During the session ‘Innovative Therapy: Access Code’ on the sidelines of SPIEF 2021, experts discussed ways to increase access to innovative drug therapy for patients. The session took place as part of the business programme of the Drug Security Forum.
The event was attended by: Deputy Minister of Health of the Russian Federation Sergey Glagolev, Federal Service for Intellectual Property (Rospatent) Director Grigory Ivliev, Federal Service for Surveillance in Healthcare (Roszdravnadzor) Head Alla Samoylova, Sanofi Eurasia General Manager and Association of International Pharmaceutical Manufacturers (AIPM) Chair of the Board of Directors Oksana Monge, World Health Innovation Summit (WISH) CEO Sultana Afdhal, National Medical Research Radiological Centre of the Russian Ministry of Health General Director Andrey Kaprin, Almazov National Medical Research Centre of the Russian Ministry of Health Director General and Russian Society of Cardiology President Yevgeny Shlyakhto, Bristol-Myers Squibb Market Access and Pricing Director Alisa Dzhangiryants, Research Centre for Medical Genetics Director and Chief External Expert in Medical Genetics Sergey Kutsev, National Medical Research Centre for Endocrinology of the Russian Ministry of Health Director Natalya Mokrysheva, and Generium General Director Daniil Talyansky.
“During the pandemic, all of our efforts were focused on developing, rapidly ensuring the availability, and scaling of the production of the entire range of drugs against COVID-19 and vaccines. Russia has the necessary expertise and biotechnology, and today we are essentially on the verge of an innovative breakthrough. We never come out of any crisis the way we got into it: during the pandemic, we improved regulation, and this had a positive effect on accelerating the processes of launching drugs on the market without compromising quality, efficacy, and safety. We have strengthened the trend towards localization and enhancing the expertise of the domestic pharmaceutical industry for the development and production of innovative medicines. In this regard, the industry has great potential,” Deputy Minister of Health of the Russian Federation Sergey Glagolev said.
National healthcare priorities focus on improving citizens’ well-being, finding cures for difficult-to-cure diseases, enhancing quality of life, and extending life expectancy. They also aim to promote widespread access to innovative drug treatments, gene therapy, and biomedical cell products.
The effective protection of intellectual property rights is one of the key factors in increasing the availability of innovative drugs. To this end, it is crucial to ensure the functioning of new tools to protect intellectual rights, such as a pharmaceutical register, which Russia plans to introduce. The register must be maintained in accordance with all legislative requirements, both those of Russia and Eurasia. It also needs to take into account WTO standards and include all types of valid patents, including information about patents for biological medicinal products and patents for inventions related to the method of production, concentration, combining substances, or application for a specific purpose. In the future, this approach should be applied when creating a pharmaceutical register for the EAEU.
Global practices in securing access to modern drugs present a number of difficulties. Besides regulatory barriers that prevent new drugs from coming to the market, developing innovative drugs requires substantial investment, which is reflected in their market price. Strategies for promoting drug innovations in clinical trials are tied to models of drug supply, among which the system of shared risk has been successfully used in international practice.
In order to improve the supply of innovative drugs in Russia, a number of programmes need to be put in place to aid the development of a full manufacturing cycle infrastructure. There also needs to be a range of incentives for domestic manufacturers of innovative drugs. No less important is the strategy of building long-term mutually beneficial partnerships on the pharma market.
During the session, experts discussed such issues as what innovative products and technologies will drive the development of present-day and future medicine, what initiatives will be able to stimulate the development of an innovative pharma industry that is attractive to investors, what regulatory decisions may help stimulate research and development in Russia, and how can the balance between the generics and innovation industries be maintained.