The current rules prevent original drug manufacturers from participating in government procurement.
The British AstraZeneca offered the Ministry of Health and FAS to revise the principles of generics price registration in Russia. The company asserts that the current rules do not allow manufacturers of original drugs to participate in state procurement.
Pharmcompany proposes to amend the Government Decree No 865 "On State Regulation of Prices for Drugs Included in the List of Vital and Essential Drugs" (VED). The proposal concerns the principle of registering the maximum selling price for generics from the List of Vital and Essential Drugs, provided that there are valid patents for original drugs and there is no shortage of them in the market. The Russian subsidiary of the British pharmaceutical company AstraZeneca addressed the FAS and the Ministry of Health with such a proposal.
According to the pharmaceutical company in the letter, a copy of which is familiar to "Vedomosti", today due to the availability of generics the state reduces the cost of state contracts for the purchase of vital and essential drugs. As a result, companies that produce original (and more expensive) drugs refuse to sign unprofitable contracts. For example, insulin glargyn from French Sanofi at a concentration of 300 units/ml (protected by a patent until 2031) costs 3,900 rubles for a package of five syringes, according to the State Register of Medicines. In December 2021 the Medsintez plant registered its counterpart, Rosinsulin Glargin, and a few months later the FAS set the ceiling price for this drug at 3,540 rubles.
According to Mikhail Shikhmuradov, an expert of the BRICS Antimonopoly Center, this situation shows the contradiction between the interests of innovative pharmaceutical companies and the government, which seeks to ensure the affordability of drugs for the population. Producers of original drugs want to receive decent compensation for their research and development, protecting their patent rights. The state, on the other hand, reduces the cost of purchasing drugs and stimulates competition in the market.
"It is important to find a balance between stimulating innovation and ensuring the availability of drugs, taking into account not only the price, but also the effectiveness, safety, quality of drugs, as well as the level of development of domestic production. It may be worth introducing a differentiated approach to pricing depending on the therapeutic group, stage of disease and clinical effect of the drug."
It is also necessary to develop mechanisms for reference pricing, which FAS has been talking about for a long time, Mikhail Shikhmuradov emphasized. Finally, it is necessary to improve the system of state regulation of prices for drugs so that it would be transparent, objective and more operative.
Source: Vedomosti
