The source of this article is Coalition for the Advancement of Medical 
Research: http://tinyurl.com/4e2ej

The Wall Street Journal
January 26, 2005
Europe Sends Mixed Signals On Stem-Cell Work

By VICTORIA KNIGHT
DOW JONES NEWSWIRES

Scientists, accustomed to setbacks while seeking breakthroughs in stem-cell 
research, often are equally confounded by uncertainty outside their labs. 
Their dilemma: Could they accomplish more if they moved their test tubes to 
a country with a more-receptive political environment?

Mixed signals abound. In Europe, staunchly Catholic Ireland, Italy and 
Poland have banned stem-cell research partly because of religious beliefs 
that harvesting stem cells destroys human embryos and thus is the moral 
equivalent of murder. But Belgium, Sweden and the United Kingdom allow most 
kinds of research, and in November, voters in Switzerland approved a law 
allowing embryo research after the government argued the country -- a global 
leader in biomedicine -- needed to keep pace with rival centers like the U.K.

In France, the government last July eased its ban on some stem-cell research 
for a five-year test period. President Jacques Chirac vowed the country can 
match the success of aircraft maker Airbus in the life sciences. But 
executives of French biotech firms complain that a continuing ban on 
therapeutic cloning -- which scientists hope will allow them to replicate 
and ultimately cure some genetic diseases -- shows moral and political 
objections continue to hamper scientists.

"France is still in the stone age when it comes to supporting research," 
says Jean-Loup Romet-Lemonne, chief executive of Immuno-Designed Molecules, 
a Paris-based biopharmaceutical company that moved part of its operations to 
the U.S. two years ago.

In the U.S., California voters in November approved a $3 billion stem-cell 
research fund, but President George W. Bush has shown no sign of easing a 
federal policy that has limited the majority of U.S. researchers to a few 
sanctioned suppliers of cells. In Singapore, which is attracting top-notch 
researchers from around the globe with generous government support of the 
life sciences, skeptics wonder how fast individual initiative can take root 
in a tightly regulated country.

The shifting directions are driven partly by the high stakes involved, 
industry executives say. "Those countries with favorable regulatory climates 
and adequate funding levels with attract the best researchers and make the 
breakthroughs. They will become the producers. The other nations will simply 
become their customers," says Johan Vanhemelrijck, secretary general of the 
Brussels-based biotechnology-industry lobbying group EuropaBio.

For scientists, the constantly changing regulatory environments are a 
frustrating distraction and pose the threat of delaying important 
discoveries. "Uncertainty is anathema to industry. It kills interest and 
innovation," Mr. Vanhemelrijck says.

In Europe, industry officials cite problems encountered by previous 
controversial research as evidence of the price of uncertainty. It took 
Germany's Hoechst AG, now part of Sanofi-Aventis SA, almost 16 years to get 
production of its genetically engineered human insulin up and running in 
Frankfurt. The local government initially approved the plant's construction, 
but later tried to prevent it from going into production because it objected 
to Hoechst's use of a type of genetically modified bacteria -- then a 
revolutionary biotech process designed to slash costs.

Stem cells extracted from early-stage embryos have the potential to turn 
into cells from any part of the body. Proponents believe embryonic stem 
cells could bring about a revolution in medicine, repairing crippling 
spinal-cord injuries and treating an array of degenerative diseases such as 
Parkinson's. But their use in experiments is controversial because the 
embryo is destroyed in the process. Central to the debate is the definition 
of when an embryo becomes a human being with legal rights. For opponents, 
this is the moment of conception; for supporters, it is after 14 days when 
the embryo shows the first sign of developing a nervous system.

The main body of research involves the use of embryos, donated by patients 
undergoing in-vitro fertilization treatments, which would otherwise be 
discarded. More controversial are therapeutic cloning, intended to produce 
duplicate cells, tissues or organs for humans and which destroys the embryo 
within 14 days; and reproductive cloning, which involves planting a cloned 
embryo into a womb and allowing it to fully develop. 

Most famously used to clone the sheep Dolly in Scotland in 1997, 
reproductive cloning involving humans is forbidden by law in many countries.

Biopharmaceutical companies such as Geron Corp., StemCells Inc., ViaCell 
Inc. and Advanced Cell Technology Inc. -- all based in the U.S. -- are 
developing regenerative therapies to treat everything from cancer to liver, 
pancreas and heart disease. But "there are no late-stage medical products 
based on embryonic stem cells," says Max Herrmann, an analyst at ING 
Financial Markets.

