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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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.

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