Biomedical cell products. New Law on Biological Cell Products

About biomedical cell products

Article 1. Subject of regulation of this Federal Law

1. This Federal Law governs relations arising in connection with the development, preclinical studies, clinical studies, expertise, state registration, production, quality control, sale, use, storage, transportation, import into the Russian Federation, export from the Russian Federation, destruction of biomedical cellular products intended for the prevention, diagnosis and treatment of diseases or conditions of the patient, preservation of pregnancy and medical rehabilitation of the patient (hereinafter referred to as the circulation of biomedical cellular products), and also regulates relations arising in connection with the donation of biological material for the production of biomedical cellular products.

2. This Federal Law does not apply to relations arising in the development and production of medicines and medical devices, donation of human organs and tissues for the purpose of their transplantation (transplantation), donation of blood and its components, when using human germ cells for the purpose of using auxiliary reproductive technologies, as well as the relationships arising from the circulation of human cells and tissues for scientific and educational purposes.

Article 2. Basic concepts used in this Federal Law

The following basic concepts are used in this Federal Law:

1) biomedical cell product - a complex consisting of a cell line (cell lines) and excipients or a cell line (cell lines) and excipients in combination with state-registered medicinal products for medical use (hereinafter referred to as medicinal products), and ( or) pharmaceutical substances included in the state register of medicines and (or) medical devices;

2) sale of a biomedical cell product - transfer of a biomedical cell product on a reimbursable basis and (or) free of charge;

3) autologous biomedical cell product - a biomedical cell product containing in its composition a cell line (cell lines) obtained from the biological material of a certain person and intended for use by the same person;

4) allogeneic biomedical cell product - a biomedical cell product containing in its composition a cell line (cell lines) obtained from the biological material of a certain person and intended for use by other people;

5) combined biomedical cell product - a biomedical cell product containing in its composition cell lines obtained from the biological material of several people and intended for use by one of them;

6) a sample of a biomedical cellular product - a biomedical cellular product or a part thereof, obtained in order to study its properties, including for assessing the quality of a biomedical cellular product and its safety;

7) cell line - a standardized population of cells of the same type with a reproducible cellular composition, obtained by removing biological material from the human body with subsequent cultivation of cells outside the human body;

8) excipients - substances of inorganic or organic origin used in the development and production of a biomedical cell product;

9) biological material - biological fluids, tissues, cells, secrets and products of human vital activity, physiological and pathological secretions, smears, scrapings, swabs, biopsy material;

10) donor of biological material (hereinafter also referred to as "donor") - a person who during his lifetime provided biological material, or a person from whom biological material was obtained after his death, ascertained in the manner established by the legislation of the Russian Federation;

11) donation of biological material - the process of posthumous provision of biological material (hereinafter - posthumous donation) or lifetime provision of biological material (hereinafter - lifetime donation);

The State Duma adopted in the third, final reading a bill regulating the donation of biomaterial and testing of biomedical cell products.

The law regulates the development, preclinical and clinical studies, examination, state registration, quality control, production, sale, storage, transportation, use, destruction, import and export of biomedical cell products.

“We have been waiting for the adoption of this law for a very long time. However, the latest version alone took five years to write. Therefore, it will come into force in stages - in 2017 and 2018. There are many subtle and complex issues in the adopted law, because we are talking about a very innovative topic. It has been repeatedly discussed by the professional community - with representatives of the Russian Academy of Sciences, representatives of all interested departments, with the public, and is also aimed at creating complex GMP- and GTP-oriented industries that will make it possible to obtain the most effective and safe cell preparations, ”said the Director of the Department of Innovative development and scientific design of the Ministry of Health of the Russian Federation Sergey Rumyantsev.

The bill, developed by the Ministry of Health, was submitted to the State Duma in early February 2015. The document updates the basic terminology, in particular, such concepts as "biological material" and "cell line", as well as defines the subjects of circulation of cell products and their rights and obligations in this area. The draft law also defines the conditions and procedure for obtaining biological material from a donor for the production of a cell product, introduces norms that allow the production and use in medical activities of personalized (autologous) cell products containing the patient's own cells.

“The law will come into force and open up broad prospects for medicine. Similar biomedical products have already been used without regulation, and now some of them will become legal and available to everyone. This is a completely new class of medical products. Investors will also have the opportunity to finance the creation of new products. This is a good impetus for the creation of new high-tech industries. In addition, doctors, biologists, technologists will need to be taught how to produce, control and apply biomedical cell products, as well as create training programs - and all in the remaining six months. And, it seems to me, whoever gets there first will get a marketing advantage,” Yury Sukhanov, Executive Director of NP Aktremed, Candidate of Medical Sciences, told a Vademecum correspondent.

According to the law "On Biomedical Cell Products", 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. It is forbidden to use human embryos for the production of biomedical cell products. Clinical trials involving children and pregnant women are allowed if necessary for their treatment.

According to the law, the donation of biomaterial is voluntary and free of charge, its purchase and sale, as in the case of organ donation, is prohibited.

Obtaining biomaterial for the production of biomedical cell products during lifetime donation is possible with a written informed voluntary consent of the donor.

It is not allowed to use for the production of biomedical cell products the biomaterial of the dead, whose identity has not been established.

Regulates the issues of donation of biological material, the 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 the director of the Department of the Ministry of Health Andrei Vasiliev, 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, the Russian Federation has not had a separate law 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 site 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 the draft Federal Law “On Biomedical Cellular 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 updated 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 circulation 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 draft law provides for state control (supervision) in the field of BMKP circulation, which includes license control in the field of BMKP production and federal state supervision in the field of BMKP circulation;

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;