Key Benefits:
The Prime Minister,
On the report of the Minister of Health and Solidarity,
Given the Civil Code, and in particular articles 16 to 16-8;
Given the code of public health, and In particular Articles L. 2151-5 to L. 2151-8;
In view of the Customs Code;
Having regard to the law n ° 78-17 of 6 January 1978 relating to information technology, files and freedoms;
In view of Law No. 2000-321 of 12 April 2000 on the rights of Citizens in their relations with administrations;
Given the law n ° 2004-800 of 6 August 2004 on bioethics, in particular Article 37;
The Conseil d' Etat (social section) heard,
Décrète:
I. -Title V of Book I of Part II of the Public Health Code (Regulations) becomes Title VI.
II. -Title V of the book I of the second part of the same code reads as follows:
"TITLE V
" SEARCH ON EMBRYON
AND EMBRYONARY CELLULES
"Single Chapter
" Section 1
"Search Implementation
" Art. R. 2151-1. -In particular, there may be major therapeutic advances, within the meaning of Article L. 2151-5, research on the embryo and embryonic cells pursuing a therapeutic target for the treatment of diseases in particular Serious or incurable, and the treatment of diseases of the embryo or fetus.
" Art. R. 2151-2. -The Director General of the Biomedicine Agency may authorise a research protocol on the embryo or on embryonic cells, after consulting the guidance, for a fixed term not exceeding five years
In addition to Verification of the conditions laid down in Article L. 2151-5, the Biomedicine Agency ensures the feasibility of the protocol and the continuity of the body and the research team. It takes into account the titles, diplomas, experience and scientific work of the research supervisor and the team members. In addition, the Biomedicine Agency takes account of premises, equipment, equipment and processes and techniques implemented by the applicant. It shall evaluate the means and devices guaranteeing the safety, quality and traceability of embryos and embryonic
. Art. R. 2151-3. -I.-Only permission to search the embryo can be obtained:
" 1 ° Public health institutions and laboratories for the analysis of medical biology authorised to keep embryos under Article L. 2142-1, as well as establishments authorised to carry out biological diagnostics carried out from cells taken from the in vitro embryo under Article L. 2131-4;
" 2 ° The establishments and bodies which have concluded Convention with at least one of the institutions or laboratories mentioned in 1 °. This Convention provides for the conditions under which the establishment or laboratory mentioned in the 1 ° preserves and makes available embryos to the benefit of that institution or body. The availability of embryos is allowed only for the duration of the search.
" II. -Only permission can be obtained for research on stem cells:
" 1 ° The institutions and bodies pursuing research activity and holders of the authorisation for the conservation of stem cells Embryo for scientific purposes referred to in Article L. 2151-7;
" 2 ° Public and private institutions and bodies pursuing a research activity having concluded an agreement with an establishment or body mentioned in 1 ° In which the latter undertakes to provide and conserve embryonic stem cells for the conduct of the search for the first.
" Art. R. 2151-4. -I.-The consent of the couple, or the surviving member of a couple, provided for in Article L. 2151-5 shall be collected in accordance with one of the following:
" 1 ° When the couple has no parental project, the registered practitioner in application of the article L. 2142-1-1 may propose to the two members of the couple, or in the event of the death of one of them, to the surviving member of the couple, to consent to the preservation of the preserved embryos, having been informed of the possibilities of reception Of these embryos by another couple or stopping their conservation. They confirm their written consent to this practitioner after a three-month period of reflection.
" 2 ° After the biological diagnosis is carried out from cells taken from the in vitro embryo, if it is found that the Embryos are carrying the abnormality sought, the licensed practitioner pursuant to Article L. 2131-4-2 for the making of this diagnosis may propose to the two members of the couple or the surviving member of the couple consenting in writing to the Embryos are searched as long as they are no longer the object of a parental project.
" 3 ° Where the couple consents to the implementation of medical assistance for procreation with the registered practitioner under the article L. 2142-1-1 for the practice of in vitro fertilization, with or without micro-handling, it may be proposed, in accordance with article L. 2141-3, to consent at the same time in writing to that the embryos, which would not be susceptible To be transferred or preserved, be searched.
