Department of Economics, University of Calgary, 2500 University Dr NW, Calgary AB, T2N 1N4, Canada. Tel.: +1403220 5861; Fax: +1403220 5861; Email: ahollis{at}ucalgary.ca ' + u + '@' + d + ' '//--> . Abstract The Health Impact Fund has been proposed as an optional, comprehensive advance market commitment system offering financial payments or ‘prizes’ to patentees of new drugs, which are sold globally at an administered low price. The Fund is designed to offer payments based (...) on the therapeutic impact of the drugs or vaccines, so that innovators will have efficient incentives to develop drugs that maximize health gains. Consumers would have improved access to such drugs because of low prices. CiteULike Connotea Del.icio.us What's this? (shrink)

Taking into consideration the extremely harsh public health conditions faced by the majority of the world population, the Health Impact Fund (HIF) proposal seeks to make the intellectual property regimes more in line with human rights obligations. While prioritizing access to medicines and research on neglected diseases, the HIF makes many compromises in order to be conceived as politically feasible and to retain a compensation character that makes its implementation justified solely on basis of negative duties. (...) Despite that current global health realities make such steps reasonable, the paper looks up the negative effects on one overlooked human right: the right to participate in scientific advancement. (shrink)

One important aspect of globalization is the increasingly dense and influential regime of global rules that govern and shape interactions everywhere. Covering trade, investment, loans, patents, copyrights, trademarks, labor standards, environmental protection, use of seabed resources, production and marketing of weapons, maintenance of public security, and much else, these rules—structuring and enabling, permitting and constraining—have a profound impact on the lives of human beings and on the ecology of our planet. It is therefore important to think carefully, in moral (...) terms, about their design. (shrink)

In an earlier piece in these pages, I described the health effects of the still massive problem of global poverty: The poor worldwide face greater environmental hazards than the rest of us, from contaminated water, filth, pollution, worms, and insects. They are exposed to greater dangers from people around them, through traffic, crime, communicable diseases, sexual violence, and potential exploitation by the more affluent. They lack means to protect themselves and their families against such hazards, through clean water, nutritious (...) food, satisfactory hygiene, necessary rest, adequate clothing, and safe shelter. They lack the means to enforce their legal rights or to press for political reform. (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)

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)

One of the most attractive, but nevertheless highly controversial proposals to alleviate the negative effects of today’s international patent regime is the Health Impact Fund (HIF). Although the HIF has been drafted to facilitate access to medicines and boost pharmaceutical research, we have analysed the burdens for the global poor a similar proposal designed to promote the use and development of climate-friendly technologies would have. Drawing parallels from the access to medicines debate, we suspect that an analogous (...) “Climate Impact Fund” will increase the already very high scientific and technological supremacy of the developed world over the Global South. We advocate countering this dominance on the ground that countries with scarce research and development capacities will be in a difficult position to reject technologies and will not have a say on how such technologies should look like. Further, addressing global hazards should be an inclusive endeavour and not only a privilege reserved for the developed world. Incentivizing grassroots innovation would be a major step to promote scientific and technological inclusion. (shrink)

The impact of recent changes in public health insurance on community‐based health‐care in the USARecent changes in US government‐funded healthcare insurance are having profound impacts on all types of community‐based health‐care, reducing access to care by vulnerable populations. This article traces the impacts of recent policies on a range of community institutions in which nurses play a critical role, such as health centers, highlighting the effects on access to care and the survival of non‐profit services (...) in less‐advantaged communities. In general, the new policies shifted revenues into fixed payment per client contracts (capitation) paid to for‐profit managed care organizations and away from non‐profit community services. The full impact of this competitive, market‐oriented system of health services has just begun to be felt. The uncertainties and dissatisfactions assure continued activity to change current conditions, including efforts by groups that seek greater access to health services for all populations and security for committed providers and personnel, including nurses. (shrink)

International research is an essential means of reducing health disparities between and within countries and should do so as a matter of global justice. Research funders from high-income countries have an obligation of justice to support health research in low and middle-income countries that furthers such objectives. This paper investigates how their current funding schemes are designed to incentivise health systems research in LMICs that promotes health equity. Semi-structured in-depth interviews were performed with 16 grants officers (...) working for 11 funders and organisations that support health systems research: the Alliance for Health Policy and Systems Research, Comic Relief, Doris Duke Foundation, European Commission, International Development Research Centre, Norwegian Agency for Development Cooperation, Research Council of Norway, Rockefeller Foundation, UK Department of International Development, UK Medical Research Council, and Wellcome Trust. Thematic analysis of the data demonstrates their funding schemes promote health systems research with five key features that advance health equity: being conducted with worst-off populations, focusing on research topics that advance equitable health systems, having LMIC ownership of the research agenda, strengthening LMIC research capacity, and having an impact on health disparities. The different types of incentives that encouraged proposed projects to have these features are identified and classified by their strength. It is suggested that research funders ought to create and maintain funding schemes with strong incentives for the features identified above in order to more effectively help reduce global health disparities. (shrink)

