European policies on conflict of interest and internal control for Ukraine

On 10 April 2026, an online meeting was held within the framework of the EU–Ukraine Twinning Project “Support to the establishment of the state control authority for medicines and medical devices.” The event focused on conflict of interest prevention, internal control, auditing, and transparency mechanisms within regulatory authorities.

The meeting brought together representatives of the Ministry of Health of Ukraine, the State Service of Ukraine on Medicines and Drugs Control, the State Expert Center of the Ministry of Health of Ukraine, as well as experts from Poland and Lithuania.

Participants included Dovilė Marcinkė, Director of the State Medicines Control Agency of Lithuania and EU Member State Project Leader, Grzegorz Cessak, President of the Polish Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Maryna Slobodnichenko, Deputy Minister of Health of Ukraine for European Integration, and Twinning project experts.

Polish Experience: Internal Regulations and Quality Management System

Polish experts presented the approach used by the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products (URPL) for developing and implementing internal regulatory documents.

It was explained that internal regulations are based on EU legislation, national legal acts, EMA guidance, and good regulatory practices. The Agency applies an integrated quality management and management control system in line with ISO 9001 standards.

Particular attention was paid to transparency mechanisms, including public access to information, publication of regulatory documents, and participation in the Benchmarking of European Medicines Agencies (BEMA) programme.

Conflict of Interest and Cooperation with Experts

During the meeting, experts presented the Polish and Lithuanian approaches to conflict of interest management.

It was noted that legislation and internal policies require mandatory declarations of interests from employees, experts, and members of working groups, as well as procedures for assessing risks and excluding individuals from regulatory activities in cases of conflict of interest.

The Lithuanian side presented a comprehensive system combining national legislation, internal institutional policies, and EU and EMA requirements.

Experts also discussed practical aspects of reviewing declarations, participation of inspectors in inspections, and application of impartiality principles in regulatory work.

Internal Audit and Internal Control

A separate part of the meeting focused on internal audit and internal control systems.

Polish experts explained the distinction between audit and control, emphasising that these are separate functions with different procedures, standards, and reporting mechanisms.

The discussion also covered risk assessment, annual planning of audits and controls, independence of auditors and controllers, and procedures for conducting inspections and responding to identified irregularities.

Public Procurement and Transparency

Representatives of the Polish side also presented the public procurement framework based on EU legislation and the principles of transparency, equal treatment of participants, and efficient management of public funds.

It was noted that procurement procedures include appeal mechanisms, control instruments, and requirements for public access to information.

Next Steps

Following the meeting, the Polish side confirmed its readiness to share internal policies, examples of regulatory documents, and materials related to conflict of interest management with the Ukrainian partners.

The participants also agreed to continue cooperation on the development of internal policies for the future Ukrainian regulatory authority.

The presentations delivered during the meeting are attached for reference.