The European Commission is referring Italy to the Court of Justice of the EU because its system of access to genetic resources from non-EU countries is considered to be dysfunctional.
These dysfunctionalities damage the ability of companies established in Italy to tap the benefits of such access for research, production and trade. Genetic resources are valuable genetic material of plant, animal, or microbial origin, such as medicinal plants, agricultural crops and animal breeds. The Access and Benefit-Sharing (ABS) requirements represent the guarantee that once a country facilitates access to its genetic resources and traditional knowledge (for example in relation to some active ingredient in a specific plant) it will have a share in the final product (new medicines etc.) developed on that basis.
Following a letter of formal notice sent by the Commission in January 2018 and a reasoned opinion in January 2019, Italy notified in July 2019 the designation of the national competent authorities. However, to date, Italy has not notified any legislation establishing the sanctions applicable for the violation of the rules.
The Commission has therefore decided to refer Italy to the Court of Justice of the EU.
Regulation (EU) 511/2014on 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, entered into force on 11 June 2014. Following entry into force of the Nagoya Protocol, the Regulation entered into application on 12 October 2014.
In accordance with Article 6(1) of the Regulation, each Member State is obliged to designate one or more competent authorities responsible for the application of the Regulation, and to notify the Commission of the names and addresses of those competent authorities as of the date of entry into force of the Regulation.
Pursuant to Article 11 of the Regulation, Member States are to lay down the rules on penalties applicable to infringements of Articles 4 and 7. Those rules, in line with Article 11(3) of the Regulation, were due to be notified to the Commission by 11 June 2015.