On Friday 20 June in Luxembourg, European health ministers supported the objectives of the proposed legislative act on critical medicines, but were divided on the financing arrangements for strategic projects involving these medicines and on the creation of collaborative procurement procedures between Member States (see EUROPE 13654/12).
The proposal also provides for public procurement procedures to encourage the resilience of critical medicines supply chains, and the possibility of forming international partnerships with like-minded countries and regions to broaden the supply chain and reduce dependency on single suppliers.
Collaborative purchasing. For the German minister, Nina Warken, the provisions on collaborative purchasing could help to resolve access problems in the EU in the long term, “provided that this is done on a voluntary basis, as set out in the proposal”. The Critical Medicine Act proposes a concept for strengthening resilience and transition in calls for tenders with third-country suppliers. “But we still see a need for clarification in order to guarantee legally secure implementation”, stressed Germany.
“It is important to us that no additional bureaucracy is created”. This is why Germany is critical of the introduction of “no less than three different collaborative purchasing procedures”.
The use of group purchases of critical medicines and medicines of common interest “will also facilitate access to treatment for all citizens of the European Union”, according to the French minister, Yannick Neuder.
Italy reiterated its reservations about collaborative public procurement. “There is a risk of reducing the negotiating capacity of States that do not adhere to this approach, with negative effects on public spending on medicines”, said Orazio Schillaci.
Ireland welcomed “the new legislative commitment to strengthen international cooperation and strategic partnerships”.
Financing. As far as financing is concerned, Germany believes it is important that it be provided from the existing envelopes of the 2021-2027 Multiannual Financial Framework. For this country, the financing of medicines by the EU seems problematic. The German minister, supported by several delegations, felt that Member States’ financial responsibility for regular healthcare should be preserved.
In Belgium’s view, “we need to guarantee sufficient financial resources, ideally at European level, to support the production of medicines for which there are vulnerabilities” that have been demonstrated.
Spain also argued for the majority of the funds to come from the EU budget, to avoid asymmetries between Member States. “The revision of the next Multiannual Financial Framework must make it possible to put in place a genuine European framework for funding health, which goes beyond health security alone and also incorporates innovation, territorial equity and industrial leadership”, said Mónica García, the Spanish minister.
As far as State aid is concerned, the draft regulation confines itself to encouraging Member States to prioritise funding, without however providing an operational framework for implementation, as France and Belgium in particular regretted.
Incentives. Germany deplored the fact that the proposal did not take sufficient account of the strategic importance of the sector of critical medicines, most of which are generic. “We need incentives to create production capacity for these critical medicines in the EU. The scope of medicines of common interest should be better adapted to the needs of the Member States and specified in concrete terms”, explained the German minister. According to Germany, duplication of critical medicine stockpiling at EU level must be avoided and “we need common principles for stockpiling”.
According to the Belgian minister, Frank Vandenbroucke, stockholding obligations in calls for tenders must be clearly defined to avoid any distortion of the market.
According to France, the measures relating to financial incentives “fall short of the needs identified to support the strengthening of production capacities”. The text does not introduce any new concrete tools.
France suggested launching a study to better qualify the distortions of environmental and social competition between Europe and third countries and to create a more favourable framework for taking certain environmental criteria into account in public procurement.
Finally, Germany asked the European Commission to simplify the law applicable to medical devices. It asked the Commission to present a legislative proposal as soon as possible. (Original version in French by Lionel Changeur)