site.btaAssociation Rejects "Misinterpretation" of Data on Supply of Unregistered Medicines

The Association of Importers of Unregistered Medicinal Products for Rare Diseases Treatment has issued a statement objecting to what it describes as a misinterpretation of data on the supply of unregistered medicines. The statement was sent to the media in response to information presented by Deputy Health Minister Vladimir Afenliev earlier in the week. 

On Wednesday, Afenliev told reporters that an internal analysis covering 2024 and 2025 had identified significant discrepancies in the prices paid by hospitals for the same medications, many of which are used to treat rare and severe illnesses in children. ”The main conclusion is that in 2025 the State paid several times more for the same medicines. This means that under normal pricing conditions, financial resources could be freed up and redirected toward more treatments,” Afenliev noted, adding that the Government was considering regulatory changes to improve oversight and transparency. 

The Association said that the information contains “inaccuracies and falsehoods from a professional and methodological standpoint” and could have harmful consequences for one of the most vulnerable groups in society - children with rare diseases, their families, and the physicians who treat them. “The diagnosis of a rare disease, as well as the prescription and dispensing of an unregistered medicinal product, is the sole responsibility of medical specialists. Such unfounded insinuations of abuse risk demotivating the medical specialists involved in treating the most seriously ill children,” the statement reads.

The information presented does not identify specific medicines, healthcare facilities, or suppliers, making independent verification impossible and opening the door to arbitrary interpretations and generalizations, the Association said. No source is provided for the data, with the exception of the information on total costs. The absence of a source for the most substantial part of the claims - the price comparisons - calls into question their reliability and objectivity, the Association added.

Comparing prices without considering key factors - such as the number of doses per package, the form of the medicine, the timing of the purchase, storage and transport conditions, and the individual needs of patients - is methodologically flawed. The cited “significant discrepancies” could simply reflect variations in packaging, concentration, or volume, the statement said. Without transparent presentation of these parameters, any conclusion about inflated prices is unfounded. “When supplying unregistered medicinal products, every payment is tied to a specific patient and a documented medical need. Each package is traceable, and every expense is directly linked to a particular health requirement. The delivery system ensures strict accountability and traceability at every stage - from the specialized committee approving medical necessity, through the regulatory authorities overseeing the supply process, to the physicians documenting therapeutic outcomes,” the statement said.

The Association also expressed readiness to engage in constructive dialogue with experts from the Health Ministry and the National Health Insurance Fund to review the current regulatory framework and explore possible improvements.