Benefit sharing in health research has been the focus of international debates for many years, particularly in developing countries. Whilst increasing attention is being given to frameworks that can guide researchers to determine levels of benefits to participants, there is little empirical research from developing countries on the practical application of these frameworks, including in situations of extreme poverty and vulnerability. In addition, the voices of those who often negotiate and face issues related to benefits in practice - frontline researchers (...) and fieldworkers - are rarely included in these debates. Against this background, this paper reports on experiences of negotiating research participation and benefits as described by fieldworkers, research participants and researchers in two community based studies. (shrink)

Systematic reviews, which were developed to improve policy-making and clinical decision-making, answer an empirical question based on a minimally biased appraisal of all the relevant empirical studies. A model is presented here for writing systematic reviews of argument-based literature: literature that uses arguments to address conceptual questions, such as whether abortion is morally permissible or whether research participants should be legally entitled to compensation for sustaining research-related injury. Such reviews aim to improve ethically relevant decisions in healthcare, research or policy. (...) They are better tools than informal reviews or samples of literature with respect to the identification of the reasons relevant to a conceptual question, and they enable the setting of agendas for conceptual and empirical research necessary for sound policy-making. This model comprises prescriptions for writing the systematic review's review question and eligibility criteria, the identification of the relevant literature, the type of data to extract on reasons and publications, and the derivation and presentation of results. This paper explains how to adapt the model to the review question, literature reviewed and intended readers, who may be decision-makers or academics. Obstacles to the model's application are described and addressed, and limitations of the model are identified. (shrink)

One‐third of all human deaths are due to poverty‐related causes, to malnutrition and to diseases that can be prevented or cured cheaply. Yet our politicians, academics, and mass media show little concern for how such poverty might be reduced. They are more interested in possible military interventions to stop human rights violations in developing countries, even though such interventions – at best – produce smaller benefits at greater cost. This Western priority may be rooted in self‐interest. But it engenders, and (...) is sustained by, a deeply flawed moral presentation of global economic cooperation. The new global economic order we impose aggravates global inequality and reproduces severe poverty on a massive scale. On any plausible understanding of our moral values, the prevention of such poverty is our foremost responsibility. (shrink)

The search for valuable new products from among the world’s stock of natural biological resources is mostly carried out by people from wealthy countries, and mostly takes place in developing countries that lack the research capacity to profit from it. Surely, the indigenous people should receive some compensation from it. But we must build a robust defense for this intuition, rooted in the Western moral traditions that are widely accepted in wealthy countries, if we are to put it into practice (...) and enforce it. (shrink)

ABSTRACT Most pharmaceutical research carried out today is focused on the treatment and management of the lifestyle diseases of the developed world. Diseases that affect mainly poor people are neglected in research advancements in treatment because they cannot generate large financial returns on research and development costs. Benefit sharing arrangements for the use of indigenous resources and genetic research could only marginally address this gap in research and development in diseases that affect the poor. Benefit sharing as a strategy is (...) conceptually problematic, even if one, as we do, agrees that impoverished indigenous communities should not be exploited and that they should be assisted in improving their living conditions. The accepted concept of intellectual property protection envisages clearly defined originators and owners of knowledge, whereas the concept of community membership is fluid and indigenous knowledge is, by its very nature, open, with the originator(s) lost in the mists of time. The delineation of ‘community’ presents serious conceptual and practical difficulties as few communities form discrete, easily discernable groups, and most have problematic leadership structures. Benefit sharing is no substitute for governments’ responsibility to uplift impoverished communities. Benefit sharing arrangements may be fraught with difficulties but considerations of respect and equity demand that prior informed consent and consultation around commercialisation of knowledge take place with the source community and their government.1. (shrink)

This chapter outlines the main ideas of my book National responsibility and global justice. It begins with two widely held but conflicting intuitions about what global justice might mean on the one hand, and what it means to be a member of a national community on the other. The first intuition tells us that global inequalities of the magnitude that currently exist are radically unjust, while the second intuition tells us that inequalities are both unavoidable and fair once national responsibility (...) is allowed to operate. This conflict might be resolved either by adopting a cosmopolitan theory of justice (which leaves no room for national responsibility) or by adopting a ?political? theory of justice (which denies that questions of distributive justice can arise beyond the walls of the sovereign state). Since neither resolution is satisfactory, the chapter defends the idea of national responsibility and proposes a new theory of global justice, whose main elements are the protection of basic human rights worldwide, and fair terms of interaction between independent political communities. (shrink)

