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EBA Health Care Committee met with the Minister of Health

30/ 04/ 2026
  On 27 April, representatives of the European Business Association’s Health Care Committee met with Viktor Liashko, Minister of Health of Ukraine, to discuss key issues related to the development of the pharmaceutical sector, the medical devices market, and clinical research. The meeting was also attended by Deputy Minister Yevhenii Honchar, Deputy Minister for European Integration Maryna Slobodnichenko, as well as heads of профильних state institutions, including Acting Head of the State Service of Ukraine on Medicines and Drugs Control Volodymyr Korolenko, Director of the State Expert Centre of the Ministry of Health Edem Adamanov, and others. From the Association’s side, participants included Anna Bezruk, Manager of the Health Care Committee, Iryna Magdik, Executive Director of the Clinical Trials Subcommittee, and members of the Committee and Subcommittee boards. Business representatives emphasised that, despite the open dialogue with the Ministry of Health and positive progress in certain areas, a number of systemic issues remain unresolved and continue to pose risks to the stability of the pharmaceutical market. Companies stressed the need for a systematic approach to legislative implementation, as well as the introduction of clear rules and coordinated processes to support market stability and enable effective planning. The discussion also covered transitional periods in the context of implementing new legislation, particularly regarding the circulation of medicinal products registered before the law enters into force, and the need to ensure their continued availability on the market during the transition phase. The Ministry of Health presented a list of key secondary legislation currently being developed to implement the new Law of Ukraine “On Medicinal Products”, along with indicative timelines for their adoption. Particular attention was paid to ensuring continuity of medicine supply, improving patient access to treatment, and removing regulatory barriers affecting market operations. Representatives of the Association and member companies once again highlighted the importance of adopting European approaches to recognising GMP certificates. The current model complicates market access for medicinal products in Ukraine, effectively turning the GMP certification process into a trade barrier for European businesses. Participants also discussed the Association’s position on amendments to licensing requirements for warehouses during wartime, which would allow companies to respond swiftly to the loss or damage of infrastructure and avoid disruptions in the supply of medicines. The parties agreed to continue working on the relevant proposals. Regarding patient access to treatment, the business community highlighted current challenges in the functioning of the “Affordable Medicines” reimbursement programme. While Association member companies generally support its further expansion, they expect additional clarification from the Ministry on how this expansion will be implemented. In this context, it is important to establish clear and well-structured approaches so that businesses can adapt their processes in a timely manner, ensuring uninterrupted supply and patient access to treatment. The parties also discussed the need to synchronise the National Price Catalogue with the list of reimbursable medicines as an important prerequisite for the predictable functioning of the programme and reliable patient access. In addition, the meeting addressed practical aspects of conducting clinical trials, including the need for Ministry support in resolving issues related to the re-export of equipment after the completion of trials, including equipment containing controlled substances. The importance of adhering to established timelines for issuing Ministry orders on clinical trials and approving substantial amendments, in line with Order No. 690, was also highlighted. Furthermore, participants discussed the regulation of medical devices, particularly the need for a clear separation of functions related to technical regulation, market surveillance, and control, in order to avoid potential conflicts of interest when shaping a new institutional framework. The European Business Association’s Health Care Committee thanks the Minister and all participants for the open discussion and looks forward to continued constructive cooperation on issues aimed at developing the sector, improving patient access to treatment, and supporting the advancement of clinical research in Ukraine.
01/

On 27 April, representatives of the European Business Association’s Health Care Committee met with Viktor Liashko, Minister of Health of Ukraine, to discuss key issues related to the development of the pharmaceutical sector, the medical devices market, and clinical research.

The meeting was also attended by Deputy Minister Yevhenii Honchar, Deputy Minister for European Integration Maryna Slobodnichenko, as well as heads of профильних state institutions, including Acting Head of the State Service of Ukraine on Medicines and Drugs Control Volodymyr Korolenko, Director of the State Expert Centre of the Ministry of Health Edem Adamanov, and others. From the Association’s side, participants included Anna Bezruk, Manager of the Health Care Committee, Iryna Magdik, Executive Director of the Clinical Trials Subcommittee, and members of the Committee and Subcommittee boards.

Business representatives emphasised that, despite the open dialogue with the Ministry of Health and positive progress in certain areas, a number of systemic issues remain unresolved and continue to pose risks to the stability of the pharmaceutical market. Companies stressed the need for a systematic approach to legislative implementation, as well as the introduction of clear rules and coordinated processes to support market stability and enable effective planning.

The discussion also covered transitional periods in the context of implementing new legislation, particularly regarding the circulation of medicinal products registered before the law enters into force, and the need to ensure their continued availability on the market during the transition phase.

The Ministry of Health presented a list of key secondary legislation currently being developed to implement the new Law of Ukraine “On Medicinal Products”, along with indicative timelines for their adoption.

Particular attention was paid to ensuring continuity of medicine supply, improving patient access to treatment, and removing regulatory barriers affecting market operations. Representatives of the Association and member companies once again highlighted the importance of adopting European approaches to recognising GMP certificates. The current model complicates market access for medicinal products in Ukraine, effectively turning the GMP certification process into a trade barrier for European businesses.

Participants also discussed the Association’s position on amendments to licensing requirements for warehouses during wartime, which would allow companies to respond swiftly to the loss or damage of infrastructure and avoid disruptions in the supply of medicines. The parties agreed to continue working on the relevant proposals.

Regarding patient access to treatment, the business community highlighted current challenges in the functioning of the “Affordable Medicines” reimbursement programme. While Association member companies generally support its further expansion, they expect additional clarification from the Ministry on how this expansion will be implemented. In this context, it is important to establish clear and well-structured approaches so that businesses can adapt their processes in a timely manner, ensuring uninterrupted supply and patient access to treatment.

The parties also discussed the need to synchronise the National Price Catalogue with the list of reimbursable medicines as an important prerequisite for the predictable functioning of the programme and reliable patient access.

In addition, the meeting addressed practical aspects of conducting clinical trials, including the need for Ministry support in resolving issues related to the re-export of equipment after the completion of trials, including equipment containing controlled substances. The importance of adhering to established timelines for issuing Ministry orders on clinical trials and approving substantial amendments, in line with Order No. 690, was also highlighted.

Furthermore, participants discussed the regulation of medical devices, particularly the need for a clear separation of functions related to technical regulation, market surveillance, and control, in order to avoid potential conflicts of interest when shaping a new institutional framework.

The European Business Association’s Health Care Committee thanks the Minister and all participants for the open discussion and looks forward to continued constructive cooperation on issues aimed at developing the sector, improving patient access to treatment, and supporting the advancement of clinical research in Ukraine.

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