I came across an interesting article written by the law firm Evershed. This article briefly summarises the content of the new environmental French law which covers the issues related to the Nagoya Protocol.
It gives the key aspects of the law with regards to ABS:
- 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.
Read here the full article.
The law should continue its parliamentary process in the first semester of 2015. Then we will need to wait for the implementing act that should describe more precisely the administrative process to get an access permit (through a PIC) and apply the mutual agreed terms (MAT).