On Tuesday 13 June, in Luxembourg, the health ministers of the EU countries showed their differing sensibilities regarding the 26 April proposals for the reform of pharmaceutical legislation.
Many called for a balance to be struck between access to medicines for all Member States and maintaining a strong pharmaceutical industry.
Ministers from several countries (including Poland, Bulgaria, Romania, Hungary and the Baltic States) have called for generic medicines to be introduced onto the market more quickly (see EUROPE 13170/2).
While some countries welcomed the modulation of incentives (protection of clinical data provided for in the proposal), others were concerned, including Germany, Ireland, Denmark and the Netherlands.
Ireland emphasised access to innovative new medicines, affordability and the industry’s competitiveness. According to Ireland, incentives must respond to unmet needs.
Germany, like others including Ireland, Denmark and the Netherlands, has defended a competitive pharmaceutical industry in Europe, particularly in the face of China and India.
France “supports the Commission’s approach”. However, “further work needs to be done on the impact of data protection modulation measures”, according to the French delegation. France has called for a rapid conclusion to the European list of critical medicines. France expressed concern at the fact that the proposed modulation of the data protection duration would only apply to a third of new medicines.
Italy has recommended reviewing the remit of the European Medicines Agency.
In particular, the Czech Republic has asked us to consider the issue of pricing.
The Council of the EU must wait until the pharmaceutical package has been translated into several languages before it can formally begin negotiations at a technical level.
“The reform is a balanced response aimed at supporting patients and our healthcare systems and creating a single market for medicines in the EU”, summarised Stella Kyriakides, the Health Commissioner. (Original version in French by Lionel Changeur)