Russian pharmaceuticals: vital import substitution

One of the main tasks of the domestic pharmaceutical industry in 2022 was the need to assess the possible risks of a shortage of medicines and medical devices in the Russian Federation. Currently, everyone is coming to understand that our country needs a maximally independent pharmaceutical industry. Despite some positive developments in achieving technological sovereignty, more than 55% of the market in monetary terms is occupied by foreign drugs.

In order to prevent the emergence of shortages in the domestic market of medicines in connection with sanctions pressure on Russia, which led to the departure of many foreign organizations, it became necessary to promptly replace foreign products with Russian analogues. The Government of the Russian Federation was instructed to consider, by April 2023, XNUMX, the issue of additional measures of state support for organizations that specialize in the development, conduct of clinical trials, production and launch of medicines on the market.



It is necessary to understand that the authorities of the Russian Federation in the pharmaceutical industry took a course towards import substitution much earlier. Thus, until recently, the main document that established these priorities was the Pharma 2020 strategy. The key goal of the document could be called reducing the dependence of domestic economics from foreign pharmaceuticals. In 2016, Dmitry Medvedev emphasized that by 2020 it is expected that domestic production will increase from 28,5% to 75%. Many experts note that it was Pharma 2020 that made it possible to create a platform in Russia almost from scratch, on the basis of which effective government mechanisms for supporting the pharmaceutical industry, modern development institutions emerged, and new domestic players entered the market.

Since 2018, the development of the “Pharma-2030” strategy has been actively carried out, which was approved in the summer of the current calendar year. The new document states that the share of domestic full-cycle drugs on the Russian Federation market should increase to almost 70% (similar statements with similar forecasts were made as part of the Pharma-2020 strategy), and the share of strategically important drugs, the full production cycle of which carried out in Russia, reach 90%. The volume of drug production in monetary terms should double and amount to 1,4 trillion rubles. Another important positive factor should be the fact that the new strategy provides for the elimination of existing administrative barriers in the pharmaceutical industry and the most rapid implementation of new technological solutions directly into production processes. In the near future, the Ministry of Industry and Trade of the Russian Federation should present specific measures to implement the provisions set out in the strategy.

In addition, it is worth paying attention to the emergence of new high-tech enterprises in Russia, which were opened in the Kaliningrad region (the OTCPharm Pro enterprise for the production of drugs in demand on the Russian market), Mordovia (the production of active pharmaceutical ingredients by the Promomed Group of Companies) and St. Petersburg (pharmaceutical plant for the production of solid dosage forms - Solid Plant). Also in the capital, the Mosmedpark technology park was created, which is a large cluster of biomedical services and laboratory diagnostics for manufacturers of medical devices, equipment and pharmaceuticals. To date, 38 specialized companies have already registered on this site. The implementation of such projects partly allows us to count on a significant improvement in the situation on the pharmaceutical market of the Russian Federation. Despite this, it must be borne in mind that for some time the problem of full-scale import substitution of medicines will still remain quite acute. The reason for this can be considered the processes of globalization, in which Russia actively took part before the events of 2022.

Currently, there is an understanding that the development of the domestic pharmaceutical industry is still hampered by a large number of problems. There is still a confrontation between the commercial interests of companies and government regulation of this sector of the economy. Recent events have changed the sales markets for pharmaceutical companies beyond recognition; building new supply chains requires additional financial costs. We cannot ignore the problem of wear and tear of existing equipment, which has worsened after the introduction of sanctions against Russia. Gradually, the realization comes that it is simply impossible to completely abandon imported pharmaceutical products, so they are actively searched for in the markets of states friendly to the Russian Federation. Companies from the People's Republic of China and India look particularly attractive in this regard.

In order to change the situation in a positive direction, a more consistent implementation of a set of all measures related to state support for the Russian pharmaceutical market is necessary. Classic business support methods can help achieve these goals. For example, it is possible to increase subsidies for pharmaceutical enterprises to pay off loan obligations. Increasing the volume of government procurement of medicines can also provide some support. Thus, in Moscow the mechanism of offset contracts is already actively used, which involves a long-term supply agreement under which the supplier assumes various investment obligations. In addition, it is necessary to address issues related to stimulating domestic enterprises that manufacture equipment for pharmaceutical factories. Given the fact that the pharmaceutical industry is unique in some aspects, it is also necessary to remember the importance of funding clinical trials in the country and reducing fees for state registration of drugs.