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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
Fifty-second Meeting
Table of Contents
Attendance
- Call to Order
- Consideration of Minutes of Previous Meeting
- Review of Requirements for Confidentiality and Conflict
of Interest Procedures
- Future Meeting Dates
- Report of the Director
- Intellectual Property Rights and NIH-Supported Foreign Entities
- Intellectual Property and Better Health: The MIHR Approach
- Closed Portion of the Meeting
- Review of Application
- Adjournment
The John E. Fogarty International Center for Advanced Study in the Health Sciences (FIC) convened the fifty-second meeting of its Advisory Board on Tuesday, September 10, 2002, at 8:45 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 8:45 a.m. to 12:05 p.m., followed by the closed session, from 1:00 p.m. to adjournment at 3:00 p.m., as provided in Sections 552b(c) (4) and 552b(c) (6), Title 5, U.S. Code, and Section 10 (d) of Public Law 92-463, for the review, discussion, and evaluation of grant applications and related information.[1] Dr. Gerald T. Keusch, Director, FIC, presided as chair.
Board Members Present:
Dr. Mary Claire King
Dr. Yvonne T. Maddox (ex officio)
Dr. Cora B. Marrett
Dr. Patricia A. Marshall
Dr. Theodore Reich
Dr. Robert E. Shope
Dr. Stephen E. Straus (ex officio)
Dr. Catherine M. Wilfert
Board Members Absent:
Dr. Cutberto Garza
Members of the Public Present:
Dr. Carola Eisenberg, Department of Social Medicine, Harvard Medical School, Boston, MA
Dr. Rose Maria Li, ASI, Inc., Bethesda, MD
Dr. Richard Mahoney, Professor, School of Health Administration and Policy, Arizona Biodesign Institute, Arizona State University, Tempe, Arizona
Dr. Bracha Rager, Ministry of Health, Israel
Dr. Sharon Landesman Ramey, Georgetown University, Washington, D.C.
Federal Employees Present:
Dr. Martin Alilio, FIC/NIH
Dr. James Lavery, FIC/NIH
Dr. Wendy Baldwin, OD/NIH
Ms. Judith Levin, FIC/NIH
Mr. Kevin Bialy, FIC/NIH
Ms. Sonja Madera, FIC/NIH
Ms. Danielle Bielenstein, FIC/NIH
Ms. Julie Marquardt, FIC/NIH
Dr. Joel Breman, FIC/NIH
Dr. Jeanne McDermott, FIC/NIH
Dr. Kenneth Bridbord, FIC/NIH
Dr. Kathleen Michels, FIC/NIH
Ms. Julie Burke, FIC/NIH
Dr. Mark Miller, FIC/NIH
Mr. Bruce Butrum, FIC/NIH
Mr. Richard Miller, FIC/NIH
Dr. Lois K. Cohen, NIDCR/NIH
Ms. Fil Nando-Fontelo, FIC/NIH
Dr. Jean-Marc Depinay, FIC/NIH
Ms. Yveline Pierre-Louis, FIC/NIH
Ms. Irene Edwards, FIC/NIH
Mr. Mark Pineda, FIC/NIH
Dr. Andrea Egan, FIC/NIH
Ms. Amanda Porter, FIC/NIH
Dr. Carola Eisenberg, OD/NIH
Dr. Aron Primack, FIC/NIH
Ms. Mollie Fletcher, FIC/NIH
Ms. Charlotte Quinn, FIC/NIH
Dr. Pierce Gardner, FIC/NIH
Dr. Mark Rohrbaugh, OD/NIH
Ms. Mildred Hatton, FIC/NIH
Ms. Minerva Rojo, FIC/NIH
Dr. Ruth J. Hegyeli, NHLBI/NIH
Dr. Joshua Rosenthal, FIC/NIH
Mr. George Herrfurth, FIC/NIH
Mr. Ted Roumel, OD/NIH
Dr. Karen Hofman, FIC/NIH
Ms. Laura Rowe, FIC/NIH
Ms. Cherice Holloway, FIC/NIH
Dr. Luis A. Salicrup, FIC/NIH
Dr. Allen Holt, FIC/NIH
Dr. Peggy Schnour, OD/NIH
Dr. Sharon Hrynkow, FIC/NIH
Dr. Barbara Sina, FIC/NIH
Dr. Dean Jamison, FIC/NIH
Dr. George Stone, OD/NIH
Dr. Gerald T. Keusch, FIC/NIH
Ms. Natalie Tomitch, FIC/NIH
Dr. Richard Krause, FIC/NIH
Dr. Sandy Warren, CSR/NIH
Dr. Linda Kupfer, FIC/NIH
Ms. Patricia Williams, FIC/NIH
OPEN PORTION OF THE MEETING
I. CALL TO ORDER
Dr. Gerald T. Keusch called the meeting to order. He introduced two new ex officio members of the board: Dr. Yvonne T. Maddox, Deputy Director, National Institute of Child Health and Human Development; and Dr. Stephen E. Straus, Director, National Center for Complementary and Alternative Medicine. Dr. Keusch noted that the terms of several Board members were expiring. He thanked Drs. Mary Claire King, Cora B. Marrett, and Patricia A. Marshall for their service to the Board and FIC and presented each with a certificate of appreciation. The members thanked the FIC for the opportunity to participate in FIC's efforts, commended the staff, and urged FIC to continue to promote and support excellent science to improve the health of the world's people.
