Cellular technologies have been legalized
The State Duma of the Russian Federation has adopted a federal law
"About biomedical cell products"
The State Duma of the Russian Federation in the third and final reading adopted the Federal Law "On Biomedical Cell Products", developed and introduced by the Ministry of Health of the Russian Federation.
The Federal Law "On Biomedical Cell Products" has been prepared taking into account the analysis of international experience, foreign law enforcement practice and is aimed at regulating relations arising in connection with the development, preclinical research, examination, state registration, clinical research, production, sale, storage, transportation, use, destruction, importation into the Russian Federation, export from Of the Russian Federation of Biomedical Cell Products for the prevention, diagnosis and treatment of diseases (conditions) of the patient, preservation of pregnancy and medical rehabilitation of the patient, as well as with the donation of biological material for the production of biomedical cell products.
For the first time, a number of fundamental concepts are defined at the legislative level, such as "biomedical cell product", "cell line", "cell differentiation", "donor of biological material", "safety of biomedical cell product", "effectiveness of biomedical cell product".
According to Sergey Rumyantsev, Director of the Department of Innovative Development and Scientific Design of the Ministry of Health of the Russian Federation, the adopted law will allow federal institutions of the Ministry of Health of the Russian Federation to use in practice a large number of biological cellular drugs that were developed outside the legal field until that time and, accordingly, did not have the possibility of wide clinical application.
– We have been waiting for the adoption of this law for a very long time. However, it took only five years to write its latest version. Therefore, it will come into force in stages – in 2017 and in 2018, – said Sergey Rumyantsev. – There are many subtle and complex issues in the adopted law, because we are talking about a very innovative topic.
Sergey Rumyantsev also added that the adopted Federal Law "On Biomedical Cell Products" has been repeatedly discussed by the professional community – with representatives of the Russian Academy of Sciences, representatives of all interested departments, with the public.
The law is aimed at creating complex GMP- and GTP-oriented productions that will allow obtaining the most effective and safe cellular preparations.
The Federal Law "On Biomedical Cell Products" defines the rights and obligations of subjects of circulation of biomedical cell products, establishes requirements for state control (supervision) in the field of circulation of biomedical cell products.
According to the adopted law, donation of biomaterial will be possible only with the consent of the donor, and clinical trials of cellular products – with the consent of the subjects. It is forbidden to use human embryos for the production of biomedical cell products. It is forbidden to test cellular materials on military personnel (with some exceptions), law enforcement officers and prisoners, and tests on children and pregnant women are possible only if it is necessary for their treatment.
The adoption of the law and the implementation of a set of measures to implement it will protect the rights of citizens in the field of biomedicine and will contribute to the development of the biomedical technology sector in the Russian Federation.
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09.06.2016