Critical medications in cardiology: strategic policy of the European Medicines Agency

Drug shortages substantially affect healthcare systems. In December 2023, the European Commission (EU) released its first list of critical medicines with the purpose of ensuring the security of supply and availability of critical medicines at the EU level. The list of critical medicines was revised last year by Member States and key stakeholders, including the European Society of Cardiology (ESC), and a new version of this list was published on 16 December 2025. In a world facing numerous political, economic, and social challenges, where conflicts escalate and events such as pandemics threaten global logistics, ensuring access to medicines is among the most pressing issues. Drug shortages, which frequently and persistently affect healthcare systems, pose substantial financial, logistical, and ethical challenges.1 The main contributing factors to drug shortages have regulatory, manufacturing, and quality-related, as well as economic and supply chain-related, origins.2 It is not feasible to provide access to ‘everything for everyone’, in case of major global crisis, necessitating the definition of a list of critical medicines. These medicines should remain accessible to patients regardless of economic or political instability or global pandemic. The inherent limitation of such a list, by definition, excludes many therapeutic options. Consequently, the decisions surrounding its composition inevitably raise concerns of a medical, ethical, and economic nature. Nevertheless, experts affiliated with scientific societies have a responsibility to provide informed opinions on this matter. In December 2023, the European Commission released its first Union List of critical medicines, encompassing over 240 active substances for human use.3 This list marked a significant step towards ensuring supply security and preventing shortages of critical medicines, an issue highlighted during recent years, particularly in times of crisis. The selection criteria for inclusion were multifaceted, with medicines considered critical if used for serious diseases and lacking easily replaceable alternatives in the event of shortages (Figure 1). Additional criteria included clinical importance in at least one-third of EU/European Economic Area Member States. European Medicines Agency methodology used to identify critical medicines for the ‘Union List of critical medicines’ (taken from EMA/432940/2023 Reference #3) Criterion 1: High risk: indications with very serious implications for the health of individual patients or public health. Medicines used to treat patients with general life-threatening acute conditions, specific life-threatening acute conditions, or irreversibly progressive conditions Medium risk: indications with serious implications for the health of individual patients or public health Low risk: other indications Criterion 2: High risk. (a) Quantitative classification: no appropriate alternative is available, OR only one appropriate alternative (product) on ATC Level 4 or 5 (same active substance or alternative is within the same ATC Level 4 group or in another ATC Level 4 group) is available. (b) Qualitative classification: treatments for which no appropriate alternative treatment exists or is available, or switching to the alternative treatment would require extensive clinical consultations not applicable for specific indications; substitution of treatment is expected to affect patient safety or disease prognosis. Medium risk. (a) Quantitative classification: at least two appropriate alternatives/products on ATC Level 4 or 5 (same active substance or alternative is within the same ATC Level 4 group) are available. (b) Qualitative classification: treatments for which alternative treatment requires additional input from medical personnel but is not expected to affect patient safety or disease prognosis, or the availability of alternative treatment may be limited. Low risk. (a) Quantitative classification: more than two appropriate alternatives/products are available on ATC Level 4 or 5. (b) Qualitative classification: treatments for which alternative treatment exists, or the availability of alternative treatment is manageable. Products can freely be substituted, and little or no input from medical personnel is required. Anatomical Therapeutic Chemical. Between February and September 2024, during the revision of first version of the list, Member States and key stakeholders, including the ESC, reviewed approximately 1500 active substances that met these criteria. This review aimed to identify additional substances for inclusion in the updated list. The ESC, along with its Working Groups and Associations, contributed significantly to this process. Under the leadership of the Working Group on Cardiovascular Pharmacotherapy and the Regulatory Affairs Committee, the ESC developed a working list of critical medicines for cardiovascular diseases. The primary criterion for inclusion was the class of recommendation in ESC guidelines. Medicines with Class I indications, signifying high therapeutic or clinical importance, were prioritized, while those with Class II indications were generally not considered critical. The adopted methodology, emphasizing Class I and select Class IIa indications, ensured the inclusion of most—but not all—therapeutically critical cardiovascular drugs. Additional medicines proposed by ESC constituent bodies, typically falling within Class I or Class IIa indications, were also included due to their therapeutic significance. This approach reflects the ESC’s mission to prioritize therapeutic indications over availability of alternatives. However, as the concept of ‘clinical alternatives’ is less rigorously defined than Class I/IIa guideline indications, some at-risk medicines may have been labelled critical based on a more sensitive rather than specific approach to Criterion 2 (availability of alternatives). To address the limitation of excluding drugs or interventions outside ESC guidelines, such as anaesthetic agents or cardioplegia solutions, the ESC also included selected products from overlapping clinical specialties, such as anaesthesiology, intensive care, cardiac surgery, and radiology (e.g. propofol) that were deemed clinically important for practicing cardiologists. Consequently, the list is inherently incomplete and represents a ‘work in progress’. The initial Union List specified critical drugs rather than drug classes. However, the ESC emphasized that criticality should extend to therapeutic classes/groups rather than specific drugs. Availability of entire therapeutic groups is crucial for maintaining care continuity. Recognizing the evolving nature of critical medicine needs, the Union List was updated and expanded in December 2024, with revisions planned annually. The European Medicines Agency, in collaboration with National Competent Authorities and Ministries of Health, finalized the second version on 16 December 2024.4 The ESC and its constituent bodies will review it accordingly and will continue to play an essential role in creating and updating this list. D.D. obtained honoraria for educational lectures from Daiichi Sankyo, outside this work. J.T. received honoraria for educational lectures from Menarini CentroAmerica, outside this work. P.S. reports honoraria from GE, Novartis, and Samsung, outside this work. D.D. is chair of the ESC Working Group on Cardiovascular Pharmacotherapy, and J.T. and P.S. are members of the ESC Regulatory Affairs Committee, which is chaired by P.S. The authors research was supported by grants from the Deutsche Forschungsgemeinschaft (Research Training Group 2989, project 517043330 to D.D.), the National Institutes of Health (RO1HL131517, RO1HL136389, RO1HL163277, RO1HL160992, RO1HL165704, RO1HL164838, and RO1HL176651 to D.D.), and the European Union (large-scale network project MAESTRIA no. 965286 to D.D.).

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