The issue of biopiracy has attracted considerable attention in recent years. The Convention on Biological Diversity adopted a principle of state sovereignty over biological resources and the genetic information contained within those resources to address this issue. It is argued that this principle has not been adequately justified and that there are other solutions to the issue of biopiracy, based on different theories of justice, that deserve greater consideration. These alternatives include the common heritage of mankind principle and the global (...) commons principle. (shrink)

Abstract Benefit sharing as envisaged by the 1992 Convention on Biological Diversity (CBD) is a relatively new idea in international law. Within the context of non-human biological resources, it aims to guarantee the conservation of biodiversity and its sustainable use by ensuring that its custodians are adequately rewarded for its preservation. Prior to the adoption of the CBD, access to biological resources was frequently regarded as a free-for-all. Bioprospectors were able to take resources out of their natural habitat and develop (...) commercial products without sharing benefits with states or local communities. This paper asks how CBD-style benefit-sharing fits into debates of justice. It is argued that the CBD is an example of a set of social rules designed to increase social utility. It is also argued that a common heritage of humankind principle with inbuilt benefit-sharing mechanisms would be preferable to assigning bureaucratic property rights to non-human biological resources. However, as long as the international economic order is characterized by serious distributive injustices, as reflected in the enormous poverty-related death toll in developing countries, any morally acceptable means toward redressing the balance in favor of the disadvantaged has to be welcomed. By legislating for a system of justice-in-exchange covering nonhuman biological resources in preference to a free-for-all situation, the CBD provides a small step forward in redressing the distributive justice balance. It therefore presents just legislation sensitive to the international relations context in the 21st century. (shrink)

Over the course of its first seven editions, Principles of Biomedical Ethics has proved to be, globally, the most widely used, authored work in biomedical ethics. It is unique in being a book in bioethics used in numerous disciplines for purposes of instruction in bioethics. Its framework of moral principles is authoritative for many professional associations and biomedical institutions-for instruction in both clinical ethics and research ethics. It has been widely used in several disciplines for purposes of teaching in the (...) classroom, during conferences, etc. (shrink)

Consisting of two essays, this work by a Harvard professor offers his thoughts on the idea of a social contract regulating people's behavior toward one another.

According to some estimates, less than 10% of the world's biomedical research funds are dedicated to addressing problems that are responsible for 90% of the world's burden of disease. This paper explains why this disparity exists and what should be done about it. It argues that the disparity exists because: 1) multinational pharmaceutical and biotechnology companies do not regard research and development investments on the health problems of developing nations to be economically lucrative; and 2) governmental agencies that sponsor biomedical (...) research face little political pressure to allocate funds for the problems of developing nations. This paper argues that developed nations have an obligation to address disparities related to biomedical research funding. To facilitate this effort, developed countries should establish a trust fund dedicated to research on the health problems of developing nations similar to the Global AIDS Fund. (shrink)

The debate over when medical research may be performed in developing countries has steered clear of the broad issues of social justice in favor of what seem more tractable, practical issues. A better approach will reframe the question of justice in international research in a way that makes explicit the links between medical research, the social determinants of health, and global justice.

In this book by the award-winning author of Just Healthcare, Norman Daniels develops a comprehensive theory of justice for health that answers three key questions: what is the special moral importance of health? When are health inequalities unjust? How can we meet health needs fairly when we cannot meet them all? Daniels' theory has implications for national and global health policy: can we meet health needs fairly in ageing societies? Or protect health in the workplace while respecting individual liberty? Or (...) meet professional obligations and obligations of justice without conflict? When is an effort to reduce health disparities, or to set priorities in realising a human right to health, fair? What do richer, healthier societies owe poorer, sicker societies? Just Health: Meeting Health Needs Fairly explores the many ways that social justice is good for the health of populations in developed and developing countries. (shrink)

The concept of benefit sharing has been a topical issue on the international stage for more than two decades, gaining prominence in international law, research ethics and political philosophy. In spite of this prominence, the concept of benefit sharing is not devoid of controversies related to its definition and justification. This article examines the discourses and justifications of benefit sharing concept.

