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Decision No. 2013-674 Dc August 1, 2013

Original Language Title: Décision n° 2013-674 DC du 1er août 2013

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Folders Laws




JORF No. 0182 of August 7 2013 page 13450
text n ° 2



Decision No. 2013-674 DC of August 1, 2013

NOR: CSCL1320657S ELI: Not available



(ACT TO AMEND ACT No. 2011-814 OF 7 JULY 2011 ON BIOETHICS UNDER CERTAIN CONDITIONS THE SEARCH ON EMBRYON AND CELLULES EMBRYONNAIRES)
The Constitutional Council has been seized, under the conditions laid down in the second paragraph of Article 61 of the Constitution, of the Law tending to change the Href=" /viewTexte.do?cidTexte=JORFTEXT000024323102 &categorieLink = cid"> Law n ° 2011-814 of 7 July 2011 on bioethics by allowing research into embryos and embryonic stem cells under certain conditions, on 18 July 2013, by MM. Christian JACOB, Elie ABOUD, Yves ALBARELLO, Julien AUBERT, Olivier AUDIBERT-TROIN, Jean-Pierre BARBIER, Etienne BLANC, Mme Valérie BOYER, MM. Xavier BRETON, Olivier CARRÉ, Yves CENSI, Jérôme CHARTIER, Guillaume CHEVROLLIER, Dino CINIERI, François CORNUT-GENTILLE, Edouard COURTIAL, Mme Marie-Christine DALLOZ, MM. Gérald DARMANIN, Bernard DEFLESSELLES, Patrick DEVEDJIAN, Nicolas DHUICQ, Mrs Sophie DION, MM. Jean-Pierre DOOR, David DOUILLET, Mrs Marianne DUBOIS, Virginie DUBY-MULLER, MM. Christian ESTROSI, Daniel FASQUELLE, Marie-Louise FORT, MM. Yves FOULON, Yves FROMION, Sauveur GANDOLFI-SCHEIT, Hervé GAYMARD, Mrs Annie GENEVARD, MM. Guy GEOFFROY, Bernard GÉRARD, Daniel GIBBES, Philippe GOSSELIN, Mme Claude GREFF, Anne GROMMERCH, MM. Jean-Jacques GUILLET, Christophe GUILLOTEAU, Patrick HETZEL, Sébastien HUYGHE, Mme Laure de LA RAUDIÈRE, M. Alain LEBOEUF, Mme Isabelle LE CALLENNEC, MM. Marc LE FUR, Dominique LE MÈNER, Jean LEONETTI, Pierre LEQUILLER, Mme Véronique LOUWAGIE, MM. Hervé MARITON, Alain MARTY, François de MAZIÈRES, Damien MESLOT, Philippe MEUNIER, Pierre MORANGE, Yannick MOREAU, Pierre MOREL-A-L ' HUISSIER, Jacques MYARD, Mme Dominique NACHURY, MM. Yves NICOLIN, Bernard PERRUT, Jean-Frédéric POISSON, Mme Josette PONS, MM. Didier QUENTIN, Frédéric REISS, Mme Sophie ROHFRITSCH, MM. Thierry SOLÈRE, Claude STURNI, Lionel TARDY, Jean-Charles TAUGOURDEAU, Jean-Marie TETART, Patrice VERCHÈRE, Philippe VITEL, Eric WOERTH, Mrs Marie-Jo ZIMMERMANN and Véronique BESSE, MEPs.
The Constitutional Council,
Given the Constitution ;
SeenOrder No. 58-1067 of 7 November 1958 amending the Organic Law on the Constitutional Council;
Seen Law n ° 2011-814 of July 7 2011 on bioethics;
Given the public health code ;
Seen civil code ;
Given the Government's observations, registered on July 24, 2013;
The reporter was heard;
1. Considering that the requesting members of the House of Commons defected to the Constitutional Council the law to amend the Law n ° 2011-814 of 7 July 2011 on bioethics by authorizing Under certain conditions research on the embryo and embryonic stem cells; that they question the procedure for the adoption of the law and the conformity with the Constitution of its single article;
On procedure:
2. Considering that, according to the applicants, the use of a proposed law resulted in the evading of the application of the Href=" /viewCodeArticle.do?cidTexte=LEGITEXT000006072665&idArticle=LEGIARTI000024324591&dateTexte= &categorieLink = cid"> article L. 1412-1-1 of the public health code that provides: " Any reform project on ethical issues and societal issues raised by the advancement of knowledge in the fields of biology, medicine and health must be preceded by a public debate in the form of general statements. These are organised on the initiative of the National Advisory Committee on Ethics for Life and Health, after consultation with the relevant permanent parliamentary committees and the Parliamentary Choice Evaluation Office Scientists and technology.
" Following the public debate, the Committee shall draw up a report before the Parliamentary Office for the Evaluation of Scientific and Technological Choices, which shall evaluate
. In the absence of a draft reform, the Committee shall be required to organize general statements of bioethics at least once every five years " ;
3. Considering that, on the one hand, the aforementioned provisions ofArticle L. 1412-1-1 of the Public Health Code, applicable to Bills, have legislative value; and, on the other hand, under the first paragraph of Article 39 of the Constitution: The legislative initiative is in conjunction with the Prime Minister and members of Parliament " ; that no constitutional or organic rule interfered with the filing and adoption of the bill referred to in the law referred to; that, as a result, the grievance alleging that the use of a bill and the absence of The provisions of Article L. 1412-1-1 mentioned above would constitute a " Procedure misappropriation " Must in any case be rejected; that the law referred to was adopted in accordance with a procedure consistent with the Constitution;
On the merits:
4. Considering that the terms of Article L. 2151-5 of the Public Health, in its drafting as a result of the single article Of the law referred to: I.-No research on the human embryo nor on embryonic stem cells can be undertaken without authorisation. A research protocol conducted on a human embryo or on embryonic stem cells derived from a human embryo can only be authorised if:
" 1 ° Scientific relevance of the research is established;
" 2 ° Research, fundamental or applied, is part of a medical purpose;
" 3 ° In the state of scientific knowledge, this research cannot be carried out without the use of these embryos or embryonic stem cells;
" 4 ° The project and the conditions for the implementation of the protocol respect the ethical principles relating to embryo research and embryonic stem
