Mykhailo Babenko, as part of the MoH delegation headed by Deputy Minister of Health of Ukraine for European Integration Maryna Slobodnichenko, visited the Swedish Medical Products Agency (Läkemedelsverket) in Uppsala, Kingdom of Sweden, on a working business trip.
The visit took place on March 14-15 at the invitation of the Agency’s Director General, Doctor of Medical Sciences Bjorn Erikson.
The purpose is to deepen bilateral relations between the Center and the Swedish Medical Products Agency within the framework of the signed Memorandum of Understanding; to exchange experience on establishing a single state control authority for medicinal products and other medical products; to improve the compliance of procedures regulating the circulation of medicinal products in Ukraine with EU standards and international agreements; to exchange experience on crisis management.
The Ukrainian delegation also included: Taras Liaskovskyi, Head of the Pharmaceutical Directorate of the Ministry of Health of Ukraine; Hanna Husieva, Deputy Director of the Center for Legal Affairs; and representatives of the SAFEMed/USAID project.
During the first day of the business trip, representatives of the Ukrainian side familiarized themselves with the work of the Agency and discussed a number of issues:
- main areas of activity and powers
- personnel management
- funding structure and fees
- procedures for regulating medical devices and cosmetics
- national procedure for the regulation of medicinal products
- information systems
- regulation and inspection of pharmacies.
During the second day of the trip, they became familiar with the work of the official medicines quality control laboratory under the Swedish regulator, and also took part, as honored guests, in the “Director General's Dialogue” — the Agency's annual report to its employees.
In a short panel presentation, M. Babenko thanked Björn Eriksson and the Swedish colleagues for the close cooperation under the concluded Memorandum, for the support, and for the valuable experience that the Center and the healthcare sector gain from this cooperation.
"Thank you for the opportunity to visit the MPA again and personally to Mr. Björn for the invitation. We have been working closely together since 2023 and highly value Sweden's experience in regulating registration procedures, clinical trials, pharmacovigilance and the work of the agency as a whole, which they shared during our thematic forums. We are now on the way to a major reform of the national regulatory authority in Ukraine. The functions of three separate institutions will be combined under one roof, and it is very important for us to study management approaches in various EU countries. The MPA is one of the most interesting examples for us. Thanks to these two days, we explored many aspects of personnel management, agency financing and IT technologies, and we will definitely apply this experience in building the new regulatory authority in Ukraine," – noted Mykhailo Babenko.
At the request of the Swedish side, the head of the Ukrainian delegation Maryna Slobodnichenko gave a presentation in which she described the experience of managing crisis situations and shortages of medical products during the full-scale invasion and martial law.
She noted that global health crises are challenges for the governance systems of many states in the modern world. The invasion by the russian federation and the introduction of martial law on the territory of Ukraine have significantly affected the healthcare system. In connection with the new challenges facing the world community, there is a need to further build capacity and the ability to maintain crisis management, and, I believe, Ukraine's experience is useful for global regulators.
At the end of the meeting, the parties discussed further ways of cooperation.
The delegation expresses gratitude to the SAFEMed project and personally to Olena Filiniuk for comprehensive support and assistance in organizing the visit to Sweden.
