We want to show that despite the reminder and the maintenance of the founding principle to prohibit the creation of human embryo for research as defined by the article L.2151-2 of the French Public Health Code “the in vitro conception of human embryo for research purposes is prohibited”, the bill of bioethics will organize everything to give an implied authorisation and favour the needs of procreation industry. It proposes to break down the barriers, to modify the conditions of the Medically Assisted Procreation (MAP), those of the research and then the condition to obtain and preserve gametes.
Modified conditions of MAP
The article L2141.3 which stipulates the conception modalities of an in utero embryo within the framework of a MAP, specified in 2004 that the MAP is made to remedy infertility. In this bill, this indication is extended to the in vitro conception, embryo transfer, artificial insemination and gamete and embryo preservation… The conception of embryos is not anymore exclusively permitted to remedy infertility but to allow performing MAP techniques, which introduces the space/time of the embryo creation for research.
The impact study accompanying the bill, reminds that in 2004 MPs explicitly refused, due to the prohibition of creation of embryos for research, the implementation of innovating MAP techniques. To get around this prohibition, the OPECST proposed in its 2008 and 2010 reports on bioethics to consider the research on embryos within the framework of the MAP as being care practices: “Any technique aiming at improving the possibilities of in utero development of a human embryo should be considered as care and not as research.” In one of these reports we also learn that several authorisation applications for clinical trials on fertilization and freezing techniques are filed to the AFSSAPS: project of oocyte vitrification, slow freezing of embryos, research project including an embryo. The bill does not accept these byzantine distinctions but to get around the prohibition, it presents these researches as simple technique improvements.
Research for medical purposes
The article 23 of the current bill, dealing with the research on the embryo, by proposing to substitute to therapeutic, the notion of medical to obtain derogations for research on the embryo, obviously signs a blank cheque for the research on the embryo within the framework of the medically assisted procreation. The last barrier of general order breaks down.
Increasing the stocks
Finally the modalities for the consent of the couple researching its embryos, as detailed by the article R. 2151-4 of the implementing decree relative to the research on the embryo and on embryonic cells signed on 6th February 2006, allow the creation of embryos for research. Within the framework of a MAP, the couple can “consent at the same time in writing, that the embryos, which would not be susceptible to be transferred or preserved, are subject to a research”. A priori this consent thus represents the in vitro conception of embryos for research purposes.
With the law arranged and consenting parents, all that remains is to organise how to obtain and preserve the gametes. The campaigns in favour of oocyte donations and different techniques of oocyte preservation have this objective. The scarce resource, the new gold standard is the oocyte and once this last obstacle lifted, all will be set up to allow in France the development of procreation industry.
Growing market of the procreation
In a lot of countries, the gametes and the MAP techniques are freely sold, constituting a child market, already globalised. There are a large number of examples: in USA, sperm (USD 275,000 per dose), oocytes (from USD 2,500 to 50,000) can be bought, according to morphological and racial criteria of the “saleswoman”); in Ukraine, a surrogate mother rents her uterus between USD 25,000 and 45,000 … This market is estimated to USD 3 billions per year in USA, without taking into account the rest of the world.
Endocell: embryo-endometrial culture
On 11th June 2010, Genévrier laboratories have inaugurated the extension of their centre “Genévrier Biotechnologie, first European centre of cell culture for therapeutic purposes”. The Sophia-Antipolis premises were converted into a “real industrial production centre” dedicated to the production of Endocell, a system of embryon-endometrial coculture. René Frydman and Jean Leonetti assisted to this inauguration.
System presented as “an advance for assisted reproduction”, Endocell provides “a culture medium, from a simple endometrial biopsy, which offers all the growth factors necessary for developing an embryo in vitro up to the blastocyst stage. It is the performance of a cell layer from cells taken from woman uterine mucosa. R. Frydman explains in the Quotidien du médecin (28th June 2010) that this would allow “single embryos to be transferred, without diminishing patients’ chance of pregnancy and avoiding the risk of multiple pregnancies”. This system seduces for several months MAP professionals whereas its marketing is only planned for January 2011, the clinical trial results still being awaited, specifies the newspaper Libération on 30th September 2010. Authorised to be marketed in 2007 by the AFSSAPS, Endocell would have been tested on approximately 300 women would result in around thirty births.
An emerging product
In its article on Genévrier laboratories from 4th October 2010, la Tribune announced for 2009, €21.4 millions dedicated to research and development, with a turnover of €120 millions against 112 millions in 2008. Today, the company, which holds 83 industrial patents, hires more than 380 employees and projects a turnover of €135 millions in 2010, which ranks it the fourth French independent pharmaceutical laboratory. We understand better that Jean Leonetti, approving the “medical act of force” of René Frydman on the oocyte vitrification declared in the Journal du dimanche (7/11/2010): “we have to offer the researchers a maximum freedom and allow them to improve the conditions of fertilization – what can only be done by handling the embryo.“
Conclusion
Despite some basic hesitations, and under the guise of simple technique improvements, the bill sets up a system which will allow no control of handlings on the embryo within the framework of the MAP. The debates on lifting the prohibition of the research on the embryo will be irrelevant if these researches on the embryo and their creation within the framework of the MAP are authorised. It is a scheduled abandonment of any control, amplified by power transfer towards the MAP. Will the legislator know to protect the embryo against covetousness?