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In brief

On 15 June 2021, after an initial consensus from health ministers in Luxembourg, the European Parliament’s health committee approved an extension of the European Medicines Agency’s (EMA) mandate. The proposed regulation, which is part of a larger European Health Union package, passed with 68 voting in favor, three against and eight abstaining. As a result, the proposal will likely advance to the trilogue stage with a view to being adopted during the July plenary session. Key features of the regulation are summarized below. 


Emergency response 

The absence of a clear legal framework guiding the response to the pandemic and inadequate preparation has impacted the majority of the member states. The regulation would increase the EMA’s capacity to respond to emergencies by creating an emergency task force that would be authorized to issue recommendations for medical products during health crises and to advise on clinical trials. 

Drug monitoring 

The report by the Committee on the Environment, Public Health and Food Safety (ENVI) [JBP1] proposed a “European medicines supply database,” which would be updated in real time to counter the drug shortages that plagued the pandemic. In the report, the committee emphasized the need to improve coordination to quickly address threats to public health and maintain a “one health” approach across the European Union (EU). The pandemic has exposed the complex international supply chains servicing the EU’s drug and medical device market, with export restrictions and border closures impeding deliveries. The report advocates a long-term approach to planning to prevent bottlenecks during emergencies. The EMA would use an electronic platform to gather data from wholesale distributors, marketing authorization holders and member states to coordinate access to medical products. This is inspired by successful projects such as CISMED[JBP2] , which was also funded by the EU. 

Clinical trials 

The EMA plans to carry out clinical trials on a larger scale through a proposed clinical trials information system. The move is inspired by larger trials such as the “UK RECOVERY” trial, which was crucial to battling COVID-19.

Data protection

In agreeing changes to the original mandate, members of the European Parliament clarified that the handling of personal data collected during the formation and execution of emergency response provisions will be subject to EU data protection rules. 

For further information, please contact Julia Gillert or Marilyn Acquah of our London office.

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Sources

CISMED: Future plans for scaling up the information on medical shortages at supranational level CISMED — DigitalHealthEurope

Council of Europe press release (15 June 2021): Council agreement paves way to reinforce European Medicines Agency — Consilium (europa.eu)

Council of Europe press release (11 November 2020): Building a European Health Union (europa.eu)

Draft report on the proposal for a regulation of the European Parliament and of the Council on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (March 2021[JBP3] ): PR_COD_1amCom (europa.eu)

Extension of the mandate of the European Medicines Agency (EMA) by Nicole Scholz (21 May 2021): EMA mandate extension | Legislative train schedule | European Parliament (europa.eu)

POLITICO Pro Health Care Alert: Parliament’s health committee OKs EMA mandate expansion by Carlo Martuscelli (22 June 2021)

Proposal for a regulation of the European Parliament and of the Council (11 November 2020): EMA text 3 November PM2 clean (europa.eu)

Outcome of proceedings (16 June 2021): pdf (europa.eu)

Author

Julia Gillert is an Associate in Baker McKenzie's London office.

Author

Marilyn Acquah is a Trainee in Baker McKenzie London office.

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