The Council of State report on the revision of the law of bioethics

On last 6th May, the Council of State (CS) published its report on the next revision of the law No. 2004-800 of 6th August 2004 related to bioethics. Here are its main recommendations.

 

Firstly, the CS reminds that the human embryo is “a potential human life and not a thing”, that “it cannot be treated like a mere research material” and that “by principle we only can undermine it for major and duly justified reasons”. It even considers the research on embryo as a “transgression” at the “superior principle” of “protection of the embryo”; this one being only admissible “for therapeutic purposes well defined and particularly important from a collective point of view.”

And yet, while recognising that keeping the current system of prohibition of research on human embryo and human embryonic stem cells with derogation would present the benefit to maintain a highly symbolic prohibition, it proposes to adopt a permanent system of authorisation “with strict conditions“. Thus it recommends writing the article L. 2151-5, as follows: “No research on the human embryo or on embryonic stem cells can be conducted without authorisation. A research protocol conducted on a human embryo or on embryonic stem cells coming from a human embryo can only be authorised if: 
– the scientific relevance of the research is established,
– the research is likely to allow major therapeutic advances,
– It is impossible, in the state of scientific knowledge, to conduct a similar research with the aid of cells other than human embryonic stem cells,
– the conditions of implementation of the protocol respect the ethical principles”.

 

In order to justify its position, the CS mentions, from one hand, a worry about “coherence” according to which “the legislator could reasonably not make a prohibition and enact at the same time, permanently, a derogation whose effect would be in practice to completely undermine this prohibition“, and, from another hand, the fact that 95% of the research projects submitted to authorisation have been accepted by the French Biomedicine Agency. 

 

Bertrand Mathieu, professor of Public Law at Paris-I, criticizes this change advocated by the CS, affirming that bioethical questions need legal stability. To reverse the situation and erect in principle the current derogation, at the contrary, make us enter “a situation of prejudicial legal incoherence”.

 

In his letter of referral of 11th February 2008, François Fillon, French Prime Minister, mentioned its worry about the possible eugenic drifts and asked the CS to first answer the following question: “do the provisions which regulate the activities of medically assisted procreation [MAP] and, in particular, those of prenatal diagnosis [PND] and of pre-implantation diagnosis [PGD], warranty an effective application of the principle prohibiting “any eugenic practice aiming at the organisation and the selection of people” ?”.

 

Defining eugenics as “all the methods and practices aiming at improving the genetic inheritance of the human species“, the High jurisdiction accepts that eugenics can be, besides “the fruit of politic deliberatively conducted by a State“, “the collective result of a sum of individually convergent decisions“. Thus, he cites the case of Down syndrome: “in France, 92% of Down Syndrome cases are detected, against 70% in average in Europe, and 96% of the cases thus detected lead to a termination of pregnancy, which translates an individual practice of elimination almost systematic of carrier foetuses“. And yet, for him it seems “illusory and even unjustified to prevent or to delay the access to screening techniques: the access to the analysis of serum markers from the first quarter” and this, in the name of an “ethical imperative towards pregnant women – to give them the possibility of choices less advanced” and of “considerations of public health – limit the number of miscarriages related to the amniocentesis“.

 

An order, currently submitted to the minister for Health, indeed proposes to change the screening examinations of Down syndrome, today performed in the second quarter of pregnancy, to the first quarter. Such measure would continue to be a calculation of risk with its false negatives (non screened Down syndrome child) and its false positives (unaffected child wrongly screened). And if the risk would be high, we would even have to confirm the diagnosis with a sample. The amniocentesis being impracticable at this stage of pregnancy, we would have to perform a trophoblast biopsy (future placenta) which induces a rate of foetal losses 1.5 to 2 times higher than with the amniocentesis, this later generating a miscarriage in 0.5 to 1% of the cases. The women, to whom we want to avoid anxiety with this measure, will have to choose between a trophoblast biopsy, earlier but more risky and an amniocentesis, later and less risky. Moreover, does the obvious willing to have results within 48 hours come up against the free and informed consent the law requires?

 

In short, the working group of the CS, managed by Philippe Bas, recognises the existence of eugenic practices in France while encouraging the implementation… Concretely, the only solution he proposes to limit the risk of eugenic drifts is the information to and the accompaniment of women.

 

In the case of the PGD, the CS estimates that the notion of “particular severity” necessary for a resort to PGD leaves “a sufficient room for interpretation“, even if the PGD has to be used for the research of predispositions to some diseases with late onset (see Letter No. 109). It does not recommend establishing a list of diseases giving right to PGD, but at the contrary it considers it necessary “to increase the human and financial means” in order to “reduce noticeably” the waiting time (between 18 and 24 months) to obtain a PGD. Moreover the CS mentions “the difference of legislative scheme” between PGD and PND which “avoids detecting some diseases in the framework of the PGD, before the transfer in utero (…), but allows performing it after, within the framework of a PND, while being pregnant. Does not it mention here the possibility to expand the access to PGD to all provisions for which the PND is accessible and this, whereas it recognises that “any relaxation of the PGD induces additional eugenic risks”? 

 

Finally, concerning the “double PGD” or PGD-HLA, more commonly called “saviour child”, the CS specifies that the “ethical questions (…) and the fact that it was not so much used could justify that the legislator envisages to put an end to this practice”. Then it proposes to expand this practice, while envisaging a deep evaluation in five years.

 

The CS recommends not modifying the conditions of access to MAP foreseen by the law of 2004 and thus rules out the possibility for single and homosexual women to resort to MAP. It also seems that it does not want to go back over the requirement of common life of at least two years.

 

Moreover, the CS affirms its opposition to the transfer of post-mortem embryo.

Without going back over the principle of gratuity of gamete donation (while wanting to neutralise the financial cost for he donor), it pronounces in favour of a partial lifting of anonymity (access to some non identifying data and possibility of a lifting of anonymity if the child asks it and if the donor agrees). 
Then the CS justifies the possibility to welcome embryos with the grounds that this “assures at a symbolic level that any supernumerary embryo is not devoted to either destruction or research”. 

Concerning surrogacy, it considers justified the current prohibition but proposes some “punctual solutions” (transcription of the paternal filiation and delegation with sharing of parental authority for the intended mother) to “alleviate the practical difficulties” of families who resorted to surrogacy, “without modifying the rules related to the filiation“.

 

In conclusion, the highest French administrative jurisdiction recommends to the legislator not to renew the obligation of reviewing the law every five years. From one hand, it says, it does not deal anymore with establishing new principles but implementing those existing and, from another hand, in some fields an “overregulation (…) would be an obstacle to the good development of research or care.” Thus the CS proposes to the legislator to rely on the annual report of the French Biomedicine Agency and the Council of State and the National Consultative Ethics Committee (CCNE) to which it could ask a regular thought on the law of bioethics.