Views are being sought from interested stakeholders on European guidance for the biotechnology sector concerning the EU’s access to genetic resources and sharing of benefits from utilisation legislation – namely the ABS Regulation.
Any stakeholders interested in having a say on this non-binding but important guidance should consider responding to this draft biotech sector guidance document directly (via Competent Authorities/National Focal Points) or via trade and industry bodies.
The Nagoya Protocol (on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation) came in to force on 12 October 2014. The Protocol is an international treaty, implementing the Convention on Biological Diversity (CBD), which requires party states to take measures to ensure that users of genetic resources and traditional knowledge associated with genetic resources, comply with access legislation so that benefits can be shared. Its purpose is to combat so-called “biopiracy” (see our earlier LawNow).
From 12 October 2014, the ABS Regulation (No 511/2014) implemented in the EU the compliance measures required under the Nagoya Protocol. Certain of these measures (concerning due diligence, user compliance and penalties for non-compliance), which were in turn required to be implemented by Member States, came into effect from 12 October 2015.
Application and extent
Broadly the compliance measures require “users” of genetic resources/associated traditional knowledge to exercise due diligence in respect of (i) access to the genetic resources/associated traditional knowledge; (ii) seeking and keeping information; (iii) declaring conformity.
“Users” can be said broadly to be those undertaking research and development on genetic resources/associated traditional knowledge. However, the terms used in the legislation (and implementing legislation), especially concerning derivatives and modified/non-naturally occurring compounds (for example in synthetic biology), may be open to more than one interpretation and this has led to confusion amongst industry and academics seeking to understand whether their activities fall within scope and, if so, what are their obligations.
The application and extent of the measures has been the subject of debate, but it is considered that the ABS Regulation (and its international source instruments) has most readily obvious impacts for the agriculture, biotech, cosmetics, food and health sectors.
There is existing (non-binding) European Commission guidance on the ABS Regulation (see here) but in view of the complex nature and potentially significant impacts for certain sectors in particular, consultants have been commissioned to draft a series of sector guidance documents, including for the biotechnology sector.
Draft biotech sector guidance
The current draft guidance document for the biotechnology sector can be accessed using the following link: EU ABS Regulation Guidance document Biotechnology V10 7 Nov 2016 CL
The guidance document’s main purpose is stated to be to lead to a shared interpretation of the particularly crucial terms to biotechnology product development, namely “utilisation” and “research and development”. It also aims to provide a general description of the types of genetic resources and research and development activities in the biotech sector, and list from these the types of activities which may fall within or outside the scope of the EU ABS Regulation illustrated with “concrete cases”. However there is work to do on this.
How to input
Interested stakeholders should contact their respective Competent Authorities or National Focal Points to understand how they may be able to input into the draft biotech sector guidance document.
Interested stakeholders who are undertaking relevant activities in the UK are invited to comment on the draft by 7 December 2016. All comments should be submitted via dedicated functional emailbox: [email protected]
The draft biotech sector guidance document states “All industries creating value by means of biotechnological processes or products are affected either actually or potentially by the implementing provisions” of the CBD, the Nagoya Protocol, and the EU ABS Regulation. It is our view that there is still some significant confusion over the interpretation of the ABS Regulation and its application, and there is a lack of awareness of its possible scope and implications, including for the biotech sector. Therefore any stakeholders interested in making their views heard should consider responding to this draft biotech sector guidance document directly or via trade and industry bodies.