Dr. Keusch welcomed and introduced the following special guests: Dr. Carola Eisenberg, Department of Social Medicine, Harvard Medical School; Dr. Richard Mahoney, School of Health Administration and Policy, Arizona Biodesign Institute, Arizona State University; Dr. Sharon Landesman Ramey, Georgetown University; and Dr. Bracha Rager, Ministry of Health, Israel. In addition, he acknowledged several staff members from other NIH institutes and centers (ICs): Dr. Sandy Warren, Center for Scientific Review; Dr. George Stone, Office of Extramural Research; Dr. Lois K. Cohen, National Institute of Dental and Craniofacial Research (NIDCR); and Dr. Ruth J. Hegyeli, National Heart, Lung, and Blood Institute.
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II. CONSIDERATION OF MINUTES OF PREVIOUS MEETING
The minutes of the Advisory Board meeting of May 21, 2002, were considered and accepted unanimously.
III. REVIEW OF REQUIREMENTS FOR CONFIDENTIALITY AND CONFLICT OF INTEREST PROCEDURES
The rules and regulations pertaining to conflict of interest were maintained.
IV. FUTURE MEETING DATES
The following meeting dates were confirmed:
Tuesday, February 11, 2003
Tuesday, May 20, 2003
Tuesday, September 16, 2003
Tuesday, February 10, 2004
Tuesday, May 18, 2004
Tuesday, September 14, 2004
All subcommittees of the Board will meet on the Monday preceding each Board meeting.
Dr. Keusch asked the Board members to inform Ms. Irene Edwards, Executive Secretary, of any scheduling conflicts they may have with the future dates.
V. REPORT OF THE DIRECTOR
Dr. Keusch reported on personnel changes, recent activities, the budget, and progress in FIC programs. He reflected on the past year and invited staff members to elaborate on several activities. The Report of the Director, which was mailed to Board members, is appended to these minutes as Attachment 2, Written Report of the Director.
Personnel Announcements
Dr. Keusch announced that Dr. Francisco Ayala, former member of the FIC Advisory Board, received the 2001 Medal of Science from the President at a White House ceremony on June 13. Dr. Harold Varmus, former NIH Director, also was honored. Dr. Gro Harlem Brundtland has announced that she will leave the World Health Organization (WHO) at the end of her current term in July 2003. Dr. Keusch noted that the process for selecting a new director general is under way, and he invited the Board members to suggest candidates to the FIC for transmittal to the Department of Health and Human Services.
Dr. Richard Carmona was confirmed by the U.S. Senate in July as the new U.S. Surgeon General. Dr. Julie Gerberding was named the new director of the Centers for Disease Control and Prevention (CDC); Dr. Keusch indicated that Dr. Gerberding will participate in the Board's February 2003 meeting. Dr. Jack Whitescarver was named permanent director of the NIH Office of AIDS Research (OAR), and Dr. Donna Dean was named deputy director of the new National Institute for Biomedical Imaging and Bioengineering (NIBIB). Dr. Roderic I. Pettigrew is the director-designate for NIBIB.
