Brussels, 21 January 2022

Medicines for Europe welcomes the regulation on reinforcing the European Medicines Agency’s mandate (EMA) for EU-wide shortages in a crisis situation. 

The agreement will help to ensure coordinated European response to health crises and that patients have access to their medicines. As was demonstrated by the COVID-19 pandemic, more coordination at EU level bring real value.

Medicines for Europe emphasizes the critical importance of a European platform for shortages reporting, based on existing IT systems, that are interoperable and avoid duplication errors. This will require a concerted effort by industry and medicines agencies to align on common reporting standards and criticality and to create an interoperable database for such reports.

Medicines for Europe is committed to work closely with the Commission, EMA and national medicines agencies to reduce and to mitigate shortages in the future.  

Medicines for Europe

Medicines for Europe represents the generic, biosimilar, and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability, and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information, please follow us at www.medicinesforeurope.com and on Twitter @medicinesforEU.

Medicines for Europe Communications:

Kate O Regan koregan@medicinesforeurope.com

Marta Pratico mpratico@medicinesforeurope.com