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N°39 - March 2003

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Questions on ICSI : Report of the French Ethical Consultation Committee

In its 75th report, released on 21st February 2003, the French Ethical Consultation Committee (CCNE) launched a debate on the use, for in-vitro fertilisation, of intracytoplasmic sperm injection (ICSI). Every year in France, some 10 000 babies are born through medically assisted procreation (MAP) of which over half involve the use of ICSI.
This in-vitro fertilisation technique (IVF) which has been used since 1992, is a means of overcoming masculine sterility by injecting a single sperm (or in some cases a sperm precursor) into an ovocyte. ICSI therefore avoids the need for sperm donation. But this technique raises a number of questions from the medical, legal and ethical points of view, especially since it is undertaken "without any sufficient animal experimentation having been undertaken, which is normally a pre-requisite to the adoption of any new therapy" we are informed by Didier Sicard, President of the CCNE.

From the medical point of view
The risks for the child are very real.
- Risks associated with the method : the ovocyte is prepared and is subjected to treatment. The sperm on the other hand is selected for its shape, its size and its mobility. The forced injection of the sperm short-circuits the normal ovocyte penetration process, and we know nothing of any repercussions this method may have on the embryo or the foetus.
- Risks associated with the technique : doubling of congenital malformations (2.4% for IVF versus 1.2% for spontaneous pregnancies) means that the combination of IVF with ICSI is a risky technique. A few studies are beginning to appear, in particular in the New England journal of Medicine (March 2002). But it is not possible to determine the share of responsibility of ICSI in these results associated with IVF.
- Risks associated with the biological material injected : infertile men are more often carriers of chromosomic and genic anomalies. The probability of transmitting chromosomic diseases is therefore higher, quite apart from the risk of transmitting the sexual anomalies responsible for potential sterility.
- Risks associated with the use of PIGD (pre-implantation genetic diagnosis)-: some people recommend the use of PIGD in combination with ICSI in order to check that no other genetic disease is transmitted to the embryo. The objections which apply to the use of ICSI, must therefore be added to those associated with PIGD (embryo selection).

From the legal point of view
ICSI was never subjected to parliamentary debate through the bioethics laws established in 1994. A decree dated 6th May 1995, simply mentions the micro-manipulation of ovocytes among the various MAP techniques. It was not until a 1999 circular covering good clinical practices, that ICSI was truly mentioned as an MAP technique, without any measures being taken with respect to evaluating the risk incurred by the resulting children.

From the ethical point of view
"Experts" are concerned about the lack of follow-up for children born through IVF. This is why they recommend "with respect to the risks associated with IVF and ICSI in particular, to ensure long-term epidemiological monitoring of children born through this technique". The CCNE insists on the importance of evaluating these techniques in order "to clear up this uncertainty". But such a study would generate worry for the families and could stigmatise the children concerned. Should one warn those born through this technique of the particular risks affecting them ?
The CCNE concludes : ICSI "should not be used freely" as it is now, but should be restricted to cases of masculine sterility.

See www.genethique.org for the CCNE report.

 

Unintended pregnancy termination offence

Statement by the legislator
On 19th March 2003, in the context of the proposed law against road violence, the members of parliament accepted the creation of a new offence for unintended pregnancy termination. This punishes "Carelessness, negligence and a breach of a particular obligation for safety and caution, resulting in the death of an unborn child without the consent of its mother, in general, and more particularly in the context of road accidents. The statement by the legislator was made necessary to fill the legal void which was uncovered by the Court of Appeals on 29th June 2001. J.P. Garraud who submitted this amendment, recalled during the debate : "We cannot be satisfied with the legal void which persists on this matter, since every year, several cases of analogous accidents occur."

The facts (Grosmangin case)
On 29th July 1995, Sylvie G., who was 6 months pregnant at the time, fell casualty to a reckless driver, driving in a state of drunkenness. She was injured in the accident, and through the violence of the impact, lost the child she was bearing: the foetus was viable. The Court in Reims, sentenced the driver, not only for the injuries caused to the mother, but also for unintentional manslaughter. The Court of Appeal in Metz, did not accept the latter sentence, considering that manslaughter could only be considered with respect to a child whose heart was beating and who breathed at childbirth. On 29th June 2001, the Supreme Court of Appeal, in plenary session, confirmed the decision by Metz. The court did not accept the qualification of unintentional manslaughter, since the foetus cannot be considered as a person.

The appeals court judgement
What about the interpretation of criminal law ? In order to avoid the idea of unintentional manslaughter, the judgement of the Appeals Court on 29th June 2001, was based in particular on the following argument : "the principle of the legality of offences and of sentences, which demand strict interpretation of criminal law, is contrary to the philosophy of article 221-6 of criminal law which punishes unintentional manslaughter of others, even by extension to unborn children". This decision was countered almost unanimously by numerous commentators who criticised the motivation of such a judgement.
Others : Article 221-6 of the new criminal code defines as unintentional manslaughter "the fact of causing death to others by mistake, carelessness, inattention, etc.". The question raised is therefore not so much as to whether or not the article is applicable or not by extension to unborn children, but, as the Appeals Court says, to know whether or not the term "others" includes the unborn child. Is the unborn child considered as other ? The foetus is indeed other, since it has no autonomy, this does not mean that it does not possess its own biological life. There is nothing to suggest that the legislator intended to exclude the unborn child from legal protection, since he included in the civil code "the law which ensures respect of the human being from the very beginning of its life". Abortion being the only exception to the rule.
Person : Some people consider that the term other corresponds to a person. They refer to the legal personality of the human being (the dominant doctrine bases this on a live birth). But this legal personality is a mere abstract construction, whereas criminal law is only concerned with the being in flesh and blood.
Viability : Certain others wish to link the notion of manslaughter with that of viability, but the notion of viability is not recognised in criminal law, which is intended to protect life and not the aptitude for life.

The fallout from the judgement
The importance of this judgement by the appeals court, is also due to the moral and medical consequences :
- The unborn child therefore finds itself stripped of any legal protection. But how can parents accept that the child they were expecting and have lost through the fault of a third party, did not exist in legal terms and therefore they have not lost anything ?
- There exists a repressive precedent sentencing a doctor for unintentional injury to a foetus which resulted in a handicap. So how can one explain that at the same time the foetus may be a victim of unintentional injury, but cannot be a victim of unintentional manslaughter.

The changes in precedent
By a judgement on 2nd December 1882, the Appeals court in Douai sentenced a woman who was illegally conducting birth deliveries, and who had caused the death of a child in utero. The judgement stated that "although the child had not breathed, it had none the less lived its intra-uterine life ; its death in itself is the proof of its previous existence". Since then, the trend of precedent, favourable to the legal protection of the unborn child, has been maintained until recent times, even after the decriminalisation of abortion.

No status for the foetus
The offence of involuntary termination of pregnancy is therefore intended to fill the legal void raised by the Appeals Court. It provides protection for the mother. Another amendment was tabled in Committee (by M. Hunault), he proposed extending the protection to the child in utero. But this was thrown out, the legislator refusing to take up position on the status of the foetus.

See www.genethique.org under "unintentional manslaughter of the foetus"

 

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