Critical medicines shortages remain a recurring issue across the EU, underscoring the pressing need for regulatory changes, a report by the European Court of Auditors found on Wednesday (17 September).
Between January 2022 and October 2024, some 136 medicines were reported as critically short in the EU.
While the problem is ongoing, the last two years have seen a particular peak in the bloc, according to Klaus Heiner Lehne, the auditor in charge of the report.
The reasons for the shortages are manifold.
One of them being vulnerabilities in supply chains. Most of the medicines used in the EU come from Asia.
“The pharmacy of the world is in China or India”, elaborated Lehne.
He added: “Indeed, active pharmaceutical ingredients, which are the core of any given medicine, are often manufactured by a few or even only one company. And often this company is in Asia. For common painkillers like paracetamol and ibuprofen, the EU is fully dependent on Asia.”
Health matters lie in the power of the member states. The European Medicines Agency (EMA) can act to support them only during a health crisis.
Thus, preventive measures against critical medicine shortages are taken nationally. Recent shortages have led to some countries changing their regulations for stockpiling of certain medicines which on the other hand can worsen the shortages in another EU member, the auditors reported.
One example listed in the report is the critical shortage of thrombolytics.
These are crucial for treating patients at risk of a heart attack or a stroke, either in prevention or after such an incident.
When the EMA intervened, they found that the production of thrombolytics was concentrated at a single manufacturing site. The supply shortage was only eased by the subsequent setting up of an additional manufacturing site, which took time.
The auditors recommended improving the reporting system to EMA to better coordinate and support member states demands for medicine and diversifying medicine supply chains.
Lehne concluded with a forecast for the coming winter: “There will be shortages in the winter. Here would be instruments to avoid it, we just have to use them.”
Legislative proposals by the EU Commission are currently with the European Parliament and the Council — among them the Critical Medicines Act, and its proposal for new pharmaceutical legislation.
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Hannah Kriwak is a junior reporter from Austria at EUobserver, covering European politics.
Hannah Kriwak is a junior reporter from Austria at EUobserver, covering European politics.