ENVI Committee voting on the EU Pharmaceutical Strategy

29 March 2024

Adopted on 25 November 2020, the Pharmaceutical Strategy for Europe aims to create a future-proof regulatory framework and to support the industry in promoting research and technologies that reach patients to fulfil their therapeutic needs while addressing market failures.

On 11 March 2024, the European Parliament’s Committee on Environment, Public Health and Food Safety (ENVI) adopted the two reports on the EU Pharmaceutical Package, namely the 2023/0132(COD)  Directive on Medicinal products for human use and the 2023/0131(COD) Regulation on Authorisation and supervision of medicinal products for human use and governing rules for the European Medicines Agency.

The European Health Management Association (EHMA)’s EPACT Alliance – The Alliance for the Digitalisation of Hospitals Medication Management Pathways welcomes the amendments on patient safety and medication shortages, tabled by the respective rapporteurs of the files: Tiemo Wölken MEP (S&D, Germany) and Pernille Weiss MEP (EPP, Denmark). More specifically, we succeeded to:

  • (Regulation – Article 4) Included the definition of adverse reaction which includes medication error from Directive 2010/84/EU in the proposed Regulation and proposed Directive (as a recital).
  • (Directive – Article 66) Introduced the progressive introduction of standardised single-unit dose barcodes, such as GS1 standards, on medication blister packs, vials, pre-prepared syringes, and ampoules to reduce the harm associated with medication administration at the patient’s bedside.
  • (Regulation – Article 101) Strengthening Reporting Mechanisms: We propose enhancing the reporting mechanisms for adverse drug reactions to include reports of unintended medication errors in the EUDRAVigilance database.
    (Regulation –  Article 111) Improving the quality and safety of medicinal products through the availability of hospital risk management and patient safety plans to reduce harm from medication errors.
  • (Regulation- Article 121) Enhancing Communication: Our position highlights the importance of collecting and sharing information on hospital medication stocks with regulatory agencies for the ESMP to proactively manage and mitigate medication shortages.
  • (Directive – Recital 137) Included the recognition that hospitals are key stakeholders supporting national and European efforts to manage and mitigate the impact of shortages on patients and healthcare professionals.

Modernising hospitals’ medication management pathways can reduce harm to patients and professionals from medication errors, reduce and better manage health professionals’ workloads and result in cost savings in pharmaceutical and care budgets. We urge Members of the European Parliament to consider our proposed amendments, which aim to advance patient and occupational safety.


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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.

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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

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