This decision was made at a meeting on December 23, 2020, № 1300. This Procedure defines the procedure for state assessment of medical technologies.
It is determined that the state assessment of medical technologies is the assessment of medical technologies, which is carried out by the authorized body with the preparation of the relevant conclusion.
Medical technology (health technology) – a method, procedure, system, or means for the prevention, diagnosis, treatment, or medical rehabilitation, including drugs (including medical immunobiological drugs), medical devices (including auxiliaries to them), procedures, and organizational systems used in the field of health care.
The act, in particular, stipulates that the state assessment of medical technologies that are not medicines will be introduced from January 1, 2022.
Until the establishment of the state unitary commercial enterprise, which will be entrusted with the functions of state assessment of medical technologies, the implementation of these functions is entrusted to the state enterprise “State Expert Center of the Ministry of Health of Ukraine”.
In this regard, the Ministry of Health is instructed to:
1) within six months to develop and approve guidelines for state assessment of medical technologies for medicines;
2) until January 1, 2022:
- take measures to establish a state unitary commercial enterprise, which is entrusted with the functions of state assessment of medical technologies;
- develop and approve guidelines for state assessment of medical technologies that are not medicines;
3) until January 1, 2023:
- to conduct a state assessment of medical technologies on the nomenclature (lists) of drugs purchased from the state budget for the implementation of programs and implementation of centralized health care measures and which are not included in the National List of Essential Medicines approved by the Cabinet of Ministers of March 25, 2009, № 333 (Official Gazette of Ukraine 2009, № 27, p. 906; 2018, № 4, p. 157), in order to make a decision on the feasibility of their further purchase;
- to conduct a state assessment of medical technologies (in particular under the abbreviated procedure) for medicines included in the specified National List, which are not in the Basic List of Essential Medicines recommended by the World Health Organization.
The act is available at the link.