The legislative framework for enhanced prescribing practices and HTA decision-making

Digest of the Project “Safe, Affordable, And Effective Medicines For Ukrainians” (SAFEMed) for February, March 17, 2022

The important work of meeting the health needs of Ukrainians is even more critical in these tragic times and SAFEMed will endeavor to continue offering its technical assistance and sharing important developments in the coming months.

STRENGTHENING THE LEGISLATIVE FRAMEWORK FOR ENHANCED PRESCRIBING PRACTICES

SAFEMed, with legal backing from our partner Legal Alliance, is supporting the Ministry of Health of Ukraine (MOH) and the National Health Service of Ukraine (NHSU), in the drafting of new legislation designed to enhance oversight of proper dispensing of prescription medicines in Ukraine and reduce inappropriate self-medication. The Cabinet of Minister’s Decree, "On amendments to License provisions for business activity related to pharmaceuticals' manufacture, wholesale and retail sale except for active pharmaceutical ingredients” and MOH Orders No.360 and No.490 aim to gradually introduce e-prescribing for pharmacies' dispensing of prescription medication, including antibiotics from April 1, 2022. These draft regulations are currently available on the MOH official website for public consultation. (Note: due to the War, these legislative changes have been put on hold).

FURTHER STEPS TO FORMALIZE HEALTH TECHNOLOGY ASSESSMENT DECISION-MAKING

On January 27, 2022, the Ministry of Justice registered the MOH Order No. 95/37431, “On approval of Procedure for inclusion (exclusion) of medicines in (from) National Essential Medicines List and/or in (from) Nomenclature of medicines procured from national budget for implementation of programs and centralized health measures, applying state health technology assessment health measures, applying state health technology assessment.” The order, drafted with the support of SAFEMed together with its partner Legal Alliance, is a major step towards completing full cycle of HTA assessment, appraisal and decision making with respect to access to medicines through public funds. It is based on the Cabinet of Minister’s Decree in December 2020, “Procedure for conducting the state health technology assessment” that formalized the use of HTA in Ukraine.

Specifically, this order approves the following:

• Creation of Expert Committee under the MOH State Expert Center, which will hold the appraisal function.
• Establishment of a unified single process, that includes HTA Assessment and Appraisal, for building both the National Essential Medicines List and the nomenclature. Further, it allows for the use previous year nomenclature as basis and only assesses new inclusions or exclusions to the list.
• All medicines procured as part of the 2023 Fiscal Year Nomenclature will be subject to the requirements of this Order.
• The MOH will establish a working group to receive recommendations from the SEC (HTA authorized body) and to review and submit final recommendations to the Minister.

When conditions allow, SAFEMed, together with our legal partner Legal Alliance, is ready to support the MOH to draft orders related to the creation, functioning, and membership of the working group. MOH also asked SAFEMed support to amend other relevant orders impacted by these new regulators to ensure a consistent, robust legal framework.