Machine generated contents note: Preface; Introduction; Part I. Global Health, Definitions and Descriptions: 1. What is global health? Solly Benatar and Ross Upshur; 2. The state of global health in a radically unequal world: patterns and prospects Ron Labonte and Ted Schrecker; 3. Addressing the societal determinants of health: the key global health ethics imperative of our times Anne-Emmanuelle Birn; 4. Gender and global health: inequality and differences Lesley Doyal and Sarah Payne; 5. Heath (...) systems and health Martin McKee; Part II. Global Health Ethics, Responsibilities and Justice: Some Central Issues: 6. Is there a need for global health ethics? For and against David Hunter and Angus Dawson; 7. Justice, infectious disease and globalisation Michael Selgelid; 8. International health inequalities and global justice: toward a middle ground Norman Daniels; 9. The human right to health Jonathan Wolff; 10. Responsibility for global health? Allen Buchanan and Matt DeCamp; 11. Global health ethics: the rationale for mutual caring Solly Benatar, Abdallah Daar and Peter Singer; Part III. Analyzing Some Reasons for Poor Health: 12. Trade and health: the ethics of global rights, regulation and redistribution Meri Koivusalo; 13. Debt, structural adjustment and health Jeff Rudin and David Sanders; 14. The international arms trade and global health Salahaddin Mahmudi-Azer; 15. Allocating resources in humanitarian medicine Samia Hurst, Nathalie Mezger and Alex Mauron; 16. International aid and global health Anthony Zwi; 17. Climate change and health: risks and inequities Sharon Friel, Colin Butler and Anthony McMichael; 18. Animals, the environment and global health David Benatar; 19. The global crisis and global health Stephen Gill and Isabella Bakker; Part IV. Shaping the Future: 20. Health impact fund: how to make new medicines accessible to all Thomas Pogge; 21. Biotechnology and global health Hassan Masun, Justin Chakma and Abdallah Daar; 22. Food security and global health Lynn McIntyre and Krista Rondeau; 23. International taxation Gillian Brock; 24. Global health research: changing the agenda Tikki Pang; 25. Justice and research in developing countries Alex John London; 26. Values in global health governance Kearsley Stewart, Gerald T. Keusch and Arthur Kleinman; 27. Poverty, distance and two dimensions of ethics Jonathan Glover; 28. Teaching global health ethics James Dwyer; 29. Towards a new common sense: the need for new paradigms of global health Isabella Bakker and Stephen Gill; Index. (shrink)

In the research integrity literature, funding plays two different roles: it is thought to elevate questionable research practices (QRPs) due to perverse incentives, and it is a potential actor to incentivize research integrity standards. Recent studies, asking funders, have emphasized the importance of the latter. However, the perspective of active researchers on the impact of competitive research funding on science has not been explored yet. Here, I address this issue by conducting a series of group sessions with researchers in (...) two different countries with different degrees of competition for funding, from three scientific fields (medical sciences, natural sciences, humanities), and in two different career stages (permanent versus temporary employment). Researchers across all groups experienced that competition for funding shapes science, with many unintended negative consequences. Intriguingly, these consequences had little to do with the type of QRPs typically being presented in the research integrity literature. Instead, the researchers pointed out that funding could result in predictable, fashionable, short-sighted, and overpromising science. This was seen as highly problematic: scientists experienced that the ‘projectification’ of science makes it more and more difficult to do any science of real importance: plunging into the unknown or addressing big issues that need a long-term horizon to mature. They also problematized unintended negative effects from collaboration and strategizing. I suggest it may be time to move away from a focus on QRPs in connection with funding, and rather address the real problems. Such a shift may then call for entirely different types of policy actions. (shrink)

The health policy community has a growing interest in the impact of nonmedical determinants of health, such as housing, nutrition, and social supports, on both health outcomes and costs. This interest has been spurred by the Affordable Care Act’s emphasis on prevention, Robert Wood Johnson’s grant‐making focus on a Culture of Health, and an uptick of research demonstrating the potential returns to health care from investments in social services. Much of this policy‐making, grant making, (...) and research has focused on older Americans.The direct policy implications of this strategy can be elusive. It has become clear that more than medicine will be necessary to improve older Americans’ health status. Real improvement likely requires the development of additional social service offerings, including housing that is accessible to people with disabilities, Meals on Wheels‐type nutrition supports, and transportation. But who should bear the costs and control the finances associated with these programs? In this essay, I explore the question of how policy‐makers should consider financing nonmedical investments in older Americans’ health. As the reader will recognize, I stop short of arguing for what will work. Rather, I identify the strands of an emerging strategy—namely, for health care dollars to be diverted into social service programming—and offer several cautions. It may be that policy‐makers still wish to continue down this path, but my hope is that this essay will allow them to so with greater attention to the risks and unintended consequences of that strategy. (shrink)

