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Bioethic information and analysis newsletter

Following Letter

N°54 - June 2004

Law on Bioethics adopted by the French Senate

Hastily, and in a climate of general indifference, the draft law on bioethics was adopted on 2^nd reading by the French Senate on the night of 8^th to 9^th June 2004.

Authorisation for research on human embryos

The Senate confirmed its authorisation for research on human embryos for the next 5 years, under a dispensation to a prohibition principle. Embryos which are covered by a parental project are intended to see the light of day, whereas all the supernumerary embryos, (currently estimated to be over 200,000), if their parents agree, are due to end up as research material for scientists.

The general discussion provided a few Senators with an opportunity to raise the point that an embryo is a human being « no research scientist worthy of the name, can deny » as was particularly stated by Mme Payet (UDF, La Réunion), who added : « does this mean that there are human beings who are not people ? We must be wary of this kind of ideology which led, for many centuries, to the legitimisation of slavery, when entire populations were not considered as humans but as mere objects for the availability of their masters ! Is history repeating itself ? »

Research scientists claim that by prohibiting research into embryonic stem cells, France would fall behind relative to other European nations.

This ignores the fact that embryonic research is prohibited in Italy, in Germany, in Ireland, in Portugal, in Austria, in Luxembourg and in the ten new European member states. And it also ignores the fact that in the nations where this research is authorised, no therapeutic results have so far been published.

"Stock" of embryos available

During voting, a particularly important modification proposed concerning the number of embryos available for research was nevertheless adopted by the Senate by 191 votes to 112. This amendment, concerning article 18, and which was tabled by the reporter, M. Giraud, stated that « couples whose embryos are preserved and which are no longer covered by any parental project on the date of promulgation of the law (...) on bioethics, may consent to its embryos being the subject of research covered by article L.2151-3 ». The stock of embryos available for research was therefore limited to those existing on the date of promulgation of the law. This amendment was not favourably received by Philippe Douste-Blazy, the Minister of Health, whose concern was to avoid limiting French research. And it was finally deleted by the mixed parity commission, which met on 15^th June 2004.

From now on, research is possible not only on supernumerary embryos "in stock", but also on future supernumerary embryos. The law thus authorises the provisioning of a "flux" of embryos for research, whereas officially it prohibits the creation of embryos for research...

Immediate implementation

This research is subject to authorisation by the Biomedicine Agency, which consists of a panel of very important decision-makers who are beyond the control of Parliament. Research scientists are therefore provided with the exorbitant responsibility of establishing the limits to their own acts. Pending the effective establishment of the agency, a transitional period has been covered by article 27. As soon as the law is adopted, the ministers of health and of research will have the power to authorise such activities ; French research scientists will therefore be in a position to respond to European tenders for which the closing date has been set in November.

"Medicine babies"

Contrary to the rejection expressed during the first reading, the Senate voted to extend the pre-implantation diagnoses in order to give birth to a child which may be useful for treating another, already born, and suffering from a serious genetic disease (art. 17, see Gènéthique No. 48).

No to cloning, but...

Cloning is prohibited, but the penalties incurred are very different according to whether the cloning is reproductive or therapeutic. However, it is the same human cloning, the only difference is in the intention under which it is undertaken : the act of producing a child, or on the contrary that of arresting the development of the embryo and then using it as a research material.

By distinguishing between these two types of cloning, the law implies that one is abominable (reproductive cloning) whereas the other (therapeutic or reproductive for research purposes) could one day be legalised.

Destruction of a human being

This is the first time in France, that authorisation has been granted for the destruction of living human beings, for use as a material. A revolution is taking place without the merest proper scientific justification... As stated by Philippe Douste-Blazy, the minister of health, who congratulates himself on this new law, this new « legislation shows our current vision of mankind »…

CCNE and screening for mucoviscidosis

Currently, some five thousand people in France are suffering from mucoviscidosis, which causes severe respiratory and digestive problems and 200 children are born each year, suffering from this genetic disease. Since 2002, systematic screening for mucoviscidosis at birth, has enabled early treatment. Risk prone families may resort to pre-natal screening, or even pre-implantation diagnosis (DPI) and 40 to 50 DPI are undertaken each year in this context.

