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Document 32014R0511

Compliance with rules on access and benefit-sharing arising from the use of genetic resources and associated traditional knowledge

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Compliance with rules on access and benefit-sharing arising from the use of genetic resources and associated traditional knowledge

 

SUMMARY OF:

Regulation (EU) No 511/2014 — compliance measures for users of genetic resources and the sharing of benefits arising from their utilization

WHAT IS THE AIM OF THE REGULATION?

This regulation concerns compliance with rules on access to genetic resources* and traditional knowledge* associated with those genetic resources, and sharing the benefits arising from their use, as set out in the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation to the Convention on Biological Diversity.

The Nagoya Protocol’s access and benefit-sharing (ABS) objective is the fair and equitable sharing of the benefits arising from the use of a genetic resource with the country that provided that genetic resource. The resource should be used sustainably and the benefits are expected to be passed on to the conservation of biodiversity.

The overall objective of the regulation is that users of genetic resources and associated related traditional knowledge must ensure that benefits are fairly and equitably shared upon mutually agreed terms.

Genetic resources are used by universities, non-commercial and commercial researchers and companies for research and development leading to commercialisation of products. They are used in many sectors such as pharmaceuticals, cosmetics and the food and feed industry, but also in plant breeding or biotechnology.

KEY POINTS

All countries (including EU countries) have rights over their natural resources and the authority to determine access to their genetic resources.

The challenge faced by provider countries is following up their genetic resource once it leaves the country. An important added value of the Nagoya Protocol is the establishment of the compliance measures. ‘User’ countries need to take measures to ensure that genetic resources used in their country were accessed in accordance with the ABS rules of the provider country (prior informed consent obtained and mutually agreed terms established). This information is then transferred back to the provider country. Regulation (EU) No 511/2014 contains the rules governing such compliance measures.

The basic requirement of the regulation is due diligence. Users of genetic resources need to seek, keep and transfer to subsequent users a set of information relevant to genetic resources. If users do not have sufficient information on the legality of access and use, they should obtain a permit, establish mutually agreed terms or stop using the resource.

Users of genetic resources are also obliged to submit a due diligence declaration. Filing a due diligence declaration is required at two stages in the EU:

  • at the stage of research funding where such research involves the use of genetic resources;
  • at the final stage of development of a product.

This means that there are two checkpoints in the EU. Information from these checkpoints is transferred to the ABS Clearing House (the international IT tool for exchange of information between all relevant actors) and to the provider countries.

Users must keep information on access and benefit-sharing of the resource for 20 years after they stop using it.

Each EU country must designate at least one authority to be responsible for the implementation of this regulation. This authority receives the due diligence declarations and is responsible for carrying out checks on users.

There are also two voluntary registers supporting implementation, a register of collections and a register of best practices.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 12 October 2014 with the exception of a few articles which have applied since 12 October 2015.

BACKGROUND

The main international framework for the conservation and sustainable use of biological diversity and the fair and equitable sharing of the benefits arising from using genetic resources is the 1993 Convention on Biological Diversity.

The Nagoya Protocol, adopted in October 2010, builds on the rules of the Convention on access to genetic resources and sharing of monetary and non-monetary benefits arising from the utilisations of genetic resources.

For more information, see:

KEY TERMS

Genetic resource: natural and domesticated or cultivated species that play a role in food production, forestry, medicines, cosmetics and bio-based sources of energy. They also play a role in strategies to restore damaged ecosystems and safeguard endangered species.
Traditional knowledge: knowledge held by indigenous and local communities.

MAIN DOCUMENT

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 (OJ L 150, 20.5.2014, pp. 59-71)

RELATED DOCUMENTS

Commission notice — Guidance document on the scope of application and core obligations of Regulation (EU) No 511/2014 of the European Parliament and of the Council on the compliance measures for users from the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilisation in the Union (OJ C 313, 27.8.2016, pp. 1-19)

Commission Implementing Regulation (EU) 2015/1866 of 13 October 2015 laying down detailed rules for the implementation of Regulation (EU) No 511/2014 of the European Parliament and of the Council as regards the register of collections, monitoring user compliance and best practices (OJ L 275, 20.10.2015, pp. 4-19)

Council Decision 2014/283/EU of 14 April 2014 on the conclusion, on behalf of the European Union, of 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 (OJ L 150, 20.5.2014, pp. 231-233)

Council Decision 93/626/EEC of 25 October 1993 concerning the conclusion of the Convention on Biological Diversity (OJ L 309, 13.12.1993, pp. 1-2)

last update 21.06.2018

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