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European Parliament adopts its position on EU pharmaceutical reform in plenary
18 September 2024
On 11 March 2024, the European Parliament’s Committee on Environment, Public Health, and Food Safety (ENVI) adopted two reports on the EU Pharmaceutical Package: 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 ENVI Committee suggested raising the EU’s research standing, making it a more attractive market for innovation. It calls for mandatory data protection schemes for at least seven and a half years for new medicines and a period of two years of market protection, during which generic or biosimilar products may not be sold following market authorisation. Extensions would only be granted under certain conditions, such as drug unavailability or during clinical trials. Drugs that meet a ‘high unmet medical need’ or are orphan drugs could gain up to 11 years of market exclusivity, during which competing products cannot enter the market.
New protocols will be developed to regulate the rational use of antimicrobial drugs, such as prescriptions being issued only for necessary dosages and limited timeframes. Additionally, there is a push for the discovery and development of new drugs, and companies will be required to provide environmental risk assessments for medicinal products that cover their entire life cycle.
A debate and vote took place in the European Parliament’s April I plenary session. On 10 April 2024, the Parliament fully supported the ENVI position without changes. It adopted its position at first reading with 495 votes in favour, 57 against, and 45 abstentions for the directive, and 488 votes in favour, 67 against, and 34 abstentions for the regulation.
More specifically, EHMA and the EPACT Alliance succeeded in the following:
New amendments adopted in plenary:
- (Directive – Recital 123) Recognised the crucial role of pharmacists in both primary care and hospital settings, stressing their importance in the safe use of medicinal products and the implementation of electronic package leaflets.
- (Directive – Article 106 paragraph 5 a) Ensured that reports of adverse reactions due to incorrect administration or dispensation of medicinal products are included in the EUDRAVigilance database, with Member States taking corrective actions to maintain high safety standards.
- (Regulation – Article 121 paragraph 2 a) Facilitated the establishment of interoperable national IT systems with the European Medicines Safety Portal (ESMP), enabling automated information exchange and preventing reporting duplication.
- (Regulation – Article 121 paragraph 1 point b a) Advocated for a system allowing patients to report medicinal product shortages and requiring hospital pharmacies to electronically communicate stock data to mitigate supply shortages.
Amendments previously adopted in the ENVI report:
- (Directive – Article 66) Introduced the progressive use of standardised single-unit dose barcodes, such as GS1 standards, on medication packaging to reduce the risk of medication errors.
- (Regulation – Article 101) Strengthened reporting mechanisms for adverse drug reactions to include reports of unintended medication errors in the EUDRAVigilance database.
- (Regulation – Article 111) Improved the quality and safety of medicinal products by promoting hospital risk management and patient safety plans to reduce harm from medication errors.
- (Regulation – Article 121) Highlighted the importance of sharing information on hospital medication stocks with regulatory agencies for the ESMP to manage and prevent shortages.
- (Directive – Recital 137) Recognised hospitals as key stakeholders in managing and mitigating the impact of shortages on patients and healthcare professionals.
EHMA calls on the Council to:
- (Regulation – Article 4) Include the definition of adverse reaction, as defined in Directive 2010/84/EU, in both the proposed Regulation and Directive.
Next Steps:
The files are now in the hands of the Council, which has not yet adopted its position. During the EPSCO Council meeting on 21 June 2024, the Belgian presidency presented the state of play of the package (‘progress report’) to the Board of Ministers. A policy debate on the incentives system in the pharmaceutical package took place.
Work will continue under the Hungarian Presidency (July-December 2024), and the new Parliament will take over the institutional negotiations.
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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