Stem cells without formalism
"It is necessary to apply special import regulations"
Mikhail Maschan, head of the Department of Hematology of the RDCB, believes that it is necessary to supply stem cells to Russia by special methods
Yaroslav Kozulin, "Vzglyad", 11.11.2010 (published on the RTKORR website).
Russian Prime Minister Vladimir Putin has promised to solve the problem of importing stem cells from abroad, which arose in connection with the creation of the Customs Union, RIA Novosti reports.
The management of the new pediatric oncology clinic, which will be opened on June 1 next year, addressed the head of the government with such a request.
According to doctors, with the introduction of new standards, stem cells are equated to goods, and therefore it is necessary to declare them, specify the cost and provide a number of documents. They have no cost, since the donor provides them for free.
At the same time, stem cells, according to experts, can be transported only during the day, and then die. Putin promised to solve this problem. "I am sure there will be no problems here," Putin said.
Mikhail Maschan, Head of the Department of General Hematology of the Russian Children's Clinical Hospital, answered the questions of the newspaper VZGLYAD about the use of stem cells, the problems of legislation in connection with the introduction of new customs regulations and the business of stem cells in Russia.
VIEW: Mikhail Alexandrovich, which stem cells did the Prime Minister talk about?
Mikhail Maschan: Exclusively about bone marrow stem cells and hematopoietic stem cells. And to say now that the Prime Minister has allowed the import of stem cells would be a mistake. There are a lot of types of such cells.
view: With the introduction of new standards, stem cells are equated with goods, and therefore it is necessary to declare them, specify the cost and provide a number of documents. Tell us in more detail about the documentation procedure itself.
M.M.: After the adoption of the new code, in order to perform one transplant, we must issue two individual permits at the level of the Ministry of Health and a one-time license for the import of one sample in the Ministry of Industry and Trade. Since a stem cell is a commodity, after that we have to issue a cargo customs declaration, respectively, conclude a contract with some customs broker. All this turns into a complicated bureaucratic procedure.
It may not be so difficult for commercial structures engaged in the wholesale import of, for example, medicines, since they have entire departments that deal with customs logistics.
And bone marrow stem cell transplantation is performed in Russia by only two clinics – ours and the St. Petersburg clinic named after him. Pavlova. In fact, after the introduction of new import rules, we are not able to comply with these rules. But customs helps us – people see that we are saving lives, and they allow us to use the old order of transportation, that is, to issue only a permit from Roszdravnadzor.
By the way, stem cells themselves are not a commodity – they cannot be resold. They are intended for a specific person, and they cannot be used for commercial purposes. Therefore, we, the hospital staff, believe that special import regulations should be applied to this, let's say, medicine. In general, transportation should not take more than 48 hours – and then transfers from plane to plane, and even a bunch of documents. We are afraid that we will not keep up – the cells will die on the way.
VIEW: How long does it take to provide documents? Is it possible to fill them out and provide them in such a time so that the stem cells remain alive?
M.M.: Theoretically, everything is possible. To be honest, in practice we have never gone through the procedure of forming and submitting documents in full – the customs helped. About 70 stem cell transplants have been performed this year, and we would like to increase this number, because the need is much greater. These operations are not commerce and not earnings, but pure help, and it is necessary that all formalities take place as quickly as possible.
VIEW: Where are the cells supplied from?
M.M.: Stem cells are always a fence from a living, healthy patient. That is, they are not taken from any storage facilities, like, say, blood. For Russia, 80% of donors come from Germany, but this is due to the fact that our volunteer search center is located there.
view: Is there a donor registry in Russia?
M.M.: We haven't done that yet. Attempts have been made to create it, but so far it is worth it. The problem is that in order to create a register, several tens of thousands of cell samples must be created. It will take several years.
In general, there is no question around the world where exactly the register is located. All of them are united in one network: in small countries it is five thousand people, in large ones – a million. There are now about 15 million donors worldwide, and it is this number that makes it possible to find compatible people with the patient. Of course, a national register is needed, but to assume that if it is in Russia and it will not be necessary to communicate with abroad is nonsense. We'll have to exchange cells anyway.
VIEW: Are Russian legislative acts ready so that stem cells can be made?
M.M.: As far as I know, the law on biotechnologies is only expected. But, to be honest, I won't say that everything is ready.
VIEW: Tell us, how relevant are stem cells today?
M.M.: I am engaged in pediatric oncology and hematology. There are situations when it is necessary to replace a diseased bone marrow with a healthy one or a diseased immune system with a healthy one. Moreover, if earlier stem cell treatment was considered experimental, now it is already a standard of treatment that does not raise questions. The treatment is paid for by insurance companies.
VIEW: Do many patients need them?
M.M.: According to our estimates, from thousands to one and a half transplants are needed among children under 18 years of age. About two or three hundred are actually performed. According to the figures, I think that a third of patients receive proper care.
view: And what happens to those who didn't get the cells?
M.M.: Some patients go abroad for surgery. In general, there is a huge unaccounted flow of patients in a clinic in Israel, Germany. In what figures it is estimated, we also do not know. I think that in terms of volume it is comparable to what is being done in Russia. And there are some patients who die without receiving help. We don't know these numbers either. Imagine: in the outback, a child needs an operation, parents believe that they will not pull the operation for money, although it is done to Russian patients for free, and the person dies.
VIEW: Do you want to say that stem cell treatment is free?
M.M.: Absolutely, and many people don't know it. For Russians, this treatment is free of charge. What the state cannot do is fully covered by charitable foundations. I claim that children who receive bone marrow transplantation at home for money simply do not exist in nature. Sometimes you can find an ad on the Internet that parents are raising money for an operation. This means that the operation will take place abroad.
VIEW: Are there "black markets" where they are traded?
M.M.: I declare with absolute certainty that there are no hematopoietic stem cells in the field of transplantation. This is due to the complex technology of donor selection: one person can be a donor for 100 thousand people, another for one million. In order to find such a person, the mechanisms of international registers must be involved, and these are absolutely open, public things, that is, it is basically impossible to do this underground.
Portal "Eternal youth" http://vechnayamolodost.ru15.11.2010