Unified approach to drug pricing introduced in Ministry of Health centralized procurement

The introduction of a unified approach for determining the maximum value of medicines paid for by the state through the Ministry of Health’s centralized procurement is now a reality. The amendments to Ordinance No. 34 have been promulgated in the State Gazette.

Under the new rules, the maximum value per unit of medicinal substance by international non-proprietary name will be determined based on the lowest price for the same medicinal product with the corresponding dosage form paid by public funds in reference countries. Where applicable, framework agreements with marketing authorization holders will also be utilized.

The new approach covers medicines intended for the treatment of infectious diseases such as HIV and tuberculosis, as well as therapy for mental and behavioral disorders due to opioid use and dependence syndrome. The scope also includes radiopharmaceuticals, radionuclide generators, kits, and radionuclide precursors.

The amendments also introduce new requirements for reporting and control. A template for an annual request for radiopharmaceuticals and related products has been established. Requests and reports will be prepared by the head of the relevant structural unit and signed by the head of the healthcare facility. Clear steps for the preparation and submission of these documents have been defined. Provisions regarding requests for medicines for infectious diseases and addiction treatment have also been refined.

Procedures that have already commenced prior to the entry into force of the new provisions will be completed under the previous regulations.

View the promulgated amendments to the Ordinance here.