After three years of preparation, hearings, debates, the revision text of the law of bioethics is finally voted. After a first reading in the National Assembly (see. Monthly letter of February 2011) and in the Senate (see. Monthly letter of April 2011), it has new modifications in second reading in both houses, before being examined by a joint committee (CMP: 7 deputies and 7 senators) which gave it its final character. The law has been adopted in the National Assembly on 21st June 2011 and in the Senate on 23rd June.
Referred to as “restrictive” or “conservator” by some people, yet the text contains new transgressions regarding the law of 2004: if the prohibition on the research on the human embryo is finally kept, the extended derogation conditions lead in the facts to an increased instrumentalization of the human being; the reinforcement of the prenatal diagnosis (DPN) expends an eugenics de jure; finally the measures simplifying even more the gamete donation contribute to deepen a little bit more the gap between sexuality and procreation.
Yet this would have been worse without the courageous fight of a small group of parliamentarians which knew how to generate, during the long process of the parliamentary procedure, some happy reversals. Here is a balance of the main provisions of the law which would govern, during the next seven years, the biomedical practices.
The parliamentarians have adopted measures to promote organ donation and transplantation. This way they opened the organ donation between living beings to “any person being able to prove a narrow affective and stable relationship for at least two years with the receiver“. The law of 2004 limited the donation between living beings to strictly family relationship.
The possibility of a crossed organ donation in case of incompatibility between the donator and the receiver can also be adopted.
Information about the legislation related to organ donations for transplantation purposes and blood donation awareness will also be conducted in high schools and higher education institutions.
Placenta and cord blood donation
Cord blood and placenta, until now considered as “surgical waste” will have now the statute of “therapeutic resources“. The article 7 of the bill specifies that the donation of placenta blood and cord blood cells can only be “anonymous and free donation” for allogeneic purpose. Nevertheless, “by derogation, the donation can be dedicated to the born child or to the brothers or sisters of this child in case of demonstrated and dully justified therapeutic necessity when sampling“.
Prenatal diagnosis (PND)
The question of access conditions to PND – very polemical – has still been in discussion until the joint committee. Whereas the law of 2004 did not institute any legal obligation for the physician to propose systematically the PND to any pregnant woman, the new law stipulates that “any pregnant woman receives, during a medical consultation, fair, clear information and adapted to her situation on the possibility to resort, on her demand, to medical biology and imaging examinations enabling to assess the risk that the embryo or the foetus presents an affection liable to modify the development or the follow-up of the pregnancy“.
This obligation of information and the new qualification of the information delivered to the woman replaces an amendment, passed in first reading in the National Assembly, which proposed that the PND is proposed to the pregnant woman only “when the medical conditions require it“, in order to limit the eugenic drifts related to the systematisation of PND.
On the contrary the voted text deals with “legalizing a eugenics policy obliging the physicians to inform all the women, in other words to warn them on the ‘risk” incurred. This amounts obviously to incite to PND with all the consequences we know“, analyses in a press release Jérôme Lejeune Foundation. The report from the Council of State, in 2009, indicating that 96% of children screened for Down syndrome were aborted, revealed the degree of eugenics drifts.
The article 9 also authorises midwives to prescribe the PND.
Yet some positive provisions have been voted. The paragraph 6 of the article 9 foresees that in case of demonstrated risk of disability, “a list of specialized and approved associations for accompanying patients with the suspected affection and their family” is proposed to the couple in order to help it to make an informed decision with complete information. The article 12b finally stipulates that “within a period of one year from the publication of this law, and then every three years, the government delivers to the parliament a report establishing the detailed balance of public funds allocated to the research on cytogenetic anomalies, in particular those allocated to the research performed for the health of patients with these diseases. “The initial reference to Down syndrome, which is subject of a particular stigmatisation, has been removed.
Preimplantation diagnosis (PGD)
Regarding PGD, the parliamentarians have voted the sustainability of the procedure of double PGD – also called PGD-HLA or “designer baby” – here again in disregard of warnings from the Council of State which noted in its report that “the questions raised by the ‘double PGD’ and the fact that it has been infrequently used could justify that the legislator plans to put an end to this practice“. The text specifies that resorting to double PGD is only possible “provided to have exhausted all the possibilities” also offered by the law.
