The American Chamber of Commerce in Ukraine (the Chamber) is concerned about the lack of a solution to ensure continuity and consistency in the management of the State Expert Center of the Ministry of Health of Ukraine (SEC).
SEC is a state expert body with the main task to ensure the justification of the permit for medical use of high quality, effective and safe medicines, mainly through examining medicine materials for further registration in Ukraine.
Continuous, consistent, transparent, and effective work of this state body is of strategic importance for Ukraine's national security in the context of the pandemic of coronavirus infection (COVID-19) and providing patients with essential medicines. SEC has a critical allotted part in introducing highly effective tools for access to innovative medicines through the implementation of the healthcare technologies assessment and managed entry agreements.
Cessation, disruption, or postponement of important SEC decisions due to any factor will lead to:
- the collapse of the examination of medicines for the prevention and treatment of COVID-19;
- disruption of clinical trial projects involving critically ill patients;
- loss of achievements and opportunities expanding access to highly effective innovative medicines and medical devices;
- leveling efforts and work on Ukraine's investment attractiveness in the healthcare field.
Changing the SEC leadership in such a difficult time and, as a consequence, changing the course of work of the state expert body will have a significant destabilizing effect on medical reform processes, development of effective mechanisms to provide citizens with effective and safe medicines and medical devices, as well as important clinical trials.
According to Chamber member companies, in recent years, the SEC's work has been characterized by transparency in registration procedures and openness to their improvement, including implementing electronic solutions. There was a constructive dialogue with representatives of manufacturers of medicines and medical devices to find balanced solutions. Effective optimization of work processes, a high level of expertise, and readiness to implement new mechanisms to ensure access to innovative medicines were also acknowledged by the business community.
The American Chamber of Commerce in Ukraine calls on the Prime Minister of Ukraine Denys Shmygal and the Minister of Health of Ukraine Maxym Stepanov to ensure the continuous and consistent work of the State Expert Center of the Ministry of Health of Ukraine.