Stem cell laws are the law, rules, and policy governance concerning the sources, research, and uses in treatment of stem cells in humans. These laws have been the source of much controversy and vary significantly by country.[1] In the European Union, stem cell research using the human embryo is permitted in Sweden, Finland, Belgium, Greece, Britain, Denmark and the Netherlands; however, it is illegal in Germany, Austria, Ireland, Italy, and Portugal. The issue has similarly divided the United States, with several states enforcing a complete ban and others giving financial support.[2] Elsewhere, Japan, India, Iran, Israel, South Korea, China, and Australia are supportive. However, New Zealand, most of Africa (except South Africa), and most of South America (except Brazil) are restrictive.
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Stem cell are cells found in most, if not all, multi-cellular organisms. A common example of a stem cell is the Hematopoietic stem cell (HSC) which are multipotent stem cells that give rise to cells of the blood lineage. In contrast to multipotent stem cells, embryonic stem cells are pluripotent and are thought to be able to give rise to all cells of the body. Embryonic stem cells were isolated in mice in 1981, and in humans in 1998.[3]
Stem cell treatments are a type of cell therapy that introduce new cells into adult bodies for possible treatment of cancer, Somatic cell nuclear transfer, diabetes, and other medical conditions. Cloning also might be done with stem cells. Stem cells have been used to repair tissue damaged by disease.[4]
Because Embryonic Stem (ES) cells are cultured from the embryoblast 4-5 days after fertilization, harvesting them is most often done from donated embryos from in vitro fertilization (IVF) clinics. In January 2007, researchers at Wake Forest University reported that "stem cells drawn from amniotic fluid donated by pregnant women hold much of the same promise as embryonic stem cells."[3]
In 2000, the NIH, under the administration of President Bill Clinton, issued guidelines that allow federal funding of embryonic stem-cell research.[3]
The European Union has yet to issue consistent regulations with respect to stem cell research in member states. Whereas Germany, Austria, Italy, Finland, Greece, Ireland, Portugal and the Netherlands prohibit or severely restrict the use of embryonic stem cells, Sweden and the United Kingdom have created the legal basis to support this research.[5] Belgium bans reproductive cloning but allows therapeutic cloning of embryos.[1] France prohibits reproductive cloning and embryo creation for research purposes, but enacted laws (with a sunset provision expiring in 2009) to allow scientists to conduct stem cell research on imported surplus embryos from in vitro fertilization treatments.[1] Germany has restrictive policies for stem cell research, but a 2008 law authorizes "the use of imported stem cell lines produced before May 1, 2007."[1] Italy has a 2004 law that forbids all sperm or egg donations and the freezing of embryos, but allows, in effect, using existing stem cell lines that have been imported.[1] Sweden forbids reproductive cloning, but allows therapeutic cloning and authorized a stem cell bank.[1][5]
In 2001, the British Parliament amended the Human Fertilisation and Embryology Act 1990 (since amended by the Human Fertilisation and Embryology Act 2008)to permit the destruction of embryos for hESC harvests but only if the research satisfies one of the following requirements:
The United Kingdom is one of the leaders in stem cell research, in the opinion of Lord Sainsbury, Science and Innovation Minister for the UK.[6] A new £10 million stem cell research centre has been announced at the University of Cambridge.[7]
In 2004, South Africa became the first African nation to create a stem cell bank. Prior to this, the South African government had enacted legislation maintaining a ban on reproductive cloning but authorizing the therapeutic cloning of embryos.[1]
China prohibits human reproductive cloning but allows the creation of human embryos for research and therapeutic purposes.[1] India banned in 2004 reproductive cloning, permitted therapeutic cloning.[1] In 2004, Japan’s Council for Science and Technology Policy voted to allow scientists to conduct stem cell research for therapeutic purposes, though formal guidelines have yet to be released.[1] The South Korean government promotes therapeutic cloning, but forbids cloning.[1] In 1999, Israel passed legislation banning reproductive, but not therapeutic, cloning.[1],[5] and leading scientists.[1] Saudi Arabia religious officials issued a decree that sanctions the use of embryos for therapeutic and research purposes.[1] According to the Royan Institute for Reproductive Biomedicine, Iran has some of the most liberal laws on stem cell research and cloning.[8][9]
In 2006, Canada enacted a law permitting research on discarded embryos from in vitro fertilization procedures. However, it prohibits the creation of human embryos for research.[1] Brazil has passed legislation to permit stem cell research using excess in vitro fertilized embryos that have been frozen for at least three years.[1]
Federal law places restrictions on funding and use of hES cells through amendments to the budget bill.[10] In 2001, George W. Bush implemented a policy limiting the number of stem cell lines that could be used for research.[3] There were some state laws concerning stem cells that were passed in the mid-2000s. New Jersey's 2004 S1909/A2840 specifically permitted human cloning for the purpose of developing and harvesting human stem cells, and Missouri's 2006 Amendment Two legalized certain forms of embryonic stem cell research in the state. On the other hand, Arkansas, Indiana, Louisiana, Michigan, North Dakota and South Dakota passed laws to prohibit the creation or destruction of human embryos for medical research.[10]
During Bush's second term, in July 2006, he used his first Presidential veto on the Stem Cell Research Enhancement Act. The Stem Cell Research Enhancement Act was the name of two similar bills, and both were vetoed by President George W. Bush and were not enacted into law. New Jersey congressman Chris Smith wrote a Stem Cell Therapeutic and Research Act of 2005, which made some narrow exceptions, and was signed into law by President George W. Bush.
In November 2004, California voters approved Proposition 71, creating a US$3 billion state taxpayer-funded institute for stem cell research, the California Institute for Regenerative Medicine. It hopes to provide $300 million a year.
President Barack Obama removed the restriction of federal funding passed by Bush in 2001, which only allowed funding on the 21 cell lines already created. However, the Dickey Amendment to the budget, The Omnibus Appropriations Act of 2009, still bans federal funding of creating new cell lines. In other words, the federal government will now fund research which uses the hundreds of more lines created by public and private funds.[11]
Australia is partially supportive (exempting reproductive cloning yet allowing research on embryonic stem cells that are derived from the process of IVF). New Zealand, however, restricts stem cell research.
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