For several months there has been talk of a possible shortage of veterinary medicines in Russia. As of September 1, 2023, veterinary products must have an international GMP (Good Manufacturing Practice) certificate. Without this, they will not be able to be sold in Russia. But not all companies pass the Rosselkhoznadzor inspections to obtain the required certificate.
According to the results of the study (available for “RG”), the CSR came to the conclusion that foreign manufacturers of veterinary drugs are denied a certificate in 66% of cases, and Russian – only in 17%. . Most of the time, companies do not have or do not have enough supporting documents or there are no separate control procedures. The CSR claims that for foreign companies inspections cost 5 million rubles. (not taking into account the costs of eliminating non-compliances based on the results of inspections), and for Russian manufacturers the cost of one inspection is equal to a tax in the amount of 7.5 thousand rubles.
At the same time, for large international manufacturers of veterinary drugs, the Russian market share in revenue is only 1-5%. They ship their products to hundreds of different countries. And in each country you need to fulfill your requirements, which entails additional costs, they say in the CSR.
All this can lead to the fact that some foreign manufacturers decide to leave the Russian market with their products. And this will mean a decrease in competition and, therefore, the risk of price increases, a decrease in incentives to improve product quality, expand the range, etc.
The CSR indicates that a high dependence on imports remains in certain market segments. For example, in immunobiological preparations (vaccines and serums), imported manufacturers represented 67% of the market in 2022.
“In case of a decrease in the supply of foreign vaccines for the prevention of pig and poultry diseases, the annual production of pork and poultry meat will decrease, which will lead to cumulative economic losses in the amount of about 0.3- 0.4% of Russia’s GDP by 2022, or 9.5 -11.5% GVA (gross value added – “RG”) from the sector “Crop and livestock breeding, hunting and provision of related services in these areas” by 2022 “, calculates the CSR.
For this reason, the experts propose postponing the entry into force of the new regulations. To allow agricultural producers to easily switch to domestic veterinary drugs, Russian manufacturers must develop foreign drug analogues of comparable quality to Western ones and increase import substitutability. At this time, foreign suppliers will be able to adapt to the new rules, pass Russian inspections and receive conclusions, the CSR argues.
Rosselkhoznadzor, in turn, believes that the point is not that inspections are expensive for foreigners. For example, in the United States, an application for registration of a new drug (plus the inspection itself) costs 59 million rubles in rubles. Make changes to the documents of the registration dossier – 29 million rubles. Plus annual fees (for the drug – about 1 million rubles, for the company – 15 million rubles), which are not in Russia. “There is no reason to believe that the new rules will lead to a shortage of veterinary drugs and a decrease in meat production. This is a completely unfounded claim,” Rosselkhoznadzor emphasizes.
For all major diseases of farm animals, there are Russian analogues of foreign vaccines.
According to the agency, at the moment 37 foreign sites have passed GMP inspection, in total they produce more than 300 types of medicines that are supplied to Russia. Another 20 sites are scheduled for inspection. All non-passing sites have the right to correct identified critical and significant deficiencies and reapply for inspection. This is absolutely normal international practice, notes the Rosselkhoznadzor.
For all epizootic and economically significant diseases for farm animals, there are Russian analogous vaccines. In addition, the domestic bio-industry is actively developing. Vaccines of strategic importance in the agricultural sector for industrial poultry and livestock farming have been registered since the beginning of 2022, for example, the vaccine against classical swine fever, the associated vaccine against viral and bacterial diseases of cattle “BoviRes-PAST” and many others. In just a year and a half, 28 new nationally produced vaccines have passed the state registry. The pharmaceutical industry also launched on the Russian market a line of domestic antimicrobial and antiparasitic drug developments that successfully compete with foreign analogues.
The Rosselkhoznadzor previously noted that the shortage of pet medicines is, in fact, artificially created by members of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM), which represents the interests of four foreign companies: MSD Animal Health, Elanco, Boehringer Ingelheim , Zoentis. . It is AVPHARM who actively advocates postponing the introduction of new rules. Therefore, MSD Animal Health has reduced the supply of popular vaccines under the Nobivak brand by three times: from 6.6 million doses in 2021 to 2.1 million doses in 2022. Supplies of the Nobivak DHPPi vaccine for dogs will be reduced six times, for cats Nobivak Tricat Trio – nine times, rabies vaccine Nobivak Rabies – 27 times. Zoetis reduced exports to Russia by 63%, from 1.3 million doses of Vanguard and Felocel vaccines to 479,000 doses.
According to the Ministry of Agriculture, there is no risk of a shortage of veterinary drugs in Russia. Currently, 782 drugs for veterinary use are registered in Russia, of which 570 (73%) are of domestic production and 212 (27%) are foreign. At the same time, the most popular foreign products have domestic counterparts.
