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Health Care, Clinical Trials

03/ 03/ 2026
  On 3 March, representatives of the European Business Association — Anna Bezruk, Health Сare Committee Manager, and Iryna Magdik, Clinical Trials Subcommittee Executive Director — took part in a meeting of the Subcommittee on the Adaptation of Ukrainian Legislation to EU Law under the Verkhovna Rada Committee on National Health, Medical Care, and Medical Insurance. The meeting was also attended by Olha Stefanishyna, Chair of the Subcommittee; Mykhailo Radutskyi, Chair of the Committee; Members of Parliament; Maryna Slobodnichenko, Deputy Minister of Health; as well as representatives from non-governmental organisations and business associations. The discussion focused on key issues regarding the Euro-integration of the pharmaceutical sector: the draft Resolution of the Cabinet of Ministers of Ukraine on the establishment of the Ukrainian Pharmaceutical Agency, the progress of the Twinning project, and the preparation of specialised draft laws to harmonise Ukrainian legislation with EU law. The Association presented its own amendments and comments to the draft resolution. According to representatives of the business community, the model of reorganisation rather than liquidation proposed by the draft resolution does not provide for a comprehensive institutional relaunch of the regulator. Given the systemic risks that have already manifested within the current functioning model of the state control body, the proposed approach fails to eliminate them or create the prerequisites for forming a modern, effective, and independent state control authority. At the same time, the Association emphasises the need to create a new, effective regulator and stresses the expediency of liquidating the State Service of Ukraine on Medicines and Drugs Control, using mechanisms that have already proven effective in Ukraine. In particular, the business community suggests taking into account the experience of institutional relaunching implemented during the establishment of the Bureau of Economic Security of Ukraine, as well as other examples of full state body restructuring. Such an approach would allow the formation of an independent body — the UPA — from scratch, with a professional team, transparent procedures, and updated operating principles. Significant attention was paid to the procedure for forming the UPA leadership. Anna Bezruk highlighted the importance of a maximally transparent and independent competitive selection process for the agencys head, with the mandatory involvement of international experts in the selection commission. This will help increase trust in the new institution, minimise risks of political or corrupt influence, and align with European governance standards. According to the business community, applying such approaches will foster a unified practice of requirements enforcement and enhance the investment attractiveness of the sector. Within its proposals to the draft, the Committee suggested approaches for organising and conducting the competition for the position of the Head of the Agency, in accordance with the Law of Ukraine On Medicinal Products No. 2469-IX. The issue of the future bodys powers was also raised. Some of the functions planned for transfer to the UPA are currently performed by the State Service on Medicines based on bylaws. Therefore, their transfer requires a comprehensive update of the regulatory framework to ensure legal continuity and avoid regulatory gaps. Similarly, technical regulation functions in the field of medical devices, currently held by the Ministry of Health of Ukraine, must be properly regulated to avoid legal conflicts. We are grateful for the opportunity to convey the position of the business community during this professional dialogue. The Association has submitted its proposals as part of the public consultation and hopes they will be taken into account. The European Business Association will continue to be actively involved in drafting the regulatory acts required to implement the new Law of Ukraine On Medicinal Products No. 2469-IX, aiming to establish a transparent, predictable, and EU-compliant regulatory environment for the pharmaceutical business and patients in Ukraine.
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On 3 March, representatives of the European Business Association — Anna Bezruk, Health Сare Committee Manager, and Iryna Magdik, Clinical Trials Subcommittee Executive Director — took part in a meeting of the Subcommittee on the Adaptation of Ukrainian Legislation to EU Law under the Verkhovna Rada Committee on National Health, Medical Care, and Medical Insurance.

The meeting was also attended by Olha Stefanishyna, Chair of the Subcommittee; Mykhailo Radutskyi, Chair of the Committee; Members of Parliament; Maryna Slobodnichenko, Deputy Minister of Health; as well as representatives from non-governmental organisations and business associations.

The discussion focused on key issues regarding the Euro-integration of the pharmaceutical sector: the draft Resolution of the Cabinet of Ministers of Ukraine on the establishment of the Ukrainian Pharmaceutical Agency, the progress of the Twinning project, and the preparation of specialised draft laws to harmonise Ukrainian legislation with EU law.

The Association presented its own amendments and comments to the draft resolution. According to representatives of the business community, the model of reorganisation rather than liquidation proposed by the draft resolution does not provide for a comprehensive institutional relaunch of the regulator. Given the systemic risks that have already manifested within the current functioning model of the state control body, the proposed approach fails to eliminate them or create the prerequisites for forming a modern, effective, and independent state control authority.

At the same time, the Association emphasises the need to create a new, effective regulator and stresses the expediency of liquidating the State Service of Ukraine on Medicines and Drugs Control, using mechanisms that have already proven effective in Ukraine. In particular, the business community suggests taking into account the experience of institutional relaunching implemented during the establishment of the Bureau of Economic Security of Ukraine, as well as other examples of full state body restructuring. Such an approach would allow the formation of an independent body — the UPA — ‘from scratch’, with a professional team, transparent procedures, and updated operating principles.

Significant attention was paid to the procedure for forming the UPA leadership. Anna Bezruk highlighted the importance of a maximally transparent and independent competitive selection process for the agency’s head, with the mandatory involvement of international experts in the selection commission. This will help increase trust in the new institution, minimise risks of political or corrupt influence, and align with European governance standards. According to the business community, applying such approaches will foster a unified practice of requirements enforcement and enhance the investment attractiveness of the sector. Within its proposals to the draft, the Committee suggested approaches for organising and conducting the competition for the position of the Head of the Agency, in accordance with the Law of Ukraine ‘On Medicinal Products’ No. 2469-IX.

The issue of the future body’s powers was also raised. Some of the functions planned for transfer to the UPA are currently performed by the State Service on Medicines based on bylaws. Therefore, their transfer requires a comprehensive update of the regulatory framework to ensure legal continuity and avoid regulatory gaps. Similarly, technical regulation functions in the field of medical devices, currently held by the Ministry of Health of Ukraine, must be properly regulated to avoid legal conflicts.

We are grateful for the opportunity to convey the position of the business community during this professional dialogue. The Association has submitted its proposals as part of the public consultation and hopes they will be taken into account.

The European Business Association will continue to be actively involved in drafting the regulatory acts required to implement the new Law of Ukraine ‘On Medicinal Products’ No. 2469-IX, aiming to establish a transparent, predictable, and EU-compliant regulatory environment for the pharmaceutical business and patients in Ukraine.

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