Biomedical cell technologies: the draft law is ready
Participants in cell technology research will be insured at the expense of clinics
"Right.Ru»The use of living human cells, the so-called biomedical cell technologies, is proposed to be regulated in Russia.
The draft law "On Biomedical cell Technologies", which has long been talked about in medical circles, is published on the website of the Ministry of Health and Social Development of the Russian Federation.
The document defines that the participation of patients in a clinical trial of a cellular product is voluntary, in addition, the patient must be insured in case of death or injury to health.
With the written consent of parents, adoptive parents, children can participate in a clinical trial as patients if it is necessary to treat the disease. In these cases, such a study can be carried out on the basis of a decision of a council of specialist doctors on the profile of the child's disease, before that, a clinical study should be conducted on adult citizens.
It is prohibited to conduct a clinical study of a cellular product with the participation of orphans and children left without parental care; women during pregnancy, women during breastfeeding; law enforcement officers; persons serving sentences in places of deprivation of liberty, as well as persons in custody in pre-trial detention centers. Research on military personnel is also prohibited, except in cases of conducting a clinical study of a cellular product specially developed for use in conditions of military operations, emergencies, prevention and treatment of diseases and lesions resulting from exposure to adverse chemical, biological, radiation factors. However, the study cannot be conducted with the participation of conscripted military personnel.
The patient or his legal representative must be informed in writing about the biomedical cell technology and the nature of the clinical study of the cell product; about the degree of risk to the participant of the clinical study, as well as the expected effectiveness. Information should also be provided about the conditions of participation in a clinical trial; about the purpose and duration of a clinical trial; about the conditions of compulsory life and health insurance of a participant in a clinical trial, and so on.
According to the bill, the patient or his legal representative has the right to refuse to participate in a clinical trial of a cellular product at any stage of such a study.
In addition, it is established that an organization that has received permission to conduct a clinical study of a cellular product is obliged to insure the risk of harm to the life and health of the patient at its own expense by concluding a compulsory insurance contract.
An insured event, according to the bill, is the death of a patient or deterioration of his health, including entailing the establishment of disability, if there is a causal relationship.
The authors of the bill propose to establish that in case of death of a patient, the amount of the insurance payment is two million rubles, in case of deterioration of the patient's health, which entailed the establishment of disability of group I – 1.5 million rubles, in case of disability of group II – one million rubles, in case of disability of group III – 500 thousand rubles. If the deterioration of health did not lead to the establishment of disability, the patient will be able to receive up to 300 thousand rubles.
The bill also establishes that only biomedical cell technologies that have passed state registration based on the results of biomedical expertise and ethical expertise are used on the territory of Russia, and a register of these technologies is maintained. The cells received from the patient (donor) cannot be objects of purchase and sale or other commercial transactions.
As stated in the explanatory note, the bill is aimed at regulating relations arising in connection with the development, preclinical research, examination, state registration of biomedical cell technologies, as well as clinical research, examination of the result of the use of biomedical cell technologies – cell products. In addition, the document defines the rights of patients participating in clinical trials. But the law does not apply to immunobiological preparations and medical devices, transplantation of organs (their parts) and human tissues, the development and use of assisted reproductive technologies, blood donation and its components, as well as relations arising from the collection and use of whole human umbilical cord blood.
Portal "Eternal youth" http://vechnayamolodost.ru
06.12.2010