Deputies took care of a new regulatory framework for biomedicine
Let's rejuvenate according to the law
Alexandra Zinoviev, "MK" from 04.05.2012.
Human blood, its cells and even internal organs have long been the subject of purchase and sale in Russia.
And medical services in this area have been provided on a commercial basis for many years. Which is unacceptable not only from the point of view of bioethics, but also in the absence of laws. Moreover, few people are still aware of the side effects of the use of almost any biomedical products.
The State Duma (finally!) held parliamentary hearings on the legislative regulation of the field of biomedical cell technologies. This was announced by the Deputy head of the Ministry of Health and Social Development of Russia Veronika Skvortsova.
In particular, she noted that the development of biomedicine is the basis not only for the prospects of human potential development, changing approaches to restoring health, increasing life expectancy, but also the basis of biosafety of the Russian population. Therefore, "... it is extremely important to develop a regulatory framework for regulating all relations in the field of biomedicine. Since the unscrupulous use of the most promising biomedical developments, taking into account their radicality and the possibility of intrusion into the most intimate mechanisms of not only the pathogenesis of diseases, but also the functioning of the human body, can have very serious consequences. In this regard, the regulation of the quality of those developments that can form the basis of practical application in the future in medicine is of great importance."
According to the Deputy Minister, "it will be necessary to separate, on the one hand, the commercial market of modern efficient technologies and products with the impossibility of any commercialization and trade in biomaterials. This is a very serious facet, which should be indicated in the regulatory framework that will be formed," Skvortsova emphasized. The same, by the way, is required by the WHO declaration, whether it concerns blood, cells or organs.
Moreover, it is assumed that this will not just be an update of the regulatory framework for biomedicine, but the creation of a new one, which will entail a whole series of legislative acts. In particular, the draft law on blood donation and its components; on organ donation and transplantation; on biomedical cell products; on tissue donation and transplantation and on a network of cryobanks. The changes will also affect the Law "On the Circulation of Medicines", where it is planned to provide provisions on biotechnological drugs. Separately, we intend to develop a bill on medical devices (although the Ministry of Industry and Trade is responsible for this document, it will have a whole block dedicated to biological and biocompatible materials). It is also planned to amend the law on genetically modified products, for which the Ministry of Agriculture is responsible. "And all this will be prepared in the near future," Ms. Skvortsova is convinced.
In principle, it may not be necessary to reinvent the wheel here. There are common approaches that have already been formulated by WHO, the Council of Europe, and the European Union. In the most developed countries of the world, expert councils are already operating in this regard. "In the last year and a half, the Ministry of Health and Social Development of Russia has been doing a lot of joint work in this regard," explains Ms. Skvortsova. – Now we are at the last stage of discussing the entry into a single worldwide database of information exchange about all side effects and undesirable effects when using any medical products. There is an agreement on the joint development of a quality certification system. We have to switch to international standards."
Portal "Eternal youth" http://vechnayamolodost.ru04.05.2012