The new law “On Medicines” provides for the establishment of the State Control Body (SCB) – a central executive body with a special status, which implements the state policy in the sphere of creation, admission to the market, quality control, safety and efficacy of medicines. Most of the articles of this law are enacted 30 months after the end of martial law.
Preliminary work is already underway to launch the work of the joint control body in time. At a regular staff meeting, Ukrainian Health Minister Viktor Lyashko heard from Mykhaylo Babenko, director of the State Expert Center of the Ministry of Health of Ukraine, and Roman Isayenko, chairman of the State Service of Ukraine for Medicines and Drug Control, on their vision of the strategy for creating a new state control body in the sphere of circulation of medicines and other medical products.
The creation of a single national regulatory body is in line with the recommendations of the EU and WHO and is another step towards bringing the system of circulation of medicines in Ukraine in line with the EU legislation. This will allow, in particular, to speed up decision-making on the circulation of medicines and medical devices and, consequently, increase their accessibility for citizens.
Several options for the creation of a new state control body were presented for consideration, and the advantages and disadvantages of each of them were discussed. The most rational now seems to be the launching on the basis of the State Service for Regulation and Supervision, taking into account the fact that it is the most specialized central body of executive power in accordance with its functions. This, in turn, will ensure a smooth transfer of functions to the new regulatory body without the risk of a regulatory imbalance or vacuum during the transition period, since most of the functions to be assigned to the UDC are already performed by the Gosliksluzhba.
In addition, the generally accepted European model assumes that state regulation is carried out in one authorized body, similar to Gosliksluzhba, the structure and organization of which corresponds to the structure of national regulatory authorities in the vast majority of European countries. Gosliksluzhba already has a network of laboratories and territorial bodies in the regions of Ukraine and in Kiev, the functioning of which is provided for by the new version of the Law of Ukraine “On Medicinal Products”. It is also a member of or cooperates with virtually all relevant and/or foreign organizations related to the circulation of medicines and the health care system in general.
The participants of the meeting also discussed a roadmap for the creation of a single regulatory body with an indication of the main stages, possible risks and options for responding to them.
