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Public health code
Public health code
Regulatory part
(Last modification: May 30 2020)
Part Two: Family, Mother and Child Health
Version in force on May 30, 2020
Version to come on June 24, 2020 Book I: Protection and promotion of maternal and child health
Version to come as of June 30, 2020 Title V: Research on the embryo and embryonic cells
Version to come on July 12, 2020 Single Chapter
Version to come on July 26, 2020
Version coming September 1
2020
Version to come on October 1, 2020 Section 1: Research implementation.
Version coming January 1, 2021
Version coming April 1, 2021
Article R2151-1 Learn more about this article ...
Version to come on July 1, 2021 Modified by DECREE n ° 2015-155 of February 11, 2015 - art. 1
Version coming January 1, 2022
The Director General of the Biomedicine Agency may authorize, under the conditions laid down in Article L. 2151-5, a
Version to come on March 1, 2022 research protocol on the embryo or on embryonic stem cells, after advice from the guidance council, for
Version to come on: date not a fixed term which cannot exceed five years, renewable under the same conditions.
specified
Article R2151-2 Learn more about this article ...
Consolidated version as of ...
Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
Day month Year
2015 In addition to verifying the conditions set out in article L. 2151-5, the biomedicine agency ensures the feasibility of the
October 15
Ex: 2020 protocol and the sustainability of the organization and the research team. It takes into account titles, diplomas,
experience and scientific work of the research manager and team members. In addition, the agency of the
Consult biomedicine takes into account the premises, materials, equipment as well as the processes and techniques used
by the applicant. It assesses the means and devices guaranteeing the safety, quality and traceability of embryos and
embryonic stem cells.
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Summary
Legislative part Article R2151-3 Read more about this article ...
Old legislative part Amended by Decree n ° 2012-467 of 11 April 2012 - art. 1
Regulatory part I.-Only can obtain authorization to carry out research on the embryo:
First part: 1 ° Public health establishments and medical biology laboratories authorized to store embryos in
General protection of the application of article L. 2142-1, as well as establishments authorized to carry out preimplantation diagnosis in
health application of article L. 2131-4;
Second part :
2 ° Establishments and organizations having concluded an agreement with at least one of establishments or laboratories
Family, mother health
mentioned in 1 °. This agreement sets out the conditions under which the establishment or laboratory mentioned in 1 °
Hide the search for canned items and provide embryos for the benefit of this establishment or organization. The provision
within the embryo code is only allowed for the duration of the research.
Enter a word from an article or a
article number II.-Only the following can be authorized to carry out research on embryonic stem cells:
Search in the entirety of 1 ° Establishments and organizations pursuing a research activity and holders of the conservation authorization
code of embryonic stem cells for research purposes mentioned in article L. 2151-7;
Limit search to 'Party
2 ° Public and private establishments and organizations pursuing a research activity having concluded an agreement
Legislative ''
with an establishment or organization mentioned in 1 ° in which the latter undertakes to supply and keep
Limit search to 'Party
embryonic stem cells for carrying out the research of the former.
Regulatory ''
Word or phrase within
articles Article R2151-4 Read more about this article ...
Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
The provision of prior information and the collection in writing of the free and informed consent of each member of the
Number
couple or of the surviving member of the couple, provided for in the last paragraph of article L. 2131-4 and in articles L. 2141-3, L. 2141-
4 and L. 2151-5, are carried out, in the case of a pre-implantation diagnosis, by the practitioner approved in application of article L.
2131-4-2 and, in other cases, by the intervening practitioner, in accordance with the fifth paragraph of article L. 2142-1,
in an establishment, laboratory or body authorized under the same article.
Search Information on the different categories of research likely to be carried out within the framework of the article
L. 2151-5 is issued. It is specified to the couple or the surviving member of the couple that the embryos having been the subject of a
research cannot be transferred for gestation and they are destroyed during the research. When he is
applies II of article L. 2141-4, the couple or the surviving member is also informed that, if necessary, the
cells derived from embryos can enter a cell therapy preparation for purposes
exclusively therapeutic.
The person responsible for the research must be able to justify at any time during the research of the collection of consents
mentioned in the first paragraph.
Article R2151-5 Read more about this article ...
Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
Embryos can only be handed over to the research manager mentioned in article R. 2151-8 only by the holder of
the authorization provided for in article L. 2151-7, by the practitioner approved in application of article L. 2131-4-2 or by the practitioner
intervening, in accordance with the fifth paragraph of article L. 2142-1, in an establishment, laboratory or organism
authorized under the same article. The research manager must produce the authorization of the research protocol.
research. The authorization holder or the practitioner gives him the document attesting to the collection of consents
mentioned in article R. 2151-4.
The delivery of embryonic stem cells to the research manager by the holder of the import authorization
provided for in article L. 2151-6 or for the storage authorization provided for in article L. 2151-7 is carried out on production of
documents mentioned in the previous paragraph. If the embryonic stem cells have been imported, the holder of
the authorization gives the research manager the documents attesting to their obtaining in compliance with the principles
mentioned in articles 16 to 16-8 of the civil code and the collection of consents mentioned in article R. 2151-13.
No information likely to allow the identification of the couple or of the surviving member of the couple at the origin of the
embryos being researched cannot be communicated to the research manager.
Article R2151-6 Learn more about this article ...
Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
The request for authorization of a research protocol on the embryo or on embryonic stem cells is
addressed to the director general of the biomedicine agency by registered post with request for acknowledgment of receipt or
deposited against receipt with the agency under the same conditions. This request is accompanied by a file
which includes all the elements allowing to verify that the legal conditions are met and whose form and
contents are set by decision of the agency's director general.
The Director General also sets the periods during which request files may be filed
authorization. The closing date for these periods runs the four-month period provided below for requests
accompanied by a complete file.
When the documents essential to the processing of the request are lacking, the advice of delivery fixes the period within which
these parts must be provided.
Within four months of the end of the period during which the complete file was submitted,
the director general of the biomedicine agency notifies the requesting establishment or body of the decision
authorization or refusal of authorization. At the end of this period, the absence of a decision by the Director General constitutes a decision
implied refusal of authorization.
The Director General's decision granting the search authorization mentions the name of the person responsible for
the research. This decision is published in the Official Journal of the French Republic.
The director general of the agency may request, by registered letter with request for acknowledgment of receipt, any
additional information, which he considers necessary for the processing of the authorization file. It indicates to the applicant the
deadline within which he must provide these elements. This request for additional information suspends the deadline mentioned in
fourth paragraph.
Article R2151-7 Learn more about this article ...
Amended by DECREE n ° 2015-155 of February 11, 2015 - art. 1
Any decision of the director general of authorization or refusal of research and the opinion of the orientation council are transmitted
simultaneously with the ministers responsible for health and research, who have one month to request
jointly a new examination of the authorization request file, in application of 1 ° and 2 ° of III of article L.
2151-5.
When a request for review of an authorized protocol is made by the ministers, the director general suspends
the authorization issued for a period of two months. The suspension decision is notified to the authorization holder.
At the end of the thirty-day period during which the agency proceeds to re-examine the request, the silence of
the administration is worth confirmation of the initial decision of the director general of the agency.
Article R2151-8 Learn more about this article ...
Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
Any research authorized under article L. 2151-5 is placed under the direction of a designated responsible person
by the request mentioned in article R. 2151-6.
The person responsible for the research sends an annual report to the director general of the biomedicine agency.
She sends him the final research report as soon as it is completed. These reports contain in particular the
information on the destination of the embryos and embryonic stem cells covered by the protocol.
The director general of the agency may at any time ask the person responsible for the research to report
account of the progress of works.
Article R2151-9 Read more about this article ...
Created by Decree n ° 2006-121 of February 6, 2006 - art. 1 JORF February 7, 2006
The establishment or organization that wishes to modify a substantial element of the protocol authorized under article L.
2151-5 must file a new authorization request file. The latter is instructed under the same conditions as
the initial request.
Article R2151-10 Learn more about this article ...
Created by Decree n ° 2006-121 of February 6, 2006 - art. 1 JORF February 7, 2006
In the event of violation of the laws or regulations or prescriptions fixed by the authorization, this
the latter can be suspended at any time for a maximum of three months by the agency's director general
of biomedicine, which informs the orientation council as soon as possible. The authorization can also be
withdrawn after advice from the orientation council. The Director General's decision is notified to the authorization holder and
communicated to ministers responsible for health and research.
Before any decision to suspend or withdraw an authorization, the authorization holder is given notice to terminate
failures or to submit observations within a time limit set by the Director General.
Article R2151-11 Learn more about this article ...
Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
I.-The establishments and organizations authorized under the first and third sections of this chapter maintain a
registry of embryos and embryonic stem cells they hold.
This register mentions:
1 ° The organization that supplied the embryos or embryonic stem cells and their identification code after
anonymization;
2 ° The title of the research protocol;
3 ° The name of the person responsible for research or conservation activity;
4 ° The number of embryos and embryonic stem cell lines being researched;
5 ° The number, designation and characteristics of the embryonic stem cell lines preserved or
obtained during research;
6 ° The results of analyzes concerning biological markers of infection;
7 ° The place (s) of research and conservation;
8 ° The destination of embryos and embryonic stem cells.
The person responsible for research or conservation is responsible for keeping this register. She ensures
the accuracy of the information which is recorded in this register as well as its conservation under conditions of
security to guarantee its integrity and confidentiality.
II.-The biomedicine agency maintains a national registry of embryos and embryonic stem cells, which includes
especially :
1 ° The authorization numbers and the names of the establishments or organizations authorized to carry out research or to
store embryos or embryonic stem cells;
2 ° For each authorization, the information mentioned in 2 ° to 5 ° and to 7 ° and 8 ° of I, with, for embryos and
embryonic stem cell lines under investigation, their identification code.
The person responsible for research or conservation on the occasion of the annual report provided for in article R. 2151-8
communicate to the director general of the biomedicine agency the information necessary for the latter to keep up to date
this national register.
The identification code assigned to each embryo, listed in the registers mentioned above, and to each line
stem cells derived from them, established and made anonymous according to the coding system defined by
decision of the director general of the agency, after opinion of the National Data Protection Commission.
The anonymization of this code has a reversible character in order, if necessary, to access data allowing to identify
the people at the origin of the embryo when a medical or health security purpose requires it.
Article R2151-12 Read more about this article ...
Amended by Decree No. 2012-467 of April 11, 2012 - art. 1
Any establishment or organization that researches embryos or stem cells
embryonic is required to keep for ten years from the end of this research the protocol provided for in article
L. 2151-5, the documents attesting to the collection of consents mentioned in articles R. 2151-4 and R. 2151-13 as well
than the final research report and the register mentioned in I of article R. 2151-11.
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