The European Commission, together with the European Medicines Agency and the heads of member states' medicines agencies (HMAs), today published the first EU list of critical medicines. Today's publication follows a commitment in the Commission's Communication on tackling drug shortages in the EU to accelerate work on this list, originally announced in the EU's pharmaceutical reform proposal. An important part of the EU's work under the European Health Union is to ensure that patients get the medicines they need by increasing security of supply of critical medicines and preventing shortages. It is also part of the EU's efforts to increase our resilience and strategic autonomy in the face of unexpected geopolitical challenges.
There is the first EU list of critical medicinal products
Published Dec. 12, 2023 12:46
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Medicines listed as critical are those that are essential to ensure the provision and continuity of quality healthcare and guarantee a high level of public health protection in Europe. This first EU list of critical medicines contains more than 200 active substances used in human medicines deemed essential in the EU/EEA.
Drug on the list. What does it mean?
Inclusion on the list does not mean that there may be shortages of a particular drug in the near future. Instead, it means that preventing shortages of these specific drugs is very important, as their unavailability can cause serious harm to patients and pose a huge challenge to health systems.
The list was developed together with the EMA and all EU member states. It is based on a rigorous criticality assessment method initially developed during the Commission's structured dialogue on the safety of the drug supply launched as part of the Pharmaceutical Strategy, which took place in 2021 and allowed lessons to be learned from the COVID-19 pandemic. Key stakeholder groups, including patient and health professional organizations and industry associations, were consulted.
Ensuring the continued supply of critical medicines on the EU list is a priority for the Commission. The Commission will do everything in its power to prevent shortages in cooperation with Member States and relevant stakeholders, including introducing additional measures if necessary.
What's next?
The EU's list of critical medicines will be reviewed annually. As announced in the Communication on tackling drug shortages in the EU, the Commission, using a phased approach, will use the critical medicines list to speed up analysis of weaknesses in the supply chains of the critical medicines included.
On this basis, the Commission and EMA, together with the Member States (through the Executive Steering Group on Shortages and Safety of Medicines), can recommend solutions to address these weaknesses. Where appropriate, this will be done in consultation with the Critical Medicines Alliance, which is expected to be established in early 2024.
Source: EC
