The Association of Importers of Unregistered Medicinal Products for the Treatment of Rare Diseases has released an official position to the media regarding statements made by Deputy Minister of Health Vladimir Afenliev and Deputy Minister of Finance Stanimir Mihaylov, in which the issue of “atypical financial expression” in the purchase of medicines for rare diseases was raised.<\/p>\n\n
The organization points out that the information presented was delivered inaccurately and carries a risk of misinterpretation. According to them, suggestions of potential abuses are unfounded and could have a negative effect, including influencing the motivation of medical specialists who care for children with severe and rare diseases. <\/p>\n\n
Here is the full text of the position:<\/p>\n\n
LADIES AND GENTLEMEN,<\/strong><\/p>\n\n We are addressing you regarding claims and suggestions made by the Deputy Minister of Health, Mr. Vladimir Afenliev, on the morning show of Nova Television on April 16, 2026, affecting the good name, reputation, and legal interests of the members of the Association of Importers of Unregistered Medicinal Products for the Treatment of Rare Diseases and our activities in ensuring access to life-saving treatment for children with rare diseases.<\/p>\n\n We express serious concern regarding the incorrect presentation of information to the public and the risks it creates. In addition to inaccuracies and untruths from a professional and methodological standpoint, it has a potentially harmful effect on the most vulnerable group in society\u2014children with rare diseases and their families\u2014as well as on the doctors who prescribe the therapy. Identifying a rare disease, prescribing, and dispensing an unregistered medicinal product is the exclusive responsibility of specialist physicians. Such unfounded suggestions of abuse create a real risk of demotivating the medical specialists involved in the treatment of the most severely ill children. <\/p>\n\n I. <\/strong>Methodology and Reliability of the Presented Data<\/strong><\/p>\n\n On national television, Mr. Afenliev confirmed the data from the press conference where comparative data on prices of medicinal products purchased by various healthcare facilities were presented, suggesting the idea of “atypical financial expression” and abuse of public resources. At the same time, we draw attention to the following: <\/p>\n\n 1. The presented data are intentionally anonymized\u2014without specifying the particular medicinal product, healthcare facility, or supplier. This anonymity practically makes any objective verification of the claims impossible and creates conditions for arbitrary interpretations and unfounded generalizations. <\/strong><\/p>\n\n 2. <\/strong> No source of data has been specified, except <\/strong>for the information on total expenditures. The lack of a source for the most significant part of <\/strong>the claims\u2014the price comparisons\u2014calls its reliability and objectivity into question.<\/strong><\/p>\n\n 3. Comparing<\/strong> prices without considering essential factors such as the number of doses per package, the form of the medicinal product, the specific purchase period, storage and transport conditions, as well as the individual needs of the specific patient, is methodologically incorrect. It is entirely possible that the mentioned “glaring differences” are due to comparing different packages\u2014<\/strong>with a different number of doses, different concentrations, or different volumes. Without a transparent presentation of these parameters, any conclusion regarding “inflated prices” is unfounded.<\/strong><\/p>\n\n 4. In its public position dated April 15, 2026, the NHIF explicitly states that for medicinal products under Ordinance No. 2\/2019, no state price regulation (ceiling price, reimbursement value, payment level) has been introduced, unlike medicinal products included in the Positive Drug List. The principal of the mentioned healthcare facilities is the Ministry of Health, which exercises the rights of the sole owner of the capital (the state); it should be emphasized that, according to the Public Enterprises Act, there is an explicit prohibition on interference in the operational management and leadership of healthcare facilities. Pricing and negotiation with suppliers fall entirely within the sphere of operational management of the respective healthcare facility. <\/p>\n\n II. <\/strong>Consequences of the Irresponsible Public Presentation of Unverified Information Regarding the Treatment of Children with Rare Diseases<\/strong><\/p>\n\n The treatment of rare diseases is an extremely sensitive topic, at the center of which are children whose lives depend on timely access to specific medicinal products, which are often unique and without therapeutic alternatives. The free choice of therapy, with strict adherence to medical criteria and the informed consent of the parent or legal guardian, is a fundamental principle of the treatment process. Precisely because no alternative treatment exists for most rare diseases, any suggestion that could cast doubt on or delay access to these medicines is potentially life-threatening.<\/strong><\/p>\n\n Presenting the topic of unregistered medicines for children with rare diseases in the context of sensational price differences, without evidence and without correct methodology, is irresponsible and harmful. Such appearances: <\/p>\n\n The sole and leading principle in the treatment of these children is and must be patient care. A child’s life should not be the subject of speculation, and it is not right for such a sensitive topic to be instrumentalized and presented to the public in a way that causes panic instead of trust. <\/strong><\/p>\n\n We point out that Mr. Afenliev himself admitted at the press conference that the audits are not yet completed. Under these circumstances, the public presentation of unverified data as established facts, including on national television, is not only premature but also institutionally irresponsible<\/strong>.