Russia has adopted a law on biomedical cell products. How the Biomedical Cell Products Act will affect innovation Federal Law 180 on Biomedical Cell Products
Article 2. Basic concepts used in this Federal Law
Article 3. Principles for carrying out activities in the field of circulation of biomedical cell products
Article 4 Preparation of the cell line
Article 5. Development of biomedical cell products
Article 6. Preclinical study of a biomedical cell product
Article 7. Specification for a biomedical cell product
Article 8. State registration of biomedical cell products
Article 9. Submission of documents for state registration of a biomedical cell product
Article 10
Article 11
Article 12
Article 13
Article 14. Ethical review
Article 15
Article 16
Article 17
Article 18
Article 19
Article 20. Decision on state registration of a biomedical cell product
Article 21. Registration certificate of a biomedical cell product
Article 22. Confirmation of state registration of a biomedical cell product
Article 23
Article 24. Cancellation of state registration of a biomedical cell product
Article 25. State Register of Biomedical Cellular Products
Article 26
Article 27
Article 28. Organization of clinical trials of biomedical cell products
Article 29. Conducting a clinical trial of a biomedical cell product
Article 30
Article 31. Rights of a patient participating in a clinical trial of a biomedical cell product
Article 32
Article 33. Obtaining biological material
Article 34. Rights and obligations of the donor of biological material, his parents and other legal representatives
Article 35. Production and sale of biomedical cell products
Article 36. Labeling of biomedical cell products
Article 37
Article 38
Article 39
Article 40. Information on biomedical cell products
Article 41 Safety monitoring of biomedical cell products
Article 42. Suspension of the use of a biomedical cell product
Article 43
Article 44. Legal entities that are allowed to import biomedical cell products
Article 45
Article 46. State control in the field of circulation of biomedical cell products
Article 47
Article 48. Compensation for harm caused to the life and health of citizens due to the use of biomedical cell products
Article 49
The law regulating the use of cellular technologies in Russia: the beginning of a new industry, the simplification of interaction between the medical and business communities, or the complication of joint work? Anton Buzdin, a researcher at the Institute of Bioorganic Chemistry named after A.I. academicians M.M. Shemyakin and Yu.A. Ovchinnikova of the Russian Academy of Sciences, CEO of PONCC (resident of the biomedical cluster of the Skolkovo Foundation). site offers excerpts from this publication
The law (FZ No. 180 "On biomedical cell products") will directly affect the medical industry, for example, aesthetic medicine. In order to rejuvenate the face and skin, SPRS-therapy (Service for Personal Regeneration of Skin) was created in Russia. This is a personalized set of procedures for the natural restoration of the skin with the help of the patient's own cells - fibroblasts. The technology consists in isolating and growing fibroblasts (cells that produce collagen, elastin and other important skin components) from a small skin fragment obtained from the patient's behind the ear area, where the cells are maximally protected from ultraviolet radiation and other adverse environmental factors. A sufficient amount of fibroblasts for therapy is delivered to clinics, where certified cosmetologists inject them into the patient's skin using a special technique. Some of the obtained fibroblasts of the patient's skin are placed in a cryobank, where they can be stored in liquid nitrogen in individual cells for an unlimited time and used throughout the patient's life. Since fibroblasts are obtained from the skin of the patient undergoing therapy, many of the risks associated with the use of cellular technologies are removed.
Anton Buzdin (second from right) during a business mission of the biomedical cluster of the Skolkovo Foundation to Israel. Photo: site
Vadim Zorin, the developer of SPRS therapy, is the only one in Russia who has passed all stages of the development of a cell drug from the first (preclinical trials) to the final (post-marketing clinical trials) stage and received official permission from Roszdravnadzor to use the technology. According to him, the successful experience of using the technology for thousands of patients allows us to speak confidently about its safety and effectiveness.
However, not all technologies can be spoken so confidently.
What are biomedical cell products
The document refers to them products containing grown living human cells. They are used in various research and medicine. It is important that technologies related to reproduction (for example, artificial insemination) and transplantation (for example, transplantation of bone marrow, skin, liver, kidneys and other organs and tissues) do not fall under the law. The use of cellular technologies for purely scientific or educational purposes is not subject to the law.
