Change in the model for establishing the Ukrainian Pharmaceutical Agency puts the reform at risk, EBA says

07/ 10/ 2026

The business community was surprised by the Government’s decision to change its approach to reorganising the State Service of Ukraine on Medicines and Drugs Control. Instead of dissolving the Service, the Government now proposes to rename it as the Ukrainian Pharmaceutical Agency, with its territorial bodies to be renamed as territorial bodies of the Ukrainian Pharmaceutical Agency. This approach differs fundamentally from the model approved by the Cabinet of Ministers of Ukraine, which envisaged establishing the Ukrainian Pharmaceutical Agency in 2027 as a new central executive body with a special status and dissolving the State Service on Medicines and Drugs Control (Resolution No. 739 of 4 June 2026). State authorities, businesses and other market stakeholders based their preparations for the transition to the new regulatory system on this model. The European Business Association has consistently supported the establishment of a modern, independent and professional state regulatory authority in the pharmaceutical sector as one of the key elements of the reform envisaged by the Law of Ukraine “On Medicinal Products” No. 2469-IX. Importantly, business was involved in discussions on the reform and had an opportunity to put forward its position. However, the change to the already approved model was not properly discussed with business and other stakeholders. Changing the approach just months before the launch of the new regulatory system creates additional uncertainty and raises questions about the transparency and consistency of the reform, as well as the predictability of state regulatory policy. In the business community’s view, this is not merely a technical change to the reorganisation process, but a change to the reform’s underlying concept. Renaming the existing institution does not provide the level of institutional renewal that underpinned the creation of the new regulator: a new governance system, modern regulatory processes, an updated organisational structure, a professional team and operating principles aligned with European approaches. It is also important to note that the introduction of a new regulatory funding model based on administrative fees, together with a significant increase in the financial burden on market participants, was justified by the need to establish a qualitatively new institution. Under these circumstances, effectively retaining the existing authority under a new name without a genuine institutional restart raises questions about whether the reform’s stated objectives can be achieved and about the rationale behind its new funding model. In the business community’s view, the new authority’s lack of readiness for full operation from 1 January 2027 should not become grounds for abandoning the concept of institutional renewal itself. If, for objective reasons, the state is not ready to ensure the establishment and full operation of the new regulatory authority within the set timeframe, a more responsible and consistent approach would be to provide for a clearly defined transition period and postpone the dissolution of the State Service on Medicines and Drugs Control and the launch of the new regulator until it is institutionally and operationally ready. This would make it possible to ensure continuity of critical regulatory processes while preserving the reform’s key objective — the establishment of a genuinely new, professional and independent regulator. In this regard, the European Business Association calls for the proposed approach to be reconsidered and for the model of establishing the Ukrainian Pharmaceutical Agency as a qualitatively new state regulatory authority to be maintained, with a realistic transition period provided, where necessary, to ensure its full launch.

This approach differs fundamentally from the model approved by the Cabinet of Ministers of Ukraine, which envisaged establishing the Ukrainian Pharmaceutical Agency in 2027 as a new central executive body with a special status and dissolving the State Service on Medicines and Drugs Control (Resolution No. 739 of 4 June 2026). State authorities, businesses and other market stakeholders based their preparations for the transition to the new regulatory system on this model.

The European Business Association has consistently supported the establishment of a modern, independent and professional state regulatory authority in the pharmaceutical sector as one of the key elements of the reform envisaged by the Law of Ukraine “On Medicinal Products” No. 2469-IX. Importantly, business was involved in discussions on the reform and had an opportunity to put forward its position.

However, the change to the already approved model was not properly discussed with business and other stakeholders. Changing the approach just months before the launch of the new regulatory system creates additional uncertainty and raises questions about the transparency and consistency of the reform, as well as the predictability of state regulatory policy.

In the business community’s view, this is not merely a technical change to the reorganisation process, but a change to the reform’s underlying concept. Renaming the existing institution does not provide the level of institutional renewal that underpinned the creation of the new regulator: a new governance system, modern regulatory processes, an updated organisational structure, a professional team and operating principles aligned with European approaches.

It is also important to note that the introduction of a new regulatory funding model based on administrative fees, together with a significant increase in the financial burden on market participants, was justified by the need to establish a qualitatively new institution. Under these circumstances, effectively retaining the existing authority under a new name without a genuine institutional restart raises questions about whether the reform’s stated objectives can be achieved and about the rationale behind its new funding model.

In the business community’s view, the new authority’s lack of readiness for full operation from 1 January 2027 should not become grounds for abandoning the concept of institutional renewal itself.

If, for objective reasons, the state is not ready to ensure the establishment and full operation of the new regulatory authority within the set timeframe, a more responsible and consistent approach would be to provide for a clearly defined transition period and postpone the dissolution of the State Service on Medicines and Drugs Control and the launch of the new regulator until it is institutionally and operationally ready.

This would make it possible to ensure continuity of critical regulatory processes while preserving the reform’s key objective — the establishment of a genuinely new, professional and independent regulator.

In this regard, the European Business Association calls for the proposed approach to be reconsidered and for the model of establishing the Ukrainian Pharmaceutical Agency as a qualitatively new state regulatory authority to be maintained, with a realistic transition period provided, where necessary, to ensure its full launch.