Our Goal Is Import Excellence

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Our Goal Is Import Excellence
Our Goal Is Import Excellence

Video: Our Goal Is Import Excellence

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Our goal is import excellence

The 1st All-Russian Pharmaceutical Run, a large-scale event, ended in St. Petersburg, the participants of which tried to raise all the main problems of the industry: from the low availability of high-quality drugs to the difficulties with the introduction of new drugs to the market.

"Our goal is import excellence"
"Our goal is import excellence"

The 1st All-Russian Pharmaceutical Run, a large-scale event, ended in St. Petersburg, the participants of which tried to raise all the main problems of the industry: from the low availability of high-quality drugs to the difficulties with the introduction of new drugs to the market.

The participants of the rally were representatives of pharmaceutical manufacturers, medical and research companies, patient associations. For the route, regions were selected where pharmaceuticals are a strategic direction. These are Tatarstan, Nizhny Novgorod, Moscow and Vladimir regions, Kaluga, Yaroslavl and St. Petersburg. In every city where Pharmprobeg made a stop, meetings were held with representatives of the pharmaceutical community and regional healthcare organizers.

As Dmitry Chagin, Chairman of the Board of the EAEU Association of Pharmaceutical Manufacturers, said at the opening ceremony of the 2019 Pharmaceutical Run in Kazan, today the industry has a huge potential for development, and in the future Russia 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 surplus." - the pharmaceutical manufacturer shared his optimism.


But this is still far from it. And the first event of the race was the round table “Effective mechanisms of drug supply in the Russian Federation. Issues of quality and availability in the regional context”.

In the ranking of the probability of death from major noncommunicable diseases between the ages of 30 and 70, Russia is in 180th place out of 187 countries,despite the fact that in terms of bed availability - in fifth place, the scientific director of the National Research Institute of Public Health named after N.A. Semashko »Ramil Khabriev. And the main problem, in his opinion, is drug provision in the outpatient sector. Or rather, in his absence. “The actual limitation of the availability of drugs for the majority of the population has a negative impact on the main indicators of health care. This is insufficient control over chronic diseases, an increase in the frequency and duration of hospitalizations and an increase in the costs of the health care system, "said Khabriev. Almir Abashev, First Deputy Minister of Health of the Republic of Tatarstan, agreed with the scientist: “Accessibility is provided at the expense of citizens themselves, and this is a great burden for patients and their families.

In addition to this, according to Khabriev, about 20% of the cost of purchasing drugs from the VED list is spent on drugs with insufficiently proven efficacy. Citizens also feel this: the presented results of the all-Russian survey of patients "Quality and Availability of Medicines - 2019" showed that the number of people who doubt the quality of purchased medicines is growing.

In addition, the situation with public procurement does not change from year to year, which speaks of the flaw in this system itself, according to the International Union of Patient Assistance and Support. “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 medicines to neighboring regions. Another problem is non-compliance with federal guidelines when a patient returns to the region to continue treatment.” - said the chairman of the organization Olga Vostrikova.

The Roundtable participants also recalled the idea of ​​changing the drug provision model, which had been discussed for several years. We are talking about the introduction of universal (and not only preferential) provision of medicines on a co-payment basis, the transition from the regulation of the maximum producer prices to the establishment of reference prices (at which citizens should be reimbursed for the costs of medicines), as well as the limitation of the maximum amount of the trade margin. However, as long as the people making decisions at the federal level cannot agree on this matter, the problem will not move off the ground.

Baby uniforms

The situation is even worse with children's medicines. “The shortage of pediatric dosage forms leaves 40% in the group with an increased risk of developing adverse events, suboptimal dosing of drugs and poor access to innovative drugs,” said Roza Yagudina, director of the center for educational programs of the FGBU “SCEEMP”: The expert listed the key problems in this area: relatively small the pediatric market, a lower prevalence of chronic diseases than in adults and, as a result, lack of interest among pharmaceutical manufacturers, and the prevalence of off-label drugs in pediatric practice. At the same time, children's mini-tablets solve a lot of problems - from the difficulties of swallowing large hard capsules to chemical, physical, and microbiological instability and inaccuracy of dosing inherent in liquid dosage forms.

This problem is faced all over the world. According to the head of the contract research organization X7 Research Sergey Simeniv, referring to the WHO data, there are no special drugs for 75% of children's diseases. There is very little data on the safety of such drugs. For 70-80% of drugs used in pediatrics, there have been no clinical trials in children (there is a large list of ethical restrictions for this), and 90% of drugs prescribed to newborns are not registered for use in this age group.

Orphan drugs

And the situation with the treatment of rare diseases remains especially difficult. Round table “Orphan Medicines Market. Development Prospects in Russian Realities”was held in the Vladimir region. Orphan theme is one of the most difficult in pharmaceuticals. A huge variety of diseases and at the same time a small number of patients makes the production of drugs unprofitable, and their prices exorbitant. As a result, as Denis Belyakov, executive director of the Union of Patients and Patient Organizations for Rare Diseases, recalled, in the presence of about 7000 different rare diseases, therapy exists for no more than 400.

Therefore, the experience of the Vladimir region, which is one of the TOP-5 world manufacturers of orphan drugs in terms of the range of drugs, is so valuable. “It's not just science and medicine here. There is a space here where others come to live, work, develop, and then give world achievements that we can be proud of,”said Maxim Brusentsov, First Deputy Governor of the Vladimir Region.

In particular, the Vladimir-based Generium JSC has completely resolved the issue of the production of Russian drugs within the framework of “7 nosologies”, and has already started a new format of “12 nosologies”. A month ago, the Vladimir enterprise broke the monopoly on the most expensive development in the world (for the treatment of nocturnal hemoglobinuria and hemolytic uremic syndrome), which was still owned by the only American manufacturer. And now these drugs will be much cheaper for the state.

“What is happening here is a real opportunity to reduce the enormous costs in federal and regional budgets. After all, the lion's share of the budget in all regions on the part of healthcare is the cost of orphan drugs, "said Dmitry Chagin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union.

For orphan drugs in JSC Generium is 37%. However, it is difficult for a company to develop this area without government support. Orphan drug developers have preferences in all developed countries, recalled the CEO of the company Dmitry Kudlai: “In the United States, preferences for developers, including subsidies for clinical trials, appeared in 1983. When this program was launched, 38 drugs for rare diseases were registered in the country, and in 2010 there were already 350”.

Problems of bringing new drugs to the market and technology transfer

The registration of new drugs and the social side of this problem were discussed at a round table in Yaroslavl. The participants in the pharmaceutical market spoke about the need for a strategy that would solve two main issues: the shortest possible terms for drug registration and ensuring the affordability of drugs for the end consumer. Indeed, even for orphan drugs, the registration procedure for which is simplified in Russia, the registration period is reduced by only one month.

But, as usually happens, the authorities and business see the situation differently. Thus, the first deputy chairman of the Federation Council committee on social policy, ex-deputy minister of health Igor Kagramanyan highly appreciates the quality of the domestic regulatory framework. “It combines both the optimization of the timing of the registration procedures and balance. We believe that our regulation is one of the most advanced, and this is recognized by the international community,”Kagramanyan is sure.

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