BioWorld International Correspondent
PARIS - French researchers now have the possibility of importing embryonic stem cells from abroad, following the government's creation of an ad hoc committee of scientists and patients' representatives to vet applications.
The move is a step toward the more general authorization of stem cell research in France, since a Biomedicine Agency is due to be established next year that would permit researchers to create their own cell lines from "abandoned," surplus embryos.
Those advances were made possible by the enactment of a new Bioethics Law in July, which legalized research on frozen embryos created as part of in vitro fertilization and no longer required for reproduction purposes. Those surplus embryos are allowed to remain frozen for up to five years, after which they have to be destroyed.
Until the new legislation comes into effect with the creation of the Biomedicine Agency, researchers will be able to import embryonic stem cells, but under strict conditions. They must show that the cells have been taken in vitro from embryos created for in vitro fertilization purposes but no longer required for that. The importer must have proof that the couple has effectively consented to the use of those embryos in research and must undertake not to divulge the identity of the donors.
Moreover, only organizations and agencies that already are authorized to conserve embryonic stem cells can import cell lines. And they have to provide a description of the procedure used by the supplier to remove and preserve the cells, which imposes an additional burden on research teams that are not always equipped for such bureaucratic tasks.
Another legal requirement is particularly baffling to French researchers. It stipulates that the research to be carried out with the cells must be "likely to bring about substantial therapeutic advances." While that could be interpreted to imply that only researchers conducting clinical studies will be allowed to import stem cells, that is not expected to be the case. Legislators wanted to ensure that establishments engaged in purely theoretical, fundamental research with no evident medical application would not be permitted to import stem cells.
Some researches also question the reasoning of the interim measure, given that the first stem cell imports cannot effectively take place before November, due to the time required to process applications, and that Health Minister Philippe Douste-Blazy pledged to establish the Biomedicine Agency around January.
But French authorities have good reason to speed up stem cell research in the country as the European Union now provides generous funding for that type of research, and French researchers need to obtain the necessary approvals from their national authorities in order to compete for the available funds.