Pharmaceuticals for Developing Countries: Conference Proceedings (1979)

Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

INTERNATIONAL HEALTH: FROM THE PERSPECTIVE OF THE CARTER ADMINISTRATION Gilbert S. Omenn Introductory Comments I am pleased to have this opportunity to describe the international health perspective of the Carter Administration. I hope that I can con- tribute to your discussions by providing our view of the broader policy context within which this Conference on Pharmaceuticals for Developing Countries is taking place. We support Institute of Medicine efforts to elucidate the nature and interactions of the many elements which comprise the complex field of endeavor we call international health. These elements are scien- tific, medical, public health, commercial, regulatory, social, politi- cal, and humanitarian. Based on the experience of the participants, the breadth of the agenda, and the quality of the presentations, I am confident that this Conference will advance our understanding of the current opportunities for use of pharmaceutical agents in the prevention and control of disease in developing countries. As a clinical investi- gator myself, I am very impressed that this Conference has brought to- gether leading people from academic and industrial sectors, both here and abroad. Several months ago, I came to the Institute of Medicine on behalf of the White House to seek assistance in addressing the complex issues associated with the conduct of clinical investigations in developing countries. The Institute has agreed to initiate a study of the ration- ale for undertaking clinical investigations in developing countries, the scientific opportunities and needs for such investigations, social, cultural, and ethical considerations, and various regulatory, legal, and logistical constraints. A distinguished Steering Committee, chaired by Dr. Robert Petersdorf, has been formed, and members of the Steering Committee are attending this Conference as a prelude to their broader review of issues and opportunities in clinical research in developing countries. 168

Background President Carter has a long-standing and deep interest in inter- national health. This interest is a logical and humanitarian component of the President's belief that world peace depends upon a commitment to basic human rights, a commitment which transcends geographical and ideo- logical boundaries. From the very beginning of his term in office, President Carter has focused attention on human rights, human needs, and health. In a number of major speeches, messages, and statements — starting with the Inaugural Address — the President and his top advisors have stressed this Nation's resolve to address the needs of the poorest people in the developing world, those who lack essential food, water, shelter, and health care. In a September 1977 message to the Pan American Health Organization's meeting of Ministers of Health of the Americas, the President emphasized: "Our commitment in this regard is total, our resolve firm, our focus on the needs of all people, regardless of poli- tics or ideology. Let me reaffirm here today the United States concern for the social and economic rights of all citizens of the world. A special concern for us is the continued cooperation with the developing nations to assist them in providing for the basic health needs of the poor majority." Consistent with this focus on basic human needs and with a planned expansion of foreign aid with emphasis on the poorest of the world's people, the Administration conducted an interagency study of inter- national health needs and a review of United States government activi- ties in international health. Chaired by Peter Bourne and including participation by the Office of Science and Technology Policy, the study sought effective ways in which the United States government and private organizations could help reduce the human and economic impact of wide- spread malnutrition, infectious diseases, and other health hazards, including those associated with frequent childbirth. That review formed the basis for a Presidential Statement on International Health, issued May 2, 1978. This statement first recog- nized the tremendous gap between the demonstrated potential for good health and the poor health of people in vast areas of the world today, and then dedicated the Carter Administration to work in partnerhsip with international organizations and with other countries to help peo- ple meet their basic human needs, and to improve health, nutrition, and family planning. The President emphasized his intention to strengthen the participation of the United States in worldwide efforts to overcome disease and to improve health. At the World Health Assembly in Geneva later that same month, 169

