Pharmaceuticals for Developing Countries: Conference Proceedings (1979)

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INTERNATIONAL HEALTH POLICY INITIATIVES United States Senator Jacob K. Javits I am especially pleased to be here today to address this prestigious gathering of American and foreign experts on international health. I would like to commend David Hamburg for his leadership in calling this Conference, Lee Cluff for his role as chairman of the Conference Steering Committee, and Harold Simon for his thorough staff work in preparation for the Conference. I am very grateful that the Surgeon General, Dr. Julius Richmond, is here, and other such distin- guished New Yorkers as Joshua Lederberg and Jim Henry. Most of you know of my long-standing commitment to alleviating the problems of disease and disability throughout the world. Few people know that my interest in international health first began in the 1930s when I was involved in establishing so-called sanitary organizations in Latin America. Over the last three decades, I have been one of the major advo- cates of our foreign aid program and often its sponsor in the House and Senate. I have come to the conclusion that there is no single thing that has a greater benefit to every level of society and that pays off better than health care in developing countries. I might say also that this has been confirmed by the many authorities whom I've talked to and who have helped me to learn this. I want to mention, in particular, Kevin Cahill of New York who is now the medical and health advisor to Hugh Carey, our Governor. He has been instrumental in educating me and in encouraging my leadership in this area. I have been the author of the last two comprehensive international health bills in the Senate. In 197l, and again last year, I introduced major legislation aimed at coordinating, strengthening, and renewing our federal programs to meet health needs of developing nations. My bill would revitalize international health programs in this country by establishing better coordination among the 22 different federal agen- cies which expend $600 million on international health, by strength- ening our manpower development and training programs, and by upgrading the tropical medicine research programs at the National Institutes of Health and at the Center for Disease Control. The bill was based in 391

part upon the excellent report published by the Institute of Medicine last year on international health. I was honored that Senator Schweiker joined with me in sponsoring the bill of last session. Today, I announce my commitment to introduce a revision of my comprehensive bill in this area. I invite your comments and support as that legisla- tion is considered in the Congress. I will consult with the Institute of Medicine and with Jim Henry's Center for Public Resources, with the Surgeon General and with our aid authorities. Also, I have visited with leaders of the World Health Organization, seen some of its departmental heads and recognize the deep problems which they face in the monumental task of alleviating suffering from diseases of various kinds. Your concerns at this Conference, however, are somewhat narrower in scope than the subject of my legislation. You are interested speci- fically in pharmaceuticals for developing countries. But the light you have shed at this Conference has served to illuminate a far graver problem. As the eminent British stateman, Benjamin Disraeli, said: The health of the people is really the foundation upon which all happiness, and all their powers as the State, depend. I believe as Disraeli that the vitality of mankind can only be measured by the health of each man, woman, and child. The magnitude of this challenge is mindboggling. I fear that the barrage of staggering statistics of death and dis- ease in far-away places has had such a numbing effect on our sensitivi- ties and awareness that they represent mere numbers rather than a chill- ing reflection of human tragedy on a global scale. Every year 15.6 million children under the age of five die, almost all of them in the developing countries of the world, most of which are located in the tropics. This is nearly twice the population of New York City; it is five times the number of children born in the United States each year. More than 700 million people still live in absolute poverty, defined as per capita income of $200 per year or less. This amounts to almost 40 percent of the developing world's total population. How can we change this situation? — a situation which is really an ongoing war against humanity. No army — not even the most awesome military machine — has caused more misery and destruction. The ques- tion that is placed before us, then, is how can we best fight this seem- ingly invincible enemy of disease and pestilence? The topic of this Conference — Pharmaceuticals for Developing 392

