Health Care, Clinical Trials

11/ 02/ 2026

On February 11, the Healthcare Committee and the Clinical Trials Subcommittee of the European Business Association took part in a working meeting with representatives of the Pharmaceutical Department of the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control. Participants discussed urgent legislative changes necessary for the stable functioning of the sector, as well as issues related to the entry into force of the new Law of Ukraine “On Medicinal Products” No. 2469-IX starting January 1, 2027. At the beginning of the meeting, Acting Head of the Pharmaceutical Department of the MoH, Oleksandr Hrytsenko, presented the Ministry’s position in response to the well-grounded risk assessment information previously shared by the Clinical Trials Subcommittee during meetings with the Minister of Health on February 5 and with the Director of the State Expert Center on February 10. In particular, this concerned potentially significant negative consequences for the clinical trials market in Ukraine, the investment climate, and Ukraine’s international commitments should the proposed amendments to Order No. 690 be adopted. These amendments would limit clinical trials exclusively to university clinics and teaching hospital bases. According to industry estimates, such an initiative could lead to a 75% reduction in the number of clinical trials. Mr. Hrytsenko noted that the information provided is currently being reviewed on the MoH platform and that the arguments presented during the meetings will be taken into account in further internal discussions on the draft regulation. Functioning of the National Price Catalogue. The practical operation of the National Price Catalogue (NPC) remains unpredictable and non-transparent. Prolonged delays in the review of applications, the absence of clearly established legislative procedures for price revisions and approvals, additional non-formalized requirements for justifications, and insufficient systematic communication create significant operational risks. In addition, the coexistence of two non-synchronized price lists — the NPC and the reimbursement list — remains an unresolved issue. The Committee emphasized the need to ensure timely updates, synchronization of both lists, and greater transparency and predictability of NPC operations. Adoption of technical regulations for medical devices and in vitro diagnostic medical devices. The business community supports harmonization with European legislation while stressing the importance of a realistic, phased transition period that takes into account market readiness and regulatory infrastructure. Restrictions limiting hospital pharmacies to the three lowest-priced medicines, introduced by Resolution No. 1802, were also discussed. According to the business community, such measures may narrow the product range and negatively affect patients’ access to treatment. Launch of the State Control Authority in accordance with the new law was highlighted as a priority — including the timely approval of the Regulation on the authority, a transparent methodology for fees and charges, the cost of expert evaluations, new Licensing Conditions, procedures for quality control, registration of medicinal products, and other secondary legislation. Predictable, clear, and economically justified rules are critical for industry stability and a favorable investment climate. Cancellation of the procedure for obtaining GMP conclusions and automatic recognition of GMP certificates issued by stringent regulatory authorities was also supported, as this would reduce administrative burden, minimize import delays, and ensure uninterrupted supply of medicines. We thank the teams of the Ministry of Health and the State Service on Medicines for the open, professional, and constructive dialogue. We are confident that such cooperation will strengthen Ukraine’s healthcare system and expand patients’ access to high-quality and innovative medicines.

On February 11, the Healthcare Committee and the Clinical Trials Subcommittee of the European Business Association took part in a working meeting with representatives of the Pharmaceutical Department of the Ministry of Health of Ukraine and the State Service of Ukraine on Medicines and Drugs Control.

Participants discussed urgent legislative changes necessary for the stable functioning of the sector, as well as issues related to the entry into force of the new Law of Ukraine “On Medicinal Products” No. 2469-IX starting January 1, 2027.

At the beginning of the meeting, Acting Head of the Pharmaceutical Department of the MoH, Oleksandr Hrytsenko, presented the Ministry’s position in response to the well-grounded risk assessment information previously shared by the Clinical Trials Subcommittee during meetings with the Minister of Health on February 5 and with the Director of the State Expert Center on February 10. In particular, this concerned potentially significant negative consequences for the clinical trials market in Ukraine, the investment climate, and Ukraine’s international commitments should the proposed amendments to Order No. 690 be adopted. These amendments would limit clinical trials exclusively to university clinics and teaching hospital bases. According to industry estimates, such an initiative could lead to a 75% reduction in the number of clinical trials. Mr. Hrytsenko noted that the information provided is currently being reviewed on the MoH platform and that the arguments presented during the meetings will be taken into account in further internal discussions on the draft regulation.

Functioning of the National Price Catalogue. The practical operation of the National Price Catalogue (NPC) remains unpredictable and non-transparent. Prolonged delays in the review of applications, the absence of clearly established legislative procedures for price revisions and approvals, additional non-formalized requirements for justifications, and insufficient systematic communication create significant operational risks. In addition, the coexistence of two non-synchronized price lists — the NPC and the reimbursement list — remains an unresolved issue. The Committee emphasized the need to ensure timely updates, synchronization of both lists, and greater transparency and predictability of NPC operations.

Adoption of technical regulations for medical devices and in vitro diagnostic medical devices. The business community supports harmonization with European legislation while stressing the importance of a realistic, phased transition period that takes into account market readiness and regulatory infrastructure.

Restrictions limiting hospital pharmacies to the three lowest-priced medicines, introduced by Resolution No. 1802, were also discussed. According to the business community, such measures may narrow the product range and negatively affect patients’ access to treatment.

Launch of the State Control Authority in accordance with the new law was highlighted as a priority — including the timely approval of the Regulation on the authority, a transparent methodology for fees and charges, the cost of expert evaluations, new Licensing Conditions, procedures for quality control, registration of medicinal products, and other secondary legislation. Predictable, clear, and economically justified rules are critical for industry stability and a favorable investment climate.

Cancellation of the procedure for obtaining GMP conclusions and automatic recognition of GMP certificates issued by stringent regulatory authorities was also supported, as this would reduce administrative burden, minimize import delays, and ensure uninterrupted supply of medicines.

We thank the teams of the Ministry of Health and the State Service on Medicines for the open, professional, and constructive dialogue. We are confident that such cooperation will strengthen Ukraine’s healthcare system and expand patients’ access to high-quality and innovative medicines.