Awaiting committee decision: A turning point for the Critical Medicines Act
16 December 2025
As the negotiations on the Critical Medicines Act (CMA) advance, the publication of the Council’s General Approach marks an important milestone in shaping the future of Europe’s pharmaceutical resilience. The Act aims to strengthen the availability and security of supply for critical medicines through industrial incentives, strategic projects, improved procurement rules, and coordinated crisis responses. While the Council text reinforces several key areas, it also leaves notable operational gaps, particularly regarding hospital-level visibility, digitalisation, waste reduction, and medication optimisation.
Drawing on the expertise of the EPACT Alliance for the Digitalisation of Hospitals’ Medication Management Pathway in Europe, EHMA has proposed targeted amendments to address these gaps and support a more resilient, data-driven, and patient-centred approach to critical medicines management.
Council priorities: progress, but limited focus on clinical realities
Industrial resilience & vulnerability assessments
Strengthened supply-chain mapping, diversification, and vulnerability assessments. However, these measures remain upstream and do not improve hospital-level visibility of shortages.
Procurement resilience measures
Member States must apply resilience criteria (diversification, security of supply, stockholding). Yet procurement remains disconnected from real-time consumption and expiry data, limiting forecasting accuracy.
Governance reinforcement (CMCG)
Clearer mandate for the CMCG on information exchange and strategic project oversight. Without timely hospital data, coordinated allocation and shortage response remain limited.
Clarification of contingency stock rules
The Council adds transparency and proportionality requirements for stockholding obligations. Still, without systems to monitor expiry, burn rate, or redeployment, risking inefficiency and waste.
Strategic gaps: opportunities to strengthen resilience through digitalisation
The Council’s text leaves several structural gaps unaddressed – gaps that our amendments aim to close.
No national stock-visibility systems (N-CMSVS)
No requirement for interoperable IT systems collecting near real-time hospital stock and consumption data.
→ Supports Article 19a on establishing N-CMSVS linked to the ESMP.
No obligation for hospitals to provide structured data
Healthcare providers are not included in supply-chain reporting obligations.
→ Hospital data is essential to predict and mitigate shortages.
No measures on digitalisation or automation
No reference to automation, traceability, or digital stock monitoring.
→ Articles 19a and 20a offer the only operational route to clinical-level resilience.
No reference to waste, adherence or polypharmacy
Leftover medicines, adherence issues and environmental/AMR impacts are not addressed.
→ Articles 17, 18 and 30 link medication optimisation and waste reduction to supply security.
Procurement reforms disconnected from demand forecasting
Resilient procurement requires accurate, timely consumption and expiry data.
→ Reinforces need for hospital-generated data feeds through Article 19a.
EPACT and EHMA proposed amendments to strengthen the CMA
To ensure the Act functions in practice and supports real-world clinical needs, EHMA proposes the following amendments:
Article 19 – paragraph 3 (Modification)
- Contingency stocks must be monitored via the N-CMSVS with expiry tracking and redeployment rules.
Article 20a – National strategies for digitalisation and automation (NEW)
- Member States must adopt national plans to digitalise medication management, improve safety, reduce waste and increase resilience.
Article 26 – paragraph 1 – Governance & coordination mechanisms (NEW)
- 26(1): Embed hospital-level visibility within CMCG coordination.
- 26(2)(b): Coordinate data standards and implementation of Articles 19 and 19a.
- 26(3): Monitor automation levels, waste reduction, and associated economic and environmental benefits.
Article 27 – paragraph 1a – (NEW)
- Commission to develop Union-wide guidance and benchmarks for implementation.
Article 30 – paragraph 2 – Waste, ADD systems and sustainability (NEW)
- Promote the deployment of Automated Dose Dispensing (ADD) systems, when clinically appropriate, across outpatient, home, long-term care and institutional healthcare settings.
- Adapt national regulatory and reimbursement frameworks to enable ADD uptake.
- Establish the objective of ensuring ADD implementation and operational use across all Member States by 2030.
- Require Member States to report periodically on:
- ADD deployment and coverage,
- Measurable impacts on adherence and leftover reduction,
- Waste prevention outcomes,
- Incentives and funding schemes,
- Barriers and best practices.
- Request the Commission to develop Union-level guidance and benchmarks, and facilitate funding and technical assistance—particularly for under-resourced regions.
Article 17 – paragraph 1b –Antibiotic pollution & AMR (NEW)
- Member States must monitor and reduce antibiotic discharge into the environment and recognise ADD’s contribution to improving adherence and reducing waste.
