EU Commission: Strategy Paper with Measures against Medicine Supply Shortages

Recommendation

Tuesday, 12 December 2023 14.00 - 16.00 h

GMP Update 2023/2024 - Live Webinar

The European Commission has adopted a package of measures to prevent and mitigate shortages of critical medicines in the EU this coming winter, next winter and beyond. The reform of the pharmaceutical legislation, announced in April 2023, includes a package of measures aimed at increasing long-term security of supply or managing medicine shortages. The "set of actions" now presented complements the reform of the pharmaceutical law.

The most important planned measures are:

• Establishment of a voluntary EU solidarity mechanism
• A Union list of critical medicines
• Regulatory flexibility
• EU guidelines for the procurement of medicines in the interest of greater security of supply
• Joint procurement at EU level of antibiotics and respiratory virus treatments

Furthermore, the Commission plans to set up a "Critical Medicines Alliance", which should become operational in early 2024. This alliance will focus on a specific number of critical medicines where the risk of shortages is highest and the impact on health systems is greatest. Among the actions it will take are:

• Coordinating public procurement procedures at EU level
• Exploring opportunities to diversify global supply chains through strategic partnerships
• Coordinated strengthening of Europe's capacity to produce critical medicines and their ingredients and to innovate in the manufacturing sector
• Developing a common strategic approach to stockpiling medicines in the EU
• To support the mobilisation and alignment of EU and national resources

To strengthen the resilience of the supply chain, the Commission will thus network with international partners. Strategic partnerships with third countries will also be launched with regard to the production of critical medicines.

Source: EU Commission press release