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On 19 May, the Health Care Committee of the European Business Association held a webinar featuring Ukrainian and international experts titled \u201cHTA Development: Current Changes and the Future of Medical Devices<\/strong>\u201d. The event focused on recent developments in the health technology assessment (HTA) system in Ukraine, the evolution of approaches to assessing medical devices, and international experience in shaping evidence-based healthcare policies.<\/p>\n The event brought together representatives of the Ministry of Health of Ukraine, the State Expert Centre of the Ministry of Health of Ukraine, international experts, as well as members of the business and professional communities. The discussion was moderated by Anna Bezruk, Manager of the Health Care Committee of the European Business Association.<\/p>\n Development of the HTA System in Ukraine<\/strong><\/p>\n Opening the event, Yevhenii Honchar, Deputy Minister of Health of Ukraine<\/strong>, and Edem Adamanov, Director of the State Expert Centre of the Ministry of Health of Ukraine<\/strong>, emphasised the importance of further developing the HTA system in Ukraine, strengthening cross-sectoral dialogue, and implementing international approaches to health technology assessment.<\/p>\n In his remarks, Yevhenii Honchar noted that HTA has already become a fully-fledged evidence-based decision-making tool for the Ministry of Health, enabling consideration of both clinical effectiveness and the financial capacity of the healthcare system. According to him, over recent years Ukraine\u2019s HTA system has evolved from a fragmented approach into an institutionalised process, and state HTA conclusions now form the basis for decisions on inclusion in the National List of Medicines, centralised procurement, and managed entry agreements.<\/p>\n The speaker also paid particular attention to the European integration dimension. He stressed that the adoption of amendments to Resolution No. 1300 marked an important step towards alignment with European approaches, as the changes provide for the recognition of EU clinical assessment results. At the same time, economic assessment, as in EU countries, will remain a national competence.<\/p>\n Edem Adamanov noted that Ukraine has already developed core expertise in HTA for medicinal products, while the next stage should focus on advancing HTA for medical devices. According to him, the emergence of new technologies \u2014 including AI-based solutions, software, and digital diagnostic tools \u2014 creates new challenges for the system. Therefore, strengthening expertise and institutional capacity will become particularly important in 2026.<\/p>\n Harmonisation with European Approaches and International Experience<\/strong><\/p>\n During the first session, Oresta Piniazhko<\/strong> presented the current state of HTA development in Ukraine, the key stages in establishing the health technology assessment system, and its future directions. In particular, participants discussed the evolution of HTA processes \u2014 from the establishment of a dedicated department within the State Expert Centre to the launch of scientific consultation procedures and the adoption in 2025 of national HTA guidelines for medical devices.<\/p>\n Participants also focused on harmonisation with European practices. The session presented approaches to joint clinical HTA under EU Regulation 2021\/2282 and discussed prospects for Ukraine\u2019s further integration into the European regulatory framework.<\/p>\n Rabia Sucu, former President of Health Technology Assessment international (HTAi), Vice President of Science and Scientific Director at Turkish Red Crescent Investment<\/strong>, shared international experience and global HTA trends. In her presentation, she focused on the changing role of HTA in modern healthcare systems amid financial challenges, rapid innovation, and the growing need to ensure sustainability. She also addressed issues of prioritisation and equal access to medical technologies, stressing the need to establish a direct link between positive HTA outcomes and the inclusion of technologies in public funding programmes.<\/p>\n Specific Features of HTA for Medical Devices<\/strong><\/p>\n The second session focused on the specific features of medical device assessment and the differences between HTA approaches for medical devices and medicinal products. Richard Charter, Co-Chair of the HTAi Medical Device Interest Group and an expert in MedTech and HTA<\/strong>, discussed the practical and methodological aspects of HTA for medical devices.<\/p>\n According to him, medical devices have shorter life cycles, faster technological updates, and different approaches to evidence generation. In addition, the effectiveness of such technologies largely depends on users, staff training, and the infrastructural readiness of healthcare institutions.<\/p>\n In this context, Real-World Evidence plays a particularly important role in HTA for medical devices, as it is often more relevant for assessing MedTech than traditional randomised clinical trials used for medicinal products. Participants also discussed challenges associated with increasing clinical evidence requirements under the European MDR and IVDR regulations and their impact on the development of HTA for medical devices.<\/p>\n Richard Charter also shared global approaches to policymaking in the field of HTA for MedTech. Among the key priorities, he highlighted the development of research and analytics to support evidence-based policymaking for medical devices, advancing dialogue on HTA methodologies for MedTech, and broader stakeholder engagement in shaping policies and approaches.<\/p>\n The UK Experience<\/strong><\/p>\n Dr Anastasia Chalkidou, Programme Director for Health Technology Evaluation at the National Institute for Health and Care Excellence (NICE)<\/strong>, presented the UK experience. She spoke about the transition to a single HealthTech programme, which replaced four separate assessment programmes.<\/p>\n The new model is based on a lifecycle approach, which provides different assessment pathways depending on the maturity of the product \u2014 from early value assessment for the rapid adoption of promising AI tools with parallel evidence generation to full assessment for wider use.<\/p>\n A landmark step in this transformation was the launch of the National HealthTech Access Programme, which from 2026 grants selected medical technologies mandatory funding status on a par with medicines. This ensures patient access to such technologies within the UK\u2019s public healthcare system.<\/p>\n Event Outcomes<\/strong><\/p>\n Participants also discussed evidence generation for medical devices, the role of real-world clinical data in HTA processes, the importance of early dialogue between technology developers and HTA bodies, and the future prospects for medical device assessment in Ukraine.<\/p>\n The Health Care Committee of the European Business Association continues to actively foster international cooperation and professional dialogue with leading international experts, HTA institutions, and regulatory authorities. Such communication promotes the exchange of practical experience, the development of modern HTA approaches, and a better understanding of how assessment outcomes can be integrated into public funding, reimbursement, procurement, and the creation of a more effective and patient-centred healthcare system.<\/p>\n The Health Care Committee of the European Business Association thanks the speakers and participants for the professional and insightful discussion.<\/p>\n <\/p>","protected":false},"excerpt":{"rendered":" On 19 May, the Health Care Committee of the European Business Association held a webinar featuring Ukrainian and international experts titled \u201cHTA Development: Current Changes and the Future of Medical Devices\u201d. The event focused on recent developments in the health technology assessment (HTA) system in Ukraine, the evolution of approaches to assessing medical devices, and […]<\/p>\n","protected":false},"author":33544,"featured_media":744563,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false},"categories":[4,5,22],"tags":[],"yoast_head":"\n