We are talking about technologies that allow you to isolate your own or someone else's cells and use them to treat a patient. Cellular products can be used in regenerative medicine - to accelerate wound healing and tissue repair after surgery, as well as in aesthetic medicine, for example, to rejuvenate the skin or prevent scarring. Ilya Eremin, head of the Center for Biomedical Technologies of the Central Clinical Hospital of the Administration of the President of the Russian Federation, mentioned in a conversation that the use of cell products in medicine has long been the present, not the future, including in Russian clinics. Some Russian medical organizations have accumulated quite a lot of experience in the use of cell products. With the adoption of the law, real rules appeared that determined the process of legitimizing the developments of regenerative medicine.
For example, all manipulations with cell cultures intended for administration to a patient will be regulated. Previously, such serious actions as the genetic modification of cells, changes in the conditions and duration of their cultivation, were practically not controlled. This led to the fact that there was an increased risk of such side effects as oncological transformation of cells and their uncontrolled growth. Well, the therapeutic effect of the entire procedure itself was also called into question, since it is precisely the thoroughness of compliance with the regulations that determines the success of the use of cellular technologies.
The essence of the document
First of all, the law will "open" the biomedical field for state regulation. In order to determine the object of regulation of the law, for the first time such concepts as “cell line”, “donor of biological material”, “cell differentiation” and many others are introduced. The law prohibits the use of biomaterial obtained from human embryos or fetuses for the production of biomedical cell products. This forces researchers and businesses to focus on the development of products based on postnatal cells, that is, taken after birth. In many ways, this allows minimizing the risk of malignant transformation of cells (which has been noted more than once for embryonic stem cells), as well as reducing ethical and criminal risks.
The law states that the donation of biological material is based on the principles of voluntariness and gratuitousness. The sale and purchase of biological material and such odious approaches as the artificial creation of a human embryo, interruption or disruption of the development of a human embryo or fetus in order to produce biomedical cell products are prohibited. In this case, the voluntariness of donation is documented either by the donor himself, if we are talking about lifetime donation, or, if we are talking about posthumous donation, by his closest relatives. In the latter case, relatives confirm that during his lifetime he did not refuse a potential donation of this kind.
It is established that medical care with the use of cellular products can only be provided by medical workers who have been trained in a specialized additional professional program. Self-administration of biomedical cell products by a patient is not permitted by law.
It also introduces a requirement for mandatory registration of cell products “to be put into circulation in the Russian Federation for the first time” for use in medicine. The registration certificate is issued for a period of five years and then renewed. For registration, the rules of ethical examination, preclinical and clinical studies, as well as the procedure for interaction with government agencies are regulated. Ultimately, the decision on registration is made on the basis of an examination of the ratio of the expected benefit to the possible risk of using the product.
At the same time, the law does not have retroactive effect, and products that have already been registered in one form or another are not subject to mandatory re-registration. This rule was initially tougher, but edited in cooperation with representatives of the business community.
To register biomedical cell products, a special state registry and a special authorized federal body are being created, which causes discussion in the specialized expert community - after all, the corresponding market in Russia today is extremely small, and the creation of a new bureaucratic body seems redundant to many. Perhaps it would be more efficient to transfer the relevant powers to some already existing structure.
Another very important provision of the law, which my colleagues welcome, is a set of measures to protect a patient who is in the group of clinical trials of a cell product. The patient must be informed in writing about the product itself and its expected efficacy, as well as about the purpose and duration of the study, as well as the degree of risk to which he may be exposed in connection with participation in the study.
The life and health of the test subject are subject to compulsory insurance at the expense of the organization testing the technology. At the same time, in the event of an insured event, payments, according to the law, should vary in the range from 500 thousand to 2 million rubles, if we are talking about the patient's disability or death during the ongoing research.
