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The Constitutional Council was seized by more than sixty deputies of an appeal against the law to amend the law Act No. 2011-814 of 7 July 2011 on bioethics by authorizing under certain conditions research on embryo and embryonic stem cells.
He drew the following comments from the Government.
I. ― The deferred law includes a single article that amends theArticle L. 2151-5 of the Public Health Code, introduced by Act No. 2004-800 of 6 August 2004 on bioethics (art. 25) on the constitutionality of which the Constitutional Council ruled (v. 29 July 2004, decision No. 2004-498 DC). Prior to the intervention of this text, the Act of 29 July 1994 prohibited "embryon experiments" but allowed, "on an exceptional basis", "studies" which did not affect him.
Section L. 2151-5 was amended by Act No. 2011-814 of 7 July 2011 (art. 41)which substituted a permanent waiver regime for the previous temporary arrangement (derogations had been opened in 2004 for a period limited to five years).
It currently provides that "research on human embryo, embryonic stem cells and stem cell lines is prohibited" (I) but that "by derogation (...)" (II) and by attempting to promote "alternative research to human embryo-compliant and ethical-compliant research", "research is allowed if the following conditions are met: 1° The scientific relevance of the research project is established; 2° Research is likely to allow major medical progress; 3° It is expressly established that it is impossible to achieve the expected result through research not using human embryos, embryonic stem cells or stem cell lines; 4° The research project and the conditions for the implementation of the protocol respect the ethical principles relating to embryo and embryonic stem cells research." The research takes place on the authorization of the Agency of Biomedicine (IV), after the consent of the couple from which the embryos are derived and only from embryos designed in vitro as part of medical reproductive assistance and which are no longer the subject of a parental project (III).
The new device lifts the ban on I and states that "no research on human embryo or embryonic stem cells can be undertaken without authorization." It retains four cumulative conditions of authorization for "a research protocol leads to a human embryo or embryonic stem cells from a human embryo". If two conditions are maintained in the state ("the scientific relevance of the research is established", 1°, and "the project and the conditions for the implementation of the protocol respect the ethical principles relating to the research on embryo and embryonic stem cells", 4°, the other two are modified. Rather than permit "major medical progress", research, "basic or applied", must respond to a "medical purpose" (2°) and be "in the state of scientific knowledge (...) without resorting to these embryos or embryonic stem cells" (3°) ―at present, it must be "especially established that it is impossible to achieve the desired result through a research not using human embryos,
II. ― Members of Parliament who make the appeal first highlight the obligation toArticle L. 1412-1-1 of the Public Health Code, from theArticle 46 of Act No. 2011-814 of 7 July 2011to precede any reform project on ethical issues of public debate in the form of general states. However, this provision has only a legislative value and does not derive from a principle or from a constitutional requirement.
III. ― The authors of the appeal then argue that the device infringes on the principle that research on the embryo can only have an exceptional character, the "general principle of protection of prenatal human life, a component of the protection of human life" and the principle of safeguarding the dignity of the human person against any form of enslavement and degradation.
1. If the authors of the appeal argue that various legislative provisions authorizing "conventions to the conceived child" bear "the mark of their derogatory character," they do not, however, refer to any provision or requirement of a constitutional nature.
2. With regard to the principle of protection of life from fertilization or "protection of prenatal human life", it was not recognized by the Constitutional Council.
The decision of January 15, 1975 (No. 74-54 DC, Law on the Voluntary Interruption of Pregnancy, p. 19, cons. 1) refers to the principle of "respect for the human being from the beginning of life" only by citation of section 1 of the referred law (currently section L. 2211-1 of the Public Health Code) which takes up the decision of theArticle 16 of the Civil Code "The law ensures the primacy of the person, prohibits any violation of the dignity of the person and guarantees respect for the human being from the beginning of his life." This is not a constitutional recognition.
The Council later found that, not possessing a power of appreciation and decision identical to that of Parliament, it was not up to the Council to "promote, in view of the existence of knowledge and techniques, the provisions made by the legislator" in 1994 "not ensure the conservation, in all circumstances, and for an indefinite period, of all embryos already formed." He took note of the fact that the legislator had "deemed that the principle of respect for every human being from the beginning of his life was not applicable to them" and found in accordance with the Constitution the provisions concerning the fate of the supernumerary embryos, which can be destroyed in the event of absence of any parental project (27 July 1994, decision No. 94-343/344 DC, cons. 9 and 10, rec. p. 100, law relating to the respect of the human body and
The Constitutional Council was also seized, on the occasion of the contestation of a law relating to the voluntary interruption of pregnancy and contraception (27 June 2001, Decision No. 2001-446 DC) of the question of whether a possible "right to life of the human person" could be applied, in particular, to deduce "natural and imprescriptible rights of Man" mentioned in Article 2 of the Constitutional Council. The decision does not contain any recognition that an embryo or fetus would be regarded as a human person with a right protected by the Constitution.
