The French Parliament is currently considering new legislation on biodiversity. The Bill will introduce important changes for companies and researchers in the pharmaceutical, cosmetics and agri-food sectors that use genetic resources from vegetal, animals and micro-organisms.
Despite the existence of international conventions (the Convention on Biologic Diversity, 1992 and the Nagoya Protocol), companies have, so far, been independent in the performance of their activities. Biodiversity has proved to be a tremendous source of innovation and production.
At EU level, Regulation n° 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 utilisation in the Union (the “Regulation”) was adopted. The Regulation implements the Nagoya Protocol since its entry into force (i.e. 12 October 2014). The Regulation also designs the legal framework for the access and benefit sharing arising from genetic resources and associated traditional knowledge.
Purpose of the new Bill in France
Along with the EU Regulation, France, as a significant provider and user of natural resources, has decided to frame its own national legislation in order to regulate bio-prospection and particularly the practice of patenting genetic resources and associated traditional knowledge. Most of the Bill’s provisions on this issue implement and develop the Regulation.
The purpose of the new legislation will be to facilitate the access to genetic resources and associated traditional knowledge for users (such as researchers and firms) and establish a clear legal framework for R&D.
In that respect, providers of genetic resources are sometimes not considered to receive the reward they deserve where the genetic resources at stake are used. Nevertheless, researchers and firms operating in this field need to maintain a high level of competitiveness and further scientific research.
The Bill is therefore intended to conciliate human activities and biodiversity.
Main legal provisions
The new framework will include three main aspects:
- Regulation of the access and their utilisation in R&D of:
- genetic resources, and
- associated traditional knowledge.
- Sharing of benefits, which will depend on the use of the resources.
- Compliance with the Nagoya Protocol and related legislation (in France and overseas).
Key changes on the access and use of genetic resources and associated traditional knowledge
- Depending on the activities carried out, access to genetic resources or associated traditional knowledge is subject to either prior notification, or prior approval by the providers (i.e. Nations/the State for genetic resources, and local communities for associated traditional knowledge) depending on the final purpose of the exploitation.
- With regard to traditional knowledge associated with genetic resources, the French public authorities will consult local communities in order to negotiate the benefit sharing contract with the user and possibly to manage the economic advantages for these communities.
- The new legislation will also provide rules on the reinvestment, in the preservation and restoration of biodiversity, of the profits created.
- According to the future article L. 412-4 II of the French Code of Environment, the triggering criteria of the legal provisions application is the use within R&D (which involves pharmaceutical use in particular), but not the access to resources or knowledge as such.
- In the event of genetic resources or associated traditional knowledge collected before the entry into force of the legislation, the obligations of the user will be triggered by any further use.
- Compliance with French regulation will be reviewed by public authorities in case of public funding or at the time a product or process based on genetic resources or traditional knowledge is placed on the market, which may lead to the filing of a patent application.
- The Bill provides for new rules regarding French companies, which are active abroad within the limits of the signatory states of the Nagoya Protocol. These companies must prove to public authorities that their access to genetic resources and associated traditional knowledge is compliant with their international compliance certificate (provided by the relevant Authorities).
- Non-compliance with French law on biodiversity can lead to a fine of € 150,000 and up to one year imprisonment. Moreover, any fraudulent commercial use will be subject to a fine of € 1,000,000.