Dr. Keusch noted that Ms. Sharon Nieberding retired from the Federal Government in June, after serving as FIC Personnel Officer for more than 20 years.
Reflections of the Year Past
Dr. Keusch commented that, 1 year ago, just before September 11, the FIC had hosted and cosponsored the successful international conference on "Stigma and Global Health: Developing a Research Agenda." The fall 2001 Board meeting was conducted as a telephone conference. Dr. Keusch noted that, since this time, FIC has reaffirmed its commitment to science for global health and is working even harder and in close collaboration with partner ICs to mobilize and extend the benefits of science to improve health and quality of life worldwide. FIC's partnership with other ICs is stronger and more extensive than ever before. In remembrance of the events 1 year ago, the Board observed a moment of silence.
Recent Activities
Dr. Keusch highlighted FIC's plans to celebrate its 35th anniversary during Fiscal Year (FY) 2003. FIC staff are organizing two major events: a year-long lecture series and a scientific symposium. The lecture series begins next month on October 28 with the David E. Barmes Global Health Lecture, co-sponsored by FIC and NIDCR. Each lecture in the series will address critical issues in global health (see the written Report of the Director for titles and presenters).
In addition, on May 20-21, 2003, in conjunction with the Board meeting, FIC will sponsor a scientific symposium entitled "Science for Global Health." FIC is organizing the symposium in collaboration with The Honorable Paul Rogers, The Honorable John Porter, and additional distinguished honorary co-chairs. The two scientific co-chairs are Dr. Charles Carpenter, Brown University, and former Board member Dr. Adel Mahmoud, Merck Vaccines. Dr. Keusch noted that the symposium, which is being designed to address current global issues in health and, in particular, the role of research, will help focus NIH thinking about international research and identify key program areas for FIC. The four sessions of presentations and discussions are entitled
- global health: why it matters;
- science for global health: challenges and opportunities;
- science for global health: building partnerships across geographic boundaries; and
- FIC program impact
Dr. Keusch reviewed the list of invited presenters, who include leaders of the major multinational, non-governmental, and research organizations contributing to international science and health. He noted that FIC will keep the Board apprised of its progress in organizing the symposium and anticipates that Board members will participate actively in the discussion.
FIC Budget
Mr. Richard Miller, Executive Officer, FIC, presented an update on the status of the FY 2003 budget for the NIH and FIC. He noted that congressional action on the President's Budget has been limited and that the NIH expects to be operating under a continuing resolution when FY 2003 begins on October 1, 2002. Under a continuing resolution, the NIH would continue to operate at the current, FY 2002, budget level. NIH does not anticipate receiving a final appropriation for FY 2003 until after the November elections.
The President's Budget for FY 2003 provides approximately $27.2 billion for the NIH, an increase of 15.8 percent over the FY 2002 budget. The Senate Appropriations Subcommittee has proposed an additional increase of $25 million; the House Appropriations Subcommittee has not taken any action yet. For FIC, the President's Budget provides approximately $63.4 million, an increase of 11.4 percent over FY 2002. The Senate Appropriations Subcommittee has proposed to reduce this provision by $2.5 million. The subcommittee also has proposed to reduce the President's Budget for two additional NIH components and to redistribute these amounts to other ICs. Mr. Miller noted that, if the Senate's proposal prevails, FIC will have to reexamine its support for both existing programs and new, planned initiatives.
In discussion, the Board asked FIC to elaborate on possible reasons for the Senate's action. Mr. Miller noted that the Congress is faced with balancing many competing demands for funding support and that budget funds are limited. Dr. Keusch commented on the difficulty of identifying an advocacy group for global health and of differentiating FIC international activities from those of its partner ICs. Also, the recent visibility of other global health efforts may lessen the perceived importance of NIH international research. Dr. Keusch noted that the Senate's proposed redistribution of $2.5 million from FIC's budget would be an enormous reduction for FIC and have a significant impact on FIC activities, but is only a small drop in a very large bucket for other ICs or NIH. He anticipated that the planned symposium in May 2003 would help clarify issues concerning governmental responsibilities for global health and inform Congress about FIC's role within this broader context.
The Board emphasized the need to change the base amount of the FIC budget, beyond the small percentage increases awarded each year. Dr. Keusch noted that, in discussions with the new NIH director, FIC is highlighting investments in global health and collaborative research as an NIH priority. He said that FIC will continue to operate within the resources available and, in its unique role, act as the NIH catalyst for international research, partnering with other ICs, some of which have a larger international budget than FIC.
