Thank you to those readers of our original article (available to read here) who mentioned the importance of the "Nagoya Protocol" when conducting research which may involve the transfer of microbes across international borders. The Nagoya Protocol on Access and Benefit Sharing is an international agreement which aims to ensure the conservation of biodiversity and the fair and equitable sharing of benefits arising from the use of non-human genetic resources. Effectively, the Nagoya Protocol codifies the right of all countries to control research on non-human genetic resources found within their territories. Benefits arising from research and development activities involving genetic resources must be shared with the country providing the resource in either monetary or non-monetary form. The Protocol entered into force on 12 October 2014 and has been signed by over 100 countries worldwide (although not, so far, by the US or China).
Amongst other things, it is hoped that the Protocol will prevent 'biopiracy', which is often described as the patenting of plants, genes, and other biological products (including microbes) that are indigenous to a foreign country without fair compensation. However, there are concerns that some requirements of the Protocol are onerous and unclear.
The EU implemented the Nagoya Protocol by Regulation (EU) 511/2014 (the 'Regulation'). The Regulation imposes several obligations on users of non-human genetic resources (including microbes). Most significantly, and before making use of genetic resources for research purposes, users must ascertain that those resources have been obtained in accordance with applicable access and benefit-sharing legislation in the country of origin. In practice, users must agree mutually acceptable terms of use with the country of origin which may be difficult and time-consuming. Users are required to evidence their compliance and must ‘seek, keep and transfer to subsequent users’ a certificate of compliance (or at least relevant documents and information). Users must also, at the final stage of product development, make a formal, detailed declaration of compliance to their national authority, who must then verify that compliance. The penalties for non-compliance are severe. Worse, in instances of a present or imminent public health emergency, users have only three months after commencing use of the genetic resources in which to agree terms of use with the country of origin. If the user is unable to achieve this, the research must stop. This could frustrate efforts to tackle public health emergencies (like the Ebola epidemic, for instance).
The Protocol has left life sciences companies facing an often burdensome due diligence exercise, increasing the cost and complexity of developing products which use genetic resources. The reality is that the scheme is still in its infancy and uncertainty remains over several aspects, including the precise breadth of the Protocol and the Regulation. The European Commission has developed a guidance document on the scope of application and core obligations of the Regulation . If you have any specific questions or concerns about the impact of the Nagoya Protocol and/or the Regulation on your business, please contact Alison Dennis at Alison.Dennis@fieldfisher.com.