Dr Eva Hilberg recently joined the Sheffield Institute for International Development (SIID) as a Post-Doctoral Research Assistant, working on a project on the social life of health IT in the field of Global Mental Health.
Ownership agreements over both plant and human genetic material have long been a controversial issue, giving rise to accusations of exploitation (or biopiracy) and to debates about the treatment of indigenous peoples in large-scale human genome biobank projects such as the Human Genome Diversity Project. As a response to these controversies, new access and benefit sharing agreements (ABS) seek to provide a more equitable distribution of benefits arising from research – but in a recent twist, an ongoing World Health Organisation (WHO) study questions whether these more complicated ABS structures can amount to a threat to health. Of course, ownership agreements in the shape of Intellectual Property (IP) have often been criticized for adversely affecting health in several ways, by raising prices for medicines and thus limiting access to treatment, creating monopolies that prevent the proliferation of knowledge, and skewing research and development towards profitable markets. But this recent question about the effects of new benefit sharing agreements on public health, part of a wider WHO review of the Pandemic Influenza Preparedness Framework (PIP), begins to explore the complex interactions between different international treaties assigning ownership over genetic materials. This takes the debate beyond criticism of traditional IP, and rather raises the hot topic of IP’s relation to genetic sovereignty contained in ABS agreements.
The WHO is currently exploring a new angle on ownership agreements over genetic materials, asking whether more complicated and arguably more equitable arrangements such as ABS could in fact amount to a threat to public health in the fight against global pandemics. This particular intervention focuses on the potential area of tension between the Nagoya Protocol under the Convention on Biological Diversity (CBD), and the virus sharing provisions under PIP. Both agreements introduce an element of ABS in order to address the uneven global distribution of research facilities and the position of countries that are often sources of significant or promising genetic materials. However, while the Nagoya Protocol aims to directly improve the disadvantaged position of countries that are predominantly sources of genetic materials, the PIP agreement focuses on facilitating the sharing of virus samples to combat the outbreak of pandemics in the name of (global) public health.
The proliferation of different ABS agreements potentially confronts the high profile public health interest of preventing global pandemics with demands made in the name of genetic sovereignty – which already showed their disruptive potential in contentions made by the Indonesian government in 2006. At the height of the bird flu scare, the Indonesian government suddenly decided to withhold further samples of the H5N1 strain of the bird flu virus. They declared viral sovereignty – and highlighted how much global public health responses rely on the unproblematic sharing of virus samples. The Indonesian government stated that the previous system amounted to “neocolonialism in global health”. Indonesia’s Health Minister, Siti Fadilah Supari, argued at the time: “Samples shared become the property of the WHO collaborating centres in rich countries, where they are used to generate research papers, patents and to commercialize vaccines. But the developing countries that supply the samples do not share in these benefits. In the event of a pandemic, we also risk having no access to vaccines, or having to buy them at prices we cannot afford, despite the fact that the vaccines were developed using our samples.” This move powerfully interrupted the existing virus sharing mechanism and resulted in a renegotiation of the WHO framework regarding the sharing of virus samples, giving rise to the new PIP agreement. However, the relation between this framework and the Nagoya Protocol under CBD remains unresolved, and the WHO is seeking an expert assessment of the relation between these agreements. This is far from the only area of ambiguity where it comes to treaties on the ownership of genetic materials – the relation between the Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPS) and these ABS agreements is equally uncertain. The fact that these tensions are now being framed as a threat to public health injects a new level of urgency into this slow-moving debate.
Intellectual Property on genetic materials has often been criticized on ethical grounds, especially in debates about biopiracy critical of bioprospecting practices. The pharmaceutical industry continues to argue that it needs patents on isolated genetic materials for conducting research and development necessary for new medicines and treatments. Internationally, this has given rise to many debates between industrialised countries and countries in which researchers source genetic materials. Some recent international treaties (such as the ABS mentioned above) aim to strike a balance between the interests of different countries, and seek to introduce a connection between the source of genetic materials and its further use. Other official expert analyses go as far as exploring alternatives to the current IP system. But all proposals thus far represent individual and unconnected efforts, and remained outside the internationally most influential and binding IP agreement: TRIPS. The Doha Declaration on the TRIPS Agreement and Public Health remains the only international agreement dedicated to exploring the connection between IP and public health within this system under the World Trade Organisation (WTO). While this agreement was negotiated in the interest of the global South, it however mainly restated previously available flexibilities of the international IP regime.
Faced with a variety of different organisations and different international agreements addressing several issues, it was left up to individual countries to decide whether to sign and ratify separate ABS agreements. However, the WHO’s desire to analyse the public health implications of potential tensions between the PIP framework and the Nagoya Protocol as part of a wider review indicates that there are fears that this unresolved and uneven implementation landscape could amount to a serious public health risk by potentially delaying virus sharing. This acknowledgement could have more far-reaching consequences. Up until now, the IP regime as contained in the TRIPS agreement has mostly avoided direct engagement with arguments based on genetic sovereignty. After all, the CBD’s Nagoya Protocol and the PIP framework were negotiated outside this most entrenched international ownership agreement. The growing influence of the Nagoya Protocol and the PIP ABS agreement could, however, increase the necessity of confronting these longstanding issues even within the WTO. As pressures and demands in the name of public health increase, the question of genetic sovereignty may be increasingly difficult to accommodate.
For further reading:
Hilberg, Eva, ‘Promoting Health or Securing the Market? The Right to Health and Intellectual Property between Radical Contestation and Accommodation’, in: Third World Quarterly, Vol. 36 (6), May 2015, pp. 1237-1252.