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Areas of Progress
Dr. Keusch invited staff to report on progress of FIC activities in HIV/AIDS, the Multilateral Initiative on Malaria (MIM), and revision of the study entitled Disease Control Priorities in Developing Countries Project (DCPP). He reported on FIC initiatives in tobacco and health and research on stigma.
HIV/AIDS Activities. Dr. Keusch noted that HIV/AIDS continues to be the single most prominent issue in global health and that FIC's capacity-building efforts for the past 15 years have had a major impact in the developing world. Staff reported on activities in China, India, and Russia and highlighted FIC's role in facilitating networking across programs within countries.
Dr. Jeanne McDermott, Program Officer, Division of International Training and Research (DITR), reported on the status of FIC's International Clinical, Operational, and Health Services Research and Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB) and on the planning for a meeting in China. The purpose of the ICOHRTA-AIDS/TB is to integrate training in clinical, operational, and health services research at foreign sites, to facilitate the translation of research findings into practice and to increase in-country capacity for grantsmanship and research management. FIC supports this program in collaboration with other ICs and the CDC. The program places primary emphasis on the leadership and role of the foreign institution. Dr. McDermott noted that FIC received 26 geographically diverse applications for phase I planning grants and will soon make the awards. Competition for phase II, full training awards will begin in FY 2003. Each phase II award (supported as a cooperative agreement) will include separate awards to the foreign site and its collaborating partner.
On November 1-3, 2002, FIC and other NIH staff will participate in a Sino-U.S. Conference on Research and Training in AIDS-Related Areas, to be held in Beijing, China. Dr. McDermott noted that the concept for this meeting arose at a networking meeting of FIC's AIDS International Training and Research Program (AITRP) directors in November 2000. Held in collaboration with the Chinese CDC, the conference will bring together U.S. investigators (including AITRP directors) and Chinese investigators involved or interested in AIDS research in China to discuss China's new 5-year plan to address AIDS, ways to increase collaborations, and ways to increase capacity within China for research on HIV/AIDS.
Dr. Kenneth Bridbord, Director, DITR, noted that FIC made a strategic decision several years ago to substantially expand AITRP activities in China and India, the world's two most populous countries, to maximize its investments in capacity building for research and prevention related to HIV/AIDS. He commented that FIC plans to convene a networking meeting among the nine AITRP program directors in India, similar to that in China, and is considering other strategies to further interrelate FIC's and other NIH investments in HIV/AIDS within different foreign sites and countries. Dr. Keusch noted that FIC's proactive approach to creating networks within countries where NIH has substantial investments is an important step forward in ensuring that countries are prepared to respond to the complex issues of HIV/AIDS. He suggested that FIC ultimately would like to foster in-country networking across disease-specific program areas, to better relate methodologies and insights.
In discussion, the Board acknowledged the progress of the Chinese Government in recognizing the seriousness of the HIV/AIDS epidemic in China, but expressed concern about the arrest in China of a public health advocate for AIDS.
Ms. Natalie Tomitch, Program Officer, Division of International Relations, reported that FIC and the National Institute of Allergy and Infectious Diseases participated in an exploratory meeting on HIV/AIDS in Russia, which was hosted by the OAR during the XIV International AIDS Conference, held in Barcelona, Spain, in July 2002. This meeting, which included legislators from the Russian parliament, followed on previous discussions with OAR initiated by Russian researchers. Ms. Tomitch noted that the Russian participants would like to develop a strategy, which includes research, to address the epidemic in Russia. During the productive meeting, the participants agreed to form a joint working group to examine the broad issue of HIV/AIDS (including opportunistic infections, drug abuse) , delineate mutual interests and priorities, identify potential collaborations, and meet regularly (possibly annually). The areas initially proposed included prevention technologies, vaccine development, microbicides, and diagnostics. Planning is under way for a June 2003 meeting in Russia, which could include high-level legislators from both the United States and Russia.
