Health is in danger: Shortcomings in the licensing of importers of medicines to Ukraine

In 2021, almost one in five Ukrainian families faced challenges in obtaining necessary medicines and medical devices due to their high cost, which had a vulnerable impact on the nation's health. According to the report of the Accounting Chamber of Ukraine, the risks of low-quality and counterfeit medicines on the market have increased significantly due to the fact that most importers of medicines to Ukraine operate without licenses, although this problem has become less relevant during the war.

According to the report, during 2021-2022 and the first nine months of 2023, the pharmaceutical industry benefited from tax breaks worth UAH 28.2 billion and a 7% VAT rate reduction. However, the effectiveness of these measures was low, according to the Accounting Chamber.

The audit also revealed the risks of spreading counterfeit, low-quality and expired medicines, as well as misuse of VAT benefits due to insufficient control by the Ministry of Finance, Ministry of Health, State Tax Service, State Customs Service and State Administration on Medicines. The State Administration on Medicines notes that after the moratorium on inspections was introduced in 2022, the number of inspections decreased six times, but fines increased by 33.3%.

The Accounting Chamber points to the limited access to the Licensing Register due to martial law, which makes it difficult to control the circulation of medicines and medical devices. Insufficient control also leads to the fact that almost 70% of importers in 2021 and 51% in 2023 operate without licenses, increasing the risks of circulation of low-quality medicines.

In the context of military events, the introduction of a moratorium on inspections in 2022 led to a decrease in the quality and safety of medicines on the market, and the amount of fines accrued increased by 19%. The Accounting Chamber points out the low efficiency of customs control and inefficiency of inspections of importers.

All these facts pose a threat to public health, as low-quality medicines can be dangerous for patients. Striving to solve these problems and increase control over the import and circulation of medicines is becoming an important task for the Ukrainian authorities.