In Europe, the industry has yet to develop. California-based Titan 
Pharmaceuticals Inc. and Germany's Schering AG are jointly developing a 
novel cell therapy, called Spheramine, for the potential treatment of 
Parkinson's disease. But it is using eye cells from cadaveric donors rather 
than embryonic stem cells, according to a spokeswoman for Schering.

The thorny question of bioethics has elicited a wide variety of responses 
from European governments, reflecting diverse religious and cultural 
traditions. The lack of a political consensus in the European Union has put 
a brake on funding from its central budget. Just €130 million ($170 million) 
has been allocated over the past three years on stem-cell research. The vast 
majority of the money went to research on adult stem cells -- which don't 
raise the same moral or ethical issues as embryonic stem cells because the 
donor is unharmed by their extraction, but which many scientists argue offer 
more limited treatment potential.

Christine Mummery, head of the stem-cells group at the Hubrecht Laboratory 
in Utrecht, the Netherlands, has submitted three embryo applications to the 
EU -- all of which were rejected -- and has three further applications 
pending. "On paper there's money. The reality, though, is different," says 
Dr. Mummery, who is trying to create heart cells from embryos to restore 
heart function in patients who have suffered heart attacks.

So far, the EU has earmarked €13 million to scientists conducting human 
embryo research, a tiny fraction of a €17.5 billion research budget for 
2002-2006. As in many other European countries, there are no dedicated state 
funds for embryo research in the Netherlands. Dr. Mummery has secured 
€150,000 in grants from the Royal Dutch Academy of Arts and Sciences and the 
Interuniversity Cardiology Institute of the Netherlands, as well as a 
one-time payment of €500,000 from a government program. But she and other 
researchers aren't seeing any money come down the pipeline.

To continue her research, Dr. Mummery has had to find foreign backers. 
Singapore biotech company ES Cell International Pte. Ltd., a joint venture 
between the Singapore government and a group of Australian investors, pays 
for five researchers, and supplies raw materials and access to its 
facilities in Singapore, according to Dr. Mummery. Singapore is investing 
billions of dollars into bioscience after the dot-com bust depressed 
electronics prices, throwing the island nation into recession. ES Cell 
International employs Alan Colman, who cloned Dolly the sheep, as its chief 
scientific officer and is based in Biopolis, a $500 million research complex.

In Europe, sharp differences in support for stem-cell research are seen 
clearly in Germany and the U.K.

History casts a long shadow over the debate in Germany. During World War II, 
the Nazis conducted infamous experiments in eugenics, and cloning raises 
fears about a similar abuse of science. German scientists can conduct 
experiments on imported stem-cell lines created only from embryos harvested 
before January 2002, subject to approval by the licensing authority, the 
Robert Koch Institute. The institute has approved seven out of 10 
applications since July 2002, when the German stem cell law came into force, 
but researchers can conduct a limited range of experiments and can't conduct 
clinical trials.

"Biotech companies fear they might get in trouble with the police and the 
local bishop," says Ulf Rapp, a researcher at the Institute for Radiology 
and Cell Research at Wurzburg. He says he is in touch with "people in 
California" but has no imminent plans to move, although he isn't ruling this 
out.

In contrast, the U.K. is the closest to a stem-cell-research hot spot in 
Europe. But even with its pro-business, pragmatic political culture and 
strong science tradition, it has tighter regulatory strings attached than 
Singapore or California.

"In the U.K. this field is quite advanced, [but] the regime is not liberal 
in the sense that anything goes," says Lorna Gorman, a spokeswoman for the 
Human Fertilization and Embryology Authority, which licenses and monitors 
the country's embryo research. Applications are vetted by ethics committees 
and undergo an extensive peer-review process. The authority has approved 10 
research applications to extract stem cells from embryos since it was set up 
in 1991 and is reviewing seven more. Most of the applications were approved 
during the past three years after the law was changed to allow research into 
serious diseases.

Licensed researchers can produce stem-cell lines from embryos donated from 
IVF treatments and also conduct a wide range of experiments on them. This 
contrasts sharply with the situation in Germany, where only some imported 
stem-cell lines can be used, and in more limited ways.

Germany bans therapeutic cloning while the U.K. has embraced it. Last 
August, the U.K. authority granted its first license to a team from 
Newcastle's Center for Life to conduct therapeutic cloning to detect and 
study a range of genetic diseases, such as diabetes. The approval came 
shortly after a team of researchers in South Korea announced -- in a world 
first -- that they had successfully cloned cells using this technique. While 
cloning human embryos to create babies is banned in the U.K., therapeutic 
cloning was made legal in 2001.

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