The Human Genome Project and the related research and development activities have raised heated discussions around some very basic ethical and social issues. A much debated concern is that of justice in human genetic research and in possible applications, especially pertaining to questions of just benefit-sharing - who and based on what sort of argumentation has the right to require benefits arising from research and discoveries, and what can even be considered as benefits? In what follows I will be examining (...) and clarifying the notion of benefit-sharing by focusing on its justifications. I will argue for certain qualifications and limitations in using this concept in specific and universal contexts. (shrink)

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high-income countries owed to parties from low and middle-income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: (...) the research target, research capacity strengthening, and post-trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. (shrink)

“Fair and equitable benefit-sharing” is one of the objectives of the UN Convention on Biological Diversity and the FAO International Treaty on Plant Genetic Resources for Food and Agriculture. In essence, benefit-sharing holds that countries, farmers, and indigenous communities that grant access to their plant genetic resources and/or traditional knowledge should share in the benefits that users derive from these resources. But what exactly is understood by “fair” and “equitable” in this context? Neither term is defined in the international treaties. (...) A complicating factor, furthermore, is that different motivations and perspectives exist with respect to the notion of benefit-sharing itself. This paper looks at six different approaches to benefit-sharing that can be extracted from the current debates on “Access and Benefit-Sharing.” These approaches form the basis of a philosophical reflection in which the different connotations of “fair and equitable” are considered, by analyzing the main principles of justice involved. Finally, the various principles are brought together in order to draw some conclusions as to how a fair and equitable benefit-sharing mechanism might best be realized. This results in several recommendations for policymakers. (shrink)

ABSTRACT In this article, we will first give a historic overview of the concept of benefit sharing and its appearance in official agreements, particularly with respect to crop genetic resources. It will become clear that, at present, benefit sharing is primarily considered as an instrument of compensation or exchange, and thus refers to commutative justice. However, we believe that such a narrow interpretation of benefit sharing disregards, and even undermines, much of its (historical) content and potency, especially where crop genetic (...) resources are concerned. We argue that benefit sharing should not be based merely on commutative justice but rather on a broader model that is also grounded in the concept of distributive justice. This has repercussions for the application of benefit sharing, which we try to clarify by distinguishing between downstream and upstream benefit sharing. Upstream benefit sharing is not so much inspired by compensation for actions done, or the distribution downstream of benefits developed, but by the idea of shared decision‐making on the research and development of resources fundamental to human welfare. Going upstream in the research process of crop genetic resources, and determining research agendas and improving crops according to the needs of the poor, benefit sharing may well be a tool to contribute to world food security and global justice. We concretize our ideas on upstream benefit sharing by introducing a set of criteria that determine the success of consultations on agricultural research agenda setting. (shrink)

Book reviewed in this article: Principles of Biomedical Ethics. By Tom L. Beauchamp and James F. Childress.

It is widely agreed that foreign sponsors of research in low- and middle-income countries (LMICs) are morally required to ensure that their research benefits the broader host community. There is no agreement, however, about how much benefit or what type of benefit research sponsors must provide, nor is there agreement about what group of people is entitled to benefit. To settle these questions, it is necessary to examine why research sponsors have an obligation to benefit the broader host community, not (...) only their subjects. Justifying this claim is not straightforward. There are three justifications for an obligation to benefit host communities that each apply to some research, but not to all. Each requires a different amount of benefit, and each requires benefit to be directed toward a different group. If research involves significant net risk to LMIC subjects, research must provide adequate benefit to people in LMICs to avoid an unjustified appeal to subjects’ altruism. If research places significant burdens on public resources, research must provide fair compensation to the community whose public resources are burdened. If research is for profit, research sponsors must contribute adequately to the upkeep of public goods from which they benefit in order to avoid the wrong of free-riding, even if their use of these public goods is not burdensome. (shrink)

Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity, adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so as to (...) enable research subjects to claim a share of the benefits to be negotiated on a case-by-case basis. Our conclusion on this question is: 'No, the CBD should not be expanded to include human genetic resources.' There are essential differences between human and non-human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity. When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as 'window dressing'. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization's Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed. (shrink)

Guidelines for health research focus on protecting individual research subjects. It is also vital to protect the communities involved in health research. In particular, a number of studies have been criticized on the grounds that they exploited host communities. The present paper attempts to address these concerns by providing an analysis of community exploitation and, based on this analysis, determining what safeguards are needed to protect communities in health research against exploitation. (edited).

