EU Takes Step To Bolster Healthcare: First Critical Medicines List Published

The Union list of critical medicines will serve as a pivotal tool in supporting the EU’s endeavors to ensure supply security and prevent shortages of vital medicines.

EU Takes Step To Bolster Healthcare: First Critical Medicines List Published

The European Union (EU) and its member states, working with the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), have published the first edition of the Union list of critical medicines. This is a major step towards protecting healthcare systems throughout the EU and EEA.

This comprehensive list encompasses over 200 active substances of medicines for human use deemed critical for healthcare systems, where continuity of supply is a top priority, and shortages must be avoided.

The Union list of critical medicines will serve as a pivotal tool in supporting the EU’s endeavors to ensure supply security and prevent shortages of vital medicines.

It is important to note that inclusion in the list does not necessarily imply an imminent shortage; rather, it signifies that the medicine is crucial, and the prevention of shortages is of paramount importance due to potential harm to patients and challenges posed to health systems.

Medicines are categorized as critical if they are used in treating serious diseases and cannot be easily substituted by other drugs.

The list spans active substances across diverse therapeutic areas, including vaccines and medications for rare diseases. It reflects the outcome of a meticulous review of 600 active substances derived from six national lists of critical medicines. The Union list is set to expand in 2024 and will undergo annual updates thereafter.

The extensive review process involved collaboration with all EU Member States, with criticality assessments based on a methodology developed in consultation with key stakeholders, including patient and healthcare professional organizations, as well as industry associations.

Importantly, medicines featured on the Union list can continue to be prescribed and used by patients and healthcare professionals as usual. However, additional reporting requirements for marketing authorization holders and national competent authorities will be established once the proposed pharmaceutical legislation becomes applicable.

The publication of the Union list will not impact existing or future national lists of critical medicines. Instead, it will bolster efforts in drafting national lists where they do not currently exist. Furthermore, it will support and expedite the EC’s analysis of the supply chain for critical medicines to identify potential vulnerabilities, aligning with the EC’s communication of October 24.

The EC and EMA’s Medicines Shortages Steering Group (MSSG) may propose measures to address vulnerabilities in the supply of these critical medicines, ultimately aiming to prevent and mitigate shortages.

This Union list of critical medicines complements other measures initiated by the EMA/HMA taskforce on the availability of authorized medicines, including good practices for industry and stakeholders, a solidarity mechanism, a toolkit, and recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections.

The publication of the Union list marks a significant stride towards ensuring the resilience and security of medicine supplies in the EU/EEA, underscoring the commitment to protect public health and maintain the availability of critical treatments. The collaborative approach involving various stakeholders demonstrates a robust framework for addressing challenges and fortifying the region’s healthcare infrastructure against potential disruptions.