IP Cases & Articles

Nagoya Protocol: European regulation now in force

The EU Regulation setting out compliance measures for users of genetic resources in the EU under the Nagoya Protocol, came into effect on 12 October 2014.

The specific provisions concerning the obligation to carry out due diligence, declarations of compliance and checks on compliance, did not come into immediate effect. They were deferred for a year while further national implementing provisions were put in place.

The one year period came to an end on 12 October 2015, hence the EU Regulation, and its various obligations on users of genetic resources, are now in force. Local legislation, such as that recently put in place in the UK, sets out separately the potential penalties for noncompliance.

The EU implementation of Nagoya focuses solely on use of genetic resources which have been accessed from fellow Nagoya Protocol territories (and not access of such resources within the EU – that has been left to individual member states, should they wish to impose access obligations).

EU implementation means therefore that, as from 12 October 2015, any entity that may be performing research and development on genetic resources in the European Union (EU), must comply with the obligations and requirements in the EU Regulation mentioned above.

The European Commission is preparing guidance on compliance with the EU Regulation and has published this in draft. It is not clear, however, when it will become final and some aspects are still being debated.

Notwithstanding the delay in EU guidance, what should your company be doing to be compliant?

Determine the date and place of access

Genetic resources accessed (although not necessarily utilised) before 12 Oct 2014 are not covered by the EU Regulation. This is therefore the first thing to try to establish.

In addition, the EU Regulation only applies to genetic resources accessed from a country that has ratified the Nagoya Protocol. (There are some other detailed legislative requirements which may affect the applicability of the EU Regulation but these are not addressed here.)

Thus the origin of a genetic resource accessed after 12 Oct 2014 should be checked in order to determine whether it has been accessed from a relevant 'Nagoya country'. If so, and you are intending to carry out research and development on that resource in the EU, you will need to comply with the due diligence obligations in the EU Regulation.

Nagoya Protocol due diligence in the EU

Due diligence will need to be carried out to determine whether access to the genetic resource in question was in compliance with local access consent and benefit sharing requirements in the Nagoya Protocol country from which it was accessed. The documentation showing the due diligence checks and the outcome must be retained for 20 years (considerably longer than most document retention policies). Ensuring all relevant employees are aware of the EU Regulation and the Nagoya Protocol, and the obligations this places on the companies they work for, is essential.

If there is any concern about whether the genetic resource has been accessed in compliance with local access and benefit sharing obligations in the Nagoya Protocol country from which it has been accessed, then any research may need to be stopped and future marketing of a product comprising that genetic resource may be compromised.

In short - actions for researchers

  1. Ensure all materials accessed prior to 12 October 2014 are documented as having been accessed before that date (as the EU Regulation will not be retroactive).
  2. Put in place systems to ensure that materials accessed after 12 October 2014 are documented to confirm compliance with the EU Regulation and relevant Nagoya Protocol access requirements.
  3. Ensure employees know about the Nagoya Protocol and associated regulations and understand that legal possession of a genetic resource does not necessarily imply the right to do any work on it.
  4. Be cautious of the origin of material that you might wish to use for research – this applies in particular to materials obtained from suppliers: due diligence requires obtaining relevant evidence of compliance from such suppliers.
  5. Consider setting best practices to conform to the legislation.

Further advice

If you believe this legislation may impact your activities and would like further advice, then please contact Richard Willoughby (rww@dyoung.com) or Aylsa Williams (aaw@dyoung.com).