Countries — is important. However, I strongly believe that we cannot restrict our concerns to this topic if we are really to address solu- tions for alleviating the pain and suffering of millions of individuals in the developing world. Pharmaceuticals are tools which have therapeutic potential. But we must ask if pharmaceuticals are appropriate tools alone for eradi- cating the causes of poor health conditions in the developing world. Simply put, I believe that health conditions in this large part of the world cannot be viewed apart from the economic, environmental, cultural, and social conditions which exist in these countries. The core disease patterns, as I understand them, are due to infectious and parasitic agents. In order to effectively control these diseases, it is essen- tial that water supplies be made safe, that there be sanitary waste disposal, that housing be adequate, that nutrition be drastically improved, and that environmental determinants of disease be controlled. Our experience in the western nations has shown conclusively that dramatically improved health status is directly related to such public health measures which are in turn a function of rising overall economic development. The role of any single therapeutic agent has been of com- paratively minor significance. What is accomplished by curing a man of a parasitic disease if he continues to live in the same environment and will become host to that parasite again within a short time? We accom- plish our objective only if we cure the stricken and eradicate or con- trol the parasitic source at the same time. I am committed to a broad-based, multinational approach to solving these problems. Responsibility for this effort must be shared by nation-states, international, and national voluntary organizations, financial institutions, academia, and the private sector in partnership with one another. For these reasons, we must involve ourselves in an unprecedented effort to attack health problems of developing nations. I wish to discuss the public service responsibility of the indus- try for joining in this effort. Yes, the private industry. The United States has been responsible for two great concepts in private enter- prise, which — if freedom prevails — will be the reason why it did. I deeply believe, and I feel most of my fellow countrymen also believe this, that unless you have the great preponderance of people of our society who wear two hats — one in the private economy and one as a citizen, you cannot preserve freedom. Once the government requires the citizen to wear one hat, freedom is finished. So, the two lessons which we have taught the world are: one — in business it is not neces- sary for A to lose so that B can gain. It is possible for both A and B to profit. This is the lesson vary well learned — it is the whole gifted key to the American business system. The other lesson, which is now just being learned, especially by the larger companies of the 393

United States, is that when you are the head of the company, you are also a public official. A successful enterprise must make its fair economic as well as social contribution. The strengths, the disci- plines, the devotion of resources, including research resources, must be applied to this public responsiblity. We must convene as soon as possible an International Health Congress, under the auspices of the White House, to which nations, the voluntary organizations throughout the world, the financial and aca- demic institutions, and the various interests in the private sector must send representatives to work out strategies and tactics that society must use to attack problems of debilitating health. I believe that in such a Congress the international pharmaceutial industry must play an essential role, a follow-up, if you will, to conferences such as this. In this Congress, representatives of the pharmaceutical industry should be prepared to discuss and to solve two distinct sets of prob- lems with respect to health policy. The first set of problems arises in the situation where there is a safe and effective drug already avail- able that is needed to treat patients in a developing country. Should the drug industry provide these drugs at cost or at a loss? Should there be an international fund to pay for these health care needs based on some percentage contribution from receiving nations? What should the United States foreign aid program's policy be with regard to subsidization of such costs? And, importantly for this Con- ference, what is the involvement of the pharmaceutical industry in the development process? The United States and other countries around the world have mounted developmental assistance programs through the years which have sought to assist developing nations in improving conditions there. United States aid efforts have adopted a basic human needs approach that focuses on the poorest people and their achievement of self-suf- ficiency to obtain the necessities of life and to bring them into the market economy. This approach recognizes that developing countries are characterized by dual economies and attempts to involve the poor in movement toward economic development. Right now, the pharmaceutical industry is expanding in the markets of the newly industrialized countries, such as Brazil and Argentina, that have affluent and rapidly Westernizing strata. It is clear that the industry has benefited from newly industrialized countries that have undergone dramatic transformation in a relatively brief time period and have a strong appetite for developed countries' products and services. It is the poorest countries and the poorest populations, however, that have the most desperate and fundamental need for our health and 394

