On Wednesday 4 June, the Permanent Representatives Committee (Coreper) approved the EU Council’s position on the reform of legislation on medicines.
A negotiating mandate was approved by a large qualified majority, with a view to opening discussions with the European Parliament, which for its part adopted its position in April 2024 (see EUROPE 13652/2).
Data protection. Under the EU Council’s mandate, companies developing innovative medicines will be able to prevent their competitors from accessing the data used in their development for a period of eight years.
Market protection. Producers of innovative medicines will benefit from one year of regulatory market protection, extendable to two years if certain predefined key targets are met.
Obligation to supply. A new article has been added to the draft directive, giving Member States the power to require the marketing authorisation holder for a medicinal product to make that product available in sufficient quantities to meet patients’ needs in their territory.
Transferable exclusivity voucher. The EU Council has introduced a clause stipulating that a transferred voucher can only be used in the fifth year of the regulatory data protection period, and only if the marketing authorisation holder demonstrates that gross annual sales of the product in the EU have not exceeded €490 million in any of the previous four years.
Intellectual property exemption. To help bring generic and biosimilar medicines to market more quickly, the EU Council’s mandate clarifies the scope of the ‘Bolar exemption’ and extends it to submissions for procurement tenders.
Franco-Italian declaration. In a declaration, Italy and France, which supported the texts of the mandate, explain that during the trilogue phase with the European Parliament, they will continue to maintain a high level of commitment and ambition to "ensure the predictability and attractiveness of the European regulatory frameworks and the objective of simplification, including with regards to the issue of market exclusivity modulation as well as the balance between access to generics and protection of intellectual property rights".
In addition, the two countries also signaled their willingness to continue promoting the objective of fair and faster access to medicines for all patients across the EU. In parallel with the trilogues, the negotiations on the Critical Medicines Act will also be essential to achieving this common objective, agreed the delegations.
Links to mandate texts: https://aeur.eu/f/h61 ; https://aeur.eu/f/h62 (Original version in French by Lionel Changeur)