Regulation (EU) No 511/2014 of the European Parliament and of the CouncilShow full title

Article 4 U.K. Obligations of users

1. Users shall exercise due diligence to ascertain that genetic resources and traditional knowledge associated with genetic resources which they utilise have been accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements, and that benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.

2. Genetic resources and traditional knowledge associated with genetic resources shall only be transferred and utilised in accordance with mutually agreed terms if they are required by applicable legislation or regulatory requirements.

3. For the purposes of paragraph 1, users shall seek, keep and transfer to subsequent users:

(a) the internationally-recognised certificate of compliance, as well as information on the content of the mutually agreed terms relevant for subsequent users; or

(b) where no internationally-recognised certificate of compliance is 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.

4. Users acquiring Plant Genetic Resources for Food and Agriculture (PGRFA) in 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 contained in Annex I to the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), will also be subject to the terms and conditions of the standard material transfer agreement for the purposes set out under the ITPGRFA, shall be considered to have exercised due diligence in accordance with paragraph 3 of this Article.

5. When the information in their possession is insufficient or uncertainties about the legality of access and utilisation persist, users shall obtain an access permit or its equivalent and establish mutually agreed terms, or discontinue utilisation.

6. Users shall keep the information relevant to access and benefit-sharing for 20 years after the end of the period of utilisation.

7. Users obtaining a genetic resource from a collection included in the register of collections within the [F1 United Kingdom] referred to in Article 5(1) shall be considered to have exercised due diligence as regards the seeking of information listed in paragraph 3 of this Article.

8. Users acquiring a genetic resource that is determined to be, or is determined as likely to be, the causing pathogen of a present or imminent public health emergency of international concern, within the meaning of the International Health Regulations (2005), or of a serious cross-border threat to health F2 ... , for the purpose of public health emergency preparedness in not yet affected countries and response in affected countries, shall fulfil the obligations listed in paragraph 3 or 5 of this Article at the latest:

(a) one month after the imminent or present threat to public health is terminated; or

(b) three months after commencement of utilisation of the genetic resource;

whichever is the earlier.

Should the obligations listed in paragraph 3 or 5 of this Article not be fulfilled by the deadlines laid down in points (a) and (b) of the first subparagraph of this paragraph, utilisation shall be discontinued.

In the event of a request for market approval or the placing on the market of products deriving from utilisation of a genetic resource as referred to in the first subparagraph, the obligations listed in paragraph 3 or 5 shall apply entirely and without delay.

In the absence of prior informed consent having been obtained in a timely manner and mutually agreed terms having been established, and until an agreement is reached with the provider country concerned, no exclusive rights of any kind will be claimed by such a user to any developments made via the use of such pathogens.

Specialised international access and benefit-sharing instruments as mentioned in Article 2 remain unaffected.

Textual Amendments

F1 Words in Art. 4(7) substituted (31.12.2020) by The Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393), regs. 1, 3(4)(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in Art. 4(8) omitted (31.12.2020) by virtue of The Nagoya Protocol (Compliance) (Amendment) (EU Exit) Regulations 2018 (S.I. 2018/1393), regs. 1, 3(4)(b); 2020 c. 1, Sch. 5 para. 1(1)