Stem Cell Research and Cloning
By Rebecca Stuart
The modern reproductive fight centers around two main issues: cloning and stem cell research. Religious and moral supporters have decried both of these procedures, claiming an interference with the role of God. A very related issue is the cloning of stem cells for use in research.
The fight over cloning began in earnest when Ian Wilmut succeeded in cloning the sheep Dolly in 1996. Since then, scientists have been able to clone many animals, including mice, cows, horses, and cats. In 2001, Advanced Cell Technology, a small company out of Boston, reported that it had successfully cloned human embryos. (For information about Advanced Cell and its research, visit the company Internet site at http://www.advancecell.com.) Most recently, scientists have touted the promise of embryonic stem cells for scientific research, and particularly for their unique properties in creating cures for diseases like Parkinson’s Disease.
Stem cell research has received a strong amount of publicity, likely due to its perceived relationship to abortion, another hot button legal and political issue. In 2001, President Bush announced a ban on federally funded stem cell research. (Press Release, The White House, Office of the Press Secretary, Remarks by the President on Stem Cell Research (Aug. 9, 2001), available at http://www.whitehouse.gov/news/releases/2001/08/20010809-2.html). President Bush kept the tight restrictions on federal funding in July 2006, when he used his veto power for the first time to strike down a measure that would have allowed couples to donate to researchers embryos frozen for fertility treatments. (CNN, Bush Vetoes Embryonic Stem Cell Bill, July 20, 2006, http://www.cnn.com/2006/POLITICS/07/19/stemcells.veto/index.html.)
States have not followed the federal government as it relates to stem cell research. In 2004, California voters approved Proposition 71 which devotes an unprecedented $3 Billion to stem cell research. Other states are following suit, and enacting their own laws to fund stem cell research.
While many states are generally accepting of stem cell research, human cloning has not fared so well. Many states have enacted laws that ban human reproductive cloning, and others also prohibit non-reproductive cloning, which spells the end of stem cell research in those states.
When stem cell research is separated from the issue of human cloning, it generally receives a great deal of support. Thus the House of Representatives, in a bipartisan effort, passed House Resolution 810, the Stem Cell Research Enhancement Act of 2005, on May 24, 2005. House Resolution 810 overturns President George W. Bush's executive order barring the use of federal funds for human embryonic stem cell research and instead requires the Secretary of Health and Human Services to conduct and support such research, regardless of the date on which the stem cells were derived from a human embryo, provided that the embryos:
(1) were donated from in vitro fertilization clinics;
(2) were created for the purpose of fertility treatment;
(3) were in excess of the needs of the individuals seeking such treatment and would otherwise be discarded; and
(4) were donated by such individuals with written informed consent and without any financial or other inducements.
Several bills in Congress purport to regulate human cloning, and each bill adopts a distinct definition. House Resolution 534, the Weldon Bill, was passed by the House of Representatives on February 27, 2003, but never approved by the Senate. It defines human cloning as occurring at the point of nuclear transplantation, thereby proscribing research and therapeutic cloning, including the production of stem cells from cloned human embryos.
Senate Bill 303, proposed by Senators Hatch, Feinstein, Specter, Kennedy, Harkin, and Miller, defines human cloning in such a way as to permit stem cell research. Specifically, the Hatch Bill defines "human cloning" as "implanting or attempting to implant the product of nuclear transplantation into a uterus or the functional equivalent of a uterus" (S. 303 at §301(a)(1)) and it labels the product of nuclear transplantation an "unfertilized blastocyst." (S. 303 at §301(a)(6)) The Hatch Bill sets forth standards regulating such research, including:
(1) voluntary donation of oocytes with informed consent,
(2) prohibition upon the purchase or sale of human oocytes or unfertilized blastocysts,
(3) Institutional Review Board (IRB) approval of all such research,
(4) prohibition of research upon unfertilized blastocysts after 14 days, and
(5) segregation of nuclear transplantation research from assisted reproductive technology treatments. (S. 303 at §499A).
Of the many commissions to have addressed the issue of cloning, all differentiate between human reproductive cloning and therapeutic cloning. The National Bioethics Advisory Commission determined that any attempt to clone human beings at this time would be immoral and contrary to public policy and recommended a moratorium on reproductive cloning, but remained silent on the issue of research cloning. (Cloning Human Beings: Report and Recommendations of the National Bioethics Advisory Commission, vol. 1, June 1997, at 107-110.) The National Academy of Sciences concluded that reproductive cloning should be prohibited, but research cloning should be permitted. (See The National Academies, Guidelines for Human Embryonic Stem Cell Research, National Academy Press, Apr. 26, 2005, at 124.) President George W. Bush's Council on Bioethics unanimously concluded that reproductive cloning should be prohibited, but divided on the issue of research cloning, with ten members supporting and seven members opposing a four-year moratorium. (Human Cloning and Human Dignity: An Ethical Inquiry, Report of the President's Council on Bioethics, July 2002 (see http:// www.bioethics.gov/reports/cloningreport/pcbe_cloning_report.pdf)) And the California Advisory Committee on Human Cloning unanimously concluded in 2001, that the state should prohibit reproductive cloning but permit research cloning subject to reasonable regulations to ensure informed consent, require institutional review board approval, and limit research upon cloned human embryos to the first 14 days, prior to development of the primitive streak. (Symposium, Cloning Californians? Report of the California Advisory Committee on Human Cloning, 53 Hastings L.J. 1143 (2002).)
