On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines (i.e., the unavailability of which may cause patients serious harm, and whose supply must be ensured even in crisis periods) and to diversify international supply chains. On the same date, the European Medicines Agency (EMA) published details on the Solidarity Mechanism, recently created by the EMA Medicines Shortages Steering Group (MSSG) to facilitate redistribution of medicines between Member States (MS) in cases of critical shortages (i.e., medicine shortages where no alternative is available).
These EU-level actions are in addition to the mechanisms to tackle shortages already included in the European Commission’s proposal for a reform of the EU Pharmaceutical Legislation (read our advisory).
The Communication introduces short, mid and long-term actions focused on critical medicines shortages. The aim is to prevent and tackle medicines shortages, improve security of supply in the EU, have predictability of needs and coordinate with companies at EU and global level.
Some of these actions may have significant impact on Life Sciences companies, including new regulatory obligations, where the real-life and tangible impact of other measures is somewhat unclear (e.g., coordination on pricing and reimbursement; the planned re-evaluation of the Transparency Directive).
Immediate short-term actions
- Closely monitoring key antibiotics: The EMA and European Health Emergency Preparedness and Response Authority (HERA) will closely monitor this winter the availability of antibiotics identified as key (e.g., amoxicillin or azithromycin), and of medicines of common use in cold seasons (e.g., ibuprofen or paracetamol). They will take measures to prevent and manage shortages when necessary.
- Union list of critical medicines: The Commission will publish a list of critical medicines by the end of 2023, and regularly update it. In this context, an analysis of supply chain vulnerabilities for selected listed medicines will be conducted by April 2024. This will serve as a basis for future EU-level corrective action (e.g., additional regulatory obligations, procurement with strong contractual obligations or delivery). The implications for marketing authorisation holders for medicinal products included in the list are yet unknown. However, the experience of the list published by the EMA during the Monkeypox outbreak shows that it is likely that, for the listed medicines, authorities will monitor even more closely compliance with requirements (i.e., comply with supply obligation and reporting information on shortages, stocks, and supply and demand forecasts). It might also be expected that safety stocks will be required.
- Use of regulatory flexibilities: The Commission plans using regulatory flexibilities to manage and mitigate shortages. Although it is up to the MS competent authority to decide on their use, marketing authorization holders (MAHs) may propose flexibility measures (e.g., accelerated review and approval of use alternative raw materials, manufacturing site or equipment, labelling exemptions, shelf life extensions). Some flexibilities are, however, considered exceptional and are to be used only as a last resort in critical situations (e.g., certain critical medicines shortages). These exceptional flexibilities can only be initiated by regulatory authorities, ideally following a recommendation of the MSSG (e.g., limited or deferred batch testing; changes to the manufacturing process on simple notification, as opposed to authorisation).
- Increased communication on supply needs: A communication platform will be developed through 2024 and 2025 to allow companies to communicate their capabilities and foster cooperation. This includes the EU Mechanism for Demand Signalling and Shortages Monitoring Platform.
- Joint procurement: The Commission aims to incorporate supply security as the award criterion instead of the lower prize criterion for public procurement. To this end, a best practice guidance for public procurement incorporating supply security as the award criterion will be issued in early 2024. A joint procurement of antibiotics and treatments for respiratory viruses is also planned.
- Coordination on pricing and reimbursement (P&R): The Commission calls for stronger MS coordination on P&R, and will further facilitate collaboration, including within the group of National Competent Authorities on Pricing & Reimbursement and public healthcare payers.
Mid and long-term structural actions
- Creation of a Critical Medicines Alliance: The Alliance intends to develop a coordinated EU-level action against critical medicines shortages, bringing together national authorities, industry, civil society, the Commission and EU agencies. One of its the strategic focus will be to boost production capacity and innovation in the manufacture of critical medicines and ingredients in the EU. It is expected for early 2024.
- Coordinating stockpiling: A common strategic approach to medicines stockpiling will be developed by the Commission and MS in the first half of 2024, and the Commission plans to launch a joint action on stockpiling to support MS improve their strategies in a coordinated manner.
- Strategic third country partnerships: The Commission intends setting up strategic partnerships with third countries for production of critical medicines and APIs to diversify global supply chains.
- Evaluation of the Transparency Directive: An evaluation of the Directive is foreseen in the future with an objective to strengthen MS cooperation in the field of P&R.
MSSG Solidarity Mechanism
The newly created Solidarity Mechanism is a voluntary mechanism for MS facing critical medicines shortages. It is considered a last-resort and its triggering is subject to meeting conditions (i.e., shortagenotification to the EMA; unavailability of sufficient therapeutic alternatives; insufficient quantities to treat critical indications; absence of alternative measures providing a prompt solution or in sufficient quantities; urgency).
In order to benefit from the mechanism, the MS in need should send a request to the MSSG via e-mail, and if conditions are met, EMA will launch the mechanism. In case a MS is able to assist the MS facing the shortage, the EMA will put them in contact, and will also set up meetings with other parties, including pharmaceutical companies and wholesalers, to discuss operational requirements. If no MS is able to assist, the MSSG will assess additional measures with the MS concerned.
The information on the active substance and outcome of the mechanism will be made public as part of the MSSG meetings minutes.