During the Employment, Social Policy, Health and Consumer Affairs Council in Luxembourg on 21 June, ministers will hold a debate on the incentives system in the pharmaceutical package that the European Commission proposed at the end of April 2023 (see EUROPE 13419/14).
The Belgian Presidency of the Council of the EU will present a report taking stock of the state of negotiations in the Council on the pharmaceuticals reform that intends to make medicines “more accessible, affordable and innovative” (see EUROPE 13388/13).
The ‘incentives cluster’ in the package (proposed by the European Commission) includes, among other things, a modulated system of regulatory data and market protection in which protection periods are granted based on certain conditions being fulfilled. The basic regulatory data protection period (during which another applicant is prohibited from referencing the dossier data) has been reduced to 6 years but, notably, may be extended 2 years.
The European Parliament has adopted its position on this reform, whereas the EU Council has been slow to do so. Work [on this matter] will continue in July under the Hungarian Presidency of the Council of the EU.
Link to the report: https://aeur.eu/f/ck5
Link to the note on the incentives: https://aeur.eu/f/ck6 (Original version in French by Lionel Changeur)