The impact of the law on innovation in Russia
Almost all of my colleagues agree on some positive features of the document: the important area of medical technology is finally being brought out of the “gray” area. Sergey Larin, Deputy Director of the Higher School of Molecular and Experimental Medicine of the Center for Pediatric Hematology, Oncology and Immunology. Dima Rogacheva, the creator of the first gene-cell antitumor vaccines in Russia for the immunogen therapy of malignant tumors, believes that the procedure for registering new products prescribed by law will give confidence to investors investing in their development. This will strengthen the pool of domestic high-tech industries in this area and accelerate the pace of introduction of new developments. Accordingly, the prerequisites for creating products that are competitive in the world market are also being created.
The law does not regulate scientific developments, so it will most likely not affect the situation with fundamental research. At the same time, the procedure for passing preclinical and clinical trials, prescribed by law, implies significantly large amounts of investment in each product. This will certainly increase the cost of developing and bringing each product to market. Other scientists agree with this. So, the laboratories of Vadim Zorin, Ilya Eremin and Pavel Kopnin from the Cancer Center. Blokhin for the first time established that the mobile part of the gum is the best source of stem cells today, capable of differentiation (transformation), including into muscle tissue, which has long been an unsolved problem. The work of scientists was published in 2016 in the prestigious journal Cell Cycle. According to Eremin, this is a huge potential for the introduction of technology into the clinic, now, thanks to the law, all the steps necessary to introduce a new product into clinical practice have become clear.
The law is a good initiative. However, it, unfortunately, does not yet have any provisions that stimulate investment in the industry, does not provide for the possibility of accelerated registration for a number of products, where appropriate, does not have simplified requirements for minimally manipulated products, and contains a number of apparently unnecessary restrictions on xenogenic cells and embryonic cell lines. In general, the law has more advantages than disadvantages for the industry. Most likely, everything else will be finalized by the regulator in the future.
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Registration number 47615
Approved
Ministry of Health
Russian Federation
dated March 31, 2017 No. 143n
The procedure for posting information related to the state registration of biomedical cell products, including the conduct of a biomedical examination of biomedical cell products and their ethical review, information on registered biomedical cell products and biomedical cell products excluded from the state register of biomedical cell products
1. This Procedure determines the rules for posting on the official website of the Ministry of Health of the Russian Federation (hereinafter referred to as the Ministry) in the information and telecommunications network "Internet" (hereinafter referred to as the official website) information related to the state registration of biomedical cell products, including the conduct of biomedical expertise of biomedical cell products and ethical review of the possibility of conducting a clinical trial of a biomedical cell product (hereinafter referred to as ethical review), information on registered biomedical cell products and biomedical cell products excluded from the state register of biomedical cell products (hereinafter referred to as information).
2. Placement of information on the official website is carried out by the Department of State Regulation of the Circulation of Medicines of the Ministry and is provided by the system information resources of the Ministry through the organization of an electronic database (hereinafter referred to as the database).
3. Information posted on the official website includes the following information about the stages of procedures carried out in relation to a particular biomedical cell product:
1) details of the applications specified in this Procedure;
2) the name of the biomedical cell product and the type of biomedical cell product (allogeneic, autologous or combined);
3) name and address of the applicant;
4) name and address of the manufacturer of biomedical cell products;
5) names (international non-proprietary, or grouping, or chemical) medicinal products for medical use that are part of the biomedical cell product, dates and numbers of registration certificates of medicinal products;
6) names of medical devices included in the biomedical cell product, dates and numbers of registration certificates for medical devices;
7) details of the decisions of the Ministry on issuing assignments for conducting a biomedical examination of a biomedical cell product, details of the requests of the Ministry to clarify the information contained in the documents submitted by the applicant;
8) details of the opinion of the ethics council on the possibility or impossibility of conducting clinical trials of biomedical cell products;
9) details of the decision of the Ministry to renew the state registration of a biomedical cell product or to refuse to renew the state registration of a biomedical cell product, details of the decision of the Ministry to terminate the state registration of a biomedical cell product;
10) details of the decisions of the Ministry on the repeated conduct of a biomedical examination of a biomedical cell product and (or) ethical examination;
11) details of the conclusions of the commission of experts of the federal state budgetary institution, which is under the jurisdiction of the Ministry and ensures the execution of the powers of the Ministry to issue permits for conducting clinical trials of biomedical cell products and (or) state registration of biomedical cell products, based on the results of a biomedical examination of a biomedical cell product;
12) details of the decision of the Ministry to issue a permit to conduct clinical trials of biomedical cell products, including an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product, or to refuse to issue the said permit;
13) details of the decision of the Ministry on state registration of a biomedical cell product or on refusal of state registration of a biomedical cell product;
14) details of the decision of the Ministry to confirm the state registration of a biomedical cell product or to refuse to confirm the state registration of a biomedical cell product;
15) details of the decision of the Ministry to amend the documents contained in the registration dossier for a registered biomedical cell product, or to refuse to amend the documents contained in the registration dossier for a registered biomedical cell product.
