On 23 December 2020, the Cupboard of Ministers of Ukraine accepted the process (“Process“) for state well being expertise evaluation (“HTA“). State HTA is meant to offer Ukrainian policymakers with information and proof to assist their choices on learn how to effectively direct restricted well being funds and choose from the vary of well being applied sciences obtainable.
Medicinal merchandise shall be topic to state HTA within the following circumstances:
1) Inclusion into, or exclusion from, the Nationwide Important Medicines Record (“NEML“);
2) Inclusion into, or exclusion from, the lists of medicines topic to centralized public procurement on nationwide stage.
- medicines included into the centralized procurement lists as at 24 December 2020;
- medicines on the NEML;
- emergency procurements required to handle epidemics, pure disasters and so forth.;
3) Conclusion and extension of managed entry agreements (“MEA“);
4) Regional procurements by native healthcare authorities exterior of the NEML.
N.B.: based mostly on beforehand launched drafts of the Process, it was supposed to postpone the HTA requirement for regional procurements until 1 January 2022. The accepted model doesn’t replicate that. Except it’s modified, in 2021 regional procurements exterior the NEML shall be doable topic to the state HTA.
Specifically designated state company to be established by 1 January 2022. Till that, State Enterprise “State Knowledgeable Heart of the Ministry of Well being of Ukraine” (“SEC“).
N.B.: Within the accepted model of the Process, the delegation of state HTA perform to SEC was delayed until 1 January 2022. This can be a technical mishap, which hopefully will probably be mounted by the Authorities. If not, it could considerably hurdle the general implementation of state HTA.
- The Process turns into efficient from (i) 24 December 2020 for medicinal merchandise, and (ii) 1 January 2022 for different well being applied sciences;
- 6 months for the MOH to approve a tenet for state HTA of medicinal merchandise;
- 1 January 2023 – deadline for finishing state HTA of medicinal merchandise that (i) are topic to public procurement on nationwide stage exterior of the NEML, and (ii) are on the NEML, however not included into the WHO Mannequin Record of Important Medicines.
Pharmaceutical corporations are suggested to concentrate to those adjustments and begin / proceed preparations for state HTA of their medicinal merchandise, notably people who might additional probably be topic to MEA or thought-about for inclusion into lists for public procurement.