Neither drug safety nor technological sovereignty can be achieved as long as the Russian pharmaceutical industry continues to develop within the generic paradigm. In an interview with GxP News, State Duma Deputy, member of the Duma Committee on the Protection of Competition, and head of the expert council on developing competition in the pharmaceutical sector, Irina Filatova, discusses whether we can overcome import dependence and what needs to change in state policy to achieve this.
How do you assess the current state of the pharmaceutical market and its potential for import substitution?
In today’s difficult conditions, despite all the sanctions, disruptions in supply chains, and the cessation of service maintenance, the pharmaceutical industry is demonstrating a high level of mobility and is actively developing. During the government’s report to the State Duma on February 25, Mikhail Mishustin specifically highlighted the pharmaceutical industry as a leader in terms of development pace.
Drug manufacturers and the professional community are achieving significant results within their own framework, but the need for a systemic restructuring of the industry is obvious. Optimizing the regulatory framework, changing the public procurement system, regulating intellectual property issues, preferential taxation for developers and research centers, and accelerated market access for innovative drugs—all these are necessary measures.
The number of international clinical trials in Russia has reached a historic low in the last few years; since 2021, their number has decreased by 15.5 times. And it’s not just about the political position of foreign pharma companies. Generics are successfully being brought to market in Russia, but only a few of the largest companies that can afford the research risks are engaged in creating innovative drugs. The main problem remains the lack of guaranteed state demand for complex, innovative drugs. If the state were to shape demand, and this were embedded in the legal framework, then the production chains from drug creation to market launch would be different.
In one of your speeches, you mentioned that the first step towards real drug security is forecasting morbidity and society’s needs for specific medicines. What progress do you see on this issue?
Speaking of forecasting, it is appropriate to recall the drug supply system that existed in the USSR. It started precisely with forecasting, because the pharmaceutical industry cannot instantly compensate for an emerging urgent need. We successfully coped with the COVID-19 epidemic because we already had the developments needed to create a vaccine, but in another force majeure situation, such opportunities might not exist. And creating a new drug takes 5–10 years. But no one is engaged in long-term forecasting here yet. The pharmaceutical industry has several regulators that do not always communicate successfully with each other on related issues, and there is no single entity responsible for the final result—that is, for innovative development and technological sovereignty.
Let me give an example. Currently, rates of depressive, anxiety, and stress disorders, as well as various psychiatric illnesses, are increasing worldwide. A long-term forecast for the country needs to be made right now to understand social needs and, in correlation with them, prepare production capacities for manufacturing the necessary drugs. This is a state task that must be reflected in the state order; without guaranteed demand, the pharmaceutical industry cannot operate at the required volumes.
Without long-term forecasting, we are quite far from achieving drug sovereignty. This can be illustrated in numbers. In 2024, the total volume of the pharmaceutical market amounted to 2.85 trillion rubles. While in 2020, spending on the most effective imported drugs for treating complex nosologies accounted for 43% in monetary terms, by 2024 their share in ruble equivalent had grown to 61.5%, despite a decrease in the number of packages.
Couldn’t this growth be linked to inflation?
No, the share of purchases of foreign drugs in rubles is increasing, but at the same time it is decreasing in terms of packages. Domestic pharma has learned to make generics, but we are purchasing all advanced and modern drugs from foreign manufacturers, thus continuing to finance them.
The sad statistics on domestic INNs only confirm this. From 2020 to 2024, 19 original INNs were created in Russia, of which 11 were biotechnological, including 6 monoclonal antibodies and 4 vaccines. During the same period, the US registers 45–50 innovative drugs annually, and the EU registers 30–35. It is obvious that if we do not invest in our own development, we will continue to purchase effective drugs from abroad.
For us to be able to develop innovation, the entire system must be built around it. Look at how advanced countries protect their market: they have created significant preferences for domestic manufacturers for a wide variety of situations. The US was the creator of this system, but China has also surged far ahead over the past 10–12 years. They have several levels of drug innovativeness, various economic packages for benefits, and ensuring accelerated market access. Moreover, preferences exist even in cases where a drug is not registered, but the phase IV clinical trials have proven a medical effect that existing drugs do not provide.
In Russian regulatory practice, there is still no definition of drug innovativeness.
Yes, we have not developed a unified definition, although everyone understands that criteria for innovativeness are necessary for the further development of the industry. The problem is that if they appear, preferential regimes will need to be revised and priorities changed, which will affect the entire drug market and impact other industries.
To summarize: for us to have innovation, political will is needed. Today, we see that conflicting and directly contradictory laws are in effect within the industry’s regulatory framework. Moreover, there is also a conflict of interest between the regulators themselves.
Federal Law No. 523-FZ “On Technological Policy in the Russian Federation” enshrines goals such as ensuring the country’s technological leadership through innovation and its accelerated implementation. It even integrates the right to reasonable risk in scientific development. But in practice, it turns out that all institutions conducting research at public expense must, de facto, enter into a work contract in which the result is specified in advance. And if the researcher does not achieve it, they must comply with the requirement to return the funds, or else face criminal liability for improper spending and use of budget funds.
You became one of the initiators of the revision of the draft Federal Law on Scientific Advice. What practical tasks could be solved by its adoption?
The draft law, which is currently going through another stage of approval, arose in response to requests from pharmaceutical manufacturers. Elevating this issue to the legislative level will make it possible to build a future system and future structure, along with all the subordinate regulatory framework, including regulations, rules, timelines, and procedures. As foreign experience shows, thanks to this mechanism, the time for the full cycle of drug development and market launch is reduced by 30–40%: from 7–10 years to 5–6 years, and the proportion of effective applications for drug registration increases to 90%.
The issue of scientific advice is discussed quite often; it is one of the basic elements of support for developers of innovative drugs. In our country, it is applied only to a limited number of biomedical cell products, whereas the scientific advice service should become part of the state registration process for medicines.
