On Thursday 26 June, the European Parliament’s Committee on Public Health asked the European Commission to provide more funding to implement legislation on critical medicines (see EUROPE 13664/3).
The question of emergency stocks and the modalities of joint (collaborative, according to the proposal) procurement tools for critical medicines are among the other issues raised by MEPs as they begin negotiations on this text.
The draft report by Tomislav Sokol (EPP, Croatian) on critical medicines will be presented in September.
Sandra Gallina, director general at DG Health and Food Safety (DG SANTE), said that the European Commission would be producing two types of guidelines: one on contingency stocks of medicines, and the other on public procurement. She pointed out that the Commission had already published guidelines on State aid.
Ms Gallina clarified that, as part of the pharmaceutical reform, there are rules imposing emergency stocks at European Union level. These rules may apply to finished products or active substances, and are binding on certain players in the supply chain. This mechanism should make it possible to support a so-called “rotating” stock, i.e. a system that avoids the problems generally associated with storage.
Ms Gallina explained that the proposal on critical medicines obliges EU Member States to apply measures reinforcing the security of supply, in order to avoid repercussions on other Member States.
The EU4Health programme has a budget of €83 million over two years. In response to questions from MEPs, Ms Gallina pointed out that opportunities also exist via the ‘Strategic Technologies for Europe Platform’ (STEP) and the Horizon Europe programme. She declined to discuss funding after 2027 due to the upcoming debates on the next Multiannual Financial Framework (MFF).
Regarding public procurement, the Commission proposed considering criteria other than price. However, competence in this area rests with the Member States, Ms Gallina pointed out, adding that the latter take production facilities into account more than prices. The proposal does, nevertheless, include an element of coordination. There is also a link with the pharmaceutical package (see EUROPE 13653/10).
Tomislav Sokol felt that the rules on joint procurement for critical medicines would be particularly useful for smaller Member States and for the most critical medicines (especially those used to treat rare diseases). He also suggested including a guarantee of certain volumes in the contracts. According to Mr Sokol, we need to focus on criteria other than price in public procurement, and support players who invest in Europe. He also felt that the issue of stocks was not sufficiently developed in the current text.
Laurent Castillo (EPP, French) deplored the lack of a “pre-purchase” mechanism for innovative medicines, as well as the absence of a real-time stock monitoring mechanism.
Aurelijus Veryga (ECR, Lithuanian) welcomed the idea of common public procurement markets. (Original version in French by Lionel Changeur)