The medical care system lacks flexibility in maintaining a balance between the interests of patients and manufacturers

The partnering “Medicines of Russia — towards an interdisciplinary dialogue” took place in Kaliningrad, bringing together recognized industry experts, representatives of specialized regulatory authorities, patient and medical associations, higher educational institutions and analytical agencies to discuss ways of innovative development of domestic pharmaceutical industry and improving the medical provision of Russian citizens. Partnering according to the Chairman of the State Duma Committee on Health Protection Badma Bashankaev, “has long laid the tradition of discussing issues that will be relevant tomorrow and the day after tomorrow.” And the head of the Federal Service for Surveillance in Healthcare (Roszdravnadzor) Alla Samoilova, addressing the participants and guests of the event with a welcoming speech, noted that the Partnering program “fully reflects modern trends in the development of the domestic pharmaceutical industry.”

On behalf of the Russian Ministry of Health, Deputy Minister Sergei Glagolev greeted those gathered, pointing out in his address the stable operation of the domestic pharmaceutical industry and the healthcare system under sanctions and emphasizing that analysis and discussion in the professional circle of appearing emergency situations will help avoiding similar failures in the future. Representative of the Kaliningrad Ministry of Health Anna Popova, in turn, expressed confidence that the ongoing dialogue will help improve the efficiency and safety of the use of medicines both in Russia in general and in the Kaliningrad region in particular.

The discussion was started by representatives of analytical agencies. Ekaterina Zadonskaya, General Director of Kursor Marketing LLC, shared comparative data on government procurement of medicines for similar periods in 2022-23 and the main trends in bidding. She noted a positive trend towards a decrease in failed procurements and an increase in the number of completed tenders (in quantitative terms), as well as a decrease in contracts with a single supplier. Her colleague in the analytical field, Development Director of DSM Group Denis Zinoviev, cited data that the average per capita consumption of medicines has been growing in recent years mainly due to public funds, while the share of the pharmaceutical market in GDP remains stable and remains at the level of 1.7-1.8 %.

The representative of the Center for the development of advanced technologies (CDAT), Egor Zhavoronkov, who heads the “Pharma” direction, also voiced his statistical data. He positively characterized the trend towards a decrease in violations of possession, which indicates the industry’s readiness for the abolition of the notification regime in the system, which entered into force at the legislative level on September 1. Innovations in the operation of the Drug Movement Monitoring (DMM) system, which recently came into force, were partly touched upon in his speech by Valery Alekseev, head of the Bureau of Investigation of the All-Russian Popular Front. He recalled the concerns expressed by some market participants in August and noted that despite the fact that there was no crisis in drug supply, the issues of doctors’ unpreparedness to competently write prescriptions still remain relevant, since this module is not included in educational programs, as well as the need to restore the ability to issue prescriptions by specialists in hospitals. In support of these proposals, the co-chairman of the All-Russian Union of Public Associations of Patients, Yan Vlasov, spoke on behalf of the patient community; he also suggested that the practice of issuing electronic prescriptions could significantly reduce the number of errors when issuing them, taking into account the fact that at the moment there are already more than 550 thousand doctors that have an electronic signature.

The FAS was represented at the conference by Daria Starykh, deputy head of the Department of Healthcare Control, who noted that at the end of 2022, monitoring of retail prices showed that the actual increase in prices for vital and essential drugs is significantly lower than the maximum indexation percentage allowed annually based on the results of economic analysis. This fact indicates the presence of fair competition in the pharmaceutical field.

The topical issue for the industry of introducing the “second wheel” mechanism became the key topic of the speech by Dmitry Galkin, Director of the Department of Pharmaceutical and Medical Industry of the Ministry of Industry and Trade of the Russian Federation. He explained that for now in the focus are only strategically important drugs, not all of which are produced in Russia in a full cycle. To stimulate full-cycle production, significant market advantages are needed, and this is precisely what the mechanism being developed is aimed at.

Reducing government costs for developing products that are the fruit of medical research in the field of health care and medical science, and bringing these products to the patient are the main goals of the federal project “Medical Science for Humans.” We are talking about developments that are being carried out in government institutions, Konstantin Belanov, director of the Center for Transfer of Medical Technologies of the Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’) of the Ministry of Health of Russia, told the participants of the Partnering. The center is engaged in supporting developments today including radiopharmaceutical, antitumor, neuroprotective and antiviral drugs, analgesics, vaccines, cell products, implants and rehabilitation hardware and software complexes. However, the state alone cannot finance such innovations; the industrial partner plays an important role in their promotion, and the Center is very interested in mutually beneficial cooperation. It is important to note that at the moment the formation of a unified database of research and development technological work (USISR NIOKR) is in the process of completion, which will accumulate all developments, this will allow in a convenient form to quickly receive information about interesting and promising products and promote their fast implementation.

Alexander Hadjidis, head of the Association of Clinical Pharmacologists of St. Petersburg, noted that global trends that can be traced in Russia are the growth of the market for generic drugs and biosimilars, as well as an increase in the share of biological drugs (both in terms of quantitative indicators and volume sales).

Issues of drug availability are closely related to preferences and restrictions when introducing generic drugs to the Russian market; this side of the problem was highlighted by the representative of the Pepeliaev Group law firm, head of the Pharmaceutics and Healthcare practice, Konstantin Sharlovsky. Along with the positive vector of stimulating the development of domestic pharmaceutical production, there is also the problem of washing out original drugs from the market, which deprives doctors and patients of the opportunity to choose, for whom the issue of using a specific drug in a specific form and dosage is often a vital issue.

The problem of the lack of qualified personnel in the industry was raised by the First Deputy Prosecutor of the Kaliningrad Region, Vladimir Rodin, complaining about how much effort the Kaliningrad Prosecutor’s Office, together with Roszdravnadzor, had made to open a large number of first-aid posts in the region, and as a result, there is a shortage of medical personnel for their functioning. Continuing the topic, Vladimir Luzhanin, rector of the Perm State Pharmaceutical Academy, recalled that with a sharp reduction in the number of industrial pharmacies, the function of a pharmacist was actually equated to the function of a sales agent, and the volume of secondary vocational education programs was also reduced. Such business processes undoubtedly need to be adjusted, because ultimately we are talking about the drug safety of the state.

A patient’s perspective on the issues of timely and high-quality drug provision was presented by the Deputy Chairman of the Commission of the Public Chamber of the Russian Federation on Public Control and Work with Citizens’ Appeals, the head of the federal project “ZdravControl” Evgeniy Martynov. He spoke about the principles of the ZdravControl project, the system of medical telegram chats that allow person to quickly resolve emerging issues, as well as the possibilities of the project in terms of public control over the process of providing drug provision to privileged categories of citizens under the conditions of a moratorium on planned inspection activities carried out by government agencies.

The dialogue was continued by the executive director of the Association of Clinical Pharmacologists, Maxim Frolov, outlining his view on the issues of rational pharmacotherapy in the conditions of drug procurement under The Federal Law No. 44. He explained that when choosing drug therapy today, it is important to take into account not only medical aspects, but also pharmaceutical logistics, the characteristics of drug provision in different regions, different categories of patients and insurance coverage.

In conclusion, Badma Bashankaev assured the audience that for his part, as a representative of the legislative branch, he had heard the problems and noted the tasks that needed to be addressed. And the head of the ARPM, Victor Dmitriev, thanked all the speakers and participants of the Partnering and emphasized that most of the issues raised are closely interconnected and can only be resolved through joint efforts in a productive dialogue.

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