Measures to accelerate market access for innovative medicines discussed at SPIEF

The development and production of innovative medicines are among the key priorities of the Russian Pharmaceutical Industry Development Strategy through 2030. The question of how to accelerate the introduction of innovative medicines, achieve technological leadership in pharmaceutical innovation, ensure Russian patients have access to high-quality and affordable domestically produced therapies, and maintain competitiveness in international markets was discussed during the St. Petersburg International Economic Forum (SPIEF 2026).

Over the past 25 years, the Russian pharmaceutical industry has undergone a remarkable transformation. Having initially focused on manufacturing generic versions of essential medicines, pharmaceutical companies are increasingly moving toward the development and production of original innovative products. Nevertheless, foreign manufacturers still account for approximately 90% of government procurement of innovative medicines.

Sergey Glagolev, Deputy Minister of Health of the Russian Federation, noted that both the regulatory framework and the capabilities of the domestic pharmaceutical industry now make it possible to manufacture «everything currently available on the global pharmaceutical landscape.» However, he emphasized that the challenge today is to increase the average value generated by the Russian pharmaceutical sector not through medicine price indexation, but through the growth of the innovative segment. In this regard, the industry faces a challenge related to ensuring predictable demand. According to the Deputy Minister, incentives and alternative mechanisms to support demand are needed to make investment in innovation more attractive.

"We understand that the current model, under which 70% of pharmaceutical ingredients are imported, is no longer sustainable. To change this situation, more than funding is required. First and foremost, regulatory processes must evolve. Regulation should be flexible and structured in a way that transforms market access for innovative medicines from a major hurdle into a streamlined process involving all relevant regulators,"

said Anastasia Stolkova, First Deputy Director for Development of the Roscongress Foundation and member of the Civic Chamber of the Russian Federation.

Today, successful approval of an innovative domestic medicine in Russia is not the end of the journey for investors but only the beginning. The path from marketing approval to broad patient access may take three to five years. Such timelines reduce both industry and investor interest in innovative projects. Rapid market access is particularly critical for companies whose business models depend primarily on the domestic market.

In particular, Mikhail Tsyferov, President of Petrovax Pharm, spoke about the barriers the company has encountered while implementing its biotechnology development strategy.

"Today, biosimilars account for 15% of our portfolio and original medicines for 85%. Yet over the past 15 months, revenue has been generated mainly by biosimilars — 85% — while original medicines are still waiting for their promising future. Our market is oriented toward protecting locally produced biosimilars and generics. Due to regulatory barriers, healthcare institutions are forced to purchase Western medicines that cost 1.5–2 times more. At the same time, the potential savings for the state budget from procurement of just the first product in Petrovax Pharm’s pipeline, camrelizumab, are estimated at RUB 150–200 billion over the next five years,"

said Mikhail Tsyferov, President of Petrovax Pharm.

Ekaterina Priezzheva, Deputy Minister of Industry and Trade, also emphasized the importance of accelerating access to innovative medicines for patients.

"As the Ministry of Industry and Trade, we see the need to revise regulatory processes in order to optimize timelines. Perhaps the stages should no longer be strictly sequential, step by step. For example, when submitting documents for marketing approval, companies could already begin considering the next stage,"

said Ekaterina Priezzheva.

Despite the growing interest of Russian pharmaceutical manufacturers in launching innovations, their number remains limited. According to Kirill Danishevsky, Vice President for Corporate Communications at Petrovax Pharm, only five fully Russian innovative medicines have been launched in the country over the past five years.

"These are, in a sense, unicorns that must be protected so they do not disappear. However, after marketing approval, Russian innovative medicines face a long path toward inclusion in the financing system. For domestic companies, a waiting period of three to five years becomes a serious financial challenge. A high key interest rate, combined with lengthy access timelines to public procurement due to slow revision of clinical guidelines and infrequent revision of the State Guarantees Program, significantly reduces the competitiveness of Russian manufacturers, slows return on investment, and limits opportunities to reinvest in new developments,"

he explained.

Another important factor is market predictability.

"We have already produced half a million doses of a fully Russian meningococcal vaccine. By the end of 2026, our production capacity will reach 4 million doses annually. This is enough to cover the entire demand of Russia and neighboring countries to which we can export it. But we are concerned about another postponement of the expansion of the National Immunization Schedule, despite a very serious epidemiological problem and a multiple increase in mortality from meningococcal infection. Such unpredictability is fatal not only for patients, but also for the Russian industry,"

concluded Kirill Danishevsky.

Experts emphasize that today the most effective way to support innovation is to accelerate market access. In particular, this involves introducing a fast-track pathway: immediate inclusion of fully Russian innovative medicines in clinical guidelines and compulsory health insurance (CHI) tariffs upon their inclusion in the Essential Drug List (EDL), especially when such medicines generate savings for the state budget. This could become a key driver of increased investment in innovation — investment that stimulates economic growth, strengthens the country’s scientific and technological potential, and supports technological sovereignty.

Previous news

04 June 2026

Petrovax Pharm announces support program for women with aggressive breast cancer at SPIEF

#Forum #SPIEF #Oncology #Areima