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.

Responsible, Inclusive Innovation and the Nano-Divide.

Policy makers from around the world are trying to emulate successful innovation systems in order to support economic growth. At the same time, innovation governance systems are being put in place to ensure a better integration of stakeholder views into the research and development process. In Europe, one of the most prominent and newly emerging governance frameworks is called Responsible Research and Innovation (RRI). This article aims to substantiate the following points: (1) The concept of RRI and the concept of justice can be used to derive similar ethical positions on the nano-divide. (2) Given the ambitious policy aims of RRI (e.g. economic competitiveness enhancer), the concept may be better suited to push for ethical outcomes on access to nanotechnology and its products rather than debates based on justice issues alone. It may thus serve as a mediator concept between those who push solely for competitiveness considerations and those who push solely for justice considerations in nano-technology debates. (3) The descriptive, non-normative Systems of Innovation approaches (see below) should be linked into RRI debates to provide more evidence on whether the approach advocated to achieve responsible and ethical governance of research and innovation (R&I) can indeed deliver on competitiveness (in nano-technology and other fields).

Turning the Tables.

In bioethics, the concept of vulnerability is applied almost exclusively to research participants and patients. We turn the tables and apply the concept to nurses caring for anorexia nervosa (AN) sufferers. In doing so, and using results from a qualitative research study undertaken in the UK, we show that AN nurses face a significant probability of incurring identifiable harms (inauthentic relationships and nonreciprocal relationships). Some recommendations on how these harms can be avoided or mitigated are given, but further research is needed.

Realizing benefit sharing - the case of post-study obligations.

In 2006, the Indonesian government decided to withhold avian flu samples from the World Health Organization. They argued that even though Indonesian samples were crucial to the development of vaccines, the results of vaccine research would be unaffordable for its citizens. Commentaries on the case varied from alleging blackmail to welcoming this strong stance against alleged exploitation. What is clear is that the concern expressed is related to benefit sharing. Benefit sharing requires resource users to return benefits to resource providers in order to achieve justice. One benefit sharing tool within health research is the duty to provide a health care intervention which has been proven to be beneficial (or alternative benefits) to research participants after a study has been concluded. This duty is generally known as a post-study obligation. It was enshrined in the Declaration of Helsinki in 2000 and re-emphasized in 2008. Yet, there are few, if any, examples of good practice. In this article, we analyse the obstacles to giving more bite to benefit sharing provisions in health research through ethical review. We conclude that the provision of post-study access to healthcare interventions is not a promising mechanism when monitored through research ethics committees. Alternative benefit provision is preferable if one focuses on achieving compliance. However, even the latter faces challenges, which we address in specific recommendations.

Benefit sharing and access to essential health care: a happy marriage?

In May 2003, one of the most important benefit sharing agreements to date was signed in South Africa. The South African San Council and the South African Centre for Scientific and Industrial Research agreed to share the benefits derived from genetic research on the Hoodia plant. Payments to the San Council started in 2005 and could reach 1.3 million US Dollars per year for approximately 15 years. Members of the San community in Southern Africa are exposed to serious poverty, resulting in malnutrition and avoidable illnesses. The question we are interested in is: could benefit sharing in compliance with the Convention on Biological Diversity be a partial solution to lack of access to essential health care? In the first part of the paper, we shall briefly introduce the legal background of benefit sharing and the San case. In the second part of the paper, we shall argue that benefit sharing and access to essential health care should not be formally linked. We shall substantiate our claim by introducing practical, normative and so-called 'bigger picture' reasons against the link.

Sharing the benefits of genetic resources: from biodiversity to human genetics.

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.