A year ago we reported on the preliminary implementation of the Nagoya Protocol in Europe by way of Regulation 511/2014 of the European Parliament and the Council (“EU Regulation”) that came into force on 12 October 2014.
Briefly, the EU Regulation applies to access and utilisation of genetic resources, access and utilisation of traditional knowledge associated with such genetic resources and to benefits arising from such utilisation. Genetic resources are genetic materials (of any origin containing functional units of heredity):
- over which the provider country (that is a party to the Nagoya Protocol) has exercised sovereign rights and has in place procedures to access such genetic resource. It is important to note that if the provider country has established access procedures for some and not other genetic resources, the EU Regulations shall only apply to genetic resources for which access measures are in place; and
- that are accessed by a user (based in a Member State) after the EU Regulation comes into force.
Implementation of the Regulation and the Nagoya Protocol
Activity in terms of compliance with the EU Regulation was not immediately necessary after its enactment as the key provisions of the EU Regulation, namely those dealing with obligations on the users of genetic resources did not come into force until 12 October 2015. However, a fair amount of legislative activity complementing the EU Regulation has taken place in the last 12 months which we have briefly commented on in this article.
New European Legislation – Implementing Regulation
On a European level, the Commission Implementing Regulation (EU) 2015/1866 (“Implementing Regulation”) that laid down rules for implementing Articles 5 (Register of collections), 7 (Monitoring user compliance) and 8 (Best practice) of the EU Regulation came into force.
1. In summary, the Implementation Regulation:
- specifies the amount of detail that must be made available on the Register maintained by the Commission for each collection of genetic resources;
- specifies the procedure each Member State and collection holder would need to follow in order to include a collection of genetic resource on the Register; and
- specifies the verification checks that must be carried on a collection of genetic resource prior to and after inclusion on the Register.
2. In addition the Implementing Regulation clarifies the amount of detail that needs to be included in the due diligence declarations submitted by the user of the genetic resource that is subject to the EU Regulation. The user is required to submit due diligence declarations twice, namely upon:
- receipt of funding for research involving “utilisation” of genetic resources and traditional knowledge associated with the genetic resources. The Implementing Regulation clarifies that funding can be financial contribution from any commercial or non-commercial source but shall not include internal budgetary resources of a private or public entity; and
- final stage of development of a product that has been developed via utilisation of the genetic resource and traditional knowledge associated with the genetic resource.
3. A country or state that is party to the Nagoya Protocol is required under the Protocol to make available on the Access and Benefit Sharing (“ABS”) Clearing House (established under the Protocol and available here), such country’s or state’s rules for making available its genetic resources (including model contractual clauses under which such country will provide the genetic resources to users). The ABS Clearing House is therefore intended to become the main source of information for users wishing to access genetic resources in relation to rules, processes and terms of signatory countries providing genetic resources. For the purposes of the EU, the Implementing Regulation sets out the level of information the relevant authorities from each Member State are required to extract from the due diligence declarations for uploading to the ABS Clearing House.
New UK Legislation
On a UK level, the Nagoya Protocol (Compliance) Regulations 2015 (SI 2015, No 821) came into force on 12 October 2015 providing procedures, sanctions and penalties (mainly civil) for failure to comply with the EU Regulation and enforcement of the EU Regulation. In addition, the National Measurement and Regulation Office has been identified as the authority responsible for enforcing the Nagoya Protocol (and accordingly the EU Regulation).
Practical effect of implementation of the EU Regulation to date
Given that the provisions dealing with obligations on users only came into force in October 2015, the impact of the EU Regulation is unlikely to be immediately obvious. The EU Regulation is not retrospective and so it is likely that at this stage most organisations are using genetic resources that were accessed prior to the EU Regulation coming into force. In addition, countries (that are signatories to the Protocol) are in the early stages of putting in procedures for users to access their genetic resources and it may be some time before these procedures are finalised and made available through the ABS Clearing House. Until the provider country has put the access procedures in place, the genetic resources from such countries will not be subject to the Regulation.
There still remain a lot of unanswered questions on interpretation of the EU Regulation (and the Nagoya Protocol) particularly in relation to the scope of application of the EU Regulation. For example, there is uncertainty around the meaning and scope of the term “utilisation of genetic resources” which is a key term as the Protocol and EU Regulation applies only in respect of those genetic resources (i) that have been obtained from a party (country) to the Protocol after the Regulation comes into force, (ii) for which the Providing Country has put in place access procedures and measures and (iii) that are utilized (as defined in the EU Regulation and Protocol).
The Nagoya Protocol and EU Regulation broadly define “utilisation of genetic resources” as “to conduct research and development on the genetic and/or biochemical composition of genetic resources, including through the application of biotechnology”. The terms ‘research and development’ have not been defined and so their ordinary meaning applies. The term ‘research’ in particular could be interpreted broadly which means that the application of the Regulation could potentially be far reaching.
In response, the European Commission has indicated (http://ec.europa.eu/environment/nature/biodiversity/international/abs/legislation_en.htm) that additional guidance on the interpretation of the Regulation will be developed during 2016 and it is anticipated that focus on the scope and/or application of the Regulation will be clarified in such guidance. We will report on the guidance as soon as it is issued.