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Protecting the Endangered Human: Toward an International Treaty Prohibiting Cloning and Inheritable Alterations

Published online by Cambridge University Press:  24 February 2021

George J. Annas ,
Lori B. Andrews  and
Rosario M. Isasi
George J. Annas
Affiliation:
Boston University School of Public Health, Boston University School of Medicine, Boston University School of Law, and Harvard College; Harvard Law School, Harvard School of Public Health
Lori B. Andrews
Affiliation:
Chicago-Kent College of Law, and Institute for Science, Law, and Technology, Illinois Institute of Technology. Yale College; Yale Law School
Rosario M. Isasi
Affiliation:
Health Law Department, Boston University School of Public Health. Pontificia Universidad Catolica del Peru; Pontificia Universidad Catolica del Peru; Boston University School of Public Health
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We humans tend to worry first about our own happiness, then about our families, then about our communities. In times of great stress, such as war or natural disaster, we may focus temporarily on our country but we rarely think about Earth as a whole or the human species as a whole. This narrow perspective, perhaps best exemplified by the American consumer, has led to the environmental degradation of our planet, a grossly widening gap in living standards between rich and poor people and nations and a scientific research agenda that focuses almost exclusively on the needs and desires of the wealthy few. Reversing the worldwide trends toward market-based atomization and increasing indifference to the suffering of others will require a human rights focus, forged by the development of what Vaclav Havel has termed a “species consciousness.”

Type
Articles
Information
American Journal of Law & Medicine , Volume 28 , Issue 2-3: The Genetics Revolution: Conflicts, Challenges and Conundra , 2002 , pp. 151 - 178
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2002

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References

1 “We still don't know how to put morality ahead of politics, science and economy. We are still incapable of understanding that the only genuine backbone of all our actions, if they are to be moral, is responsibility—responsibility to something higher than my family, my country, my company, my success.” Havel, Vaclav, Excerpts from Czech Chief's Address to Congress, N.Y. Times, Feb. 22, 1990Google Scholar, at A14. See also Amartya Sen, Development as Freedom (1999); Annas, George J., Mapping the Human Genome and the Meaning of Monster Mythology, 39 Emory L.J. 629, 661-64 (1990)Google Scholar.

2 See The Charter of the United Nations: A Commentary 49 (Bruno Simma et al. eds.,1995).

3 Commencement Address at American University in Washington, Pub. Papers 459, 462 (June 10, 1963). President George W. Bush echoed Kennedy's words almost forty years later:

All fathers and mothers, in all societies, want their children to be educated and live free from poverty and violence. No people on earth yearn to be oppressed or aspire to servitude or eagerly await the midnight knock of the secret police. . . . America will lead by defending liberty and justice because they are right and true and unchanging for all people everywhere.

No nation owns these aspirations and no nation is exempt from them. We have no intention of imposing our culture, but America will always stand firm for the non-negotiable demands of human dignity: the rule of law; limits on the power of the state; respect for women; private property; free speech; equal justice; and religious tolerance.

Address Before a Joint Session of the Congress on the State of the Union, 38 Weekly Comp. Pres. Doc. 133, 138 (Jan. 29, 2002).

4 See Steiner, Henry J. & Alston, Philip, International Human Rights in Context: Law, Politics, Morals 137-41 (2d ed. 2000)Google Scholar.

5 Quoted in Mary Ann Glendon, A World Made New: Eleanor Roosevelt and the Universal Declaration of Human Rights 223 (2001).

6 See generally M. Cherif Bassiouni, Crimes Against Humanity in International Criminal Law (1992) (exploring the history and evolution of “crimes against humanity”). See also Annas, George J., The Man on the Moon, Immortality, and Other Millennial Myths: The Prospects and Perils of Human Genetic Engineering, 49 Emory L.J. 753, 778-80 (2000)Google Scholar (discussing the possibility of species-alteration becoming a new category of “crimes against humanity”).

7 See, e.g., Francis Fukuyama, Our Posthuman Future: Consequences of the Biotechnology Revolution (2002). Of course, these actions have not yet been recognized as crimes against humanity or any other type of international crime, and this is one reason why some still see these activities as legitimate.

