On 2 May 2023, the Belgian federal Minister of Social Security and Health published a brief policy document defining three proposed action points to deal with medicine shortages in the EU (see, attached "non-paper" – the Proposals). The Proposals seem to be backed by 18 further Member States, including France and Italy, and will be discussed on 4 and 5 May 2023 during an informal meeting of health ministers under the Swedish Presidency of the Council of the EU.
The Proposals reflect a three-pronged approach to
shortages.
First, they envision the creation of an EU voluntary solidarity
mechanism that would be set up within the Executive Steering
Group on Shortages and Safety of Medicinal Products (Medicines
Shortages Steering Group or MSSG), a body
established last year in the European Medicines Agency which will
be given more powers when the package of pharmaceutical
legislation, proposed last week, enters into force (see,
Van Bael & Bellis Life Sciences News &
Insights of 3 May 2023). Under the mechanism, Member
States would be able to signal critically low stocks of important
medicines in hopes of obtaining temporary relief from other Member
States.
Second, the Proposals advocate an accelerated creation of the
European list of critical medicines.
Third, the Proposals also call for the adoption of a Critical
Medicines Act (CMA) that would
emulate the examples in other industries of the European Chips Act
and the Critical Raw Materials Act. The CMA would support European
manufacturing initiatives with regard to key medicines, active
pharmaceutical ingredients, and intermediate ingredients in cases
where Europe is currently dependent on a single country (often
China) and/or a limited number of producers. The Proposals
contemplate the creation of a toolbox of instruments while
acknowledging "the need for appropriate financing
mechanisms", a sensitive subject that will require extensive
discussions.
Attachments:
Non Paper
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