Ironically, Congress may have more power to ban research or therapeutic cloning than they do to ban reproductive cloning. Congress’ power to regulate interstate commerce may limit their authority to regulating research, which may have a widespread effect on the national economy. In contrast to this effect, reproductive cloning likely will not have an effect outside of the state in which the cloning is taking place. (Ashutosh Bhagwat, Cloning and Federalism, 53 Hast. L.J. 1133 (2001-2002)) However, there is also an argument that if reproductive cloning became widespread, it would become a highly profitable business that will market itself across state boundaries. If this is the case, perhaps the constitution will allow for more stringent federal regulation. (Michael J. Malinowski, Choosing the Genetic Makeup of Children: Our Eugenics Past--Present, and Future?, 36 Conn. L. Rev. 125, 179- 97 (2003).)
The United Kingdom is the primary example of a nation supporting a more expansive allowance for cloning that would include therapeutic cloning. "The U.K. has decided the potential benefits that will result from human embryonic stem cell research outweigh the ethical problems." In 2004, the United Kingdom provided researchers with a license to create human embryonic clones for the purposes of research. To help aid in the research developments, the United Kingdom funds the creation of embryos for research purposes. (George Kanellopoulos, Embryonic Stem Cell Research: A Comparative Study of the Philosophies of the United States and the United Kingdom, 4 J. Int'l Bus. & L. 170, 170 (2005).) Nevertheless, UK Scientists have to work under strict standards set by the government
South Korea is another country that allows research on cloned embryos. The National Assembly of South Korea passed the Bioethics and Biosafety Act on December 29, 2003, which strictly banned human reproductive cloning and experiments, but permitted therapeutic cloning in limited cases for the cure of otherwise untreatable diseases. Human embryos may not be created for any purpose other than pregnancy, but the excess embryos may be used for research in limited areas. (Mikyung Kim, An Overview of the Regulation and Patentability of Human Cloning and Embryonic Stem Cell Research in the United States and Anti-Cloning Legislation in South Korea, 21 Santa Clara Computer & High Tech. L.J. 645, 650 (2005).)
France's government has publicly opposed human cloning based upon ethical concerns and scientific doubt, and due to these beliefs, the government has imposed strict bans against it. A bioethics law passed in 2004 prohibits both reproductive and therapeutic cloning, imposing harsh sanctions for both and calling reproductive cloning "a crime against the species." The law imposes a maximum sentence of thirty years in prison along with a fine of 7.5 million euros for reproductive cloning, while therapeutic cloning carries a maximum prison sentence of seven years and a fine of 100,000 euros. The severe penalties France imposes for violations of the law indicate its strong stance towards a total ban on human cloning. (British Embassy, France, France Adopts New Bioethics Legislation (July 2004), available at http://www.britishembassy.gov.uk/servlet/Front? pagename=OpenMarket/Xcelerate/ShowPage&c=Page&cid=1101389956890.)
Not surprisingly, the Vatican is opposed to both reproductive and therapeutic cloning. The nation's view is based on the official opinion of the Roman Catholic Church, which is that "every possible act of cloning humans is intrinsically evil" and could never be justified. (Institute on Biotechnology and the Human Future, Religious Viewpoints on Cloning, http:// www.thehumanfuture.org/topics/humancloning/impact_religious.html) Its religious and ethical traditions, largely based on its interpretation of the creation story from the Bible, provide this viewpoint on cloning. However, it is somewhat surprising that the Vatican's United Nations representative characterized therapeutic cloning as worse than reproductive cloning since it results in the creation of embryos specifically for the purpose of being destroyed. (LifeSite, Vatican Tells United Nations 'Therapeutic' Cloning is Worse than Reproductive Cloning, Nov. 20, 2002, http:// www.lifesite.net/ldn/2002/nov/02112002.html.) Since the Vatican views all embryos as human lives, it believes therapeutic cloning results in the destruction of human lives. While the Vatican is not a nation likely to directly affect the research arena, its views are still a matter of contention for United Nations decisions.
In March 2005, after hearing proposals from many member nations, the United Nations adopted a declaration on human cloning. The Declaration "prohibit[s] all forms of human cloning inasmuch as they are incompatible with human dignity and the protection of human life." (United Nations Declaration on Human Cloning, G.A. Res. 59/150, U.N. Doc. A/R/59/80 (Mar. 23, 2005).) Since the Declaration is non-binding, it seeks "to protect human life in the application of life and reproductive sciences, by urging member states to adopt domestic legislation compatible with the Declaration's text."