The European Medicines Agency (EMA) has published a solidarity mechanism and toolkit to address critical medicine shortages within the EU.
The two new documents will enable Member States facing critical shortages to aid each other in obtaining medicine stock.
Developed by the EMA Medicines Shortages Steering Group (MSSG), the solidarity mechanism, which is based on an informal setup during COVID-19, will complement a number of actions that the MSSG carries out to address shortages in the EU.
Developed as a last resort following member states exhausting all options, the solidarity mechanism can be submitted under five very limiting conditions that must be met.
The conditions include the lack of or insufficient amounts of therapeutic alternatives available in the Member States, as well as stockouts within one month or less.
Published as part of the MSSG Toolkit on recommendations on tackling shortages of medicinal products, the toolkit includes suggestions for monitoring supply and demand, as well as guidance on interactions with marketing authorisation holders and manufacturers that influence stock and regulatory responsibilities.
The guidance on stock increase and redistribution and the implementation of regulatory flexibilities includes the exceptional supply of specific medicines that may not be authorised for use in certain Member States, or full or partial exemptions to certain labelling to protect the EU from future shortages.
Stella Kyriakides, European commissioner for health and food safety, said: “In a strong European Health Union, it is unthinkable that patients are left without the medicines they need.
“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.”
Previously, in the autumn and winter seasons of 2022 to 2023, the monitoring supply and demand approach was used to combat the widespread critical shortages of antibiotics, which influenced coordinated action, including a revision of pharmaceutical laws and the outlining of new measures to address supply challenges, to make EU medicine supply chains more resilient.