On 12 October 2014, 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 (“Nagoya Protocol”) entered into force. By placing the parties under obligations to establish legislative, administrative and/or political measures with regard to access to genetic resources, the Nagoya Protocol aims to prevent biopiracy (i.e. the commercial development of biological compounds or genetic sequences by a technologically advanced country or organization without obtaining consent from or providing fair compensation to the peoples or nations in whose territory the materials were discovered1) and intends to ensure the participation of the countries of origin and/or indigenous or local communities in the benefits of the use of genetic resources. The European Union (“EU”) is a party to the Nagoya Protocol.
This article explains the implementation of the Nagoya Protocol in the EU.
Implementation of the Nagoya Protocol in the EU
The Nagoya Protocol has been implemented in the EU by Regulation (EU) No 511/2014 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 EU (“Reg. 511/2014”) that fully entered into force on 12 October 2015. Regulation (EU) No 2015/1866 (“Reg. 2015/1866”) that entered into force on 09 November 2015 lays down detailed rules for the implementation of Reg. 511/2014 as regards the register of collections, monitoring user compliance and best practices. Constituting directly applicable law in all EU Member States, Reg. 511/2014 and Reg. 2015/1866 shall ensure a proper application of the Nagoya Protocol throughout the EU. Reg. 511/2014 applies to genetic resources over which states exercise sovereign rights and to traditional knowledge associated with genetic resources (“traditional knowledge”), both within the scope of the Nagoya Protocol, which are accessed after the entry into force of the Nagoya Protocol for the EU. It also applies to the benefits arising from the utilisation thereof. Furthermore, Reg. 511/2014 is also applicable to genetic resources and traditional knowledge to which access and benefit-sharing legislation or regulatory requirements of a Party to the Nagoya Protocol are applicable.
Obligations of users
Reg. 511/2014 imposes several obligations on users of genetic material or traditional knowledge (“users”). According to Art. 4 Reg. 511/2014 users are obliged to exercise due diligence to ascertain that:
- genetic resources and traditional knowledge utilised have been accessed (i.e. acquired in a party to the Nagoya Protocol) in accordance with applicable access and benefit-sharing legislation or regulatory requirements, and
- benefits are fairly and equitably shared upon mutually agreed terms, in accordance with any applicable legislation or regulatory requirements.
For these purposes, users have to seek, keep and transfer to subsequent users either:
- a so-called internationally-recognised certificate of compliance (i.e. a permit or its equivalent issued at the time of access as evidence that the genetic resource it covers has been accessed in accordance with the decision to grant prior informed consent, and that mutually agreed terms have been established for the user and the utilisation specified therein by a competent authority in accordance with Articles 6(3)(e) and 13(2) of the Nagoya Protocol, that is made available to the Access and Benefit-sharing Clearing House established under Article 14(1) of the Nagoya Protocol) as well as information on the content of the mutually agreed terms; or
- where no such certificate is available, information and relevant documents on:
- date and place of access of the genetic resource or traditional knowledge;
- description of the genetic resources or traditional knowledge utilised;
- source from which the genetic resources or traditional knowledge were directly obtained, as well as subsequent users of genetic resources or traditional knowledge;
- presence or absence of rights and obligations relating to access and benefit-sharing including rights and obligations regarding subsequent applications and commercialisation;
- access permits, where applicable; and
- mutually agreed terms, including benefit-sharing arrangements, where applicable (“alternative information”).
In case the information in the users’ 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. Otherwise, they shall discontinue utilisation.
Reg. 511/2014 also provides an obligation for users to keep the information relevant to access and benefit-sharing for 20 years after the end of the period of utilisation.
According to Art. 7 Reg. 511/2014, all recipients of research funding involving the utilisation of genetic resources and traditional knowledge will be requested by the EU Member States and the Commission to declare that they exercise due diligence in accordance with the obligations of users set by Reg. 511/2014. Reg. 2015/1866 in its Annex II provides a template for submission of such declaration.
Above all, at the stage of the final development of a product developed via the utilisation of genetic resources or traditional knowledge, users have to declare to the competent national authorities that they have fulfilled the obligations of users set by Reg. 511/2014 and simultaneously submit either the relevant information from the internationally-recognised certificate of compliance, or, where such certificate is not available, the above-mentioned alternative information with the exception of benefit-sharing arrangements. A template for submission of the declaration is provided in Annex III of Reg. 2015/1866.
Checks on user compliance and penalties
According to Art. 9 Reg. 511/2104, the national competent authorities shall carry out effective, proportionate, and dissuasive checks to verify whether users comply with their obligations under Reg. 511/2014. These checks may include examination of measures taken by a user to exercise his obligations under Reg. 511/2014, examination of documentation and recordsdemonstrating the exercise of due diligence and, if appropriate, on-the-spot checks. In case any shortcomings are detected, the competent national authorities shall issue a notice of remedial action or measures to be taken by the user.
The EU Member States shall lay down rules on effective, proportionate and dissuasive penalties applicable to infringements of obligations of users under Reg. 511/2014 (Art. 11 Reg. 511/2014). Therefore, violating the obligations under Reg. 511/2014 may have different consequences in the different EU Member States.
Register of collections
Art. 5 Reg. 511/2014 provides that an internet-based register of collections (i.e. sets of collected samples of genetic resources and related information that is accumulated and stored, whether held by public or private entities) is established within the EU. Users obtaining a genetic resource from a collection included in this register shall be considered to have exercised due diligence in accordance with Reg. 511/2014.
Nagoya Protocol and European Patents
With regard to European Patents (“EPs”), there are currently no plans to amend the European Patent Convention or the respective rules in the light of the Nagoya Protocol or Reg. 511/2014. However, although it is to be expected that there will be no such amendment in the future either, it is very likely the Nagoya Protocol and the general principles of Reg. 511/2014 will at least be taken into consideration indirectly, as supranational legislation, with regard to the future grant of EPs.
In order to meet the obligations of Reg. 511/2014, users acquiring genetic resources or traditional knowledge thereof in a country which is a party to the Nagoya Protocol have to exercise the aforementioned due diligence and seek and keep the internationally-recognised certificate of compliance or the alternative information. In addition, users receiving research funding involving the utilisation of genetic resources and traditional knowledge have to declare that they exercise due diligence in accordance with Reg. 511/2014. Moreover, having developed a product via the utilisation of genetic resources or traditional knowledge, users have to declare that they have fulfilled the obligations under Reg. 511/2014 and submit the relevant information from the internationally-recognised certificate of compliance or the alternative information with the exception of benefit-sharing arrangements.
With regard to the application of patents, although currently it cannot be predicted whether a violation of the obligations under Reg. 511/2014 will have consequences for the grant of a patent or the possibility of exploiting a patent, or what these consequences will be, it is to be expected that competitors or other third parties will try to attack a patent for violation of these obligations. Therefore, patentees and researchers should in any event take the obligations under Reg. 511/2014 very seriously.