EC Proposes Draft Regulation on Biopiracy and Research

EU4 October 2012: The European Commission (EC) has introduced a draft Regulation to implement the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS), aimed at protecting the rights of those possessing genetic resources and traditional knowledge, while providing researchers in the EU with reliable, more legally certain access to samples of these resources at low cost.

The draft Regulation, which will be considered by the European Parliament and the Council, would benefit researchers and companies in the EU, particularly small and medium size enterprises (SMEs) and public-funded, non-commercial research.

It is designed to clarify the rules over the use of genetic resource for research in areas including plant and animal breeding, cosmetics and pharmaceuticals. The intent is to protect the holders of genetic resources and traditional knowledge from the loss of benefits associated with these resources, a concern known as "biopiracy," while encouraging research and development.

The actions associated with this draft Regulation include plans for an EU-register of trusted seed banks, botanical gardens and other collections committed to supplying only genetic resource samples that have been fully documented.

The EC also released a summary of the definition of and provisions included under the term "access and benefit sharing." According to the EC, ABS is a basic principle of the Convention on Biological Diversity (CBD), which recognizes that States have sovereign rights over the genetic resources found within their jurisdiction, and that they can set conditions for access to such resources. It requires that any benefits that arise from the commercial use of the resources are shared fairly and equitably with the country providing the resources. The summary also addresses: why ABS has been problematic in the past; how the Nagoya Protocol will help achieve conservation goals; what happens in cases of non-compliance; whether countries with genetic resources must adopt access rules; and how the Protocol addresses the needs of indigenous communities; and questions on the draft regulation, including potential costs and benefits for users in the EU. [EC Press Release] [Questions and answers on access and benefit-sharing]