The Nagoya Protocol is the regulatory and legislative framework for the fulfillment of one of the three objectives of the Convention on Biological Diversity – the fair and equitable sharing (access and benefit sharing) of the benefits arising out of the utilization of genetic resources which form the capital of biological diversity. The ultimate goal is to funnel benefits to protect and maintain the biological diversity of the planet, particularly in countries rich in biodiversity, but economically poor that until now were exploited or subjected to “bio-piracy”, without clear conditions and rules. The Protocol also regulated access to traditional knowledge related to genetic resources and which possess local communities and indigenous peoples in particular.
The Protocol consists of three pillars: the regulation of access to genetic resources, the sharing of benefits arising from their utilization and compliance measures by users of genetic resources.
Regarding the first two pillars, the parties are required to facilitate access to genetic resources derived from plants, animals or microorganisms in their jurisdiction, with a view to using them for research, development and commercial exploitation. Such genetic resources are, for example, plant species that can be exploited in the research and development of medicines and cosmetics. The protocol ensures that users, e.g. pharmaceutical companies, can have reliable access to genetic resources or traditional knowledge of the local people of a country, with transparency and legal certainty, which will facilitate research and development of products with benefits to the country-provider.
Secondly, the Contracting Parties may, in the exercise of their sovereign rights, to define rules for access and benefit-sharing, provided that they regulate the basis of the legal framework that defines the Protocol. The resulting benefits can be monetary or not and include for example the transfer of knowledge and technology, joint research or research funding, access fees to collected samples, payment of royalties etc.
The third pillar of the Protocol concerns the obligation of Contracting Parties to take measures (legislative, administrative and policy measures) for the compliance of users to ensure the legality of the acquisition and use of genetic resources. This pillar is regulated at Community level by Regulation 511/2014/EC which lays down rules for compliance with due diligence by users and specifies a monitoring and control system for the compliance of users by the national competent authorities. The Regulation was implemented in parallel with the Protocol on 12 October 2014. The Commission implementing regulation that defines in detail the rules for keeping a collection archive, the monitoring of the compliance by its users and best practices entered into force in October 2015.
Under the Protocol and the Regulation, users are obliged, before granted access to genetic resources from a country that is a party to the Protocol, to consult with the competent authorities (notably the Access and Benefit Sharing Focal Point) so that they can determine whether laws on access and benefit-sharing are applicable. If there are obligations, users must show due diligence on compliance and the EU member states must implement the provisions of the Regulation for the control and monitoring of user-compliance. For the purpose of easy and direct information, an online information exchange platform has been set up called the ABS Clearing House, through which all Contracting Parties can enter the existing legislative measures and other relevant information on the implementation of the Protocol.