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

CHAPTER II USER COMPLIANCE

Article 4 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 Union 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 as defined in the Decision No 1082/2013/EU of the European Parliament and of the Council(1), 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.

Article 5 Register of collections

1. The Commission shall establish and maintain a register of collections within the Union (‘the register’). The Commission shall ensure that the register is internet-based and is easily accessible to users. The register shall include the references of the collections of genetic resources, or of parts of those collections, identified as meeting the criteria set out in paragraph 3.

2. A Member State shall, upon request by a collection holder under its jurisdiction, consider the inclusion of that collection, or a part of it, in the register. After verifying that the collection, or a part of it, meets the criteria set out in paragraph 3, the Member State shall notify the Commission without undue delay of the name and contact details of the collection and of its holder, and of the type of collection concerned. The Commission shall without delay include the information received in the register.

3. In order for a collection or a part of a collection to be included in the register, a collection shall demonstrate its capacity to:

(a) apply standardised procedures for exchanging samples of genetic resources and related information with other collections, and for supplying samples of genetic resources and related information to third persons for their utilisation in line with the Convention and the Nagoya Protocol;

(b) supply genetic resources and related information to third persons for their utilisation only with documentation providing evidence that the genetic resources and the related information were accessed in accordance with applicable access and benefit-sharing legislation or regulatory requirements and, where relevant, with mutually agreed terms;

(c) keep records of all samples of genetic resources and related information supplied to third persons for their utilisation;

(d) establish or use unique identifiers, where possible, for samples of genetic resources supplied to third persons; and

(e) use appropriate tracking and monitoring tools for exchanging samples of genetic resources and related information with other collections.

4. The Member States shall regularly verify that each collection or part of a collection under their jurisdiction included in the register meets the criteria set out in paragraph 3.

Where there is evidence, on the basis of information provided pursuant to paragraph 3, that a collection or a part of a collection included in the register does not meet the criteria set out in paragraph 3, the Member State concerned shall, in dialogue with the collection holder concerned and without undue delay, identify remedial actions or measures.

A Member State which determines that a collection or a part of a collection within its jurisdiction no longer complies with paragraph 3 shall inform the Commission thereof without undue delay.

Upon receipt of that information, the Commission shall remove the collection or the part of the collection concerned from the register.

5. The Commission shall adopt implementing acts to establish the procedures for implementing paragraphs 1 to 4 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).

Article 6 Competent authorities and focal point

1. Each Member State shall designate one or more competent authorities to be responsible for the application of this Regulation. Member States shall notify the Commission of the names and addresses of their competent authorities as of the date of entry into force of this Regulation. Member States shall inform the Commission without undue delay of any changes to the names or addresses of the competent authorities.

2. The Commission shall make public, including via the internet, a list of the competent authorities of the Member States. The Commission shall keep the list up-to-date.

3. The Commission shall designate a focal point on access and benefit-sharing responsible for liaising with the Secretariat of the Convention with regard to matters covered by this Regulation.

4. The Commission shall ensure that the Union bodies established under Council Regulation (EC) No 338/97(2) contribute to the achievement of the objectives of this Regulation.

Article 7 Monitoring user compliance

1. The Member States and the Commission shall request all recipients of research funding involving the utilisation of genetic resources and traditional knowledge associated with genetic resources to declare that they exercise due diligence in accordance with Article 4.

2. At the stage of final development of a product developed via the utilisation of genetic resources or traditional knowledge associated with such resources, users shall declare to the competent authorities referred to in Article 6(1) that they have fulfilled the obligations under Article 4 and shall simultaneously submit:

(a) the relevant information from the internationally-recognised certificate of compliance; or

(b) the related information as referred to in Article 4(3)(b)(i)-(v) and Article 4(5), including information that mutually agreed terms were established, where applicable.

Users shall further provide evidence to the competent authority upon request.

3. The competent authorities shall transmit the information received on the basis of paragraphs 1 and 2 of this Article to the Access and Benefit-Sharing Clearing House, established under Article 14(1) of the Nagoya Protocol, to the Commission and, where appropriate, to the competent national authorities referred to in Article 13(2) of the Nagoya Protocol.

4. The competent authorities shall cooperate with the Access and Benefit-Sharing Clearing House to ensure the exchange of the information listed in Article 17(2) of the Nagoya Protocol for monitoring the compliance of users.

5. The competent authorities shall take due account of the respect of confidentiality of commercial or industrial information where such confidentiality is provided for by Union or national law to protect a legitimate economic interest, in particular concerning the designation of the genetic resources and the designation of utilisation.

