Medicinal products shortages
This issue has been in the spotlight for many years and is making a major comeback in national and European legal and regulatory news.
In France, the draft decree implementing the Law on the Financing of Social Security (LFSS) for 2024 will enable the implementation of measures to combat medicinal products shortages. It addresses the security of supply of medicines of major therapeutic interest (MMTIs) and covers three aspects.
The first aspect relates to the conditions under which the Minister of Health may authorise, by order, on an exceptional and temporary basis, the production of the special officinal formulae now provided for in 3° of article L. 5121-1 of the Public Health Code. The purpose of this authorisation is to deal with stock shortages or the discontinuation of marketing of an MMTI by the MA holder, or to deal with a serious public health threat or crisis.
The second part of the draft decree defines the types of public health surveillance measures that may be taken by the ANSM to ensure appropriate and continuous supply by MA holders and operators to meet patient needs.
Finally, the draft decree sets out the terms and conditions for implementing the obligation to find a buyer or grant a licence. With regard to the declaration of suspension or cessation of marketing of an MMTI provided for by law (article L. 5124-6-II), the draft refers to guidelines defined by decision of the Director General of the ANSM. It specifies that these guidelines must address the foreseeable impact on patients of the suspension or cessation of marketing, as well as the therapeutic alternatives available on the market.
The issue of shortages is also at the forefront of the European stage. The EMA has recently clarified its data access policy for the European Shortages Monitoring Platform (ESMP), established under Regulation 2022/123 concerning the enhanced role of the EMA in crisis preparedness and management related to medicines and medical devices. The ESMP became fully operational on 29 January 2025. Meanwhile, the European Commission has recently released a regulatory proposal following extensive consultations with stakeholders. This proposal aims to complement the measures suggested in the revision of the pharmaceutical package to address vulnerabilities in the critical medicines supply chain and ensure the security of supply and availability of these medicines—the Critical Medicines Act (CMA).
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