Health, Education, and Welfare Secretary Califano presented four basic principles underlying the program announced by the President: • A basic level of health, nutrition, and family planning services should be available to the world's poor, whether they live in rural areas or urban slums. • Developing nations can eventually meet their own health needs if we assist them in strengthening their institu- tions and building their own health systems. • Community-based primary health care, including the use of community resources and the local training of appro- priate personnel, is the most effective means of achiev- ing the standard of health we desire for all people. • Prevention of disease and ill health, with special emphasis on providing clean drinking water, basic sani- tation, nutrition, and basic immunizations, will be reflected in our own programs and in our support of priorities established by various international organizations. International Health Strategy and Programs With these principles in mind, a general strategy for increasing the effectiveness of United States efforts in international health has been formulated. There are six components to this strategy: 1. Build greater awareness, among the American people, of the legitimacy and importance of our foreign policy goal of improv- ing other people's capacity to meet their basic human needs. A major theme of the Carter Administration's foreign policy is the use of American know-how and financial and human resources to help other nations achieve economic and social development objectives and meet the basic human needs of their peoples. 2. Strengthen institutions in our government which deal with international health problems and improve the use of existing resources through better coordination. A number of initia- tives have been taken to strengthen Federal institutions involved with various aspects of international health and to increase substantially the cooperation among these institutions. Department of Health, Education, and Welfare (HEW) Current HEW authority in international health is limited to those activities that benefit United States citizens at home or abroad. This authority does 170

permit agencies such as the National Institutes of Health, the Center for Disease Control, and the Food and Drug Administration to undertake certain international activities in scientific exchange, collaborative research, and disease surveillance and investigation. However, many believe that the resources and capabilities of the Department should be available to meet a broader range of international health needs. An International Health Policy Board within HEW has been assessing the need for an expanded mandate in international health, organizational options for strengthening HEW international health efforts, and poten- tial legislative initiatives. There is also Congressional interest in enhancing the role of HEW in international health. Two of the Congressonal figures most inter- ested in these issues — Senator Javits and Senator Kennedy — are addressing this Conference. Senator Javits sponsored a sweeping inter- national health bill last year (S. 3103) and is preparing to reintro- duce legislation this session. I understand Senator Kennedy also is contemplating international health legislation this session. However, as Senator Kennedy and especially Walsh McDermott emphasized, health should not be viewed in isolation from other efforts to improve the lives and living conditions of the poor majority. Department of State The State Department is responsible for development, implementation, and monitoring of United States foreign policy as it relates to both the developed and the developing countries. Its foreign assistance programs aimed at developing countries are ad- ministered by the Agency for International Development (AID) (see below). In addition, the State Department has a Bureau for Oceans and Inter- national Environmental and Scientific Affairs (OES) with responsibility for policy related to population, the environment, and oceans and fish- eries. This Bureau recently has been greatly strengthened by the ap- pointment of Ambassador Thomas Pickering to be the Assistant Secretary responsible for OES. A Congressional mandate contained in Title V of the Foreign Relations Authorization Act for FY 1979 (PL 95-426) directs the Secretary of State to assume primary responsibility for coordina- tion and oversight of all major science and technology activities between the United States and foreign countries or multilateral organi- zations. To facilitate these responsibilities for interagency coordi- nation under Title V, Ambassador Pickering has activated a Committee on International Science, Engineering, and Technology within the Feder- al Coordinating Council on Science, Engineering, and Technology (chaired by Frank Press). This Committee will integrate and coordinate Federal agency planning and implementation of international science and technology programs, including those related to international health. Agency for International Development (AID) The AID program forms the core of United States government efforts to promote better health in the Third World. AID is strengthening its attack on the major health problems of the poor — common infectious diseases, malnutrition, and high fertility — by focusing on four key elements: (l) integrated 171

