Bioethics information and analysis newsletter - January 2010 - N°121

Revision of the laws of bioethics: a transgressive report

The parliamentarian mission’s report on the revision of the laws of bioethics presented by Jean Leonetti was published on Wednesday 20th of January 2010. As the UMP-PCD deputy from the Yvelines department Jean-Frédéric Poisson notes it, "the report was not the occasion of a deep challenge of the principles and practices whose scientific, medical and ethical validity is yet clearly challenged", but it goes further with the transgression. It is particularly proved to be alarming regarding the research on the embryo, the extension of the preimplantation diagnosis for Down syndrome children, and the role allocated to the Agency of Biomedicine.

Research on the embryo
The laws of bioethics of 2004 prohibit the research on supernumerary embryos, except derogations during five years. The authorisations should only be granted by the Agency of Biomedicine (ABM) on two conditions: the project research has a "therapeutic purpose" and that it has not “alternative method of comparable effectiveness”.
In real life, the ABM has immediately and systematically compromised these conditions and today some people propose that the prohibition system on research on the embryo is removed to the benefit of an authorisation system with conditions. "The time has come to free this research from any constraint", the PS deputy Alain Claeys declared, chairman of the parliamentary mission of information, on 20th January.

The meaningless prohibition
However the proposals 43 and 44 of the report keeps the principle of prohibition for its symbolic value, but modify so much the derogation conditions that they render it meaningless. The moratorium would be removed and the exceptionally authorised researches would not be anymore limited in time. Moreover, the requirement of "therapeutic purpose" would be replaced by a "medical purpose", constraint with a weakest content since it only excludes the researches for cosmetology. Finally, and even if today alternative method of effectiveness not only comparable but also superior with the development of researches on adult stem cells and iPS cells exist, the report proposes to remove "the condition limiting the researches to those which cannot“ be followed by an alternative method of comparable effectiveness, in the state of scientific knowledge".
For the rapporteur Jean Leonetti, it is not absurd to set at the same time the prohibition and the suppression of restrictive conditions from the derogation: "There are great principles and applications, thus particular situations. We have to prohibit because it is a principle. We said what is totally prohibited: the experiment on the embryo intended to be born. Today, we know that there are frozen embryos intended to be destroyed. Thus if there is a transgression, it is to destroy the embryo, not to collect a cell before destroying it".
Theses measures are motivated by financial reasons and the freedom of the research. The preoccupation to make profitable the millions invested in the research on the embryo indeed led to a very lucrative business of molecule screening techniques on human embryonic stem cells for pharmaceutical laboratories. The Swiss pharmaceutical laboratory Roche thus signed a research partnership of €7.5 million with the French public biology laboratory I-Stem in July 2009. Moreover, Jean Leonetti affirmed that "thinking about laws, it is at the same time to free the medical research, because we do not have to block the intellectual research of the man, above all if it is oriented to the improvement of human health and particularly that of the most vulnerable, and at the same time to preserve the human dignity, it is a conflict of values".

What to recommend?
It would be advisable to adopt a strict prohibition system of research on the embryo without derogation and to develop the alternative research solutions: research on adult stem cells and cord blood which are already used for therapeutic applications, research on reprogrammed cells (iPS) which replace without ethical damage and usefully the embryonic cells, and research on animal embryonic cells.
If derogations are granted, we have to keep a prohibition system, keeping the current conditions of derogation, the moratorium to not perpetuate the practice and the control by the Parliament to limit the observed drifts.

Creation of embryos for the research
The proposal 15 also proves to be worrying. It advises to "keep the current frame concerning the conception, the freezing and the future of supernumerary embryos". Yet, the implementing decree of the 6th February 2006 contradicts in the facts the prohibition of the conception of embryos for the research affirmed by the law of 2004. This decree sets indeed that within the framework of a medically assisted procreation (MAP), the couple has the possibility “to consent at the same time in writing to have the embryos, which would not be liable to be transferred or preserved, been subject to a research". This previous agreement for the future of the embryo comes down de facto to conceive supernumerary embryos for research purposes. We have to foresee to modify this decree which transgresses the law.

Cloning
The prohibition of any kind of cloning is maintained with the following precision: "members of the mission estimate that the question of nuclear transfers for medical purpose, with prohibition of implantation and subject to the availability of human oocytes, must remain in debate".