4. The information specified in this Procedure is placed in the database no later than five working days from the date of receipt by the Ministry of the applications specified in this Procedure.
The information specified in this Procedure is placed in the database within three working days from the date the Ministry makes the relevant decision, the Ministry receives the relevant conclusion, the application for the renewal of the state registration of the biomedical cell product, or the Ministry sends the relevant request to the applicant.
5. Access to the database is provided to the following subjects of circulation of biomedical cell products (hereinafter referred to as the applicant):
1) an organization that has the rights to the results of preclinical studies of a biomedical cell product, clinical studies of a biomedical cell product and (or) to the production technology of a biomedical cell product, which has submitted an application to the Ministry for state registration of a biomedical cell product;
2) the owner of the registration certificate of the biomedical cell product, who has submitted to the Ministry an application for confirmation of the state registration of the biomedical cell product;
3) to the owner of the registration certificate of the biomedical cell product, who has submitted to the Ministry an application to amend the documents contained in the registration dossier for the registered biomedical cell product;
4) an organization that organizes a clinical trial of a biomedical cell product and has submitted an application to the Ministry for permission to conduct an international multicenter clinical trial of a biomedical cell product or a post-registration clinical trial of a biomedical cell product.
6. The applicant's access to the database is carried out by providing the applicant with a personal entry by the Department of Information Technologies and Communications of the Ministry within 5 working days from the date of receipt by the Ministry of an application for granting access to the database.
7. The reason for refusal to provide access to the database is the absence of the status of the applicant specified in this Procedure in relation to a particular biomedical cell product.
If the grounds for refusal to grant access to the database are established, the Department of Information Technologies and Communications of the Ministry shall send (deliver) to the applicant a reasoned refusal in writing or in the form of an electronic document.
8. The Department of Information Technologies and Communications of the Ministry at least once a day creates a backup copy of the database in order to protect the information contained in it, and also protects the information contained in the database from unauthorized access.
Document overview
The issues of posting information related to the state registration of biomedical cell products (BCP), including the conduct of biomedical and ethical expertise, data on registered BCPs and those excluded from the register, have been settled.
Information is published on the website of the Ministry of Health of Russia. A special database is being formed. The order of access to it is fixed.
The composition of the posted information is determined. The deadlines for their submission are indicated.
Regulates the issues of donation of biological material, use, storage, transportation, import and export from Russia of biomedical cell products, their destruction, RIA Novosti reports. The document also regulates the use of biomaterial obtained by interrupting the development of a human embryo or fetus.
According to the new law, the donation of biomaterial will be possible only with the consent of the donor, and clinical trials of cell products - with the consent of the subjects. A capable adult citizen can be a donor of biological material. If a citizen is partially capable, incompetent or a minor, then his biological material can be used only for himself.
It is forbidden to use human embryos for the production of biomedical cell products. It will also not be possible to use biomaterial obtained with the interruption or disruption of the process of development of the human embryo and fetus. According to Andrey Vasilyev, director of the Department of the Ministry of Health, if the use of embryonic material is legalized, the commercialization of the female reproductive sphere under a certain order may occur. The order for the conception of a person, who will then be “taken apart for parts” for money, does not stand up to criticism from a moral and ethical point of view, the representative of the department believes.
It is forbidden to test cellular materials on military personnel (with some exceptions), law enforcement officers and prisoners, and testing on children and pregnant women is possible only in cases where it is necessary for their treatment. A patient may voluntarily participate in a clinical trial of a biomedical cell product. He or his legal representative must confirm his consent with a signature on the patient information sheet. Compulsory insurance of his life and health is provided. The patient may also refuse to participate in the study at any stage.