<\/p>\n\n This appearance by Mr. Afenliev is not an isolated case. We recall that as early as November 2024, the then-interim Minister of Health, Dr. Galya Kondeva, sent an official letter to the Governor of the NHIF, in which she qualified public statements by Mr. Afenliev\u2014at that time an employee of the NHIF\u2014as inappropriate and non-institutional, and expressed the opinion that such statements damage the prestige and trust in the Ministry of Health and the NHIF. In the same letter, the Minister insisted on taking measures to prevent future such appearances that threaten the stability of the system and public trust in the institutions. It is evident that despite clearly expressed institutional disapproval, such behavior continues in Mr. Afenliev’s current position. <\/p>\n\n IV. <\/strong>Protection of the Healthcare System<\/strong>, Improvement of the Procedure for Access to Treatment<\/strong><\/p>\n\n The healthcare system of the Republic of Bulgaria has established a procedure and conditions for access to treatment for children with rare diseases through unregistered medicinal products. This procedure is based on Art. 82, para. 1a and para. 3 of the Health Act, on Ordinance No. 2 of March 27, 2019, and the relevant secondary legislation. It includes a commission of three doctors at the healthcare facility, approval by the NHIF, control by the Bulgarian Drug Agency (BDA), and the informed consent of the parent. <\/p>\n\n It should be emphasized that the model itself for delivering an unregistered medicinal product for the needs of a specific patient represents an exception to the general rules, provided for in Art. 5, paragraph 1 of Directive 2001\/83\/EC of the European Parliament and of the Council (the so-called “bona fide unsolicited order” \u2013 use by individual order). The purpose of this exception is precisely to guarantee access to treatment in cases where registered medicinal products cannot satisfy the medical needs of a specific patient. The special regime is transposed into national legislation through Art. 9 of the Medicinal Products in Human Medicine Act (MPHMA) and the relevant secondary legislation, including Ordinance No. 10 of 2011. Every step of the process\u2014from diagnosing the rare disease, through prescribing and approving the therapy, to the delivery and administration of the medicinal product\u2014is accompanied by strict control mechanisms and regulatory oversight. <\/p>\n\n This procedure is a guarantee that every child with a rare disease receives access to life-saving treatment in compliance with medical criteria, while protecting patient rights and ensuring the expedient expenditure of public resources. It is unacceptable for the behavior of an interim deputy minister to undermine these efforts and destroy trust in the system, which was built specifically to help the most vulnerable. <\/p>\n\n Furthermore, unlike many other areas of public funding, in the delivery of unregistered medicinal products, every payment is linked to a specific patient and documented medical necessity. <\/strong>Every package is traceable, and every expense is directly linked to a specific health need. The delivery system ensures strict accountability and traceability at every stage\u2014from the specialized commission approving the medical necessity, through the regulatory bodies tracking the delivery, to the doctors documenting the therapeutic results. It is this model that should be built upon\u2014one that recognizes the specific nature of unregistered medicinal products and rare diseases, with a balanced approach between ensuring access to therapy and protecting the public interest. <\/p>\n\n V. Position of the Association<\/strong><\/p>\n\n The Association of Importers of Unregistered Medicinal Products for the Treatment of Rare Diseases consistently upholds the principles of transparency, quality, and timeliness in providing life-saving medicines for children with severe and rare diseases. We support every effort to improve accountability and control in the expenditure of public funds, provided it is lawful, based on facts, correct methodology, and respect for patient interests. <\/p>\n\n At the same time, we categorically oppose:<\/p>\n\n We call for a responsible and professional attitude toward the topic of treating rare diseases. Every reform and every improvement of the system should be based on evidence, expert analysis, and dialogue with all stakeholders\u2014healthcare facilities, patient organizations, traders, and regulatory bodies\u2014rather than on public suggestions without evidentiary value. <\/p>\n\n We declare our readiness to participate in constructive dialogue and working meetings with experts from the Ministry of Health and the NHIF to jointly discuss and analyze the regulatory framework and the possibilities for its improvement. <\/p>\n\n <\/p>\n","protected":false},"excerpt":{"rendered":" The Association of Importers of Unregistered Medicinal Products for the Treatment of Rare Diseases has released an official position to the media regarding statements made by Deputy Minister of Health Vladimir Afenliev and Deputy Minister of Finance Stanimir Mihaylov, in which the issue of “atypical financial expression” in the purchase of medicines for rare diseases […]<\/p>\n","protected":false},"author":2,"featured_media":5259,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_jet_sm_ready_style":"","_jet_sm_style":"","_jet_sm_controls_values":"","_jet_sm_fonts_collection":"","_jet_sm_fonts_links":"","footnotes":""},"categories":[96],"tags":[],"class_list":["post-5313","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"\n\n
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