PGD and Down syndrome
The second cause for concern is the extension of the preimplantation diagnosis (PGD) to Down syndrome children. According to the proposal of the opinion No 107 of the National Consultative Ethics Committee (CCNE), pronounced on 17th November of 2009 (see Gènéthique letter No 119), the proposal 26 suggests to add the detection of Down syndrome to the preimplantation diagnosis (PGD). This way, Down syndrome would become the first and only disease explicitly mentioned as liable to be subject to this diagnosis, and this is in contradiction with the first paragraph of this same proposal which marks the will to maintain "the absence a priori of a list of diseases liable to be subject to this diagnosis" as set forth by the law.
During his hearing before the parliamentary mission (31st March 2009), Pr Israël Nisand, head of the department of obstetrics and gynaecology of the University Hospital Centre of Strasbourg, gave an economic justification to the eradication of Down syndrome people: "Yes, we choose the children to be born in our country and for a long time, even if we do not like it. You should know that with the increase of the age of the mothers- 4 years in 20 years- 1,600 additional Down syndrome babies are conceived each year. Today they are 30,000 with a life expectation of seventy-five years. If we counted the 1,600 additional Down syndrome babies per year, the money of the State would not be sufficient to alleviate their dependence. Also, we could not prohibit the marketing of a screening test of Down syndrome by blood collection. And if you do not do it, the blood would be sent to Las Vegas”.
This proposal goes further in the escalation of eugenics.
- because it modifies the nature of the PGD by introducing an element of subjective assessment. Resorting to this examination for Down syndrome is not justified by taking into account the familial past of the couple since this disease is a genetic disease, but not hereditary. Thus which prevails is only the social rejection of Down syndrome, already created, maintained and financed by the State through its policy of generalised screening.
- because it concludes, in advance, that parents who resort to PGD to avoid the birth of a child with hereditary disease do not tolerate – by principle – the birth of a Down syndrome child. A Down syndrome child conceived in vitro and submitted to PGD is presumed dead.
For Jean-Marc Nesme, UMP deputy, "the stigmatisation of Down syndrome in the law, would be, for families who had or has Down syndrome child, unbearable. It is not our competence to determine the humanity threshold”.
This provision intervenes when significant advances are made in the research of a treatment for Down syndrome. This way, on 18th November of 2009, American researchers from Stanford University, California, announced they succeeded in restoring the intellectual capacities of Down syndrome model mice.

MAP and transfer of post-mortem embryo
For the medically assisted procreation (MAP), the report proposes to maintain its resort within the framework of a medical purpose. It relaxes the conditions the couples have to satisfy but keeps the one according which the couple must be composed of a man and a woman. It maintains the prohibition of post-mortem insemination and surrogacy (surrogate mothers) and facilitates the possibility for an infertile couple to welcome the supernumerary embryos of another couple. Thus the proposal 19 recommends levying the exceptional character of this alternative to the donation to the research and to the destruction of the embryo.
"The post-mortem transfer of embryo would also be exceptionally possible when the parental project has been committed but was suddenly interrupted by the death of the spouse". The transfer could be authorised by the ABM after a period of 3 to 6 months of widowhood and up to 18 months or 2 years after the death of the spouse, and this to "allow possibly a second attempt".

Antenatal diagnosis (PND and PGD)
Within the framework of a preimplantation diagnosis, the saviour child procedure, or double PGD, is maintained, contrary to the warnings of the Council of State which wanted that its suppression was very seriously envisaged. If this provision is conserved, it would be in any case desirable to maintain the experimental character of the procedure.
Moreover, the proposal 27 ratifies the selection of embryos by PGD for some predispositions to cancer.

Organ donation
The proposal 54 which stipulates to fix assessed objectives for the census of donors in the state of brain death must be treated with caution in order to avoid any pressure to obtain organs. Also we are surprised that the report does not mention the will issued by the panel during the Estates General on Bioethics to go back on the presumed consent which governs the organ collection. Concerning the cord blood stem cells, the proposal 68 invites the ABM to conduct information campaigns against the autologous cord blood conservation. It would rather be desirable to encourage cord blood donation campaigns.

Role of the ABM
The report recommends to not revise anymore the law every 5 years. In case of evolution, the only necessity to resort to ABM, CCNE and Estates General is mentioned. Anyway it deals with the debate and votes of the MPs. Thus it is advisable to be very vigilant on this point so that the democratic debate is not confiscated to the benefit of agencies which would be judges and parties.

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