On May 26-27, 2019, the opening of the First All-Russian Pharmaceutical Run was held in Kazan. The ceremonial launch of the event was supported by leading representatives of the pharmaceutical industry.
On May 27, the grand opening ceremony of Farm Run 2019 was held. Welcoming and grateful words were opened by Dmitry Chagin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the EAEU: “Today, our industry has great potential for development, in the future we will not only be able to produce medicines, but also produce original and innovative drugs. Our goal today is not just a focus on import substitution, but a transition to the stage of import import. ” Participants of the rally were greeted by the head of the inter-factional deputy of the group of the State Duma of the Federal Assembly of the Russian Federation on improving the legislation in the field of pharmaceutical supply Ayrat Farrakhov , director of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation Alexey Alyokhin, President of the cluster FarmMedPolis Albert Gaifullin and the head of Eurasia business unit of Bosnalek JSC Valentina Buchneva .
“I’m sure that every point on the Farm Run route will contribute to solving urgent problems of the industry, will help us take a step forward in improving the availability of effective and high-quality medical care for our fellow citizens,” the Minister of Industry and Trade of the Russian Federation said in a welcoming speech Denis Manturov .
As part of the opening of the event, a meeting was held at the Government House of the Republic of Tatarstan with the President of the Republic of Tatarstan Minnikhanov Rustam Nurgalievich with regulators of the pharmaceutical industry of Russia and representatives of companies participating in the I All-Russian Pharmaceutical Run.
In addition, on the day of the grand opening, the possibilities of the Republic of Tatarstan and the directions for the development of the PharmMedPolis cluster, which offers to pay special attention to the problems of children’s dosages and the production of children’s dosage forms, were presented.
The main event of the day was the round table “Effective mechanisms for drug provision in the Russian Federation. Issues of quality and accessibility in the regional context. “
The moderator was the supervisor of the Federal State Budgetary Scientific Institution National Institute of Public Health named after N. A. Semashko » Ramil Khabriev , who raised the problem of drug provision in the outpatient sector: in the ranking of the probability of death from major noncommunicable diseases between the ages of 30 and 70, Russia ranks 180 out of 187 countries, while in terms of provision of beds – on the fifth. About 20% of the cost of purchasing drugs from the list of vital drugs is spent on drugs with insufficiently proven effectiveness. “The actual limitation of the availability of drugs for the main part of the population is negatively affecting the main health indicators. This is a lack of control over chronically occurring diseases, an increase in the frequency and duration of hospital admissions, and an increase in the costs of the healthcare system. ”
Almir Abashev , First Deputy Minister of Health of the Republic of Tatarstan, continued the stated theme: “Accessibility is provided at the expense of citizens, and this is a big challenge so that dispensary groups, people who need constant outpatient care, have opportunities to maintain one’s health. This is a big burden for patients and their families. ”
Anna Plessovskikh , general director of the Pharm-Run interdisciplinary association, spoke about some preliminary results of the all-Russian patient survey “Quality and Availability of Medicines – 2019”. The dynamics taking into account past years shows that the percentage of people who doubt the quality of purchased medicines has increased, and there is also a big problem with their availability.
Director of the Department for the Development of the Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of Russia Aleksey Alyokhin spoke about the main priorities of the unit: “We focus on providing our citizens with the necessary medicines. Children’s dosage forms also meet these priorities. We also focus on the development of local innovation. The third important point is the development of our regulatory system. ” The speaker outlined the importance of introducing a personalized approach, talked about plans for the withdrawal of new drugs in a period of 6-7 years and explained the need to ensure their recognition and recognition through the introduction of international practices. Also, Aleksey Alekhin indicated that localization can be stimulated by offering long-term state contracts for the production of medicines.
Vadim Kukava , Executive Director of Innovative Pharma, continued the theme posed by Ramil Khabriev, outlining the main problems from the point of view of the health of the nation: hypersortality, low life expectancy, low birth rate, high mortality rate at working age from heart diseases vascular system (50% of the total), low diagnosability, insufficient supply of drugs in the outpatient sector. Among the causes of the problem, the expert highlighted the high costs of the population, limited reimbursement, suboptimal distribution of expenses, the lack of remuneration for innovations from the point of view of the regulatory system and an effective system of price revision, as well as limited commercial stability. As a solution, a modified model of drug supply and price regulation was proposed. It will include the introduction of universal drug coverage on a co-payment basis, the transition from regulating producer price caps to setting reference prices (reimbursement price caps), introducing a formalized mechanism for annual review of drug reimbursement prices and setting a margin for the margin in absolute terms for each INN, as well as limitation of the margin for trade margins.