This chapter outlines the main ideas of my book National responsibility and global justice. It begins with two widely held but conflicting intuitions about what global justice might mean on the one hand, and what it means to be a member of a national community on the other. The first intuition tells us that global inequalities of the magnitude that currently exist are radically unjust, while the second intuition tells us that inequalities are both unavoidable and fair once national responsibility (...) is allowed to operate. This conflict might be resolved either by adopting a cosmopolitan theory of justice (which leaves no room for national responsibility) or by adopting a ‘political’ theory of justice (which denies that questions of distributive justice can arise beyond the walls of the sovereign state). Since neither resolution is satisfactory, the chapter defends the idea of national responsibility and proposes a new theory of global justice, whose main elements are the protection of basic human rights worldwide, and fair terms of interaction between independent political communities. (shrink)

Benefit sharing has been a recurrent theme in international debates for the past two decades. However, despite its prominence in law, medical ethics and political philosophy, the concept has never been satisfactorily defined. In this conceptual paper, a definition that combines current legal guidelines with input from ethics debates is developed. Philosophers like boxes; protective casings into which they can put concisely-defined concepts. Autonomy is the human capacity for self-determination; beneficence denotes the virtue of good deeds, coercion is the intentional (...) threat of harm and so on. What about benefit sharing? Does the concept have a box and are the contents clearly defined? The answer to this question has to be no. The concept of benefit sharing is almost unique in that various disciplines use it regularly without precise definitions. In this article, a definition for benefit sharing is provided, to eliminate unnecessary ambiguity. (shrink)

The main aim of this paper is to challenge the validity of the distinction between legal justice and social justice. It is argued that what we usually call legal justice is either an application of the more fundamental notion of social justice to legal rules and decisions or is not a matter of justice at all. In other words, the only correct uses of the notion of legal justice are derivative from the notion of social justice and, hence, the alleged (...) conflicts between criteria of social and legal justice result from the confusion about the proper relationship between these two concepts. Two views about the social justice/legal justice dichotomy are of particular importance and will provide the focus for the argument: this dichotomy is sometimes identified with a classical distinction between distributive and commutative justice and sometimes with the distinction between substantive and procedural justice. (shrink)

In 2004 Emanuel et al. published an influential account of exploitation in international research, which has become known as the 'fair benefits account'. In this paper I argue that the thin definition of fairness presented by Emanuel et al, and subsequently endorsed by Gbadegesin and Wendler, does not provide a notion of fairness that is adequately robust to support a fair benefits account of exploitation. The authors present a procedural notion of fairness – the fair distribution of the benefits of (...) research is to be determined on a case-by-case basis by the parties involved in each study. The fairness of the distribution of benefits is not assessed against an independent normative standard. Emanuel et al.'s account of fairness provides a framework for objecting only to transactions that occur without the fully informed consent of the weaker party. As a result, a debate about exploitation collapses into a debate about consent. This is problematic because, as the proponents of the fair benefits framework acknowledge, neither the trial participants' consent nor the host community's consent preclude exploitation. Attempts to stipulate normative standards of fairness to protect research subjects in developing countries have been controversial and divisive, and it is therefore understandable that bioethicists would be tempted to develop accounts of exploitation that are independent of such prescriptive principles. I conclude, however, that the utility of the fair benefits model of exploitation as a policy tool will ultimately depend on whether a substantive principle of fairness can be developed to underpin it. (shrink)

The “fair benefits” approach to international research is designed to produce results that all can agree are fair without taking a stand on divisive questions of justice. But its appealing veneer of collaboration masks ambiguities at both a conceptual and an operational level. An attempt to put it into practice would look a lot like an auction, leaving little reason to think the outcomes will satisfy even minimal conditions of fairness.

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

How international research might contribute to justice in global health has not been substantively addressed by bioethics. Theories of justice from political philosophy establish obligations for parties from high‐income countries owed to parties from low and middle‐income countries. We have developed a new framework that is based on Jennifer Ruger's health capability paradigm to strengthen the link between international clinical research and justice in global health. The ‘research for health justice’ framework provides direction on three aspects of international clinical research: (...) the research target, research capacity strengthening, and post‐trial benefits. It identifies the obligations of justice owed by national governments, research funders, research sponsors, and investigators to trial participants and host communities. These obligations vary from those currently articulated in international research ethics guidelines. Ethical requirements of a different kind are needed if international clinical research is to advance global health equity. (shrink)

