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From the perspective of movement – the potential for the development of the pharmaceutical industry

The I All-Russian Pharmaceutical Run, dedicated to the development of national health goals, united under its banner the entire professional community and key market players, including the media and the patient environment. Dmitry Chagin, Chairman of the Board of the Association of Pharmaceutical Manufacturers of the Eurasian Economic Union, spoke about the main results of the large-scale event.

– Dmitry, tell me, what is the key issue of national health goals and why are the topics raised at I All-Russian Pharmaceutical Run important for the industry?

A key topic for the industry is national security. Until 2018, the President’s decree was implemented, where at least 90% of the drugs from the VED list should be localized in the Russian Federation. The issues of export, international cooperation, and the possibility of reducing budget costs for the purchase of expensive drugs due to new developments are now relevant.

For Pharmaceutical Run, the main task is to show the self-sufficiency of the industry, both from the point of view of the pharmaceutical industry, and from the position of the necessary regulation, legislative initiatives, and the possibility of seriously supporting the industry through legislation and subsidies.

In the strategy for the development of the pharmaceutical industry until 2020, we were mainly based on world experience and studied the global statistics on the formation of large multinational companies. In the Pharma-2030 strategy, a serious analysis of ten-year practice and the results of the previous strategy was carried out. This was a continuation of Pharma 2020, but with additional tasks.

– What are the new challenges facing our country in the new strategy? Does this mean that old goals are now not so important?

Today it is important to purposefully develop full-cycle pharmaceutical enterprises. Being the chairman of the board of the Association of Pharmaceutical Manufacturers of the EAEU, I represent full-cycle enterprises, such as the Generium and GEROPHARM companies that we visited as part of the Pharmaceutical Run, as well as Pharmstandard, BIOCAD, POLISAN, and Active Component.

In the Pharma 2020 strategy, about 13 billion rubles were spent annually, and the total program volume is 155.7 billion rubles. Guaranteed purchases from the state – about 450 billion. This is what is spent on all categories that are guaranteed to be provided with drugs by the state. Guaranteed purchase amounted to about 4 trillion in total spending over 10 years, and this amount is not comparable with the subsidies provided by the Ministry of Industry and Trade of Russia. Therefore, the most important thing for our industry is to be necessary in terms of procurement for government bodies and gradually return the meaning of the postulate “market in exchange for investment.”

When creating complex full-cycle enterprises and investing that will pay off for decades, it is very important to be able to completely close the volumes required for procurement at the state level in the context of manufactured medicines. This is a priority for the pharmaceutical business, which, if implemented well, will contribute to the development of RD, the emergence of innovative dosage forms, and the building up of export potential – all that is laid down in our new strategy.

Speaking of investments in the Russian pharmaceutical industry – how can you increase the attractiveness of this sector, what options have been proposed? What are the goals facing the state in the field of development of innovations in healthcare and, in particular, in the pharmaceutical industry? What are the challenges facing pharmaceutical manufacturers?

All we are talking about is definitely an investment. Each region wants an active and good partner.

Imagine that you are an investor and want to invest. You look at the regions where you can locate your company. To begin with, there are special economic zones where the infrastructure is well-established, there are no issues with water intake and water discharge, air intake and air removal, there are “clean” rooms. You want that you have minimal risks associated with possible difficulties in registering land plots, with connections.

In addition, the environment is important. If you were robbed at the airport, poured mud on the road, because there are no sidewalks, and you come to a meeting with the profile vice-governor, who is responsible for the industrial sector, then, of course, there will be no desire to invest.

Also, any investor is interested in the availability of competent scientific and educational centers for the training of necessary personnel. You need to train people in parallel with construction, because when you build a plant, you need to bring in a staffed staff that will have the necessary professional knowledge and competencies.
A worthy example, in my opinion, is the St. Petersburg Chemical and Pharmaceutical University, which this year celebrates its centenary. Today there is a brilliant project there – a mini-factory located inside the educational process itself. Students have the opportunity to work on innovative equipment, to learn the mechanisms of production directly during training at the university.

