European Commission Adopts Plan to Tackle Medicine Shortages in EU
On 24 October 2023, the European Commission (the Commission) presented its plan to tackle medicine shortages in the EU (see, attachment). The plan combines both existing and new measures and anticipates in part on rules that will only be rolled out when the pharmaceutical package, a comprehensive set of draft regulatory and intellectual property measures promising a profound impact on the pharmaceutical industry, is turned into law (see, Van Bael & Bellis Life Sciences News & Insights, 3 May 2023). European Commissioner for Health and Food Safety Stella Kyriakides had already offered a preview of the Commission’s plan to the European Parliament in early October 2023 (see, Van Bael & Bellis Life Sciences News & Insights, 4 October 2023).
The plan distinguishes immediate and short-term measures from more structural measures for the mid and long term.
The plan lists the following short-term measures:
- Antibiotics - Several measures to ensure an adequate supply of key antibiotics in the winter of 2023-2024. The Commission expresses confidence that supply will “generally match demand”.
- Voluntary Solidarity Mechanism for Medicines – The scheme, which was conceived of by Belgium (see, Van Bael & Bellis Life Sciences News & Insights, 4 May 2023), allows Member States to signal to other Member States their need for a given medicine in critical shortage at national level.
- Union list of critical medicines – A first version of the list will be published by the end of 2023.
- Improving forecasting capabilities of supply and demand.
- Accelerating and anticipating the reform that will be provided for by the pharmaceutical package – The plan contains a list of elements of the anticipated new rules whose implementation could be advanced.
- Enhanced use of regulatory flexibilities – Examples include measures to facilitate the quick authorisation and roll-out of alternative medicines; and the temporary extension of the shelf-life of given medicines. In 2024, the Commission will also launch a joint action on regulatory flexibilities, including magistral preparations.
- Increased cooperation for pricing and reimbursement – It is remarkable that this item should feature in the plan, given the attitude of most Member States to preserve jealously their exclusive competencies in the areas of pricing and reimbursement. The Commission is reportedly also looking at possible changes to Directive 89/105/EEC which governs the transparency of medicine pricing and specific aspects of the reimbursement of medicines. The results of a study regarding this Directive are expected to emerge in November 2023.
- Procurement – The Commission will seek to have the use of appropriate procurement mechanisms maximised. It will thus consider relying on joint procurement (of the Member States) to obtain antibiotics and treatments for respiratory viruses ahead of the winter of 2024-2025. Similarly, the Commission will publish EU guidance on procurement by early 2024.
Mid and long-term structural measures
The Commission plans the creation of a Critical Medicines Alliance (CMA) with the Member States by early 2024 which would allow all stakeholders, including industry, to develop coordinated action at the EU level to combat medicine shortages of high-risk critical medicines. To reach this objective, the CMA will rely on several instruments, including public procurement; the possible diversification of global supply chains; measures to improve innovation and manufacturing capacity; stockpiling measures; the development of dedicated skills; and financial support.
The Commission will also consider proposing a Critical Medicines Act to improve the security of medicines supply further. This is another component of a Belgian plan to fight medicine shortages (see, Van Bael & Bellis Life Sciences News & Insights, 4 May 2023). However, the Commission has been warning repeatedly that the adoption of such an instrument requires thorough preparation ((see, Van Bael & Bellis Life Sciences News & Insights, 1 September 2023). This is why it will launch a specific study by the end of 2023.
The European Council formally endorsed the Commission’s plan on 27 October 2023 and called for a “swift follow-up” of the plan and its broader policy goals of access to medicines and the creation of an innovative and competitive pharmaceutical sector.