On the 14th April 2014, the European Council adopted the European Commission’s Regulation on Access to Genetic Resources and the fair and equitable sharing of benefits arising from their utilization (COM(2012)0576). This followed adoption on the 11 March by the European Parliament.
The Regulation is aimed at establishing a framework which lays down compliance measures for users of genetic resources, in line with the 2010 Nagoya Protocol.
The Nagoya Protocol is intended to provide a legal framework for implementing one of theConvention on Biological Diversity’s (CBD) primary objectives: ‘the fair and equitable sharing of the benefits arising out of the utilisation of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those technologies and resources.’
The CBD did not however specify how fair and equitable sharing of genetic resources should be achieved in practice. Therefore, the Nagoya Protocol seeks to give effect to this by establishing more predictable conditions for access to genetic resources, ensuring benefit-sharing between users and providers, and ensuring that only legally acquired sources are used. Whilst all parties to the Protocol must take measures regarding user compliance, they are free to decide whether to regulate access, but, if they decide to do so, they must implement the detailed provisions set out in the Protocol. The EU ratified the Protocol in March 2014. The Protocol will not enter into force until it has been ratified by 50 Parties. The EU was the 30th ratification and so it still has a long way to go before it enters into force.
Article 6 of the Protocol provides that access to genetic resources should be subject to the prior informed consent (PIC) of the party providing genetic resources. Bilateral negotiations of mutually agreed terms (MATs) between the provider and user of genetic resources should be used to ensure that there is fair and equitable benefit-sharing of the genetic resources. The right to determine the terms of access and benefit-sharing through PIC and MATs is derived from the sovereign rights of states to exploit their own resources. This is enshrined in CBD, article 15(1) as well as in customary law.
The EU Regulation will oblige users (such as the feed and food industry, the pharmaceutical and cosmetics industry and researchers) to exercise due diligence to ascertain that genetic resources and associated traditional knowledge, which they utilise have been accessed in accordance with the applicable legal requirements, and that the benefits are fairly and equitably shared in accordance with mutually agreed terms.
In effect, this will force private collectors and companies, academic researchers or scientific institutions, to check that genetic resources and associated knowledge have been accessed legally and that the benefits are shared fairly and equitably.
This reflects one of the challenging features of the framework as the legal basis of access and benefit sharing is in a state’s sovereign rights over its genetic resources, but that the exchange of genetic resources is negotiated primarily by private institutions. Therefore the authority to grant access to genetic resources lies with the state, which can attribute this authority to for example research institutes. In contrast, those acquiring and using genetic resources are in many cases non-state entities, mostly private companies.
Under the Regulation, users will have to obtain an international certificate of compliance, in order to prevent illegal access to resources. Every member state will designate one or more competent authorities responsible for the application of the Regulation. The competent authorities will, among other things, carry out checks to verify users’ compliance with their obligations. The European Commission will make public a list of such authorities, including on the internet, and keep it up-to-date.
The Regulation also requires that collections, which are major suppliers of genetic resources and associated traditional knowledge, must be entered on an EU register established and maintained by the European Commission. In addition, the regulation provides for complementary measures obliging the Commission and member states to promote and encourage information and awareness raising and training activities to help all stakeholders understand their obligations and the implementation of this regulation as well as to encourage the development of, in particular, sectoral codes of conduct, guidelines and best practices, particularly where they would benefit academic, university and non-commercial researchers and small and medium-sized enterprises.
Member States must also establish penalties for infringing the rules.
In the UK, Defra have been consulting on the implementation of the Nagoya Protocol (closed April 2014). The consultation sought views on the rules the implementation of the rules, which are based on those established under the EU Regulations, which will be binding in the UK. The consultation included the setting of penalties for users who fail to meet their requirements under the Protocol, carrying out checks on compliance by users, and providing advice and support for users.
