EU gives drug watchdog new ‘crisis management’ powers

The European Medicines Agency (EMA) has been given a new role in tackling shortages of critical medical devices during public health emergencies. From February 2023, the agency, which primarily regulates medicines, will coordinate a Europe-wide response to ensuring health systems have the devices, diagnostics and medicines they need to provide essential services.

The new role is included an EU Regulation designed to reinforce the EMA’s role in crisis management, triggered by challenges faced across the bloc during the early months of the COVID-19 pandemic. Access to ventilators, protective clothing and COVID-19 tests was severely disrupted in 2020, as demand surged, and stockpiles were rapidly depleted.

The agency is setting up a new Medical Devices Shortages Steering Group (MDSSG) to work with other EU bodies, national governments, and Notified Bodies which regulate medicine devices.

The MDSSG will draw up a list of medical devices considered to be critical in responding to declared public health emergencies. Manufacturers and distributors of products on this list will have new reporting obligations, helping authorities to monitor supplies and take action if shortages arise.

‘The manufacturers, authorised representatives, importers, and distributors of those critical medical devices included in any list of critical medical devices will need to register their single point of contact (EO-SPOC) through EMA’s IRIS platform to facilitate rapid communication during a declared public health emergency,’ the EMA said. ‘Relevant information, including supply and demand data, will be monitored via a reporting system.’

Meanwhile, the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has confirmed that a surge in respiratory infections over the winter has resulted in a shortage of amoxicillin, a commonly used antibiotic.

EU regulators have met with suppliers to discuss increasing production capacity by finding alternative sources of raw materials and identifying additional manufacturing sites. It says supply will be stepped up, with the acute shortages likely to end in the coming weeks.