The enforcement decree relative to research on embryo and embryonic cells was signed on 6th February 2006 and published in the French Official Journal of 7th February. It implements the bioethics law of 4th August 2004 which authorized research on human embryo. This text – very expected or very feared – is not a surprise, to the following reserves.
Silence about the principle of research prohibition on embryo
Everybody may have forgotten it but the law of 2004, in its article L. 2151-5, first paragraph, stated: “the research on human embryo is prohibited”.
It is only at the end of the third paragraph that, “by derogation to the first paragraph (…), researches can be authorised on embryos and embryonic cells when they are susceptible to allow major therapeutic progress and provided that they cannot be followed by an alternative method of comparable effectiveness, in the current state of scientific knowledge“.
But, the decree totally passes in silence over the principle of this prohibition which made this research on embryo a subsidiary research. Without reference to the principle of prohibition, the decree just rules the exception (the authorization of the research on embryo) which, for that reason, appears as a rule.
Silence on conditions laid down for research on embryo
The law laid down – we have just seen it – two cumulative conditions: prospects of major therapeutic progress and an impossibility to carry on researches by an alternative method of comparable effectiveness, in the current state of scientific knowledge (for instance the researches on adult stem cells or taken from umbilical cord).
But, from one hand, the decree does not mention anymore the condition which is due to the absence of alternative method of comparable effectiveness. That shows how scientists will not be much encouraged to work on adult stem cells or taken from umbilical cord. On the other hand, the decree, in its article R. 2151-1, gives a tautological and incantatory definition of the condition relative to major therapeutic progress: “are particularly susceptible of enabling major therapeutic progress (…) the researches on embryos and embryonic cells with a therapeutic purpose for the treatment of particularly serious or incurable diseases, as well as the treatment of embryo or foetus affections.”
But it is not by repeating that researches for therapeutic purpose are therapeutic that the therapeutic certainty increases, nor by detailing the list of potential beneficiaries that research on embryo will become more therapeutic.
Silence on the prohibited conception of embryos for research
The article L. 2151-2 of the law states that in vitro conception of embryo for research purposes is prohibited.
But, the modalities of the couple consent, or of a surviving member of a couple, for the research on his embryos, as they are detailed by the article R. 2151-4 of the decree, allow the creation of embryos for research.
- First, when the couple has no parental project with his supernumerary embryos, he can consent to the research on this latest. This could be the case for the 120,000 frozen human embryos.
- Then, when in vitro embryos have been diagnosed to be (by preimplantatory diagnosis) carriers of an anomaly, they can be given to the research.
- Finally, in the framework of a medically assisted procreation (MAP), the couple can “consent in writing at the same time that the embryos, which could not be susceptible to be transferred or preserved, are object of a research“.
Thus this a priori consent allows very clearly in vitro conception of embryos for research purposes which was prohibited by the law of 2004.
Is the Biomedicine Agency a machine to produce transgression?
The articles R. 2151-2 and R. 2151-15 state that “the chairman of the Biomedicine Agency can authorise a research protocol on the embryo or on the embryonic cells (…)” and “authorises the import and the export of embryonic or foetal tissues and cells for research purposes (…)“.
In the eyes of the great discretion of the decree on restrictive conditions stipulated by the law which we have just reminded – and particularly of the subsidiarity of the research on embryo – the freedom of the Biomedicine Agency to authorise or not some projects will apply thus in the field of the research on the embryo. The Agency will be able to authorise some research projects on the embryo rather than other research projects on the embryo.
Also when the chairman explains that “the mission of the Biomedicine Agency is to guarantee that researches on embryo are performed with all ethic guarantees”, it has to be understood: destroying the embryo – with competence and without polluting the environment – is globally the only ethic of the decree.