The Health Impact Fund (HIF) is a project aimed at expanding access to life-saving drugs worldwide and incentivizing pharmaceutical companies to invest in research and development for neglected diseases. The HIF would invert the existing patent framework by rewarding ideas through their diffusion rather than protecting against this diffusion, by encouraging a collective rather than privatized wealth scheme. The basic idea behind the HIF is the creation of a new competitive market that centers on individuals who, under (...) normal circumstances, exert very little force on the tide of market demand. The HIF does not operate on standard market measures of demand, but instead measures demand as a product of needs, while in conventional market scenarios, private citizens and national welfare states pay for needs. The idea is that the HIF would create a functional, competitive market in which pharmaceutical profit is determined by the actual health impact of each new drug, a measure born from pharmacological and distributive efficacy. In this article, the basic features of and main challenges to the HIF are addressed. (shrink)

If funding allocation is an indicator of a field’s priorities, then the priorities of the field of bioethics are misaligned because they perpetuate injustice. Social justice mandates priority for the factors that drive systematic disadvantage, which tend not to be the areas supported by funding within academic bioethics. Current funding priorities violate social justice by overemphasizing technologies that aim to enhance the human condition without addressing underlying structural inequalities grounded in racism, and by deemphasizing areas of inquiry most frequently pursued (...) by Scholars of Color. This lack of attention to upstream determinants of health in bioethics research perpetuates a gap in the resources needed to understand the experiences of communities disproportionately experiencing poor health, which is itself a form of epistemic injustice. Both social and epistemic injustices are apparent in the impact of these funding priorities on people of color, both in the public and in the bioethics community. (shrink)

In October 1993, a survey of health care agency administrators was undertaken shortly after they had experienced two sudden reductions in public funding. The purpose of this investigation was to gain insight into the role of ethics in health administrator decision making. A mail questionnaire was designed for this purpose. Descriptive statistics and content analysis were used to summarize the data. Staff reductions and bed closures were the two most frequently reported mechanisms for addressing the funding reductions. Most (...) administrators did not believe that these changes would have a negative public impact. In contrast, the majority indicated that future changes in reaction to additional funding reductions would have a negative public impact. Approximately one-third of the administrators reported ethics to be an element of recent administrative decision making, and one-half could foresee that ethics would be important in the future if reductions continued. These findings are discussed in relation to ethics. Issues for additional research are outlined. (shrink)

Many medical services lack robust evidence of effectiveness and may therefore be considered “unnecessary” care. Proactively withdrawing resources from, or de-funding, such services and redirecting the savings to services that have proven effectiveness would enhance overall health system performance. Despite this, governments have been reluctant to discontinue funding of services once funding is in place. The focus of this study is to understand how the framing of an issue or problem influences government decision-making related to de-funding of medical services. (...) To achieve this, a framework describing how problem frames, or explanatory naratives, influence government policy decisions was developed and applied to actual cases. The two cases selected were the Ontario government’s decisions to de-fund the drug Oxycontin and blood glucose test strips used by patients with diabetes. A qualitative content analysis of public discourse surrounding these two resource withdrawal examples was conducted and described using the framework. In the framework, government decision-making is a partial reflection of the visibility of the policy issue and complexity of the causal story told within a problem frame. By applying this framework and considering these two key characteristics of problem frames, we can better understand, and possibly predict, the shape and timing of government policy decisions to withdraw resources from medical services. (shrink)

A free world is one in which human beings can live free, self-directed lives. A great obstacle to such a world is severe poverty, still blighting the lives of half of humankind. We have the resources, technologies, and administrative capacities to eradicate severe poverty, but doing so requires some restructuring of existing social arrangements. We might begin with the current regime governing innovation, which has monopoly markups as its key funding source. Such monopoly rents encourage the quest for innovations, but (...) also greatly impede their diffusion. This headwind harms the poor, who cannot afford monopoly prices and whose specific needs innovators thus tend to ignore. It also works against potential innovations whose benefits would mostly go to third parties whom buyers care little about. Both problems can be much alleviated through a supplementary alternative reward mechanism that would enable innovators to exchange their monopoly privileges on any patentable technology for impact rewards based on the social benefits achieved with it. By promoting innovations and their diffusion together, international impact funds would bring substantial gains in justice and cost-effectiveness, especially in the pharmaceutical and green-technology sectors. (shrink)

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)

