An ethico-legal analysis of benefit sharing for health research in South Africa

Abstract

Health care research conducted in LMICs, including South Africa, has exploded in the last few decades. Albeit a welcome development, there has emerged the fear of and actual exploitation of host communities. As health care research has become funded by private business and often in North-South collaborations at academic institutions by foreign government agencies, potential exploitation is a reality, as there is usually an unfair distribution of risks and benefits among the parties involved. While it stands true that the overall goal of health research is to attain global health and wellness for all, health research using HBMs cannot occur in an exploitative environment that takes unfair advantage of people’s vulnerabilities. Benefit sharing should be a tool for guarding against exploitation and not the basis of a strategy to address urgent global health needs or resolve inherent issues of global distributive justice. In an attempt to identify the best benefit sharing model for health research for South Africa from an ethico-legal view perspective, one that tempers (not diminishes) commercial interests, redresses economic imbalance and gives research participants fairer and more active roles in influencing the sharing of benefits, this thesis canvasses the current legal framework for benefit sharing in South Africa, as well as other jurisdictions. The thesis concludes that a benefit sharing framework, based on the charitable trust model, could be adopted in South Africa. This framework recognises the various stakeholders that are part of a research project at different levels of society, whilst simultaneously acknowledging that it is possible to have different types of fair benefits at each stakeholder level, even in the absence of a final, tangible benefit. In terms of this model, academic medical centres and/or research institutions would cease to be brokers of the HBMs and instead become custodians of the samples. This proposed framework will promote compliance with data privacy and informed consent requirements without compromising its value as an information-rich HBM supplier. It would also make the first recipients of HBMs the trustees of the HBMs instead of brokers having legal fiduciary duties over the HBMs, whilst permitting the use of the donated HBMs in a way that benefits the donor as a beneficiary of the trust. Moreover, this trust model will be in the ideal position to create and facilitate continuous communication channels with the donor community, researchers, policymakers and teaching hospitals for fostering trust in health research and its benefits for all stakeholders involved.