01/04/2014
DEFRA, the Department for Environmental Food & Rural Affairs, has recently launched a consultation (see here) on implementing in the UK the Nagoya Protocol “on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization to the Convention on Biological Diversity [CBD]”. For life science businesses in particular, this is an important opportunity to influence aspects of the Protocol implementation in the UK before the consultation closes on 21st April 2014.
The Nagoya Protocol (see here) is an international treaty which aims to ensure that the owners or guardians of genetic resources receive a “fair share” of any benefits that arise from research carried out on those resources. The sovereign rights of countries over their genetic resources are recognised under the CBD; the Nagoya Protocol provides practical implementation of the principles established by the CBD. Key aspects of the Protocol are enforceable procedures to ensure that removing a genetic resource from its country of origin is done only with the Prior Informed Consent of that country and, if required, also entering into Access and Benefit Sharing arrangements with the country. The term “genetic resources” is not defined in the Protocol, other than to explicitly exclude human genetic resources.
The Protocol has been signed both by the European Union (EU) and by its Member States, and responsibility for implementing the Protocol is divided between the two. An EU Regulation (see here for expected final text), due to be adopted in May 2014, will implement the Protocol’s obligations that fall within EU competence. The UK must implement the Protocol’s provisions that fall under Member State competence. Unlike in some countries, for example where concerns about “biopiracy” are high, there do not appear to be proposals in the EU Regulation or the intended related UK legislation to have checks in the patent system for compliance with the Protocol.
DEFRA’s consultation seeks views on how to implement the EU Regulation and the Protocol in the UK. The consultation covers setting penalties for users who fail to meet their requirements under the Protocol as implemented in the UK, carry out the necessary checks on compliance by users, and provide advice and support for users. If you have an opinion on how the UK should be doing this, do engage with DEFRA’s consultation.
If this article raises issues which you would like to discuss, or if you need further information on the Nagoya Protocol, please contact us.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking before any action in reliance on it.
