The code of life: how to achieve drug safety in Russia

The availability of high-quality medicines has long been a necessity, on which, among other things, the security and sovereignty of the country as a whole depends. In the current conditions, the issue of drug safety is acute, therefore, special attention is being paid to the introduction of innovative technologies. The topic of accessibility of medicines and drug safety in the global context became one of the most discussed on the first day of the SPIEF. For more information about what steps are being taken in these areas today, see the Izvestia article.

Innovation in action

The introduction of innovations in modern Russian medicine is one of the key provisions in the strategy for the development of the Russian pharmaceutical industry until 2030 (Pharma—2030), adopted in 2023. This area covers several areas at once, including digitalization, robotics, and, of course, the development of original drugs and vaccines.

Over the past year and a half, 85% of registered drugs are of domestic production, Russian Minister of Health Mikhail Murashko noted during the forum. In 2024, two thirds of all packages and 41% in financial terms in pharmacies and public procurement were Russian, in turn, Dmitry Galkin, Director of the Department of Pharmaceutical and Medical Industry Development at the Ministry of Industry and Trade, cited statistics.

Petrovax Pharm, one of the Russian companies working within the framework of the Pharma 2030 strategy, focuses on the development and market launch of the most sought-after innovative drugs for the treatment of socially significant diseases. During the SPIEF, Mikhail Tsyferov, President of the company, spoke about the project to bring biotech products to the Russian market, which was launched about five years ago.

One of the main issues here is the source of advanced technology. According to experts, today it is primarily the pharmaceutical companies' own developments and cooperation with scientific centers. The partnership of pharmaceutical manufacturers with scientific institutes allows us to form a strong platform for developing advanced approaches to modern medical care, narrowing the gap between science and practice, making innovative developments available to patients.

In the early days of the SPIEF, a number of companies and scientific institutions concluded cooperation agreements. In particular, Petrovax Pharm announced the signing of a memorandum of strategic cooperation with the N.F. Gamalei National Research and Development Center. Together, they will engage in cutting-edge research in the field of oncology. The first of these will be the study of the prospects for combination therapy using revolutionary mRNA technologies in combination with the immuno-oncological drug camrelizumab.

According to Alexander Gintsburg, Director of the N.F. Gamalei National Research Center of the Russian Academy of Sciences, Academician of the Russian Academy of Sciences, the combination of therapeutic mRNA vaccines with other immuno-oncological drugs can give the doctor additional opportunities to stimulate the immune system of a cancer patient, which means additional chances for tumor regression and remission of the patient.

Another partnership between Sechenov University and Petrovax Pharm is aimed at developing joint effective solutions to accelerate import substitution in the pharmaceutical industry and increase the availability of innovative medicines for Russian patients.

The partners plan to launch a series of scientific studies that will show in practice that Russian developments can be not just an alternative to foreign ones, but leaders in their field. This, in particular, will help to overcome the problem of distrust of Russian-made drugs. This issue is regularly raised by experts. At the recent Semashko Russian Pharmaceutical Forum, Ekaterina Priezdeva, Deputy head of the Ministry of Industry and Trade, noted that the ministry is working to resolve this issue, including by creating working groups with the participation of key freelance specialists.

The first joint study of Sechenov University and Petrovax Pharm is aimed at one of the most complex areas of medicine — orphan diseases. Specialists, in particular, will evaluate the use of the domestic drug agalsidase beta in the treatment of patients with Fabry's disease. The complete localization of this orphan drug, including the synthesis of the substance from the cell line, is a project implemented by Petrovax Pharm in partnership with the N.F. Gamaleya Research and Development Center. To date, 57 patients have already received therapy with a biosimilar of the drug agalsidase beta (Fabagal).

The path to the patient

The availability of innovative therapies consists not only of research and development, price, but also regulatory processes after registration. Thus, for domestic vaccines, the cornerstone issue of accessibility is the inclusion of preventive vaccinations in the National Calendar. Petrovax Pharm plans to launch a meningococcal vaccine on the market next year with further full-cycle production, including the synthesis of the substance. Meningitis caused by this infection is not only the most lethal among vaccine-preventable diseases, but also the most disabling disease — it causes deafness, amputation of limbs, cognitive impairment, and epilepsy. Given the increasing incidence, doctors and the patient community are calling for meningococcal vaccination to be included in the NCT as soon as possible, in accordance with the strategy for the development of immunoprophylaxis of infectious diseases for the period up to 2035.

For rare and a number of oncological diseases, the availability of patient therapy can be solved through federalization of procurement, experts say. Auctions for orphan drugs in the regions are often organized by trade name, as a result, expensive foreign drugs are purchased in the presence of high-quality domestic ones. As a result, there may simply be no money left for other patients.

— Our proposal is federalization of procurement. This would allow the government to save money. And we could treat more patients with a 40% lower drug price," said Petrovax Pharm President.

Oleg Shukhov, Head of the Drug Supply Analysis Department at the National Medical Research Center for Hematology, shares a similar opinion. He noted the critical importance of shortening the route from the moment of patient registration to the moment of his access to drug therapy.

A new approach

The introduction of innovations in the medical sector also brings with it the need to develop new approaches. Market participants emphasize that the regulatory cycle — inclusion in clinical guidelines, VED and other post—registration procedures - can take up to two years. This not only distances therapy from the patient, even with a high demand from the medical community, but it can also affect the price.

— The sooner we start selling the drug, the lower we can offer the price to domestic healthcare, — said Mikhail Tsyferov.

Valeria Lemeshko, head of the Roche Russia division for healthcare development and cooperation with federal government agencies, drew attention to the same problem.

— Innovation is always a new approach. <...> The decision-making process itself, in our opinion, is a potentiating point. We really believe that the inclusion of innovations in the drug supply system is a mutually important task, not only for the manufacturer, but also for the healthcare system," Lemeshko emphasized.

The international vector

The SPIEF also discussed drug safety in the global context, as well as Russia's integration into global processes. Speaking about the importance of international cooperation in the field of medicines, Valentina Kosenko stressed the importance of harmonizing the requirements for the examination and registration of medicines and the issues of mutual recognition of certain studies and procedures within the framework of registration for the introduction of medicines to the markets of other countries.

For the development of exports, it is equally important to have local innovative products that are in demand abroad.

Mikhail Tsyferov, for his part, pointed out the enormous potential for cooperation with Asian pharmaceutical companies that are open to projects with a deep degree of localization, the possibility of supplying drugs reproduced in Russia to other markets, as well as the exchange of scientific data and further drug development by Russian scientists.