A More Powerful EMA To Better Protect Consumers In Crisis Times: Recommendations for the trilogue negotiations

One of the early consequences of the COVID-19 pandemic was a shortage of medicines such as painkillers or sedatives, particularly in hospital intensive care units. At the same time, there was insufficient coordination on clinical trials for new medicines, leading to inefficiencies that might have delayed drug development. To ensure that the EU responds more effectively in future health crises, it is necessary to reinforce the role of the European Medicines Agency. This will contribute to improve the availability of medicines and medical devices across Member States.

Trilogue recommendations include:

• Adequate engagement with consumer groups must be ensured.

• The processes for establishing the critical lists of medicines and devices must be inclusive.

• Companies must submit detailed shortage prevention and mitigation plans to the authorities.

• The definition of drug shortages must cover the various root causes.

• The EMA must communicate to the public about the shortage of critical medicines and medical devices.

• Consumer reporting on drug shortages should be enabled.

• Companies must face sanctions for non-compliance.

• There must be enhanced transparency on clinical trials in emergency situations.

• Impartiality of the Steering Groups must be ensured.