Resilient and secure supply of medicinal products through European and international coordination.

On 24 October, the European Commission presented a comprehensive package of measures to eliminate and prevent supply shortages of critical medicines within the European Union (EU). In view of recent shortages, particularly that of supply-critical antibiotics, the communication aims to make the supply of medicines in the EU more resilient in both normal as well as crisis times. According to the European Commission, a new approach to tackling the shortage of medicines within the EU is urgently needed. Some existing problems are being addressed as part of the pharmaceutical reform that was published in April. However, there is an urgent need to implement some of the pharmaceutical reform's proposed elements more quickly in the short term. The legislative process up to the adoption of new regulations and their subsequent implementation could take years - one cannot wait that long.

In its communication, the European Commission has outlined short- and long-term measures to eliminate bottlenecks and improve the supply reliability of medicines. In principle, it calls for a comprehensive and coordinated approach involving national authorities, industry, civil society representatives and EU agencies at national, EU and global levels, focussing on preventing or mitigating critical supply shortages, especially with regard to key medicines.

Short-term measures

• The European Commission has complied with the request from EU member states for a voluntary European solidarity mechanism for medicinal products (see News 06/2023). The mode of action introduced in October will ensure that a member state must notify other member states of its need for a particular medicinal product. They can respond by redistributing medicines from their available stocks.
   
• A Union list of critical medicinal products must also be prepared by the end of 2023. This list will be used to analyse the supply chains of selected medicinal products until April 2024 in order to derive further follow-up measures.
   
• EU member states will also benefit from the flexibility of the regulations. They should make use of exemptions to ensure that medicinal products reach patients in good time, e.g. by extending the shelf life or by speeding up the authorisation of alternative medicinal products. There will be a joint action in 2024 to promote the effective utilisation of this leeway.
   
• How medicinal products are procured will also taken into consideration. The European Commission intends to publish a revised EU guideline for procuring medicinal products to improve supply reliability by the beginning of 2024. Mutual EU procurement of antibiotics and medicinal products for combating respiratory viruses will also be examined.
   

Long-term measures

In addition to their short-term measures, the European Commission is also proposing structural long-term measures to strengthen the supply reliability of medicinal products.

This is why the European Commission plans to form an Alliance for Critical Medicines by the beginning of 2024 to promote cooperation between national authorities, industry, civil society and EU agencies. According to the European Commission, the alliance is intended to supplement the European Health Union as an industrial policy pillar. It will also focus on diversifying supply chains, promoting and modernising the production of critical medicines and active ingredients, diversify global supply chains through strategic partnerships and coordinate public procurement practices and stockpiling at EU level.

The work of this alliance could be an important step towards a "Critical Medicine Act". Many EU member states have also called for such measures. This is why the European Commission intends to commission a preparatory study by the end of 2023 to pave the way for an impact assessment.

International cooperation will also be important in addition to European cooperation. A network of international partners and strategic partnerships with third countries will be established for the production of key medicinal products, taking into consideration both local demand and needs at both EU and global levels.

Parallels to the pharmaceutical reform

It makes sense that the European Commission wants to strengthen the supply reliability medicinal products within the EU through this package of measures. Some measures, such as the list of critical medicines, the EU solidarity mechanism or the review of mutual procurement of supply-critical medicines, are well-known political demands. it will be challenging to initiate - and legitimise - measures in addition to the regular negotiations about pharmaceutical reform. One must be particularly vigilant with statements such as "more flexibility, e.g. through measures that enable rapid authorisation of medicinal products and the introduction of alternatives". DSV's point of view is that there must be no loss of quality in drug authorisations. In order to improve availability and supply reliability, marketing authorisation holders must be held more accountable in the future and EU-wide monitoring must be expanded, e.g. with regard to the further use of safety features for medicinal products. DSV has set out these and many other demands in its position paper covering pharmaceutical reform.