Proposals of the Biomedicine Agency for the revision of the law of bioethics

In the perspective of the revision of the law of bioethics and of the Convention foreseen in 2009, the Minister for Health asked the Biomedicine Agency to draw up an inventory of the application of the law of 6th August 2004. In this report, the Agency made proposals for 2009 1.

 

 

The Biomedicine Agency decided to support, in 2008, the financing of four new cord blood banks, increasing the number up to eight banks of the national network (see the following article – Hermange Report).

 

 

Currently, the law authorises resorting to medically assisted procreation (MAP) in the event of medical indications but the Agency mentions the possibility to plan the MAP ”as a new procreation mode, alleviating the impossibilities to procreate in an extensive way whether they are physiological or social with an approach to help single people or couples to have children”. Abroad, some countries consider “the social infertility” as a condition to resort to MAP and open the access to these techniques to single and homosexual women (Great Britain, Spain, Belgium, Holland, Finland, USA, Canada and more recently Denmark). The Agency also proposes to extend the provisions concerning the age of procreating or the obligation of common life. We can note that the report does not deal with physio-psychological problems generated with these forms of procreation.

 

 

To remedy the “lack” of oocytes, the Agency proposes to think about the improvement of the indemnification linked with the “donation”, to the possible raising of the condition of previous procreation and of the extension to the private lucrative sector of the authorisations of this activity. We can note that this financial proposal is hardly concealable with the principles of gratuity and non-commercialisation of human body.

 

 

The report deals with the current prohibition to reimplant embryos on which we have made researches. For the Agency, this prohibition is not desirable because it “excludes” the embryo from the research for itself [we note this sudden interest for the embryo health] and prevents assessing MAP techniques. A “solution proposed” by the Agency would be to consider the transfer of embryos in vitro as a field of clinical research.

 

 

Taking into account the results of the research on embryonic stem cells and the promising therapeutic advances obtained with adult stem cells – and particularly with cord blood cells and iPS cells – the Biomedicine Agency thinks that some of the conditions required for the authorisation of the research on embryo “prevents” the submission of research project. Thus, it suggests, not to stop these researches on embryo but to modify the legislative texts by replacing the condition of “major therapeutic advances” by “improvement of knowledge to the benefit of humanity health and to delete the notion of “alternative method of comparable effectiveness”.

 

 

Although the report does mention that ”no clinical trial using embryonic stem cells was initiated for the moment”, the Agency wants to go back to the derogation regime to the prohibition on embryos set for five years, in favour of a ”perennial authorisation regime”. And this, in particular to benefit from private investments. Finally, it does not exclude the creation of embryos for research purposes.

 

 

The Biomedicine Agency states that the “term of “therapeutic cloning” is not anymore justified” and that ”the term of “nuclear transfer” is much more adapted”. [We recall that it deals here with a same reality…] The report underlines the “difficulty of the technique and the problem raised by oocyte collection” which ”raises its future” and recognises that ”no embryonic stem cells line was obtained with this technique in the countries where it can be performed” and that ”the initial argument of immunological compatibility of lines obtained with the patient is very weakened by the alternative which offers the possibility to reprogram somatic cells (iPS cells)”. Nevertheless, it estimates that the cloning technique may be interesting for ”understanding the process of nuclear reprogramming”. Finally, the Agency mentions the creation of human-animal hybrid embryos like we do in the United Kingdom.

 

 

In conclusion, the Biomedicine Agency wants for itself ”a greater autonomy” which ”could prevent in particular the law of bioethics to comply with the constant technological and scientific developments, to focus on the affirmation of permanent principles”. In other words, the Biomedicine Agency proposes here to switch from a law detailed and regularly reviewed to a law called “framework law”.

 

This idea to establish a framework law which fixes the great principles was already mentioned, during hearings at the Assembly organised by the OPECST (Parliamentary office for assessing scientific and technological choices) in November 2007, by Jean-Claude Ameisen, director of the ethical committee of Inserm, Alain Claeys, chairman of the OPCEST and rapporteur of the parliamentary mission on the revision of the law of bioethics and Axel Kahn, geneticist and chairman of the University Paris-Descartes. More recently, on last 4th November, during his hearing by the parliamentary mission on the revision of the law of bioethics, Alain Grimfeld, chairman of the national consultative ethics committee (CCNE) took up this idea. Nevertheless, it seems that all are not agree about the form the law could take. For the first ones, it deals about establishing a law fixing the great principles governing all bioethics questions and to settle independent agencies – like the Biomedicine Agency – whose role would be to decide and then to deliver or not the authorisations these agencies could have a jurisprudential role concerning the new biomedical practices. For Alain Grimfeld, this law would set out what is ”majorly unacceptable” based on principles like the unavailability of the body and would not go in further ”details”. For Emmanuelle Prada-Bordenave, director of the Biomedicine Agency, the framework law would leave it to the Agency to submit each year a report to the Parliament on the evolutions planned, to have its green light.

 

This proposal should particularly alert the reader when we know that the “details” could be the access conditions to the MAP, the implementation of the oocyte donation and to the research on embryo and embryonic stem cells, cloning, the chimeras… one of the advantages explicitly emphasized by the defenders of this solution would be to prevent the legislator a periodic, heavy and demanding revision, but this could also confiscate the French citizens the debate on these fundamental questions… is it not here a paradox when for the first time, the public opinion will be, via the Conventions, consulted on these subjects? The steering committee will be held by J. Leonetti, physician and French deputy (UMP) and composed of: S. Beloucif, physician and chairman of the Orientation Council of the Biomedicine Agency (ABM), A. Claeys, C. Esper, professor of medical legislation and member of the OC of the ABM, M.-T. Hermange, senator (UMP) and member of the CCNE and S. Rameix, professor of philosophy and head of the medical ethics department of Paris-XIII.

 

1 – Bilan d’application de la loi de bioéthique du 6 août 2004, Agence de la biomédecine, rapport au ministre de la santé, octobre 2008