Mikhail Mishustin’s meeting with Veronika Skvortsova, Head of the Federal Medical-Biological Agency
From the transcript:
M. Mishustin: Dear Veronika Igorevna!
You are a head of a very important structure – the Federal Medical-Biological Agency, with a very significant function. It is the procurement of donated blood and donor blood components. On their basis, special medicines are created that increase people's immunity and help restore health. Blood transfusion is not an easy procedure, but often necessary to save the lives of patients. When I was reporting to the State Duma, a large number of questions were about the new law on blood donation.
The President signed two laws that relate directly to the activities of the Federal Medical-Biological Agency. They come into effect this fall. One of them actually expands the possibilities for the supply of donated blood directly to pharmaceutical plants so that they can quickly obtain the necessary components, increase capacity and provide citizens with the necessary drugs.
The other document concerns the creation of a registry of bone marrow donors. The government in mid-April approved the rules for its conduct. Its operator will also be the agency you head. With such a large database, doctors will be able to quickly find suitable donors for patients across the country. The problem is very important. Often the time spent on this is the price of a saved human life.
Please tell us how the work is progressing in these areas.
V.Skvortsova: Despite the rather difficult period of 2020-2021, which was also associated with the epidemic of a new coronavirus infection, we managed to increase the number of donors by almost 47,000 in two years. Over the past year - 20,000, and, it is important to note, 99% of them are gratuitous donors, which guarantees the safety of the blood we receive.
Despite the imposed restrictive measures on the movement of citizens, we managed to do this thanks to our joint work with the Russian Red Cross, youth volunteer organizations, in particular the Molodezhka ONF. It was a special set of measures that allowed us to increase the number of donors. Thanks to this, we increased the harvesting of whole blood by more than 10%, and of all formed elements. We have crossed the threshold of 2 million liters of whole blood, and received up to 850 thousand liters of blood plasma - which is 10% more in one year..
Thus, we do not have any restrictions, we provide all medical organizations - both subjects of the Russian Federation and federal, including law enforcement agencies.
Thanks to the fact that we work on the basis of a unified blood donation information system, we have the opportunity to see what kind of blood we have where, in what quantities, and to distribute and redistribute it very quickly.
A special task that we face is to increase the volume of plasma procurement for the production of drugs. We thank the President and the Government of the Russian Federation for the task to develop amendments to the law on blood donation. The agency worked very actively on it, thanks to this, a set of novelties was actually adopted, which allow us to quickly increase these volumes.
If last year the base stock in the country was 30 tons of plasma for industrial purposes, this year we will already reach more than 90 tons, and next year - 300 tons. This increase of 3 and 10 times will allow us to become self-sufficient in terms of providing ourselves with albumins and immunoglobulins by 2024. We will actively continue to work in this direction together with the Ministry of Industry and Trade.
M. Mishustin: I know that these are very important components.
V.Skvortsova: Yes, these drugs are absolutely necessary for the treatment of patients in intensive care, in shock states, with acute losses of blood and fluid in the body, as well as with a wide range of hematological diseases, and so on.
We are very grateful that in April the issue of transferring to us the functions of organizing and coordinating a unified registry of bone marrow and hematopoietic stem cells in the country was resolved. FMBA has the richest experience in the country, we have been donating bone marrow for more than 10 years. In total, 17 local registries are now combined into a single database, where there are 126.5 thousand donors, of which more than half are donors from the agency's register. Already now this register is connected with 67 subjects of the Russian Federation.
M. Mishustin: An important activity of the Federal Medical and Biological Agency is to build up its own competencies in the field of biomedicine and pharmaceuticals. Technological independence, including in the field of medicine, scientific research, which you are actively engaged in (you regularly report this to the Government) is a priority for our work as a whole. Here the agency has a special role. How is this work going and what are the results already?
V.Skvortsova: Of course, we are trying very hard to be a serious help and support in the direction of ensuring technological independence. In two years, we have managed to create the main scientific and technological platforms that allow us to create drugs of the same type for different goals very quickly from scratch. This applies to both drugs and test systems. An example is the AmpliTest platform, which was developed by the Center for Strategic Planning; it allows us to quickly develop tests for any genetic modifications, variants of pathogenic viruses in a matter of days. Other such platforms exist for some species and bacterial flora, and so on.
If we talk about the production of immunobiological preparations, primarily recombinant protein preparations, I would like to note that it is very important to have an industrial platform already at the stage of their creation. Such a platform was created at the St. Petersburg Institute of Vaccines and Serums. It allowed the development of an innovative vaccine against a new coronavirus infection within a year.
Another example is the development of influenza vaccines. It seems that this is an old topic, in fact, the 3-4-valent vaccines of the new generation are now fully consistent with the best standards in the world. This is also evidenced by the fact that there are only four licensed sites in the world that allow you to make reference samples of both specific sera and various standards for assessing specific activity. These are the UK, USA, Japan and Australia. Currently, we have received a proposal to create a fifth site in the Russian Federation, which we are working on with the Ministry of Health.
I would like to note the relevance of import substitution of these vaccines, which traditionally came to us from other countries. In particular, vaccinations against pneumococcal, meningococcal, and hemophilic infections were carried out by American vaccines. And in the last five years, about 36 billion rubles have been spent on these vaccines for children from three months to five years old and older age groups.
We did not have the competence to create polysaccharide conjugate vaccines. And over the past two years, we've completely mastered the technology behind these vaccines and how they're made.
Currently, one of the three vaccines is already completing the second phase of clinical trials and the other two are fully prepared for conducting regulated trials.
It is important that these vaccines are not only safe, they are targeted, they work with those strains and serotypes that are typical for Russia, and not for other countries. And besides, we get a great economic effect, reducing the cost of these drugs by almost 10 to 60%.
We can talk about other platforms - the platform for the synthesis of peptide and oligonucleotide sequences is unique for the country. These are DNA, RNA, micro-RNA and so on. On the basis of this technological platform, we have created a drug - a highly specific antiviral antidote, which reduces the activity of the virus by 10,000 times with its rapid use.
We are very grateful to you and the entire Government for supporting the expansion of this platform. By the end of the year, we will increase the ability to manufacture products of this platform by 100 times compared to the beginning of the year.
Of course, we are faced with the task of providing and synthesizing those medicinal substances that are not yet synthesized and produced in the Russian Federation. First of all, this concerns orphan diseases, rare diseases. In this regard, our two state-owned enterprises are now ready to develop, together with the Ministry of Health and the Ministry of Industry, a "road map" for the synthesis of the necessary drugs. We have these competencies. We are ready to actually create active substances for rare drugs and transfer them to the Ministry of Industry for scaling up at any industrial sites.
A separate topic is biologics. There are many questions here with which other departments turn to us. We have the competence to create therapeutic vectors for genetic therapy, which is already being used, including for orphan diseases. For example, with spinal amyotrophy - the well-known drug "Zolgensma" and some of its analogues. Also, monoclonal antibodies are necessary for the treatment of demyelinating diseases, a variant of multiple sclerosis, systemic connective tissue diseases, rheumatoid diseases and a number of others.
These technologies have already been debugged so much that they are ready-made platforms. Together with the Ministry of Industry and Trade and our manufacturers, we are ready to help develop these drugs in cooperation.
M. Mishustin: Thank you, Veronika Igorevna.
The main thing - not to stop on the achieved, to continue to carry out new projects, to create new technologies. It is very necessary for national health care, you are well aware of it. And of course, to ensure the biosafety of the country, for independence in the field of both pharmaceuticals, and medicine in general.
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