The Hungarian Presidency of the EU Council has managed to make some progress during this six-month period on revising the legislation on pharmaceutical products, but it is not enough. On Tuesday 3 December in Brussels, the European health ministers indicated that they were counting on the Polish Presidency of the EU Council to complete the work in the first half of 2025.
Olivér Várhelyi, European Commissioner for Health, expressed his willingness to support the EU Council and the European Parliament in completing the reform.
Austria has called on EU countries to accept the modulation of incentives, rather than the status quo, which includes 7 years’ protection. Estonia has advocated an EU sanctions mechanism.
Denmark expressed its concern at the way the negotiations were going (too much red tape). Germany insisted on the protection of patent data to guarantee innovation. Sweden supported the Danish and German positions on data protection.
Poland promised to work at a steady pace to try and find a balanced compromise.
The progress report from the Hungarian Presidency of the EU Council confirms the issues to be resolved:
- the modulation of incentives, guaranteeing all Member States greater equality of access to the market and a continuous supply of innovative medicines;
- ensuring that the combined provisions of voluntary participation by Member States in the mutual recognition procedure and the decentralised procedure, and the requirement that holders of national and centralised marketing authorisations supply medicines to certain markets on a permanent basis, do not infringe the freedom to conduct a business;
- guaranteeing the viability of the costs generated for healthcare systems by the use of transferable data exclusivity for priority antimicrobials;
- a guarantee that the provisions relating to environmental risk assessment have no impact on the availability of medicines.
Several countries (Croatia, Finland, France, Germany, Ireland, Luxembourg, Malta, Romania and Slovenia) have called (https://aeur.eu/f/elw ) for a revision of the regulations on medical devices and in vitro diagnostic medical devices. Voluntary cooperation between Member States on group purchasing of medicines has been requested by Cyprus, Croatia, Denmark, Greece and Latvia (https://aeur.eu/f/elx ). (Original version in French by Lionel Changeur)