Andrey Ivashchenko, Head of the Innovative Pharmaceuticals Committee of the National Champions Association, named the first signs of degradation in the pharmaceutical industry

The expert believes that the first signs of degradation have appeared in the industry. To ensure real technological sovereignty it is necessary to replace 9% of INN of own innovative drugs. Such targets were announced at the meeting of the Expert Council in the State Duma, dedicated to the problems o pharma innovations development in 2025-2036.

The main parameters of the new innovative cycle of domestic pharmaceutical innovations creation within the period of 2025-2036 were discussed by representatives of the pharmaceutical industry at the meeting of the Expert Council on Regulation of Drugs and Medical Devices Circulation of the State Duma Committee on Health Protection, held by the State Duma Deputy Aleksander Petrov, reports the PhV correspondent.

“The systemic development of original (innovative) drugs manufacture is an important state task and will allow domestic players not only to develop the national market, but also to increase cooperation in the field of joint development and technology localization with companies from BRICS countries”, – the State Duma said in its press release. According to parliamentarians, it may create conditions for managing the cost of original drugs in the Russian market and will allow competing with Big Pharma products in the markets of friendly countries, as well as will give additional economic benefits for the domestic pharma innovations development. Providing Russian patients with the best domestically manufactured drugs (“first and best in class”) is an ambitious but achievable goal.

To achieve real technological sovereignty it is necessary to carry out import substitution of 9% of innovative drugs (191 INN out of more than 2,000) in the segment of public procurements, which accounts for 310 billion RUB of costs. Such data was cited by Andrey Ivashchenko, Head of the Innovative Pharmaceuticals Committee of the National Champions Association, Chairman of the Board of Directors of ChemRar Group of Companies. “It is a potential for creating our own innovative drugs that act on the same targets, in the same nosologies, but are the next technological stage for treatment,” – Mr. Ivashchenko said. According to him, it is these drugs that will have a potential for export.

The main risk for the loss of technological sovereignty in the pharmaceutical industry is a breakdown of the innovation chain between science and industry, – Mr. Ivashchenko believes. Among the key problems he named a small number of own developments in science, which can go to the “valley of death”, the withdrawal of foreign innovations, as well as the consolidation of the generic model in the industry, which led to the appearance of “the first signs of degradation of the industry”.

To overcome this situation, Andrey Ivashchenko suggested revising the targets of the Pharma-2030 Strategy from 40% of localized drugs to 70%. Other measures may include the creation of a “preliminary order” for innovations from the healthcare system, improvement of regulatory support for domestic innovations, including mandatory “preliminary review” by the regulator, as well as the creation of tools for pharmaceutical developments “growth completing”.

The need to introduce support measures in the “valley of death” and to build a system of coordination between regulatory authorities and pharmaceutical companies was pointed out by Oleg Lavrov, Advisor to the Director General of Innovation Engineering Center, Autonomous Non-Profit Organization. “A system should be created along the entire chain, with non-financial and financial support measures at each stage,” – Oleg Lavrov believes.

The need to update approaches to the creation of innovative drugs is also seen in the Association of Pharmaceutical Manufacturers of the EAEU (APhPEAEU), which was confirmed by Aleksey Kedrin, the Chairman of the Board. He noted that companies need a methodology for determining which drugs will be in demand.

Aleksander Semenov, President of Active Component, emphasized the “launch, approval of criteria and, in fact, the list of strategically important drugs itself”. In his opinion, “it is a critical success factor for the launch of our innovative pharmaceutical industry”. He also pointed out the need to form “a basis in the form of a full cycle”.

Oleg Astafurov, Vice President for Government Relations of Pharmasintez Group of Companies, proposed to introduce a system of incentives for pharmaceutical companies by compensating a part of their costs for innovative development. Roman Dry, R&D Director of Geropharm, drew attention to the need to improve regulation in the field of clinical trials.

Sourse: https://pharmvestnik.ru/