" II. -The head of research must be able to justify at any time during the course of the investigation that he has ascertained the existence of such consents referred to in I.
" Art. R. 2151-5. -Embryos may only be given to the research officer referred to in Article R. 2151-8 by registered practitioners in accordance with Article L. 2142-1-1 or Article L. 2131-4-2. This authority must produce the authorization of the research protocol. The approved practitioner shall deliver the document attesting to the collection of consents referred to in R. 2151-4.
" The delivery of embryonic cells to the head of research by the holder of the import authorization provided for in the article L. 2151-6 or the conservation authorisation provided for in Article L. 2151-7 shall be carried out on the production of the documents referred to in the preceding paragraph
No information likely to identify the surviving spouse or member of the Couple at the origin of the embryos being searched cannot be communicated to the research officer.
" Art. R. 2151-6. -The application for authorisation of a research protocol on the embryo or on embryonic cells shall be addressed to the Director General of the Biomedicine Agency under cover recommended with a request for notification of receipt or lodged against the receipt of the Of the Agency under the same conditions. This application shall be accompanied by a file, the form and content of which shall be determined by decision of the Director General of the
. The Director General shall also determine the periods during which application files may be filed Of authorization. The closing date for these periods shall run the following four-month period.
" Where the documents required for the processing of the application are lacking, the notice of receipt shall determine the period within which such documents must be Provided.
" Within four months from the closing date of the period in which the complete file has been filed, the Director General of the Biomedicine Agency shall notify the requesting institution or body of the Decision on authorization or refusal of authorization. At the end of this period, the absence of a decision of the Director General shall constitute an implied decision to refuse authorisation.
" The decision of the Director General granting the research authority shall refer to the name of the person responsible for the Research. This decision shall be published in the Official Journal of the French
. The Director General of the Agency may request, by registered letter with the request for a notice of receipt, any additional information, which it considers necessary for The authorization folder statement. It shall indicate to the applicant the time limit within which it must provide these elements. This request for further information shall suspend the period referred to in the fourth paragraph.
" Art. R. 2151-7. -The decision of the Director General and the advice of the guidance board shall be transmitted simultaneously to the ministers responsible for health and research, who shall have a period of one month for, if they consider it necessary:
" 1 ° Hold or Remove Authorisation in accordance with a contradictory procedure, pursuant to the fifth paragraph of Article L. 2151-5;
' 2 ° Request a new examination of the application for authorisation, pursuant to the sixth paragraph of Article L. 2151-5, In case of refusal by the biomedicine agency.
" Art. R. 2151-8. -Any research authorized under Article L. 2151-5 shall be under the direction of a responsible person designated by the application referred to in Article R. 2151-6.
" The person responsible for the research shall contact the Director General of The Biomedicine Agency an annual report. The final report of the research is sent to the Commission as soon as it is completed. These reports shall contain, in particular, information concerning the destination of embryos and embryonic cells which have been the subject of the Protocol, in particular their destruction
The Director General of the Agency may at any time Ask the person responsible for the search to report on the progress of the jobs.
" Art. R. 2151-9. -The institution or body which wishes to amend a substantial part of the protocol authorised under Article L. 2151-5 must file a new application for authorisation. The latter is instructed under the same conditions as the initial request.
" Art. R. 2151-10. -In the event of a breach of the laws or regulations or requirements laid down by the authorisation, the latter may be suspended at any time for a maximum period of three months by the Director General of the Agency of the Biomedicine, which informs the Governing Council as soon as possible. The authorisation may also be withdrawn after the advice of the guidance board. The decision of the Director General shall be notified to the holder of the authorisation and communicated to the Ministers responsible for health and research
Before any decision to suspend or withdraw authorisation, the holder of the authorisation shall be Put an end to its shortcomings or to submit its observations within a period specified by the Director General.
" Art. R. 2151-11. -I.-The institutions and bodies authorised under the first and third sections of this Chapter shall maintain a register of embryos and embryonic cells held by
. This registry mentions:
" 1 ° The body having Provided embryos or embryonic cells and their identification code after anonymization;
" 2 ° The search protocol label;
" 3 ° The name of the search or preservation activity manager;
" 4 ° Number Embryos and embryonic stem cell lines searched;
" 5 ° The number and designation of embryonic stem cell lines preserved or obtained during the research;
" 6 ° The results of Testing for biological markers of infection;
" 7 ° Search and preservation location (s);
" 8 ° The destination of embryos and embryonic cells: search, transfer or destruction.