Anonymity of gamete donation
Initially registered in the text from the Government, the lift of anonymity of gamete donation has been refused by the parliamentarians. The debates revealed that the very particular statute of gametes, which, transmitting heredity, cannot be considered as cells like others. The consequences of this measure should be even more sensitive that the law expends a simplification of gamete donation.
Medically assisted procreation (MAP)
After lively discussions, the MAP remains reserved to couples in situation of “medically diagnosed” infertility. The access is thus prohibited for homosexuals and singles. Let’s note that PACSed couples and their partners will be able to resort to it in the same conditions as married couples.
The article 19A also foresees to promote the gamete donation, asking physicians and gynaecologists to regularly inform their patients on this donation. Gamete donation by nulliparous major people is authorized.
The article 19 authorizes the oocyte vitrification. Its supporters have said that this technique of ultra-rapid freezing would allow creating oocyte stock which would avoid resorting to supernumerary embryo freezing, as well as developing oocyte donation. In the facts, it is more likely, like said a certain numbers of MAP specialists, that two parallel stocks will be developed. Nevertheless, the article 19 specifies that “the implementation of the medically assisted procreation favours the practices and the processes which allow limiting the number of preserved embryos. ”
Post-mortem embryo transfer and surrogacy remains prohibited.
Research on the embryo and embryonic cells
Crucial and emblematic challenge of the revision of the law, the prohibition of the research on the embryo and embryonic cells with derogations has finally been adopted in second reading in the Senate with 164 votes against 161. The vote ratified the choice of the National Assembly, the Senate pronounced in first reading for the regulated authorization of the research. If this prohibition has a symbolic importance, the fact remains that the research on the embryo, even if by derogation or exceptional, affects the respect of the “human being at the beginning of its life” as it is mentioned on the article 16 of the Civil Code and weakens the scope of the dignity principle. In the facts, the expansion of the conditions for derogating the prohibition – the condition of the “therapeutic purpose” being replaced by the largest one of “medical purpose” – opens the door to an instrumentalization of the human being for the benefit of scientist lobbies and pharmaceutical industry.
The article 23b also foresees that the “Government presents to the Parliament, before 1st July 2012, a report related to the conditions of implementation of biological resource centres under the form of a centralised system for collecting, storing and distributing supernumerary embryos donated to the science“, in order to facilitate the access to embryos for researchers. Yet the text stipulates that “the alternative researches and compliant with ethics must be favoured“. The article 24 b A thus foresees that the Government delivers each year to the Parliament a report on these alternative methods.
Let’s note that the conscience clause has been granted to any “researcher, engineer, technician or research assistant, any physician or physician assistant who would be faced with a research protocol on human embryos or human embryonic stem cells (article 24 d).
Biopower of the ABM
The Agency of biomedicine (ABM), an institution whose functioning is far from having always been transparent, will be better regulated. Regarding the research on the embryo, it will have to deliver every year a report consisting in “an assessment of the progress state of the researches on the embryo and the embryonic stem cells, including a comparison with the researches concerning adult stem cells, induced pluripotent cells and the cells from cord blood, umbilical cord and placenta, as well as a comparison with international research“. Its members will have the obligation to declare each year “their direct or indirect relationships with companies or institutions whose activities fall within the jurisdiction of the agency“. 6 parliamentarians instead of 2 currently would also have to sit in its Advisory Board.
Assessment of the law
The periodic revision of the law of bioethics has been very much discussed, some parliamentarians fearing this gave the impression that the ethical rules are unstable. Others wanted that a regular appointment is given for the parliamentarian and democratic debate in order to avoid ethical drifts. The text by the joint committee finally foresees that the text voted will be revised in 7 years, which will be preceded by the Estates General of bioethics and an assessment of its application by the Opecst. The opposition worked for the adoption of this measure: “for me the clause of revision of the law seems undoubtedly necessary, when the prohibition of the research on the embryonic stem cells was maintained“, declared the PS vice-chairman of the joint committee Alain Claeys. “we will have to come back as soon as possible on this restrictive text“, added another parliamentarian of the opposition, who affirmed that if the majority changes the research on the embryo will be instantly authorised.
If the law is voted, the vigilance is more than ever necessary regarding the application and the possible evolution of the text.