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As the U.S. Senate prepares to debate proposed bans on cloning, legal scholars, special interest groups, scientists and others are plumbing old law for new grounds to mount court challenges to whatever finally emerges. The House of Representatives already has approved and sent to the Senate a measure that completely bans human cloning — both reproductive cloning to create a newborn genetically identical to another human being and so-called therapeutic cloning, to create embryonic stem cells for clinical and research purposes. A number of cloning bills are pending in the Senate. The debate there is likely to focus on two approaches: a complete ban as passed by the House and endorsed by President Bush or a ban only on reproductive cloning. “I can understand that there are public policy reasons why the Senate would want to bifurcate the debate,” says Elizabeth Foley of Detroit College of Law at Michigan State University, who has written on cloning and the law. “But from a legal standpoint, there are just as many legal issues raised by a ban on therapeutic cloning as by a reproductive ban. There are constitutional problems all over the place.” Senate Majority Leader Thomas Daschle, D-S.D., has said floor debate on cloning will begin by the end of this month. However, some watching the internal politics voice skepticism as to whether anything final will occur this year. Cloning legislation has triggered intense feelings across the political and social spectrum — from right-to-life groups, who see a human being even in the cloned embryo that has yet to be implanted in a woman’s uterus, to advocates for the disabled who see in cloned cells the potential to overcome the effects of a stroke and other debilitating diseases. In approaching the legislative debate and the possible legal fallout, it’s important to recognize “that initially cloning has not received a very warm reception at any level of government, whether here or internationally,” says Douglas Kmiec, dean of Catholic University School of Law. Despite reassurances by some in the scientific and legal communities, Kmiec adds, there is still the fear that cloning “borders on eugenics.” CLONING LAWS The National Academies of Sciences explains the cloning process as follows: The initial step — called nuclear transplantation of somatic cell nuclear transfer — involves removing the nucleus of an egg cell and replacing it with the nucleus of a cell from an adult. The reconstructed egg is then stimulated to begin dividing. If the procedure is successful, the cell divides several times to produce a pre-implantation embryo that is composed of about 150 cells. If the embryo is placed in a uterus, it can implant and form a fetus — reproductive cloning. There is a related procedure — nuclear transplantation to produce stem cells, also known as nonreproductive cloning or therapeutic or research cloning. Instead of implanting the embryo in a uterus, cells are isolated from the embryo about five days after the transplantation procedure and are used to make stem cell lines for further study. Although American eyes are now focused on the U.S. Senate, the states have been a step ahead of the federal government on the cloning issue for some time. California was the first state to address human cloning, which it banned for reproductive purposes in 1997. The law has a sunset provision — Jan. 1, 2003 — and the state’s lawmakers are now considering legislation to make the moratorium a permanent ban. Four other states — Louisiana, Michigan, Rhode Island and Virginia — have enacted measures to prohibit human cloning. Michigan’s ban, unlike the other four states’ ban, extends to the cloning of human embryos for any purpose — reproductive or research. And Missouri forbids the use of public funds for human cloning research. As of last month, 23 states had cloning legislation pending in their legislatures. Despite bans at the state level, there have been no legal challenges, say most scholars who are following this area of the law. “It may be there is a problem of ripeness since the technology has never been shown to be usable in human beings,” says Alta Charo of the University of Wisconsin Law School. “But a ban at the federal level might attract a challenge.” CHALLENGES A ban on reproductive cloning could generate a court challenge based on the right to reproductive freedom, says Foley. “One of the problems with speculating in this area is there have been very few times in history where government has tried to restrict somebody’s ability to reproduce,” she explains. “Other than the mandatory sterilization laws at the turn of the 20th century, the government, for the most part, has allowed people to reproduce when and how they want.” Although it was an equal protection case, Skinner v. Oklahoma, 316 U.S. 535 (1947), would be important in this kind of a challenge, says Foley, because it made clear that there is a “right to have offspring” and a law that infringes that right is subject to the Constitution’s most searching review — strict scrutiny. The limited case law that does exist dealing with