Strengthening Europe’s pharmaceutical sovereignty.

Across the European Union, 2023 and 2024 saw record levels of medicine shortages reported, with 136 medicines running critically short across Member States. From antibiotics and cancer therapies to cardiovascular medicines and basic hospital treatments, shortages have increasingly become a direct threat to patients, healthcare systems, and public trust. The COVID-19 pandemic exposed the fragility of global supply chains, but the challenges did not disappear when the pandemic ended. Instead, they evolved into a structural vulnerability for Europe.

At the same time,

The European Union has become dangerously overdependent on imports of active pharmaceutical ingredients (APIs) and key medicinal components from third countries, especially India and China. Today, a significant share of the medicines used by European citizens relies on supply chains located far outside Europe.

This dependency creates serious risks for the Union’s strategic autonomy, particularly in a world shaped by growing geopolitical instability, trade tensions, and increasing global competition.

The new geopolitical reality makes it clear that Europe must strengthen its competitiveness and resilience in the pharmaceutical sector, which is undeniably a strategic sector for the Union. This has also been strongly underlined in the Draghi Report, which emphasized the urgent need for Europe to invest in industrial capacity, innovation, and strategic sectors capable of safeguarding European security and competitiveness. Pharmaceutical production and medicine security must therefore become central pillars of Europe’s industrial and health policy.

This is precisely why the Critical Medicines Act represents a historic step forward.

After we concluded political work on the broader pharmaceutical legislation at the end of last year, we were also able to deliver on the Critical Medicines Act. A historic agreement was reached after 13 hours of intense negotiations, just minutes before 6 a.m. on Tuesday, 12 May. The agreement demonstrates that when Europe faces strategic challenges, it can act decisively and with unity.

As Rapporteur of the European Parliament, I worked to ensure that the Critical Medicines Act becomes much more than a symbolic response to shortages. It is a concrete and ambitious instrument designed to address shortages, ensure the availability and accessibility of medicinal products, strengthen Europe’s production capacities, and boost the competitiveness of the EU pharmaceutical sector.

The Critical Medicines Act introduces a new strategic approach to pharmaceutical manufacturing in Europe. According to the new rules, building pharmaceutical factories and modernising existing capacities will be treated as strategic projects. This is a major shift in European industrial policy. Strategic projects will benefit from streamlined procedures, including faster permitting and licensing procedures, easier access to EU financing, and enhanced administrative and technical support.

For too long, pharmaceutical investment in Europe has been slowed by excessive bureaucracy and fragmented national procedures. Meanwhile, competing global economies have been investing aggressively in domestic pharmaceutical production. Europe cannot afford to lose further ground in such a critical sector.

That is why the Act creates the conditions for more investment in European pharmaceutical manufacturing. More EU funding will be available for projects that contribute to strengthening Europe’s security of supply and reducing strategic dependencies. 

However, strengthening Europe’s pharmaceutical sovereignty is not only about production capacity. It is also about how public authorities purchase medicines.

One of the most important achievements of the Critical Medicines Act is the reform of public procurement rules for critical medicinal products and their active substances. Until now, procurement procedures were often driven almost exclusively by the lowest price. This approach may have reduced costs in the short term, but it also contributed to the relocation of production outside Europe and increased dependency on third countries.

The new rules change this fundamentally.

For medicinal products where Europe is highly dependent on third countries, preference should be given to production based in the European Union. Price will no longer be the sole or dominant criterion in public procurement. Instead, contracting authorities will be able to favour suppliers of critical medicinal products and their active substances manufactured in the Union by applying a scoring system that proportionately rewards the share of manufacturing taking place within the EU.

In this context, contracting authorities may allocate additional points to manufacturers that offer 50% or more of the medicinal products and their active substances manufactured in the Union. This creates a powerful incentive for companies to invest in European production capacities and supply chains.

This is not about protectionism. It is about resilience, reliability, and security of supply. Europe cannot continue outsourcing the production of critical medicines while expecting guaranteed access during crises. Strategic autonomy in healthcare is no longer optional but a necessity.

The same principles will also apply to collaborative procurement conducted by the European Commission on behalf of Member States. By coordinating procurement at the European level and prioritising secure and diversified supply chains, the Union can better protect patients and healthcare systems across all Member States.

Europe has recognised that medicine security is inseparable from strategic sovereignty. We cannot allow shortages of critical medicines to become the new normal. We cannot remain dependent on fragile external supply chains for products that are essential for the health and safety of our citizens.

The Critical Medicines Act provides Europe with the tools to change this reality. It strengthens resilience, supports European production, modernises procurement rules, and reinforces Europe’s competitiveness in one of the world’s most important strategic industries.

Our objective is simple but ambitious: to build a resilient, competitive, and self-sufficient European Union when it comes to medicines. European patients deserve secure access to the medicines they need, produced through supply chains that Europe can rely on even in times of crisis.

This is what pharmaceutical sovereignty means. And this is what the Critical Medicines Act is designed to achieve.