3. However, the Constitutional Judge considers that the principle of dignity of the human person against any form of enslavement and degradation, which he recognized by the decision of 27 July 1994 (cons. 2) on the basis of the Preamble to the 1946 Constitution, is applicable to the provisions relating to the embryo (cons. 18 of that decision) or to the fetus (cons. 5 of Decision No. 2001-446 DC).
Only the principle of dignity is constitutional. The principles laid down by the legislator in the Bioethics Act in 1994 – to which the authors of the appeal refer – of the primacy of the human person, of respect for the human being from the beginning of his life, of inviolability, integrity and absence of a heritage character of the human body tend to ensure respect for the principle of dignity without, however, in themselves, constitutional requirements. Therefore, the only question is whether the law referred to provides guarantees to reconcile the constitutional requirement of respect for the dignity of the human person with the objectives pursued, including the interest of research.
That is the case.
Any research on human embryo or embryonic stem cells is subject to authorization from the Biomedicine Agency. It must respect, as stated, four sets of criteria. These are of a scientific order ("scientific relevance", the "medical purpose" of the research and the impossibility of driving it without using embryos or embryonic stem cells) and ethical ― the 4th of the I of Article L. 2151-5 reiterates the current requirement that "the project and the conditions for the implementation of the protocol respect the ethical principles relating to the research on embryo and embryo cells". This condition was set out in 2011 in relation to the subject being treated, since it was originally referred in 2004 to the "conditions for implementation under ethical principles".
In stipulating this condition, the legislator, in 2004, heard referring to the general principles relating to the donation and use of human body elements and products, introduced in 1994 by the first bioethics laws and confirmed in 2004 and 2011. These are the provisions of Chapter II of Title I of Book I of the Civil Code, including the prohibition of any heritage rights (art. 16-1) or the prohibition of harm to the integrity of the human species (art. 16-4) , as well as the provisions of the Public Health CodeGenerally attached to articles L. 1211-1 and s. and, specifically for research on embryo and embryo stem cells, to articles L. 2151-1 to L. 2151-4 (prohibition of cloning for therapeutic or research purposes, the creation of transgenic or chimeric embryos, as well as the design of embryos or their use for industrial purposes).
In addition, under Article L. 2151-5 II, research can only be conducted from embryos designed in vitro in the context of medical reproductive assistance and that are no longer the subject of a parental project. And it is legally possible to design embryos in vitro only as part of a procedure of medical assistance to procreation (art. L. 2141-3, para. 1). In vitro design and cloning of human embryos for research purposes, or for industrial or commercial purposes, are expressly prohibited (arts. L. 2151-2 and L. 2151-3). Criminally sanctioned both the use of a procedure for medical assistance in procreation for purposes other than those authorized by law (art. 511-24 of the Criminal Code, which provides for a sentence of five years imprisonment and 75,000 euros fine) that in vitro design or cloning of embryos for research or industrial or commercial purposes (art. 511-17 and 511-18 Criminal Code, which provides seven years of imprisonment and 100,000 euros of fine).
Thus, research on embryo or embryonic stem cells can only be conducted on the condition that embryos were not designed for research but for a parental project, that the couple gave their express and informed consent and that they are cumulatively respected with strict conditions of authorization. The law thus ensures, on the one hand, that the breach of the embryo, which is a potential human life and not a mere research material, is justified by major reasons for the protection of health and that, on the other hand, the use of human embryos for research purposes is subsidiary to other possibilities.
In these circumstances, the principles invoked by the authors of the appeal have not been ignored.
IV. ― In the third place, the law is grieved to lay unclear or intelligible criteria whose flexibility would be to create a "general authorization regime" with no warranty.
1. However, the criteria of a scientific nature are clear and unambiguous — whether it is the "scientific relevance of research", a criterion that exists since the 2004 law and is commonly used in research, or the "medical purpose", which excludes any research conducted in a commercial setting or for a foreign purpose in medicine. As to the reference to "ethical principles relating to embryo and embryonic stem cell research", it must be considered, as stated in the III, as referring to the general principles relating to the donation and use of the human body elements and products derived from the 1994 Act and which are currently contained in the 1994 Act. Civil code and Public Health Code.
2. The amendments to two of the criteria (at 2° and 3° of I) are consistent with the desire to remove certain ambiguities of the current provisions.
On the one hand, if it is now planned not that the research should allow "major medical progress" but that it must register "in a medical purpose", it is because the major or not character of the expected progress is in fact not a relevant criterion: the research can be fundamental and have a cognitive purpose, while the notion of progress anticipates the result of the research.
