The EU has agreed its landmark law against drug shortages. The regulator who has to deliver it just put a number on the work ahead.
Nineteen active substances. Around 3,400 medicines that rely on them. That’s the scale of the task now facing the European Medicines Agency (EMA), which must assess each product for hidden supply-chain vulnerabilities just as the EU finalises its flagship Critical Medicines Act aimed at preventing drug shortages
The figure came from Emer Cooke, EMA’s Executive Director, in her recent final annual appearance before the European Parliament’s Public Health Committee (SANT). She outlined what it will take to turn the law into reality.
A political win
Earlier that day, the committee approved the provisional agreement reached between the European Parliament and the Council on the Critical Medicines Act. It is the EU’s answer to years of shortages of antibiotics, insulin and other essential drugs.
Its rapporteur, Croatian EPP lawmaker Tomislav Sokol, urged colleagues to back it before the vote that carried the deal, describing the law as “a win for European patients.”
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“(The Critical Medicines Act) strengthens security of supply, helps prevent shortages and reinforces solidarity between member states.”
— MEP Tomislav Sokol (EPP/HRV)
It was also, he said, “a win for Europe’s pharmaceutical industry.” The heart of the law is a shift away from buying medicines on price alone. Instead of awarding contracts purely to the cheapest supplier, the law allows governments to take supply security into account, giving an advantage to companies that manufacture in Europe.
MEP Sokol Sokol pointed in particular to generic medicines, saying Europe’s dependence on imports from China and India had grown too large. The generic industry, providing everyday drugs, is “the backbone of our health insurance systems”, he said.
The law also makes it easier for countries to buy medicines together. That matters most, Sokol said, for “patients from smaller markets, who will be able now to get medicines much faster and with a better price.” Rare disease patients were not “left behind” either, he said, because orphan medicines were written into the law.
“If I had to talk about one challenge, it would be the sheer numbers that we are talking about. The pilot’s 19 substances amount to 3,400 medicines.”
— Emer Cook, EMA’s Executive Director
The provisional deal now moves to Parliament’s plenary, where lawmakers are expected to adopt their first-reading position, possibly in November. The Council will then give its final approval before the law enters into force.
“The sheer numbers”
When Emer Cooke took the floor later that day, MEP Sokol asked her about the biggest implementation challenge and what EMA would need to make it work.
Ms Cooke said the agency had already begun preparing, running a pilot project to identify weak points in medicine supply chains for 19 active substances.
“If I had to talk about one challenge, it would be the sheer numbers that we are talking about here,” Cooke said. The pilot’s 19 substances, she explained, “amounts to 3,400 medicines”. Each of those medicines must be assessed to see whether it depends on a single supplier, whether alternative suppliers exist, and where shortages could emerge.
“Trying to evaluate those vulnerabilities is a complex matter, and it requires resources, good methodology and continuous improvement,” she said. Much of the work, she said, will be done by national authorities, while EMA develops the methodology and coordinates the overall effort using digital tools, including AI.
Why it can work
Ms Cooke had a reason for confidence, and it came from the crisis that reshaped her agency. Asked what EMA’s strengthened shortages powers, granted in 2022, had actually delivered, she reached for a hard figure.
New coordination structures, she said, helped “cut antibiotic shortages by 50%” over the 2024-2025 winter compared with the year before. EMA has also persuaded manufacturers to commit to opening new production sites in Europe, one of which is expected to begin operating this July.
According to EMA’s 2025 annual report, several new tools are now in place. A European Shortages Monitoring Platform became fully operational in January 2025, making it mandatory for companies to report shortages of centrally authorised medicines. The agency also expanded its list of critical medicines to nearly 300 active substances and used its voluntary solidarity mechanism six times last year, allowing countries to share medicine stocks whenever shortages emerged.
The next ambition, said Kristina Garuolienė, one of Parliament’s representatives on EMA’s Management Board, should be to move “from managing shortages to preventing them.”
A handover, mid-project
All of this comes as Ms Cooke prepares to step down. Her mandate ends in April 2027, closing six years that took in four public-health emergencies: COVID-19, mpox, hantavirus and now Ebola.
Whoever succeeds her inherits the unfinished work: the wider pharmaceutical package, a new role in medical devices, and a Critical Medicines Act that only takes effect once formally adopted. The law now travels to the November plenary, then back to the Council for final sign-off, while the 3,400-medicine pilot runs on in the background.
“We are truly stronger together,” Ms Cooke told the committee, one last time.
