Towards Drug Sovereignty: The Moscow Ecosystem's Experience

What successes has the capital's clinical drug research ecosystem achieved, and why is it important to research domestic original molecules?

The changing geopolitical situation has inevitably impacted the pharmaceutical industry. Due to disruptions in supply chains, many pharmaceutical companies have suspended clinical trials and have no plans to initiate new ones. Clinical trials  offer an opportunity to register innovative drugs on the Russian pharmaceutical market, thereby ensuring early patient access to highly effective treatments.

In his decree "On the Strategy for Scientific and Technological Development of the Russian Federation" dated February 28, 2024, President Vladimir Putin outlined the country's scientific and technological development priorities. One of the key priorities is the transition to personalized, predictive, and preventive medicine, high-tech healthcare, and health-preserving technologies, including through the rational use of drugs and the use of genetic data. This requires the development of innovative medical technologies, including pharmaceuticals, and the meticulous study of their properties in properly organized research.

To this end, Moscow, in accordance with a decree of the capital's government, has implemented its own comprehensive support program for clinical trials, within the framework of which a multi-component infrastructure for their implementation has been created in the city.

In the fall of 2024, Moscow celebrated the two-year anniversary of its program to support clinical drug trials. The initiative was initially launched during the pandemic.When the Russian Sputnik V vaccine was first tested for COVID-19 , it required 40,000 volunteers to participate in post-registration trials. The study, involving approximately 33,000 volunteers, was conducted at 22 medical facilities in Moscow.

The program became fully operational in October 2022. At that time, the Moscow mayor's decree outlined support measures, including organizational and financial, for pharmaceutical companies conducting clinical trials in Moscow healthcare institutions.

Moscow Center for Innovative Technologies in Healthcare (Photo: Press Service of the Moscow Social Development Complex)

Since the program's inception, according to the Moscow Department of Healthcare (DZM), the city's ecosystem has supported over 100 studies initiated by 20 pharmaceutical companies and research institutes. The vast majority of applications came from domestic pharmaceutical manufacturers, although Moscow also received applications from a number of international companies. Some of the supported studies have already been completed, and drug registration certificates have been issued based on their results.

Interest in conducting clinical trials at Moscow's medical institutions is no coincidence, as Moscow has developed an ecosystem for the rapid conduct of clinical drug trials. This ecosystem has a vast base in the city: over the past 15 years, Moscow's state-run medical institutions have conducted over 2,300 clinical trials in 83 therapeutic areas. Clinical centers operate at more than 90 medical institutions. Outpatient care is also involved: specialists from 11 outpatient clinics have participated in the trials over the past three years.

Another part of the ecosystem is a centralized laboratory, which operates 24/7 and has an extensive logistics system. Next is a telemedicine center, allowing researchers to conduct part of their work remotely. Another participant in this system is the Moscow City Ethics Committee (MCEC), which oversees every clinical trial.

Finally, a single digital network unites the entire clinical research ecosystem. Using the Unified Medical Information and Analytical System (UMIAS), specialists can find volunteers for study inclusion, maintain electronic documentation, track data on ambulance calls, drug therapy, and more. Patient information is available to researchers in real time. The entire ecosystem is managed by the Moscow Center for Innovative Technologies in Healthcare.

A distinctive feature of the capital's clinical research system is the predominance of high-tech Phase I–IV projects, which require sophisticated diagnostic equipment and highly qualified personnel. In the first half of 2024, medical organizations within the capital's Department of Health received 45 permits for such projects, significantly exceeding the figures in other regions of the Russian Federation.

How the clinical research ecosystem can help the pharmaceutical market

In 2023, the Russian Ministry of Industry and Trade unveiled the "Pharma-2030" pharmaceutical industry development strategy, which had been in development since 2018. According to the strategy, the Russian pharmaceutical market is expected to grow from 2.2 trillion to 3.7 trillion rubles by 2030. The share of Russian-made drugs in monetary terms is planned to increase from 35.9% to 42.6%. Commenting on the strategy's implementation, Deputy Prime Minister Tatyana Golikova called for efforts to ensure that 70% of all medications dispensed are of high quality and effective Russian origin.