International research, sponsored by for-profit companies, is regularly criticised as unethical on the grounds that it exploits research subjects in developing countries. Many commentators agree that exploitation occurs when the benefits of cooperative activity are unfairly distributed between the parties. To determine whether international research is exploitative we therefore need an account of fair distribution. Procedural accounts of fair bargaining have been popular solutions to this problem, but I argue that they are insufficient to protect against exploitation. I argue instead (...) that a maximin principle of fair distribution provides a more compelling normative account of fairness in relationships characterised by extreme vulnerability and inequality of bargaining potential between the parties. A global tax on international research would provide a mechanism for implementing the maximin account of fair benefits. This model has the capacity to ensure fair benefits and thereby prevent exploitation in international research. (shrink)

Debates about justice in international clinical research problematically conflate two quite different forms of obligation. International research ethics guidelines were intended to describe how to conduct biomedical research in a just manner at the micro or clinical level (within the researcher-participant interaction) but have come to include requirements that are clearly intended to promote justice at the global level. Ethicists have also made a variety of claims regarding what international research should contribute to global justice. This paper argues that the (...) conflation of debates about justice at the micro and macro-levels has not only resulted in the placement of obligations upon the wrong actors but has also served to exclude relevant actors from the ethical picture. Suggestions for who should properly bear macro-level obligations of justice in international clinical research are offered. The paper further contends that, unlike researchers who violate informed consent requirements, no similar type of accountability exists for obligations of global justice, even for those obligation-bearers (incorrectly) identified by current ethics guidelines. (shrink)

ABSTRACT Benefit sharing aims to achieve an equitable exchange between the granting of access to a genetic resource and the provision of compensation. The Convention on Biological Diversity (CBD), adopted at the 1992 Earth Summit in Rio de Janeiro, is the only international legal instrument setting out obligations for sharing the benefits derived from the use of biodiversity. The CBD excludes human genetic resources from its scope, however, this article considers whether it should be expanded to include those resources, so (...) as to enable research subjects to claim a share of the benefits to be negotiated on a case‐by‐case basis. Our conclusion on this question is: ‘No, the CBD should not be expanded to include human genetic resources.’ There are essential differences between human and non‐human genetic resources, and, in the context of research on humans, an essentially fair exchange model is already available between the health care industry and research subjects. Those who contribute to research should receive benefits in the form of accessible new health care products and services, suitable for local health needs and linked to economic prosperity (e.g. jobs). When this exchange model does not apply, as is often the case in developing countries, individually negotiated benefit sharing agreements between researchers and research subjects should not be used as ‘window dressing’. Instead, national governments should focus their finances on the best economic investment they could make; the investment in population health and health research as outlined by the World Health Organization’s Commission on Macroeconomics and Health; whilst international barriers to such spending need to be removed. (shrink)

“Fair and equitable benefit-sharing” is one of the objectives of the UN Convention on Biological Diversity and the FAO International Treaty on Plant Genetic Resources for Food and Agriculture. In essence, benefit-sharing holds that countries, farmers, and indigenous communities that grant access to their plant genetic resources and/or traditional knowledge should share in the benefits that users derive from these resources. But what exactly is understood by “fair” and “equitable” in this context? Neither term is defined in the international treaties. (...) A complicating factor, furthermore, is that different motivations and perspectives exist with respect to the notion of benefit-sharing itself. This paper looks at six different approaches to benefit-sharing that can be extracted from the current debates on “Access and Benefit-Sharing.” These approaches form the basis of a philosophical reflection in which the different connotations of “fair and equitable” are considered, by analyzing the main principles of justice involved. Finally, the various principles are brought together in order to draw some conclusions as to how a fair and equitable benefit-sharing mechanism might best be realized. This results in several recommendations for policymakers. (shrink)

Can genomics working with crop genetic resources, which can be relevant for developing countries, contribute in reducing the gap between rich and poor countries in using modern biotechnologies? In this paper we concentrate on the extent to which benefit sharing of genetic resources can be a mechanism to harness genomics for development and to reduce the “biotechnology divide” or “genomics divide”. First we analyze the existing arrangements and we conclude that these presuppose predominantly a concept of commutative justice, which is (...) at the basis of considerable drawbacks. Secondly we propose arrangements founded on another concept of justice, distributive justice, which forbids enhancing inequalities. Upstream benefit sharing of genetic resources is proposed as an interesting alternative, which connects with several coalitions of scientists and poor farmers in the third world. These alternatives offer good prospects to contribute to the reduction of the “genomics divide”. (shrink)