On Tuesday 2 December in Brussels, the European health ministers reached a ‘General approach’ concerning the proposal for a regulation on the availability and security of supply of critical medicinal products (see EUROPE 13760/17).
The European Parliament is expected to adopt its position in early 2026.
The EU Council’s position includes provisions for a European preference. For example, in public procurement procedures relating to critical medicinal products for which a vulnerability has been identified in the supply chains - i.e. when an assessment has revealed a high level of dependence on a single country or a limited number of countries outside the EU - contracting authorities are encouraged to favour critical medicinal products, or their active substances, manufactured in the EU and making it possible to remedy the vulnerability and dependence identified.
The Czech Republic considered the text not ambitious enough, particularly in terms of European preference for the production of medicines, and expressed hope for progress during the trilogue negotiations with the European Parliament.
For the French delegation, introducing mandatory European preference for products with a high dependency on third countries is “a first step” but remains “insufficient” to guarantee a truly resilient European industry. France lamented the risk of fragmented practices.
Contingency stocks. The text also provides that, when requiring marketing authorisation holders and other operators in the supply chain to hold stocks in order to ensure the security of supply of critical medicinal products on their territory - or when amending existing requirements - Member States shall endeavour to avoid such obligations, in whatever form, having a negative impact on the security of supply in other Member States. They must ensure that any requirement to build up contingency stocks, including their size or the timeline for their establishment, remains proportionate and respects the principles of transparency and solidarity.
Italy and other countries, such as the Czech Republic, have warned of the possible negative effects of contingency stocks, including shortages of medicines.
Lithuania supports the text, but would have preferred to retain the option of jointly procuring critical medicinal products with the European Commission (see EUROPE 13760/17).
Furthermore, Belgium has indicated that it will abstain from the vote, believing that the text has been weakened rather than strengthened compared to the European Commission’s proposal.
European Commissioner for Health and Animal Welfare Olivér Várhelyi said he was “delighted” that the EU Council had reached a common position on this text. “The central principles of our proposal have been retained”, he also pointed out. He welcomed the fact that the EU Council’s position respects the initial proposal concerning European preference. He expressed hope that the Cypriot Presidency of the EU Council (from 1 January to 30 June 2026) would quickly reach a final agreement on critical medicinal products.
Link to the EU Council’s position: https://aeur.eu/f/jsz (Original version in French by Lionel Changeur)