8 Obviously, the only current candidate is the United Nations.

9 Protecting Public Health and the Environment: Implementing the Precautionary Principle 354 (Carolyn Raffensperger & Joel A. Tickner eds., 1999).

10 This proposed Convention is the product of many people, including the participants at a September 21-22, 2001 conference at Boston University on “Beyond Cloning: Protecting Humanity from Species-Altering Procedures.” The treaty language was the subject of a roundtable that concluded the conference. The authors, together with others, most especially Patricia Baird and Alexander Morgan Capron, had drafted language to be considered at the conference, and revised it after the conference based on the discussion that occurred there and comments on the draft by others.

The original draft also included the following codicil to encourage individual countries to examine broader issues as well:

Issues for Nations to Consider in Furtherance of the Convention on the Preservation of the Human Species

In the course of discussions about the Convention on the Preservation of the Human Species, countries may desire to expand the provisions to deal in greater detail with other matters. Perhaps there will be a desire to add a moratorium on the creation of cloned human embryos for research. It may also be thought useful to include provisions that deal more comprehensively with assisted reproduction and life-science patents. Such provisions could take into consideration the following issues:

Assisted Human Reproduction

Potential Regulation:

The regulation of the practice of assisted human reproduction could include such provisions as requirements of a license for any healthcare professional who or healthcare facility that:

  • Facilitates assisted human reproduction, e.g., via donor insemination or in vitro fertilization;

  • Undertakes research or treatment using an in vitro embryo;

  • Collects, stores, transfers, destroys, imports or exports sperm, ova or in vitro embryos for reproduction or research purposes; or

  • Undertakes genetic screening on anex utero embryo.

The regulation of the practice of assisted human reproduction could also include provisions to ensure:

  • Free and informed consent of prospective parents and gamete donors as a prerequisite to the use of the techniques;

  • Quality assurance and proficiency testing for labs;

  • Reporting to a governmental entity the outcomes (including births per attempt and data about morbidity and mortality of the resulting children for the first five years) and disclosure to the public of this information;

  • Non-misleading advertising (to the extent that advertising is permitted at all); and

  • Confidentiality of individually identifiable health information.

Other prohibitions beyond those on human cloning and germline intervention might include bans on:

  • Extracorporeal gestation of a human being;

  • Transfer of a human embryo into an animal;

  • Creation of embryos solely for research purposes; or

  • Transplanting reproductive material (including gametes, ovaries or testes) from animals into humans.

Gene Patents

The purpose of the patent system is to encourage innovation and the development of products by providing the holder of a patent with a twenty-year monopoly over the use of an invention. Patenting genes runs counter to this purpose because gene patents are stifling innovation and impeding access to genetic diagnostic and treatment technologies. Many researchers who are searching for genes that predispose individuals to diseases are reluctant to share information and tissue samples with other researchers because they want to discover the gene themselves and to reap the financial rewards of discovery. These rewards can be high. For example, one particular gene patent in the United States is worth $1.5 billion annually.

Once a gene is discovered, the patent holder can prevent any doctor or laboratory from even checking a person's body to see if he or she has a mutation of the gene. Alternatively, the patent holder can collect a very high royalty from the doctors and laboratories that examine the gene. The patent holder can even stop any use of the patented gene. One patent holder, for example, will not permit the use of its gene in prenatal screening because of the controversy surrounding abortion. Another patent holder, a major European pharmaceutical company, will not allow anyone to use its patented gene to develop a test which shows which patients will benefit from one of the company's drugs and which will not. Another biotechnology company has a patent on the genetic sequence of a particular infectious disease and is stopping another company from instituting inexpensive public health screening to determine if people are infected.

On the other hand, patent holders themselves may encourage premature adoption of genetic diagnostic tests and unsafe efforts at gene transfer experiments to benefit the patent holder rather than patients or research subjects. Moreover, special issues are raised in the case of patenting human tissue, including the ethical and legal propriety of ownership of one person's genetic information by another.

Potential regulation:

No patents shall be granted on human genes, parts of human genes or unaltered products of human genes, nor on the genes of bacteria, viruses or other infectious agents that cause disease in humans.

