The implementation plan for the Pharma 2030 strategy has been presented

The Ministry of Industry and Trade on Tuesday published a draft action plan for the implementation of the Pharmaceutical Industry Development Strategy, one of the goals of which is to increase the share of domestic companies in the drug market. The document contains about fifty both new and already known measures: from improving the regulatory framework and creating tax regimes for technology transfer to financial support for drug development and returning part of the cost of exported drugs to manufacturers. Pharmaceutical companies assess the plan positively, but are not sure that all measures can be implemented on time.

The Ministry of Industry and Trade presented the draft action plan for the implementation of the Strategy for the Development of the Pharmaceutical Industry of the Russian Federation for the period up to 2030 yesterday at the Biotechmed forum. Let us remember that the strategy itself was approved in the spring of this year. Among its goals is to increase the volume of the drug market from 2.2 trillion to 3.7 trillion rubles by 2030, the share of Russian drugs – from 35.9% to 42.6% (in monetary terms), exports – from $1.26 billion to $3.4 billion, the share of drugs that are produced within the full cycle and are included in the list of strategically important ones—from 67% to 80% (for more details, see Kommersant on April 4).

The implementation plan for this strategy consists of 47 points, grouped into seven sections. Deputy Head of the Ministry of Industry and Trade Ekaterina Priezzheva explained that when preparing the project, the department actively consulted with the industry community. Until the end of November, the Ministry of Industry and Trade is collecting feedback from ministries on the plan; it is planned to submit it to the government by December 7. While the project describes activities with a launch date until 2026, later measures will be formulated after the implementation of its first part.

In terms of regulatory regulation of the market, efforts are expected to improve the registration of drugs and pharmacological supervision, to optimize licensing procedures and to introduce the practice of scientific consulting in the development of drugs. A separate section describes ways to provide priority in the market for Russian pharmaceutical products. These include the introduction of a system for traceability of the origin of pharmaceutical substances, the “second wheel” principle in government procurement of drugs and the creation of a feedback mechanism between domestic manufacturers and doctors.

The section on measures to support drug production in the Russian Federation includes the creation of tax regimes for technology transfer, financial assistance for drug development, grants for institutions conducting preclinical and clinical trials of drugs. The section on export support, among other things, contains a proposal for an incentive return to exporters of up to 10% of the cost of exported products. There are also sections on the creation of a common research infrastructure for the industry, on the development of connections between pharmaceutical and chemical production, and on personnel training.

General Director of PSK Pharma Evgenia Shapiro confirmed to Kommersant that the Ministry of Industry and Trade’s plan does indeed include proposals put forward by the companies. For example, about the need to develop a transparent methodology for creating a list of strategically important medicines, about the practice of scientific consulting at the stages of development and production of medicines, about improving the procedure for re-registration of maximum selling prices. “We also support the organization of working groups for interaction between the medical community and the production level with the participation of regulators to increase doctors’ awareness of domestically produced drugs,” she noted.

The list of activities in the plan looks quite positive, says Alexey Torgov, vice president for corporate relations and communications at Biocad. But taking into account the fact that, as a rule, all plans “shift to the right,” the question arises whether we should expect the implementation of measures within the specified time frame. “For example, the introduction of the “second odd one out” rule to support domestic producers at state auctions has long been discussed, but the transition to it is constantly being postponed. Previously, they talked about 2024, but now the plan is for 2025,” notes Alexey Torgov.

Anastasia Manuilova