The communication from the European Commission addressing medicine shortages in the EU, published on 24 October 2023, highlights the importance of the continued availability of safe, effective and affordable medicines for patients as a foundation of the strong European Health Union.
The planned reform of the EU pharmaceutical legislation foresees a number of structural measures to ensure the availability and security of supply of medicinal products, among others, the development of the Union list of critical medicines (the “Union list”).
In order to ensure a continued supply of medicines that are considered the most critical for healthcare systems, the EMA, the European Commission and the Heads of Medicines Agencies have worked together to develop the first version of the Union list, which contains human medicines whose continued supply is considered a priority in the EU to avoid serious harm to patients and minimise the risk of supply disruptions. The European medicines regulatory network will prioritise critical medicines for EU-wide actions to strengthen their supply chain.
For the critical medicinal products included in the Union list, the EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) may propose measures to address vulnerabilities in their supply chain and strengthen the security of supply for these medicines.
The MSSG was set up according to Regulation (EU) 2022/123 (the Regulation) to ensure a robust response to major events or public health emergencies, including through the provision of advice and recommendations on necessary actions to safeguard the quality, safety and efficacy of medicinal products, as well as to safeguard the supply of medicinal products, and to ensure a high level of human health protection. The MSSG is supported by a working party comprised of single points of contact related to shortages from national competent authorities for medicinal products, the so-called Medicine Shortages SPOC Working Party (SPOC WP).
The proposed reform of the EU pharmaceutical legislation foresees additional reinforcement of the role of the MSSG, including a provision that the MSSG may provide recommendations on appropriate security of supply measures of medicines included in the Union list to Marketing Authorisation Holders (MAHs), the Member States, the Commission or other entities. This document is drafted in the context of the anticipation of this new role.
In case of critical shortages of medicinal products included in the Union list, the MSSG Toolkit on recommendations on tackling shortages of medicinal products would apply.
This is a living document that will be updated when needed, e.g. if additional types of recommendations to address vulnerabilities in the supply chain are identified.
The MSSG will cooperate with the Critical Medicines Alliance (CMA) to avoid duplication of work and to discuss long-term measures to address vulnerabilities. The work of the MSSG and the CMA will be complementary; the MSSG will develop regulatory recommendations focused on short- to mediumterm actions and governmental policy recommendations while the CMA will be a consultative mechanism focused on long-term activities in the field of industrial policy.
To continue reading this article please go to EMA .