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Bioethic information and analysis newsletter

Following Letter

N°48 - December 2003

The French National Assembly authorises research on human embryos

The draft law on bioethics was adopted at its second reading at the French National Assembly on 11th December 2003 (see the explanations on its first reading in Gènéthique No. 38, February 2003).

Research on human embryos
Although prohibited in principle, research may be authorised, by dispensation and for a limited period of five years, if it is liable to lead to major therapeutic progress and subject to it not being possible to undertake it by any alternative method of comparable efficiency, in the present state of medical knowledge (art. L2151-3 of the French code of Public Health).

The research is conducted on :
- "Supernumerary" embryos, conceived in vitro, with the consent of the couple having generated them (art. L2151-3),
- embryos and foetuses resulting from abortions, with the written consent of the mother (art. L.1241-5),
- embryonic and foetus tissues imported for research purposes ; their importation, and their exportation, is now possible with prior permission from the Biomedical Agency (art. L2151 3 1).
In order to initiate such research as soon as the law comes into effect, the Minister of Health has introduced a transition period.

Cloning
Cloning is prohibited. However, the penalties incurred vary considerably according to whether the cloning concerned is considered to be reproductive or therapeutic : 30-year prison sentence and 7,500,000 Euro fine for reproductive cloning, 7-year prison sentence and 100,000 Euro for cloning for industrial, commercial, therapeutic or research purposes (art. 214-2, 511-17, 511-18 and 511-18-1 in the French Penal Code).

"Medicine babies"
Pre-implantation genetic diagnosis (PIGD) has been extended to allow for the conception of « medicine babies » (new art. L.2131-4-1A of the French Public Health code) if « the couple has given birth to a child suffering from a genetic disease leading to death in the first years of life…»

The amendment proposes the couple conceives embryos which can then be selected to choose those which are not suffering from the disease and which are compatible with the child already born, to save the latter, by drawing cells from its umbilical cord. 

To understand the stakes : a few definitions

Human embryo
The embryo is a small living human being which develops from the moment of fertilisation, since from the very instant of fertilisation, all the genetic pool is present. From fertilisation to death, human life is a continuous sequence : embryo (up to 2 months), foetus, new-born, child etc. and there is no pre-embryonic stage, because before the embryo, the human being does not exist, there are only two sexual cells : the ovum and the sperm.
 

Embryonic stem cells
The cells constituting the embryo are called « stem » cells because they are capable of generating all other cells in the human body in order to produce muscle, skin, nerve tissues etc.
Note : The draft law on bioethics covers the use of stem cells for so-called therapeutic purposes. But that involves the destruction of embryos and therefore instrumentalisation of human beings for the benefit of other human beings.

Adult stem cells
Certain cells in the adult human's body are called « stem » cells because they are able to generate a large number of other cells. Thus nerve cells can generate neurones or convert into muscle cells, pancreatic cells can trans-differentiate into liver cells etc. (See on http://www.genethique.org/en.htm the file on "Stem cells").
Note : Contrary to research on « embryonic stem cells », research on « adult stem cells » does not involve any ethical problems whilst at the same time proving to be more effective.

Embryonic research
Envisaged by the draft law on bioethics, the intention is not to treat a diseased embryo, but to draw cells off an embryo (thus destroying it) for use as experimental material.

Human cloning
Manipulation intended to asexually reproduce a human being identical to the original. (This should not be confused with the simple cultivation of cells as is undertaken in the treatment of severe burns).
Technique : The nucleus of the ovum is drawn off and is replaced with the nucleus of a (non sexual) cell taken from the body of a donor. This thus produces a « twin » embryo of the donor, merely a few years older.

Reproductive or "therapeutic"
In the context of human cloning, if the development of the embryo is halted at one week old, in order to use its cells for research, this is (incorrectly) referred to as therapeutic cloning. If the embryo is allowed to develop to birth, this is known as reproductive cloning. In both cases, the technique is exactly the same, a human being is being reproduced.
Note : Producing a clone for research purposes, therefore involves creating an embryo which will subsequently be destroyed and used as research material.
Some prefer to call this "therapeutic" cloning « transfer of somatic cell nuclei » in order to facilitate acceptance.

Garraud amendment, impossible penal protection for pregnant women...

The pro-abortion lobby has fought the Garraud amendment which recognised the offence of unintentional pregnancy termination in an attempt to fill a gap in the law.

Gap in the law
When an unintentional pregnancy termination is the result of an intentional fault by a third party, this is currently punishable under article 223-10 of the penal code by a 5-year prison sentence and a 75,000 Euro fine. On the other hand, if the unintentional pregnancy termination is the result of carelessness, and in particular following a driving accident, no offence is currently established. Up till 1999, the supreme court of appeals pressed charges of unintentional manslaughter against drivers having caused accidents resulting in loss of a foetus before birth.
This precedent was abandoned in 1999 and 2001 and henceforth the court of appeals only recognises unintentional manslaughter after birth of the child (Gènéthique No. 39, March 2003).
 

The Garraud amendment
In order to strengthen the legal protection of pregnant women, the Garraud amendment, was put to the vote in the context of the draft law aimed at « matching the law to the crime », intended to create the offence of unintended pregnancy termination resulting in the death of an unborn child without the consent of the mother, and specifying a one-year prison sentence and 15,000 Euro fine in the event of pregnancy termination through « clumsiness, carelessness, inattention, negligence or failure to observe due safety or prudence ». In view of the outcry this caused with the pro-abortion lobbies, the French Minister of Justice decided not to support this amendment which he had previously approved.

In Le Figaro for 2nd December, Professor Michèle Laure Rassat expressed her astonishment : "it is difficult to understand, in view of the common sense involved in such a proposal, the furore which it causes and one can only wonder, whether this is due to a total lack of understanding on the part of those concerned, of the subject which they claim to be discussing, or whether there is a will in principle to cause disruption."

Regarding voluntary induced abortion, Pr Rassat recalls the first article of the Veil law in 1975 : "the law guarantees respect for all human beings from the very beginnings of life. This principle may only be infringed in the event of absolute necessity and under the conditions specified by the present law". In other words, it specifies that voluntary induced abortion is an exception with respect to the legal rules. In order to modify the law on voluntary induced abortion, the law itself must be specifically modified, it cannot be modified by "knock-on" effect.

The European courts in defence of pregnant women ?
Is it possible to provide legal protection to pregnant women in France ? Perhaps the answer may be found with the European courts on human rights.

On 10th December, a French woman denounced the rejection by French legislation to qualify as unintended homicide of her unborn child which she lost as a result of a medical error (she was confused with a woman wishing to have an IUD removed). Quoting article 2 (right to live) in the European Convention of Human Rights, she claimed that the State has an obligation to establish penal legislation intended to suppress and to punish such an offence.

Will Europe fund research on human embryos ?

Ministerial disagreement
On 19th November 2003, a majority of European Members of Parliament, when questioned, declared that they were in favour of funding research involving the destruction of embryos. In view of the ethical problems involved, the European ministers for research, who had to make the final decision, were unable to reach agreement.

The deadlock
In the absence of agreement, several possibilities are envisaged :
- the moratorium can be extended. This solution implies a concrete refusal to fund any research which involves the destruction of new human embryos,
- the Irish presidency is due to raise the question again in January 2004, but it is highly improbable that an agreement will be found,
- the European Commissioner for Research wishes nevertheless to submit for approval the requests for funding on an « individual basis », to a committee including the experts from the member States.

But the Commission does not have the authority and the declared differences are likely to be confirmed.

The question is particularly sensitive in Germany, which contributes some 20% of the EU budget and prohibits research on supernumerary embryos at home.

Breaking the deadlock
A decision to fund exclusively research on adult stem cells with the 2.2 billion Euro allocated to the 6th Framework Research Programme, is the only alternative which avoids the technical and ethical problems and which could satisfy the urgent needs of patients, since the therapeutic results achieved are already encouraging.