On Wednesday, March 28, 2001, at 12:00 p.m. in 2123 Rayburn House
Office Building, the Subcommittee on Oversight and Investigations
will hold a hearing on issues raised by human cloning research. The
purposes of the hearing are to: (1) assess the status of cutting-edge
science relevant to human cloning research; (2) examine scientific,
medical, ethical, and moral issues raised by human cloning research
intended to create a child; (3) convene some of the best experts
and advocates in the area of human cloning to discuss these issues
with Subcommittee members; and (4) determine whether federal legislation
is needed to regulate or ban human cloning research intended to create
The third panel will feature witnesses who are ethical, religious, or policy advocates in the area of human cloning research. These witnesses include: Dr. Gregory Pence, Professor of Philosophy, University of Alabama at Birmingham (pro-cloning advocate and bioethicist); Dr. Michael Soules, President, American Society of Reproductive Medicine (opposed to the human cloning experiments); Mr. Randolfe H. Wicker, Founder, Clone Rights United Front, and Spokesman, Human Cloning Foundation (pro-cloning advocate and supporter of the international team effort); "Rael", Leader of the Raelian Movement, United States Raelian Movement (pro-cloning advocate and leader of the religious group supporting the Clonaid project); Dr. Arthur L. Caplan, Director, Center of Bioethics, University of Pennsylvania (opposed to the human cloning experiments); Mr. Jaydee Hanson, Assistant General Secretary, The United Methodist Church (opposed to the humancloning experiments); Sharon Terry, Vice President for Consumers, Genetic Alliance (opposed to the human cloning experiments); Mr. Mark Eibert, Esq., Law Offices of Mark Eibert (pro-cloning advocate); and Dr. Nigel Cameron, Strategic Futures Group, LLC, (will testify on foreign laws on cloning).
Although the international team has said that it will conduct its human cloning experiment outside the United States, the Raelians at times have said their human cloning experiment is taking place in a laboratory somewhere in the U.S. If the Raelians' claim is true, it squarely presents the issue of what federal law, if any, is applicable to this experiment. There is no definitive federal statute governing privately funded human cloning experiments. However, on April 16, 1998, in response to an announcement by a scientist in the U.S. regarding his intent to clone human beings, FDA issued a statement addressing its jurisdiction over human cloning. FDA concluded that the somatic cell clone produced for the purpose of creating a cloned human being is a "product" subject to regulation by FDA. The basis for FDA's jurisdiction derives from its classification of the somatic cell clone as a "biological product" under Section 351(a) of the Public Health Service Act (PHS Act) and as a "drug" under Section 2019(g) of the Federal Food, Drug and Cosmetic Act (FD&C Act). Pursuant to regulations promulgated under the authority of these Acts, clinical research on investigational drugs and biological products can proceed only when an investigational new drug application (IND) is in effect. To date, FDA has not received an IND for the cloning of a human being. It should be noted that some legal scholars have questioned whether FDA's assertion of jurisdiction over human cloning is legally supportable. Currently there are four states that have laws banning the cloning of human beings: California, Louisiana, Michigan, and Rhode Island. In addition, there are eight states with pending legislation to ban human cloning: New York, Illinois, Indiana, Massachusetts, Missouri, Oregon, Texas, and Virginia. On March 1, 2001, the first international agreement to ban human cloning took effect upon the ratification by Slovakia, Slovenia, Greece, Spain, and Georgia. The measure, called the Protocol to the Convention on Human Rights and Biomedicine on the Prohibition of Cloning Human Beings committed signatory countries to prohibit by law "any intervention seeking to create human beings genetically identical to another human being, whether living or dead. To date, 24 countries have signed this protocol. Those countries are: Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Hungary, Iceland, Italy, Latvia, Lithuania, Luxembourg, Moldova, The Netherlands, Norway, Poland, Portugal, Romania, San Marino, Sweden, Switzerland, Turkey, and Macedonia. Furthermore, the following countries have laws prohibiting the cloning of a human being: United Kingdom, Japan, France, Denmark, Spain, Ireland, Germany, Israel, Malaysia, Colombia, Austria and Argentina. (See Appendix)
Although there has been no recent formal consideration by a federal agency over the issues raised by human cloning, the NBAC issued its June 9, 1997 report on human cloning discussing the various issues pertinent to this hearing. In its report, the NBAC concluded that "at this time it is morally unacceptable for anyone in the public or private sector, whether in a research or a clinical setting, to attempt to create a child using somatic cell nuclear transfer cloning." NBAC's conclusion was based largely on the serious safety issues associated with attempting to create a human being through cloning. Four years of animal cloning since the report have borne out the safety issues for both the clone and the surrogate mother. For the clone there are issues of physical abnormalities to psychological repercussions. Data from animal cloning studies show that somatic cell nuclear transfer in mammals has resulted in high rates of failure, high rates of spontaneous abortion, severe defects and deformities in the clone, and death soon after birth. Since a substantial number of clones will self abort, there are also health and safety concerns for the surrogate mothers. The technology used to clone mammals is still relatively new and thus the potential problems that may arise are not fully understood. For example, cloning experts and biologists have said that the cloning process seems to create random errors in the expression of genes and can produce any number of unpredictable problems.
While the report's conclusion was largely based on efficacy concerns, NBAC recognized the gravity of the ethical and moral issues associated with the cloning of human beings and the need for more scholarly review of these issues. The report also included recommendations, including the continued ban on federal funding in support of any attempt to clone a human being as well as the voluntary moratorium for the private and non-federally funded sector. Further, NBAC recommended that federal legislation be enacted to prohibit the attempt to create a child through somatic cell nuclear transfer.
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