Owl

How can I comply with the rules and minimise the administrative burden?

In short

You can minimise your administrative burden

  • through access to genetic resources under an internationally recognized Certificate of Compliance;
  • through access to genetic resources from a registered collection in the European Union;
  • by establishing fixed procedures in your user community and having these procedures recognised as best practice, or by joining a user community which already has a recognised best practice;
  • by integrating your documentation obligations in an existing internal quality management scheme;
  • by receiving plant genetic resources (including those not listed in Annex I of the ITPGRFA) under the conditions of the SMTA of the ITPGRFA. This procedure ensures that you are deemed to have complied with your due diligence obligations under EU law.

If you access genetic resources from the Multilateral System of the ITPGRFA by signing the fixed Standard Material Transfer Agreement, all your obligations are included in this Agreement.

When complying with the rules, you should first check whether your organisation or company has established a policy on accessing genetic resources. Your organisation may also form part of a user community whose best practice has been recognised by the EU Commission under EU Regulation 511/2014. In such cases, follow that policy or best practice.

Your obligations

In all cases, you must fulfil the user obligations laid down in Article 4 of EU Regulation 511/2014 implementing the Nagoya Protocol in the European Union. In short, these obligations include the following:

  1. As a user, you shall exercise due diligence to make sure that the genetic resources and traditional knowledge associated with genetic resources that you utilise have been accessed in accordance with applicable ABS legislation or regulatory requirements, and that the benefits arising from such use are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements, in particular of the country providing your genetic resources.
  2. Genetic resources and traditional knowledge associated with genetic resources shall only be transferred and utilised in accordance with mutually agreed terms.
  3. As a user, you shall seek, keep and transfer to subsequent users an internationally recognised certificate of compliance, as well as information on the content of the mutually agreed terms relevant for subsequent users; or if an internationally recognised certificate of compliance (IRCC) is not available, information and relevant documents on:

    (i) the date and place of access of genetic resources or of traditional knowledge associated with genetic resources;

    (ii) the description of the genetic resources or of traditional knowledge associated with genetic resources utilised;

    (iii) the source from which the genetic resources or traditional knowledge associated with genetic resources were directly obtained, as well as subsequent users of genetic resources or traditional knowledge associated with genetic resources;

    (iv) the presence or absence of rights and obligations relating to access and benefit-sharing including rights and obligations regarding subsequent applications and commercialisation;

    (v) access permits, where applicable;

    (vi) mutually agreed terms, including benefit-sharing arrangements, where applicable.

Minimising your administrative burden

Your organisation may already document some or all of the information you are required to have under an internal quality scheme. If you wish to minimise your administrative burden and where such options exist, access to genetic resources under an internationally recognised Certificate of Compliance is preferable. If you have obtained a genetic resource from a collection included in the register of collections within the European Union, you are considered to have exercised your due diligence obligations. When you receive, under the conditions of the SMTA of the ITPGRFA, plant genetic resources that are not listed in Annex I of the ITPGRFA, you are deemed to have performed your due diligence obligations under EU law. More formally, this means that users acquiring PGRFA from a country that is a Party to the Nagoya Protocol which has determined that PGRFA under its management and control and in the public domain, not listed in Annex I to the ITPGRFA, shall also be subject to the terms and conditions of the SMTA of the ITPGRFA, shall be considered to have exercised due diligence. Establishing and gaining approval for your user community’s best practice, if possible, may also reduce your administrative burden.