In December, the Government amended the Procedure for Conducting State Health Technology Assessment in Ukraine (Cabinet of Ministers of Ukraine resolution of 22.12.2023 No. 1365). Specialists of the Center, as the authorized body for conducting state HTA, were among those who worked on its provisions. To update the Procedure, the best foreign and domestic experience, as well as recommendations of applicants and stakeholders, were taken into account.
The amendments improve certain organizational and procedural issues of conducting state HTA, including for medical devices, clarify the grounds for conducting health technology assessment under an abbreviated procedure, and strengthen openness and interaction with applicants and other stakeholders.
Key changes include:
- the authorized body may provide preliminary consultations to the applicant on methodological issues of preparing the dossier for HTA
- applicants and other interested parties are given the opportunity to review the draft conclusion of the state HTA and to submit comments and proposals on it
- clarifications have been made regarding the grounds for conducting state health technology assessment under the abbreviated procedure
- criteria of reliability and sufficient open information were defined for conducting state health technology assessment under the abbreviated procedure
- the tasks and procedure of activity of the Expert Committee on State Health Technology Assessment operating under the authorized body are regulated.
At the same time, in accordance with the amendments, the establishment of a separate state unitary commercial enterprise that will be entrusted with performing the functions of state HTA has been postponed until 01 January 2026.
Resolution of the Cabinet of Ministers of Ukraine of 22.12.2023 No. 1365 came into force on 27.12.2023.
You can read the text of the amendments at the link https://www.kmu.gov.ua/…/pro-vnesennia-zmin-do…