pharmaceutical technology. While the poorest people and countries are not yet participating in market economies, the potential demand for health products and services is immense. Only economic development can translate this desperate need into market demand. The responsibility for development has been delegated to official assistance programs and international aid institutions. However, I do not believe development will occur without the essential factor of private sector participation and involvement. For humanitarian reasons I would like to see private industry play a larger role in the development process because of the tremendous bene- fit to millions of people through the improvements in living standards that would result. However, I believe the pharmaceutical industry has an extremely pragmatic interest in furthering economic development. Only when the developing countries "take off" will they provide new markets for pharmaceutical products and services. The industry itself must decide what their role is and the extent of their involvement in the development process — specifically public health. However, it is undeniable that, as developing countries pro- gress toward economic realization, they will benefit the pharmaceutical industry. Therefore, I urge the industry to support international for- eign assistance efforts. In the long-term, foreign aid and the eco- nomic development it fosters have tremendous implications for the indus- try represented here today. I also believe that the challenge of improving international health must be undertaken by a partnership of government and business. This joint effort approach is the basis of a proposal put forward by the President that has important ramifications for the health industry. The proposed Institute for Scientific and Technological Cooperation (ISTC) is an institution that will identify critical problems of devel- oping countries and apply technological expertise toward their solu- tions. An example of an ISTC project might be to finance studies on causes of vaccine and chemotherapy failure in tropical countries or to develop current satellite technology for use in mineral exploration and planning natural resource development. An advisory council drawn from private industry, universities, foreign participants, and other institutions will develop priorities on which basis ISTC will make grants and contracts. This is the kind of imaginative and long-term thinking that I believe would be of immea- surable service to developing countries and to the United States phar- maceutical industry. In addition to acquisition problems — who pays — there is the very serious problem of an appropriate delivery system. Many develop- ing countries have attempted to model their health delivery systems on the Western style, with super-specialized, hospital-based care, which 395

may in fact use up 75 percent of that nation's health care expenditures and serve fewer than 25 percent of the people. In most developing countries, the greatest health needs are located in the often inaccessi- ble rural areas. Such rural populations may have little access to drugs, let alone other health care and follow-up treatment. These complex questions can only be tackled, and solutions found, in the context of an International Health Congress at which the entire universe of health needs and solutions can be discussed in full context. I raise this issue to challenge you who are attending this speci- fic Conference to wrestle with the full seriousness and complexity of the problems associated not only with the use of existing drugs to treat patients in developing countries, but also to recognize that the health needs of developing countries require much more than treatment which can be provided by drugs. The second situation I wish to discuss is one in which a clearly needed safe and effective pharmaceutical has not yet been developed. This situation raises serious questions about the responsiblity of the drug industry to engage in needed types of drug research in the face of uncertain economic rewards. What incentives can be created to attract the industry's capital to these activities? Should United States com- panies be required to engage in this research? And if so, shouldn't non-United States companies be treated similarly so as to maintain equity among their contributions? If the private sector is unwilling to undertake this effort, should the government enter directly into drug research and development? I realize that this Conference is designed to address these issues. However, I believe that research and development in a wider range of health areas is needed to address the immediate problems in achieving improved health status in the developing world. I do not believe that activities in drug research alone will achieve that objective. I believe that we can address the need for a wider range of health care solutions .in an International Health Congress. Such a Congress would remind us all of the complexity of the problems of the developing world, many of which are reflected in the health status of their people. An International Health Congress would emphasize the need to address health-related problems by a coordinated, multifaceted, and multidisci- plinary approach that is directed not only at the symptoms of disease but also and most importantly at the causes of disease. In addressing international health we cannot forget that there can be no economic development in a community if the people are ill and dying. And there can be no real solution to the health condition of a people without some economic development. What is needed is a coordi- nated plan for dealing with these interrelated conditions. 396

An International Health Congress could provide the umbrella organi- zation to begin dealing with the complex issues that translate into the deaths, disfigurement, and debilitation of men, women, and children the world over. The United States and other countries around the world have mounted developmental assistance programs through the years which have sought to assist developing nations in improving conditions there. Unfortunately, as a proportion of gross national product, United States aid has fallen from half of one percent in 1965 to one-fourth of one percent in 1976. The role of the United States in these efforts must be increased but in such a way as to involve more nations, as well as involving private industry and the voluntary sector. Some have said that there are insuperable obstacles to substan- tially improving the health of millions of people. Some argue that there are political, economic, and cultural barriers which can never be overcome, and therefore we must simply make what limited effort we can to extend the benefits of Western technology and achievement to those classes in the Third World who are able to utilize and afford our level of health care. The human imperative dictates our course. We must not rest until we can overcome this tragedy in all of its complexity and in all of its breadth. 397