http://www.legislation.gov.uk/uksi/2015/821/regulation/8The Nagoya Protocol (Compliance) Regulations 2015texttext/xmlenStatute Law DatabaseENVIRONMENTAL PROTECTION2022-09-23Expert Participation2020-12-31 These Regulations implement, within the United Kingdom, compliance measures for users of genetic resources or traditional knowledge associated with genetic resources resulting from 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 Protocol”). The Protocol aims to promote the conservation and sustainable use of biodiversity by ensuring the benefits from the use of genetic resources and traditional knowledge associated with genetic resources are shared fairly. Regulation (EU) No 511/2014 of the European Parliament and of the Council 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 Utilisation in the Union (OJ No L 150, 20.5.2014, p 59) (“the EU Regulation”) requires users to exercise due diligence that they only utilise genetic resources or traditional knowledge associated with genetic resources that have been accessed in accordance with the Protocol. Users are also required to make a declaration confirming due diligence at the final stage of development of a product. PART 3 81Subject to paragraphs (2) and (3), civil sanctions may be imposed in relation to a failure to comply with any of the following provisions—aArticle 4(1) of the EU Regulation (obligation to exercise due diligence);bArticle 4(3) of the EU Regulation (obligation to seek, keep and transfer information and documentation to subsequent users);cArticle 7(2) of the EU Regulation (obligation to make a declaration of due diligence).2There is no failure to comply with the provisions referred to in paragraph (1) if the Secretary of State is satisfied that the user has shown that they have effectively implemented best practice recognised under Article 8(2) of the EU Regulation.3There is no failure to comply with Article 4(3) of the EU Regulation if the Secretary of State is satisfied that—athe user is considered to have exercised due diligence under Article 4(4) of the EU Regulation (use of the Plant Treaty's Standard Material Transfer Agreement for material not listed in Annex 1 to that Treaty);bthe user is considered to have exercised due diligence under Article 4(7) of the EU Regulation (users obtaining material from a registered collection); orcthe use is in accordance with Article 4(8) of the EU Regulation (use of pathogen for the purpose of public health emergency preparedness).