Work on a national regulatory scheme for the new reproductive technologies will, of course, be most relevant to countries that have an in-vitro fertilization (IVF) industry. We also believe that the best existing guidance for approaching such regulation is contained in the final report of Canada's Royal Commission on New Reproductive Technologies. 1 Patricia Baird, Proceed With Care: Final Report of the Royal Commission on New Reproductive Technologies, 564-76 (1993). Also, to the extent that a country wants to proceed with research cloning (e.g., for the purpose of making stem cells or studying embryonic growth), regulation of the infertility industry will be needed to prevent a cloned embryo from being implanted in a woman's uterus. Such regulation could include, for example, the prohibition of freezing cloned embryos, and the prohibition of any physician or embryologist involved in IVF from making or possessing a cloned embryo.

11 While we believe these crimes should be subject to the jurisdiction of the International Criminal Court, this may not be possible in the near future, and it is more important to establish them as international crimes than to broaden the definition of “crimes against humanity” as it applies to the International Criminal Court at this time.

12 Nat'l Bioethics Advisory Comm'n, Cloning Human Beings 109 (1997), available at http://bioethics.georgetown.edu/nbac/pubs.html.

13 For example, during the 1998 debate on cloning in the U.S. Senate, more than sixteen scientific and medical organizations, including the American Society of Reproductive Medicine and the Federation of American Societies for Experimental Biology (which includes more than sixteen scientific and medical organizations), believed that there should be a moratorium on the creation of humans by cloning. See 144 Cong. Rec. S434-38 (1998); 144 Cong. Rec. S661 (1998). None of these organizations has since changed their position. See, e.g., Press Release, Am. Soc'y Reproductive Med., ASRM Statement on Attempts at Human Cloning (Apr. 5, 2002) (“[W]e caution policy makers not to be rushed into approving over-reaching legislation that will criminalize valid scientific and medical research and the therapies they might lead to.”)available at http://www.asrm.org/Media/Press/cloningstatement4-02; Letter from Carl B. Feldbaum, President, Biotechnology Ind. Org., to President George W. Bush (Feb. 1, 2002) (“The current moratorium on cloning humans should remain until our nation has had time to fully explore the impact of such cloning.”), available at http://www.bio.org/bioethics/cloning_letter_bush.html. See also Rudolf Jaenisch & Ian Wilmut, Don't Clone Humans!, 291 Science 2552 (2001) (“We believe attempts to clone human beings at a time when the scientific issues of nuclear cloning have not been clarified are dangerous and irresponsible.”); Editorial, Reasons to be Cloned, 414 Nature 567 (2001) (“[T]he health risks to mother and child inherent in [cloning] . . . demand that it be banned.”).

14 Nat'l Research Council, Scientific and Medical Aspects of Human Reproductive Cloning l (2002).

Human reproductive cloning .. . is dangerous and likely to fail. The panel therefore unanimously supports the proposal that there should be a legally enforceable ban on the practice of human reproductive cloning. . . . The scientific and medical considerations related to this ban should be reviewed within 5 years. The ban should be reconsidered only if at least two conditions are met: (1) a new scientific and medical review indicates that the procedures are likely to be safe and effective and (2) a broad national dialogue on the societal, religious, and ethical issues suggests that a reconsideration of the ban is warranted.

Id. at ES-1 to ES-2. See also Nat'l Research Council, Stem Cells and the Future of Regenerative Medicine (2001).

15 Stuart A. Newman, Speech at the “Beyond Cloning” Conference, Boston University (Sept. 21,2001).

16 See, e.g., Gordon, Jon W., Genetic Enhancement in Humans, 283 Science 2023, 2023 (1999)CrossRefGoogle Scholar.

17 Hans Jonas, for example, argued that it is a crime against the clone by depriving the cloned child of his or her “existential right to certain subjective terms of [ ] being.” Hans Jonas, Philosophical Essays: From Ancient Creed to Technological Man 160 (1974). Jonas believes that a clone will not have a “right to ignorance” or the “right.. . to a unique genotype.” Id. Instead, a clone knows:

[Altogether too much about himself and is known .. . altogether too well by others. Both facts are paralyzing for the spontaneity of becoming himself . . . . [T]he clone is antecedently robbed of the freedom which only under the protection of ignorance can thrive: and to rob a human-to-be of that freedom deliberately is an inexplicable crime that must not be committed even once.

