SCANDAL involving reimbursed medicines/ HSA finds 43 unauthorized drugs and 46 “not imported” but placed on the market

The High State Audit has found serious problems in the verification of medicines included in the reimbursement list.

According to an audit report referring to the follow-up and implementation of recommendations issued by the High State Audit during the second half of 2024, out of 458 medicines checked for 2023, 43 did not have marketing authorization and were not listed in the medicines register for that year.

In another verification, the High State Audit also found 46 medicines that were authorized for sale but did not appear to have been imported into Albania during 2023.

The findings highlight weaknesses in the monitoring of a list directly related to the medicines reimbursed for patients.

For the 43 medicines without marketing authorization, the High State Audit found that institutions had not been effective in verifying whether medicines listed as first-choice alternatives on the reimbursement list were actually authorized for sale and properly registered. The audit links this issue to a lack of coordination between the Ministry of Health, subordinate institutions, and the National Agency of Medicines and Medical Devices.

The second issue was of a different nature. For 46 medicines, the problem was not a lack of authorization, but the fact that, although they were listed as authorized for sale, they did not appear to have been imported during 2023. According to the High State Audit, this indicates weak monitoring by the National Agency of Medicines and Medical Devices of the actual circulation of medicines, particularly products that remain on official lists but do not enter the market for long periods.

This High State Audit report once again highlights problems with the reimbursed medicines list. If a medicine is listed as a first-choice alternative but does not have marketing authorization or is not actually available on the domestic market, this creates uncertainty about the practical implementation of the reimbursement scheme and patients’ access to medicines that are supposed to be available.

Specifically, the audit identifies a twofold problem: some medicines on the reimbursement list were not properly registered, while others, despite being authorized, did not appear to have entered the country at all. This shifts the focus not only to the quality of administrative controls, but also to the reliability of the list on which the reimbursement of medicines is based.

“KORÇA BOOM”