Research on the human embryo: to the challenge of the principle of prohibition?

Publié le 31 Dec, 2012

While the law of Bioethics 2011 maintained the principle of prohibition of the research on the human embryo, a bill adopted on last 4th December by the Senate could challenge this founding prohibition. Will the principle of protection of the human being be an exception?


The law of bioethics 2011


Keeping the principle of prohibition: the logic of the respect of the protection of the human being


If the prohibition of the research on the embryo was one of the crucial and emblematic challenges of the debates on the revision of the law of bioethics 2011, it is because this principle comes directly from the fundamental principle of the protection of the human being from the beginning of its life (article 16 of the civil Code). The national representation resisted to preserve this prohibition, today threatened.


  • First breach: the extension of the conditions of derogation


Since 2004, researchers have the possibility to derogate to this principle of prohibition if they meet some conditions. Within the framework of a scheme of prohibition, the derogation is only conceived as a strictly supervised exception. Yet the law of bioethics of 2011 extended the conditions which allow obtaining derogations. To derogate to the prohibition, it is not anymore necessary researchers prove the objective of “major therapeutic advances”, in other words of concrete perspectives of care, but simply that of “major medical advances”. This formula allows the pharmaceutical industry to perform research on the embryo. Moreover, while the law of bioethics of 2004 authorized derogations “for a period limited to five years”, that of 2011 removes this moratorium, for a long-term possibility to derogate to this prohibition.


  • Second breach: the application of the derogations


Despite the prohibition of the research on the embryo, since 2004, the Agency of Biomedicine (ABM), in charge of the examination of the derogation requests has already granted 173 authorizations of research for only 9 refusals; what makes some people doubt about the legibility of these authorizations. Among them, Jerôme Lejeune Foundation intended several legal actions for illegality. The first of them was favourably welcome by the Administrative Court of Appeal of Paris which condemned the ABM for having illegally granted an authorization of research on the embryo breaching the legal derogations (order of the 11th May 2012).


An imminent change: a bill removing the principle of prohibition


The Senate voted on the quiet on last 4th December at 10 pm a bill by the radical group “authorizing under certain conditions the research on the embryo and the embryonic stem cells”. If this is adopted in the same terms by the National Assembly, France will shift from a scheme of prohibition to a scheme of authorization. The principle of protection of the human being will be an exception.


  • An illegal adoption procedure


It should be noted an element of illegality in the adoption of this bill, because it should have been preceded by national Estates general. Under article 46 of the law of bioethics of 2011: “any reform project on ethical issues (…) must be preceded by a public debate in the form of Estates general”.


  • From the prohibition to the supervised authorization:


Passing from a supervised scheme of authorization would generate an unprecedented change of paradigm after which the founding principle of the protection of the human being would become an exception to the new rule of its non-protection.

In fine the authorization of principle will extend more the possibility to resort to human embryos for the research than compared to a prohibition scheme.


  • Conditions of authorizations rendered ineffective


Moreover, the bill adopted by the Senate sets ineffective conditions. Far from attaching the authorization scheme with strict conditions aiming at controlling the liberalization of the research on the embryo, on the contrary this aims at extending current derogations.

For the first time, it will be expressly foreseen in the law that a “fundamental research” will be performed on human embryos, in other words without any concrete therapeutic perspective. Moreover, where it is today necessary to “establish expressly that it is impossible to lead to the expected outcome through a research not resorting to human embryos” it will be sufficient to affirm that “this research cannot be performed without resorting to these embryos…”. The requirement of scientific evidence demonstrating the impossibility to perform an alternative research then will not be any more required. And this, while IPS (Induced Pluripotent Stem) cells whose discoverer is Nobel Prize for Medicine in 2012 offers an alternative to the research on the human embryo.


  • A campaign for protecting the embryo: “Do you find it normal?”


In this context, Jerôme Lejeune Foundation launched an awareness campaign “www.vous trouvezç ? “. It reminds that the debate relative to the prohibition scheme of the research on the human embryo “commits a society choice which […] must be opened to all the citizens and in the full light of day.” It emphasizes the paradox existing in France “between a determined and consensual protection of the animal and the disinterest even the hostility against the defence of the human being”. The objective: “not to let the challenge of the research on the embryo outside the debate”, when a fundamental legislative change could be approved by the National Assembly on next 28th March, on the occasion of the next parliamentary niche of the radical group.


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