Globalized in 1995 through the TRIPs Agreement, humanity’s dominant mechanism for encouraging innovations involves 20-year product patents, whose monopoly features enable innovators to reap large markups or licensing fees from early users. Exclusive reliance on this reward mechanism in the pharmaceutical sector is morally problematic for two main reasons. First, it imposes a great burden on poor people who cannot afford to buy patented treatments at monopoly prices and whose specific health problems are therefore neglected by pharmacological research. Second, (...) it discourages pharmaceutical firms from fighting diseases at the population level with the aim of slashing their incidence. These problems can be alleviated by establishing a supplementary alternative reward mechanism that would enable pharmaceutical innovators to exchange their monopoly privileges on a patented product for impact rewards based on the actual health gains achieved with this product. As such, an international Health Impact Fund would create powerful new incentives to rapidly develop remedies against diseases concentrated among the poor, provide such remedies with ample care at very low prices, and deploy them strategically to contain, suppress, and ideally eradicate the target disease. By promoting innovations and their diffusion together, the HIF would greatly enlarge the benefits, and thereby also the cost-effectiveness, of the pharmaceutical sector, especially in favor of the world’s poor. (shrink)

International negotiations on anthropogenic climate change are far from running smoothly. Opinions are deeply divided on what are the respective responsibilities of developed and developing countries with regard to the reduction of greenhouse gas emissions and the alleviation of the negative effects of global warming. A major bone of contention concerns the role of intellectual property rights (especially patents) in the development and diffusion of climate-friendly technologies. While developing countries consider IPRs as a formidable barrier to the rapid transfer and (...) the widest possible diffusion of such technologies, developed countries, by contrast, see IPRs as a vital prerequisite for the development and transfer of these same technologies. This debate shows some similarity with the earlier debate on patents and access to lifesaving medicines, although there are also important differences. In our contribution we will explore both the analogies and the differences with this earlier debate. To provide a focus for our discussion, we will examine whether something similar to the Health Impact Fund (HIF), which has been proposed by philosopher Thomas Pogge as a reasonable solution to the ethical dilemmas of protection and accessibility in the field of pharmaceuticals, can also be elaborated for the development and diffusion of climate-friendly technologies. Thus the central question is how an analogous ‘Climate Impact Fund’ would look like and how it would work. This whole exercise will also yield a normative yardstick for assessing the various designs for a Green Climate Fund or a Technology Mechanism that are currently on the table of the international climate negotiations. (shrink)

Can the institutional systems that prepare Black nurse researchers question the ways their systemic pathways have impacted health equity knowledge development in nursing? We invite our readers to keep this question in mind and engage with our conversation as Black nurse researchers, scholars, educators, and clinicians. The purpose of our conversation, and this article, is to explore the transactional impact of knowledge development pathways and Black faculty retention pathways on the state of health equity knowledge in nursing (...) today. Over a series of conversations, we discuss the research exploitation of communities of color, deficit research funding, knowledge capitalization, the marginalization of diversity as a continuous process, a lack of sociocultural authority, and our thoughts on solutions. We conclude by using the wisdom of a generation to answer our initial question. (shrink)

The impact of managed care on nurses’ workplace learning and teaching This paper examines the impact of managed care on the informal learning process for nurses in a major US‐based health organisation. Through the analysis of focus group data we report the nurses’ view of the effect recent changes have had on the nurse/patient/care relationship. Managed care, our research indicates, has transformed the learning milieus for nurses with two effects. First, nurses have seen their need for informal (...) learning increase while the time and context for that learning has diminished. Second, the process of teaching patients and families has also been adversely affected even as managed care creates the need for more patient education. We report the analysis of the data collected at group interviews involving nurses working in both hospital and community settings of a leading US‐based HMO. All interviews took place during September of 1997 at various sites in California. This study is part of a larger Social Science Research Council of Canada funded investigation into managed care in the US and Canada. (shrink)

This study aimed to analyse the contribution of infaq funds to the social and economic resilience of the community during the COVID-19 pandemic in West Papua, Indonesia. This study uses a mixed-method approach, combining qualitative and quantitative studies. Qualitative data were collected through focus group discussions with administrators, Dai [Islamic preacher] and mosque congregations to obtain information about the form and mechanism for disbursing infaq funds. Furthermore, the state of distribution of infaq funds is confirmed to the recipient community with (...) an online survey as quantitative data. The data obtained were tabulated and analysed with descriptive and inferential statistics using multiple linear regression assisted by SPSS software 25 version. The research findings show that: firstly, the form of the social-economic contribution of infaq funds is carried out by: (1) financial assistance, (2) social assistance, and (3) health assistance. Secondly, infaq, an instrument of Islamic economics, can contribute to tackling the social and economic impacts of the community amid the COVID-19 outbreak. Thirdly, of the three forms of assistance provided, the health assistance aspect contributed 38.320%, the financial assistance aspect amounted to 37.173% and 24.339% to social assistance. This study shows that the community most needed health and financial assistance from infaq funds during the COVID-19 pandemic.Contribution: This study complements the existing literature and provides a new scientific treasure. That the infaq fund, as a philanthropy, turned out to be able to contribute to realising the social-economic resilience of the community during a disease outbreak. The form of health, financial and social assistance from infaq funds is a priority in accelerating the community’s economic recovery. It can be a countermeasure to socio-economic impacts during disasters and disease outbreaks. (shrink)