Id. at 161. Human reproductive cloning poses both physical and psychological risks to children who might be conceived using this technique. In animals, cloning currently only results in a successful pregnancy three to five percent of the time. And, even in those rare instances, many of the resulting offspring suffer—one-third die shortly before or right after birth. Other cloned animals seem perfectly healthy at first and then suffer heart and blood vessel problems, underdeveloped lungs, diabetes, immune system deficiencies and severe growth abnormalities. The mothers who gestate clones are also at risk, due to the often abnormally large size of the offspring produced—some cattle clones for example, are born up to twice the normal weight expected for calves.

18 Tim Adams, Interview: The Clone Arranger, The Observer, Dec. 2, 2001, at 3 (comments of Severino Antinori).

Male infertility grows . . . . My invention of ICSI has helped. I have helped men whose sperm are misformed or too slow. I have helped men whose sperm does not come out from their testes! And the next step [cloning] is to help men who—traumatico!—have lost their ability to produce any sperm at all. Through war or accident or cancer. I will help only stable, loving couples. Some doctors say this is a step too far, but those same doctors have said that about all the other steps too. Very few doctors are pioneers! Very few have both the knowledge and the, the, the .. . courage.

Id. See also Robert Winston, The Promise of Cloning for Human Medicine, 314 Brit. Med. J. 913 (1997) (advocating for the use of cloning to help infertile men have genetically-related children). Zavos and Antinori dissolved their partnership in 2002. David Brown, Human Clone's Birth Predicted, Wash. Post, May 16, 2002, at A8.

19 See generally, Michael H. Shapiro, /Want a Girl (Boy) Just Like the Girl (Boy) that Married Dear Old Dad (Mom): Cloning Lives, 9 S. Cal. Interdisc. L.J. 1 (arguing, in part, that cloning should be considered reproduction, for the essence of reproduction is the creation of a new person).

A variety of personal desires may interest people in creating a child through cloning or germline genetic engineering. The NBAC report suggests it would be “understandable, or even, as some have argued, desirable” to create a cloned child from one adult if both members of the couple have a lethal recessive gene; from a dying infant if his father is dead and the mother wants an offspring from her late husband; or from a terminally ill child to create a bone marrow donor. Cloning Human Beings, supra note 12, at 78-80. Some of the experts testifying before the NBAC suggested that cloning should be appropriate in exceptional circumstances. Rabbi Elliot Dorff opined that it would be “legitimate from a moral and a Jewish point of view” to clone a second child to act as a bone marrow donor so long as the “parents” raise that second child as they would any other. Id. at 55. Rabbi Moshe Tendler raised the scenario of a person who was the last in his genetic line and whose family was wiped out in the Holocaust. “I would certainly clone him,” said Tendler. Id. For other Jewish perspectives supporting cloning, see Peter Hirschberg, Be Fruitful and Multiply and Multiply and Multiply, Jerusalem Rep., Apr. 16, 1998, at 33. In contrast, the Catholic viewpoint is that cloning “is entirely unsuitable for human procreation even for exceptional circumstances.” Cloning Human Beings, supra note 12, at 55.

20 Before a U.S. Senate Committee, which also heard from Ian Wilmut shortly after he had announced the birth of Dolly, one of us made the argument that a human clone would be the first human being with one genetic parent. Testimony on Scientific Discoveries and Cloning: Challenges for Public Policy, Before the Sen. Subcomm. on Public Health and Safety, Sen. Comm. on Labor and Human Resources, 105th Cong. 25 (1997) (statement of George J. Annas), available at http://www.bumc.bu.edu/www/sph/lw/pvl/Clonetest.htm. Population geneticist Richard Lewontin challenged this assertion, writing:

A child by cloning has a full set of chromosomes like anyone else, half of which were derived from a mother and half from a father. It happens that these chromosomes were passed through another individual, the cloning donor, on the way to the child. The donor is certainly not the child's “parent” in any biological sense, but simply an earlier offspring of the original parents.

R.C. Lewontin, Confusion over Cloning, N.Y. Rev. Books, Oct. 23, 1997, at 20.

