A spot check by Bulgaria’s health ministry has uncovered significant price discrepancies in medicines for rare diseases in children, with state hospitals paying up to €50,000 more for the same product and, in some cases, prices differing by as much as sixteenfold. To address the issue, the health ministry is considering pegging the cost of these medicines to average EU prices.
The audit examined procurement deals for ten medicines not authorised in Bulgaria, which hospitals are allowed to purchase through direct negotiations. It found price differences exceeding €50,000 per unit, with some hospitals buying identical products at prices up to sixteen times higher than others.
Several major pharmaceutical companies have expressed surprise at the prices at which their products were sold in Bulgaria, according to officials familiar with the matter.
“We are in contact with several marketing authorisation holders among Europe’s top ten pharmaceutical companies, who expressed astonishment upon seeing the prices at which their medicines were sold in Bulgaria. We will continue discussions to explore whether some form of arrangement can be reached, such as indicative pricing for their products,” Deputy Health Minister Vladimir Afenliev said.
Wide price deviations
The cases concern some of Bulgaria’s largest public hospitals, in a country that has long struggled with chronic underfunding in healthcare and ranks among the lowest in the EU in terms of public health expenditure. The health ministry has not disclosed the names of the hospitals or the commercial brands of the medicines involved.
There is a case involving a medicine purchased by one state hospital for €23,300, while another paid more than €75,000 for the same package. In another instance, a hospital in Sofia bought a product for €260, compared with over €4,500 paid by a hospital in Plovdiv.
As previously reported by Euractiv, Bulgaria faces structural problems in the regulation and funding of its pharmaceutical market. Heavy administrative burdens and requirements for substantial mandatory rebates have reduced incentives for companies to register high-cost medicines for rare diseases in a small market such as Bulgaria.
Despite these domestic challenges, Bulgaria has argued during negotiations on the EU’s new pharmaceutical legislation that it should retain full autonomy over rules governing procurement and marketing authorisations on its national market.
A vicious policy cycle
The current price discrepancies highlight the difficulty Bulgaria faces in effectively regulating its pharmaceutical sector on its own.
Under national law, when no alternative treatment is available domestically, a medicinal product not authorised in Bulgaria but approved in another EU member state may be imported for an individual patient.
Each year, the health ministry approves a list of these medicines. Over the past decade, this list has expanded to include hundreds of branded products.
The list includes both innovative medicines that have yet to be launched on the Bulgarian market and older, established products that have been withdrawn by manufacturers due to a lack of funding or administrative obstacles.
Pharmaceutical companies withdraw hundreds of medicines from the Bulgarian market every year, due to a lack of commercial incentives, driven by regulatory pressures such as high fees, price controls and significant mandatory discounts imposed by the state.
In response, Bulgaria’s parliament in 2018 allowed hospitals to purchase such medicines without public tenders, relying solely on direct negotiations with suppliers. In 2025 alone, the use and procurement of unauthorised medicines increased by nearly 25%, with the budget rising from €56 million to €72 million.
The health ministry is now considering linking purchase prices of these medicines to average EU price levels. It is also in talks with pharmaceutical companies to introduce indicative pricing mechanisms.
“All purchases and deliveries of unauthorised medicinal products to hospital pharmacies should be registered in real time. Work is currently underway to establish this technological capability within the National Health Information System,” the ministry said.
[VA, BM]
Source:
www.euractiv.com