Dr. Bridbord reported that FIC is working with Dr. Michael Merson at Yale University on a special pilot project to involve participants from all FIC-supported U.S.-Russia collaborative programs (not just HIV/AIDS) in a collaborative venture to train a world-class faculty of public health in Russia. The FIC is supporting an initial planning meeting in St. Petersburg in January 2003. Dr. Bridbord noted that this effort is another example of FIC's catalytic investments in strategic activities. This unique attribute of FIC serves the global health agenda and helps to meet areas of need internationally. Dr. Bridbord noted also the U.S. Civilian Research and Development Foundation has agreed to fund a networking meeting in Georgia of NIH-supported investigators working in the region.
Tobacco Use and Control Research Training Program. Dr. Keusch said that FIC will present a funding plan for this program to the Board during the closed session of the meeting. He noted that FIC is collaborating with other ICs to generate a significant amount of funding for this exciting area of research, which has not heretofore been supported in developing countries and which will link with tobacco control programs supported by WHO. The aim is to create a global network of researchers in the field. Following the Board's action, FIC will announce the program publicly.
Stigma and Global Health Research Program. As follow-up to the successful international conference on "Stigma and Global Health: Developing a Research Agenda," FIC issued a Request for Applications on August 28, 2002, for support of interdisciplinary research on stigma in health and interventions to prevent or mitigate its effects. Applications are due by November 14. Dr. Keusch noted that this is the first research program to understand issues of stigma, which is a pervasive global problem, and to develop evidence-based intervention methodologies. The FIC is supporting this effort in collaboration with 11 NIH partners, the Health Resources and Services Administration, and two international science-funding agencies.
Multilateral Initiative on Malaria. Dr. Andrea Egan, Coordinator, MIM Secretariat, reported that the MIM Secretariat will move from FIC to Sweden (Stockholm University, Karolinska Institute, and the Swedish Institute for Infectious Disease Control) for 2003 to 2005. FIC has served as Secretariat since 1999; the first Secretariat was The Wellcome Trust in the United Kingdom. In its final months, the Secretariat at FIC has introduced a new training program in leadership and management for directors of research institutes in Africa and will hold a 2-week pilot training workshop in October 2002 in Arusha, Tanzania, for 19 research directors and potential directors. It is organizing the Third MIM Pan-African Malaria Conference, for November 2002 in Arusha, Tanzania, and is collaborating with the American Society of Hematology to organize a future training workshop for malariologists from Africa, for December 2002 in Philadelphia. The Pan-African Malaria Conference is expected to draw 900 individuals (one-half from malaria-endemic countries), and close to 800 abstracts have been submitted. A final report on FIC's activities under the MIM will be provided later. Dr. Egan noted that the Swedish Secretariat is dedicated to working with African institutions with a view to potentially locating the next MIM Secretariat in Africa.
Disease Control Priorities in Developing Countries Project. Dr. Joel Breman, Senior Scientific Advisor, Division of International Epidemiology and Population Studies, noted that the aim of the DCPP is to define and quantify health problems in developing countries and to marshal thought and action on cost-effective interventions to decrease the prevalence and incidence of these problems. He reported that the Bill & Melinda Gates Foundation would provide $3.5 million to support this collaborative FIC-WHO-World Bank project. Authors are being selected for the 75 chapters in the second, revised edition of the document, which will be published in 2005. Intermediate consensus conferences and workshops are being organized. These include a meeting on methodologies to assess cost-effectiveness, to be held November 6-7 at FIC; a workshop at the Third MIM Pan-African Malaria Conference, at which 18 presenters will address issues related to malaria as a medical and economic priority; a tropical diseases workshop, to be held in Brazil in spring 2003; and other workshops to address other disease areas. Dr. Breman stated that FIC serves as the Secretariat for DCPP and is obtaining input from other ICs to help define science as a priority for developing countries, an important aspect that will differentiate the second edition of DCPP from the first edition published in 1993. Dr. Breman noted that DCPP is a "living activity" (i.e., more than publication of a book).
In discussion, the Board emphasized the importance of ensuring that the revised edition is distributed broadly. Dr. Breman reported that the partners are developing a plan for electronically disseminating the working papers developed for the book and that the Oxford University Press, in collaboration with the World Bank, will market the final printed edition at very low cost worldwide, particularly in developing countries. Dr. Keusch commented that the first edition has been very useful for many constituencies worldwide and that the process for preparing the second edition will engage thousands of individuals and multiple disciplines north to south.