. II. -Research can only be carried out from embryos conceived in vitro in the context of medical assistance for reproduction and which are no longer the subject of a parental project. The research may be carried out only with the prior written consent of the couple whose embryos are derived, or of the surviving member of that couple, otherwise duly informed of the possibilities for the reception of embryos by another couple or of a judgment Their conservation. With the exception of the situations referred to in the last paragraph of Article L. 2131-4 and the third paragraph of Article L. 2141-3, consent must be confirmed following a three-month period of reflection. The consent of the two members of the couple or surviving member of the couple is revocable without reason as long as the search has not started.
" III. -Research protocols shall be authorised by the Biomedicine Agency after verification that the conditions laid down in the I of this Article are satisfied. The decision of the Agency, together with the advice of the guidance, shall be communicated to the Ministers responsible for health and research who may, within a period of one month and jointly, request a new examination of the file which has served as a Basis for decision:
" 1 ° In case of doubt on the respect of ethical principles or the scientific relevance of an authorised protocol. The Agency shall carry out this new examination within thirty days. If the decision is confirmed, validation of the protocol is deemed acquired;
" 2. In the interest of public health or scientific research, when the protocol was refused. The Agency shall carry out this new examination within thirty days. In the event of confirmation of the decision, the refusal of the protocol shall be deemed acquired;
" In the event of a breach of the legislative and regulatory requirements or those laid down by the authorisation, the Agency shall suspend the authorisation of the research or withdraw it. The Agency shall conduct inspections comprising one or more experts who have no connection with the research team, under the conditions laid down in Article L. 1418-2.
" IV. -Embryos on which research has been conducted cannot be transferred for the purpose of gestation " ;
5. Considering that the applicants submit that the authorisation of research on the human embryo and embryonic stem cells infrings the principle of safeguarding the dignity of the human person in that it disregards both Principle of respect for the human being from the very beginning of his life, the principle of the integrity of the human species, the principle of inviolability, as well as the principle of non-patrimoniality of the human body; that they argue that the infringement of these principles Results in particular from the imprecision and unintelligibility of the provisions Disputed;
6. Considering that, according to the applicants, the conditions listed in paragraph 1 of Article L. 2151-5 of the Health Code To research on the embryo is imprecise; in particular, the third condition would be unintelligible; that the fourth condition would refer to ethical principles that are not defined and that the Parliament would thus have disregarded the scope of its jurisdiction;
7. Considering that the applicants also submit that by providing for a new examination within thirty days' In case of doubt on the respect of ethical principles or the scientific relevance of an authorised protocol ", or In the interest of public health or scientific research, where the protocol has been refused ", III of the Article L. 2151-5 of the Public Health Code does not define precisely the conditions of this new examination; that the legislature thus disregarded the scope of its jurisdiction; that the absence of guarantees of adversarial examination and of procedure Would also be a breach of the guarantee of rights In Article 16 of the 1789 Declaration of Human and Citizen Rights;
With regard to the complaints alleging negative incompetence and lack of awareness of the objective of the constitutional value of accessibility and Intelligibility of the law:
8. Considering that it is for the legislator to exercise fully the competence entrusted to it by the Constitution and, in particular, Article 34; that the full exercise of that competence, as well as the objective of constitutional value of accessibility and Intelligibility of the law, which derives from Articles 4, 5, 6 and 16 of the 1789 Declaration, requires it to adopt sufficiently precise provisions and unambiguous formulae;
As for section I of article L. 2151-5 of the public health code :
9. Considering, on the one hand, that the legislation before the law referred to provides that research on the human embryo and embryonic stem cells may be authorised where " Research is likely to lead to major medical progress " And it " Is expressly established that it is impossible to achieve the desired result through research that does not use human embryos, embryonic stem cells or stem cell lines " ; that the contested provisions replace these two conditions by allowing the authorisation of the research " Fundamental or applied " Which " Is part of a medical purpose ", where," In the state of scientific knowledge, this research cannot be carried out without the use of these embryos or these embryonic stem cells " ;
10. Considering that by requiring that the project and the conditions for the implementation of the Protocol respect the Ethical principles relating to embryo research and embryonic stem cells ", the legislator has heard reference to the principles laid down in particular at articles L. 2151-1 et seq. Of the code of public health, relating to the design and preservation of fertilized embryos in In vitro and the principles established in particular at articles 16 and following of the Civil Code and L. 1211-1 and following of the Public Health Code, relating to respect for the human body;