health delivery systems which provide health, nutrition, and family planning services at the community level; (2) safer water and better sanitation, especially in rural areas; (3) control of malaria and devel- opment of better approaches to the control of other tropical diseases requiring special campaigns (_e•£. , onchocerciasis, schistosomiasis, and trypanosomiasis); and (4) health planning and management to promote co- ordinaation of these and related developmental efforts for improving health. In Fiscal 1979, AID is obligating $130 million to support health delivery programs, environmental health, disease control, and health planning. An additional $185 million is being devoted to AID's expanded population planning programs, in cooperation with developing countries and other donors. Peace Corps Through its well-placed volunteers, the Peace Corps is involved in various aspects of international health. Volunteers work as community health personnel, in the training of host-country nationals, in local resource development, and in special disease cam- paigns, such as immunization programs. The Peace Corps is seeking to strengthen its programming in international health, recognizing that health is a critical component of the development process and of basic human needs. Interagency Coordination An International Health Subcommittee of the Development Coordination Committee (chaired by AID Administrator John Gilligan) has been established to facilitate coordinated and effec- tive planning and implementation of United States government inter- national health programs. Co-chaired by Jack Bryant of HEW and Steve Joseph of AID, the Subcommittee consists of representatives of HEW, AID, State Department, Department of Defense, ACTION (Peace Corps), Office of Management and Budget, National Security Council, OSTP, and the ISTC Planning Office (see below). 3. Create a new Federal agency to mobilize science and technology for the needs of developing countries, to be called the Insti- tute for Scientific and Technological Cooperation. In his speech in Caracas in March of 1978, President Carter announced he would seek the creation of an Institute for Scientific and Technological Cooperation (ISTC) (earlier called the Founda- tion for International Technological Cooperation.) The ISTC will work directly with United States and developing country institutions and agencies to improve scientific and technical capabilities for problem-solving in the developing countries and to address cooperatively critical long-term problems of development. The ISTC would be the principal central research and technology development agency within an International Development Cooperation Administration, currently under con- sideration by the President's Reorganization team. ISTC will provide a key mechanism to implement certain of our objectives in international health as well as appropriate recommendations from the President's Commission on World Hunger, headed by 172

Ambassador Linowitz. An extremely important part of the ISTC mandate is to work with the middleincome countries in addition to the less developed countries (LDCs). A planning office was formed to prepare a prospectus and budget for the ISTC which was included in the President's Budget Message to Congress last week. The Institute is expected to begin operation in the fall of 1979. 4. More fully involve American universities, technological founda- tions, and other private organizations in making United States scientific and professional resources more accessible to the developing world. The greatest reservoirs of professional talent in areas related to international health are in the aca- demic community, private foundations, and various private vol- untary organizations. The Federal government needs to work in closer partnership with these institutions and organizations to draw more effectively upon those talented people, with their experience and their flexibility, to undertake field-ori- ented assignments. With the increasing visibility of American commitment to bilateral and multilateral assistance and cooper- ation, and with the creation of the ISTC, we are confident that the government can build more productive and supportive relationships with private institutions and organizations. 5. Increase cooperation with private industry. The Carter Administration is committed across the board to improving interactions between industry and government and attempting, where feasible, to define complementary governmental and pri- vate sector roles. The Administration, on President Carter's instructions, has initiated a major review of industrial inno- vation. This review is designed to generate recommendations for reducing disincentives to private sector investment in research and innovation and for stimulating industrial innova- tion through new policies, programs, or incentives. We be- lieve that innovation is important to productivity, trade balance, jobs, and worldwide problem solving. In international health, the commercial sector accounts for a major portion of all United States international health activity, al- though the greatest proportion of this commerce, investment, and trade is among developed countries. There is need to enchance commercial sector involvement in international health efforts aimed at the poorer countries, to complement government and private voluntary efforts to improve health in the developing countries. This Conference, supported by HEW, is an important stimulus to such an effort. 6. Work closely with the nations around the world, individually and through organizations such as WHO, UNICEF, the World Bank, and the Regional Development Banks, to improve the health of 173

people everywhere. The United states Is joining with other nations bilaterally and through multilateral organizations such as WHO to develop cooperative approaches to meeting basic human needs and improving health. We have joined with WHO in developing long-term health goals and in developing strategies and plans to meet those goals. We are providing support for such WHO initiatives as the Tropical Disease Research Program, the Expanded Program for Immunization, and the Program for Pre- vention of Blindness. We were pleased to have Dr. Mahler of WHO visit here in October, and I personally had an opportunity at that time to meet Dr. Mahler, Dr. Lucas, Director of the Tropical Disease Program, and Dr. Bergstrom, Head of the WHO Advisory Committee on Medical Research. The Carter Administration has strengthened the government's capa- bilities and financial resources to address health needs of developing countries. We look to the pharmaceutical industry and others in the commercial sector, to universities and foundations, to private voluntary organizations, and to the American people for greater recognition of human needs, and greater efforts to overcome poverty and ill health of a kind that most of us here are fortunate enough not to have known. We believe we and you, here and abroad, have the experience, ingenuity, and commitment to make substantial progress for people throughout the world. 174