Utilization of genetic resources and associated traditional knowledge on research and development.
The protocol on "Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from Their Utilization", known as the Nagoya Protocol, was adopted in 2010 and signed by 92 countries.
The aim of the protocol is to establish a clear, legally-binding framework determining how researchers and companies can acquire access to the genetic resources of a country and to the traditional knowledge associated with these resources. It also explains how the benefits arising from the use of these genetic resources and associated traditional knowledge will be shared.
Users of genetic resources and/or associated traditional knowledge – those conducting research and development – are required to exercise due diligence to demonstrate that genetic resources and / or associated traditional knowledge are accessed and utilized in accordance with applicable legislation of the providing country.
Genetic resources refer to genetic material of actual or potential value. Genetic material is any material of plant, animal, microbial or other origin containing functional units of heredity. Examples include material of plant, animal, or microbial origin, such as medicinal plants, agricultural crops and animal breeds.
Genetic resources might be utilized in the development of medicines, cosmetics and health products or similar products. A genetic resource might also be utilized in basic research in fields such as ecology and taxonomy.
The ABS Regulation (Regulation No 511/2014 of the European Parliament and of the Council) applies to Member States of the EU.
The Regulation does not apply to the human genome and genetic resources utilized under the International Treaty on Plant Genetic Resources for Food and Agriculture, nor to pathogens that are the cause, or likely cause, of a present or imminent public health emergency of international concern (see also the ABS Regulation).
Users of genetic resources and traditional knowledge associated with genetic resources must comply with EU Regulation 511/2014 on the implementation of the Nagoya Protocol (the ABS Regulation) by declaring that they have exercised due diligence.
Due diligence means in this context that the user must be able to provide evidence that the genetic resource and/or traditional knowledge associated with a genetic resource has been obtained in compliance with the relevant legislation in the country of access. In addition, the potential benefits arising from the genetic resource and/or traditional knowledge associated with the genetic resource are to be shared fairly and equitably in accordance with mutually agreed terms.
Many different types of utilization are covered by the Regulation, such as the development of medicines, cosmetics or health products, and also basic research, such as research in the fields of ecology and taxonomy.
A) The first stage is that the user applies for access to a genetic resource from another country (inside or outside the EU) that is a signatory to the Nagoya Protocol, and which has national legislation regulating the utilization of the country’s genetic resources. The user can either utilize a genetic resource that is part of a registered collection, or apply for access to the genetic resource via the competent authority in the country in question. If the resource comes from a registered collection, the due diligence requirement is deemed to be met. Otherwise, the user must be satisfied that the genetic resource has been acquired under the relevant national legislation regulating access, and that the benefits will be shared fairly and equitably in the country on mutually agreed terms in accordance with the legislation of that country.
B) Applications for research funding
C) Users awarded research funding are required to submit a declaration of due diligence to the Swedish Environmental Protection Agency.
D) In the final stage of development of a product, the user is required to make a declaration of due diligence to the Swedish Environmental Protection Agency.
E) The user is required to keep the information relevant to access and benefit-sharing for 20 years after the end of the period of utilization.
Under the ABS Regulation, the holder of a collection of genetic resources may have it registered with the European Commission, provided that it meets certain criteria.
Making the genetic resource a registered collection means that users of the collection do not need to declare due diligence themselves, because the genetic resources contained in the collection are deemed to have been accessed in accordance with the ABS Regulation.
The Swedish EPA has been appointed as only competent authority in Sweden under the ABS Regulation.
This means that the Swedish EPA is responsible for: