Andrey Ivashchenko: Pharma-2030 Strategy requires more ambitious goals to ensure technological sovereignty
If we consider pharmaceuticals to be an industry where we should have technological sovereignty, then we should have not only fully localized pharmaceutical manufacturing facilities, but also our own development lines for innovative drugs.
On June 5, 2024, Andrey Ivashchenko, Chairman of the Board of Directors of ChemRar Group, Doctor of Engineering, Professor of the Russian Academy of Sciences, took part in the business program of SPIEF 2024 within the framework of the Drug Safety Forum, which was opened with “Today’s Day – a Look into the Future. Pharma-2030 and Course to Long-Term Planning” session, organized with the support of the Association of Pharmaceutical Manufacturers of the EAEU (APhPEAEU).
Only 1 year has passed since the Russian Government approved the Pharma-2030 Pharmaceutical Industry Development Strategy, and despite this, analyzing the first results, the session participants noted the need to modernize the Strategy, including the issues of improving the drug supply regulation system, updating the tools to support domestic pharma, primarily in the field of innovative developments, as well as the manufacture of active pharmaceutical substances and ingredients for their creation. Today, the pharmaceutical industry and government efforts are focused on tactical tasks, such as, for example, localization of pharmaceutical ingredients manufacture; it is well-justified, as market participants believe, and is a priority, as it is difficult to talk about technological sovereignty without it. However, it cannot be underestimated that in the near future the current trends of a multiple reduction in clinical trials of innovative drugs will lead to the industry degradation. If we do not start taking drastic measures to launch the innovation cycle now, we will not see new next generations drugs appear in our country.
The Pharma-2030 Strategy, adopted a year ago, is already outdated, as it does not meet the objectives of the industry innovative development, and, in fact, preserves the generic scenario”, – believes Andrey Ivashchenko. – If we look at the key indicator of this strategy, it is planned to increase the volume of domestic pharmaceutical products up to 43% by 2030. At the moment, this indicator is 36% in monetary terms. Consequently, we plan to buy the remaining 57% from abroad. It means, we will spend a significant part of the money spent on pharmaceuticals on the development of the innovation industry in other countries. I believe that we should be more ambitious and set the goal of 70% share of domestic drugs by 2030 in monetary terms, then at least 30% of these 70% will be innovative drugs, and the rest – generic drugs. It should be noted that our industry has learned to make both bio- and synthetic generics, but these are low-margin products, and pharmaceutical manufacturers will not be able to earn enough on them to invest in the innovations creation.
Yekaterina Priyezheva, Deputy Minister of Industry and Trade of the Russian Federation, commenting on Andrey Ivashchenko’s speech, supported the importance of revising the Strategy indicators towards increasing innovative import substitution, and noted that the Ministry of Industry and Trade of the Russian Federation is open for cooperation and is waiting for specific proposals from the industry on how the industry will achieve these ambitious goals. In addition, Yekaterina Gennadievna emphasized in her speech that active work is already underway to identify technologies and promising developments, which should be focused on first of all. “The main task is not just to keep the pace, but to break ahead. Out of the 40 items of the Pharma-2030 Strategy, we have to show results for 14 of them already in 2024. The state and business should analyze the first results and develop proposals for the measures modernization. Now, we can see that for some items, for example, introduction of changes to the list of Strategically Important Drugs, we need to accelerate and adjust the timing”, – said Deputy Minister of Industry and Trade of the Russian Federation.
But, unfortunately, the majority of the domestic market in monetary terms, still remains behind foreign Big Pharma, most of these companies are located in unfriendly countries, and many of them have stopped clinical trials of their innovative drugs in Russia. This situation creates significant risks for the domestic health care system, even if it is possible to avoid defects in already registered foreign drugs, including via the use of compulsory licensing, as early as in the next 5 years, our patients will not be able to receive next generation drugs, such as those that are effective against new resistant forms of infectious diseases and cancer. In this regard, the question of creating our own lines for the development of innovative drugs on the territory of our country becomes acute.
These and other issues of stimulating and developing innovative pharmaceuticals in Russia continued to be discussed at the next expert session of SPIEF 2024, which was held with the organizational support of Innopraktika Company and the National Champions Association.
The participants see the main problem hindering the innovation industry development in a gap between science and industry, where there are high scientific and financial risks – the first and the second phases of clinical trials. Today, only a few companies take on their financing, and the Ministry of Health through its subordinate organizations takes on a small part of it, but it is definitely not enough. The program of these stages financing should be seriously expanded to include the development of corporations, including in cooperation with state research organizations, in order to significantly increase the flow of innovations.
Natalia Popova, First Deputy Director General of Innopraktika Company, Public Ombudsman in the Field of High-Tech Leading Companies’ Rights Protection, also noted during the discussion that at the moment there is a shortage of funding for innovative projects of pharmaceutical companies. “The support measures available at the moment cannot cope with the shortage of funding sources for the pharmaceutical industry, which obviously exists if we compare it with other industries – primarily IT, but also electronics and instrumentation. In this regard, it is necessary to envisage additional measures that will be aimed at assisting companies in developing their projects at various stages of pre-clinical and clinical trials, especially at early stages”, – said Natalia Popova.
Pavel Dvornichenko, Director General of Engineering and Innovation Support Center, Autonomous Non-Profit Organization, told about the creation of a special grant program for pharma, based on the principles of the “growth completing” program for technology companies to meet the needs of large Russian corporations. “For the pharmaceutical industry, together with initiative companies, we are working out the parameters of a specialized program to support innovation. On the one hand, retaining the basic mechanism and approaches from the “growth completing” program, on the other hand – adapting the terms of the program to the specifics of the pharmaceutical industry itself”, – said Pavel Dvornichenko.
“Pharmaceutical companies need “start-up order”, systemic support measures for all the stages of the life cycle of innovative pharmaceuticals development and manufacture, as well as tools to launch products both into the Russian market and for export for their development. This program will allow companies to test a system solution – from demand forecasting to implementation into treatment standards and domestic drugs export in case of success”, – explained Oleg Lavrov, Advisor to the Director General of Innovation Engineering Center, Autonomous Non-Profit Organization.
“I would like to thank the National Champions Association and the Innovative Pharmaceuticals Committee created under it that we have this platform where we can focus and discuss strategic issues related to our own innovative drugs creation, in partnership with the academic sector, including foreign market participants, but we are talking about our own innovative drugs in our industry,” – emphasized Andrey Ivashchenko, Head of the Innovative Pharmaceuticals Committee of the National Champions Association. – If we consider the pharmaceutical industry, where we should have technological sovereignty, and this is reflected in the Decree of the President of the Russian Federation dated 28.02.2024 № 145 “On the Strategy of Scientific and Technological Development of the Russian Federation”, then we need not only localized production of medicines, but also our own lines of development of these drugs should appear, and urgent measures should be taken right now”.