France allows stem cell work

New bioethics law permits ES cell research, but not cloning

By | July 15, 2004

The French Parliament last Friday (July 9) adopted a new bioethics law that allows embryonic stem cell research, and for at least one research group, the decision has made the difference between conducting their work in France or the United States.

The new law states that human reproductive cloning is a "crime against the human species," and although therapeutic cloning will remain illegal in France, research on embryonic stem cells will be allowed within strict parameters.

"For the first time, thanks to the law on bioethics, reproductive cloning is very clearly made a crime against the human species, and therapeutic cloning an offense," said Philippe Douste-Blazy, minister of health. "Protecting human embryos is an explicit goal of the civil code," he added. Reproductive cloning experiments will be punishable by up to 20 years in prison.

However, in recognition of their medical potential, Douste-Blazy and François d'Aubert, minister of research, will soon ratify a text enabling researchers to import embryonic stem cells. They will be able to begin research projects using these as soon as this fall.

For Michel Puceat, director of a team studying embryonic stem cells and cardiac differentiation in Montpellier, the status quo meant he was very near to taking some of his experiments to the United States.

"We are working in collaboration with an American lab and got a NIH grant 1 month ago to work with human embryonic stem cells," Puceat told The Scientist. "We were under quite a lot of pressure these last weeks since we were not sure to be able to perform this research in France. We had planned to move to the US to do it."

For Puceat, several lines of research in mice have been stagnating while he awaited permission to pursue them in human cells.

Puceat's team has created a protocol to commit mouse embryonic stem cells to cardiac cell lineage and would like to test them in humans. They have also uncovered a transcriptional pathway that is key to specifying the cardiac fate of embryonic stem cells in mice. He says the pathway includes a transcription factor that does not appear to be regulated in the same way in mice and in humans, and he would like to study it in human cells.

Finally, Puceat has been wanting to apply for European funding, but has not been able to so far despite a promising research background in mice.

Research on supernumerary frozen embryos—resulting from in vitro fertilizations—will be authorized within 5 years.

The uncertainty regarding how many such embryos there are in institutes across the country—estimates are between 100,000 and 200,000—was called a "grave anomaly" by Douste Blazy. It led him to call for more stringent protocols for the preservation of embryos so that precise statistics may be collected from the various institutes.

The new law also allows for "baby medicine," whereby parents may select one embryo among several to produce an offspring that is best matched to a sibling suffering from an incurable genetic disorder.

In order to legislate matters relating to embryology and reproduction as well as human genetics and grafting, a new "national agency for biomedicine" is to be created. According to Douste-Blazy, it will be operational by January 1, 2005.

France adopted its first law on bioethics comparatively early, in 1994. However, conscious of the fast-paced progress of research and medicine, the legislators of the 1994 law stipulated that it should be revised within 5 years.

The 2004 revisions therefore come 5 years late. They are the product of 3 years of deliberation and two administrations.

"We have been waiting and requesting this law or a derogation to the previous one to import human embryonic stem cells for more than 2 years," said Puceat. He and his colleagues had prepared an application to obtain permission to import these cells over 2 years ago, but were repeatedly "neglected."

Puceat says it took a change in government to get the ball in motion. "Finally, when the government changed a few months ago," he told The Scientist, "we got the feeling that something could happen. The new minister of health, Mr. Douste Blasy, even sent me a letter to assure me that he was doing his best to obtain the ratification of the new law."

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