On the other hand, the criterion that it must be established that it is impossible to use an alternative method to research on embryos or embryonic stem cells is a source of application difficulties. It can be interpreted as leading the applicant team to carry out comparative research even before it has been authorized to begin ― whereas the current knowledge of all types of stem cells (adults, induced pluripotents or embryonics) does not allow to exclude either of the research field or even of the same research project. However, if article L. 2151-5, 3rd of I, intends to lift the opposition that can be made between the different pathways of research on stem cells, it remains that the project must incorporate the question of the relevance of conducting research on embryonic stem cells rather than on other types of cells.
3. These amendments are not such as the authors of the appeal, that the guarantees have declined and that the authorisation procedure is trivialized and assimilable to that of other types of research.
On the contrary, several elements bear the mark of the particular requirement of the device.
The regulations provide for the control of the feasibility of the protocol and the sustainability of the organization and the research team, titles, diplomas, experiments and scientific work of the research manager and team members, premises, materials, equipment, processes and techniques implemented by the applicant and finally of the means and devices guaranteeing the safety, quality and traceability of embryos and stem cells. It should be emphasized that it is not the researchers who present the files that consider the respect for these criteria and the scientific relevance of the research they present. The assessment goes to the College of Experts of the Agency of Biomedicine and then to the agency's guidance board (composed for a large part of non-scientific personalities), the decision being finally taken by the director of the agency.
In addition, when applying for authorization is filed, specific commitments are required. In particular, the positioning of the research in relation to the state of scientific knowledge, its originality and its added value, the program in which the research protocol is inscribed ―with, where appropriate, the national or international cooperation envisaged ―, the methodology and techniques envisaged (including the number and characteristics of embryos or lines used) as well as the objectives set, expected results and timelines.
Finally, at the end of the authorization, both the stem cells or the lines used as well as the material to which it was used must be destroyed, except for special conservation authorization.
Therefore, grievances relating to the intelligibility or imprecision of the law will be dismissed.
V. ― Fourth, the authors of the appeal consider that the powers conferred on the Agency of Biomedicine in paragraph III of Article L. 2125-5 and their articulation with those recognized to ministers responsible for health and research are not sufficiently precise and that the process of suspension or withdrawal of a search protocol authorization by the agency infringes on the guarantee of rights under Article 16 of the Declaration of 1789.
1. Under the provisions of the III, which do not differ from those introduced in the IV of Article L. 2151-5 by the legislator of 2004 or 2011 (see above), the Biomedicine Agency can only authorize a research protocol if all four conditions laid down in I are met cumulatively. The authorization procedure and powers conferred on the Agency for Biomedicine are specified by decrees of 6 February 2006 and 11 April 2012.
It is anticipated that the Ministers responsible for health and research may, within one month and jointly, request a further review of the file that served as the basis for the decision. If the protocol has been refused, their intervention can only be based on "the interest of public health or scientific research" (2°), thus leaving the appreciation of ethical criteria to the Biomedicine Agency. If the protocol has been authorized, Ministers may request a further review if one of the conditions laid down in I does not appear to be satisfied. The reference to "respect for ethical principles" or "the scientific relevance of an authorized protocol" (1°) must be considered as referring to both ethical and scientific criteria (i.e., the four criteria of the I), unlike the other situation. The notion of "scientific relevance" used at the 1st of the III has a wider scope than at the 1st of the I.
2. As for the last paragraph of the III, which authorizes the Biomedicine Agency to suspend or withdraw the authorization, i.e., to put an end to it for the future, it is an existing system, which is only a reminder of the principles applicable under the common law regime of authorizations. The procedure initiated in this case by the agency complies with the requirements of the conflict. It is intended to apply section R. 2151-10, which states that "before any decision to suspend or withdraw authorization, the holder of the authorization is still required to terminate his or her failures or to present his or her observations within a period specified by the Director General". Thus, and as long as there is no right to maintain the authorization, the requirements of Article 16 of the Declaration are not unclear.
This other series of grievances will therefore also be rejected.
VI. ― Finally and even if the latter grievance is inoperative, the Oviedo Convention of April 4, 1997 has not at all been unrecognized. Article 18 of this Convention for the Protection of Human Rights and Human Dignity in the Application of Biology and Medicine, ratified by France on 13 December 2011 and entered into force on 1 April 2012, provides that "1. When research on in vitro embryos is permitted by law, it ensures adequate protection of the embryo" and "2. The constitution of human embryos for research purposes is prohibited." These two stipulations are respected as, as previously demonstrated in the preceding points, embryo research is limited to embryos created in vitro as part of medical reproductive assistance and is subject to strict supervision.
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For all of these reasons, the Government considers that the appeal against the law to amend the law must be rejected. Act No. 2011-814 of 7 July 2011 on bioethics by authorizing under certain conditions research on embryo and embryonic stem cells.
