Results of the conference «State regulation and the Russian pharmaceutical industry: continuation of the dialogue»

The XII scientific-practical conference "State regulation and the Russian pharmaceutical industry: continuation of the dialogue", organized by the Association of Russian pharmaceutical manufacturers and the National Research Institute of Public Health named after N.A. Semashko. The event was attended by representatives of regulatory authorities, expert organizations, pharmaceutical companies, medical communities and patient organizations.

The discussion focuses on the challenges and issues facing the pharmaceutical industry. Experts noted that COVID-19 has highlighted problematic points in domestic health care, in particular, the lack of a National Drug Policy. The purpose of the National Drug Policy is the availability, quality and rational use of drugs. Healthcare objectives can be complemented by economic components.

“Russia needs a national drug policy that would satisfy universal access to modern high-quality medicines and their rational use, as well as stimulate the development of the pharmaceutical industry in two directions: ensuring national drug safety and integration into the global pharmaceutical industry,” stressed the Chairman of the ARPM Supervisory Board Denis Chetverikov, president of Akrikhin.

The issues of the availability of medicines are key for the government, the scientific community and business. In 2020, it was planned to start pilot projects that will allow working out mechanisms for the transition to a system of reimbursing the cost of drugs in the outpatient link. However, at present, there are no pilot projects or other projects to reimburse the population for the purchase of drugs for the prevention of cardiovascular diseases in the regions. What prevents the launch of the project?

“The existing regulatory framework does not allow for the implementation of drug reimbursement mechanisms and requires the adoption of new legislative acts. The regulator fears massive demand for drugs and refers to the inability to predict the amount of medicines and drugs that will be needed. Officials explain that starting the experiment requires a special structure for implementation and serious investments, in addition, experts are not sure that it is impossible to show in two years how important it is to introduce such an innovation. Although the experience of introducing a co-payment system in the Kirov region convinces of the opposite and has proven itself very well,” — the academician of the Russian Academy of Sciences, scientific director of the Federal State Budgetary Scientific Institution «National Research Institute of Public Health named after N.А. Semashko» Ramil Khabriev.

Currently, in the absence of a functioning system of universal drug insurance, the legislation of the Russian Federation provides for several mechanisms of preferential (free) provision of drugs on an outpatient basis for certain categories of citizens. Funding for preferential drug provision is carried out at the expense of the federal and regional budgets.

The conference presented an analytical overview of the drug market. Over the past 8 years, its volume has grown by 76%. “Over the past decade, we have seen stunning results, now the market has stabilized and by the end of the year will grow by only 6%,” forecasts Sergey Shulyak, CEO of DSM Group.

Within the framework of the dialogue, the participants assessed the results of the Pharma2020 development strategy, analyzed the Pharma2030 project, considered the legislative innovations adopted during the pandemic, discussed issues of interchangeability and pharmacovigilance, and also summed up the results of the transition period and the prospects for the EAEU single market.

Summing up the results of the conference, General Director of the Association of Russian Pharmaceutical Manufacturers Victor Dmitriev touched upon the most painful topic of recent days — drug labeling.

 Failures in the system became one of the reasons for the shortage of drugs in pharmacies and the withdrawal of foreign pharmaceutical companies from the Russian market. The Ministry of Industry and Trade promised that in the near future the problem of lack of medicines will be resolved.

“Labeled products can move along the distribution chain without notifying the operator. If this is so, then goal-setting is lost, because when this whole system was started, it had to prevent counterfeit and poor-quality drugs from getting into circulation. It is not yet very clear to us whether we will pay for Control identification marks, today we pay 60 kopecks for each code: 50 — to the operator, 10 kopecks — VAT. Right now, we do not see that the operator to be able to make a workable system, it is necessary to create an alternative to the Advanced Technology Development Center, and secure the operator’s responsibility, including financial. For now the industry is waiting for regulatory legal acts, we hope that everything will change by the end of the week,” concluded Victor Dmitriev, General Director of the Association of Russian Pharmaceutical Manufacturers.

The conference was attended by: Director of the FSBSI "National Research Institute named after N. A. Semashko Alexander Zudin, Director of the Department of State Regulation of the Circulation of Medicines of the Ministry of Health of Russia Philip Romanov, Deputy Head of the Department for Organization of State Quality Control of Medical Products of  the Federal Service for Surveillance in Healthcare (Roszdravnadzor) Kirill Gorelov, President of the Association of International Pharmaceutical Manufacturers in the Republic of Kazakhstan Vyacheslav Lokshin, Head of the Department of Clinical Pharmacology of the State Budgetary Institution of Healthcare of the City of Moscow "Morozovskaya Children’s City Clinical Hospital of the Department of Healthcare of the City of Moscow" Anna Vlasova and other leading experts.

All proposals made during the XII scientific-practical conference "State regulation and the Russian pharmaceutical industry: continuation of the dialogue" will be transferred to the regulator.

Conference partners:

“AKRIKHIN” is one of the leading Russian pharmaceutical companies producing effective, affordable and high-quality medicines for the therapeutic groups most demanded by Russian patients. The company’s product portfolio includes about 200 drugs, more than 55% of which are sold are included in the VED list. The drugs belong to the main pharmacotherapeutic areas: pulmonology, endocrinology, dermatology, cardiology, neurology, gynecology, etc. and are produced in full compliance with GMP standards. Fully complying with the state and industry priorities, AKRIKHIN JSC actively participates in the localization and import substitution of medicines both by its own Research and Development Center and in partnership with international pharmaceutical manufacturers. The “AKRIKHIN” company employs 1,500 employees, of which more than 800 are at the production site in Staraya Kupavna, Moscow region.

PHARMASYNTEZ is a leading domestic manufacturer of medicines for the treatment of socially significant diseases such as tuberculosis, HIV, oncology, diabetes mellitus, and hepatitis. Production facilities are represented by five modern high-tech factories in the cities: Ussuriysk, Irkutsk, Bratsk, Tyumen, St. Petersburg. The company’s product portfolio includes over 170 types of drugs in various dosage forms: capsules, tablets, granules, infusion solutions, dry sterile powders and lyophilisates, as well as solutions for injections. More than 80% of manufactured drugs are included in the list of vital and essential drugs. The annual production volume exceeds 70 million packages. Revenue at the end of 2019 amounted to 22.7 billion rubles.

Long Sheng Pharma is a structural division of the Chinese State Holding for the production and trade of chemical and pharmaceutical equipment, pharmaceutical raw materials and petrochemical products. Today Long Sheng Pharma has three international offices (Hong Kong, Beijing, Moscow), dozens of highly qualified employees, about 200 business partners in more than 40 countries. Over 20 years in the pharmaceutical industry, Long Sheng Pharma has gained a reputation as a reliable international business partner, a leading supplier to the CIS and Eastern Europe.

General information partner — Pharmaceutical Bulletin

Media partners: Duma TV channel, Komsomolskaya Pravda publishing house, Regions of Russia media holding, information and analytical portal, GMP News Media project, Moskovskiye Apteki (Moscow Pharmacies) newspaper for pharmacy specialists, social network for professionals of the pharmaceutical industry "Pharma RF", information and analytical journal "Pharmacy Union", the scientific journal "Development and registration of medicines", the journal "Pharmaceutical technologies and packaging", journal "Polyclinic".

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