According to the bill, the donation of biomaterial is voluntary and free of charge, its purchase and sale are not allowed. The donor of biological material during lifetime donation is obliged to undergo a medical examination. An adult capable person may, in writing, certified by the head of a medical organization or a notary, express his consent or disagreement to the posthumous provision of a biomaterial for the production of a biomedical cell product. Information about this will be entered in his medical records. If this is not done during the life of a possible donor, the decision is made by the spouses. And in their absence - the relatives of the deceased.
The bill also requires the creation of a state registry of biomedical cell products. In order to produce, use, transport, import into Russia and export such products from the country, to destroy biomedical cell products, it will be necessary to carry out their state registration.
The bill, if passed, will enter into force on January 1, 2017. Until now, there was no separate law in the Russian Federation that would regulate the use of biomedical technologies.
A.N. Borisov., A.M. Borisova
Commentary on the Federal Law of June 23, 2016 No. 180-FZ "On Biomedical Cellular Products" (item-by-article)
COMMENTARY TO FEDERAL LAW
ON BIOMEDICAL CELL PRODUCTS
(ITEMIZED)
Borisov A.N., Borisova M.A.
Commentary to Federal Law of 23 June 2016 No. 180-FZ "On Biomedical Cell Products" (Itemized) / A.N. Borisov, M.A. Borisova. – M.: Yustitsinform, 2017. – 420 p.
978-5-7205-1411-2
In this book the issues of development, preclinical and clinical research, expertise, state registration, production, quality control, implementation, application, storage and transportation of biomedical cell products (BCP) are considered in detail.
The norms of considered law are analyzed in conjunction with the norms of the Federal Laws "On Fundamentals of Health Care of Citizens in the Russian Federation" and "On Circulation of Medicines". Comparison with the provisions of EU Directive "On Establishing Quality and Safety Standards for Donation, Acquisition, Control, Processing, Conservation, Storage and Distribution of Human Tissues and Cells" is held.
The book is intended, first of all, for law enforcers – persons of the sphere of circulation of the BCR The book will also be useful to everyone who is interested in the issues of legal regulation of this sphere in Russia.
keywords: biomedical cell products, donation, registration of biomedical cell products, state regulation and control in the field of biomedical cell products, biomedical expertise.
List of abbreviations
State authorities, other state bodies and organizations:
EAEU - Eurasian Economic Union;
State Duma - the State Duma of the Federal Assembly of the Russian Federation;
The Supreme Court of Russia - the Supreme Court of the Russian Federation;
SAC of Russia - the Supreme Arbitration Court of the Russian Federation;
Treasury of Russia - Federal Treasury;
Ministry of Health of Russia - Ministry of Health of the Russian Federation;
Ministry of Health and Social Development of Russia - Ministry of Health and Social Development of the Russian Federation;
Ministry of Justice of Russia - Ministry of Justice of the Russian Federation;
Roszdravnadzor - Federal Service for Surveillance in Healthcare;
FTS of Russia - Federal Tax Service;
FCS of Russia - Federal Customs Service;
Rosimuschestvo - Federal Agency for State Property Management;
Federal State Budgetary Institution "NTsESMP" of the Ministry of Health of Russia is the federal state budgetary institution "Scientific Center for Expertise of Medicinal Products" of the Ministry of Health of the Russian Federation.
Legal acts:
EU Directive on Human Tissues and Cells (2004) - Directive No. 2004/23/EC of the European Parliament and of the Council of the European Union on the establishment of quality and safety standards for the donation, acquisition, control, processing, preservation, storage and distribution of human tissues and cells”, adopted in Strasbourg on March 31, 2004;
part four of the civil code of the gf civil code of the gf (part 4)
2010 Law on Medicinal Products – Federal Law No. 61-FZ of 12 April 2010 “On the Circulation of Medicinal Products”;
Law of 2011 on Health Protection - Federal Law of November 21, 2011 No. 323-FZ “On the Fundamentals of Protecting the Health of Citizens in the Russian Federation”;
draft Law in connection with the adoption of the commented Law (2016) - the draft Federal Law “On Amendments to Certain Legislative Acts of the Russian Federation in Connection with the Adoption of the Federal Law “On Biomedical Cellular Products”, prepared by the Ministry of Health of the Russian Federation, not submitted to the State Duma Federal Assembly of the Russian Federation (October 5, 2016).
