Lawmakers want to protect Russians from unscrupulous biotechnologists
Need armor
Svetlana KRYMOVA, "Search" No. 37-2012
The parliamentary autumn that has begun promises to be hot. And the last session, especially its completion, has become so high-status for deputies that problems not related to big politics have gone into the shadows. However, the relevant committees continued to work on "highly specialized", but still no less important issues for all Russians. Thus, the State Duma Committee on Science and High-Tech Technologies held a round table "On improving legislative support for the development of biomedical cell technologies in the Russian Federation."
The discussion was attended by almost the entire scientific and medical elite of the biomedical field, deputies, heads of the Ministry of Health and Social Development (not yet divided into two departments), research institutions, universities, commercial and non-profit enterprises, representatives of public and religious organizations. The Chairman of the committee, Academician Valery Chereshnev, noted that currently a new branch of medical biotechnology is being formed in the world, creating drugs to restore the structure and function of cells, tissues and organs. This will lead to the formation of a new model of healthcare in our country, the priority of which will be regenerative medicine, and its main tool – stem cells (SC).
SC are immature cells capable of reproducing themselves and developing differentially into specialized cells of the body. They are used to repair or replace damaged tissue. The list of diseases that can be treated with cellular technologies is impressive: myocardial infarction, heart failure, Alzheimer's, Parkinson's, cerebral palsy, stroke, extensive burns, spinal injuries, multiple sclerosis, glaucoma, diabetes, AIDS, and this list can be continued. In fact, we are talking about growing "spare parts" for the human body. Fiction? Not at all.
According to Nikolay Semenov, Director of the Department of Analysis, Prognosis, Development of Healthcare and Medical Science of the Ministry of Health of the Russian Federation, "the whole world is preparing for a technological revolution in medicine associated with the mass arrival of biomedical technologies, including cellular ones." Thanks to them, the life expectancy of a person born in the XXI century will increase to 100 years! The global market for cellular technologies is 2.5 billion US dollars with a projected growth to 15-30 billion by 2025. Today, only a few cellular products have been registered in the world, and hundreds are in the stage of clinical trials.
In the arsenal of Russian scientists there are technologies that are ready for implementation in medical practice and are at the stage of development and clinical trials. It is estimated that every year hundreds of thousands and even millions of Russians can be returned to a normal healthy life with the help of cellular technologies.
But how ready are we for such a revolution? What tools have been created in the country to support and develop an important industry? What federal laws, federal target programs, and state programs exist? How many research and industrial sites have been created that meet international standards, how many innovative educational standards in terms of biotechnology?
Nikolay Semenov's answer to these questions during the round table was discouraging: with the exception of individual unique laboratories and their developments, "there is nothing." Moreover, he said, cellular technologies in the Russian Federation are actually outlawed, and he described the situation that has developed in this area as "a bacchanalia and annihilatingly cynical violation of moral, humanitarian and universal values."
– One can only guess what is being injected into women in cosmetology offices under the guise of innovative cellular products, – N. Semenov was indignant. – The number of new cases of cancer that we will face tomorrow and the extent of the harm that will be inflicted on our fellow citizens cannot be predicted.
The absence of the law is not only a threat to the biosecurity of the country, but also discrediting Russian cellular technologies. Nikolay Semenov reminded the participants of the discussion what caustic articles appeared in the American press regarding the export of fetal tissues (obtained from aborted human fetuses) and the use of Russia as a "farm for growing embryonic material for California consumers." He finished his speech very abruptly:
– The most monstrous thing that can happen to us is the transformation of our clinics into "suppliers of raw materials" for developed countries, the transition to a "raw material economy", the basis for which will be our women. God is our judge if we allow it.
Scientists warn that in the absence of a legal field in the industry, which, in the words of the first deputy chairman of the committee Nikolay Gerasimenko, "is not only not sown, but not even plowed," many problems of a social, legal, ethical, religious, economic nature will arise.
