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German Research Minister Edelgard Bulmahn and Health Minister Ulla Schmidt issued a joint statement last week patting themselves on the back for what they described as the success of a new law that allows German researchers to import human embryonic stem cells. But not everyone in Germany's stem cell research community was patting along.
Stem cell researcher Jürgen Hescheler, head of the Institute of Neurophysiology at the University of Cologne, told The Scientist: "I would tell the ministers that they should go to the labs and speak with the basic scientists. They never spoke with us. I guess they just assumed the law was good."
Is he satisfied with the new law? "Definitely not," Hescheler said.
The two ministers issued their statement in conjunction with release of an 18-page "progress report" detailing the first 18 months of the law, which took effect July 1, 2002. After describing the law a success, the two ministers said: "The possibilities for using human embryonic stem cells for research made possible by the law have been seized [by researchers]."
The progress report states that from July 1, 2002, through the end of 2003, some seven applications to use imported human embryonic stem cells were submitted to the Robert Koch Institute, which must give regulatory approval before import is allowed. Five were approved.
Koch spokeswoman Susanne Glasmacher told The Scientist that as of Monday (August 2), a total of eight applications had been submitted under the new law. Five were approved (including an application from Hescheler). Two applications were still pending, and one had been rejected, she said.
Annette Schmidtmann, program director of the German Research Foundation's life sciences division, told The Scientist that the new law is "reasonable insofar as it provides a legal base to work on human embryonic stem cells." But she does not see approval of five stem cell research projects since the law took effect as reason to celebrate.
"The stem cell act did not stimulate research on embryonic stem cells, which can be seen in the fact that only five proposals have been approved under the new law," Schmidtmann said. "Young researchers in particular have been hesitant to place their future on a subject area that not only is very limited legally, but also viewed critically in the public eye."
Before the new law took effect, use of human embryos in Germany had been banned for all purposes except reproduction. The highly controversial new law was passed by the German parliament only after much public debate and ethical input from religious leaders, philosophers, scientists, lawyers, and others.
The law requires that imported stem cells come from embryos produced by in vitro fertilization but not needed for pregnancies and that couples providing the stem cells are not paid money. But the requirement most often criticized by German scientists is that only stem cells that date before January 1, 2002, may be imported into Germany.
Hescheler, of the University of Cologne, said that older stem cell lines are adequate for basic research, but that new stem cell lines are needed for clinical research. Banning the import of new stem cell lines effectively makes it impossible for Germany to participate in a proposed European stem cell bank, an initiative he supports, he said.
One of the biggest problems in stem cell research is immunologic rejection, Hescheler said.
"This problem can only be solved with a stem cell bank," he said, adding that to be effective, such a bank would have to have anywhere between "a few hundred stem cell lines to more than 2000."
Oliver Bruestle, head of the Institute for Reconstructive Neurobiology at the University of Bonn and one of Germany's most celebrated stem cell researchers, spoke out on the issue in May, saying that the import ban on newer embryonic cell lines must be lifted.
Schmidtmann, of the German Research Foundation, agreed: "The current stem cell act is not very future oriented, as it prevents scientific experiments on clinically applicable cell lines in Germany."
In an interview with The Scientist, Research Ministry spokesman Florian Frank said that Minister Bulmahn was well aware that new stem cell lines would be needed for clinical research.
"But at the moment, at this very moment, we are doing only basic research in Germany," Frank said. "We do not yet need a new law." When the time comes for German scientists to start clinical stem cell research, "then we will have a new [legislative] discussion," Frank said.
Hescheler disagreed: "It is important now to have the right regulations. If we want to go in 5 to 10 years to clinical applications, then we must now have a clear statement that Germany is ready to do this."
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