In 1992, the Rio Convention on Biodiversity set the goal of fighting practices known as biopiracy and which are generally seen in developing countries. These involve identifying certain genetic resources of a country and indigenous traditional knowledge that may be linked to their use, developing them, protecting them through patents and extracting commercial gain without any benefit to the indigenous populations in question. The Nagoya Protocol, an extension of the Rio Convention, enshrines a move from mere declarations of intent to concrete measures.
The Nagoya Protocol has been ratified by more than 100 countries, including France and its main goal is to ensure that each member country incorporates into its national law provisions seeking to:
- make access to genetic resources in its territory, and such traditional knowledge as may be linked thereto, the subject of a system of prior registration or authorisation;
- ensure that the advantages arising from the use of the said resources and knowledge are indeed shared with indigenous populations.
As far as the European Union is concerned, the principles of the Nagoya Protocol have been incorporated into Regulation 511/2014 and Implementing Regulation 2015/1866. In France, the provisions of the Protocol and the above-mentioned EU Regulations have for the most part been incorporated into the Environmental Code. The latter notably ensures, for all research activity (involving genetic and/or biochemical compositions) concerning genetic resources available in French territory, mandatory compliance with the following formal requirements:
- filing a declaration prior to accessing any genetic resources with a view to their study, the keeping thereof in a collection or uses thereof not being linked to immediate commercial development;
- obtaining an authorisation and entering into a contract concerning the sharing of benefits prior to any access to genetic resources with a view to their study and commercial uses thereof, as well as prior to any use of traditional knowledge linked to genetic resources (a specific authorisation and procedure have been laid down to this end).
Furthermore, in cases where there is simultaneous use both of genetic resources and traditional knowledge linked thereto, supplementary reporting obligations are foreseen in the two following cases:
- for obtaining funding in order to carry out research;
- for the final development of a product which, if it gives rise to the filing of a patent application, will also result in the requirement to forward to the French Intellectual Property Office (INPI) supplementary information using the form appearing in Annex III of the Implementing Regulation 2015/1866.
It may be noted that the corresponding provisions of the Environmental Code are accompanied by criminal penalties.
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