The key goal of the actions set out in Communication on addressing medicine shortages in the EU (available at commission.europa.eu), are to prevent and mitigate critical shortages at the EU level. The Commission says that “recent critical shortages, including  certain antibiotics last winter, show that continued coordinated action is needed to address supply challenges and to make Europe’s medicine supply chains more resilient in the long run”. It puts a particular focus on the most critical medicines, for which the Commission says, “security of supply in the EU must be ensured at all times”.

This Communication builds on work under the European Health Union, notably the reinforced mandate of the European Medicines Agency and the upcoming proposed EU pharmaceutical legislation reform. It follows a strong call by Member States at the 2023 June European Council, confirmed in Granada in October 2023, and from the European Parliament.

 

Mitigating critical shortages this winter and beyond

To better prepare for this winter, a number of measures have already been taken. This includes work undertaken by the European Health Emergency Preparedness and Response Authority (HERA) and the European Medicines Agency (EMA) to identify key antibiotics (including specific paediatric formulations), for which they anticipate the risk of critical shortages ahead of the winter months. Measures have been put in place to ensure the availability of these antibiotics for patients. Further actions  include:

 

• The launch of a European Voluntary Solidarity Mechanism for medicines (October 2023): the mechanism flags a Member State’s needs for a given medicine to other Member States, thus facilitating a response from other member states  to encourage redistributing medicines from their available stock;

 

• A Union list of critical medicines (available by the end of 2023): once established, this list will be the first step to analyse the supply chain of selected medicines by April 2024. This analysis will then show where additional measures are needed;

 

• Regulatory flexibilities: Member States can use regulatory exemptions to allow medicines to reach patients in a timely manner, including extending shelf-life or the quick authorisation of alternatives. There will be a dedicated Joint Action in 2024 to promote effective use of these flexibilities;

 

• EU guidance on procurement of medicines to strengthen security of supply issued by the Commission by early 2024; and

 

• EU joint procurement for next winter for antibiotics and treatments for respiratory viruses.

 

Critical Medicines Alliance

The Commission also intends to set up a Critical Medicines Alliance to be operational in early 2024. The Critical Medicines Alliance will add an industrial policy pillar to the European Health Union, and will allow national authorities, industry, civil society representatives, the Commission and EU agencies to coordinate action at the EU level against the shortages of medicines and to address supply chain vulnerabilities. The work of the Alliance will focus on a targeted number of critical medicines with the highest risk of shortages and impact on healthcare systems. It will draw from a varied toolbox of policy measures to mitigate risks of shortages and increase supply, including:  

• Coordinating public procurement practices at the EU level;
• Exploring how to diversify global supply chains through strategic partnerships;
• Boosting Europe’s capacity to produce and innovate in the manufacturing of critical medicines and ingredients in a coordinated way;
• Developing a common strategic approach to medicines stockpiling in the EU; and
• Helping leverage and align EU and national funding.

 

The Commission say this could pave the way for a possible ‘Critical Medicines Act’ in the future. To that end, the Commission will launch a dedicated, preparatory study by the end of 2023, paving the way for an impact assessment.

In the first half of 2024, the Commission will also develop a common strategic approach to medicines stockpiling to prevent and mitigate shortages in cooperation with Member States.

International partnerships for supply

The Commission says, “international cooperation and the genuine integration of the global pharmaceutical industry is key to ensure the availability of medicines in the EU and across the world”. To that end, the Commission will establish a network of international partners to address supply chain resilience. Strategic partnerships with third countries for the production of critical medicines will also be set up, reflecting both local demands and needs at the EU and global level.