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.
Preservation of cord blood
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).
Assistance to procreation
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.
Oocyte donation
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.
Biomedical researches
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.
Research on embryo and human embryonic
cells
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”.
To abolish the derogation regime?
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.
Human cloning and human – animal hydrides
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.
A framework law
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
|
|
In a report
published on 4th November 2008 1, Marie-Thérèse Hermane (UMP
senator) denounced, in the name of the Senate commission on Social Affairs,
the French delay concerning the storage of cord blood (see
Letter Gènéthique No 91). 20 years after the first global cord blood
graft, performed by Pr Eliane Gluckman (Saint-Louis hospital, Paris), France
ranks 16 at global level in terms of umbilical cord blood units USP) (stored
per inhabitant, with 7,000 USP when 50,000 would be necessary to comply with
the national needs. It is the objective fixed by this report up to 2008.
Marrow/blood comparison
The cells extracted from cord blood are pluripotent and yet used
successfully in nearly 85 therapeutic indications, related to blood diseases,
which affect over 126,000 people per year in France. In 1988, from the
success of Pr Eliane Gluckman’s team, 20,000 people could benefit from this
type of graft.
Cord blood grafts replace advantageously marrow grafts, especially because
they tolerate differences of HLA system. "It has to be note that the non
HLA identical cord blood graft gives also as good results as marrow graft,
if the cord blood is HLA identical, the results are even better than for
marrow graft", explains Pr Gluckman. When only 9% of the patients
waiting for marrow graft find a compatible donor, all patients who have to
receive cord blood graft find a compatible donor. We note that, each year,
the part of cord blood graft increases to the detriment of marrow grafts.
Thus, in 2007, cord blood grafts represented 27% of allogeneic grafts
performed in France.
High therapeutic potential
In addition to blood diseases, scientists think they can use cells from cord
blood to reconstitute the bones, the skin of severely burned people and also
plan to treat juvenile diabetes, some neurologic and cardiac diseases or
even some hepatic and renal diseases. This therapeutic richness assumes the
State’s liability: "its inaction (…) could one day be analysed as
a loss of chance for French families who could not stored the umbilical cord
blood".
A lack which can cost a lot
In 2007, 64% of the grafts used in France have been imported, which, with an
average cost of import of 18,000 euro per unit, resulted in a deficit of 3.6
million euro paid by the social security. Today, only eight maternity homes
are habilitated to collect cord blood in France. Today, in the absence of
collection policy, the quasi-totality of umbilical cords are considered as
surgical wastes and are incinerated.
The report proposals
The Senate’s report defends a “more ambitious collection policy”
performed “in the respect of ethical principles of anonymous donation,
free and non directed”. It insists on the need to create a network of
maternity homes habilitated to sample cord blood, develop professional
training and the information to the public and favour the research. The
report proposes also to associate private clinics deprived from collection
activity and to authorise, for experimental purposes, the implantation of
private banks – today prohibited in France – while respecting the principles
of solidarity. The storage in these banks would be chargeable and made with
a graft perspective but, in parallel, the grafts would be registered in the
national list and then susceptible to be used for solidarity allogeneic
needs. Moreover, the simultaneous development of an activity deprived from
public banks would enable consolidating their financing.
1 -
Le potentiel thérapeutique des cellules souches extraites du sang de cordon,
M.T Hermange, Rapport d’information du Sénat n° 79, 4 nov. 2008. |
