The Nagoya Protocol on Access to Genetic Resources is an international agreement which aims to share the benefits arising from the use of genetic resources in a fair and equitable way. The protocol, which entered into force in October 2014, falls within the scope of the EU Access and Benefit Sharing (ABS) Regulation.
As stated in the European guidance document for the biotechnology sector, “all industries creating value by means of biotechnological processes or products are affected by the implementing provisions of the Convention on Biological Diversity (CBD), the Nagoya Protocol (NP), and its implementation in the EU (Regulation (EU) No 511/2014) respectively. There can be no single answer to the question as to how far individual sectors of the industry are affected. In particular, this will depend on the nature of their activities and their position within the industrial value creation chain. Nevertheless, the provisions of the EU ABS Regulation are applicable across these value creation chains and throughout value creation networks, and the specific conditions for utilization that are laid down in the EU ABS Regulation need to be satisfied.”
The ongoing implementation of this protocol in Belgium will have an impact on companies that use genetic resources and traditional knowledge related to genetic resources to develop their products. It will enter into force in Belgium in 2018, with responsibility for its implementation shared between federal and regional authorities. Constructive dialogue with the competent authorities and the federal National Focal Point may help to avoid a heavy burden being imposed on companies active in R&D and to support a federal “single standard approach” for all innovative sectors.
The protocol will not be implemented by all regions in exactly the same way. It will therefore be crucial to adopt a realistic approach in what is already a highly regulated industry. An industry working group has been set up by Bio.be/essenscia to support biopharma and pharma companies in the implementation process.