For additional details on personnel changes, the FIC budget, and FIC activities, see the written Report of the Director (Attachment 2).
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VI. INTELLECTUAL PROPERTY RIGHTS AND NIH-SUPPORTED FOREIGN ENTITIES
Dr. Wendy Baldwin, Deputy Director for Extramural Research, NIH, discussed the proposed revisions in NIH policy regarding intellectual property developed under NIH funding agreements with foreign institutions. NIH published the proposed revisions, entitled "Planned Modification of Rights to Subject Inventions Made Through Funding Agreements to Foreign Entities," in the March 14, 2002, issue of the NIH Guide to Grants and Contracts. NIH is proposing to modify the terms for NIH-funded awards (contracts, grants, cooperative agreements) to foreign entities, to allow foreign entities to retain the right to elect to retain title to the inventions in their countries while the NIH would have the entire rights in all other countries. Foreign entities could request greater rights (e.g., to license an invention for which the U.S. Government has title, or to retain the title to an invention in designated countries) on a case-by-case basis.
Dr. Baldwin noted that with the passage of the Bayh-Dole Act in 1980, the rights to intellectual property developed under Federally funded research accrue to the grantee or contractor institution, whether domestic or foreign. The current NIH proposal would "switch the default setting" so that all rights and title to an invention would not automatically convey to the foreign institution; some would be retained by the U.S. Government, and requests for greater rights could be reviewed separately, at the time of award, for individual cases. The NIH revisions are proposed as a strategy for protecting U.S. taxpayers' investment in U.S.-funded research overseas. Dr. Baldwin emphasized that most NIH awards do not result in an invention or a patentable product, although they often yield other returns such as the creation of jobs or formation of small businesses, which also serve to "drive" the economic engine. Dr. Baldwin noted that by establishing a thoughtful overall strategy, NIH could avoid having to make quick decisions in incident cases or to exercise "march-in" to affect the grantee/contractor's rights-a difficult, slow, and costly process that has never, in fact, been invoked.
Since the publication of the NIH Guide announcement in March, the NIH has received inquiries and comments from several foreign grantees. Dr. Baldwin noted that, to ensure full and fair discussion, NIH recently extended the discussion period such that the proposed policy change would not take effect until August 2003 at the earliest. She invited the Board's comments.
Discussion
The Board expressed concern that the planned modification may discourage foreign scientists from applying for NIH grants because it could make the grant application process seem even more intimidating to them and heighten their institutions' sensitivities to perceptions of American scientific colonialism. Dr. Baldwin noted that the planned modification would not change the application requirements for potential grantees. She suggested that the potential costs (e.g., psychological, political) of the proposed modification need to be fully discussed and weighed against the unintended and potentially substantial risks of not protecting U.S. rights to the outcome of NIH-supported research. The policy change would apply to all NIH components, including FIC.
The Board asked about how the NIH was obtaining input from the international scientific community and the extent to which the proposed policy would affect FIC grantees. Dr. Keusch commented that extension of the comment period will give FIC additional time to discuss and clarify the issues involved with its international colleagues. He said that the comments received so far indicate both concern and a lack of understanding, which could best be approached through face-to-face discussions in a conference setting. Dr. Keusch noted that, for the past 2 years, FIC has been exploring the issue of intellectual property concerning needs of developing countries (see section VII below), and he encouraged the Board to provide input on systematic efforts that FIC could undertake.
The Board commented that U.S. taxpayers and foreign countries should both have an opportunity to benefit from NIH-funded research that involves foreign institutions and yields subject inventions. The members also noted that determining the rights to inventions on purely a case-by-case basis, without having an overall strategy, was untenable. NIH-supported international research is extensive and often involves complex co-funding arrangements that may include multiple domestic and international partners from both public and private sectors. Dr. Keusch highlighted this complexity as a key issue to be addressed. Additional concerns include, for example, the possibility that the proposed revision could result in underreporting of inventions by foreign institutions and the co-opting of foreign scientists' inventions by their governments.
In closing, Dr. Baldwin emphasized the need to protect the fundamental precepts of the Bayh-Dole Act and to protect NIH's ability to make funding awards outside the United States. She encouraged the Board members to communicate directly with her on this issue. She accepted Dr. Keusch's proposal to convene a consultation of scientists from the developing world and funding agencies to hear firsthand any comments on the proposed policy change.
