State Support Measures for Pharmaceutical Manufacturers. Subsidies for All Stages of Clinical Trials of Medicines

As part of the implementation of the Strategy for the Development of the Pharmaceutical Industry through 2030, approved by Decree of the Government of the Russian Federation No. 1495-r of 7 June 2023 (“Pharma Strategy 2030”), and discussions at the “Healthy Society” forum organized by the Roscongress Foundation with the support of the Ministry of Health (16–17 March 2026, Moscow) (“Forum”), key areas of state support for domestic drug developers and manufacturers were identified, including subsidies for clinical trials[1]. 

In addition to existing support programs, subsidies for clinical trials at all stages will help overcome the financing barrier for high-risk phases of medicines clinical trials and accelerate the market launch of medicines. The combination of current and planned measures will create the legal and economic foundation for strengthening the production and technological capacity of the domestic pharmaceutical industry and increasing its presence in international markets.

Below, we will examine planned initiatives and support measures for pharmaceutical manufacturers that have already been implemented.

Initiatives

Support for Phase III Clinical Trials

On 29 September 2025, a draft Resolution of the Government of the Russian Federation was published “On the Specifics of Providing Subsidies from the Federal Budget to Russian Organizations to Reimburse Part of the Costs of Implementing Projects to Develop Original Medicines or Expand Medical Indications for Their Use” (“Draft Resolution”), aimed at compensating for costs associated with the final (Phase III) stage of clinical trials of original medicines[2].

The new subsidy mechanism, including options for calculating “success-based compensation[3]”, was planned to be extended to medicines falling under the “First-in-class” and “Best-in-class” categories, with indicative support limits:

However, the Ministry of Industry and Trade has decided to narrow the scope of state support by excluding the “Best-in-Class” category from the subsidy mechanism.

It is worth noting that the specified parameters (categories of drugs, their indicated support amounts) are not currently reflected in the Draft Resolution itself.

At the same time, the “First-in-Class” medicines category was established on 25 May 2026, with the publication of the draft Resolution of the Government of the Russian Federation “On Approval of the Rules for the Selection of Promising Original Medicines for Medical Use for Inclusion in the List of Promising Original Medicines for Medical Use” (“Selection Rules for Promising Original Medicines” / “Rules”).

According to the Rules, the list of projects includes those for which marketing authorizations have been obtained for medicines with a new mechanism of action (First-in-Class) – medicines containing an active substance with a unique pharmacological mechanism not previously present in official global medical practice[4].

The Rules also specify therapeutic areas in which project selection is possible, including: tuberculosis, epilepsy, obesity, Alzheimer’s disease, influenza, and others.

It is anticipated that the project selection will take place annually starting from 2026. For the selection of projects, a special Interdepartmental Commission is to be established, which will include representatives of the Ministry of Industry and Trade, the Ministry of Health, the Ministry of Education and Science, the Federal Antimonopoly Service (FAS), Rospatent, Rospotrebnadzor, and the Federal Medical and Biological Agency (FMBA).

Support for Phase I and II Clinical Trials

Among the initiatives under discussion was also the expansion of support measures to Phase I and II clinical trials, including through a mechanism for providing funding from the Ministry of Industry and Trade. In particular, a model of repayable financing for drug development is being considered, subject to the developer providing a bank guarantee.

This approach could be implemented as a separate program within the framework of state programs supporting drug development. We anticipate the introduction of a corresponding bill regarding this initiative.

Current Support Measures

Currently, domestic drug developers are provided with the following support measures, for example[5]:

In addition to the above measures, the Ministry of Industry and Trade is developing mechanisms to stimulate the export of Russian medicines to international markets, including incentives in the form of export cashback[6]. An official publication of the draft regarding this support measure is also expected.

The implementation of these initiatives is linked to a framework document defining the strategic direction for the development of the pharmaceutical industry – the Pharma Strategy 2030. Among these directions are:

• reducing dependence on imported medicines and expanding full-cycle local production;

• prioritizing domestic medicines, including through the introduction of a “second one is superfluous” mechanism in government procurement aimed at increasing the competitiveness of domestic full-cycle manufacturers[7];

• systemic measures to support medicines developers, including, for example:

- the conclusion of offset contracts under Federal Law No. 44-FZ of April 5, 2013, “On the Contract System in the Sphere of Procurement of Goods, Works, and Services to Meet State and Municipal Needs” (“Law 44-FZ”) within the framework of major regional and interregional projects. An offset contract is a long-term government contract with one or more regions. In exchange for making investments, the investor is provided with sales guarantees for the manufactured products[8].The term of an offset contract may not exceed ten years, and the minimum investment amount starts at one hundred million rubles.

A large number of offset contracts in the pharmaceutical and medical device manufacturing sectors are being implemented in the “Technopolis Moscow” SEZ, where a special pharmaceutical cluster has been established. Residents of the “Technopolis Moscow” SEZ are granted the following benefits:

• free customs zone status – exemption from customs duties and VAT,

• preferential land lease rates,

• reduced income tax,

• zero rates for property tax, transportation tax, and land tax;

- preferential loans for the development and production of pharmaceuticals through the State Corporation “Development Bank” (VEB.RF), etc.

Support measures are also being maintained through government-funded research projects, which are currently focused on pressing priorities (import substitution, biosafety) and the development of novel medicines from the List of Strategically Important Medicines. Government contracts fully cover the stages of exploratory research, computer modeling (in silico), synthesis of new molecules, and preclinical testing (in vitro / in vivo), and may additionally be issued for Phase 1-2 clinical trials.

Main Budget Administrators:

• Ministry of Education and Science: Funds fundamental research into new chemical compounds at academic institutes of the Russian Academy of Sciences (RAS) and universities.
• Ministry of Health: Assigns tasks to specialized medical research centers and institutes for applied research and translational medicine.
• Federal Medical Biological Agency (FMBA): Focused on the development of high-tech biomedical cell products (HBCPs), vaccines, and antidotes.

As a rule, state assignments are issued to subordinate institutions in response to their submitted applications, which include a description of the final development and the budget. A key feature of this system is the transfer of the completed development to an industrial partner for the preparation of a registration dossier and the registration of the medicines or medical devices in the industrial partner’s name. In this context, royalties or other payments may be made for the use of intellectual property rights arising from the intellectual property generated during the execution of the government assignment by subordinate institutions. Thus, this expands the opportunity for commercial pharmaceutical companies to acquire a development at a later stage with a complete set of documents for its further registration and to bring a relevant development to market faster than if they had developed it on their own.