" The Person Responsible for the research or conservation is responsible for the maintenance of this register. It shall ensure the accuracy of the information which is recorded in this register and its retention in security conditions to ensure its integrity and confidentiality
II. -The Biomedicine Agency maintains a national register of embryos and embryonic cells, which includes:
" 1 ° Authorisation numbers and names of establishments or bodies authorised to carry out research or to keep Embryonic stem cells;
" 2 ° The name of the search or retention manager;
" 3 ° The search protocol label;
" 4 ° The number of embryos and embryonic cell lines subject to a Search and their identification code;
" 5 ° The number and designation of embryonic stem cell lines preserved or obtained in the course of research;
6 ° Results of analyses for biological markers Infection;
" 7 ° Search and preservation location (s);
" 8 ° The destination of embryos and embryonic cells: search, transfer or destruction.
" The person who is responsible for the research or conservation The annual report provided for in Article R. 2151-8 shall communicate to the Director General of the Biomedicine Agency the necessary information to keep this national register up to date.
" The identification code assigned to each The embryo, listed in the registers referred to above, and each line of embryonic cells derived from it, shall be established and made anonymous according to the system of encoding defined by decision of the Director General of the Agency, after notice of the National Computer and Liberties Commission.
" The anonymization of this code has a reversible character in order, where appropriate, to access the data identifying the persons who have the origin of the embryo when a medical purpose or Health security requires it.
" Art. R. 2151-12. -Any establishment or body which carries out research on embryos or embryonic cells shall be required to retain for ten years from the end of that search the protocol provided for in Article L. 2151-5, the document certifying that Compliance with the conditions set out in R. 2151-4 and the final search report and the registry referred to in I of R. 2151-11.
"Section 2
" Importing and exporting embryonic or foetal
tissues or cells for search purposes
" Art. R. 2151-13. -Embryonic or fetal tissue or cells as defined in this section:
" -embryonic or fetal tissue or cells collected or collected after termination of pregnancy;
" -embryonic stem cells removed In vitro human embryos that have been designed for reproductive health care and are no longer the object of a parental project.
" Any organism that imports or exports embryonic or foetal tissue or cells Referred to in this Article must be able to justify that they have been obtained in accordance with the principles laid down in Articles 16 to 16-8 of the Civil Code, with the prior consent of the woman having suffered a termination of pregnancy or In the case of reproductive medical assistance, and without any payment, whatever the form, was allocated to them.
" Art. R. 2151-14. -Only authorization to import or export for research purposes of embryonic or fetal tissue or cells, agencies:
" 1 Incumbents of authorization to conduct embryo and cell research Embryo under Article L. 2151-5;
" 2 Incumbents of the authorisation to preserve embryonic stem cells provided for in Article L. 2151-7;
" 3 ° Having filed a research protocol concerning tissues or cells Embryo or foetal collected or collected after termination of pregnancy under Article L. 1241-5.
" Art. R. 2151-15. -The Director General of the Biomedicine Agency authorizes the import and export of embryonic or foetal tissue and cells for research purposes, after advice of the guidance board. This authorization is valid for the duration of a year.
" This authorisation shall be issued for each operation envisaged and shall contain the information referred to in Article R. 2151-16.
" The provisions of R. 2151-6, R. 2151-9, R. 2151-10 and R. 2151-12 apply to the authorizations provided for in this section.
" Art. R. 2151-16. -Any import or export operation for research purposes, excluding transit and borrowing of the customs territory on the occasion of a transfer between two other Member States of the European Community, tissues or cells Embryo or foetal defined in Article R. 2151-13 is subject to the outer packaging of the following information:
" 1 ° "Embryonic or fetal tissue or cells;
" 2 ° Designation of Tissue Or cells concerned;
" 3 ° The use to which these tissues or cells are intended;
" 4 ° For the importation, the name and address of the foreign supplier, the organization authorized to import and the recipient;
" 5 ° For Export the name and address of the authorized organization to be exported and the recipient.
