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Scandal with antitumor medications/KLSH: 46% of drugs have never been imported

2026-02-09 12:20:00, Denoncim CNA

The Supreme State Audit Office's report on the financial and compliance audit of the Mandatory Health Care Insurance Fund has revealed a number of serious problems with antitumor drugs.

The audit by the Albanian Supreme Audit Institution (ALSI) found that out of 253 drugs authorized to be imported into Albania, 45% of them were never imported during the period January 2021-March 2025.

" From the data made available by the Distribution Sector on the import of medicines, it resulted that out of 253 antitumor medicines authorized for marketing in
the Republic of Albania, 116 of them, or 46%, were never imported during the audit period, January 2021 - March 2025. Some of these medicines were approved through the accelerated procedure, based on authorizations granted by the European Medicines Agency (EMA), and are included in international protocols for the treatment of tumor diseases ," the SAI report states.

Scandal with antitumor medications/KLSH: 46% of drugs have never been imported

The ALSHI report states that the failure to import these antitumor drugs poses a potential risk to the effectiveness of the mechanisms and negatively affects the implementation of treatments.

“ This situation carries potential risks to the efficiency of existing mechanisms for translating trade authorizations into real supply of medicines on the domestic market, as well as negatively affecting the implementation of modern treatment protocols and the achievement of the objectives of the health system. The failure to import medicines authorized for trade is in violation of Article 16, point d and Article 32, point 1 of Law No. 105/2014 “On medicines and pharmaceutical services” , the report states.

Scandal with antitumor medications/KLSH: 46% of drugs have never been imported

The Albanian Supreme Audit Office recommends that the Medicines and Medical Devices Distribution Sector at the Ministry of Health and Family Welfare strengthen mechanisms to ensure that every medicine authorized for sale is accompanied by an obligation to import and place on the market. An obligation that would guarantee patients' access to essential medicines.

" The Medicines and Medical Devices Distribution Sector at the Ministry of Health, to review and strengthen regulatory mechanisms to ensure that every drug authorized for marketing is accompanied by the obligation to import and place on the market, guaranteeing real access of patients to necessary medicines ," recommends the SAI.

Scandal with antitumor medications/KLSH: 46% of drugs have never been imported

CNA has published parts of this audit report of the Albanian Supreme Audit Institution (ALSH) for several days, which has identified a series of serious problems that directly affect the lives of patients using antitumor drugs, jeopardizing the quality and safety of medical treatment in the country./CNA