Commission Proposes Critical Medicines Act to Rebuild EU Drug Supply Chains

The Commission links the proposal to repeated shortages in recent years and to vulnerabilities exposed by the COVID-19 pandemic and geopolitical tensions. Shortages, it says, can be caused by manufacturing problems, supply chain vulnerabilities or global competition for resources. The Act is described as an industrial policy toolbox that complements the pharmaceutical reform still being negotiated by the European Parliament and the Council.

What the proposal contains

• Strategic Projects: industrial projects that create, increase or modernise EU manufacturing capacity for critical medicines or their key ingredients could benefit from fast-tracked permitting, streamlined environmental assessments, administrative and scientific support, and easier access to funding. Projects receiving financial support would have to prioritise EU supply. State aid guidance was published alongside the proposal.
• Public procurement: for critical medicines, procurers would have to apply requirements other than price, such as diversified sources of input material, stockpiling or supply chain monitoring. Where there is high dependency on one or a few countries, they would, where justified, have to favour suppliers manufacturing a significant share of the product in the EU.
• Collaborative procurement: Member States could ask the Commission to support cross-border or joint procurement, on a voluntary basis.
• International partnerships with like-minded countries to broaden supply chains.

Which medicines are covered

According to the Commission's questions and answers, the Critical Medicines Act focuses mainly on medicines on the Union list of critical medicines, which ranges from antibiotics and anti-thrombotics to cancer and cardiovascular treatments. Critical medicines are those with limited or no alternatives, where a shortage would seriously harm patients. Some provisions apply only to those with specific supply chain vulnerabilities. The Act also reaches other medicines of common interest affected by market failures, such as certain medicines for rare diseases.

Who is affected and what happens next

Generic and active ingredient manufacturers considering EU capacity, hospital and national procurers, and suppliers relying on single-country sourcing are most directly affected, since tender criteria for listed medicines would change. The proposal now goes to the European Parliament and the Council under the ordinary legislative procedure.

Sources

• European Commission: Commission proposes Critical Medicines Act to bolster the supply of critical medicines in the EU
• European Commission: Questions and answers on the Critical Medicines Act