Belgium Garners European Support for Initiative to Improve Security of Medicines Supply in Europe
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.