Sources of legal acts:
pravo.gov.ru - "The official Internet portal of legal information http://www.pravo.gov.ru";
regulation.gov.ru - "Official website for posting information on the preparation by federal executive authorities of draft regulatory legal acts and the results of their public discussion http://regulation.gov.ru (federal portal of draft regulatory legal acts)";
BNA FOIV - "Bulletin of normative acts of federal executive bodies";
Bulletin of the USSR Armed Forces - "Bulletin of the Supreme Soviet of the USSR";
Statements of the SPD and the Sun of the Russian Federation "Statements of the Congress of People's
deputies of the Russian Federation and the Supreme Council of the Russian Federation”;
RG - Rossiyskaya Gazeta;
SZ RF - "Collection of Legislation of the Russian Federation";
SPS - reference legal systems.
Other abbreviations:
BMCP – biomedical cellular product (biomedical cellular products);
EGRIP - unified state register of individual entrepreneurs;
Unified State Register of Legal Entities - Unified State Register of Legal Entities.
Introduction
The publication of a separate legal act, which will regulate the development, production and medical use of BMCP, in the form of the Federal Law "On the circulation of biomedical cell products" was planned for 2014 by the State Program of the Russian Federation "Health Development", approved. Decree of the Government of the Russian Federation of December 24, 2012 No. 2511-r (recognized as invalid by Decree of the Government of the Russian Federation of April 15, 2014 No. 294 “On Approval of the State Program of the Russian Federation “Health Development”). Accordingly, in January 2013, the Ministry of Health of Russia submitted for discussion the draft Federal Law “On the Circulation of Biomedical Cellular Products”. However, the development of the relevant bill was carried out earlier. So, back in December 2010, the Ministry of Health and Social Development of Russia presented a draft Federal Law "On Biomedical Cell Technologies".
Prior to this, the relevant issues were regulated fragmentarily. Thus, the relevant act was only the Order of the Ministry of Health of Russia dated July 25, 2003 No. 325 "On the development of cellular technologies in the Russian Federation", which approved the Instructions for the procurement of umbilical / placental blood for research work, Instructions for the isolation and storage of stem cell concentrate human umbilical cord/placental blood and Regulations on the Human cord/placental blood stem cell bank. The draft law was submitted to the State Duma by the Government of the Russian Federation two years later in February 2015 (see Decree of the Government of the Russian Federation of February 5, 2015 No. 160-r) - with changes, including with the specified title "On biomedical cell products ". As noted at the same time, the bill was 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 studies, examination, state registration, clinical trials, production, sale, storage, transportation, use, destruction , import to Russia, export from Russia of biomedical cellular 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 BMCP. It was also noted that the adoption of the draft law and the implementation of a set of measures for its implementation are aimed at developing the biomedical technology sector in Russia.
With regard to the concept of the bill, the explanatory note to it states the following:
For the first time at the legislative level, the concepts of “biomedical cell product”, “cell line”, “cell differentiation”, “donor of biological material”, “safety of a biomedical cell product”, “efficacy of a biomedical cell product” and other concepts that are fundamentally important for the implementation of the appeal are defined at the legislative level. BMKP;
The draft law defines the rights and obligations of the subjects of circulation of the BMCP - individuals, including individual entrepreneurs, and legal entities operating when applying for the BMCP;
The bill provides for state control (supervision) in the field of circulation of BMCP, which includes license control in the field of production of BMCP and federal state supervision in the field of circulation of BMCP;
BMCP will be used to diagnose, treat and prevent diseases with direct injection into the human body, which, if used incorrectly, can lead to significant damage to human health. In order to ensure the safety and effectiveness of the use of BMCP, the bill provides for a biomedical examination of the BMCP;