challenges to assisted reproduction methods, such as in vitro fertilization and artificial insemination, “suggests there would be constitutional problems with a blanket ban on reproductive cloning,” Foley says. But given recent Supreme Court rulings, challenges based on a right to procreative liberty probably would fail, says Wisconsin’s Charo. The high court, she explains, is very protective of the reproductive right when government mandates a bodily intrusion, such as sterilization. It is also protective in areas involving the family — contraceptives and abortion — believing that the government should intrude as little as necessary. But this concept of protecting bodily integrity, she says, essentially stops short of allowing the individual to do whatever he or she wants with his or her own body — a psychological autonomy. The latter can be seen in the Court’s assisted suicide rulings, says Charo. “There’s a bodily integrity issue in cloning but there’s very weak support for the idea the Supreme Court will find you have the right to do anything with your body, and cloning is a kind of psychological autonomy question.” Kmiec notes that the Rehnquist Court, when faced with liberty/bodily integrity/privacy claims, traditionally searches history to see if the claim is rooted in the nation’s traditions and common law. “Insofar as this cloning process is unknown to anyone in the past, [a reproductive cloning right] is not going to be found to be a deeply embedded societal notion,” says Kmiec. The legal and scientific communities are struggling with this issue, says Charo, noting that a number of law review articles have been written about whether reproductive cloning is a form of reproduction and if it is, whether it would be constitutionally protected. RESEARCH CLONES But Kmiec does think the government would have a more difficult time defending a ban on therapeutic or research cloning. “The cause of action there will be one that might be anchored in just the liberty interest to pursue a medical cure, or in pursuing the medical profession to find that cure,” Kmiec says. A challenge to the research ban could also be based on the First Amendment, says Charo. “Here there is extremely little precedent,” she explains. “One could make the case that research is expressive activity and the search for knowledge is intrinsically within the First Amendment’s protection for freedom of thought.” Although he believes a ban on therapeutic cloning would impede scientific inquiry and likely drive research and American scientists overseas, bioethicist Alan Meisel of the University of Pittsburgh School of Law does not believe a ban would violate the First Amendment. “I don’t think it’s going to fly, certainly not with this Supreme Court,” he says, based on recent literature in this area. “Scientists may have the right to pursue knowledge in any way they want cognitively, intellectually, but when it comes to concrete action in the lab, that becomes conduct and the First Amendment protection for that is far, far weaker.” But it is an open question, insists Mark Eibert, a San Mateo, Calif., solo practitioner who has lobbied against the California ban on behalf of infertile couples. “I think cloning may be the case which gets the scientific freedom question to the Supreme Court,” he says. “It would be the first time in American history that an entire field of medical research has been outlawed.” If a federal law banned only reproductive cloning, there could be a challenge to allowing therapeutic cloning. “Once you’ve cloned an embryo, you now have a new human being,” says James Bopp Jr. of Terre Haute, Ind.’s Bopp, Coleson & Bostrom, who has represented the National Right to Life Committee and other anti-abortion groups. “Because the legalization of cloning for research purposes also requires that the cloned embryo be killed, it would seem to me that the parent of the cloned embryo, if they decide they are not going to kill the child, the clone, they would have grounds to challenge the law forcing them to destroy their own embryo.” ANOTHER QUAGMIRE? The bill passed in the House and parts of the Senate bill contain another potential legal quagmire, say legal experts. Besides banning all cloning, they also prohibit the importation into the United States of medical treatments developed abroad using nuclear transplantation. “Do people have a constitutional right to import?” asks Charo. “Probably not. We want to ban products developed by slave labor or sweatshop. A ban on importation of proven therapies developed abroad because of their origins would create some very interesting political dynamics.” Charo believes ultimately nothing will be enacted at the federal level. “If we do see challenges, they’ll be at the state level and they’ll pull in federal constitutional arguments.” Eibert agrees. “I’m considering bringing a constitutional challenge to California’s law if the ban becomes permanent,” he says. “If research cloning gets outlawed as well, there will be a much broader coalition wanting to get it overturned. We’re just watching to see what happens.”

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