicable conditions (diseases) and countries, clarification of the terms and conditions for nonexclusive licenses, and the potential for developing countries to continue to introduce other drugs in the nonexclusive environment.

Discussion

The Board raised specific questions about the model proposed by Dr. Lanjouw. Members asked about the extent of NIH subsidies for R&D, the applicability of the model to non federally funded R&D, the feasibility of offering non-exclusivity in developing countries that have extreme disparities of income and a significant middle class (e.g., India), the discrimination of exclusivity among the portfolio of patents usually awarded for any one drug, and the practical and operational aspects of implementing such a model. Dr. Lanjouw suggested that implementation of the model is feasible, could have significant impact, and would not necessarily threaten a firm's initial profits. She encouraged the FIC to consider the model further.

The Board suggested that the conditions proposed in this innovative model could be applied outside of the patenting system to agreements with institutions that accept grants from the Federal Government. The Board also noted that the willingness of firms to participate in such measures is not an economic issue, but a political issue. With public support by the Congress and the Administration, firms would willingly contribute to resolution of the world's health crisis.

Dr. Keusch thanked the speakers for initiating the Board's discussion of IPR and the global public good and for presenting interesting proposals and potential solutions for consideration. The FIC will be seeking the Board's advice on how best to pursue these issues further.

X. CLOSED PORTION OF THE MEETING

This portion of the meeting was closed to the public in accordance with the determination that it was concerned with matters exempt from mandatory disclosure under Sections 552b(c)(4) and 552b(c)(6), Title 5, U.S. Code and Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2).

There was a discussion of procedures and policies regarding voting and confidentiality of application materials, committee discussions, and recommendations. Members absented themselves from the meeting during discussion of and voting on applications from their own institutions or other applications in which there was a potential conflict of interest, real or apparent. Members were asked to sign a statement to this effect.

XI. REVIEW OF APPLICATION

A total of 139 applications requesting $21,708,205 in FY 2000 funds were reviewed by the FIC Advisory Board as follows:

• 7 applications for Senior International Fellowship (SIF) awards requesting $234, 716;

• 29 applications for Fogarty International Research Collaboration Awards (FIRCAs) requesting $1,096,202;

• 4 applications for AIDS-FIRCA awards requesting $155,200;

• 44 applications for AIDS International Training and Research Program (AITRP) awards requesting $6,191,164;

• 16 applications for Ecology of Infectious Diseases Program awards requesting $6,904,177;

• 6 applications for International Research Scientist Development Awards (IRSDAs) requesting $446,150;

• 10 applications for International Training and Research Program in Population and Health (ITRPH) awards requesting $2,133,265;

• 4 applications for Actions for Building Capacity (ABC) awards requesting $406,608;

• 5 applications for International Malaria Research Training Program awards requesting $718,480; and

• 14 International Bioethics Education and Career Development Awards requesting $3,422,243.

The Board concurred with the initial review group recommendations for 139 proposals, recommending $21,708,205.

XII. ADJOURNMENT

The meeting was adjourned at 3:00 p.m. on September 19, 2000.

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