A socially oriented non-financial development institution and a major organizer of nationwide and international conventions; exhibitions; and business, public, youth, sporting, and cultural events.

The Roscongress Foundation is a socially oriented non-financial development institution and a major organizer of nationwide and international conventions; exhibitions; and business, public, youth, sporting, and cultural events. It was established in pursuance of a decision by the President of the Russian Federation.

The Foundation was established in 2007 with the aim of facilitating the development of Russia’s economic potential, promoting its national interests, and strengthening the country’s image. One of the roles of the Foundation is to comprehensively evaluate, analyse, and cover issues on the Russian and global economic agendas. It also offers administrative services, provides promotional support for business projects and attracting investment, helps foster social entrepreneurship and charitable initiatives.

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Drug Security: Strategic Course of Social Policy in the Far East. Challenges and Opportunities
6 September 2022
15:00—16:30
KEY CONCLUSIONS
Import substitution is a key challenge to achieving drug security

A very important topic is, of course, import substitution, but an improved one. For example, there are very expensive drugs that are used for rare diseases. The most expensive drug is Zolgensma, a genetic drug against type I spinal muscular atrophy. The cost ranges from RUB 150 to 180 million for a single injection... The Russian government has set the goal to develop active substances for rare diseases — Veronika Skvortsova, Head, Federal Medical-Biological Agency of the Russian Federation.

We are talking about expansion into global markets, not just import substitution. This is a tactical task in fact, and we will overcome it. Our super-objective is to expand into global markets. This means bringing technology to the countries that want to cooperate with us. The Gulf countries... the Pacific region, for example — Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.

Perhaps, with regard to import substitution, although we are not very fond of this word lately – import independence or something else should be used – we are striving to increase the share of our drugs, and our drugs that are based on the synthesis of substances. But to say that 100% – from synthesis of substances to production and packaging – will be domestic is probably wrong. It is hard to come with such countries,” would have to try very hard to remember — Victor Fisenko, First Deputy Minister of Health of the Russian Federation.

Drug safety and quality control remain a top priority

The agency’s task is to secure the pharmaceutical industry. We work very closely with the Ministry of Health, we work with Roszdravnadzor. Our task, among other things, is to develop quality control technologies. It is not easy given the development of synthetic biology, synthetic virology. Using common methods to see and to verify the hazard is not enough — Veronika Skvortsova, Head, Federal Medical-Biological Agency of the Russian Federation.

We have introduced labelling for medicines, which is unique. I want to emphasize: this labelling is the only one in the world. And it works. There are some problems, but they are minor problems. Generally, the system works fine. Every package of drugs has a unique cryptocode... You can look at a lot of parameters. Isn’t that control? You could only dream of this ten years ago — Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.

In terms of quality, our country has made a significant leap in the last few years. We have practically forgotten what substandard counterfeit medicines are... When we moved to a new level of quality, the export of medicines also went up, COVID-related ones. So, it is a recognized quality standard — Victor Fisenko, First Deputy Minister of Health of the Russian Federation.

The quality of pharmaceuticals is improving every year. We see this in the statistics of withdrawal from circulation of medicinal products the quality of which does not meet the established requirements. Over the past five years, this trend has been going down every year. Literally, according to the test results in 2021, this figure was 0.1% of the total number of tested series. And we test over 36,000 medicinal products a year — Alla Samoylova, Head, Federal Service for Surveillance in Healthcare (Roszdravnadzor).

ISSUES
The accessibility of medicines to citizens must be ensured

We have a systemic problem because it has not been solved for years... People are asking for it: they need medications. But we have been unable to. Because taking five packs from Moscow to the Far East is much harder than delivering one tonne. The governor of the Jewish Autonomous Region sometimes brings medications in his suitcase, because two or three people need it. Maybe we should change this system somehow? — Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.

Accessibility has three components. Availability, i.e. the patient has to understand where he can get it – for money or for free. The range, i.e. he must understand that he can buy or get for free exactly what he needs. The price: it does not matter whether the person pays, or the healthcare system represented by the regional or federal budget pays — Victor Fisenko, First Deputy Minister of Health of the Russian Federation.

We need think in terms of the whole system of reimbursed medicine. Because reimbursable drug provision is about accessibility. A medicine that is registered in the Russian Federation, but is financially inaccessible to the patient, for the sake of which the patient has to sell flats, cars or take loans: it means that the medicine is inaccessible. The system of reimbursed drug coverage should be expanded and modernized — Yuriy Zhulev, President, Russian Hemophilia Society.

SOLUTIONS
The regions need assistance in procuring medicines

Centralized procurement has a proven efficiency already... In this regard, we need both to expand the list of medicines, the list of diseases and drugs procured by the federal budget, and to think about the ways to help the regions... The idea is not new: helping the regions procure certain types of drugs through centralized procurement by reducing the prices of these drugs — Yuriy Zhulev, President, Russian Hemophilia Society.

I do see that there are weak regions in the Far East and in Siberia. They have been making the same mistake for decades. The same problem of non-provision of medicines to beneficiaries is already systemic. We need to help them. Managers change, financing changes, but the problem remains. It seems to us that we should at least have joint bidding by several regions, where the federal centre has an organizational role — Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.

Now we are going to do joint or centralized tenders for oncology drugs within the federal institutions of the Ministry of Health. And after this first joint experience, we will analyze it and, with your participation, we will definitely start sharing this experience in the regions. I think that in the next few months we will try to launch a pool of tenders between a strong region, a donor, and a recipient — Victor Fisenko, First Deputy Minister of Health of the Russian Federation.

The system of quality control of medicines needs to be further strengthened

The question is simple: do we control imports of raw materials and substances from China, which, together with India, imports 80% of our substances? We say: ‘No, we do not control it.’ We need to ensure control of all incoming raw materials for drug production — Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.

Before we can ensure mass production of a pharmaceutical, we have to ensure its quality. It includes entry control, i.e. the introduction into civil circulation – medicinal products are controlled on a mandatory basis. Selective controls — Alla Samoylova, Head, Federal Service for Surveillance in Healthcare (Roszdravnadzor).

Private business and patients need to be more involved in pharmaceutical issues

Who else besides the state should be included in the national drug security system? Of course, the private pharmaceutical industry, which has now become a very strong factor in the development of the industry as a whole in the Russian Federation... To say that the state alone is responsible for providing medicines today is probably no longer correct — Aleksandr Petrov, Chairman of the Subcommittee on Medicines, Development of the Pharmaceutical and Medical Industry, Committee of the State Duma of the Federal Assembly of the Russian Federation on Health Protection.

An important part of our work is openness to patients. Today, our patients can get all the information from our electronic resources, from our website – in particular, the section on services and on medicinal products. Full information about the quality of medicines, the introduction of medicines into civil circulation, and rejected series is available — Alla Samoylova, Head, Federal Service for Surveillance in Healthcare (Roszdravnadzor).