European Commission: Steps to Ensure the Availability of Medicines
On 24 October 2023, the European Commission adopted steps to prevent drug shortages and increase the security of supply in the European Union.
Following supply disruptions in the EU lately, the Commission, with the help of other authorities and associations, has developed a set of measures to prevent critical shortages of key medicines in the future.
In preparation, the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA) have already identified the key antibiotics expected to face shortages during the winter months.
In addition, the following measures have been and are being taken:
- a voluntary solidarity mechanism allows member states to share medicines among themselves
- a Union list of critical medicines will be established to identify weak links in the supply chain
- regulatory flexibilities to ensure rapid access to medicines
- EU guidelines on drug procurement to increase security of supply
- a joint procurement of antibiotics and respiratory therapeutics on EU level for the next winter
Regulatory flexibilities for essential medicines are expected to be a key element. This is specifically aimed to accelerate the approval and introduction of alternative medicines, to increase production and approval of alternative suppliers, to temporarily extend the shelf life of products, and to allow for the redistribution of medicines between member states.
The European Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has provided further insight into how these flexibilities will be applied this winter. Competent authorities will decide on a case-by-case basis whether recommendations will be implemented.
To secure the long-term supply of medicines, the Commission plans to establish a Critical Medicines Alliance that will focus on particularly important medicines. This alliance will include measures to diversify manufacturing and modernize supply chains. It is expected to be launched early next year.
The availability of medicines worldwide requires international cooperation and partnerships, including with third countries.
Source:
EC: Press release
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