The fair and equitable sharing of benefits arising from the use of genetic resources is one of the three objectives of the Convention on Biological Diversity (CBD). In 1992 CBD recognized the sovereign rights of countries over their genetic resources, and access to those resources has been subject to the provisions of each country’s national legislation since then. The Nagoya Protocol (NP) entered into force on the 12th of October 2014 and develops the third objective of the CBD, namely instructions on access to genetic resources and fair and equitable sharing of benefits arising from their use (ABS, Access and Benefit Sharing).
This Protocol seeks to strengthen compliance with national access rules of countries providing genetic resources by requiring the implementation of compliance and monitoring measures in third countries where these genetic resources are used. Thus, the signatory countries of the protocol commit themselves to ensure that the genetic resources used within their jurisdiction are accessed in accordance with the national framework of the country where the resource was originated, thus committing themselves to fighting against biopiracy. Therefore, countries must establish control points in the territory under their jurisdiction, to which the users of genetic resources must provide information on the legal access to such resources, mainly through the Internationally Recognised Certificate of Compliance (IRCC). A bulk of the legislation in place, as well as the contact information of the National Focal Points of each signatory country, can be found at ABS Clearing-House.
In the case of Spain, access to Spanish genetic resources is regulated by the Law 33/2015 on Natural Heritage and Biodiversity and the Royal Decree 124/2017, which regulates access to genetic resources from wild taxa and the sharing of benefits derived from their use. The access permit is requested through the Ministry of Ecological Transition (MITECO) online portal (link).
Regarding the control mechanisms described in the Nagoya protocol, the measures for the entire European Union are included in EU Regulation (EU) no. 511/2014, which entered into force together with the NP on the 12th of October 2014 and establishes the measures for compliance by users on access to genetic resources and the fair and equitable sharing of benefits arising from their use in the European Union.
This establishes that when genetic resources are used, according to the definition included in Royal Decree 124/2017, the corresponding access authorisation must be requested prior to accessing them, and subsequently, depending on the situation in which the user finds himself (beneficiary of research funds; final stage of development of a product; application for a patent), the due diligence declaration form must be submitted.
It is the responsibility of the user of biological resources provided by ECIMAT to ensure that the use that the user will carry out of these genetic resources complies with the ABS legislation of the country of origin of the genetic resource (generally Spain, but in the case of strains, the country of origin could be another one) and usage monitoring.
To facilitate users’ compliance with ABS legislation regarding access to Spanish genetic resources, ECIMAT has a guide to assist users (ABS_Guide). Information on how to submit the due diligence declaration form can be found on the ministry’s website.
Useful resources:
- Royal Decree 124/2017, of 24 February, relative to the access to genetics resources from wild taxa and to the control of the utilization
- Questions and answers regarding the implementation of Royal Decree 124/2017, of February 24, on access to genetic resources from wild taxa and the control of utilisation.
- Regulation (EU) No 511/2014 of the European Parliament and of the Council of 16 April 2014 on compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization in the Union
- Text of the Nagoya Protocol
- Seminar: “Utilisation of genetic resources and Nagoya Protocol: legal framework and use cases of marine resources” (In Spanish)
- Paper of Dr. Laura Movilla (University of Vigo) “Advances and uncertainties in compliance measures for users from the Nagoya Protocol in the European Union”