Antibiotics, insulin and everyday painkillers have become surprisingly hard to guarantee in Europe, and lawmakers have now agreed a plan meant to keep them on pharmacy shelves.
The Critical Medicines Act, on which the Council and Parliament struck a provisional deal on 12 May 2026, tries to loosen the bloc’s heavy dependence on a handful of foreign suppliers. Negotiators built the law around a simple worry: more than half of recent critical medicines shortages traced back to manufacturing problems, and Europe makes far too few of the ingredients itself.
The numbers explain the alarm. Roughly 80 percent of the active pharmaceutical ingredients the EU imports come from just five countries, with China alone accounting for close to half. A single factory outage or export restriction can ripple through hospitals from Lisbon to Helsinki within weeks.
To shift that balance, the act pushes production closer to home. It lets governments write resilience requirements into public procurement, so buyers can reward suppliers who manufacture inside Europe rather than simply picking the cheapest bid. A flexible EU preference clause gives home-grown makers an edge, and the law makes it easier for countries to club together and buy scarce drugs jointly. The Council has published the full outline of the new rules for anyone tracking the detail.
Supporters argue the change is overdue. The pandemic and later supply shocks exposed how fragile the system had become, and industry groups have long warned that thin margins on generic medicines drove manufacturing to Asia. Building capacity at home, backers say, buys insurance against the next disruption.
Critics see costs and complications. Reshoring production could raise prices, and campaigners caution that an inward turn might squeeze supply to poorer countries that rely on the same factories. Health Policy Watch reported concerns that the act could disrupt medicine access in Africa if Europe starts hoarding capacity.
The law still has hurdles to clear. Both institutions must formally endorse the text after legal and linguistic checks, and the practical work of standing up new factories and stockpiles will take years, not months. Money remains the open question, since neither reshoring nor joint procurement comes cheap.
For patients, the promise is straightforward: fewer empty shelves and fewer frantic hunts for a substitute drug. Whether the act delivers depends on how firmly governments use their new powers and how much they are willing to pay for the security of making critical medicines closer to home.