The positive experience of the Republic of Tatarstan in the field of palliative medicine was shared by the head of the territorial body of the Federal Service for Supervision of Health in the Republic of Tatarstan Lyubov Shaikhutdinova : “Once it was difficult to get a medicine, there were many obstacles. But after the proactive correction of federal orders, the situation has now completely changed. “There used to be a huge number of complaints about getting painkillers, now there is one treatment in 3-4 months.” In the report, the expert drew attention to the importance of organizing events that do not require large expenditures and help to lower the problem from higher bodies to a lower level. Love also recalled the issue of orphan diseases: “There is still no clear mechanism for the provision of this category of patients in need of drugs.”
During the discussion, considerable attention was paid to the topic of children’s drugs. Rosa Yagudina, Director of the Center for Educational Programs of the Federal State Budgetary Institution NTsESMP of the Ministry of Health of Russia, said: “The lack of pediatric dosage forms leaves 40% of the child population at risk for developing adverse events. There are also problems with suboptimal dosing of drugs and poor access to innovative drugs. ” The report highlighted key issues in this area: the relatively small pediatric market, the prevalence of off-label drugs in pediatric practice, the lack of initiatives to develop drugs for generic drugs, and the lower prevalence of chronic diseases than in adults. The expert also demonstrated the capabilities of mini-tablets – a children’s dosage form that does not have such drawbacks of liquid drugs as limited use of excipients, problems with chemical, physical, microbiological stability, dosing accuracy and controlled release. At the same time, they solve the problem of swallowing, which occurs when using solid forms.
The topic of children’s drugs was continued by Vladislav Shestakov , director of the FSBI “GILS and NP” and talked about joint activities with the research center RNIMU im. Pirogov on the development of children’s dosage forms: “Suppositories, mild forms are under development. Different directions are immunomodulating, antispasmodics, antipyretic drugs and drugs for the cardiovascular system. We have a huge program until 2022. We plan that upon completion, effectiveness and safety will be confirmed, the university itself will conduct preclinical and clinical studies, and we will jointly look for a manufacturer to whom we can transfer this technology ”
Victor Dmitriev , general director of the Association of Pharmaceutical Manufacturers, outlined two principles that must be observed for the successful development of the topic under discussion: “It is extremely important for us when we think about drug provision, to maintain a balance of interests and look forward.” He explained that within the regulators there are contradictions and inconsistencies affecting the result. The expert also spoke about the shortcomings of the existing marking system in terms of the size of crypto-tails.
Olga Vostrikova, Chairman of the International Patient Union , presented the point of view of the consumers themselves at the event. Special attention in the report was given to public procurement planning in the region: “We know that in some regions drugs are purchased that are not needed by patients. And at the same time, it is almost impossible to transfer these drugs to neighboring regions. This is a question that may lead to federal procurement of expensive drugs. ” The necessity of introducing a unified system of recommendations was also discussed: “Another problem is non-compliance with federal recommendations. When a patient returns to the region to continue treatment, not all regional clinics and hospitals comply with them. ”
Sergey Simeniv , head of the contract research organization X7 Research, discussed the topic of childhood forms in terms of clinical trials, citing figures on the state of the CI market according to WHO data: “For 75% of childhood diseases, there are no special drugs yet. Extremely little data on the safety of the use of such drugs. For 70-80% of the drugs used in pediatrics, there have been no clinical studies in the pediatric population. 90% of drugs prescribed for newborns are not registered for use in this age group. ” The speaker said that there is a large list of ethical restrictions for research, and noted that the pharmaceutical companies are the driver of this area.
The deputy director for educational activities of Kazan State Medical University of the Institute of Pharmacy Svetlana Egorova examined the existing children’s dosage forms, noting their positive and negative sides. At the end of the discussion, the speaker transferred the vector of this topic from pharmaceutical manufacturers to manufacturing pharmacies, noting the large role of additive technologies such as a farm printer in the future.
On May 26, the day of preparation for the car mileage, a showroom of the Tatarstan Investment Development Agency was held in Kazan with a demonstration of the investment attractiveness of the region, as well as a meeting with its head Talia Minullina . On May 27, the runners visited the Tatkhimpharmpreparat production site.
You can take part in the patient survey “Quality and Availability of Medicines – 2019” at pharmprobeg.ru/opros.