On 25-29 November 2024, an MoH delegation headed by Minister Viktor Liashko and Deputy Minister for European Integration Maryna Slobodnichenko made a working visit to Denmark. The State Expert Center was represented in the delegation by Director Mykhailo Babenko and Head of the HTA Department of the Center Oresta Piniazhko.
The purpose of the visit is to obtain practical recommendations on implementing EU acts in the process of establishing a regulatory authority in the pharmaceutical sector, as well as improving the public health system in Ukraine based on the experience of Denmark's advanced and well-functioning public health system.
Main tasks include:
- Further development of bilateral cooperation between the health authorities of Ukraine and Denmark
- Gaining experience in monitoring and actions to minimize the risks of antibiotic resistance
- Gaining knowledge about Denmark's experience in ensuring implementation of EU directives on medical devices
- Expanding cooperation between the Danish Medicines Agency and Ukrainian regulators
- Gaining knowledge about Denmark’s experience with HTA and medicinal product pricing
- Further strengthening of cooperation between healthcare institutions of Ukraine and Denmark, other important issues.
As part of the visit, the team of Ukrainian representatives visited the state research institute for combating infectious diseases Statens Serum Institute (SSI), during which they became familiar with the Institute's work, its role and tasks in the prevention and control of AMR. The delegation members were presented with Denmark's Program for Surveillance of Antimicrobial Consumption and the development of genomic epidemiology capacity in national reference laboratories in Europe.
Also, a visit was made to the WHO Regional Office for Europe, where current issues in Ukraine’s healthcare regarding improving patients’ access to medicinal products and global trends were discussed.
27-28 November: official meetings with representatives of the Danish Health Authority (DHA) and the Danish Medicines Agency (DKMA). The parties met to discuss current issues in the field of healthcare and to exchange experience in order to improve the pharmaceutical sector, based on the experience of Denmark's advanced and well-functioning regulatory system.
During the meeting at the Danish Health Authority, the parties exchanged experience on action plans and priorities in the field of mental health in Denmark and Ukraine.
At the meeting at the Danish Medicines Agency, the Agency’s representatives spoke about its role and powers in medicinal product registration, pharmacovigilance and the regulation of medical devices.
For its part, the Ukrainian side presented the medicines regulation system in Ukraine. The Director of the Center Mykhailo Babenko presented the structure and statutory tasks of the Center, its areas of authority, its role in the healthcare system, the system of registration of medicinal products, and steps toward the creation of the ODK.
A separate thematic session was devoted to improving access to medicinal products and discussing approaches to pricing and reimbursement in Denmark. Representatives of the Danish side presented the principles of pricing of medicinal products for both hospital (in patient sector) and outpatient (out patient sector) provision. It was noted that there is a single price for a given medicinal product in every pharmacy in Denmark; free price formation for reimbursement, with the subsequent submission of price offers by applicants (ensuring competition), and obtaining low prices for reimbursement. For hospital provision, price negotiations and tenders are held.
During the discussion, Oresta Piniazhko shared experience in implementing a health technology assessment tool in Ukraine for the well-founded rational selection of new medicinal products for inclusion in regulatory lists. She also spoke about the use of medicinal product pricing tools such as external and internal reference pricing and value-based pricing (HTA).
