A new solidarity mechanism that allows EU Member States to support each other in obtaining medicine stocks during a critical medicine shortage has been developed by the European Medicines Agency (EMA) Medicines Shortages Steering Group (MSSG).
The voluntary solidarity mechanism, which is based on an informal setup during Covid-19, will enable any Member State that is facing a critical shortage and has already notified the EMA to request assistance from other Member States, which will then be able to support by redistributing medicines from its own available stock.
To be used under very limited conditions, the mechanism has been developed as a last resort for Member States after they have exhausted all other possibilities such as therapeutic alternatives.
An MSSG Toolkit has also been released, which includes recommendations for monitoring supply and demand such as controlling distribution by optimising and rationing existing stocks and ensuring that patients with the highest need get treatment first.
The toolkit also covers guidance on interactions with marketing authorisation holders and manufacturers to increase and redistribute existing stocks and the implementation of regulatory flexibilities, such as the exceptional supply of certain medicines that may not be authorised in a particular EU Member State, or full or partial exemptions to certain labelling and packaging requirements for medicines.
The solidarity mechanism and MSSG Toolkit form part of a wider European Commission (EC) initiative to protect Europe against medicines shortages this winter and in the future through a set of coordinated actions.
Immediate and short-term actions include the creation of a Union list of critical medicines, which will be available by the end of 2023, guidance on procurement and further regulatory flexibilities to follow in 2024.
A Critical Medicines Alliance will be operational in early 2024 and will coordinate mid-term and long-term measures, the EC said.
Margaritis Schinas, the EC’s vice-president for promoting our European way of life, said: ‘The Covid-19 pandemic and the Russian military aggression against Ukraine exposed Europe’s supply chains dependencies and the risk that economic dependency could be weaponised. Ensuring the availability of medicines within the EU is fundamental to building a strong European Health Union.’
Stella Kyriakides, EC commissioner for health and food safety, added: ‘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… 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.’