Ministry of Health Prepares Regulatory Changes to Control Prices of Pediatric Medicines

The Ministry of Health is taking action to introduce stricter controls on the prices of so-called off-label medicines used in pediatric treatment, after significant discrepancies were found in the prices at which different hospitals purchase the same medications.

“The Ministry of Health is working on a very important issue related to the price regulation of unregistered medicines concerning the treatment of children, the so-called off-label drugs. In the past, these were regulated and dispensed by the Fund for Treatment of Children, which is now a unit within the NHIF. Over the years, very large discrepancies have been established in the prices of these medications across various medical facilities. What we are currently doing is amending two regulations to stop these practices, which currently appear legal but are extremely unacceptable, immoral, and inadmissible,” stated Minister of Health Mikhail Okoliyski after a Council of Ministers meeting.

The topic was also raised by acting Prime Minister Andrey Gyurov, who described the case as a moral issue and called for a swift resolution.

According to Okoliyski, the ministry’s primary task at the moment is to clarify the prices at which these medications were purchased. In this regard, detailed information will be published for all medicinal products—their names, costs, and the medical facilities that purchased them. The data will be available on both the Ministry’s website and the National Health Insurance Fund website.

The Minister specified that the health department does not have investigative functions but will assist in clarifying these practices. If irregularities are found, the competent institutions will be involved. So far, examples have been cited for seven state hospitals, and audits are ongoing in other medical facilities. The results will be announced upon completion of the inspections.

“Regarding the talks with the medical union, we as the Ministry of Health declared that we support the need to index underfunded clinical pathways and to find funds to bridge the gaps between needs and the services actually offered. This can happen after the adoption of the state budget, but we have initiated talks as a mediator between the BMA and the NHIF because we want to create the most effective basis for starting negotiations on an annex to the National Framework Agreement that is the result of a consensus between these two parties,” Okoliyski noted.

He emphasized that the Ministry will play the role of a balancing factor, observing the interests of both patients and those working within the system.

The primary goal of the actions taken remains the limitation of inefficient spending of public funds and the creation of a more transparent and sustainable framework for financing healthcare activities.