Klondike for the market: innovations in Russian biopharmaceuticals discussed at SPIEF

Photo: Alexey Nikolsky

The Russian biopharmaceutical industry is a new growth driver for the national economy, which has the potential to match the raw materials and space industries. This was stated by Peter Bely, Chairman of the Board of Directors of PJSC Promomed, speaking at the RBC site as part of the St. Petersburg International Economic Forum (SPIEF-2024). Sergey Glagolev, Deputy Head of the Russian Ministry of Health, Yuri Zubov, head of Rospatent, Artem Zdunov, Head of the Republic of Mordovia, Vyacheslav Shulenin, General Director of the Moscow Center for Innovative Technologies in Healthcare, and representatives of the pharmaceutical industry discussed issues of intellectual property protection in pharmaceuticals, the innovative status of the industry, and ongoing government support measures at the panel "Intellectual Property in Pharmaceuticals: Dispute or Discussion."

"Innovative medicines around the world create huge added value due to the possibility of creating blocking reliable patent protection. It is important that the potential of our biopharmaceuticals is realized here in Russia. Then this is not only a powerful breakthrough and a huge capitalization of the pharmaceutical industry, but also the capital of the whole country and the basis for economic growth and exports," said Vyacheslav Shulenin, CEO of the Moscow Center for Innovative Technologies in Healthcare.

The Russian pharmaceutical industry has all the necessary resources to create innovative breakthrough solutions in healthcare, not only domestic, but also worldwide. "Back during COVID-19, we showed that we can find solutions as soon as possible and manufacture drugs that are vital for the country. When another crisis occurred and at the beginning of 2023, patients with diabetes mellitus were left without treatment due to withdrawal from the Ozempika market, we were able to develop and manufacture the most important drugs in a very short period of time, and not just a domestic analogue, but even an improved version — we launched Quincenta on the market. It is important to note that in both cases, the government provided significant support by creating a favorable regulatory environment and, in exceptional cases, resorting to compulsory license mechanisms. Thanks to this, the patients received the necessary therapy, and this is the most important thing," Bely stressed.

Building reliable patent protection is an important factor in developing the innovative potential of the pharmaceutical industry and bringing it to a "cosmic" scale. And here Rospatent plays an important role, as an agency that objectively evaluates the state of technology and novelty and has maximum expertise in creating high-quality and internationally recognized patents. And Rospatent is ready to focus its work on solving this problem and provide assistance. Great importance is attached to the support of domestic innovations. A Center for the Promotion of Advanced Technologies has been established, which helps the pharmaceutical industry create highly capitalized world-class intangible assets. The strategic objective of the industry's development is to increase the number of domestic pharmaceutical innovations and high-quality drugs.

"What should happen in the coming years? Most of the "initial applications" for the molecules should be submitted by Russian pharmaceutical companies," said Yuri Zubov, head of Rospatent. Experts concluded that then a huge reserve of added value would be formed in our country. And this is an economic effect that in the future can be compared with the effect of the country's largest export destinations: oil, gas, and atom.

"This capital and added value do not come from anywhere. They are shaped by scientific research. And the "brains" that Russia has, our intellectual capital, in my opinion, should be directed towards creating advanced products and technologies that will be competitive. This requires development and time. We need to discuss government support measures to ensure that such innovations are created in our country," Zubov added.

The Russian Ministry of Health, in turn, has already created mechanisms to accelerate the withdrawal of innovations and plans to expand this practice for domestic drugs that provide breakthrough therapeutic solutions.

"We have already expanded our practice for accelerated registration of breakthrough drugs at the EAEU level and plan to continue to create all conditions for the development of domestic pharmaceuticals and drug independence. And if we resort to the practice of "compulsory licenses", then it is worth knowing that all the criteria and norms of compulsory licensing in our legislation comply with international standards and are applied only in case of threat to the life and health of patients," Deputy Head of the Ministry of Health Sergey Glagov said during the session.olev. "We also hope to increase the interaction of representatives of the pharmaceutical industry with our research institutes, which already have many developments. After all, we are not talking about innovation for the sake of innovation — they must be clinically meaningful, implemented in medicines, launched in production, so that the latest therapies can become available to patients faster. And, of course, these products should be well protected and bring the royalties necessary for the further work of our scientific colleagues," the official added. "And for the development of exports, an important topic is the synchronization of the strategies of Rospatent and the Eurasian patent offices," Glagolev is sure.

"We devote very little time and attention to protecting our pharmaceutical companies," Artyom Zdunov, the head of the Republic of Mordovia, said during the discussion. — Many foreign companies have occupied this market and do not give us the opportunity to take a variable look at its capabilities. I think now is the time to review this policy. Before our eyes, in Mordovia, with the cooperation of an advanced biopharmaceutical company and the Moscow State University. Ogareva has developed a whole class of innovative drugs for the treatment of infections, oncology, HIV, diabetes, etc., which have already saved millions of lives. So there really is a potential. Now it is important to fully implement it for the benefit of the country."

The development of domestic medicines is supported, among others, by the Moscow government, said Vyacheslav Shulenin, General Director of the Moscow Center for Innovative Technologies in Healthcare. "We are currently supporting 77 clinical trials. There is not a single one from a foreign company among them. Moreover, of these studies, only 24 drugs are generics and biosimilars, and the rest are original domestic medicines and vaccines. We can do a lot of our own domestic and good things. And given the added value of innovation and the growing demand for such therapies around the world, pharmaceutical innovation is also a new Klondike for the stock market," he said.

Experts agreed that the interaction of all participants in the pharmaceutical market and government representatives aimed at developing innovative biopharmaceuticals and ensuring its reliable legal protection will not only ensure drug and even medical independence, but also become a key factor in significant economic growth and capitalization of the country.

Source: RBC

1. https://www.rbc.ru/industries/news/66633aa29a79473b89f98634