Inoculation of national importance
On January 15, within the program of the Gaidar Forum 2020, roundtable “Immunoprophylaxis: Prospects of Development up to 2035” took place. Participants of the session shared their suggestions and ideas on how to achieve successful implementation of the immunoprophylaxis development strategy until 2035.
According to Alexander Plakida, Discussion Moderator; Executive Director, the Effective Health Care platform, the activities to provide operation of the immunoprophylaxis system cover awareness, transparency and quality control system. That is why, issues of planning and decision-making procedure in production and procurement of preparations, awareness and enhancement of public trust towards the vaccination system, and also efficiency of interdepartmental interaction were selected as the major discussion points.
Sergei Kraevoi, Deputy Minister of Health of the Russian Federation, spoke about the major aspects and vectors of strategy 2035 being developed, having noted that, subject to possible amendments and improvements to the document by the Government, it may be adopted in Q1 this year. According to him, the issues of awareness and promotion of public commitment to preventive vaccination ring true even against the background of medical research solutions: “We are facing the situation when decrease of infectious disease rate as a result of vaccination generates the assurance that inoculations are no longer needed. In Europe, the growth of infectious diseases against the background of the migration flow occurs in parallel with revitalization of anti-vaccination lobby. That is why, one of the most critical objectives of the future strategy shall be to convince our citizens that vaccination is important.”
In his report, Sergey Tsyb, First Deputy Minister of Industry and Trade of the Russian Federation, shared some indicators of localization dynamics of immunobiological preparations. According to the announced data, for the last 5 years, the share of vaccines manufactured in Russia grew from 39 to 89% in physical terms. Among manufacturers support tools, Sergey Tsyb highlighted legislative innovations in making special investment contracts (SPIC 2.0), subsidizing creation of preparations in the amount of RUB 4 billion for 2020 and support of research and development of drug products within the venture fund established together with Russian Venture Company. “As regards localization and preferences, it is obvious that manufacturers benefit from establishment of factories in Russia when state support is available. And we do have such capabilities,” Sergey Tsyb summed up his speech.
Marwan Akar, Director General, MSD Pharmaceuticals LLC; Managing Director, MSD Russia and EAEU, spoke about recent projects of the company in production localization in Russia. In July 2019, MSD and Russian Scientific and Production Company FORT declared their cooperation in stage-by-stage localization of production of rotavirus infection, chicken pox and human papilloma virus (HPV) vaccines. According to Mr. Akar, a long process of assessment of production capabilities, infrastructure of investment plans, and also strategic vision and business culture prefaced the signing of such an important agreement. “The agreements reached are an important step aimed at increase in accessibility of preventive measures, such as vaccination, for most common viral diseases, and also at increase in life expectancy as the major goal outlined by the Russian President,” Marwan Akar noted.
In turn, Pavel Vandyshev, Director General, FORT LLC, emphasized that the main factor for a manufacturer is interest of the state in the preparation and the time factor. According to him, it may take decades to launch a preparation, including the development, registration and localization period. That is why, long-term contracts are a wonderful initiative to plan all production aspects.
When speaking about critical localization aspects of Sanofi Pasteur pharmaceutical company, Guillaume Haushalter, General Manager of the company in Russia and Belarus, noted the utmost importance of working on quality of vaccines. In addition, according to him, the planning horizon of supply contracts must consider the fact that it takes years to develop and launch a vaccine, while 70% of time is spent on quality control of the preparation.
Furthermore, addressing the subject of state support to manufacturers, Vladimir Khristenko, President, Nanolek LLC, noted that guarantees of development of the national vaccination schedule and procurement of vaccines may be more efficient than other state support measures, as the lack of demand guarantees is the major risk of the manufacturer.
In his speech, Mikhail Murashko, Head of the Federal Service for Supervision in Healthcare, outlined pain points in quality control of drug preparations. Furthermore, the Head of the Federal Service for Supervision in Healthcare spoke about the need for introduction of administrative and pecuniary liability of the manufacturer for product non-conformity to the necessary parameters that is common international practice.
Nikolay Briko, Head of the Department of Epidemiology and Evidence-Based Medicine, Faculty of Preventive Medicine, Federal State Autonomous Educational Institution of Higher Education I.M. Sechenov First Moscow State Medical University, supported the raised points. According to him, the immunoprophylaxis law should be reassessed and amended, especially as regards for liability for refusal and plea for refusal of vaccination.
Ayrat Farrakhov, Deputy of the State Duma of the Russian Federation, summed up the discussion. Having emphasized once again the importance of planning in the immunoprophylaxis system, the representative of the lower chamber of parliament suggested to be intent on serious lawmaking work that will allow to build a stable market.
The Gaidar Forum is held at the RANEPA under the auspices of the Government of the Russian Federation and in 11 years it has become one of the most respected expert venues, which traditionally sets the vector for public and scientific discussion at the beginning of each year. The organizers of the 11th Gaidar Forum are the Russian Presidential Academy of National Economy and Public Administration, the Gaidar Institute for Economic Policy, and the Association of Innovative Regions of Russia.
The title partners of the Gaidar Forum are Gazprom PJSC and Gazprombank JSC. The strategic partners are Coca-Cola, Mastercard, Russian Railways, Pharmstandard group of companies, Johnson & Johnson, Sanofi, Novartis group of companies, MSD, AKIG group of companies, EF Education First. Partners are Prosveshchenie group of companies, EY, Huawei, RVC JSC, Russian Agricultural Bank JSC.
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