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The Times OnLine - UK

EU curbs threaten British stem cell research
By Mark Henderson, Science Correspondent




TONY BLAIR’S ambition to make Britain the world leader in stem cell
research is in danger of being undermined by Brussels, one of the
country’s most influential science administrators said yesterday.

European Union regulations could seriously limit medical experiments
involving the embryonic master cells even though Parliament has
approved them, according to Mike Dexter, who retires today after five
years in charge of the Wellcome Trust, Britain’s biggest research
charity.

The Government has passed the most liberal legislation in the world
on stem cell research, which promises treatments for Alzheimer’s and
Parkinson’s diseases and paralysis. It has invested £40 million in
the research. Most EU states oppose it because it involves the
destruction and cloning of human embryos.

In an interview with The Times to mark his retirement, Dr Dexter gave
warning that this mood could constrain the freedom of British
scientists.

Although an outright EU ban is unlikely, Brussels directives and
funding decisions could block stem cell research by the back door,
regulating the work so tightly that it becomes too costly or
impractical to pursue.

“My great worry is these EU directives that seem to face UK science,”
he said. “The challenge is how are we going to deal with these
directives that are trying to reflect one culture, when in Europe
there isn’t a single culture.

“On stem cells, for example, in the UK we have taken an attitude that
is very different to the rest of Europe, and which I would say is
more perceptive and thoughtful.” Asked whether Brussels initiatives
could overturn this, he said: “There is a danger that they could,
yes. From what I can see, a lot could come out of Brussels that could
be damaging.”

Already, embryonic stem cell work has been excluded from the EU’s £10
billion Framework Programme for Research, removing funds that might
be used to develop therapies for devastating diseases.

“I am not saying it is wrong to have these religious views that
object, but I think these people should be listening to patients who
have got these disorders,” Dr Dexter said.

EU directives are blunt regulatory tools that are already having a
serious impact on British science, he said. The Clinical Trials
Directive, for example, which is due to be implemented shortly, has
threatened the role of charities in medical research. Though designed
with the honourable goal of protecting patients who volunteer for
medical research, its provisions for supervision of clinical trials
would have raised costs so greatly that many charities which
currently support such work would have had to withdraw funding.

“This directive would make it remarkably difficult for non-commercial
organisations to sponsor medical research, or even to engage in
medical research,” Dr Dexter said.

“The goal is to protect patients, to ensure that the clinical
research sponsored by pharmaceutical companies is done in an
appropriate regulatory environment.

“We have no quarrel with this. But the directive didn’t take into
account that, particularly in the UK, a lot of this work is not done
by pharmaceutical companies but the charitable sector, which is very
much larger here than in Europe.”

The Association of Medical Research Charities is meeting next week to
consider its response to the directive, and Dr Dexter is hopeful that
its most damaging provisions will be headed off. The greatest threat,
he said, would be a directive influenced by the numerous opponents of
stem cell research in Brussels. Its full implications might become
clear only once they were difficult to stop.

The Wellcome Trust distributed grants worth a total of £490 million
in 2001-2002. It has recently begun to support embryonic stem cell
research, and has awarded grants worth £5.5 million, with more
anticipated as the field takes off.

How laws differ across the world

UK: Stem cell research using surplus IVF embryos and “therapeutic
cloning” — the cloning of embryos for research purposes — is
permitted under licence.

US: Federally-funded scientists may work only with existing lines of
embryonic stem cells, but may not create fresh lines. Private
research is not restricted, though an outright ban on therapeutic
cloning is being considered in the Senate.

Germany: The extraction of stem cells from a human embryo is a crime,
though it is legal to import stem cell lines.

France: All human cloning, including for therapeutic purposes, will
be prohibited in June.

Canada: Legislation under consideration to ban therapeutic cloning.
This would prohibit much stem cell research.

Australia: Surplus IVF embryos may be used in stem cell work.

DEBATE
Will it be regretable if EU regulations kill off stem cell research
in Britain?
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SOURCE: The Times OnLine - UK
http://www.timesonline.co.uk/article/0,,2-626734,00.html

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