Participants of St. Petersburg International Economic Forum 2024 (SPIEF 2024) discussed ways to stimulate and develop innovative pharmaceuticals in the country
On June 5, within the framework of SPIEF, a session dedicated to the development of domestic innovative pharmaceuticals was held with the organizational support of Innopraktika Company and the National Champions Association.
As part of the discussion, the speakers considered the specifics of development, introduction into manufacture and launch of innovative pharmaceuticals into the Russian market.
“Today, innovative pharmaceuticals are becoming a key element of healthcare development in our country. Therefore, it is worth understanding what factors and mechanisms are necessary to build an innovative environment that will increase the share of high-quality domestic drugs, including within the framework of import substitution”, – said Vadim Tarasov, Director of the Institute for Translational Medicine and Biotechnology of I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation in his opening remarks as the session moderator.
At the beginning of the session, Deputy Minister of Health of the Russian Federation Tatyana Semenova drew attention to the fact that the pharmaceutical industry is now in transition to technological leadership. In this regard, it is important to pay attention to the academic science sector as a driver in achieving national goals in the pharmaceutical industry.
At the same time, the issue of supporting companies from the pharmaceutical industry, including “national champion” companies, also remains relevant. According to Natalia Popova, First Deputy Director General of Innopraktika Company, Public Ombudsman in the Field of High-Tech Leading Companies’ Rights Protection, 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”, – Natalia Popova shared her opinion.
Currently, the pharmaceutical industry and government efforts are focused on tactical tasks, such as, for example, localization of pharmaceutical ingredients manufacture; it is well-justified 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 stagnation in the industry. 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, according to the “national champion” companies.
“Pharma-2030 Strategy adopted a year ago does not meet the task of innovative development of the industry, and in fact, preserves the generic scenario. Pharmaceutical manufacturers will not be able to earn enough on low-margin generics to invest in the creation of innovative products. The main problem is an existing 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. If we consider the pharmaceutical industry, where we must have technological sovereignty, as it is also reflected in the Presidential Decree on the Strategy for Scientific and Technological Development of the Russian Federation, then we need not only localized manufacture of pharmaceuticals, but also our own lines of development of these drugs must appear, and urgent measures must be taken right now,” said Andrey Ivashchenko, Head of the Innovative Pharmaceuticals Committee of the National Champions Association, Chairman of the Board of Directors of ChemRar Group of Companies.
“Research and development of new drugs is a key component of successfully expanding a portfolio of innovative products. Investing in research, development of new formulations and technologies allows companies to create innovative products that can attract new customers and strengthen their market position. Therefore, it is now important to support companies at the stage of clinical trials that can change the industry and improve the quality of patients’ lives”, – expressed his opinion Oleg Astafurov, Vice President for Government Relations, Pharmasintez Group.
The possible most demanded support measures, which were emphasized by the speakers, include: grants, soft loans, investments in capital and entry into the stock market. All these financing tools can be used in the development of advanced projects in the pharmaceutical industry, resulting in increased efficiency of enterprises and potentially reduced innovation costs.
Pavel Dvornichenko, Director General of Engineering and Innovation Support Center, Autonomous Non-Profit Organization, spoke in more detail about a possibility of forming a separate industry grant program for companies implementing projects in the field of innovative pharmaceuticals, based on the principles of the “growth completing” program. “There are industries that require a special approach for the implementation of support measures. In particular, to meet all the requirements, for the pharmaceutical industry, together with initiative companies, we are working out the parameters of a specialized program for innovative pharmaceuticals. 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.
The idea to create a special grant program in the pharmaceutical industry was supported by Oleg Lavrov, Advisor to the Director General of Innovation Engineering Center, Autonomous Non-Profit Organization. He stated that 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.
The session participants also discussed issues related to the process of bringing innovative drugs into the market, to the ways to increase the product portfolio of companies, to protection of intellectual property for drugs, to the need to regulate the procedure of scientific consultation during the development and introduction of innovative drugs to the pharmaceutical market, to healthcare technologies assessment (HTA) in the system of public and private investment during new technologies development, etc.
Summarizing the session results, the speakers agreed that stimulation and development of the pharmaceutical industry requires a comprehensive approach, including investment in research, partnership with medical institutions and professional development of specialists. Only if these conditions are met it will be possible to ensure the availability of innovative technologies and drugs for all citizens of the country.
The discussion was attended by: Vadim Tarasov, Director of the Institute for Translational Medicine and Biotechnology of I.M. Sechenov First Moscow State Medical University of the Ministry of Health of the Russian Federation; Tatyana Semenova, Deputy Minister of Health of the Russian Federation; Oleg Tsetlin, Director of the VEB.RF Project Office; Pavel Dvornichenko, Director General of Engineering and Innovation Support Center, Autonomous Non-Profit Organization; Natalia Popova, First Deputy Director General of Innopraktika Company, Public Ombudsman in the Field of High-Tech Leading Companies’ Rights Protection; Vadim Kukava, Executive Director of the Pharmaceutical Innovations Association of Pharmaceutical Companies (“Infarma”); Larisa Matveeva, Executive Director of the Association of International Pharmaceutical Manufacturers; Tadzio Shilling, CEO of the Association of European Businesses (AEB); Oleg Lavrov, Advisor to the Director General of Innovation Engineering Center, Autonomous Non-Profit Organization; Nadezhda Rukavitsina, Head of the Innovation Implementation Support Center of the Center for Expertise and Quality Control of Medical Care of the Ministry of Health of the Russian Federation; Sergey Masyuk, Director General of Artgen Biotech, PJSC; Andrey Ivashchenko, Chairman of the Board of Directors of ChemRar Group of Companies; Oleg Astafurov, Vice President for Government Relations of Pharmasintez Group of Companies.
Source: https://www.natchamp.org/