site.btaExperts Warn against Closing Medicines Pricing Council

Professional and patient organizations opposed plans to close the National Council on Prices and Reimbursement of Medicinal Products at a news conference on Wednesday.

The Bulgarian Association of Pharmacoeconomics organized the event in response to a proposal to abolish the Council as an independent body and transfer its functions to the Drug Policy Directorate General at the Ministry of Health. The experts called instead for strengthening the Council and improving its effectiveness and resilience.

They said closing the Council risked undermining the consistency, predictability and transparency of its decisions.

The Council held 47 regular and five extraordinary meetings, issued 3,272 decisions and considered 6,317 procedures in 2025, Bulgarian Association of Pharmacoeconomics President Maria Dimitrova said, citing its annual report. A total of 35 medicinal products covering 22 new international non-proprietary names were added to the Positive Drug List.

The Council’s experts represented Bulgaria in all four subgroups of the Member State Coordination Group on Health Technology Assessment and attended 69 international meetings in 2025, Dimitrova added. Closing the Council will result in the loss of institutional and scientific memory and delay patients’ access to treatment, Dimitrova warned.

“The Health Ministry’s proposal would set us back 13 years,” Bulgarian Association of Pharmacoeconomics founder Guenka Petrova said. Petrova said the Ministry recognized at the time that the Council’s functions exceeded its capacity and asked why the decision was being made without any analysis.

“Setting medicines policy is the Health Minister’s job,” Association of the Research-Based Pharmaceutical Manufacturers in Bulgaria Executive Director Deyan Denev said. “If the rest of Europe is developing independent bodies while Bulgaria alone moves backwards, that would be an unreasonable decision,” Denev added.

“Over the years, we have maintained communication with health ministers who were proud of this body and consulted it,” Bulgarian Generic Pharmaceutical Association Executive Director Evgeni Tassovski said. “Its level of expertise has been maintained continuously, and its system is among the most transparent in Europe. We cannot imagine how a functional, transparent and digitalized body would work as part of the Health Ministry,” Tassovski added.

“Time is our patients’ most valuable resource,” Joint National Oncology Network representative Marchela Koleva said. “Doctors and patients do not care who makes the decision. They care about quality care. While an institution goes through changes and adapts, patients lose critical time. If the Health Minister does not understand that, the Minister is not suited to the job,” Koleva added.

“This reform must not cost us our time and our lives. For patients, the priority is timely access to medicines, backed by expertise and transparency. Timely access to innovative medicines also saves the state money,” Association for the Development of Bulgarian Healthcare Management Board Chair Boryana Boteva said.

The wider restructuring plan also proposed replacing the 28 Regional Health Inspectorates and the Centre for Assisted Reproduction as independent legal entities with units of the central administration. The Health Ministry planned a broad public consultation on the structural changes.

The Council’s and the National Health Insurance Fund’s information systems were connected in March 2026 to exchange data in real time. From April 1, 2026, changes to the Positive Drug List were reflected automatically in the Fund’s systems, replacing manual checks and reducing the risk of technical errors.