The EMA will also coordinate the responses of EU and EEA countries to shortages of vital medical devices and in-vitro diagnostics in crisis situations
The European Union (EU) has sought to strengthen access to medicines and medical products in response to weaknesses that came to light during the COVID-19 pandemic.
New regulations that came into force on 2 March 2022 place the European Medicines Agency (EMA) in charge of monitoring medicine shortages in EU member states before they result in critical scarcities.
The Amsterdam-based agency will also assume responsibility for coordinating the responses of EU and EEA countries to shortages of vital medical devices and in-vitro diagnostics in crisis situations, following a transition period that will run until 2 February 2023.
Because the UK has left the EU, as of 1 January 2021, EU pharmaceutical law as laid out in the acquis communautaire is only applicable to Northern Ireland. As part of an agreed transition period, the UK will continue to adopt decisions taken by the European Commission on the approval of new marketing authorisations for a further 2 years. However, that does not affect the expanded role the EMA is taking in preventing medicinal shortages.
Lack of EU coordination
The regulations for crisis management are recognition of the fact that the EU needs to adopt a more centralised approach to the acquisition of medicines and medical devices, after the pandemic caused supply chain disruptions and led to member states competing on the open market.
According to the regulatory preamble, ‘The COVID-19 pandemic has exacerbated the problem of shortages of certain medicinal products considered to be critical to addressing the pandemic, and has highlighted the Union’s external dependence in terms of domestic production of medicinal products and medical devices, the lack of coordination and the structural limitations in the Union’s and member states’ ability to rapidly and effectively react to such challenges during public health emergencies.’
The EU also acknowledged that its problems were compounded by dependence on third country imports of some critical medicinal supplies.
In wider terms, ‘The COVID-19 pandemic, and the subsequent public health emergency, revealed the need for a more coordinated Union approach in crisis management’, it said.
Public health crisis preparation
The regulatory change will see the EMA set up new institutions—and adapt existing bodies—to manage its responsibilities.
It has also established a permanent secretariat to support 12 medical device expert panels to improve the safety of medical devices marketed in the EU and the EEA.
In addition, an Executive Steering Group on Shortages and Safety of Medicinal Products will be tasked with monitoring supply issue problems across member states. After it starts work in April, the steering group will provide scientific advice on the development of products intended for use during a public health emergency, review scientific data to provide recommendations on the use of unauthorised medicines, and coordinate independent vaccine effectiveness and safety monitoring studies.
The EMA said that it plans to draw up a list of the main therapeutic groups of medicines needed for emergency care, surgery, and intensive care, to aid preparation for public health emergencies or major events.
An updated plan for emerging public health threats will be issued in the coming weeks or months, the EMA said.
This article originally appeared on Medscape, part of the Medscape Professional Network.
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