In 2024, 152 drugs were withdrawn from the Bulgarian market following the suspension of their marketing authorisations, leaving many patients at risk.
According to the Bulgarian Executive Agency for Medicines’ annual report, all of the drug authorisations were withdrawn from the market for commercial reasons.
Of those suspended, 22% are cytostatics and immunosuppressants, 15% are non-steroidal anti-inflammatory drugs and narcotic analgesics, another 15% are medicines for the cardiovascular system, 10% are hormones, and 9% are antibiotics.
Boryana Marinkova, executive director of the Bulgarian Association for Medicines Parallel Trade Development (BAMPTD), said Bulgaria is still not an attractive market for pharmaceutical companies, and the authorities must make efforts to remedy this.
“The solution is to make the market attractive. There is no point in stockpiling medicines that are not being used,” Marinkova told Euractiv.
Patients are the last to know
When a medicine is withdrawn, the information doesn’t reach patients promptly, which can lead patients to procure counterfeit medicines from illegal online traders who obtain them from abroad.
“Prescription medicines should be purchased only from licensed pharmacies. Otherwise, patients put their health and lives at risk,” Marinkova emphasised.
According to BAMPTD, patients often realise too late that some medicines have been withdrawn, as there is no fast-track procedure to protect them when this occurs.
When a medicine is withdrawn, patients should seek medical guidance as quickly as possible to obtain an available, equally effective therapy. However, this seldom happens.
Boryana Marinkova gives the example of an innovative drug for hyperactivity, the supply of which was stopped for several months. This drug is one of a kind, and patients were left to fend for themselves.
Parallel trade ban
BAMPTD received 2,700 reports of missing medicines on the Bulgarian market in one year.
Bulgaria had banned the re-export of certain diabetes medicines and children’s antibiotics for over a year. In 2024, the country faced a severe shortage of basic oncology medicines.
At the beginning of 2025, the Ministry of Health announced that it would take measures to improve the supply of 40 medicinal products for the treatment of oncological diseases by reducing bureaucratic obstacles for companies that import them.
Despite serious problems with bureaucracy and an unattractive internal market, Bulgaria insists that the EU’s Critical Medicines Act should include clauses allowing for voluntary implementation.
Bulgaria is one of the poorest countries in the EU, and for the past two years, Sofia has insisted on retaining control over its medicines policy after the new pharmaceutical legislation is adopted.
The EU legislation aims to facilitate investment in the production of critical medicines and to make supply chains faster and more sustainable. It also promotes member state collaboration on production and procurement to increase purchasing power. The act also provides guidelines on funding to help member states financially support such strategic projects.
[Edited by Vasiliki Angouridi, Brian Maguire]