Public goods, as well as commercial commodities, are affected by exclusive arrangements secured by intellectual property (IP) rights. These rights serve as an incentive to invest human and material capital in research and development. Particularly in the life sciences, IP rights regulate objects such as food and medicines that are key to securing human rights, especially the right to adequate food and the right to health. Consequently, IP serves private (economic) and public interests. Part of this charge claims that (...) the current IP regime is privatizing the very building blocks of research and development – that used to be part of the commons. The public domain, in contrast to the private domain, may be the locus of much more diverse forms of creativity that at the same time ensures a wider plurality of productive traditions. An IP regime must support a sense of public morality because it is dependent upon civil support. This inevitably prompts questions of what are “good” exclusive rights and what are “bad” exclusive rights, and how shall such IP rights be developed. We argue that the democratization of the current IP regimes is an important first step to respond to these issues. (shrink)

As a worldwide economic crisis emerged at the end of 2008, international health agencies were quick to highlight its predictable impact on health in the poorest of communities. The World Health Organization underscored the need for a multisectoral approach to the crisis, “seeking health gains through demonstrating the importance of health in all policies” and whether current investments in health addressed the broader social determinants of health. However, despite good intentions and decades (...) of discussion addressing the need for transformative changes globally to reduce poverty and improve health equity, little progress has been made.A recent report on progress towards the Millennium Development Goals indicates that many targeted goals have not been met, with some goals lagging many years behind schedule. Although progress towards achieving the MDGs has been made for some specific conditions, where targeted interventions have had an immediate impact, limited progress is reported in more complex areas such as maternal child health. Such complex health issues require structural changes, strong political will, long-term funding, and consideration of other health determinants, such as education and exposure to environmental hazards. (shrink)

In 2000, the Center for Disease Control and Prevention’s National Center for Environmental Health issued a report that explored some of the ways in which “sprawl” impacts public health. The report has generated great interest, and state health officials are beginning to discuss the relationship between land use and public health. The CDC report has also produced a backlash. For example, the Southern California Building Industry Association labeled the report “a ludicrous sham” and argued that the (...) CDC should stick to “fighting physical diseases, not defending political ones.”In retrospect, it is probably unfortunate that this report was funded by an organization called “Sprawl Watch.” “Spraw” is a word that has no clear meaning but is applied to a huge range of issues involving suburban development. (shrink)

In 2000, the Center for Disease Control and Prevention’s National Center for Environmental Health issued a report that explored some of the ways in which “sprawl” impacts public health. The report has generated great interest, and state health officials are beginning to discuss the relationship between land use and public health. The CDC report has also produced a backlash. For example, the Southern California Building Industry Association labeled the report “a ludicrous sham” and argued that the (...) CDC should stick to “fighting physical diseases, not defending political ones.”In retrospect, it is probably unfortunate that this report was funded by an organization called “Sprawl Watch.” “Spraw” is a word that has no clear meaning but is applied to a huge range of issues involving suburban development. (shrink)

The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development (USAID) and the US National Institutes of Health (NIH), have policies that restrict how research funds may be used. Among these are the (...) now-rescinded Mexico City Policy, elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken. (shrink)

Both developing and developed countries face an increasing mismatch between what patients expect to receive from healthcare and what the public healthcare systems can afford to provide. Where there has been a growing recognition of the entitlement to receive healthcare, the frustrated expectations with regards to the level of provision has led to lawsuits challenging the denial of funding for health treatments by public health systems. This book analyses the impact of courts and litigation on the way (...) health systems set priorities and make rationing decisions. In particular, it focuses on how the judicial protection of the right to healthcare can impact the institutionalization, functioning and centrality of Health Technology Assessment (HTA) for decisions about the funding of treatment. Based on the case study of three jurisdictions - Brazil, Colombia, and England - it shows that courts can be a key driver for the institutionalization of HTA. These case studies show the paradoxes of judicial control, which can promote accountability and impair it, demand administrative competence and undermine bureaucratic capacities. The case studies offer a nuanced and evidence-informed understanding of these paradoxes in the context of health care by showing how the judicial control of priority-setting decisions in health care can be used to require and control an explicit scheme for health technology assessment, but can also limit and circumvent it. (shrink)

