On Tuesday 11 November, representatives of the Council of the European Union and the European Parliament made some progress in their negotiations on proposals to revise the legislative framework for pharmaceutical products.
At this third trilogue on the subject, the Danish Presidency of the Council of the EU reiterated the importance of reaching a complete agreement on the pharmaceutical package by the end of 2025. The final trilogue, scheduled for 10 December, promises to be intense, given the number of issues that still remain open (see EUROPE 13747/15).
On Tuesday, the co-legislators were able to reach a preliminary political agreement on incentives for the development of priority antimicrobials, combining the EU Council’s mandate for a system of transferable exclusivity vouchers for new antibiotics with the voluntary subscription model (fixed payments guaranteeing supply) sought by the Parliament. Work on the details of this compromise will continue on the technical level.
The EU Council and the European Parliament discussed ‘potential political landing zones’ concerning the ‘Bolar’ provision (which allows generic manufacturers to prepare their regulatory trials and dossiers before patent expiry in order to bring their products to market quickly), regulatory protection periods and provisions on access to medicines in order to prepare the necessary work at technical level to present and agree on a final package at the last trilogue.
In addition, the co-legislators agreed to reach a technical preliminary agreement on the awareness card and the prescription status of antimicrobials in the very near future.
In addition, with regard to orphan medicinal products, the co-legislators explored future flexibilities and compromises and agreed that the European Parliament’s approach would form the basis of a potential compromise. In this context, the Danish Presidency of the EU Council has stressed that these issues are linked to regulatory protection.
Furthermore, with regard to security of supply, the Danish Presidency presented the EU Council’s position and stressed that any compromise should ensure that the scope of the plan to prevent shortages remains manageable for industry and the authorities, that the European Commission’s role remains proportionate and that Member States’ national competences are upheld. The European Commission has noted that legislation on critical medicinal products could help to address some of these issues. The negotiators tasked the technical experts with exploring compromises with a view to establishing a reliable, transparent and applicable framework. (Original version in French by Lionel Changeur)