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 (hereon referred to as the Nagoya Protocol) is a supplementary agreement to the Convention on Biological Diversity (CBD). It is intended to provide a legally binding framework setting out access to genetic resources and traditional knowledge. The implementation of the Protocol and in particular the provisions that govern due diligence will affect many users of genetic resources, including companies in various industry sectors, scientific research institutes and culture collections.
CBD is a multilateral agreement aimed at conserving biological diversity. It entered into force in 1993 and has 193 parties, including the EU and its member states. The Convention and has three primary objectives:
- The conservation of biological diversity;
- The sustainable use of the components of biological diversity and
- The fair and equitable sharing of the benefits arising out of the utilization of genetic resources.
The concepts of access benefit-sharing (ABS) are set out in Art. 15 of the Convention. However, many countries which are party to the CBD, including the member states of the European Union, while recognising the general principles of Article 15 of the CBD, did not consider it sufficiently clear to be implemented into national law. This need for a more specific and legally binding agreement led to the Nagoya Protocol which was adopted in October 2010 in Nagoya, Japan.
The Nagoya Protocol has so far been ratified by 59 parties and entered into force on 12 October 2014. The Protocol only applies to genetic resources accessed after that date and thus has no retrospective effect. Notably, the USA, China, Canada and Russia are not signatories to the Protocol.
The European Parliament and the Council adopted the new Regulation ((EU) No 511/2014) on 16 April 2014 to bring EU law in line with the Nagoya Protocol. Some of the key provisions of these Regulations will not apply until one year after the Regulation comes into force, that is 12 October 2015.
Objectives and key points of the Protocol
The objective of the Nagoya Protocol is set out in Art. 1 of the Protocol as providing “fair and equitable sharing of the benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and to technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components”.
The Nagoya Protocol sets out obligations for its contracting parties to take measures in relation to access to genetic resources, benefit-sharing and compliance. In particular, it details information that needs to be included in the prior informed consent (PIC) given by the provider country. It also contains a general obligation on the establishment of a benefit sharing agreement based on mutually agreed terms (MAT) between the provider and the user.
The Nagoya Protocol applies to genetic resources that are covered by the CBD, and to the benefits arising from their utilisation. It also covers traditional knowledge associated with genetic resources that are covered by the CBD and the benefits arising from its utilisation. Human genetic resources are excluded from the scope of the Protocol. Further, genetic resources obtained from areas beyond national jurisdictions (e.g. the high seas) are also excluded from its scope.
One of the key and perhaps most contentious points of the Protocol is that all users will have to exercise 'due diligence' to ascertain that the genetic resources and any associated traditional knowledge they use have been accessed in accordance with applicable legal requirements. Users also need to ensure that, where relevant, benefits are shared. This is set out in Art. 4 of EU Regulation No 511/2014. To demonstrate due diligence, users are required seek, keep and transfer to subsequent users an internationally-recognised certificate of compliance. In the absence of such a certificate, information such as the date, place of access and of genetic resources or of traditional knowledge associated with genetic resources must be provided together with a detailed description of the genetic resource and access permits. Check points to monitor user compliance are also introduced.
Users are required to keep the information relevant to access and benefit-sharing for 20 years after the end of the period of utilisation. Users who acquire a genetic resource from a collection included in the Union register will be considered to have exercised 'due diligence'.
The details of several aspects of the new legislation are to be implemented by the EU member states. In particular, the EU member states have the authority on how to implement the due diligence requirements. Member states can appoint the competent authority to administer the Nagoya regime and have responsibility for enforcing the Nagoya Protocol, including any monetary or potentially criminal sanctions for failure to comply with due diligence obligations.
In the UK, the Department for Environment Food and Rural Affairs (DEFRA) is responsible for implementing the EU Regulation relating to the Nagoya Protocol. The competent authority enforcing the legislation in the UK will be the National Measurement Office.
DEFRA ran a consultation on the Nagoya Protocol which closed in August 2014. Several questions were asked including whether there should there be a of £250,000 cap on monetary penalties for non-compliance with the protocol.
The Nagoya Protocol has met with considerably criticism both in the UK and in other member states, for example Germany. In response to DEFRA’s consultation, the BBSRC and the Welcome Trust expressed concerns that the implementation of the Nagoya Protocol could unreasonably restrict access to biological material for research purposes. As yet there is no set guidance by DEFRA on how the due diligence requirements will be implemented, but implementation of the Protocol is likely to be held up due to UK election in May. In any case, EU Member states are required to notify to the Commission of the rules on penalties by 11 June 2015.
How does the Nagoya Protocol affect you?
It is clear that the implementation of the Protocol has wide reaching consequences both for research institutes and commercial entities. Whilst it remains to be seen how the rules that govern due diligence are implemented in the UK, it is clear that the burden on the users of genetic resources will be increased. Record keeping to demonstrate compliance with the Protocol will be of paramount importance to avoid hefty fines and potentially other penalties.
Although the provisions of the Regulation dealing with the obligations of users and the monitoring of user compliance will not take effect until 12 October 2015, companies and researchers that work with genetic resources or traditional knowledge should consider implementing systems to ensure that required documentation is prepared and kept in accordance with the Protocol.