Aghaidh a thabhairt ar Ghanntanais Cógas

Addressing medicine shortages
Own-initiative
COM(2023) 672 final
COR-2023-05498 ‒ NAT-VII/040
161st Plenary Session – June 2024
Rapporteur: Erika VON KALBEN (DE/GREENS)
SANTE – Commissioner VÁRHELYI
European Commission position on points of the European Committee of the Regions (COR) opinion considered as essential
The Commission welcomes the Committee’s support on actions addressing medicine shortages, such as the extension of the mandate of the European Medicines Agency, the proposed pharmaceutical legislation and the Critical Medicines Alliance, and appreciates the Committee’s support for increasing the EU’s strategic autonomy in medicine production. The Commission also welcomes the Committee's support for continuing the development various actions to enhance transparency, interoperability, monitoring, funding, reshoring, precise definitions and collaboration between Member States to enhance the security of supply chains in health.
In April 2023, the Commission adopted proposals to revise the EU’s pharmaceutical legislation . The reform of this legislation aims amongst others to promote the availability, accessibility and affordability of medicines across the EU, whilst assuring the competitiveness of the European pharmaceutical industry. In this respect, the reform introduces (i) modulated incentives that specifically reward innovation and supply in all Member States, (ii) cheaper medicines, through earlier availability of generics and biosimilars and (iii) faster procedures and the simplification of the marketing authorisation process. It also contains a requirement for the pharmaceutical industry to be transparent about the direct public financial support received in relation to the research and development of medicinal products. The reform also proposes additional provisions on critical shortages of medicines and security of supply of critical medicines.
The 23 October 2023 Communication on ʻAddressing medicine shortages in the EU’ sets out mechanisms and processes to mitigate and manage critical shortages at EU level in a coordinated manner and proposes measures to further strengthen security of supply of critical medicines for EU citizens and health systems. It brings forward certain elements of the pharmaceutical reform, including the first version of the Union List of critical medicines. The latter is based on an agreed methodology developed in consultation with Member States and key stakeholder groups and will provide the basis for decisions on further remedial action.
Critical Medicines Alliance
The Commission has welcomed the request of the Committee to join the Forum of the Alliance, as the Alliance would benefit from the Committee’s analysis to provide recommendations on the most appropriate actions and instruments to tackle vulnerabilities. These recommendations aim to suggest ways to secure access to critical medicines for EU citizens.
Critical Medicines Act
The aforementioned Commission Communication on Addressing medicines shortages in the EU states that ‘the EU needs a strategic and coordinated industrial approach to enhance security of supply of the most critical medicines’ and that this ‘may require new legislation’. The implementation of the broad range of actions set out in the Communication on addressing shortages in the EU will continue.
In line with the call from 23 Member States and other stakeholders, and as announced in the political guidelines from President von der Leyen, the Commission will prepare a proposal for a Critical Medicines Act to reduce dependencies relating to critical medicines and ingredients. The proposal will complement the measures set out in the revision of the pharmaceutical legislation. Also, the proposal will build upon the work of the Executive Steering Group on Shortages of Medicines under the EMA extended mandate, Structured Dialogue on security of medicines supply and the Critical Medicines Alliance and the dedicated on-going study. The Commission in the pharmaceutical review package already proposes to define ‘shortage’, ‘critical shortage’ and what is a ‘critical medicine product’.
Stockpiling/Contingency Stocks
The Commission has worked on Common Strategic Approach to Stockpiling, that would be the basis for cooperation and future actions on stockpiling of medical countermeasures in the next 3 years. It defines 10 key actions that Member States and the Commission will develop. Some of these actions will be supported by the EU4Health 2024 Joint Action on stockpiling that will begin in 2025 for a period of three years.
Although the Common strategic approach to stockpiling has a strong focus on medical countermeasures, it also refers specifically to stockpiling to ensure continuity of supply of critical medicines outside of health crises. As mentioned in the Political Guidelines, a new strategy will be developed to support medical countermeasures against public health threats such as those linked to Chemical Biological Radiological Nuclear (CBRN) security, including joint procurement and stockpiling. The strategy could identify common priorities to reinforce synergies by including reflections on national and European strategic inventories of key medicines, EU and national stockpiling of critical medicines.
Regarding requirements for actors of the supply chain to hold EU-wide contingency stocks of critical medicines, this is provided for in the proposed pharmaceutical legislation. The Commission has also taken actions to support increased transparency between Member States on their national measures and has started a discussion on possible common principles for contingency stock requirements with a view to ensuring proportionality and solidarity among EU countries.
Funding
The aforementioned Commission Communication on Addressing medicines shortages in the EU suggests that a ‘new Important Project of Common European Interest (‘IPCEI') could focus on developing innovative and sustainable manufacturing and production technologies and processes for generic medicines.
This would both enable to increase innovative domestic production and foster environmental standards. It would also be an opportunity for the EU to lead in the greening of generic medicines production.’
On 28 May 2024, the Commission has adopted, under EU State aid rules, the ‘IPCEI Med4Cure', to support research, innovation and the first industrial deployment of healthcare products, as well as innovative production processes of pharmaceuticals. The majority (9) of the 13 direct participants qualify as small and medium-sized enterprises (SMEs).
Procurement
Regarding the Committee’s opinion on procurement, the Commission is working, together with Member State experts, on EU guidance on good practices for the public procurement of medicines by Member States focusing on security of supply and availability measures. Further use of procurement at EU level might be an option for improving resilience. Aggregating volumes in this way could enhance demand signalling and provide incentives for long-term investment in more resilient supply chains in the EU. The Commission will explore, with Member States, different options to improve access and availability in this way.
Monitoring
Regarding the Voluntary Solidarity Mechanism for medicines, lessons learned from a number of pilot cases have resulted in changes to the procedure and template. Further review and need for adaptation will continue to be considered based on further experience in order to improve the Voluntary Solidarity Mechanism.
The Commission welcomes the Committee’s call for strengthening national IT systems for data collection and monitoring of medicines and their interoperability with IT tools currently developed at EU-level, such as the European Shortages Monitoring Platform (ESMP) and ATHINA. Therefore, the Commission supports Member States in their efforts of harmonisation of IT tools through dedicated programmes, for example through the EU-HIP project and CHESSMEN Joint Action.
The Commission also takes note of the Committee’s call to investigate how data collected within the European Medicines Verification System (EMVS) could be interoperable with the ESMP and potentially ATHINA. As part of the ongoing development of the ESMP, the European Medicines Agency will be evaluating the content, quality and accuracy of data from the EMVS to examine its suitability as an additional data source for monitoring the supply and availability of products, and hence the potential for ESMP data interoperability.