6. The Commission shall adopt implementing acts to establish the procedures for implementing paragraphs 1, 2 and 3 of this Article. In those implementing acts, the Commission shall determine the stage of final development of a product in order to identify the final stage of utilisation in different sectors. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).

Article 8 Best practices

1. Associations of users or other interested parties may submit an application to the Commission to have a combination of procedures, tools or mechanisms, developed and overseen by them, recognised as a best practice in accordance with the requirements of this Regulation. The application shall be supported by evidence and information.

2. Where, on the basis of evidence and information provided pursuant to paragraph 1 of this Article, the Commission determines that the specific combination of procedures, tools or mechanisms, when effectively implemented by a user, enables that user to comply with its obligations under Articles 4 and 7, it shall grant recognition as best practice.

3. An association of users or other interested parties shall inform the Commission of any changes or updates made to a best practice for which recognition was granted in accordance with paragraph 2.

4. If there is evidence of repeated or significant cases where users implementing a best practice have failed to comply with their obligations under this Regulation, the Commission shall examine, in dialogue with the relevant association of users or other interested parties, whether those cases indicate possible deficiencies in the best practice.

5. The Commission shall withdraw the recognition of a best practice when it has determined that changes to the best practice compromise a user’s ability to comply with its obligations under Articles 4 and 7, or when repeated or significant cases of non-compliance by users relate to deficiencies in the best practice.

6. The Commission shall establish and keep up-to-date an internet-based register of recognised best practices. That register shall, in one section, list the best practices recognised by the Commission in accordance with paragraph 2 of this Article, and, in another section, list the best practices adopted on the basis of Article 20(2) of the Nagoya Protocol.

7. The Commission shall adopt implementing acts to establish the procedures for implementing paragraphs 1 to 5 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 14(2).

Article 9 Checks on user compliance

1. The competent authorities referred to in Article 6(1) shall carry out checks to verify whether users comply with their obligations under Articles 4 and 7, taking into account that the implementation by a user of a best practice in relation to access and benefit-sharing, recognised under Article 8(2) of this Regulation or under Article 20(2) of the Nagoya Protocol, may reduce that user’s risk of non-compliance.

2. Member States shall ensure that the checks carried out pursuant to paragraph 1 are effective, proportionate, dissuasive and detect cases of user non-compliance with this Regulation.

3. The checks referred to in paragraph 1 shall be conducted:

(a) in accordance with a periodically reviewed plan developed using a risk-based approach;

(b) when a competent authority is in possession of relevant information, including on the basis of substantiated concerns provided by third parties, regarding a user’s non-compliance with this Regulation. Special consideration shall be given to such concerns raised by provider countries.

4. The checks referred to in paragraph 1 of this Article may include an examination of:

(a) the measures taken by a user to exercise due diligence in accordance with Article 4;

(b) documentation and records that demonstrate the exercise of due diligence in accordance with Article 4 in relation to specific use activities;

(c) instances where a user was obliged to make declarations under Article 7.

On-the-spot checks may also be carried out, as appropriate.

5. Users shall offer all assistance necessary to facilitate the performance of the checks referred to in paragraph 1.

6. Without prejudice to Article 11, where, following the checks referred to in paragraph 1 of this Article, shortcomings have been detected, the competent authority shall issue a notice of remedial action or measures to be taken by the user.

Depending on the nature of the shortcomings, Member States may also take immediate interim measures.

Article 10 Records of checks

1. The competent authorities shall keep, for at least five years, records of the checks referred to in Article 9(1), indicating, in particular, their nature and results, as well as records of any remedial actions and measures taken under Article 9(6).

2. The information referred to in paragraph 1 shall be made available in accordance with Directive 2003/4/EC.

Article 11 Penalties

1. Member States shall lay down the rules on penalties applicable to infringements of Articles 4 and 7 and shall take all the measures necessary to ensure that they are applied.

2. The penalties provided for shall be effective, proportionate and dissuasive.

3. By 11 June 2015, Member States shall notify to the Commission the rules referred to in paragraph 1 and any subsequent amendments thereto without delay.

(1)

Decision No 1082/2013/EU of the European Parliament and of the Council of 22 October 2013 on serious cross-border threats to health and repealing Decision No 2119/98/EC (OJ L 293, 5.11.2013, p. 1).

(2)

Council Regulation (EC) No 338/97 of 9 December 1996 on the protection of species of wild fauna and flora by regulating trade therein (OJ L 61, 3.3.1997, p. 1).