October 24th, 2002
Penny Gilbert and Robert Fitt
When it comes to stem cell research, U.S. companies may soon be facing a fundamental choice: Should I stay, or should I go?
The U.S. position on human cloning and stem cell research is at an impasse. Last year President Bush announced that the federal government would fund only limited embryonic stem cell research using existing cell lines. The President's Council on Bioethics recently recommended, by a 10 to 7 vote, that the president support a permanent ban on reproductive cloning and a moratorium of at least four years on cloning for biomedical research. And the Senate and the House are embroiled in various legislative efforts over the legality of performing any type of cloning. One bill in the Senate proposes to make any form of human cloning a criminal offense punishable with a $1 million fine and up to 10 years imprisonment.
What's a U.S. company to do? Should it invest time and money in embryonic stem cell and cloning research in a place where public funding is limited and the possibility of criminal charges looms? Or should it carry out research in the United Kingdom? The U.K. government is actively encouraging stem cell research -- and at least one U.S. academic has moved there for that reason.
The U.K.'s publicly funded Medical Research Council has set up fast-track grants to entice international academics and is reportedly investing $57 million a year to support training, fellowships, and other research programs in the field. At press time, the Council planned to announce the creation of the world's first stem cell bank. Prime Minister Tony Blair has already pledged to make the U.K. "the best place in the world" for stem cell research.
What's so controversial about stem cells? A stem cell can become any other particular cell type -- heart muscle, bone, skin. Researchers are trying to discover ways to help stem cells become blood cells to boost dwindling supplies, skin to replace that lost by burn victims, or heart muscle damaged by disease. Stem cells can only be derived from embryos, fetal tissues, and to a certain extent, some adult organs. Critics worry that cells may come from aborted embryos or from cloning. Some fear that the use of cloning in order to treat disease (therapeutic cloning) will inevitably lead to the use of cloning to produce babies (reproductive cloning).
These ethical concerns exist in the U.K., but have not stymied research. Embryo research in the U.K. is governed by the Human Fertilisation and Embryology Authority, which was established in 1991 to deal with issues arising from in vitro fertilization. Licenses are required for all relevant research projects and cloning using fertilized eggs is banned.
Pro-life groups have challenged the Embryo Authority in court, and even won a lower court ruling curtailing its licensing authority, but that decision was overturned on appeal in January.
In a further development some weeks after the appeal, a House of Lords select committee gave the go-ahead to a limited form of human cloning and authorized the Embryology Authority to issue the appropriate research licenses. Anti-abortion and religious groups decried the decision, but it helped put a comprehensive regulatory framework in place for scientists to conduct research. Within days, the Embryology Authority issued two licenses for scientists to generate stem cells from human embryos, and the U.K.'s BioIndustry Association reported that it had been contacted by a number of U.S. companies with stem cell operations wanting information about the U.K.
Professor Roger Pedersen, a stem cell specialist, had already jumped ship. He moved from the University of California in San Francisco last year to Cambridge University. Pedersen has stated that he would not be surprised if other researchers followed his lead.
Geron Corp., based in Menlo Park, Calif., has started to invest in the U.K. biotech industry as a hedge. In May 1999 the U.S. company acquired Roslin Bio-Med Limited, a company created to license the research of the Roslin Institute, home of Dolly the cloned sheep. Geron can now do research in either country.
The future of stem cell research will give rise to further ethical debates and controversies, but at least in the current climate the U.K. offers a clearly regulated environment that some believe will enable the country to become a world leader in stem cell technology.
Penny Gilbert is a partner in the biotechnology and pharmaceuticals
group at London's Bristows. Robert Fitt is an associate at the firm.
© 2002, IP Worldwide