Negotiations between the Council of the EU and the European Parliament on the pharmaceutical package will resume on Tuesday 11 November.
The aim of the Danish Presidency of the Council of the EU is to conclude the talks between the EU institutions at a final trilogue (which will be the fourth), scheduled for 10 December (see EUROPE 13725/20).
At the meeting of the Committee of Permanent Representatives of the Member States to the EU (Coreper), scheduled for Friday 7 November, the Danish Presidency of the Council of the EU will be asking delegations whether they can show flexibility on several key points: market exclusivity for orphan drugs, regulatory protection periods (the Commission’s proposal would reduce the current length of the normal regulatory data protection period from eight to six years) and provisions on access to medicines (see EUROPE 13720/18).
The Danish Presidency of the EU Council will also be asking for some room for manoeuvre on antimicrobial resistance (AMR).
The proposals for a regulation and a directive, which make up the so-called ‘pharmaceutical package’, represent the most far-reaching reform of EU legislation on medicinal products for over twenty years. (Original version in French by Lionel Changeur)