The establishment of a unified state control body (USCB) in the pharmaceutical market, which has been ongoing for 2.5 years, should be a top priority, believes Sergey Sur, the director of the pharmaceutical company "Arterium Ltd."
“The process of creating the USCB has been underway for 2.5 years and is still at the stage of preparing the conceptual project. Establishing the USCB must become a priority since it is a key condition for developing a modern regulatory system for products in the 'pharmacy basket' and preparing the pharmaceutical sector for Ukraine's accession to the EU,” he told the Interfax-Ukraine agency.
Sur noted that “a key condition for the successful and rapid establishment of the USCB is the selection of a leader who will head the process of its creation and will likely manage it.”
In commenting on the Ministry of Health's proposals regarding the number of staff for the USCB and its funding volumes, Sur pointed out that the proposed figures “significantly exceed the current total indicators for the State Expert Center and the State Drug Service (by 1.4 and 2.5 times, respectively).” Specifically, according to Sur's calculations, state budget expenditures will increase by 1.9 times, and business expenditures by 2.7 times.
In Sur's opinion, these figures “should be discussed after clarifying the functions, tasks, and scope of work when approving the conceptual project for establishing the USCB.”
He also emphasized that “until the USCB is established, it would be prudent to impose a moratorium on the approval of new laws and regulatory acts concerning products in the 'pharmacy basket' to prevent resources from being diverted to changes in the regulatory system for less prioritized tasks.”
“The approval of regulatory acts before the establishment of the USCB will lead to the necessity of revising dozens of regulatory documents after its creation,” Sur believes.