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VII. INTELLECTUAL PROPERTY AND BETTER HEALTH: THE MIHR APPROACH
Dr. Richard Mahoney, Professor, School of Health Administration and Policy, and Arizona Biodesign Institute, Arizona State University, Tempe, described the origin, organization, and planned activities for the Centre for the Management of Intellectual Property in Health Research and Development (MIHR). Dr. Mahoney is currently Acting Chief Executive Officer of MIHR. He has more than 30 years of experience in formulating international policies and management guidelines for intellectual property rights.
Dr. Mahoney noted that the concept of a concerted approach to the management of intellectual property (IP) in health research and development was proposed by Dr. Keusch at a December 2000 meeting at The Wellcome Trust Genome Research Center in Hinxton, United Kingdom. The concept subsequently was explored in a feasibility study sponsored by the Rockefeller Foundation and conducted by Dr. Mahoney. The central question was "Can better public-sector management of IP in health research and development have an important impact on health equity, and, if so, how can these management needs be addressed?" Dr. Mahoney defined IP as including patents, trade secrets, copyrights, and trademarks; management of IP involves the securing and management of these IP with licenses. Two inequities in health potentially related to management of IP are availability of products and affordability of new products, both of which are being addressed by the public and private sectors.
Dr. Mahoney noted that the feasibility study was a broad consultative process that involved almost 100 organizations in developed and developing countries. Four main conclusions were derived: IP is increasingly important among public-sector leaders; understanding of how the public sector can better manage IP is limited; the public sector is at a disadvantage and has limited capabilities, compared with the private sector, for managing IP, particularly in developing countries; and understanding of the quantitative value of better managing IP (e.g., by increasing the availability of products) is limited. Dr. Mahoney noted that, for the public sector, IP is a "huge black box" and public leaders expressed a need to be able to manage IP more effectively to achieve their goals. He suggested that the importance placed on better management of IP is related to regulatory requirements and the exercise of democracy (i.e., the right of individuals to receive safe and effective pharmaceuticals). Since the time 50 years ago when Jonas Salk asked "would you patent the sun?," IP has become a critically important issue in the development, testing, production, and distribution of drugs. The costs for developing a new vaccine have risen to very high levels, making it absolutely necessary to have IP protection to attract investment capital.
Dr. Mahoney elaborated on some of the more important clauses in negotiated licenses to manage IP related to international health research and development. He highlighted field of use (e.g., special provisions that may apply to possible uses of a product for diseases that affect poor populations), ownership of IP (e.g., by the public sector, in proportion to its contribution to product development), territory (e.g., the extension of licensing rights to different countries), and sharing of revenues (e.g., pricing of products, royalties from product sales, special provisions to benefit the public or poor populations).
Dr. Mahoney noted that dozens of public-sector organizations, including NIH, are involved in health research and development worldwide, and they may not (and perhaps should not or cannot) give specific professional attention to the highly complex and vitally important area of IP management. The range of issues for developing countries is extensive and includes government, research, university, and transnational concerns that need to be addressed in a dedicated and focused manner. A central resource would facilitate the sharing of successes and failures in management of IP across organizations; offer a center of excellence that could provide technical assistance; serve as an independent body that would be perceived as sensitive and trustworthy by developing countries; and expand on the related IP efforts of other organizations that do not address in detail the particular issues in health research and development [e.g., WHO, World Intellectual Property Organization (WIPO)].
The purpose of MIHR is to provide this central resource. It will address public-sector needs for better management of IP in health research and development. The board of directors, recently formed, is composed of diverse international leaders and is chaired by a former FIC Scholar-in-Residence, Dr. S. Ramachandran. The headquarters are in London, and MIHR will have a presence in Asia, Africa, and Latin America. Dr. Mahoney said that four outstanding candidates are being considered for the position of chief executive officer, which will be filled in January 2003. He emphasized that MIHR will not be a new, large bureaucracy, but will rely on the participation of interested organizations and highly qualified individuals, many of whom are already volunteering to contribute their time pro bono. Dr. Keusch will chair the Committee of Interested Parties, which already consists of many major international organizations and groups working in developing countries. MIHR will be launched at the first meeting of its board of directors at the end of September and, again, on a global basis at the Global Forum on Health Research, to be held in Arusha, Tanzania, in November.
