Ukraine risks losing up to 75% of the clinical trials market if amendments to the Сlinical Trials Procedure are adopted

13/ 02/ 2026

The business community supports the development of university clinics and the strengthening of the scientific component in research, particularly academic research. At the same time, the proposed amendments to the Procedure for Conducting Clinical Trials create significant risks for market stability, the investment climate, and Ukraine’s fulfilment of its international commitments. According to member companies of the Clinical Trials Subcommittee of the European Business Association, the proposal to limit the conduct of clinical trials exclusively to university clinics and clinical bases of higher medical education institutions could reduce their number by nearly 75%. International experience shows that academic clinics account on average for around 35% of all research centres, while the majority of clinical trials are conducted by healthcare institutions that comply with Good Clinical Practice (ICH GCP) requirements, regardless of their ownership structure or organisational status. Under the EU–Ukraine Association Agreement, Ukraine has committed to harmonising pharmaceutical regulation, including clinical trial rules, with European standards. The new Law of Ukraine “On Medicinal Products”, which is due to enter into force on 1 January 2027, establishes regulation of clinical trials in line with the principles of Regulation (EU) No 536/2014. The proposed amendments contradict the European approach: Regulation (EU) No 536/2014 does not restrict the types of institutions eligible to conduct clinical trials and is based on the principle of equal access for all healthcare institutions that comply with GCP standards. Introducing selective organisational requirements in Ukraine would diverge from the European model and complicate integration into the EU’s single clinical trials market. According to conservative estimates by experts of the Association’s Subcommittee, the potential contraction of the clinical trials market could amount to USD 100–150 million per year. This would result in the loss of at least USD 13–20 million in direct tax revenues (approximately UAH 500–800 million) annually, excluding indirect economic losses, reduced employment, and lower local budget revenues. Clinical trials are not only about investment and taxes. For many patients, particularly those with oncological and autoimmune diseases, participation in trials provides real access to modern and innovative therapies that are typically unavailable under state funding programmes. A reduction in the number of research centres would directly limit such patients’ access to treatment. We are convinced that the development of university clinics is possible without narrowing the market or departing from international GCP standards. Ukraine must maintain its competitiveness in the global clinical trials market, and regulatory decisions should strengthen rather than weaken its position. The business community calls for a balanced and professional approach to the implementation of any changes that may create barriers to conducting clinical trials in Ukraine, especially in wartime conditions. This issue requires a thorough analysis of the economic consequences, an assessment of the impact on patients, and open dialogue with the expert community to develop a balanced model aligned with international practice and supportive of the country’s European integration course.

According to member companies of the Clinical Trials Subcommittee of the European Business Association, the proposal to limit the conduct of clinical trials exclusively to university clinics and clinical bases of higher medical education institutions could reduce their number by nearly 75%. International experience shows that academic clinics account on average for around 35% of all research centres, while the majority of clinical trials are conducted by healthcare institutions that comply with Good Clinical Practice (ICH GCP) requirements, regardless of their ownership structure or organisational status.

Under the EU–Ukraine Association Agreement, Ukraine has committed to harmonising pharmaceutical regulation, including clinical trial rules, with European standards. The new Law of Ukraine “On Medicinal Products”, which is due to enter into force on 1 January 2027, establishes regulation of clinical trials in line with the principles of Regulation (EU) No 536/2014. The proposed amendments contradict the European approach: Regulation (EU) No 536/2014 does not restrict the types of institutions eligible to conduct clinical trials and is based on the principle of equal access for all healthcare institutions that comply with GCP standards. Introducing selective organisational requirements in Ukraine would diverge from the European model and complicate integration into the EU’s single clinical trials market.

According to conservative estimates by experts of the Association’s Subcommittee, the potential contraction of the clinical trials market could amount to USD 100–150 million per year. This would result in the loss of at least USD 13–20 million in direct tax revenues (approximately UAH 500–800 million) annually, excluding indirect economic losses, reduced employment, and lower local budget revenues.

Clinical trials are not only about investment and taxes. For many patients, particularly those with oncological and autoimmune diseases, participation in trials provides real access to modern and innovative therapies that are typically unavailable under state funding programmes. A reduction in the number of research centres would directly limit such patients’ access to treatment.

We are convinced that the development of university clinics is possible without narrowing the market or departing from international GCP standards. Ukraine must maintain its competitiveness in the global clinical trials market, and regulatory decisions should strengthen rather than weaken its position.

The business community calls for a balanced and professional approach to the implementation of any changes that may create barriers to conducting clinical trials in Ukraine, especially in wartime conditions. This issue requires a thorough analysis of the economic consequences, an assessment of the impact on patients, and open dialogue with the expert community to develop a balanced model aligned with international practice and supportive of the country’s European integration course.