Udo Schuklenk udo-schuklenk

1. Udo Schuklenk www.udo-schuklenk.org The 10/90 Gap in International Health Research and Drug Research and DevelopmentWhose Moral Responsibility is it? 1/

2. 10 percent of the world’s health research expenditure addresses diseases that account for about 90 percent of the global burden of diseases afflicting mostly the developing world. [GFHR] From 1975-2004, for instance, 1,446 new drugs were made publicly available but only 20 of these were for tropical diseases and tuberculosis – diseases that affect the developing more than the developed world. [AWSJ] Communicable diseases kill app. 14 million people p/a [WHO] Eliminating these diseases would level the mortality gap between developed and developing countries [World Bank] Between 2/3rd and 9/10th of ‘new’ medicines coming to the market are ‘me-too’ drugs. The Issues

3. Markets not health needs dictate commercial research agendas. The patent regime arguably fails to stimulate innovation in the field of neglected diseases [MSF/Ford] Those medicines that do exist more often than not are unavailable to the developing world’s poor due to patents designed to guarantee the IPR owner a substantial return on their investment (eg HAART drugs). We could, spending the same resources, prevent almost immediately millions of preventable deaths by immunising newborns with existing (but unaffordable vaccines), instead of waiting for the outcomes of various (AIDS and other) vaccine initiatives. The Issues

4. Drug R&D – ie inventing and producing the needed medication Access – ensuring affordable access for those in need How should we decide which diseases to research (and who should decide)? (At Least)Three Problems

5. HR: Human Right to Health Utilitarianism: Avoidable suffering Kantianism: Respect for persons Contractarianism: Support for attainment of normal species functioning as pre-condition of living a good life. [GSK] Egalitarianism: All human lives count equally, regardless of where they are located. Virtue ethics: Living a flourishing life requires to behave decently toward those in need. Ethical Responses

6. Who should be responsible for delivering the goods? Various potential actors have been suggested: Industry Philanthropy States (on behalf of their citizens) Individuals Which begs the question

7. Two takes Industry is a moral player capable of preventing avoidable deaths Might have agent-relative duties due to specific R&D competencies/capacities that are unavailable elsewhere Our pharmaceutical industry related finger pointing seems inconsistent. We do not require other commercial organisations to assist the developing world (say Daimler-Chrysler supplying vehicles to transport the sick to clinics, for instance). Private enterprises have no societal mandate to provide health care to the sick. Publicly listed companies exist to generate maximum returns to their owners. They deliver value by being innovative, employing people and pay taxes that the state may use as it sees fit. Industry

8. Philanthropic giving is usually meant to ‘give something back’ to society that permitted someone to become very wealthy. As Carnegie argued, business should pursue profit, but the wealth created should be utilised philanthropically by individual owners for the benefit of the community. Eg Ford Foundation, Wellcome Trust, Gates Foundation Nice as such – usually very public – giving might be, it seems doubtful that the called-for solution to our problems should have to rely on rich volunteers such as Mr Gates. It’s also disconcerting that unaccountable individuals should make decisions affecting millions of people re drug R&D research priorities. Philanthropy

9. Developed countries have long since accepted some responsibilities toward the world’s poor. Rationales for this remain sketchy but often include the suggestion of a kind of reparation for past colonial exploitation of developing nations’ peoples, self-interest (‘instability over there might eventually affect me here’), but rarely include any of the ethical rationales suggested initially. Others have suggested that the State acts on behalf of its citizens. Citizens are moral agents and should act to assist those in dire need. The State could be seen as the instrument deployed to achieve this objective. (see also Individuals) States

10. Main rationale: private citizens can, by pooling their resources (eg donation to MSF, GAVI) resource drug R&D. They are moral agents and therefore responsible for their decision not to contribute personally toward preventing preventable suffering and premature death in the developing world. (See also States) Individuals

11. Drug Donations by Industry Price Reductions by Industry PPP Compulsory Licensing Only CL has so far managed to deliver the goods in appreciable quantities. Proposed Solutions to the Access Problem

12. Pull Mechanisms PPP Problem: Has not delivered the goods. Push Mechanisms AMCs/APCs Problem: Has not delivered the goods, seems an inefficient, high-risk means to push private players into funding drug R&D. Proposed Solutions to the R&D Problem

13. Much of the current rhetoric on a proposed human right to health doesn’t address the question of whose responsibility. Private sector will never have sufficient capacity and/or the will to deliver the required medicines in a timely and reliable fashion. Even the Gates Foundation admits that it won’t be able to develop medicines (to market) for most tropical diseases due to budget constraints. Equally, it seems unreasonable to entrust the survival needs of millions of impoverished people into the hands of commercial operators and unaccountable do-gooders. So, Whose Responsibility

14. It is necessary to find a persuasive answer to the question of who ought to finance drug R&D for neglected diseases. It is necessary to find a persuasive answer to the question of who ought to finance the production and delivery of drugs developed to fight neglected diseases. Relatedly, we should probably consider which international institution should manage that process, and which international regulatory frameworks should be put in place to ensure subsequent availability of the developed medicines. Should we aim for the international equivalent of the Manhattan Project? What’s Needed – Opportunities for Research 