Article 18 – paragraph 4 –Procurement and medication optimisation (Modification)
- Allow procurement criteria to include polypharmacy management, structured medication reviews, deprescribing and adherence interventions.
Article 31 – Implementation timeline (NEW)
- Establish an EU-wide objective to achieve widespread digitalisation and automation of hospital medication practices by 2030.
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What our Members say
I have been active in EHMA since the first years of the '90s and I have seen its evolution from a small association of members interested in sharing knowledge on health management practices to the current status of reference and advisory key player for EU, health systems and organisations, stakeholders associations, industry and universities. EHMA is now a unique knowledge hub, policy advisor, community of practice and network of best in class organisations involved in health policy and management. A place where health managers can build their competences, policy-makers and stakeholder associations envision how to implement and sustain change through health management, industry leaders understand how to engage more effectively with health organisations and systems. The right place to nurture and grow health management capabilities and capacity for every stakeholder of health systems.
Prof. Federico Lega, University of Milan, Italy
Health management has a crucial function in shaping public health and health system challenges. The Medical University of Varna, Bulgaria had success in collaborating with EHMA on EU-funded projects that has resourced us to create new health management competencies for the future workforce. In addition to all classical definitions, health management is a science dealing with individuals, groups, and society at large. It is an art contributing to the beauty of our lives and an interactive communication process at all levels of institutions and human energy. I have also had the pleasure to chair the South Eastern European Special Interest Group which gives members a space to discuss and tools to address how health systems are managed in our regions.
Prof. Todorka Kostadinova, Medical University of Varna, Bulgaria
I enjoy the high level of interaction and engagement in EHMA’s activities, in particular during the annual conference where the panel discussions are rich and well prepared. As a hospital manager and professor of health management, EHMA motivates and inspires me to be creative. You go back home feeling energised from seeing old friends and making new connections, as well as being convinced of serving as EHMA’s ambassador. It’s a strong feeling of interdisciplinary engagement, but it also feels like being part of family-like community.
Prof. Sandra C. Buttigieg, University of Malta, Malta
EHMA is a pre-eminent organisation for everyone working in planning, managing and delivering health services across Europe. As a long standing member of EHMA I have always been impressed by the vibrant community of managers, researchers and academics it has created and by the many opportunities for sharing knowledge and funding opportunities it has brought to its members. Its international scope is impressive and its impact is often felt in management and research across European and national health systems.
Prof. Axel Kaehne, Edge Hill University, UK
Health workforce has become more essential in operating, managing and maintaining health systems lately, particularly in crisis and emergency situations. European healthcare professions and the workforce need to be high on the agenda of managers and decision makers. The Health Services Management Training Centre, Semmelweis University in Hungary is a longstanding EHMA member, because it connects us with collaborators and experts, with whom we can have complex debates, from whom we can learn and at the end find solutions in various challenging fields of healthcare management.
Dr Eszter Kovács, Health Services Management Training Centre, Semmelweis University, Hungary
As a hospital administrator and health management professor, I see on a daily basis that the healthcare challenges require talented and skilled managers to transform it. the EHMA membership has been beneficial to bring healthcare management research and education to the demanding healthcare services world, promoting healthcare management competencies and knowledge creation.
Dr Alexandre Lourenco, APAH - Association of Portuguese Hospital Managers, Portugal
Many healthcare systems in Europe and beyond are facing similar challenges which require innovative and creative solutions. EHMA’s annual conference, webinars, Programme Directors’ group and other activities and resources provide incredible opportunities for networking, connecting and sharing experiences. A distinct feature of EHMA is the diversity of members with representation from many countries, sectors and different communities of practice – academic, policy-makers, practitioners, managers, leaders and students. The annual conference is a highlight in the calendar year, offering a friendly, fun and learningful environment for emerging and established members to engage, collaborate and meet up with old and new friends. I am proud to be a member of the EHMA Board.
Prof. Ann Mahon, University of Manchester, UK
Society evolution, pandemics and ageing modify health needs. So, health policies and services are to change dramatically. EHMA, through webinars, workshops and annual conference provides an excellent insight to a professional changing world, favouring closeness to management innovation and the protagonists of these changes. As a primary care services’ manager, participating in EHMA activities is really worth it and allows to involve oneself in the innovation processes.
Dr Antoni Peris Grao, Consorci Castelldefels Agents de Salut (CASAP), Spain