EQUITABLE ACCESS TO HUMAN BIOLOGICAL RESOURCES IN DEVELOPING COUNTRIES: Benefit Sharing Without Undue Inducement.

The main research question of this thesis is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed to achieve equity for developing countries? Access to and benefit sharing for human biological resources is not regulated through an international legal framework such as the Convention on Biological Diversity, which applies only to plants, animals and micro-organisms as well as associated traditional knowledge. This legal vacuum for the governance of human genetic resources can be attributed (in part) to the concern that benefit sharing might provide undue inducements to research participants and their communities. This thesis shows that: (a) Benefit sharing is crucial to avoiding the exploitation of developing countries in genomic research. (b) With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other medical research (e.g. clinical trials). (c) Concerns remain over research involving indigenous populations and some recommendations are provided. In drawing its conclusions, the thesis resolves a highly pressing topic in global bioethics and international law. Originally, it combines bioethical argument with jurisprudence, in particular reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue influence

The Rooibos Benefit Sharing Agreement – Breaking New Ground with Respect, Honesty, Fairness and Care

The 1992 Convention on Biological Diversity (CBD) and its 2010 Nagoya Protocol brought about a breakthrough in global policy making. They combined a concern for the environment with a commitment to resolving longstanding human injustices regarding access to, and use of biological resources. In particular, the traditional knowledge of indigenous communities was no longer going to be exploited without fair benefit sharing. Yet, for 25 years after the adoption of the CBD, there were no major benefit sharing agreements that led to significant funding streams for indigenous communities. This changed with the signing of the Rooibos Benefit Sharing Agreement in South Africa, described in this paper. As the authors report, the Rooibos Agreement is a superlative in two respects. It is the biggest benefit sharing agreement between industry and indigenous peoples to date. It is also the first industry-wide agreement to be formed in accordance with biodiversity legislation. This article is a co-production between traditional knowledge holders, the lawyer who represented their interests, the Co-Chair of the Nagoya Protocol negotiations, and an ethicist who analyzed the major challenges of this historic agreement. With no precedent in the benefit sharing world, the agreement stands as a concrete example of the ‘art of the possible.’ Although the rooibos case is unique in a number of aspects, the experience offers many transferable insights, including: patience; incrementalism; honesty; trust; genuine dialogue; strong legal support; a shared recognition that a fair, win-win deal is possible; government leadership; and unity amongst indigenous peoples. Such ingredients of success can apply well beyond southern Africa

Equitable Research Partnerships A Global Code of Conduct to Counter Ethics Dumping

This open access book offers insights into the development of the ground-breaking Global Code of Conduct for Research in Resource-Poor Settings (GCC) and the San Code of Research Ethics. Using a new, intuitive moral framework predicated on fairness, respect, care and honesty, both codes target ethics dumping – the export of unethical research practices from a high-income setting to a lower- or middle-income setting. The book is a rich resource of information and argument for any research stakeholder who opposes double standards in research. It will be indispensable for applicants to European Union framework programmes, as the GCC is now a mandatory reference document for EU funding

Vulnerability Revisited

Open access. This open-access book discusses vulnerability and the protection-inclusion dilemma of including those who suffer from serious poverty, severe stigma, and structural violence in research. Co-written with representatives from indigenous peoples in South Africa and sex workers in Nairobi, the authors come down firmly on the side of inclusion. In the spirit of leaving no one behind in research, the team experimented with data collection methods that prioritize research participant needs over researcher needs. This involved foregoing the collection of personal data and community researchers being involved in all stages of the research. In the process, the term ‘vulnerability’ was illuminated across significant language barriers as it was defined by indigenous peoples and sex workers themselves. The book describes a potential alternative to exclusion from research that moves away from traditional research methods. By ensuring that the research is led by vulnerable groups for vulnerable groups, it offers an approach that fosters trust and collaboration with benefits for the community researchers, the wider community as well as research academics. Those living in low-income settings, in dire situations that are summarized with the term ‘vulnerability’ know best what their problems are and which priorities they have. To exclude them from research for their own protection is a patronizing approach which insinuates that researchers and research ethics committees know best. The team from this book have shown that minimally risky and minimally burdensome research tailored towards the needs of highly marginalized and stigmatized communities can be scientifically valuable as well as inclusive and equitable. I congratulate them. Prof. Klaus Leisinger, President Global Values Alliance, Former personal advisor to Kofi Annan on corporate responsibilit

Vulnerability Revisited: Leaving No One Behind in Research

This open-access book discusses vulnerability and the protection-inclusion dilemma of including those who suffer from serious poverty, severe stigma, and structural violence in research. Co-written with representatives from indigenous peoples in South Africa and sex workers in Nairobi, the authors come down firmly on the side of inclusion. In the spirit of leaving no one behind in research, the team experimented with data collection methods that prioritize research participant needs over researcher needs. This involved foregoing the collection of personal data and community researchers being involved in all stages of the research. In the process, the term ‘vulnerability’ was illuminated across significant language barriers as it was defined by indigenous peoples and sex workers themselves. The book describes a potential alternative to exclusion from research that moves away from traditional research methods. By ensuring that the research is led by vulnerable groups for vulnerable groups, it offers an approach that fosters trust and collaboration with benefits for the community researchers, the wider community as well as research academics

Traditional Knowledge and Benefit Sharing After the Nagoya Protocol: Three Cases from South Africa

The Nagoya Protocol of the Convention on Biological Diversity (CBD) has finally produced a negotiated framework intended to significantly advance the achievement of its core objectives, chief amongst them benefit sharing with indigenous and local communities who are holders of traditional knowledge related to genetic resources. The interpretation, in particular of central concepts contained in the Protocol, namely traditional knowledge (TK), community, and ownership of TK, and the practical application thereof by governments, are key to the success of the emerging access and benefit sharing regime. This article examines the manner in which the South African Biodiversity Act deals with these concepts. Three recent case studies are described, namely the Hoodia, Sceletium and Pelargonium cases, in which a range of issues relating to holders of TK were resolved, including the question of who the indigenous knowledge holders are. Moreover the debate on the question as to whether the intellectual property rights of TK holders are property rights as such, leads to the author’s suggestion that TK rights are a sui generis form of property rights, and that the legal principles contained in the law of equity provide useful and accessible guidance towards resolution of potentially competing claims of TK rights by indigenous peoples

Equitable Access to Human Biological Resources in Developing Countries ::Benefit Sharing Without Undue Inducement /

The main question explored by the book is: How can cross-border access to human genetic resources, such as blood or DNA samples, be governed in such a way as to achieve equity for vulnerable populations in developing countries? The book situates the field of genomic and genetic research within global health and research frameworks, describing the concerns that have been raised about the potential unfairness in exchanges during recent decades. Access to and sharing in the benefits of human biological resources are aspects not regulated by any international legal framework such as the Convention on Biological Diversity, which applies only to the exchange of plants, animals and microorganisms, as well as to associated traditional knowledge. Examples of genetic research perceived as exploitative are provided in order to illustrate the legal vacuum concerning the global governance of human genetic resources. The main conclusions drawn from the legal and ethical analysis are: · Benefit sharing is crucial in order to avoid the exploitation of developing countries in human genetic research. · With functioning research ethics committees, undue inducement is less of a concern in genetic research than in other areas of medical research (e.g. clinical trials). · Concerns remain over research involving indigenous populations; accordingly, recommendations are provided. In drawing these conclusions, the book addresses in detail a highly pressing topic in global bioethics and international law. In this regard, it combines bioethical arguments with jurisprudence, in particular with reference to the law of equity and the legal concepts of duress (coercion), unconscionable dealing, and undue inducement