This paper discusses the economic, legal, moral, and political difficulties in developing drugs for the developing world. It argues that large, global pharmaceutical companies have social responsibilities to the developing world, and that they may exercise these responsibilities by investing in research and development related to diseases that affect developing nations, offering discounts on drug prices, and initiating drug giveaways. However, these social responsibilities are not absolute requirements and may be balanced against other obligations and commitments in light of economic, (...) social, legal, political, and other conditions. How a company decides to exercise its social responsibilities to the developing world depends on the prospects for a reasonable profit and the prospects for a productive business environment. Developing nations can either help or hinder the pharmaceutical industry’s efforts to exercise social responsibility through various policies and practices. To insure that companies can make a reasonable profit, developing nations should honor pharmaceutical product patents and adhere to international intellectual property treaties, such as the Trade‐Related Aspects of Intellectual Property Rights agreement. To insure the companies have a good business environment, developing nations should try to promote the rule of law, ethical business practices, stable currencies, reliable banking systems, free and open markets, democracy, and other conditions conducive to business. Overall, this paper advocates for reciprocity and cooperation between pharmaceutical companies and developing nations to address the problem of developing drugs for the developing world. In pursuing this cooperative approach, developing nations may use a variety of other techniques to encourage pharmaceutical companies to act responsibly, such as subsidizing pharmaceutical research, helping to design and implement research protocols, providing a guaranteed market, and bulk buying. (shrink)

This paper addresses the appropriate role for public input into priority setting for federal funding of biomedical research and development. The public should be involved in priority setting because researchers should be publicly accountable, because the public has a right to oversee government activities, and because public input is needed to assess normative questions related to the burden of disease and health care needs. On the other hand, political factors arising from public input can also hamper the governmentÕs ability to (...) allocate funds according to the burden of disease or to promote the progress of biomedical science. When it comes to public input into R & D priority setting, more is not necessarily better. What is needed is the right balance of public and expert decision making with respect to the setting of biomedical R & D priorities. (shrink)

Clinical research has become a burgeoning activity in recent years, largely stimulated by the pharmaceutical industry's interest in new drugs with high marketing profiles. Several other forces fuel this thrust: the increasing dependence of academic medical institutions on research funding from industry; the need for large, efficient multicenter trials to obtain reliable and statistically significant results in the shortest possible time for drug registration purposes; and access to research subjects in countries. The intense interest in HIV/AIDS research and recent controversies (...) about revisions to the Helsinki Declaration, which have been seen by some to be motivated by the desire to facilitate exploitative research in countries, have stimulated renewed interest in the ethics of clinical research. (shrink)

Recent economic and political advances in developing countries on the African continent and South East Asia are threatened by the rising death and morbidity rates of HIV/AIDS. In the first part of this paper we explain the reasons for the absence of affordable access to essential AIDS medication. In the second part we take a closer look at some of the pivotal frameworks relevant for this situation and undertake an ethical analysis of these frameworks. In the third part we discuss (...) a few of the proposed solutions to the problem and conclude with an argument in support of our preferred course of action. In this article we argue for compulsory licensing of essential AIDS medications in the current conditions of public health emergency. We argue on broadly consequentialist grounds that compulsory licensing is preferable both morally and pragmatically to the alternatives, notably the currently offered price cuts and drug donation schemes. (shrink)

In this paper, we provide an overview of how the outcomes of the Uruguay Round affected the application of pharmaceutical intellectual property rights globally. Second, we explain how specific pharmaceutical policy tools can help developing states mitigate the worst effects of the TRIPS Agreement. Third, we put forward solutions that could be implemented by the World Bank to help overcome the divide between creating private incentives for research and development of innovative medicines and ensuring access of the poor to medicine. (...) Fourth, we evaluate these solutions on the basis of utilitarian considerations and urge that equitable pricing is morally preferable to the other solutions. (shrink)