The governing body has launched a European Voluntary Solidarity Mechanism, will create a union list of critical medicines, and has announced regulatory flexibilities
The European Commission has detailed measures to tackle medicine shortages and enhance supply security. (Credit: EmDee/Wikimedia Commons)
The European Commission (EC) has adopted a series of measures to tackle the critical shortages of medicines and bolster the security of supply in the European Union (EU).
The actions are intended to better prevent and mitigate medicine shortages in the member countries for the upcoming winter, the following one, and beyond.
To better prepare, the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA) have identified key antibiotics that can pose the risk of critical shortages ahead of the winter.
The European health agencies are taking measures to ensure the availability of these antibiotics.
The EC has launched a European Voluntary Solidarity Mechanism for medicines. It alerts a member state’s demands for a given drug to other member states for redistribution of medicines from the available stock.
A union list of critical medicines will be developed by the end of this year to assess the supply chain of selected medicines by April 2024.
The European Commission has also announced regulatory flexibilities to allow member states to use regulatory exemptions that will enable drugs to reach patients in a timely manner.
To strengthen the security of supply, the Commission is stepping up action with EU guidance on the procurement of medicines, which is expected by the start of 2024.
European Commissioner for Health and Food Safety Stella Kyriakides said: “Improving the management of critical shortages of medicines and ensuring a steady security of supply for the EU has been our priority since day one.
“We need a single market for medicines in the EU and a new approach to better tackle shortages of critical medicines.
“Today we are putting forward collective actions to work closer with the industry and help Member States improve the security of supply for the coming winter and in the long-term.”
In addition, the Commission plans to establish a Critical Medicines Alliance that will begin operations in early 2024 with the goal of stimulating and modernising the production of critical medicines with all stakeholders while also diversifying the supply.
Furthermore, Europe’s governing body will create a shared strategic plan along with member states for drug stockpiling in the first half of 2024 in order to prevent and reduce shortages.