Drug Shortages: a European Solution at Last?

Recommendation

13/14 December 2023
Berlin, Germany

Root Cause Analysis
A CAPA Workshop on Successful Failure Investigation

The European Parliament's Committee on the Environment, Public Health and Food Safety had prepared a "Report on the Shortage of Medicines - how to address an emerging Problem", which has now been adopted by the European Parliament. The aim is to make the European Union regain its independence with regard to healthcare.

What does this mean? The decision calls on the EU Commission to "secure rapidly and efficiently its supply of affordable medicines, medical equipment, medical devices, active substances, diagnostic tools and vaccines, and to prevent shortages thereof". Among the options identified are the following:

• Encouraging the return of pharmaceutical manufacturing to Europe, including through financial incentives.
• Safeguarding existing pharmaceutical production in Europe, e.g. by encouraging investment in the quality and safety of the pharmaceutical supply.
• Taking account of investments in the production of active substances and finished products in the EU in tendering procedures.
• Taking into account the number of production sites and investment in research and development in tendering procedures.
• Sourcing from several manufacturers, preferably with production facilities in the EU.
• Drafting of a directive setting minimum standards for health systems in the Member States.
• More flexible rules for packaging formats.
• Possible longer expiry dates.
• Introduction of an emergency European pharmacy.

Although the report is not binding, it will be taken into account in the current development of the EU Commission's pharmaceutical strategy.