Led by Belgium, 19 EU countries called on Tuesday 2 May for tougher rules to tackle medicine shortages in the EU and reduce dependence on imports from China and India.
“Considering the complexity of the problems and the risks associated with them, we believe that the EU must take more drastic steps to improve the security of medicines supply”, according to a non-paper presented by countries including Belgium, France, Germany and Italy. The subject will be debated on Friday 5 May during the informal meeting of the European health ministers (see EUROPE 13173/2).
These countries advocate three areas of action:
- establishing a ‘voluntary solidarity mechanism’ within the MSSG (Executive Steering Group on Shortages and Safety of Medicinal Products) to temporarily alleviate acute shortages in Member States as a last resort;
- establishing a European list of critical medicines whose supply, production and value chains need to be monitored;
- exploring a ‘critical medicines law’ to reduce dependencies for critical medicines and ingredients (especially for products for which there are only a few supplying manufacturers or countries).
These three lines of action are aimed at the short, medium and long term and should be seen as “complementary” to the initiatives already taken (work by EMA and the MSSG) or announced (pharmaceutical legislation).
“Together, they should prevent the worst case scenarios of patients not being properly treated due to empty stocks”.
The Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), bringing together experts from the EMA, the Commission and the EU Member States, was set up in order to prevent worsening medicine shortages in the EU. However, progress in this area is insufficient in the eyes of these countries.
Link to the document: https://aeur.eu/f/6nk (Original version in French by Lionel Changeur)