Laying Down the Law

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By Amber Lepage-Monette

Stem cell research can be a complex minefield of moral and ethical conundrums, often made more complicated when one considers that regulation not only varies from country to country, but sometimes even within a nation’s borders.
American, British and Canadian policies are quite divergent — the U.K. is often portrayed as being the most permissive country, and the U.S. as the most restrictive, with Canada falling somewhere in between.
But Rosario Isasi, a post-doctoral fellow at the University of Montreal’s (Montreal, QC) Centre for Research in Public Law, says the lines aren’t quite so clear.
“Each of the countries . . . Canada, the U.S. and the U.K., adopt different policy frameworks,” Isasi says, noting that the rigidity of each policy is in the eye of the beholder.
“I would say the U.S. is not the most restrictive one, because there are so many nuances on how research can be conducted,” she says.
Currently, individual states within the U.S. set their own legislation regulating embryonic stem cell research supported by state funding. Several states, such as California and Massachusetts, permit embryonic stem cell research and the creation of embryos for research purposes.
When it comes to federal funding from the National Institutes of Health, researchers are only allowed to work with surplus embryos derived from in vitro fertilization (IVF) procedures prior to August 2001, thereby restricting researchers to approximately 60 existing lines.
Isasi says that the U.S. is the only country that currently distinguishes between privately and publicly funded research, and that in the U.K. and Canada, all research conducted falls under the same set of regulations.
U.S. researchers who apply for federal funding need to tread carefully when working with private money to ensure that none of their public dollars get used in their private research.
“It’s very tricky and very hard for scientists in the United States to conduct the research, especially if they know that if they violate this prohibition of using any public funding, they lose all public funding,” Isasi says, adding that the mere appearance of violating the public versus private provision can result in a loss of public financial support.

Keeping a Close Eye
The U.K., on the other hand, allows more research to be conducted, but also imposes tight restrictions on how and who can perform the research.
And these regulations are precisely why Stephen Minger, PhD enjoys working in the U.K. so much.
“I would say if you want to do stem cell research, the U.K is probably one of the best places in the world to do it,” says Minger, director of the Stem Cell Biology Lab at King’s College, London (London, UK). “It’s got the right regulatory environment and it’s got very constructive and supportive governmental policies.”
Minger spoke at the Ontario Genomics Institute’s (Toronto, ON) stem cell conference in Toronto last October to explain not only his area of research, but also how the Human Fertilization and Embryology Authority (HFEA) (London, UK) in the U.K. regulates stem cell research.
To work with existing stem cell lines derived in the U.K., researchers must apply to the stem cell bank steering committee, Minger says, though the research itself does not require a permit. When importing lines from other countries, researchers are required to register with the committee, he says, so that all lines coming into the U.K. can be accounted for.
Additionally, researchers may create embryos for research purposes, but must obtain a licence from the HFEA, though Minger notes that the majority of researchers use surplus embryos derived through IVF procedures, with patient informed consent.
Minger says that the U.K.’s tight oversight is the optimal framework in which to conduct such controversial research.
“I don’t know of anyone in the U.K., in the research community, who is opposed to the kind of regulation that we have here,” he says. “We are all fairly unanimous in the fact that we think the regulation provides a very tight, rigourous framework in which to operate, and I think it provides a great deal of public confidence that they know exactly what’s going on.”
The HFEA has an open-information policy, which means the public can find out who has what licence for what research.
Isasi agrees that such regulations help allay the public’s fears.
“I think it’s vital, because it provides transparency to how the research is conducted,” she says. “And because there’s transparency, the scientific discoveries and the research can be widely supported for both the civil society and the government.”
The U.K. model provides reassurance, Isasi says, particularly when compared with countries such as South Korea, where the public doesn’t have access to similar information.
“Having a governmental agency or administrative agency with this mechanism, such as the one in the U.K., I think is a win-win situation,” she says. “Both for the researchers . . . and also for the public.”
The British government’s continuing support was clearly demonstrated last month when it pledged to double its spending on stem cell research to 100 million pounds (approximately $ 200 million Cdn).
The funding is specifically focused on supporting the national stem cell bank, financing clinical trials, and funding research into cell-production facilities.

Middleman
Canada’s stem cell regulation policy is often seen as an intermediate between those of the U.S. and the U.K.
Creating embryos for research purposes is banned in Canada, as is therapeutic and reproductive cloning.
Embryonic stem cell research is permitted when using surplus embryos from IVF procedures, but requires a license under the Assisted Human Reproduction Act (AHR).
The AHR Act received royal assent in March 2004, and will be overseen by the Assisted Human Reproduction Agency of Canada, which is expected to be established early this year in Vancouver, B.C.
In both Canada and the U.K., it is illegal to purchase embryos, egg and sperm. One can, however, compensate for the expenses the donor incurs, though what qualifies as an expense is not so clearly defined.
Legislation surrounding the purchase of such human materials is undefined in the U.S., Isasi says, which opens the door for the commercialization of human reproductive material.
“There’s no federal law, and few state laws deal with embryo donation or purchases . . . it’s a grey area,” she says. “In some states, the compensation from donation, the amount and the way they are handling it, it’s equivalent to the buying and selling of embryos.”
When it comes to the controversy surrounding stem cell research, both Isasi and Minger say the debate will change once therapies become available.
“Once it is proven the scientific discoveries are translated into effective medical therapies and medicines, the public in general will be more tolerant, will embrace more of this research, and of course, the government (will) as well,” Isasi says.
Minger adds that governments may also have to struggle with the point of view they have chosen.
“I ask this of people all the time who work and regulate in countries that are adamantly opposed to this research — what will you do when there are therapies that are available?” he says. “Are you then going to say to the people in your countries, ‘No, sorry, you can’t have these therapies because this was created by what we consider to be immoral research.’ People will go where there are therapies.”