Golikova also noted that support measures are planned to be provided primarily to developers of original and localized drugs, as "they [manufacturers] are currently more focused on producing generics." Indeed, according to the Association of Clinical Research Organizations (ACRO), 2023 marked a record share of bioequivalence studies of domestic generics, at 62.2% of the total number of studies since 2004.

Moscow Center for Innovative Technologies in Healthcare (Photo: Press Service of the Moscow Social Development Complex)

According to DSM analysts, the share of domestic original-brand drugs on the Russian pharmaceutical market has been declining since 2022. In 2022, Russian original-brand drugs accounted for 5.2% in monetary terms, 3.9% in 2023, and 3.8% in the first nine months of 2024. In terms of package equivalents, this figure fell from 2.7% in 2022 to 2.2% in 2024. A total of 117 million packages of Russian original-brand drugs were produced in 2023. By comparison, nearly 3.1 billion packages of domestic generics were produced during the same period.

Thanks to the Moscow Research Support Program, Russian pharmaceutical companies can receive organizational and financial support for their clinical developments, with more than a dozen drugs already approved for registration. Over the two years of the program's operation, four original innovative Russian drugs, three new vaccines, and six biosimilars, significant for import substitution, have been registered based on the results of already completed trials.

Against the backdrop of the approved "Pharma-2030" program and the drive to develop original drugs, clinical trials of original molecules are crucial. According to the Moscow Health Department, 50 clinical trials of original molecules, 14 vaccine trials, and 36 trials of generic drugs and biosimilars have been and continue to be conducted with the support of the Moscow ecosystem. Research is being conducted in 15 therapeutic areas, including infectious diseases, oncology, rheumatology, endocrinology, and others. Infectious diseases account for 21 clinical trials, including nine related to the prevention and treatment of COVID-19. Oncology and oncohematology account for 20 trials, including seven on melanoma, three on breast cancer, and trials in complex areas such as neuroblastoma and head and neck tumors. Endocrinology accounted for six trials, two of which were on type 2 diabetes.

The Moscow ecosystem collaborates with leading Russian research institutes to develop strategic vaccines, antimicrobial agents, and cardiology medications. These institutions include the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Ministry of Health, the St. Petersburg Research Institute of Vaccines and Serums, the E.I. Chazov National Medical Research Center of Cardiology of the Russian Ministry of Health, and others.

Anastasia Rakova (Photo: Press Service of the Moscow Social Development Complex)

Of the 100 applications for research support, 78 required organizational support . Financial support for more than a dozen drug trials significant for Moscow healthcare was approved by the Clinical Committee, and the pharmaceutical companies conducting these trials are already receiving the approved funds, reported Moscow Deputy Mayor for Social Development Anastasia Rakova.

• Organizational support includes assessing the feasibility of conducting a clinical trial, selecting city medical organizations with the necessary equipment, forming a research team, recruiting volunteers, interacting with ethics committees, and providing legal support.
• Financial support means reimbursement of a portion of the costs of conducting clinical trials—up to 50% of the total costs—for those drugs that are important specifically for Moscow healthcare.

Benefits of the ecosystem approach

All Moscow medical organizations are connected by a single digital platform, ensuring the safety and quality control of the trials. It provides doctors with access to patient data when creating a volunteer database and allows them to record every request for medical care, whether it's a house call, a clinic visit, a hospitalization, or an ambulance call.

The Clinical Research Department, a specialized division of the Moscow Center for Innovative Technologies in Healthcare (Medtech), coordinates these processes. It helps pharmaceutical companies quickly integrate into the city's infrastructure, expediting the selection of sites, volunteers, and organizational issues.

The coordinated work of all structural elements allows for the launch of clinical trials as quickly as possible. The Clinical Research Department assists pharmaceutical companies in selecting medical organizations under the jurisdiction of the city's Department of Health, recommends researchers, and facilitates the recruitment of volunteers.

This approach makes Moscow a key center for clinical research, ensuring high quality research and the reliability of the results obtained.