Dr. Mahoney noted that MIHR already is receiving requests for technical assistance in IP management from all regions of the world. Five main activities envisaged for MIHR, which promise to have high impact, include (i) identification of best practices in licensing, including development of a handbook on technology transfer for developing countries, which will be published in early 2003; (ii) training of scientists and university administrators, potentially in collaboration with FIC; (iii) provision of technical and legal services; (iv) development of information services, which will include a database of patents; and (v) research on quantitative relationships between IP and the availability and cost of health products. In closing, Dr. Mahoney invited the Board's advice, suggestions, and recommendations for assuring the effectiveness of MIHR.
Discussion
Dr. Keusch said that additional efforts are coalescing around the issues of IP and that FIC and NIH will continue and expand its activities in this area. He mentioned an organization of IP lawyers, Public Interest Intellectual Property Advocates, that is forming and will provide legal advice pro bono. Dr. Keusch emphasized the need to continue to push the public good in IP that is generated, in particular, with public funding and especially licensing.
Dr. Mark Rohrbaugh, Acting Director, Office of Technology Transfer, NIH, commented that NIH continues to be very interested in supporting and licensing the development of therapeutics, drugs, and vaccines for developing countries and in finding new and creative ways of using licensing strategies to do this. NIH continues to seeks ways to provide incentives for development of products in developing countries and will pursue actual licensing of products in developing countries that have a capacity for manufacturing and in middle-income countries that could serve as centers for building capacity and as less-expensive manufacturing sites. In response to questions, Dr. Rohrbaugh said that NIH is required by law to favor small U.S. businesses in its licensing, but can also work with large multinational or foreign companies to include multinational marketing incentives in licenses with them (e.g., foregoing NIH royalties in developing countries and/or requiring the submission of plans to bring products to market in developing countries prior to licensure by the Food and Drug Administration). NIH is considering many other options and strategies (e.g., regional licensing or sub-licensing) to accelerate the licensing of affordable products in developing countries.
In closing, Dr. Keusch noted that, over the past 2 years, FIC's focus on research and research training has expanded from the traditional spectrum of research per se to include core disciplines such as bioinformatics, bioethics, and IP which are essential components of the research endeavor. He noted that FIC has provided leadership in advocacy, funding, and programmatic activity in each of these areas directly and in collaboration with other NIH components. FIC's contribution to the organization of MIHR is a key example. These efforts reflect a broader concept of capacity development, adopted by FIC and NIH, that includes not only support for research, but also for the capabilities and infrastructure that underpin this research.
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VIII. 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.
IX. REVIEW OF APPLICATION
Dr. Sharon Hrynkow chaired the remainder of the meeting during which the Research Awards Subcommittee reported on its activities. A total of 91 scored competing applications were reviewed by the FIC Advisory Board at the September 10 meeting.[2] The applications were in the following programs:
2 applications for the International Malaria Research Training Program (IMRT), out of a total of 2 applications;
26 applications for the Fogarty International Research Collaboration Award (FIRCA) program, out of a total of 48 applications;
7 applications for the HIV-AIDS and Related Illnesses Collaboration Award (AIDS-FIRCA) program, out of a total of 8 applications;
9 applications for the International Research Scientist Development Award for U.S. Postdoctoral Scientists (IRSDA), out of a total of 16 applications;
18 applications for the International Clinical, Operational, and Health Services Research and Training Award for AIDS and Tuberculosis (ICOHRTA-AIDS/TB), out of a total of 25 applications;
9 applications for the International Collaborative Genetics Research Training Program, out of a total of 24 applications
20 applications for the Global Health Research Initiative Program for New Foreign Investigators (GRIP), out of a total of 41 applications.
The Board concurred with the initial review group recommendations for the 91 applications.
X. ADJOURNMENT
There being no further business, the meeting was adjourned at 3:00 p.m. on September 10, 2002
[1] Members absent themselves from the meeting when the Board discusses applications from their own institutions or when a conflict of interest might occur. The procedure applies only to individual applications discussed, not to en bloc actions.
[2] Applications that were noncompetitive or unscored or were not recommended for further consideration by initial review groups were not considered by the Council.
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