Any system for the protection of intellectual property rights (IPRs) has three main kinds of distributive effects. It will determine or influence: (a) the types of objects that will be developed and for which IPRs will be sought; (b) the differential access various people will have to these objects; and (c) the distribution of the IPRs themselves among various actors. What this means to the area of pharmaceutical research is that many urgently needed medicines will not be developed at all, (...) that the existing medicines will not be suitable for countries with a precarious health infrastructure or not target the disease variety that is prevalent in poorer regions. Such effects are commonly captured under the rubric of the “10/90 gap” in biomedical research. High prices will also restrict access to medicines as well endanger compliance to treatment schemes. IPRs are mainly held by multinational corporations situated in the developed world, which not only raises egalitarian concerns, but also severely limits the possibilities of companies in poorer countries to realize improvements on existing inventions, as they cannot financially afford to secure freedom to operate, which systematically shrinks the number of potential innovators. Those inequities lead to an enormous burden for the global poor and since no institution is willing to assume the responsibility to fulfil the right to health and the corresponding right of access to essential medicines, we have to analyse alternatives or additions to the actual intellectual property regimes in order to create new incentives to fill this gap. (shrink)

Background: Seeking consent for genetic and genomic research can be challenging, particularly in populations with low literacy levels, and in emergency situations. All of these factors were relevant to the MalariaGEN study of genetic factors influencing immune responses to malaria in northern rural Ghana. This study sought to identify issues arising in practice during the enrolment of paediatric cases with severe malaria and matched healthy controls into the MalariaGEN study. Methods: The study used a rapid assessment incorporating multiple qualitative methods (...) including in depth interviews, focus group discussions and observations of consent processes. Differences between verbal information provided during community engagement processes, and consent processes during the enrolment of cases and controls were identified, as well as the factors influencing the tailoring of such information. Results: MalariaGEN participants and field staff seeking consent were generally satisfied with their understanding of the project and were familiar with aspects of the study relating to malaria. Some genetic aspects of the study were also well understood. Participants and staff seeking consent were less aware of the methodologies employed during genomic research and their implications, such as the breadth of data generated and the potential for future secondary research.Moreover, trust in and previous experience with the Navrongo Health Research Centre which was conducting the research influenced beliefs about the benefits of participating in the MalariaGEN study and subsequent decision-making about research participation. Conclusions: It is important to recognise that some aspects of complex genomic research may be of less interest to and less well understood by research participants and that such gaps in understanding may not be entirely addressed by best practice in the design and conduct of consent processes. In such circumstances consideration needs to be given to additional protections for participants that may need to be implemented in such research, and how best to provide such protections.Capacity building for research ethics committees with limited familiarity with genetic and genomic research, and appropriate engagement with communities to elicit opinions of the ethical issues arising and acceptability of downstream uses of genome wide association data are likely to be important. (shrink)

This article is a critical discussion of the Advance Market Commitment (AMC) proposal for how to incentivize research and development of drugs for neglected diseases. The main claim of the article is that the ‘winner-takes-all’ problem that mars a simple prize proposal for how to incentivize research and development of drugs for neglected diseases also tarnishes the AMC proposal. The conclusion of the article is that the AMC proposal should be rejected as an incentivizing scheme for research and development of (...) drugs for neglected diseases. This conclusion follows from the main claim of the article together with two plausible assumptions that are not argued for in the article. (shrink)

Thomas Pogge has included responsibilities for global health at the core of his liberal agenda and has urged corresponding, efficient reforms in practice. The current article focuses on his proposal for establishing a global fund for the development and delivery of essential medicines for the poor. It is argued that while Pogge interestingly attempts to harness both moral and non-moral human resources to serve global health, the efficiency of his proposed fund is not evident. First, its internal logic implies that (...) part of valuable development aid would end up as profit for drug corporations. Hence, the corporations should be able to utilise the other part of the public funding remarkably efficiently. Second, several existing programmes for global health (such as the Global Fund to Fight AIDS, Malaria and Tuberculosis) have achieved significant results. This provides them with a firm basis for applying for additional funding. In accordance with the United Nations Millennium Development Goals, the plea for additional funding for global health seems overwhelmingly justified; in order to coordinate its use efficiently, a significant degree of public management is needed. (shrink)

