The European Medicines Agency (EMA) started operating under its new
legal mandate on 1 April 2022. The mandate brings new responsibilities
to the Agency in three different areas: • Reinforcement of the role and
activities of the EMA pandemic Task Force(which is now known as the
Emergency Task Force (ETF)). • A stronger role of EMA in the monitoring
of shortages of critical medicines, medical devices and in-vitro
diagnostics, both in anticipation of and during a crisis. • A more
coordinated mechanism of European Union (EU) experts advice on medical
devices classified as high-risk (class IIa and III or class D (1)) and
in-vitro diagnostic medical devices. Here we consider the impact of the
COVID-19 pandemic on the operations of EMA and the European medicines
regulatory network, and how EMA’s new mandate will strengthen the
Agency’s and the Network’s ability to face crises. EMA’s extended
mandate brings clear benefits in terms of response to public health
emergencies at EU level, which ranges from improvements in crisis
management to avoiding medicine shortages and improving access to
diagnostics and medical devices that are safe and conform to their
expected function.
Background In July 2019, the Heads of Medicines Agencies/European Medicines Agency (HMA/EMA) Task Force on Availability of Authorised Medicines for Human and Veterinary Use (TFAAM) published good practice guidance which provides key principles for European Union (EU) regulatory authorities for communication on shortages and availability issues. The use of a shortage catalogue was a key recommendation. Objectives To assess how EU/European Economic Area (EEA) national competent authorities have implemented the recommendations of the good practice guidance. Methods A survey was run in 2020 among EU/EEA national competent authorities to assess communication practices. The results were compared with those of a similar survey carried out 2 years earlier, before publication of the guidance. The survey covered human medicines only and was sent to 31 authorities: one per EU/EEA member state (and two to Germany's two medicines regulatory authorities).
ResultsIn 2020, 81% of authorities (25/31) had a dedicated public shortage catalogue on their website. This was an increase from 74% (23/31) in 2018, when a similar survey was run. In future this is expected to increase to 87% with two more member states making plans to implement catalogues. Although many member states publish information on shortages there is still selection in terms of the details that are being published, and there is further scope to extend the information currently provided. Conclusion Since publication of the EMA/HMA good practice guide in 2019, transparency has increased across the EU/EEA, and public catalogues of shortages are now a routine tool used by many medicines agencies. Further opportunities to improve transparency on supply issues lie ahead with the EMA network strategy to 2025, the revised EU pharmaceutical legislation and the new legal mandate reinforcing the role of the EMA.
HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY⇒ This study yields new data on transparency in the field of shortages, which has not been widely studied before. It also helps to promote the good practice guidance for communication to the public on medicine availability issues, and helps to increase awareness among pharmacists of shortage catalogues.
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