The Law of Ukraine “On Medicines” provides for the creation of the Ukrainian Pharmaceutical Agency, which will start operating on January 1, 2027. The agency will control the circulation of medicines, medical products, blood, narcotic and psychotropic substances, precursors, cosmetics, and substances of human origin (SoHO) in accordance with European standards. This is one of the key conditions for Ukraine's accession to the EU.
The draft government resolution on the establishment of the agency defines the mechanism for its creation, functions, sources of funding, and staffing structure.
"Among the issues under discussion are the scope of the organization's powers, the procedure for the competition for the position of head, and the format of the reorganization of the State Service of Ukraine on Medicines and Drugs Control and the State Agency for the Control of Narcotic Drugs (merger or liquidation). In my opinion, we have successful examples of open competitions with the participation of international partners — for the positions of heads of NABU (National Anti-Corruption Bureau of Ukraine), SAP (Specialized Anti-Corruption Prosecutor), NACP (National Agency on Corruption Prevention), and FIS (Financial Investigation Service). There is no need to invent anything new; it is worth applying a proven procedure," emphasised Mykhailo Radutskyi, Chairman of the Committee on National Health.
According to him, thanks to the support of the European Commission, Ukraine is accelerating the creation of the Ukrainian Pharmaceutical Agency. Since October last year, the Twinning project has been underway, implemented by a consortium of experts from Lithuania, Poland, and Germany. The Twinning project is directly aimed at implementing the idea of creating the agency and provides advice and support on three key issues: preparing regulatory acts in accordance with EU standards, developing the structure of a single regulator, and training Ukrainian specialists. Experts are currently preparing decisions that Ukraine will implement when creating the agency.
During the subcommittee meeting, they also talked about the plan to prepare European integration bills, which the Committee is working on together with the Ministry of Health.
It particular it was about:
amendments to the law on medicine in according to the EU requirements;
regulation of substances of human origin (SoHO);
development of cross-border healthcare;
issues related to psychoactive substances;
ratification of the WHO Protocol to Eliminate Illicit Trade in Tobacco Products.
The subcommittee meeting was attended by members of the Ukrainian parliament, the Deputy Minister of Health, and representatives of civil society organizations and business associations.