European Parliament endorses legislation bolstering EU’s ability to tackle shortages
The European Parliament approved legislation to increase the powers of the European Medicines Agency (EMA) in monitoring and responding to drug and device shortages.The measure advanced by a 655-31 vote, with eight abstentions. The legislation is based on an agreement reached last October between Parliament and the European Council on changes intended to improve the management of future health crises and shortages of drugs and medical devices. (RELATED: EU Parliament and Council reach provisional agreement to strengthen EMA, Regulatory Focus 4 November 2021)
The legislation was first drafted in 2020 and is part of a triad of documents aiming to strengthen the EU’s health security framework and to reinforce the crisis preparedness, and to increase the EU’s ability to track and mitigate drug and device shortages. (RELATED: EC proposes crisis-related devices role for EMA, Regulatory Focus 17 June 2021)
Under the plan, two “shortages steering groups” will be created, one for drugs and the other for devices to facilitate data collection on drug shortages.
Further, EMA will set up and manage the European Shortages Monitoring Platform to collect information on drug shortages. The agency will also establish a webpage with information on “critical” medical device and drug shortages.
During a public health emergency, drug sponsors of clinical trials will have to make study protocols publicly available in the EU clinical trials register and provide a summary of trial results.
Further, EMA will publish the conditions of the drug’s use and clinical data received once a drug is granted marketing authorization, with commercially confidential information redacted.
Rapporteur Nicolás González Casares announced his support for the legislation. “With this agreement, Parliament makes both the agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies. Moreover, we pave the way to promoting clinical trials for the development of vaccines and treatments, boosting transparency on those issues.”
Further, he said that the new European Shortages Monitoring Platform will provide EMA with a “key tool to monitor medicines supply and prevent shortages.”
The legislation, which has not yet been published in the Official Journal of the European Union, is expected to come into force on 1 March 2022.
This legislation complements other EU-wide efforts to respond to the public health emergency, including the launch of the European Health Emergency preparedness and Response Authority (HERA) to prevent and respond to public health emergencies.
European Parliament