A wide range of proposals to alleviate the negative effects of intellectual property regimes is currently under discussion. This article offers a critical evaluation of six of these proposals: the Health Impact Fund, the Access to Knowledge movement, prize systems, open innovation models, compulsory licenses and South-South collaborations. An assessment on how these proposals target the human rights affected by intellectual property will be provided. The conflicting human rights that will be individually discussed are the rights: to (...) benefit from one’s own scientific work, to benefit from the advancement of science, to participate in scientific enterprises and to self-determination. (shrink)

The number of women living with HIV/AIDS is increasing worldwide, and there is an urgent public health need to develop new user-initiated HIV prevention methods, including microbicides. Although funding for microbicide development has increased since 2000, financial support is provided predominantly by governmental agencies and private foundations. Many donors, including the US Agency for International Development and the US National Institutes of Health, have policies that restrict how research funds may be used. Among these are the now-rescinded Mexico (...) City Policy, elements of the US Foreign Assistance Act, and restrictions on non-study-related care. The effect of these restrictions on the design and conduct of clinical research is poorly understood. As part of a recent mapping exercise conducted by the Global Campaign for Microbicides, we reviewed the impact of donor restrictions on seven HIV prevention trials. We found considerable confusion within the HIV prevention field as to whether and how Mexico City and other policies affect the use of research funds. We also found that these donor-imposed policies limited the level of care provided to trial participants and the types of capacity building projects undertaken. (shrink)

The article argues the thesis that institutions have a prima facie obligation to fund the feedback of individual findings in genomic research conducted on the African continent by drawing arguments from an underexplored Afro-communitarian view of distributive justice and rights of researchers to be aided. Whilst some studies have explored how institutions have a duty to support return as a form of ancillary care or additional foreseeable service in research by mostly appealing to dominant principles and theories in the (...) Global North, this mostly normative study explores this question by appealing to underexplored African philosophy. This is a new way of thinking about institutional responsibility to fund feedback and responds to the call to decolonise health research in Africa. Further studies are required to study how this prima facie obligation will interact with social contexts and an institution’s extant relationships to find an actual duty. The research community should also work out procedures, policies and governance structures to facilitate feedback. In our opinion, though the impacts of feeding back can inform how institutions think about their actual duty, these do not obliterate the binding duty to fund feedback. (shrink)

The UK’s National Institute for Health and Care Excellence is responsible for conducting health technology assessment on behalf of the National Health Service. In seeking to justify its recommendations to the NHS about which technologies to fund, NICE claims to adopt two complementary ethical frameworks, one procedural—accountability for reasonableness —and one substantive—an ‘ethics of opportunity costs’ that rests primarily on the notion of allocative efficiency. This study is the first to empirically examine normative changes to NICE’s (...) approach and to analyse whether these enhance or diminish the fairness of its decision-making, as judged against these frameworks. It finds that increasing formalisation of NICE’s approach and a weakening of the burden of proof laid on technologies undergoing HTA have together undermined its commitment to EOC. This implies a loss of allocative efficiency and a shift in the balance of how the interests of different NHS users are served, in favour of those who benefit directly from NICE’s recommendations. These changes also weaken NICE’s commitment to AfR by diminishing the publicity of its decision-making and by encouraging the adoption of rationales that cannot easily be shown to meet the relevance condition. This signals a need for either substantial reform of NICE’s approach, or more accurate communication of the ethical reasoning on which it is based. The study also highlights the need for further empirical work to explore the impact of these policy changes on NICE’s practice of HTA and to better understand how and why they have come about. (shrink)

Background The ethical governance of Artificial Intelligence (AI) in health care and public health continues to be an urgent issue for attention in policy, research, and practice. In this paper we report on central themes related to challenges and strategies for promoting ethics in research involving AI in global health, arising from the Global Forum on Bioethics in Research (GFBR), held in Cape Town, South Africa in November 2022. Methods The GFBR is an annual meeting organized by (...) the World Health Organization and supported by the Wellcome Trust, the US National Institutes of Health, the UK Medical Research Council (MRC) and the South African MRC. The forum aims to bring together ethicists, researchers, policymakers, research ethics committee members and other actors to engage with challenges and opportunities specifically related to research ethics. In 2022 the focus of the GFBR was “Ethics of AI in Global Health Research”. The forum consisted of 6 case study presentations, 16 governance presentations, and a series of small group and large group discussions. A total of 87 participants attended the forum from 31 countries around the world, representing disciplines of bioethics, AI, health policy, health professional practice, research funding, and bioinformatics. In this paper, we highlight central insights arising from GFBR 2022. Results We describe the significance of four thematic insights arising from the forum: (1) Appropriateness of building AI, (2) Transferability of AI systems, (3) Accountability for AI decision-making and outcomes, and (4) Individual consent. We then describe eight recommendations for governance leaders to enhance the ethical governance of AI in global health research, addressing issues such as AI impact assessments, environmental values, and fair partnerships. Conclusions The 2022 Global Forum on Bioethics in Research illustrated several innovations in ethical governance of AI for global health research, as well as several areas in need of urgent attention internationally. This summary is intended to inform international and domestic efforts to strengthen research ethics and support the evolution of governance leadership to meet the demands of AI in global health research. (shrink)

