Auditors say the EU must strengthen its response to critical medicine shortages

In a special report, published today (17 September), the European Court of Auditors (ECA) warns that critical medicine shortages continue to arise, posing a threat to health across the EU.

“Medicine shortages can have severe consequences for patients, compromise public health and come at a high cost for doctors, pharmacies and countries alike,” said ECA auditor Klaus Heiner Lehne. “The EU needs an effective remedy to cure critical shortages and must tackle them at their roots, also as a matter of European strategic autonomy.”

This is hardly news to either the Commission or the European Medicines Agency (EMA). The EU institutions are currently locked in negotiations for a revision of the general pharmaceutical legislation (GPL), introduced in 2023, which includes measures to address shortages. Likewise, the Critical Medicines Act, published in March of this year, is aimed at securing the production and supply of critical medicines within the EU.

The special report involved an examination of the work of the EMA and the European Commission up until October 2024. Apart from only partly taking account of proposed legislation, its recommendations sometimes take little account of EMA’s work in pre-empting and mitigating shortages.

A survey of national competent authorities (NCAs) found that EMA’s support on shortages was of “significant added value”. Although many of its actions are currently voluntary, they have had a significant impact, reducing shortages and securing commitments from manufacturers to increase their capacity. What is remarkable is what it has achieved without yet having a firmer legal basis, including the launch of its shortages monitoring platform in January.

The ECA auditors make little acknowledgement of the extensive groundwork that has taken place in anticipation of the new legal provisions in the revised GPL and notable successes.

While both the European Commission and EMA take on board many of the recommendations, they defend their progress to date and point to some of the limitations they face.

In the week when the EU marks the anniversary of the Draghi report, it is worth noting that some of the complaints about the fragmented nature of the single market in medicines are shared, but not easily resolved. Healthcare is a substantial portion of national spending in all countries, and how prices are determined remains closely guarded.

Pricing and reimbursement of medicines, as a notable example, undoubtedly affect supply and can result in parallel trading, where drugs destined for one country can be diverted to a country where the medicine is more expensive. The ECA makes some useful recommendations on addressing barriers, such as on consistency of names and packaging. Still, the real difference may come through greater joint procurement and cooperation on stockpiling, something that is included in the Commission’s recent proposals.