EFPIA and Vaccines Europe welcome the Regulation on a reinforced role for the European Medicines Agency
31.01.22
EFPIA’s Director General Nathalie Moll said: “The COVID-19 crisis has shown the value and necessity of EU coordination, and the importance of close dialogue between EU authorities and the industry to address medicine shortages. Strengthening the role of the EMA is an important step forward to enhance the ability of the EU to respond to health emergencies”.
Medicine shortages represent a threat to patients and societies, and combating shortages has been a long-standing priority of the industry. EFPIA and Vaccines Europe see an efficient EU medicine shortage monitoring tool as the fundamental cornerstone on which to build an effective shortage prevention policy. EFPIA and Vaccines Europe welcome the creation of a harmonised multi-stakeholder system for the monitoring of shortages via the Regulation. This tool will rely on a European definition of shortages, which should be based on patient demand. EFPIA and Vaccines Europe call on EU authorities to ensure that the EU platform is fully interoperable with Member State IT systems, to avoid duplication of efforts, errors, and unjustified burden on stakeholders.
To complete the shortage monitoring and prevention system, EFPIA and Vaccines Europe also recommend national authorities use the already existing data stored in the National Medicines Verification Systems[1], originally created to prevent counterfeits. Further measures could reinforce shortage prevention, such as Shortage Prevention Plans for certain categories of products.
EFPIA and Vaccines Europe also warmly welcome the creation of the Emergency Task Force, that will provide advice on scientific questions related to the development of treatments and vaccines, and on clinical trial protocols. The Regulation’s focus on the need for international collaboration and increased cooperation among stakeholders are positive elements. As medicine and vaccine development is global, it is only by working collaboratively that future health pandemics can be tackled. Equally, EFPIA and Vaccines Europe support the robust provisions on cybersecurity included in the legislation, that recognise the critical need to protect sensitive information stemming from health research.
Sibilia Quilici, Vaccines Europe’ Executive Director, went on to say: “The reinforced mandate of the EMA will provide for a more agile and robust response for future public health crises. EFPIA and Vaccines Europe stand ready to work with the EU authorities and all stakeholders towards a successful implementation of the Regulation”.
[1]https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/using-the-fmd-data-repositories-for-shortages-monitoring/