The country's top leadership is also concerned about the situation with biomedical technologies. In April, Dmitry Medvedev, still in the rank of president of the country, instructed the government to analyze the regulatory framework governing the development of biomedical technologies, to submit proposals for its improvement, including in terms of the feasibility of adopting a separate Federal law "On Biomedical cell Products."
Leading scientists, experts of the Russian Academy of Sciences, the Russian Academy of Medical Sciences, and healthcare specialists have been working on the draft law for the third year. The first option was criticized, and it was not even put up for discussion in the State Duma. Then many people thought that the law was not needed at all. But time has shown that its absence creates favorable conditions for the commercialization of health-threatening cellular products and technologies.
One of the participants in the discussion witnessed an egregious case when, at some council, pseudo-researchers requested money for preclinical tests of mouse cancer cells in order to then treat "all types of human cancer." They were asked on what basis to allocate funds? And they say we have already cured 2,200 people of cancer, we see that they have become better (and SC stimulate immunity), and now we will investigate why these cells help!
The law is needed, deputies, scientists, doctors believe. Even if it is imperfect, it is still better than lawlessness. And it does not matter what it will be called – the law, regulations or any other document. The main thing, said the participant of the round table, referring to Bulgakov's Professor Preobrazhensky, is that it should be "The final piece of paper. Actual. Real. Armor", which will protect you from all sorts of shvonders and will not allow you to ruin the idea.
Everyone understands that it is necessary to hurry with the adoption of the law, but the discussion process is not over yet. Corresponding member of the Russian Academy of Sciences, Academician of the Russian Academy of Sciences Vladimir Smirnov proposed two alternatives. The first is to adopt a federal law "sufficiently tough and long–lasting." The second is to approve not the Federal Law, but other normative legal acts. Vladimir Nikolaevich gave the following argument in favor of the second solution:
– The rate of accumulation of information in the field of stem cell research is such that it is impossible to predict where this section of medicine will go tomorrow. Against the background of permanent changes in the subject of regulation, it is impossible to introduce a permanent law without harm to science and medicine. It loses its meaning and slows down progress.
Vladimir Smirnov believes that it is possible to quickly prepare a set of rules – an analogue of those according to which the FDA (US Food and Drug Administration) works, issue an appropriate order or regulation to it and be guided by them in further work.
Veronika Skvortsova, at that time Deputy Minister of Health and Social Development, drew the attention of those present that the legislative base in the United States and the entire legislative system are built differently than ours. They don't have federal laws, but there are federal acts that the president signs. And cellular products are prescribed not only in the fundamental act on the protection of the health of US citizens, but also in a special law that came out in 2010, "under it" there are many rules and recommendations. The FDA, V. Skvortsova said, sent a letter to the ministry regarding the construction of a regulatory framework for cellular products in the United States, these rules and recommendations "are on every table." She confirmed that the FDA "takes an active part, including in the external independent examination of documents that will be issued by the Ministry of Health of Russia."
In general, in the USA and the EU, an effective multi-stage system of quality control and safety of the use of a cellular product has been created. State examination bodies impose strict requirements not only on the safety of the products themselves, but also on the standards of laboratory, industrial, clinical, and tissue practice. All participants in the biomedical cell technology market (researchers, developers, manufacturers, medical professionals who conduct clinical research) are actually in a single legal field, in which requirements are clearly formulated not only for products, but also for their developers.
But is it worth transferring someone's model to Russian soil? Speakers at the round table tend to believe that, after all, each state chooses the most optimal scenario for the development of the industry. After all, for example, the starting conditions for developers and manufacturers of cellular products and technologies are not the same here and abroad. And the industry in question, today all over the world, is itself in the process of formation and is the subject of discussion. And therefore it is difficult to find a reference legislative model.
Nevertheless, the foundation of civilized relations in the field of biomedical cell technologies should be laid by next year. In the regulatory framework, it is necessary to clearly delineate the line between the possibility of developing a market for modern cellular technologies and products and the impossibility of trading biomaterials, be it blood, tissue, cells or human organs. Everyone's life should be protected by the law like armor.
Portal "Eternal youth" http://vechnayamolodost.ru17.09.2012