– Dmitry, what can you say about lawmaking? Do Legislative Initiatives Meet Industry Requests?

In matters of lawmaking, we try to act together. For example, if I or any member of our association has a legal question, then we immediately try to broadcast it to all our participants, legal departments, and these are hundreds of people in all companies. As a result, it turns out that we have a verified opinion of leaders, champions of the pharmaceutical market, because leading companies are part of our association. This is not just the opinion of a couple of people or several officials who understand how this law will have a regulatory impact. These are entire legal departments that come to a common agreement.

Now, on a number of issues, there is a consensus on the part of all major associations. Such serious conclusions concern issues and labeling, and the initial maximum price, and re-registration of drugs, and subsidizing exports. We raise these topics with our colleagues at various conferences, round tables, and meetings. We want the initiatives to be reasonable at the level of decisions that are sometimes made without our opinion.

Say, in connection with a number of national projects, the task itself was reformatted. But the export subsidies that we have enshrined in the relevant regulations have been worked out for years before they begin to work. Competent support from the industry is important.

For us, the most important thing is that on the one hand, a worthy assessment of the work done is given. So that there is a consistent and logical continuation of the begun stage of creating a domestic pharmaceutical industrial sector.

Now there is no talk about the confrontation of factories, companies, now there is a confrontation of entire state systems. Look at the tremendous support in China: $ 270 billion will be spent there in the near future on subsidizing large companies to provide new technological solutions for the production of medicines in order to develop export potential. Look at the support from India: they have guaranteed payments within the framework of securities that companies receive for certain volumes of export and can be calculated by them.

States are interested in introducing the products of their leaders to international markets, which cannot be done without a systematic approach, and it can only be worked out by those who implement these projects on the ground every day.

I am often surprised when we get legislative initiatives that have nothing to do with reality and are very divorced from life, and then, in an insane amount, amendments begin to be made. Isn’t it better to listen to the industry, find out what guarantees it gives? And believe me, thanks to the active development of the market, we give serious guarantees of dynamic development and the possibility of closing a number of relevant areas.

What are the main complaints from the patient community regarding the availability or quality of drugs?

There are various complaints. Moreover, if you look at the current level of drugs that are on the lists of Vital and Essential Drugs, this is a global and comprehensive account of all that is needed. Now there are much fewer violations of 44-FZ related to the procurement of trade names. It takes into account issues related to the holding of auctions and competitions, where the best conditions and prices are provided, and companies, within the framework of fair competition, realize their goals.

Everything should be for the good of the patient. By producing complex drugs, we already understand in detail the real cost of drugs. And when the question is only in the availability of money and deciding whether a person will live or not, this is unacceptable. But if you saved one person and you think that you saved the whole world – this seriously changes the whole perception. Thus, it depends on many companies on the prices of drugs whether a person will live or not.

The position of the medical community towards the competent prescribing of drugs is important. Therefore, we are very pleased that we attended a large number of journalists in the Farm Run, because only they can convey to the medical and patient communities a number of important messages: domestic drugs are high-quality, effective and safe, and doctors need to know which drugs exist, which ones will be released shortly and how they fit into the overall treatment regimen.

– Do pharmaceutical manufacturers follow a social line? Does the state support it?
Now there is the concept of socially responsible companies. I expect that over time, if companies will actively participate in charity events, as, for example, Generium does, this will be encouraged in terms of preferential tax directions. We need to live honestly, well, so that families are happy, children study, work is a pleasure. This is a serious investment block, which every company should evaluate for itself. It is impossible to do only earnings. It is clear that the conditions of our financial operators and banks are seriously different from world practice. These are issues of lending, opportunities to receive preferential financing. There are a number of funds that are built into the overall investment structure. These are funds for the development of industry at the regional and federal levels, and various support programs for the Ministry of Industry and Trade. But this is not enough, because a single financial system and the possibilities of using banks are very disadvantageous and limited in comparison with China, India and other world practices.

