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Parts of the whole
July 2011
by Jeffrey Bouley  |  Email the author


It's not an uncommon refrain for proponents of stem cell research in the United States—particularly those who want to see more progress on the human embryonic stem cell (hESC) front—to bemoan that U.S. restrictions on stem cell research will put the nation behind the rest of the world.  
That sentiment isn't altogether accurate, as there are many first-world nations that put up just as many, and sometimes even more, barriers to stem cell research. On the other hand, there are nations that have been operating under more liberal policies than U.S. researchers have had to face and who could gain ground and pull ahead. But as the stem cell research community stands now, with so much promise and very little commercialization, "pulling ahead" doesn't mean beating the United States to the next punch and doing a victory dance. Many of the other nations very much want Americans in the mix to keep collaborative efforts strong.  
Major English-speaking nations definitely make a strong showing in terms of stem cell research. In the Asia-Pacific region, looking at government grants and stimulus funding, the most active participant in the stem cell sector on both the academic and industry ends of the spectrum is Australia, according to market research firm Frost & Sullivan in its "Stem Cell Research— Technology Investment Opportunities" report released in March 2011. This is despite having what Frost & Sullivan calls "a notable absence of work" in the induced pluripotent stem cell (iPSC) arena. The nation also figures strongly in terms of stem cell publications, with 663 such articles between 2001 and 2009, beat out in the region only by Japan with 2,852, China with 946 and Korea with 703, according to Douglas Sipp in his article, "Stem Cell Research in Asia: A Critical View," in 2009 in the Journal of Cellular Biochemistry.  
In Canada, "certainly there is a strength in fundamental stem cell biology, and I think that has to some degree been enabled by the lack of political hurdles around embryonic stem cell research as countries like the United States have faced," says Dr. Michael H. May, CEO of the Centre for Commercialization of Regenerative Medicine, which is based in Canada but seeks to be a global facilitator of commercializing stem cell breakthroughs in the future.
Looking toward Europe, the United Kingdom has long boasted one of the more liberal sets of societal, academic and government policies around stem cell research, and there the government is the major source of funding, making up more than 70 percent of investment in stem cells, according to Frost & Sullivan. However, the United Kingdom is having a hard time getting companies past early-stage status in this sector due to a lack of strong venture capital funding.  
Because the United Kingdom has had very permissive policies for a long time, "It's also important to note that in the Bush years, the U.S. lost a lot of researchers to the U.K. and other areas," says Dr. Debra J.H. Mathews, assistant director for science programs at Johns Hopkins University's Berman Institute of Bioethics, a senior policy and research analyst at the Presidential Commission for the Study of Bioethical Issues and a member of the Hinxton Group, an international consortium on stem cells, ethics and law.  
Glyn Stacey, director of the UK Stem Cell Bank, notes that much pretranslational activity on cell biology is occurring in the United Kingdom, with some "significant" adult stem cell clinical trials and hESC trials in the pipeline, though she says the United States remains ahead of the curve there. "But the U.K. is generally strong on developmental biology and stem cell research—alongside Germany—and has a regulatory advantage through the HFEA regulator for embryonics and also a U.K. regulatory road map for stem cell therapy."
Looking elsewhere in Europe, Sweden has a well-organized public funding system, permissive research policies and significant venture funding; Denmark boasts strong public funding for basic research; and Switzerland, while its policies focus on adult stem cells and don't favor hESC work, also has strong governmental funding.  
The European picture is "extremely varied," notes Göran Hermerén, a professor of medical ethics in the medical school faculty of Lund University in Sweden. "In some countries, it is forbidden to create new embryonic stem cell lines, in others it is permitted, and permitted under varying conditions and with certain methods—somatic cell nuclear transfer, 'cloning,' is allowed in some countries but not in others—and even the definition of key terms like 'embryo' is not the same in all European legislations.  
"In between more restrictive countries like Malta, Ireland, Italy on the one hand and more liberal ones like U.K. and Sweden on the other," he adds, "there are countries which permit research on human embryonic stem cells under different restrictions and rules. The latter ones include Denmark, the Netherlands and Belgium."  
Major funding systems can also be found in Singapore and Israel, according to Frost & Sullivan, which also notes that China and South Korea participate strongly in the stem cell sector. China has a cost advantage over many nations, particularly Western ones, thanks to lower wages, overhead and material costs, but is hindered by a lack of any standardized regulatory setup that meets global requirements.  
For a small nation, Israel has been very active, with the second-highest publication of stem cell research per capita globally, as well as at least 10 start-up companies that focus on adult and embryonic stem cell research and applications.  
Muddying the waters for potential commercial applications, at least in Europe, is the possibility that the European Court of Justice may rule against the patent-eligibility of hESCs in Europe if it follows the recommendation of the court's advocate general, which has traditionally been the case in other legal matters.  
As Lori P. Knowles writes in a white paper from the Stem Cell Network, "Commercialization and Stem Cell Research," there seems to be a reluctance globally to extend legal property rights to include reproductive tissue, such as gametes and embryos. "International policies differ, although there is relatively widespread consensus that a principle of non-commercialization of both the human body and especially of human reproduction respects human dignity," she notes, adding, "Non-commercialization of human tissue is not, however, the policy in much of the United States, where commercial transactions are permitted in human tissue, ranging from blood and plasma to semen and ova."  
But as many stem cell research proponents note, commercially viable products are still mostly a long ways off, whether in hESC, iPSC or adult stem cells.  
"Because it's still a relatively young industry, there is a great passion for collaboration and many research opportunities for everyone," May notes. "Once there are business opportunities and people vying for revenues, it may become more competitive, but right now, that isn't really the case."  
"There are absolutely tons of international collaborations going on," adds Mathews. "I think it is actually politicians who tend to think of what we're doing versus what they are doing, but I do not think most scientists view things that way."
Code: E071126



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