Europe focuses on own production of medicines

Strasburgo – The European Commission adopted a proposal for a new Critical Medicines Act (CMA) and presented the draft Act in plenary today, followed by a debate with MEPs.

The CMA is meant to address severe medicines shortages and medical device shortages, and reduce external reliance on critical medicines and ingredients, as well as ensure the supply of affordable medicines. On 25 February, the Alliance for Critical Medicines published its recommendations to strengthen the security of supply of medicines in the European Union.

The Critical Medicines Act aims to improve access to the list of 270 essential medicines, to fill shortages and to strengthen the autonomy of the European Union in this sector. A second objective of the Act is to address supply chain vulnerabilities, reduce the European Union’s dependence on Asian producers of medicines and raw materials in order to strengthen the supply of critical medicines and improve access to all other medicines.

“An extremely worrying shortage of critical medicines has been on the rise across the EU for many years now. The situation is urgent: in Europe, there is a lack of vital medicines, products like insulin, antibiotics and painkillers, for example,” warned Tomislav Sokol MEP (EPP, Croatian) ahead of today’s Commission’s proposal on the Critical Medicines Act.

“Faced with increasing global instability, the threat of trade wars and tariffs, it is beyond time to act. Our citizens cannot wait – they rely on these medicines every day. While health is primarily a national competence, we firmly believe there is much that the EU can and must do to alleviate this problem.” MEP Sokol describes the forthcoming Critical Medicines Act as “an opportunity for Europe to reinforce its pharmaceutical resilience by strengthening its pharmaceutical industry and supply chains.”

According to Sokol MEP: “Boosting European production is crucial. The EU needs to reduce its dependence on third countries for active pharmaceutical ingredients (APIs) and increase medicine production in Europe”. “The EPP Group wants to ensure fair and timely access to medicine for citizens across all Member States. Reforming EU procurement rules to prioritise the security of supply and supporting EU-funded investments in medicine manufacturing are steps in the right direction”, he concluded.

Nicolás González Casares (S&D, Spanish) welcomed the possibility of joint purchasing and said it was unfair to provide incentives to companies that innovate by producing abroad rather than those producing in the EU.

The announcement of a CMA was made last year by Ursula von der Leyen in her political guidelines and mission letter to Health Commissioner Várhelyi. In his confirmation hearing, Commissioner Várhelyi committed to launching the CMA within the new College’s first 100 days as a priority action of the new Commission mandate, and the proposal was subsequently included in 2025’s work programme.

A Critical Medicines Coordination Group would be set up, made up of representatives from the Member States and the Commission.