The European Business Association participated in the Ukraine Pharmacy Summit 2025

09/ 12/ 2025

On 1 December, Anna Bezruk, Manager of the European Business Association’s Health Care Committee, spoke at the Ukraine Pharmacy Summit 2025, which brought together leading pharmacy retailers, representatives of pharmaceutical companies, and industry experts. One of the key topics of discussion was the market’s readiness for the implementation of the new Law of Ukraine “On Medicinal Products”. The EBA fully supports the objectives of the Law, aimed at harmonising Ukrainian legislation with EU regulations and raising standards of quality, efficacy, and safety of medicinal products. The business community views the implementation of the Law as a strategic step towards building a transparent, competitive market that is integrated with the European Union. At the same time, Anna Bezruk highlighted several challenges, particularly the tight timelines and the readiness of the regulatory infrastructure. Since the Law enters into force on 1 January 2027, it is critically important to ensure the timely adoption of secondary legislation in the areas of registration, licensing, pharmacovigilance, quality control, and verification. Representing the position of the EBA business community, Anna Bezruk stressed that companies need an adequate transition period, clear requirements, and realistic timelines to adapt their operations to the new standards. Among the Association’s key recommendations are: Prioritising the preparation of draft secondary legislation, ensuring public consultation and official approval no later than six months before the relevant provisions come into force; Involving business in the development of regulatory documents, including through the creation of working groups with the participation of the state and industry; Taking a balanced approach to determining the fees and charges of the future state control body, with consideration of Ukraine’s economic context, market specifics, and differences in the “value” of regulatory services compared with EU regulators; Ensuring a transparent and open competitive selection of the head, deputies, department directors, and key experts of the future State Control Body. The EBA business community supports the establishment of an independent and effective state control authority and is ready to contribute to its development. At the same time, companies expect the authority’s financial model to be transparent and economically sound. The European Business Association extends its gratitude to the organisers for the opportunity to convey the business community’s voice to market participants and stands ready to continue working actively towards building a stable, predictable, and EU-integrated regulatory environment in Ukraine.

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The EBA fully supports the objectives of the Law, aimed at harmonising Ukrainian legislation with EU regulations and raising standards of quality, efficacy, and safety of medicinal products. The business community views the implementation of the Law as a strategic step towards building a transparent, competitive market that is integrated with the European Union.

At the same time, Anna Bezruk highlighted several challenges, particularly the tight timelines and the readiness of the regulatory infrastructure. Since the Law enters into force on 1 January 2027, it is critically important to ensure the timely adoption of secondary legislation in the areas of registration, licensing, pharmacovigilance, quality control, and verification.

Representing the position of the EBA business community, Anna Bezruk stressed that companies need an adequate transition period, clear requirements, and realistic timelines to adapt their operations to the new standards. Among the Association’s key recommendations are:

Prioritising the preparation of draft secondary legislation, ensuring public consultation and official approval no later than six months before the relevant provisions come into force;
Involving business in the development of regulatory documents, including through the creation of working groups with the participation of the state and industry;
Taking a balanced approach to determining the fees and charges of the future state control body, with consideration of Ukraine’s economic context, market specifics, and differences in the “value” of regulatory services compared with EU regulators;
Ensuring a transparent and open competitive selection of the head, deputies, department directors, and key experts of the future State Control Body.

The EBA business community supports the establishment of an independent and effective state control authority and is ready to contribute to its development. At the same time, companies expect the authority’s financial model to be transparent and economically sound.

The European Business Association extends its gratitude to the organisers for the opportunity to convey the business community’s voice to market participants and stands ready to continue working actively towards building a stable, predictable, and EU-integrated regulatory environment in Ukraine.