Europe marks key milestone in adopting Critical Medicines Act

The European Parliament has agreed proposals for the planned Critical Medicines Act, which aims to help address medicine shortages in the region, marking a key milestone in its delivery.

The plenary vote made on 20 January follows the parliament’s adoption last month of the draft Critical Medicines Act. This latest step comes after initial proposals were made by the European Commission in March 2025 for the regulation.

A key element of the recent proposals is for Europe to invest in its pharma manufacturing capacity to increase its regional autonomy.

It’s a similar direction of travel to that seen with increased domestic onshoring in the US, as put in place by the likes of major pharma companies such as Novartis and Eli Lilly, a shift largely shaped by tariff-related pressures from the US administration.

European Parliament Rapporteur Tomislav Sokol said: “We agreed today on clear priorities: the coordination of national stockpiles and contingency stocks, boosting the competitiveness of the EU’s pharmaceutical industry, and addressing shortages of medicines by ensuring their accessibility and availability for EU patients.

“We also established a clear and strong principle for public procurement: price can no longer be the sole criterion when awarding contracts for medicines. Security of supply, the resilience of production chains, and manufacturing capacity within the EU must be taken into account. This ‘Buy European’ approach ensures public procurement supports reliable suppliers, strengthens EU-based production of medicines, and contributes to long-term supply security.”

Medicines for Europe Director General Adrian van den Hoven said: “We applaud the progressive position to advance Europe’s health security with this important vote.

“We are ready to work with the co-legislators to deliver a meaningful act that will enable the off-patent medicines sector to be competitive, especially in today’s unpredictable geopolitical landscape.”

He cautioned however that the act’s goals “should not be undermined by outside factors such as the Urban Wastewater Treatment Directive that must be urgently paused”.

The EU Parliament will now begin to finalise its proposals on the Critical Medicine Act so it can be made into the law.