Ida Ismail
A system that should guarantee the lives of citizens is failing, offering them expired and substandard medications. The latest report by the Supreme State Audit raises a serious alarm about the safety of medicines in Albania.
During the report to the subcommittee on public sector audit, the Albanian Supreme Audit Institution (ALSH) raised concerns that 80% of the medicines circulating in our country are generics, i.e. they are copies of original medicines, with lower cost and quality, but which are sold at prices similar to those in the European Union, if not even more expensive.
"With the legal changes of 2014, which aimed to reduce hospital costs and increase beneficiaries through the replacement of trade names with generic drugs, the introduction of drugs that were not manufactured according to EU standards was allowed into the Albanian market. This situation resulted in the departure of several commercial companies from the Albanian pharmaceutical market, replacing the medications they were marketing with generic medications," said the Director of the Performance Department at the Supreme State Audit Office, Arminda Bushi.
Albania has been importing more medicines over the years, but even though the number of medicines increases, the costs of purchasing them decrease. For the Supreme State Audit Office, this is the first alarm bell that the quality of the medicines and the effects they provide may be far from standards.
"In 2023, there will be a significant increase in imports of 837 tons of pharmaceutical drugs compared to 2022, but at a lower cost of 791.000 lek per ton of drugs," underlined Arminda Bushi.
The list of reimbursed medicines is also worrying, according to the report of the Supreme State Audit Office. The first 43 alternative medicines are not in the medicines register.
"The lack of a special structure in the Ministry of Health for the periodic control of the activities of the Medicines Agency weakens accountability and increases the risk of recurrence of problems in the system," emphasizes the SAI.
Medicines without analysis: The system exists only on paper
Several types of medicines enter Albania without undergoing analysis, according to a 2015 government decision and according to the SAI representative in Parliament, posing a considerable risk to quality and safety, especially since these medicines can be imported from third countries without mandatory laboratory analysis.
"The audit results show that for 2020 the laboratory did not conduct any sample analysis for 740 issued trading authorizations. While for the period 2021-2023, only 644 analyses were conducted for 2884 issued authorizations," added the SAI representative.
The report also identified shortcomings in inter-institutional cooperation, including data exchange with customs and international partners, which enables the circulation of prohibited drugs in EU countries.
The report directly criticizes the role of the Ministry of Health and the National Agency for Medicines and Medical Devices: "These institutions have failed to ensure effective controls and continuous supervision."
The Supreme State Audit Office has issued 35 recommendations to improve the safety situation of marketed medications, while a hearing session is expected in Parliament with the Ministry of Health and responsible institutions.acqj.al
