Stakeholder involvement for more transparent and inclusive Health Technology Assessment (HTA)
28 June 2023
The Health Technology Assessment (HTA) Stakeholder Network convened its first meeting in Brussels on 14 June, bringing together 59 representatives from 44 stakeholder organisations, including EHMA represented by Prof Americo Cicchetti, Director of the Graduate School of Health Economics and Management (ALTEMS), Università Cattolica Sacro Cuore. The discussions centred around the implementation of the EU Health Technology Assessment Regulation, with a focus on stakeholder roles and the draft Terms of Reference. Acknowledging the vital role of stakeholders and their diverse expertise, the meeting highlighted the importance of HTA in evaluating medical, economic, social, and ethical aspects of health technologies. The EU HTA Regulation aims to enhance access, affordability, and quality of innovative technologies while respecting national authority responsibilities. HTA can assist health managers in making evidence-based decisions and enhancing the quality, equity, and efficiency of care delivery.
The inaugural meeting of the Health Technology Assessment Stakeholder Network took place in Brussels on 14 June. The meeting gathered 59 representatives from 44 stakeholder organisations, including EHMA, along with representatives from 16 Member States and the European Medicines Agency. Discussions focused on implementing the EU Health Technology Assessment Regulation, including stakeholder roles and the draft Terms of Reference of the HTA Stakeholder Network.
Health Technology Assessment summarises information about medical, economic, social and ethical issues related to the use of a health technology. Examples of health technologies include medicinal products, medical equipment for diagnostic and treatment, and prevention methods. When HTA bodies are asked to evaluate a new health technology, they have to assess whether it works better, equally well, or worse than existing alternatives. HTA assess the impact of health technologies on the organisation of healthcare systems in the administration of treatment.
Voluntary coordination between national authorities in the field of HTA existed for long years already before the EU Regulation on health technology assessment. Their collaboration was project-based, supported via the EUnetHTA joint actions. The EU HTA Regulation replaces now this voluntary-based collaboration by more structured and regulated clinical assessment efforts for more available, affordable, higher quality and safer innovative technologies and drugs. The principle of this new regulation is that the assessment remains only on clinical domains. National authority HTA bodies will keep their responsibilities to draw conclusions for any pricing or reimbursement decisions in their health system. The regulation respects timeliness, transparency and inclusiveness as values.
The EU HTA Regulation entered into force in 2022, and its direct application deadline by the member states as the highest-level and most binding EU legislative act is set by January 2025. To support this process, the European Commission is currently organising information sessions in all corners of Europe to raise awareness about this piece of legislation. In the Nordic countries one event, covering Finland, Denmark, Iceland and Norway took place in May, another one is planned in South-East Europe covering Greece, Cyprus, Bulgaria and Romania in September and another one, grouping Spain, Italy, Portugal and Malta is scheduled for November 2023, further information workshops will be organised in 2024.
The implementation is progressing gradually. The governance structure such as the coordination group of the national authorities, the subgroups around the HTA collaboration areas were brought into life in the course of 2022 and in early 2023. Additionally, complementing this governance structure, Article 29 of the Regulation stipulates that a stakeholder network has to be established through an open call to support the coordination group. The stakeholder network shall amongst others provide advice and expertise upon request to the coordination group and the subgroups. To this end, the stakeholder network was established in April 2023 and their first meeting took place in Brussels on 14 June 2023.
The framework of cooperation which the regulation formalises embraces the following areas: joint clinical assessment, joint scientific consultation, emerging health technologies and methodologies across the EU.
From the health management point of view, driven by the quality of care and patient safety, the clinical assessment of innovative technologies, devices and drugs is essential. EHMA being selected as one of the stakeholder organisations to act in support of the national authorities’ coordination group and the aforementioned four subgroups opens the door to the health management ecosystem to share its specific expertise and opinion for the benefit of European-level impartial clinical assessment of medical innovations. Following this first meeting between the coordination group and subgroup co-chairs, and the stakeholder organisations, concrete plans will be developed on the input requested from the stakeholders for each collaboration domain.
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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