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 Germany.
Implementation of the Nagoya Protocol in Germany
On 15 October 2015, the German draft law regarding the Nagoya Protocol (DS 18/5219) passed the German parliament. On 1 December 2015, it was officially promulgated in the Federal Law Gazette. Therefore, Germany will become a party to the Nagoya Protocol in its own right on the ninetieth day after the date on which Germany deposits its instrument of ratification, acceptance, approval or accession to the Nagoya Protocol.
Also on 15 October 2015, the draft law for the implementation of obligations under the Nagoya Protocol and for the implementation of Regulation (EU) No 511/2014 as well as for changes with regard to the Patent Act and to the Environmental Audit Act (DS 18/5321) (“implementation act”) passed the German parliament. On 2 December 2015, the implementation act has been officially promulgated in the Federal Law Gazette. With the exception of the provision regarding changes of the Environmental Audit Act that are taking effect immediately, the implementation act will enter into force on 1 July 2016.
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 implements the Nagoya Protocol in the EU. 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 obliges users of genetic material or traditional knowledge associated with genetic resources (“traditional knowledge”) within the scope of the Nagoya Protocol 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.
Therefore, Reg. 511/2014 includes obligations for documentation and record keeping as well as – for users of genetic resources and traditional knowledge receiving research funding or developing a product via the utilisation of genetic resources or traditional knowledge –obligations to declare that the requirements under Reg. 511/2014 are fulfilled. Users of genetic resources and traditional knowledge developing a product via the utilisation of genetic resources or traditional knowledge must also submit information specified in Reg. 511/2014.
According to the implementation act, the Federal Agency for Nature Conservation (i.e. Bundesamt für Naturschutz “BfN”) will be the competent authority for the enforcement of the provisions of the Nagoya Protocol and Reg. 511/2014 in Germany.
Furthermore, the German Patent Act will be amended. Therefore, the implementation act provides that the German Patent and Trademark Office will inform the BfN if a patent application contains information on the geographic origin of biologic material. This measure will allow future patent applications to be checked for the use of biological material from other countries and, if applicable, in regard to whether the biological material has been obtained legally. However, as currently only a non-mandatory provision which requires indicating in the patent application the geographic origin of biologic material, the practical consequences of the amendment will probably be rather limited.
According to Reg. 511/2014, the EU Member States have to lay down penalties with regard to infringement of obligations under this regulation. Therefore, the implementation act prescribes that the intentional or negligent violation of the obligations under Reg. 511/2014 is considered an administrative offence that will be punished by regulatory fine up to EUR 50.000. However, according to Art. 17(4) of the German Code of Administrative Offences, which is also applicable, the regulatory fine shall exceed the financial benefit that the perpetrator has obtained from commission of the regulatory offence. If the statutory maximum does not suffice for that purpose, it may be exceeded. Thus, the BfN is in principle able to impose fines of unlimited amount. Additionally, certain exploitation activities can be prohibited in case a user does not comply with an order of the BfN to eliminate violations of Reg. 511/2014. Although it is rather unlikely that this will be construed in a way making it impossible to file, obtain or enforce IP rights, the practical exploitation of the IP rights in such a case can be limited.
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 comply with the said obligations for documentation and record keeping. Users of genetic resources and traditional knowledge receiving research funding or developing a product via the utilisation of genetic resources or traditional knowledge also have to comply with the obligation to declare that the requirements laid down in Reg. 511/2014 are fulfilled. Users of genetic resources and traditional knowledge developing a product via the utilisation of genetic resources or traditional knowledge must also submit information specified in Reg. 511/2014.
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.