It's not an uncommon refrain for proponents of stem cellresearch in the United States—particularly those who want to see more progresson the human embryonic stem cell (hESC) front—to bemoan that U.S. restrictionson stem cell research will put the nation behind the rest of the world.
That sentiment isn't altogether accurate, as there are manyfirst-world nations that put up just as many, and sometimes even more, barriersto stem cell research. On the other hand, there are nations that have beenoperating under more liberal policies than U.S. researchers have had to faceand who could gain ground and pull ahead. But as the stem cell researchcommunity stands now, with so much promise and very little commercialization,"pulling ahead" doesn't mean beating the United States to the next punch anddoing a victory dance. Many of the other nations very much want Americans inthe mix to keep collaborative efforts strong.
Major English-speaking nations definitely make a strongshowing in terms of stem cell research. In the Asia-Pacific region, looking atgovernment grants and stimulus funding, the most active participant in the stemcell sector on both the academic and industry ends of the spectrum isAustralia, according to market research firm Frost & Sullivan in its "StemCell Research—Technology Investment Opportunities" report released in March2011. This is despite having what Frost & Sullivan calls "a notable absenceof work" in the induced pluripotent stem cell (iPSC) arena. The nation alsofigures strongly in terms of stem cell publications, with 663 such articlesbetween 2001 and 2009, beat out in the region only by Japan with 2,852, Chinawith 946 and Korea with 703, according to Douglas Sipp in his article, "StemCell Research in Asia: A Critical View," in 2009 in the Journal of CellularBiochemistry.
In Canada, "certainly there is a strength in fundamentalstem cell biology, and I think that has to some degree been enabled by the lackof political hurdles around embryonic stem cell research as countries like theUnited States have faced," says Dr. Michael H. May, CEO of the Centre forCommercialization of Regenerative Medicine, which is based in Canada but seeksto be a global facilitator of commercializing stem cell breakthroughs in thefuture.
Looking toward Europe, the United Kingdom has long boastedone of the more liberal sets of societal, academic and government policiesaround stem cell research, and there the government is the major source offunding, making up more than 70 percent of investment in stem cells, according toFrost & Sullivan. However, the United Kingdom is having a hard time gettingcompanies past early-stage status in this sector due to a lack of strongventure capital funding.
Because the United Kingdom has had very permissive policiesfor 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'sBerman Institute of Bioethics, a senior policy and research analyst at thePresidential Commission for the Study of Bioethical Issues and a member of theHinxton Group, an international consortium on stem cells, ethics and law.
Glyn Stacey, director of the UK Stem Cell Bank, notes thatmuch pretranslational activity on cell biology is occurring in the UnitedKingdom, with some "significant" adult stem cell clinical trials and hESCtrials in the pipeline, though she says the United States remains ahead of thecurve there. "But the U.K. is generally strong on developmental biology andstem cell research—alongside Germany—and has a regulatory advantage through theHFEA regulator for embryonics and also a U.K. regulatory road map for stem celltherapy."
Looking elsewhere in Europe, Sweden has a well-organizedpublic funding system, permissive research policies and significant venturefunding; Denmark boasts strong public funding for basic research; andSwitzerland, while its policies focus on adult stem cells and don't favor hESCwork, also has strong governmental funding.
The European picture is "extremely varied," notes GöranHermerén, a professor of medical ethics in the medical school faculty of LundUniversity in Sweden. "In some countries, it is forbidden to create newembryonic stem cell lines, in others it is permitted, and permitted undervarying conditions and with certain methods—somatic cell nuclear transfer,'cloning,' is allowed in some countries but not in others—and even thedefinition of key terms like 'embryo' is not the same in all Europeanlegislations.
"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 stemcells under different restrictions and rules. The latter ones include Denmark,the Netherlands and Belgium."
Major funding systems can also be found in Singapore andIsrael, according to Frost & Sullivan, which also notes that China andSouth Korea participate strongly in the stem cell sector. China has a costadvantage over many nations, particularly Western ones, thanks to lower wages,overhead and material costs, but is hindered by a lack of any standardizedregulatory setup that meets global requirements.
For a small nation, Israel has been very active, with thesecond-highest publication of stem cell research per capita globally, as wellas at least 10 start-up companies that focus on adult and embryonic stem cellresearch and applications.
Muddying the waters for potential commercial applications,at least in Europe, is the possibility that the European Court of Justice mayrule against the patent-eligibility of hESCs in Europe if it follows therecommendation of the court's advocate general, which has traditionally been thecase in other legal matters.
As Lori P. Knowles writes in a white paper from the StemCell Network, "Commercialization and Stem Cell Research," there seems to be areluctance globally to extend legal property rights to include reproductivetissue, such as gametes and embryos.
"International policies differ, although there is relativelywidespread consensus that a principle of non-commercialization of both thehuman body and especially of human reproduction respects human dignity," shenotes, adding, "Non-commercialization of human tissue is not, however, thepolicy in much of the United States, where commercial transactions arepermitted in human tissue, ranging from blood and plasma to semen and ova."
But as many stem cell research proponents note, commerciallyviable products are still mostly a long ways off, whether in hESC, iPSC oradult stem cells.
"Because it's still a relatively young industry, there is agreat passion for collaboration and many research opportunities for everyone,"May notes. "Once there are business opportunities and people vying forrevenues, it may become more competitive, but right now, that isn't really thecase."
"There are absolutely tons of international collaborationsgoing on," adds Mathews. "I think it is actually politicians who tend to thinkof what we're doing versus what they are doing, but I do not think most scientistsview things that way."