" Art. R. 2151-17. -Any incident occurring during the transport of tissues and embryonic or foetal cells shall be the subject of a declaration to the Director General of the Biomedicine Agency by the holder of the import authorisation or Export.
" In the event of an incident likely to affect health safety, the Director-General of the Biomedicine Agency shall immediately inform the Director General of the French Health Products Safety Agency and the Minister responsible for health.
"Section 3
" Keeping embryonic stem cells
for scientific purposes
" Art. R. 2151-18. -Any body that retains embryonic stem cells for scientific purposes must be able to justify that they have been obtained in accordance with the fundamental principles laid down in Articles 16 to 16-8 of the Civil Code and with the Prior consent of the parent couple and without any payment, whatever their form, has been allocated to them. It must be able to justify that it has done so.
" Art. R. 2151-19. -The Director-General of the Biomedicine Agency authores the conservation of embryonic stem cells, after the opinion of the Guidance Council, for a fixed term, which may not exceed five years. The authorization refers to the name of the person responsible for the conservation activity.
" Prior to the decision of the Director General, the Biomedicine Agency evaluates the conditions for implementing conservation.
" To this Effect, the Agency checks in particular that the conditions of supply, the preservation of embryonic stem cells have sufficient guarantees to ensure compliance with the provisions of Title I of Book II of the first part of the Code, the rules in force for the safety of persons engaged in professional activity on the site, and applicable provisions on environmental protection.
" The Agency ensures the competence of the team In charge of conservation. It takes into account the titles, diplomas, experience and scientific work of the team members. In addition, the Biomedicine Agency takes account of premises, equipment, equipment and processes and techniques implemented by the applicant. It assesses the means and mechanisms implemented to ensure the safety, quality and traceability of embryonic stem
. Where the applicant organisation for a conservation authorisation simultaneously operates on the same site Of the activities provided for in Articles L. 1243-2 and L. 1243-5, the Director General shall verify that the body has provided for procedures to ensure that the risk of contamination is
. Art. R. 2151-20. -The provisions of R. 2151-6 and R. 2151-8 to R. 2151-12 apply to the authorizations provided for in this section.
" Art. R. 2151-21. -When withdrawing an authorisation for the conservation of embryonic stem cells, the Director General of the Biomedicine Agency organises the transfer of these cells to another body authorised to keep them.
" In case of failure Liable to affect health safety, the Director General of the Biomedicine Agency shall immediately inform the Director General of the French Health Products Safety Agency. "
Authorisations granted under Decree No. 2004-1024 of 28 September 2004 on the import for the purpose of research of embryonic stem cells, research protocols and the conservation of These cells and applying the provisions of Article 37 of the Law n ° 2004-800 of 6 August 2004 on bioethics are maintained until their expiry. As from the date of publication of this Order, these authorities are governed by the provisions of this Order, except those of sections R. 2151-2, R. 2151-6, R. 2151-7 and R. 2151-19 of the Public Health Code.
Decree n ° 2004-1024 of 28 September 2004 on the import for the purpose of research into embryonic stem cells, the research protocols and the conservation of these cells and applying The provisions of article 37 of Law No. 2004-800 of 6 August 2004 on bioethics are repealed.
However:
-applications for an educational authorization, as of the date of publication of this Decree, by the " Ad hoc committee " Expected by Section 37 of Act No. 2004-800 of 6 August 2004 on bioethics is the subject of a decision by the Ministers responsible for health and research under the conditions laid down in this article and by Decree No. 2004-1024 of 28 September 2004. Taken for application;
-applications filed in front of " Ad hoc committee " And not yet heard on the date of publication of this Order are forwarded to the Biomedicine Agency for hearing and decision According to the rules laid down by this Decree.
The Minister of National Education, Higher Education and Research, the Minister of Health and Solidarity, and the Minister for Higher Education and Research are responsible, Each in respect of the execution of this Decree, which shall be published in the Official Journal of the French Republic.
Done at Paris, February 6, 2006.
Dominique de Villepin
By the Prime Minister:
The Minister of Health and Solidarities,
Xavier Bertrand
The Minister of National Education,
of higher education
and search,
Gilles de Robien
Delegate Minister
to higher education
and search,
François Goulard
