Moroz T.L., Ryzhova O.A. 63

Problems of domestic production of strategically significant anti-retroviral drugs 

Purpose. The aim of the study was to assess the problems of providing patients with HIV in the Russian Federation with antiviral drugs of the ATС group – J05AF (nucleosides and nucleotides - reverse transcriptase inhibitors) included in the list of strategically important drugs, and the prospects for its improvement. Materials and methods. The scientific research was carried out sequentially and included four interrelated stages. The objective of the first stage was to analyze the auctions for public procurement of antiretroviral drugs of the ATС- J05AF group for 6 INNs included in the list of strategically important drugs. The task of the second stage of the work was a comparative analysis of the dynamics of the range of antiretroviral drugs and substances for their production, registered in the Russian Federation, of the ATС group - J05AF by 6 INN. At the third stage, an analysis was made of the availability of interchangeable drugs for each INN. The objective of the fourth stage was to analyze the registered prices for domestic and foreign medicines for each INN. Results. It was found that by 2020 the share of domestic drugs was 63% of the planned 90%. In the Russian Federation, only 4 manufacturers in a limited range produce drugs for the treatment of HIV-infected patients. For individual INNs, domestic substances are completely absent, or are produced in insufficient quantities, which forces manufacturers to purchase pharmaceutical substances from the same enterprises, mainly in China and India. In the State Register of Medicines by 2020, for various INNs, interchangeable medicines appeared, the price of which does not differ statistically significantly, nevertheless, 91% of auctions in 2018 were held with a single supplier. Such a result of the auctions is difficult to explain, since the price of interchangeable drugs in the ATС - J05AF group does not differ statistically significantly between domestic and foreign manufacturers. Conclusion: In order to increase the level of import substitution of strategically important antiretroviral drugs, it is necessary, first of all, to solve the problem of providing Russian manufacturers with domestic pharmaceutical substances.
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