– Is it possible to optimize the situation with drug provision in the regions in the near future?

Many journalists ask a question about the percentage of purchases of domestic companies in the regions and their changes. This question is understandable because companies are developing, portfolios are expanding, and the number of drugs is expanding. We were at the site of JSC Generium and saw the organization of production of drugs for night hemoglobinuria, Gaucher disease. Such companies are ready to provide the government with a procurement package. This is important: for example, if we consider the orphan block, then a long-term agreement with the state and the possibility of such a package of necessary drugs is a salvation for a number of companies and for the state. Because, due to some drugs, the price of other drugs will be balanced, but in the total volume it turns out that all the necessary demand is satisfied.

Issues regarding the use of subject capabilities are important. In St. Petersburg, we analyzed the situation with the implementation of the program to provide assistance to cancer patients, provide medical care, diagnose and prevent cancer. It is necessary to build an effective patient routing system, keep a high-quality record in electronic registers, and use modern patient models based on clinical recommendations. BIOKAD is an industry leader in the development and manufacture of drugs for the treatment of cancer in Russia. BIOCAD is located in St. Petersburg. It has built modern RnD centers, a production complex that meets all international quality standards and production certification. It is important that the state, in dialogue with local manufacturers, find the best way to provide the maximum possible number of patients with the drugs they need, while remaining within the budget. Actual tools now are the practice of concluding long-term contracts and offset contracts in other entities that allow attracting investment in the region, creating high-tech jobs, and most importantly, providing the maximum number of residents of St. Petersburg with modern effective therapy.

Using the example of companies localized in the Russian Federation that participate in the Pharmaceutical Run, it can be seen that even at more or less comparable prices, taxes from foreign manufacturers remain here, and research centers are built on the proceeds, specialists are invited, specialists are being created, necessary infrastructure. Entire cities of the city are growing up, to which scientists who left after the collapse of the Soviet Union return with great pleasure. I am sure that many of those who live abroad today have a great desire to return, to adequately engage in their main profession, to live in Russia, to raise children. However, for this it is necessary that the conditions comply with normal world requirements.

In relation to regions, everything is connected with money and opportunities. St. Petersburg, Moscow, Kazan are self-sufficient regions. When we talked with the President of the Republic of Tatarstan, Rustam Nurgalievich Minnikhanov, he showed a serious attitude that domestic production would help the region get rid of the serious burden of colossal multi-million costs for a limited circle of patients, providing a good and high-quality alternative. On the other hand, everyone understands that without the development of science, the creation of new enterprises, this is impossible.

We looked at the regions, talked with ministers, met with representatives from the health systems. We have an active supporter – this is an all-Russian popular front that periodically analyzes the public procurement system and identifies obvious violations.
We want to show, not only within the framework of Farm Run, but also on all existing discussion platforms, that we are the main ally of the state, because we remove the most important issues related to the provision of medicines.

– What do you think, how can you increase the availability of orphan drugs?

With the availability of orphan drugs, everything again comes down to money. Many clinical protocols have not been fully documented in terms of ideal practices, because patient groups are very small, and clinical trials are not easy. Also, many doctors do not understand the features of continuous use, do not know if there are any breaks that will not entail a decrease in vital activity. At the same time, 10 new nosologies for orphan diseases are registered every year. And these are new drugs, completely different clinical studies, new tasks related to the assessment of medical technologies, the appropriateness of certain expenses.

But the question of expediency cannot have an equal sign with human life. It is important to understand that now we are evaluating the real cost of treatment, because now Russia takes the first place in terms of reproduced drugs, and industry leaders are able to carry out new developments.

In fact, it’s important to understand that every person is orphan. It’s about uniqueness. We all tolerate even common diseases in different ways. & nbsp; Also, often our genetic codes undergo changes depending on the region, environmental conditions, and life situations. Everything changes throughout life, and no one can guarantee that a person will not receive an orphan diagnosis at birth.

