On 17 September 2025 the European Court of Auditors (ECA) published a report on critical medicine shortages (the Report – see, attachment) which some press reports labelled as “alarming” or featuring “stinging” criticism, but which could just as well be categorised as alarmist, futile, and ill-timed.

The ECA’s principal task is to control the accounts of all revenue and expenditure of the European Union and, subject to exceptions, of all bodies, offices, and agencies established by the European Union (Article 287, §1 of the Treaty on the Functioning of the European Union (TFEU)). Additionally, the ECA may also prepare “special reports” on “specific questions” (Article 287, §4, TFEU), a competence which, as the Report shows, the ECA interprets as going far beyond the realm of financial scrutiny.

The ECA’s stated and threefold goal was to inquire whether the European Commission (Commission) and the European Medicines Agency (EMA) had

1. established an effective framework to prevent and mitigate critical shortages;
2. identified and addressed the root causes of shortages generally; and
3. addressed market barriers to ensure a functioning single market for medicines.

The ECA defined a critical shortage as a situation in which a medicine is not available; for which no appropriate alternative is available at national level; and for which coordinated action at EU level is required to address the shortage.

Given the ECA’s study design, especially the question whether the Commission managed to achieve the holy grail of the single market in medicines, the predictable outcome was a finding of failure. Specifically, the ECA reached the conclusion that

1. the EU system to prevent and mitigate critical shortages lacks an adequate regulatory framework and also faces practical challenges (Report, p. 14 and following);
2. the Commission identified the root causes of shortages but is facing major challenges addressing them (Report, p. 28 and following); and
3. the market for medicines is fragmented (Report, p. 39).

The Report does not contain any new facts or analysis. While there is a broad consensus that shortages are a reality and have to be addressed, the solutions are, like their causes, multifactorial and have to be implemented at different levels of government, not just those of the Commission and the EMA. Moreover, both critical shortages and shortages of critical medicines are rare and get solved. In addition, and as the Report acknowledges, both the Commission and the EMA have taken several important regulatory initiatives to tackle shortages but the critical pieces of the new regulatory edifice, the pharmaceutical package and the draft Critical Medicines Act, are still under review by the European Parliament and the EU Member States. Above all, while a true Single Market for medicines would certainly have its place in an ideal world, this is a pipedream. As is again apparent from the Report (at p. 45), the Commission sought to expand the transparency rules governing the pricing and reimbursement of medicines but faced a rejection of its proposal by the Member States. While this refusal may be regarded as regrettable, it would seem a justified manifestation of the budgetary sovereignty of the Member States. Similarly, it is not by coincidence that public health is one of the exceptions to the free movement of goods provided for by Article 36, TFEU. All of this suggests that a balance is needed and being looked for. Moreover, some time will be required to see if and how the recent and incipient rules will deliver.