BioWorld International Correspondent

PARIS The French National Assembly was due to start discussion Tuesday of the government’s new “bioethics” bill, which is designed to update the existing legislation enacted in 1994. As presently drafted, the bill authorizes research using cells from superfluous embryos left over from in vitro fertilization programs, but outlaws therapeutic cloning of stem cells.

However, BioWorld International learned that a leading member of the ruling socialist party, Henri Emmanuelli, chairman of the parliamentary finance committee, planned to introduce an amendment that would legalize the cloning of stem cells for therapeutic purposes. Moreover, he is said to be able to count on the support of a large number of deputies.

His amendment would permit stem cell research to be conducted “using stem cell lines created from embryos that have been obtained for that purpose and have not reached the stage of cellular differentiation, conceived from cells taken from people within the framework of existing protocols.” He also will argue that “banning therapeutic cloning is not justified by ethical considerations, especially as it may eventually bring major medical discoveries.”

To support his amendment, Emmanuelli will make the following points: “Stem cell research holds out great hopes in the long term as regards new therapies that could in the future successfully treat numerous diseases that are incurable at present. They offer the hope, for example, of being able to replace the brain cells destroyed by Parkinson’s and Alzheimer’s diseases, treat multiple sclerosis, and renew myocardial cells destroyed after infarction and bone cells in the case of osteoporosis. While no one can predict what discoveries this research might lead to, nor over what time frame, no avenue should be closed off. The seven years during which research into embryonic cells has been banned (since the 1994 act) have been a serious handicap for our scientists and for medical progress.”

Emmanuelli’s arguments echo those of the French biotechnology industry association, France Biotech, which issued a statement in the run-up to the debate warning that French medical research would be seriously penalized if therapeutic cloning remained banned. While welcoming the bioethics bill, especially as it relates to gene therapy, cellular therapies, organ donation and the strict ban on reproductive cloning, France Biotech regards the ban on research involving therapeutic cloning as an “excessive limitation on stem cell research.” Pointing out that therapeutic cloning is an “equivocal term” used to describe DNA grafting techniques, it asserts that “in the opinion of the majority of experts in France and abroad, stem cells derived from therapeutic cloning could open up new treatment possibilities in the medium term, especially in the areas of cardiac insufficiency, diabetes and hepatic diseases.”

Emmanuelli and France Biotech also are singing from the same hymnbook on the ethics question. France Biotech argues that authorizing research into therapeutic cloning would not raise any major ethical issues, since society has already accepted organ transplants and medically assisted procreation, and the possible health benefits are substantial. It acknowledges that the bill’s limited approval for embryonic stem cell research is “certainly useful,” provided such research gets under way immediately, since it will prevent French research in this area from being completely sidelined, but it does not permit researchers to study the transfer of cells into eggs in humans, nor to produce stem cells that are perfectly compatible with a patient’s immune system.

France Biotech warns that if cells derived from supernumerary embryos collected in specialized medically assisted procreation centers were used for implants, it could create rejection problems because the cells would come from donors that are not related to the patient. There would not be the same danger if the implanted stem cells carried the patient’s own DNA. The association suggests that donating eggs for the purpose of DNA transplants should be treated like any other donation of human organs or tissue for therapeutic purposes, such as blood, kidneys and bone marrow.