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EC proposes crisis-related devices role for EMA

Posted 17 June 2021 | By Kari Oakes 

EC proposes crisis-related devices role for EMA

The European Council (EC) has proposed that the European Medicines Agency (EMA) take a stronger role in crisis management and preparedness, increasing its administrative oversight of medicinal products and also medical devices during emergencies such as the recent COVID-19 pandemic.
 
The proposal, first drafted in November 2020, is part of a triad of documents “aiming to strengthen the EU's health security framework and to reinforce the crisis preparedness and response role of key EU agencies,” notes the introduction to the proposal. The proposal sets forth changes designed to increase EU’s ability to track and mitigate drug and device shortages; to ensure “high quality, safe and efficacious” medicinal products can be developed, especially those that address public health emergencies; to provide a structure for expert panels to assess “high-risk medical devices,” and to advise EMA and the EC on crisis preparedness and management matters.
 
The body of the proposal reviews the history and lessons learned from the recent COVID-19 pandemic; as the novel coronavirus blossomed first in Northern Italy and then spread rapidly and unpredictably through the EU, production and distribution hiccups resulted in serious shortages and bottlenecks of medical devices such as ventilators, tests, and personal protective equipment.
 
A variety of ad hoc solutions emerged during the pandemic; the proposed regulation aims to clarify “the procedures and the respective roles and obligations of different concerned entities involved,” building on the solutions that worked well during the pandemic.
 
Some of the particulars proposed in the draft regulation include developing a harmonized way to monitor medicinal products and medical devices, each equally important to public health. An executive steering group for shortages and safety of medicinal products, and a parallel group addressing medical device safety and shortages, should be established.
 
However, for medical devices, the steering group will primarily focus on critical medical devices needed during public health emergencies. According to the proposal, this group should maintain tight liaison with the Medical Devices Coordination Group (MDCG). “Effective coordination with the MDCG could be useful for the definition of the list of critical medical devices and information to be provided as well for the adoption of recommendations by the Executive Steering Group on Shortages of medical devices,” notes the proposal, which lays out details of the procedures for establishing the steering groups and steps to take in the even of a public health emergency.
 
The draft regulation also proposes that EMA, given its “long-standing and proven record of expertise” in both working with medicinal products and in working with a variety of expert groups, monitor potential device shortages and “host the expert panels on medical devices.”
 
“This would allow for long-term sustainability for the functioning of the panels and provide clear synergies with related crisis preparedness work for medicinal products,” notes the draft regulation. The document clarifies that none of these proposed changes would alter the medical device regulatory system or other medical device-related procedures in the EU, “which should remain clearly distinct from the one for medicinal products.”
 
An expert weighs in
In an interview with Focus, a regulatory affairs expert in the EU thinks the proposal marks one – or maybe several – steps in the right direction, and builds logically on an existing framework.  
 
When asked whether the draft proposal will proceed to finalization, Rainer Voelksen, FRAPS, responded in the affirmative, noting that the European Parliament will probably weigh in favorably. EMA’s budget has already provided for the new functions, and EMA will begin its administrative support of the Medical Device Expert Group as of 1 March 2022. “As this leaves enough time for discussion and fine-tuning, I don’t see any major hurdle,” he said.
 
No date has yet been set for the initial convening of the proposed steering group for medical device shortages.
 
In response to a query whether this proposal marks the beginning of more expansion of EMA’s role into medical device regulation, Voelksen, director of regulatory affairs and quality assurance at Paris-based CAIRDAC, pointed out that EMA’s proposed role in crisis management is currently limited to coordination and administrative functions.
 
“So, in general, it is a good thing to support the EU Commission and member states with coordinating administrative tasks,” said Voelksen, noting that “EMA has experience, is faster and more flexible than the EU Commission for administrative activities.”
 
“The medical devices shortages steering group is currently just planned to be set up on paper and shall only meet first when a new public health emergency, meaning a public health emergency at the EU level recognized by the European Commission… is declared,” Voelksen pointed out. “Only then the group would meet and determine the ‘essential’ medical devices and [in vitro diagnostics] needed for this very emergency,” he said.
 
Despite this proposal for more centralized coordination during a crisis, Voelksen said that gaps still exist. Speaking of the COVID-19 pandemic, he said, “What was missing during the crisis -- and is not written down on a European level -- is the [emergency use authorization] as it exists for medicines in Europe through EMA or on a national basis, or for devices and IVDs in the US under FDA.”
 
The European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI) is the responsible committee and has appointed a rapporteur; ENVI is expected to cast a vote on the file during its upcoming June meeting.
 
Editor’s note: This article has been corrected to clarify that the draft regulation is proposing both a steering group for medical device safety and shortages, and an increased administrative role for EMA in supporting medical device work during a crisis. An incorrect characterization of Voelksen’s perspective has also been corrected.
 
European Commission
 

 

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