On Wednesday 21 May, the EU Member States failed to adopt a common position on proposals concerning the pharmaceutical package (see EUROPE 13625/8).
The Committee of Permanent Representatives of the Member States to the EU (Coreper) failed to approve a mandate to begin negotiations with the European Parliament on this issue.
At the Coreper meeting, a group of countries (Germany, France, Italy, Denmark, Sweden and Finland) called for maintaining the eight-year regulatory data protection period. These countries also remain critical of the introduction of transferable data exclusivity vouchers.
The compromise text presented by the Polish Presidency of the EU Council proposed a seven-year protection period, with a one-year bonus under certain conditions. Several Member States consider this difference of one year very significant.
The Danish Presidency will take up the torch in an attempt to establish a ‘general approach’ in the EU Council and launch talks with Parliament.
Based on the examination of the European Commission’s proposals, comments from delegations, discussions held within the working group and guidelines from Coreper and the EU Council, the Polish Presidency prepared compromise texts which were examined at the working group meetings on 5, 6 and 12 May.
An EU Council note dated 16 May, consulted by Agence Europe, summarises the main issues under discussion:
- modulation of regulatory protection periods for innovative medicines, with the aim of simplifying the system to ensure greater predictability for manufacturers and patients;
- the introduction of a marketing obligation throughout the European Union, and European sanctions in the event of non-compliance;
- the risk of an excessive budgetary impact linked to using the ‘transferable exclusivity voucher’;
- the scope of the ‘Bolar’ exemption to intellectual property rights (a legal exception which allows generic manufacturers to use patented medicines before the expiry of the patent without infringing the patent holder’s intellectual property);
- the Commission’s powers in the event of medicine shortages;
- the possibility for Member States to set up an information system concerning the distribution of medicines from one market to another;
- the introduction of an electronic package leaflet alongside the paper version, unless a Member State opts for the electronic version alone, for some or all medicines;
- a guarantee that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) will be able to draw on appropriate expertise;
- representation and voting rights for patients and healthcare professionals within the CHMP and the Pharmacovigilance Risk Assessment Committee;
- technical adjustments to certain pharmacovigilance provisions;
- clarification of the rules governing decentralised manufacturing;
- modification of the provisions concerning joint inspections;
- clarification of exemptions relating to officinal and magistral formulas;
- defining the scope of adapted regulatory frameworks and regulatory sandboxes. (Original version in French by Lionel Changeur)