In two recent essays, Thomas Pogge addresses the question of how research and development of essential drugs should be incentivized. Essential drugs are drugs for diseases that ruin human lives. The current incentivizing scheme for such drugs is, according to Pogge, a significant causal factor in bringing about a state of affairs in which millions of people die or suffer from lack of access to essential drugs. Pogge, therefore, suggests a reform plan for how to incentivize research and development of (...) these drugs, and he is of the opinion that implementation of this plan will have a significant positive impact on the global disease burden. This paper is a critical examination of Pogge's reform plan. In the first part of the paper, Pogge's reasons for being dissatisfied with the current incentivizing scheme are spelled out. The reform plan is then presented, and in the final part of the paper, it is argued that the reform plan is flawed at a number of levels. (shrink)

Michael Ravvin, Department of Political Science, Columbia University, 420 W. 118th Street, New York, NY 10027 Email: mer2133{at}columbia.edu ' + u + '@' + d + ' '//--> Abstract The existing intellectual property regime discourages the innovation of, and access to, essential medicines for the poor in developing countries. A successful proposal to reform the existing system must address these challenges of access and innovation. This essay will survey the problems in the existing pharmaceutical patent system and offer critical analysis (...) of some reform proposals. I will argue that existing mechanisms that are intended to mitigate the harms of the current pharmaceutical patent system, such as bulk buying, differential pricing and compulsory licenses, are inadequate and perhaps even counter-productive over the long-term. Other incentive mechanisms based on push funding, such as government research grants, are inefficient and limited in scope. Pull mechanisms, which offer some reward for successful pharmaceutical innovations, offer a more promising incentive mechanism. I will evaluate three pull mechanisms -- Priority Review Vouchers, Advance Market Commitment (AMC) and the Health Impact Fund -- on the basis of their capacity to incentivize access and innovation, as well as their efficiency and political feasibility. Though the Health Impact Fund appears to be the most promising proposal, more work must be done to overcome challenges of its implementation. CiteULike Connotea Del.icio.us What's this? (shrink)

Professor Thomas Pogge, Professorial Fellow, Centre for Applied Philosophy, LPO Box 8260, Canberra. Tel.: +61 261255485; Email: tp6{at}columbia.edu ' + u + '@' + d + ' '//--> Abstract I would pay three million to go into space, says the banker to his attorney. — I wouldn't go if you paid me, the latter laughs, for me the French Riviera is quite exciting enough. Ah, I would pay a million for an extra year of life , the elderly tourist effusively (...) tells his lover. — We have never had even a hundred dollars , the Cambodian teenager replies, we are a large family. CiteULike Connotea Del.icio.us What's this? (shrink)

Vaccines are a powerful measure to protect the health of individuals and to combat outbreaks such as the COVID-19 pandemic. An ethical dilemma arises when one effective vaccine has been successfully developed against an epidemic disease and researchers seek to test the efficacy of another vaccine for the same pathogen in clinical trials involving human subjects. On the one hand, there are compelling reasons why it would be unethical to trial a novel vaccine when an effective product exists already. First, (...) it is a firm principle of medical ethics that an effective treatment or vaccine should not be withheld from patients if their life may depend on it. Second, since epidemic outbreaks often emerge in settings with less-resourced health systems, there is a pronounced risk that any trial withholding an effective vaccine would disproportionately affect the vulnerable populations that historically have been exploited for biomedical research. Third, clinical trials for novel vaccines may be at odds with efforts to control active outbreaks. On the other hand, it may be justified to conduct a trial for a candidate vaccine if it is expected to have certain advantages compared with the existing product. This essay discusses key factors for comparing vaccines against epidemic pathogens, including immunological, logistical and economic considerations. Alongside a case study of the development of vaccines for Ebola, the essay seeks to establish a general framework that should be expanded and populated by immunologists, epidemiologists, economists and bioethicists, and ultimately could be applied to the case of COVID-19 vaccines. (shrink)

When exercising their public health powers, states claim various rights against their subjects and aliens. The paper considers whether public health considerations can help justify some of these rights, and explores some constraints on the justificatory force of public health considerations. I outline two arguments about the moral grounds for states’ rights with regard to public health. The principle of fairness emphasizes that those who benefit from public health measures ought to contribute their fair share in upholding them. Alternatively, states’ (...) rights might be justified by a natural duty of justice to uphold and not to obstruct institutions implementing public health policies. I indicate some reasons for preferring the latter justification. I further argue that the assignment of some rights to states via public health-based justification is undermined on several counts. Domestic political institutions cannot effectively perform some of their functions in protecting public health. Furthermore, transborder public health threats pose collective action problems at the global level. Finally, concerns about human rights work against the assignment of some rights to states. I conclude by arguing that these concerns call for global coordination, and that some rights claimed by states ought instead to be assigned to global institutions. (shrink)

This paper rebuts suggestions made by Littlejohns et al that NICE is not ageist by analysing the concept of ageism. It recognises the constraints that finite resources impose on decision making bodies such as NICE and then makes a number of positive suggestions as to how NICE might more effectively and more justly intervene in the allocation of scarce resources for health.

