Semyon Zhavoronkov, AVPHARM: All leading suppliers of imported veterinary drugs continue to work in Russia

At the Business and Government section of the XXX Moscow International Veterinary Congress, Executive Director of the Association of Veterinary Pharmaceutical Manufacturers (AVPHARM) Semyon Zhavoronkov spoke about the main challenges facing the veterinary drug market in the current conditions, as well as the risks of new and existing legislation in this area.

“Our association stands for the preservation of currently in demand drugs for the treatment and prevention of animal diseases, as well as the availability of funds and technologies to provide the necessary veterinary care. It is necessary to ensure the quality, safety, efficiency and competitiveness of manufactured products and the application of the best practices in the organization of veterinary care, clear and predictable regulation, as well as equal working conditions in the market of domestic and international manufacturers.

As for the import substitution of veterinary drugs, which is now being talked about a lot, I would like to draw attention to a number of points. Firstly, medicines are a mandatory humanitarian exception to any sanctions; moreover, all leading suppliers of imported medicines continue to operate in Russia. All this creates an opportunity to keep proven and popular drugs on the market, if regulation does not limit their presence.

Secondly, up to 70% of new human diseases are animal diseases, with an average of two new diseases appearing every year. At the same time, due to the current restrictions, since August 2019, not a single innovative veterinary medicinal product, not a single new pharmaceutical substance has been registered in Russia. The impossibility of fulfilling the requirements that come into force, for example, the requirements for putting into civil circulation, may even lead to the loss for the market of up to 90% of veterinary medicinal products imported today, the total market share of which exceeds 50%.

Thirdly, to date, 1257 veterinary drugs registered in Russia are produced in the country, and 866 are imported. At the same time, many are now talking about the possibility of compulsory licensing of veterinary drugs, but this mechanism is used exclusively in cases of national security and it is not cheaper, and often even more expensive, than any other.

In addition, the consequences of logistical restrictions and excessive demand can be further alleviated by allowing, by analogy with medicines, to supply medicines in primary packaging for foreign markets with stickers in Russian on the market. In particular, such an approach could help address the increased demand for anesthetics. Regulatory barriers are among the industry's main challenges.

So, on September 1, 2023, Federal Law No. 317 of July 2, 2021, containing the requirement for the mandatory introduction of medicinal products for veterinary use into civil circulation, comes into force. One of its articles does not provide for the provision by manufacturers of veterinary preparations, when they are put into civil circulation, of a conclusion on the compliance of the production site with GMP rules. No more than 10% of imported medicinal products for veterinary use registered in Russia are produced today at enterprises that have a valid GMP certificate issued by the authorized Russian body.

Taking into account the expiration of already issued certificates and the pace of new inspections in the industry, it is predicted that by September 2023, no more than 7% of currently available foreign veterinary medicinal products can be imported into Russia. Also, from August 13, 2019, the registration dossier for a medicinal product for veterinary use must contain information on the state registration of genetically modified organisms (GM organisms) contained in it or used in its production. The regulation resulted in a situation in which, since August 2019, not a single innovative immunobiological preparation produced using GM organisms has been registered for veterinary use in Russia.

On March 13, 2022, Decision No. 1 of the EEC Council (2022) came into force, approving the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the EAEU, which will come into force on March 13, 2024. The decision expanded the capabilities of the authorized bodies and actually legitimized the practice of the so-called. "black" lists, without regulating a number of significant aspects of its application: the document does not explain the possibility of circulation of veterinary medicinal products that entered circulation before the introduction of the restriction, it does not specify the procedure and terms for lifting the ban on circulation. The problem can be solved by launching a dialogue with the EEC on introducing a number of clarifications to the text of the EAEU Rules with a corresponding postponement of the entry into force of the Rules themselves.”