Realising the societal gains from publicly funded health and medical research requires a model for a reflexive evaluation precedent for the societal impact of research. This research explores UK Research Excellence Framework evaluators’ values and opinions and assessing societal impact, prior to the assessment taking place. Specifically, we discuss the characteristics of two different impact assessment extremes – the “quality-focused” evaluation and “societal impact-focused” evaluation. We show the wide range of evaluator views about impact, (...) and that these views could be conceptually reflected in a range of different positions along a conceptual evaluation scale. We describe the characteristics of these extremes in detail, and discuss the different beliefs evaluators had which could influence where they positioned themselves along the scale. These decisions, we argue, when considered together, form a dominant definition of societal impact that influences the direction of its evaluation by the panel. (shrink)

As of December 1991, the Patient Self-Determination Act mandated that health care institutions which receive funding from Medicare or Medicaid provide written information about persons rights to participate in medical decision-making and formulate advance directives. The PSDA required each state…acting through a State agency, association, or other private nonprofit entity develop a written description of the law of the State concerning advance directives that would be distributed by providers or organizations under the requirements of [the Act].

As of December 1991, the Patient Self-Determination Act mandated that health care institutions which receive funding from Medicare or Medicaid provide written information about persons rights to participate in medical decision-making and formulate advance directives. The PSDA required each state…acting through a State agency, association, or other private nonprofit entity develop a written description of the law of the State concerning advance directives that would be distributed by providers or organizations under the requirements of [the Act].

Pharmaceutical industry funding has transformed much grassroots community activism on health into corporate-sponsored advocacy. This critical commentary outlines recent evidence about industry funding of patient advocacy groups, offers a commentary on the history of grassroots activism appearing in this issue of the journal, and calls for greater scrutiny of the impacts and ethics of such sponsorship.

The burdens of resource constraints in publicly funded healthcare systems urge decision makers in countries like Sweden, Norway and the UK to find new financial solutions. One proposal that has been put forward is co-payment—a financial model where some treatment or care is made available to patients who are willing and able to pay the costs that exceed the available alternatives fully covered by public means. Co-payment of this sort has been associated with various ethical concerns. These range from worries (...) that it has a negative impact on patients' wellbeing and on health care institutions, to fears that co-payment is in conflict with core values of publicly funded health care systems. This article provides an overview of the main ethical issues associated with co-payment, and ethical arguments both in support of and against it will be presented and analyzed. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food (...) and Drug Agency (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

It is an axiom of contemporary conversations about austerity and health care that the relationship between the two is essentially direct. Cutting funds damages health care systems and hurts the health of individuals who rely on them. Though this premise has provoked necessary discussion about global politics, the global economy and their impact on individual well-being, it is nonetheless intrinsically problematic. Assigning health and health care as objects of austerity not only obscures the complexity (...) of health care systems and the opacity of health’s definitional borders, but also misunderstands austerity, its manifestations and its significance. The ambition of this essay is to bring health care back into the debate, in order to establish the greater dynamism of the contemporary austerity and health care relationship. This historical reconstruction will challenge the significance of our current situating of austerity as health care’s bogeyman, press for a reconsideration of our contemporary definitions of the key factors involved here and finally conclude with some thoughts on how we might more productively approach the problem of health now. (shrink)

Publicly-funded health systems, including those national health services and social or National Health Insurances, are institutionalized solidarity in health. In Europe, solidarity originated from the legacies of labor movements, the Judeo-Christian traditions, and nationalist sentiments in the re-construction Era after the WWII. In middle-to-high income East Asian countries, such as Japan, Taiwan, Korea, the health systems were built on different grounds and do not have such ethical origins of solidarity. As health systems in Europe (...) and East Asia are both facing sustainability crises due to aging population, stagnant economy, changing boundaries, and advancing medical technologies, how those systems with the European solidaristic ethical traditions can be revived and how those without the European traditions could survive become a matter of theoretical interests and an urgent policy problem to be addressed. Drawing on contemporary theories of solidarity, this essay analyzes the boundary problem and its impact on the sustainability of the health system in Taiwan. It then considers two plausible origins of solidarity in Taiwan. One is the re-emerged civic nationalism, and the other is an ethos of common life. It is argued that after years of implementation, the National Health Insurance in Taiwan might have shaped the social values and people’s habits and formed an ethos of common life. Such ethos could be an ethical origin of solidarity in non-western societies and help the health systems endure the prolonged sustainability crises. (shrink)

