On September 6th, the European Commission and the Heads of Health Technology Assessment (HTA) Agencies Group (HAG) convened their sixth in a series of seven regional events across the European Union. This Budapest gathering brought together representatives from Slovenia, Hungary, Croatia, Czechia, and Slovakia, continuing the EU’s initiative to engage neighbouring countries in each session.
The primary objective of the event was to inform stakeholders about the impending changes due to the new HTA regulation, set to take effect in January 2025, and to prepare for broader awareness campaigns in each participating country. Attendees represented a diverse cross-section of the healthcare ecosystem, including national HTA administrators, patient associations, health professionals, scientific societies, industry representatives, national decision-makers, and regional health authorities.
The Health Technology Assessment Regulation (HTAR) represents a significant shift in how the European Union evaluates and adopts innovative health technologies. This new framework aims to improve patient access to cutting-edge medicines and medical devices while ensuring efficient resource allocation across member states. By establishing a Coordination Group of HTA authorities and a stakeholder network, the HTAR seeks to reduce duplication of efforts, enhance business predictability, and ensure the long-term sustainability of EU HTA cooperation. The regulation also emphasizes the involvement of patients, clinical experts, and other relevant stakeholders in joint clinical assessments and scientific consultations. As the European Commission actively works on its implementation, events like the Budapest gathering play a crucial role in preparing diverse stakeholders for this transformative change in the European healthcare landscape, promising a more harmonized and efficient approach to health technology assessment across the EU.
Slovenia’s delegation made a particularly strong showing, with approximately 20 participants who gathered for a pre-event dinner the evening before. Eva Turk, head of HTA at Slovenia’s Ministry of Health, captured a group selfie of the Slovenian contingent, with Gregor Cuzak visible at the far right.
The official proceedings, hosted at the National Centre for Public Health and Pharmacy, focused on three key areas:
1. Understanding key elements of the EU HTA Regulation
2. Challenges and opportunities in the implementation process
3. Involving stakeholders in EU HTA implementation
Two panel discussions emerged as highlights of the event. The first featured Heads of HTA Agencies, including Eva Turk representing Slovenia. The second panel brought together various stakeholders affected by HTA, with notable participation from Marko Korenjak, a Slovenian patient representative and President of the European Liver Patients Association (ELPA).
Mr. Béla Dajka from the Directorate-General for Health and Food Safety, European Commission, delivered the opening address, setting the tone for the day’s discussions. A key takeaway from the event was the imminent integration of the HTA process into Europe’s clinical, medical, and research landscape. HTA builds upon existing regulatory frameworks, envisioning a unified approach to drug development, medical devices, and healthcare management. This convergence is increasingly necessary as more therapies emerge in hybrid forms, combining drugs with medical devices and specific provisioning regimes—all crucial elements for achieving optimal therapeutic outcomes.
During the first session, a critical question was raised to EU and European Medicines Agency (EMA) representatives regarding the affordability of new therapies, particularly in the challenging area of rare diseases. Advanced Therapy Medicinal Products (ATMPs) for rare conditions have gained significant attention in the past decade but often come with prohibitively high costs, especially for ultra-rare diseases with very small patient populations.
Responding to this concern, Ms. Roisin Adams, Chair of the Member State Coordination Group on HTA, clarified that while HTA is not directly responsible for pricing—which remains at the discretion of developing companies—she acknowledged that current market entry prices are unsustainable. This response underscores the complex interplay between innovation, accessibility, and economic feasibility in the evolving European healthcare landscape.
For those interested in delving deeper into the HTA implementation process, comprehensive documentation is available in both English and Slovenian. The event agenda can also be accessed online for reference. We will provide a link to the event recording, which will provide valuable insights for those unable to attend in person, once it is available.
This Budapest gathering marks a significant step in preparing European stakeholders for the forthcoming changes in health technology assessment. As the January 2025 implementation date approaches, such regional events play a crucial role in fostering understanding, collaboration, and preparedness across EU member states.
Written by
Gregor Cuzak, on joint behalf of CTGCT and Patient Organisations Association of Slovenia