In this review, I survey theoretical accounts of exploitation in business, chiefly through the example of low wage or sweatshop labor. This labor is associated with wages that fall below a living wage standard and include long working hours. Labor of this kind is often described as self-evidently exploitative and immoral (Van Natta 1995). But for those who defend sweatshop labor as the first rung on a ladder toward greater economic development, the charge that sweatshop labor is self-evidently exploitative fails (...) adequately to explain the nature of the alleged wrongdoing. While all sides might agree that poor working conditions are unfortunate and undesirable, defenders of sweatshop labor argue that they provide the best available employment alternative for some workers and the best chance at economic development for many low and middle income countries (LMICs). Some defenders of sweatshop labor even embrace the label of exploitation. <br><br>Unless there is a clear, widely understood account by which exploitation is a moral wrong, then charging a practice as exploitative will do little to advance debates over whether and why a practice is morally problematic. A considerable body of work has been developed applying a growing literature on exploitation to sweatshop labor. While many forms of moral wrong are associated with sweatshop labor, I will focus specifically on the worry that low wages allow relatively wealthy employers wrongfully to take advantage of or gain from relatively poor workers, especially in LMICs. In particular, I will focus on instances of alleged exploitation in employment relationships that are voluntary and mutually beneficial. I have two reasons for doing so. First, by restricting this review to voluntary and mutually beneficial instances of exploitation, I can isolate the moral wrong of exploitation from other moral wrongs, especially the wrongs of coercion and outright harms to workers. Second, the focus on mutually beneficial and voluntary relationships will allow for arguments that sweatshop labor is not only not exploitative, but is a morally praiseworthy means of helping to encourage economic growth in poor areas of the world and to provide jobs that pay better and are more stable than any existing alternatives.<br><br>In this review, I aim to accomplish three goals. First, I will provide an overview of the many different uses of the charge of exploitation in business practice through an examination of the uses of the term in the literature on sweatshop labor. While it is often not clear what kind of moral wrong is assumed to take place when the charge of exploitation is used, I will demonstrate that many distinct types of exploitation, connected to distinct moral wrongs, are used in the literature on sweatshop labor and elsewhere in business ethics. Specifically, I will identify two broad categories of exploitation—exploitation as unfairness and exploitation as the mere use of others—with subgroups under each main category of exploitation. Second, I will discuss which of these senses of exploitation are defensible as identifying clear moral wrongs that take place in the context of business and, specifically, sweatshop labor. As I will argue, not all uses of the charge of exploitation are capable of persuasively identifying clear moral wrongs. Moreover, there is not a single, clear type of exploitation that takes place in business but, rather, several distinct forms. Third, I will apply the lessons learned from my exploration of exploitation in sweatshop labor to other specific areas of business. As I will argue, there are multiple viable models of exploitation in the sweatshop literature that can illuminate exploitative practices of relatively well compensated employees, customers, suppliers, and entire communities. <br><br>While discussions of theories of exploitation tend to argue for a single, correct account of this moral wrong, my review of the literature on exploitation in sweatshop labor supports the conclusion that there are multiple defensible accounts of the moral wrong of exploitation. For this reason, those who would charge that a relationship is exploitative should specify the form of exploitation that they believe is taking place. (shrink)

The Belmont Report was written by a US Commission charged by the US Congress to advise on research supported by the US government. Its focus was understandably domestic. In the 40 years since its publication, clinical research has become increasingly international. Many clinical trials have sites in multiple countries, and many of the host countries are relatively impoverished. Such research raises some distinctive ethical issues. This paper outlines some of the key ethical challenges that have been raised by clinical research (...) conducted in low- and middle-income countries (LMICs) and sponsored by high-income country (HIC) institutions. It then considers whether the Belmont Report has the resources to address these problems and argues that it does not. The article closes by noting some parallels between this international research and domestic US research, which suggest that the US might benefit from the discussions abroad. (shrink)

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)

BackgroundPromoting the social value of global health research undertaken in resource poor settings has become a key concern in global research ethics. The consideration for benefit sharing, which concerns the elucidation of what if anything, is owed to participants, their communities and host nations that take part in such research, and the obligations of researchers involved, is one of the main strategies used for promoting social value of research. In the last decade however, there has been intense debate within academic (...) bioethics literature seeking to define the benefits, the beneficiaries, and the scope of obligations for providing these benefits. Although this debate may be indicative of willingness at the international level to engage with the responsibilities of researchers involved in global health research, it remains unclear which forms of benefits or beneficiaries should be considered. International and local research ethics guidelines are reviewed here to delineate the guidance they provide.MethodsWe reviewed documents selected from the international compilation of research ethics guidelines by the Office for Human Research Protections under the US Department of Health and Human Services.ResultsAccess to interventions being researched, the provision of unavailable health care, capacity building for individuals and institutions, support to health care systems and access to medical and public health interventions proven effective, are the commonly recommended forms of benefits. The beneficiaries are volunteers, disease or illness affected communities and the population in general. Interestingly however, there is a divide between "global opinion" and the views of particular countries within resource poor settings as made explicit by differences in emphasis regarding the potential benefits and the beneficiaries.ConclusionAlthough in theory benefit sharing is widely accepted as one of the means for promoting the social value of international collaborative health research, there is less agreement amongst major guidelines on the specific responsibilities of researchers over what is ethical in promoting the social value of research. Lack of consensus might have practical implications for efforts aimed at enhancing the social value of global health research undertaken in resource poor settings. Further developments in global research ethics require more reflection, paying attention to the practical realities of implementing the ethical principles in real world context. (shrink)

This article attempts to map the broad ethical and legal contours of global child health realities. Its interest is in international duties to reduce disparities in the health of children. Specifically, it inquires into loci of collective rights and responsibilities in this context. Clarity on the sources of this responsibility and the nature of such rights will, it is hoped, contribute to enhanced and sustained action to attenuate these inequalities. A review and critique of the current topography of global health (...) ethics is followed by an analysis of international human rights law as it pertains to global health, with a particular focus on the legal dimensions of child health outcomes. Thus grounded, the article seeks to build conceptual synergies between public health ethics and human rights paradigms to underwrite collective action on global child health disparities. (shrink)

I am grateful to Feeney and colleagues for their thoughtful engagement with, and application of, the normative analysis I developed concerning gene patents in Farrelly (2016). Their exploration of...