– Regarding the shortage of children’s forms and dosages: what are the main problems and solutions?

We started with Kazan, and it seems logical to me if there would be a certain resolution at the level of a well-executed pilot in this city. Children’s dosages need, first of all, subsidies from the state. We have in vain destroyed manufacturing pharmacies and prescription departments. In hospitals, there used to be small manufacturing pharmacies that produced everything that was now imported for completely different money. It is possible to create optimal conditions for creating drugs.

From my own experience I know that creating drugs is not so difficult. Why is it impossible to prepare a medicine for a child in a pharmacy, for an orphan, having all the necessary nomenclature and substance?

We have a huge failure in children’s dosages for a number of nomenclatures. We consider it important to try to work out such an experiment at the Kazan level.

– The theme of clusters and technology transfer was laid in the business program of Pharmrobeg. What are the key issues in this area?

Today there is no longer any violent activity in the construction of factories, especially from foreign companies. Those who wanted to have already built, and the enterprises themselves now allow attracting foreign companies: Generium with Takeda Pharmaceuticals, POLYSAN with Bayer and Pfizer – there are many such examples.

On the one hand, this shows that our production meets all international requirements, because not a single large multinational company will ever put its name next to a production in which one could doubt. On the other hand, serious training is underway. If this is a technology transfer, then it is necessary to bring employees to the original enterprise from where the transfer is made.

We have a large number of interesting scientific and educational universities and programs. This year will be the 100th anniversary of the University of Chemistry and Pharmacy. This is an outstanding educational institution, more than 2000 people work, teach, study. It is impossible to create a cluster where the head would not be a serious educational or scientific university, because without personnel training – who will you bring to the enterprise?

Next comes serious legal work to protect intellectual property rights. For any company that deals with transfer, it is important to maintain the foundation that they transfer to another state.

Gradually, I think, issues related to mutual recognition and mutual assessment by various world inspectorates will increase, which is very important during the transfer. I am interested in the fact that as many large companies as possible know who works in Russia, what is the level of these enterprises, with whom it is worth having a relationship for further guaranteed many years of experience in working together.

In Russia there are enough lines, volumes of industrial space. The entire set of documents has been worked out by both our structures and foreign consultants who accompany the company on transfer projects. There remains an important big task – to choose the right partner.
For example, the Vladimir region has a worthy desire to make a decent pharmaceutical cluster. Cluster initiatives are important in terms of the participation of regional authorities in working with federal centers. It’s not just that now there are tripartite special investment contracts with the participation of entities, when both the federal and regional authorities give certain guarantees to the investor.

– What are your main conclusions about the results of the Farm Run for yourself?

I sincerely fell in love with all of the participants, all the guys. I am grateful to the journalists, I had never spent so many days with them before. All people are very worthy. & Nbsp; Even the little boy German, who traveled with his mother (German Kalinovsky – the son of the correspondent of the publication “Pharmaceutical Bulletin” Elena Kalinovskaya – approx. Ed.). For me it is life. We are truly doing a noble cause.

Talking about actions and doing them are two different things. Someone discusses the affairs of others – and you do it yourself, try, organize. It is always very difficult.

The participants of the Farm Run showed their versatility. We are a professional community, but in order to become interesting inside it, you need to be an interesting person, and here everyone reveals great.

In each region of the Farm Run we were greeted with great hospitality, and showed how they love their land. I think if you are a worthy resident of your region, then you want other people to admire him. It is very important.

The regions of Russia, as Dmitry Kudlay (General Director of Generium, ed.) Said, are a patchwork, a purely Russian phenomenon, beautiful and varied. We were convinced of this ourselves and with enthusiasm we will continue to reveal the potential of the regions and the versatility of our industry, wrapping our patients in a warm and comfortable patchwork quilt.

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