Health Care, Clinical Trials

05/ 02/ 2026

On 5 February, representatives of the European Business Association met with Viktor Liashko, Minister of Health of Ukraine; Edem Adamanov, newly appointed Director of the State Expert Centre of the Ministry of Health of Ukraine; Volodymyr Korolenko, Acting Head of the State Service of Ukraine on Medicines and Drugs Control; and their colleagues. The meeting was attended by Anna Bezruk, Manager of the Association’s Health Care Committee; Iryna Mahdik, Executive Director of the Clinical Trials Subcommittee; and members of the Boards of the Committee and Subcommittee. During the meeting, representatives of the EBA discussed with the heads of the relevant authorities and their teams a range of key sectoral issues important to the Association’s business community, as well as further avenues for cooperation. In particular, the discussion covered: The Ministry’s plans for changes in the regulation of the medicines, medical devices and clinical trials markets, and continued cooperation with the Association; Systemic solutions to expand patient access to treatment, including a new co-payment mechanism for medicines within the reimbursement programme, synchronisation of price lists, planned expansion of the programme in 2027, and the practical impact of certain regulatory decisions adopted in 2025, such as the introduction of the National Price Catalogue; The impact of the proposed amendments to the Procedure for Conducting Clinical Trials on the availability of trials, and the need to develop a national strategy for the recovery and development of the clinical trials sector; European integration processes and institutional changes, including the establishment of a state supervisory authority and implementation of the new Law of Ukraine “On Medicinal Products”; Anti-crisis instruments to ensure the resilience of pharmaceutical supply chains under wartime conditions, including the possibility of simplified import procedures, recognition of GMP certificates issued by regulatory authorities of countries with stringent control systems, and expanded opportunities for importers and distributors. Representatives of the business community emphasised that, despite ongoing structured dialogue with the Ministry and joint efforts to ensure patient access to treatment during wartime, companies are increasingly experiencing a lack of regulatory predictability. Participants underlined the expectation of systemic reforms and the development of a modern regulatory framework that will ensure stable and transparent rules for the market — from the introduction of European approaches to regulatory procedures, the development of clinical trials and implementation of a national strategy in this area, to ensuring the continuity of medicine supply. The business community also highlighted the importance of the practical implementation of the new legislation, the timely adoption of secondary legislation, and a transparent model for launching the new state supervisory authority, to be developed in partnership with the market and in line with European approaches. In the view of companies, predictable regulatory policy and high-quality legislative reform are key prerequisites for improving patient access to treatment and ensuring the resilience of the pharmaceutical system in wartime conditions. The European Business Association expresses its sincere gratitude to the Minister and all colleagues for the open and constructive dialogue. The parties agreed to continue cooperation on the above issues. For its part, the Association remains ready to share its expertise and contribute to the development of effective solutions for the advancement of the sector.

The meeting was attended by Anna Bezruk, Manager of the Association’s Health Care Committee; Iryna Mahdik, Executive Director of the Clinical Trials Subcommittee; and members of the Boards of the Committee and Subcommittee.

During the meeting, representatives of the EBA discussed with the heads of the relevant authorities and their teams a range of key sectoral issues important to the Association’s business community, as well as further avenues for cooperation. In particular, the discussion covered:

The Ministry’s plans for changes in the regulation of the medicines, medical devices and clinical trials markets, and continued cooperation with the Association;
Systemic solutions to expand patient access to treatment, including a new co-payment mechanism for medicines within the reimbursement programme, synchronisation of price lists, planned expansion of the programme in 2027, and the practical impact of certain regulatory decisions adopted in 2025, such as the introduction of the National Price Catalogue;
The impact of the proposed amendments to the Procedure for Conducting Clinical Trials on the availability of trials, and the need to develop a national strategy for the recovery and development of the clinical trials sector;
European integration processes and institutional changes, including the establishment of a state supervisory authority and implementation of the new Law of Ukraine “On Medicinal Products”;
Anti-crisis instruments to ensure the resilience of pharmaceutical supply chains under wartime conditions, including the possibility of simplified import procedures, recognition of GMP certificates issued by regulatory authorities of countries with stringent control systems, and expanded opportunities for importers and distributors.

Representatives of the business community emphasised that, despite ongoing structured dialogue with the Ministry and joint efforts to ensure patient access to treatment during wartime, companies are increasingly experiencing a lack of regulatory predictability. Participants underlined the expectation of systemic reforms and the development of a modern regulatory framework that will ensure stable and transparent rules for the market — from the introduction of European approaches to regulatory procedures, the development of clinical trials and implementation of a national strategy in this area, to ensuring the continuity of medicine supply.

The business community also highlighted the importance of the practical implementation of the new legislation, the timely adoption of secondary legislation, and a transparent model for launching the new state supervisory authority, to be developed in partnership with the market and in line with European approaches. In the view of companies, predictable regulatory policy and high-quality legislative reform are key prerequisites for improving patient access to treatment and ensuring the resilience of the pharmaceutical system in wartime conditions.

The European Business Association expresses its sincere gratitude to the Minister and all colleagues for the open and constructive dialogue. The parties agreed to continue cooperation on the above issues. For its part, the Association remains ready to share its expertise and contribute to the development of effective solutions for the advancement of the sector.