Over the past 20 years, international development assistance for health has increased, albeit for some diseases more than others. However, the triple crises of food, fuel, and finance have raised questions regarding whether aid flows will continue to increase, or even be maintained in the coming future. Health and education are often the first victims of budget cuts in times of limited funding and competing priorities as they are viewed to be in the realm of “low politics” as (...) opposed to security and military spending, which are seen as “high politics.” Cuts in overseas development aid will have a drastic impact on countries where external funding makes up a significant proportion of national health budgets. Although global health aid accounts for only 0.3% of total expenditures on health globally, in some countries like the Solomon Islands and Mozambique, for example, 82% and 66% of the national health budgets respectively come from external resources. WHO estimates that 23 countries have over 30% of their total health expenditures funded by donors. (shrink)

Heath care and public health are typically conceptualized as separate, albeit overlapping, systems. Health care’s goal is the improvement of individual patient outcomes through the provision of medical services. In contrast, public health is devoted to improving health outcomes in the population as a whole through health promotion and disease prevention. Health care services receive the bulk of funding and political support, while public health is chronically starved of resources. In order to reduce (...) morbidity and mortality, policymakers must shift their attention to public health services and to the improved integration of health care and public health. In other words, health care and public health should be treated as two parts of a single integrated health system. Furthermore, in order to maximize improvements in health status, policymakers must consider the impact of all governmental policies on health. (shrink)

The budget battles have hit the Indian Health Service hard: sequestration forced a 5 percent reduction in funds, followed by an additional 0.2 percent rescission in the recently passed Consolidated and Further Continuing Appropriations Act. Exempted from sequestration (and rightly so) were other very important health care programs such as the Veterans Administration Health Programs, the State Children's Health Insurance Programs, and Medicaid. Medicare has been reduced by only 2 percent, with that cut targeted to provider (...) reimbursement so as to avoid a reduction in service to beneficiaries. In March 2013, Representatives Betty McCollum, Tom Cole, and Michelle Lujan Grisham introduced a bill to reduce the impact of sequestration on the IHS to 2 percent (H.R. 1371). This bill was referred to the Committee on the Budget, but to date, there has been no movement on it.Why was the IHS susceptible to sequestration? Why is it considered a “discretionary” line item in the federal budget? Why is there not parity for Indians, whose health status remains far below that of mainstream America? As a matter of legal requirement, social contract, and moral obligation, the United States should fundamentally change how Indian Health is funded. (shrink)

In March 1994, a health care conference was held in Edmonton, Alberta, at which the values of conference participants towards health care were systematically recorded and analysed. This exploration is significant because the values that underpin the structure of the current publicly-funded and administered Canadian health care system rarely enter current discussions regarding health care system reform. Rather, economic and other sociopolitical forces now seem to be having a major impact on plans and actual changes (...) within the health care system. Thus, the underlying attitudes and beliefs of Canadians towards health care have not been articulated or given due credence. The conference par ticipants identified three dominant values: (1) the dignity of the human person as an indi vidual and social being; (2) respect for pluralism and difference; and (3) accountability These values were found to be robust, in that they sustain a focus on the 'common good'. The common good is the core of the Canadian health care system, and is enshrined in the 1984 Canada Health Act. Conceptually, these values could also lead to significant changes in health care, in keeping with the common good, particularly those changes focusing on the current deficiencies of the Canadian health care system. (shrink)

Next SectionBackground International and national agencies play a major role in setting HIV care-and-treatment priorities in low-income-countries. Little is known about priority setting at lower health-system levels. The objective of this article is to explore experiences of HIV priority decisions, at what levels these decisions are made and how they might influence the distribution of health benefits in a high-endemic region in Tanzania. Methods This is a qualitative study using observations, key documents and semistructured focus-group and individual interviews (...) (43) with health workers, patients and administrators at one regional and one district hospital. The analysis was based on an editing analysis style. Results Health workers did not perceive themselves as bedside rationing agents and they reported following national recommendations and felt they have little impact on important priority decisions. Health benefit distributions were largely determined by priority decisions made at a national level. External factors, such as eligibility criteria, inadequate funding and barriers to access seemed to play a major role in the actual distribution of health services and benefits in the region. Patient groups who were actually given high priority were the sickest patients, those living near a facility and those who could afford long journeys and frequent visits. Low-priority groups were those experiencing other co-morbidities or treatment failure, children, asymptomatic patients and the poorest. Conclusions/significance The interaction of priority setting across health-system levels and their impact on distribution of health outcomes in the population has been underestimated. The distributional pattern of health outcomes calls for further normative assessment. (shrink)