CCNE opposed to generalisation of the screening

The national ethics consultancy Commission (CCNE) has been challenged by Pr. Alain Kitzis from the CHU in Poitiers for its screening protocol for the mutation of the CFTR gene (responsible for mucoviscidosis) proposing to combine the prenatal screening for mucoviscidosis with that for trisomy 21. At stake was the decision to generalise such screening : should one propose screening the 750,000 women who become pregnant each year, to submit to a screening test in order to avoid, by medically aborting the pregnancy, the birth of 200 children suffering from mucoviscidosis ?

The CCNE was opposed to such generalisation for technical reasons, and it provides more general thinking on such screening which is considered to be insufficiently reliable (the test would only be able to detect some 80% of risk prone couples, causing too much distress to parents, being difficult to apply in the context of « blanket consent » and by nature eugenic.

The CCNE also recalled the risk associated with amniocentesis : 1 to 3 % miscarriages. This rate of miscarriages when applied to the number of pregnancies (750 000) for screening 200 children, gives food for thought... The example of screening for trisomy 21 speaks for itself. Professor Israël Nisand recalled in 2000 in La Croix : out of some 55,000 women who resorted to amniocentesis because they presented a higher risk of trisomy, 550 miscarriages were caused, whereas "only" 280 cases of "trisomy were detected...

Eugenic risk 

The CCNE raised « the question of the possibility of eugenic resonance » in such a test and the « increased social stigmatisation » of children not screened and of parents who refuse such screening, as is already the case with trisomy 21. It stressed that the sick children « could consider as a great suffering the fact that their birth could be considered as inappropriate. » Father Olivier de Dinechin, a member of the CCNE, « dreads terribly the development of such tests. This excessive pathologisation of pregnancy and the danger of leaving after-effects in the parent-child relationship, is out of all proportion compared with the true risk of occurrence of mucoviscidosis in the unborn child. »

A screening policy to the detriment of research 

 « The effort which could be applied to such screening is in danger of being so to the detriment of patients… who require active research into procedures for curing their affliction. The funding for generalised screening is liable to be found to the detriment of funding for the corresponding research. Whereas progress in this domain remains quite possible ». It is difficult not to see the parallel with the current screening for trisomy 21. It is interesting to note that the fears expressed here by the CCNE are a reality in the case of trisomy 21. 100 million euros are spent each year on such screening whereas no public funds are assigned to research (figures taken from the 2003 national accounts). Surely the 50,000 trisomic patients living in France should be allowed to hope for something more from Public Health than to be screened ! Remember that one foetus out of 700 carries trisomy 21...

The CCNE is currently working on the appropriateness of pre-natal screening for deafness…

In utero foetus: person, material or nothing ?

Illegal caesarean in Bogota

An eight-months pregnant Columbian woman, after being drugged, suffered an illegal caesarean. Abandoned and losing her blood, she came round in a wood some 150 kilometres from Bogota. " When I touched by belly, it was empty. I heard a baby crying. The last thing which I saw was a woman walking away with my baby wrapped in swaddling clothes ". Kidnapping ? Material theft ? Or nothing ?

Accidental death of a foetus in France

In France, a pregnant woman died in a road accident with her unborn child.

The father's lawyer asked the court to set a legal precedent under the name "Elias", being the name of the child, claiming that his client had lost a wife and a child whose heart he had heard beating and who he had felt kicking.

The Quarter sessions court in Thionville merely condemned the driver to a one year prison sentence for causing the death of the woman. The tribunal based its decision on the current legal precedent set by the Court of Appeals, which has been questioned by many jurists, according to which unintended manslaughter cannot be extended to the foetus whose death cannot be blamed on anybody.

(Cf. Thionville tribunal Quarter sessions, 25th May 2004.)