11. Considering that the conditions listed in paragraph I of Article L. 2151-5 of the Public Health Code, which are not Unclear or equivocal, are not contrary to the objective of the constitutional value of accessibility and intelligibility of the law;
12. Taking the view, on the other hand, that by making the grant of any research authorisation on the human embryo or the embryonic cells derived from a human embryo conditional on compliance with these conditions, the legislator did not give authority to an authority Administrative care to establish rules that are in the field of the law; that it has not disregarded the extent of its jurisdiction;
As to Article L. 2151-5 of the Health Code Public :
13. Considering that the provisions of paragraph III of Article L. 2151-5 of the Public Health Code allow ministers For health and research to jointly request, within one month following the decision of the Biomedicine Agency on an application for authorisation of a research protocol, a new examination of the file which has served as the basis for The decision; that the provisions of 1 ° and 2 ° of the In respect of any request for review, whether pursuant to an authorisation or refusal, the Biomedicine Agency must once again ensure that all the conditions laid down in the 1 ° to 4 ° of paragraph I are fulfilled; that the Agency Biomedicine has a period of thirty days from the request for review; that, as a result, the legislator has defined precisely the possibility of a review of the research protocols by the Biomedicine Agency and the conditions of this Review and did not disregard the extent of its jurisdiction;
With respect to the grievance Infringement of the principle of safeguarding the dignity of the human person:
14. Considering that the Preamble to the 1946 Constitution reaffirmed and proclaimed constitutional rights, freedoms and principles, pointing out at the outset that: In the aftermath of the victory of the free peoples on the regimes which attempted to enslaved and degrade the human person, the French people once again proclaim that every human being, without distinction as to race, religion or belief, Has inalienable and sacred rights " ; that the preservation of the dignity of the human person against any form of enslavement and degradation is a principle of constitutional value;
15. Considering that, under the terms of the tenth preambular paragraph of the Constitution of 1946: The Nation shall provide the individual and the family with the necessary conditions for their development " And under its eleventh preambular paragraph: " It guarantees to all, including the child, the mother ..., the protection of health " ;
16. Considering that the contested provisions provide that no research on the human embryo or embryonic stem cells can be undertaken without authorisation; that they submit to the conditions listed in Section I of Article L. 2151-5 of the Public Health Code any research protocol conducted on a human embryo or on Embryonic stem cells derived from a human embryo; Establish the rule that research can only be authorized if it is part of a " Medical purpose " ; that they lay down the principle that research is carried out only from embryos conceived in vitro in the context of medical assistance for procreation and which are no longer the subject of a parental project; that they also provide for Principle according to which the research is subject to the prior written consent of the couple whose embryos are derived or of the surviving member of that couple, and the principle that the embryos on which a search has been conducted do not May be transferred for pregnancy; set conditions Authorisation of research protocols by the Biomedicine Agency and the possibility for health and research ministers to request a new examination of the file; that, contrary to the applicants' support, the Paragraph III does not establish an implied search authorization procedure;
17. Considering that it follows from the above that, if the legislator has amended some of the conditions allowing the authorisation of research on the human embryo and on embryonic stem cells for medical purposes only, in order to promote This research and the securing of the authorisations granted, it has surrounded the grant of these authorisations for the search for effective guarantees; that these provisions do not disregard the principle of safeguarding the dignity of the human person ;
18. Taking into account, finally, that, contrary to the applicants' support, the administrative procedure for the review of the file used as the basis for the decision of the Biomedicine Agency does not infringe the right to an appeal And the adversarial principle arising from Article 16 of the 1789 Declaration;
19. Considering that it follows from all the foregoing that the law referred to, which does not disregard any other constitutional requirement, must be declared in conformity with the Constitution,
Decides:

Item 1 More about this Article ...


The law to modify Law n ° 2011-814 of 7 July 2011 relating to Bioethics by allowing research into embryos and embryonic stem cells under certain conditions is in conformity with the Constitution.

Article 2


This decision will be published in the Official Journal of the French Republic.
Issued by the Constitutional Council at its meeting on 1 August 2013, attended by: Mr Jean-Louis DEBRÉ, President, Mr Jacques BARROT, Mrs Claire BAZY MALAURIA, Nicole BELLOUBET, MM. Guy CANIVET, Michel CHARASSE, Renaud DENOIX de SAINT MARC, Valéry GISCARD d' ESTAING, Hubert HAENEL and Nicole MAESTRACCI.


The President,

Jean-Louis Debré


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