This paper offers an economic rationale for compulsory licensing of needed medicines in developing countries. The patent system is based on a trade-off between the “deadweight losses” caused by market power and the incentive to innovate created by increased profits from monopoly pricing during the period of the patent. However, markets for essential medicines under patent in developing countries with high income inequality are characterized by highly convex demand curves, producing large deadweight losses relative to potential profits when monopoly firms (...) exercise profit-maximizing pricing strategies. As a result, these markets are systematically ill-suited to exclusive marketing rights, a problem which can be corrected through compulsory licensing. Open licenses that permit any qualified firm to supply the market on the same terms, such as may be available under licenses of right or essential facility legal standards, can be used to mitigate the negative effects of government-granted patents, thereby increasing overall social welfare. (shrink)

Not all intellectual property rights grant the right to exclude that is indicative of “property rules,” as that term was used by Guido Calabresi and A. Douglas Melamed in their seminal article. Some intellectual property rights are “liability rules,” in which the right holder has an entitlement to compensation for use of the protected invention, not a right to preclude the use. Although patent laws normally grant a right to exclude others from use of the protected invention as a default, (...) most countries’ laws allow the government to convert the patent property rule into a liability rule through a compulsory license. It has been noted, for example, that by the end of the 1950s, the U.S. had issued compulsory licenses covering 40 to 50 thousand patents, including substantial portions of the patent portfolios of AT&T, General Electric, IBM, and Xerox. The U.S. Supreme Court recently expressed a willingness to accept liability rules over injunctions in some patent infringement cases. (shrink)

Thomas Alured Faunce, College of Law, Fellows Road, Acton, Canberra ACT 0200, Australian National University, Fax: 61 2 61253971, Email: Thomas.Faunce{at}anu.edu.au ' + u + '@' + d + ' '//-->This paper sets out to analyse three different academic proposals for addressing the needs of the poor in relation to new, rather than ‘essential’ medicines. It focuses particularly on research and development prize funds, a health impact fund system and a multilateral treaty on health technology cost-effectiveness evaluation and competitive tender. (...) It compares the extent to which each responds to the ‘market fundamentalist’ philosophy and begins to analyse their respective strengths and weaknesses. CiteULike Connotea Del.icio.us What's this? (shrink)

Synthetic biology is a series of scientific and technological practices involved in the application of engineering principles to the design and production of predictable and robust biological systems. While policy discussions abound in this area, emerging technologies like synthetic biology present considerable challenges in the articulation of concrete policy options given that their introduction into society may still be in the distant future. This paper reports on a series of governance workshops that focused on synthetic biology’s ethical, legal, and social (...) implications as they pertain to human health, and discusses particular limitations of the ELSI approach that we encountered in our work. In an attempt to avoid policymaking for potential implications of uncertain future applications we instead conclude by proposing tangible forms of anticipatory governance that may be more adequate in addressing the more immediate concerns raised by synthetic biology. (shrink)

A well-known problem in the health sciences is the distorted research agenda: the agenda features too little research that is tailored to the health problems of the poor, and it features too little research that supports the development of other solutions to health problems than medicines . This article analyzes these two sub-problems in more detail, and assesses several strategies to deal with them, resulting in some specific recommendations that indicate what governments should do to make the research agenda in (...) the health sciences less distorted. (shrink)

This paper addresses an apparent dilemma that must be resolved in order to respond ethically to global climate change. The dilemma can be presented as follows. Responding ethically to global climate change requires technological innovation that is accessible to everyone, including inhabitants of the least developed countries. Technological innovation, according to many, requires strong intellectual property protection, but strong intellectual property protection makes it highly unlikely that patent-protected technologies will be accessible to developing countries at affordable prices. Given this, responding (...) ethically to global climate change is highly unlikely. I argue that this apparent dilemma – which I call ‘the patent dilemma in global climate change’ – should be taken seriously. I discuss a number of possibilities for resolving it, and I argue that any acceptable strategy must satisfy the criteria of near-term feasibility and non-paternalism. Finally, I propose a multi-pronged, multi-tiered strategy that meets these conditions. (shrink)

This article claims that the account of specification as a way to solve conflicts between rights, suggested by Göran Collste, is unsatisfactory. It is argued that specification is not a solution on its own, but is better described as a remedy in response to a political failure.

Henry Shue’s model of basic rights and their correlative duties provides an excellent framework for analysing the requirements of global distributive justice, and for theorising about the minimum acceptable standards of human entitlement and wellbeing. Shue bases his model on the claim that certain ‘basic’ rights are of universal instrumental value, and are necessary for the enjoyment of any other rights, and of any ‘decent life’. Shue’s model provides a comprehensive argument about the importance of certain fundamental goods for all (...) human lives, though he does not consider health or health care in any significant detail. Adopting Shue’s model, I argue that access to health care is of sufficient importance to the enjoyment of any other rights that it qualifies as what Shue describes as a ‘basic’ right. I also argue that the basic right to health care is compatible with the basic rights model, and is required by it in order to for it to achieve its goal of enabling right holders to enjoy any decent life. In making this claim I also explore the requirements of the basic right to health care in terms of Shue’s triumvirate of duties and with reference to several key examples. (shrink)