It should be noted that Lewontin's position takes genetic reductionism to its extreme: people become no more than containers of their parent's genes, and their parents have the “right” to treat them not as individual human beings, but rather like embryos—entities that they can “split” or “replicate” without consideration of the child's choice or welfare. Children, even adult children, under this view have no say as to whether or not they are replicated because it is their “parents,” not them, who are “reproducing.” This radical redefinition of reproduction and the denial to children of the choice to procreate or not turns out to be an even stronger argument against cloning children than its biological novelty. George J. Annas, Some Choice: Law, Medicine & The Market 13 (1998).

21 See, e.g., Ethics Comm., Am. Soc'y Reproductive Med., Human Somatic Cell Nuclear Transfer (Cloning), 74 Fertility & Sterility 873, 873-76 (2000).

22 John A. Robertson, Two Models of Human Cloning, 27 Hofstra L. Rev. 609 (1999).

23 Ronald Dworkin, Sovereign Virtue: The Theory and Practice of Equality 437-42 (1997).

24 Leon Kass made this point in another context. Leon R. Kass, Toward A More Natural Science: Biology and Human Affairs 110-111 (1985).

25 See Rael, The True Face of God (Int'l Raelian Movement 1998).

26 See Jay Katz, Experimentation with Human Beings (Russell Sage Found. 1972).

27 Lee Silver, Remaking Eden: Cloning and Beyond in A brave New World 123 (1997).

28 » Id. at 4.

29 Colin Tudge, The Impact of the Gene: From Mendel's Peas to Designer Babies 4 (2000).

30 Id. at 342. See also Ian Wilmut Et. Al., The Second Creation: Dolly and the Age of Biological Control 267-98 (2000) (discussing the implications of cloning for humankind).

31 See the appendix to this Article for current national laws on human cloning and inheritable modifications.

32 Seegenerally The Nazi Doctors and the Nuremberg Code 3 (George J. Annas & Michael A. Grodin eds., 1992) (exploring the “history, context, and implications of the Doctor's Trial at Nuremberg and the impact of the Nuremberg Code on subsequent codes of research ethics and international human rights”).

33 Jonas, supra note 17, at 161-62.

34 It is in this sense that children become “manufactured” products. See Kass, supra note 24, at 71-73.

35 See Annas, supra note 6, at 776-780; Fukuyama, supra note 7, at 22; Francis Fukuyama, Natural Rights and Human History, Nat'l Interest, Summer 2001, at 19, 30. For arguments favoring inheritable genetic modifications, see, for example, Engineering the Human Germline (Gregory Stock & John Campbell eds., 2000); Gregory Stock, Redesigning Humans (2002) (arguing, among other things, that it is inherent in our human nature to want to change our human nature, and that an international treaty would be unenforceable because every nation would have an economic incentive to defect and capture the market for inheritable modifications).

36 See, e.g., Wilmut Et Al., supra note 30, at 5-6 (discussing how the post-Dolly experiments were designed to use cloning techniques to make “better animals,” which was always Ian Wilmut's and Keith Campbell's plan for cloning technology). See also Angelika E. Shnieke et al., Human Factor IX Trans-genic Sheep Produced by Transfer of Nuclei from Transplanted Fetal Fibroblasts, 278 Science 2130(1997).

37 See, for example, Nancy Kress'sBeggars series: Beggars in Spain (1993); Beggars and Choosers (1994); and Beggar's Ride (1996).

38 See Annas, supra note 6, at 778-81. An alternative scenario, that sees equal access to genetic “improvement” by all seems like pie in the sky to us in a world where fewer than ten percent of the population has access to contemporary medical care, and even in the world's richest country, more than forty million people lack health insurance. We do not think it is reasonable to even discuss equal access to genetic alterations until all members of the species have access to current medical technologies as a matter of right.

39 Prohibition of Genetic Intervention Law No. 5759 (1998).

40 Id. § 3(1).

41 Id. § 3(2).

42 See Ania Lichtarowicz, Scientist Warns on Human Cloning, BBC News, at http://news.bbc. co.uk/hi/English/ world/Europe/newsid_1719000/1719195.stm (Dec. 21, 2001) (noting that Spain and Belgium are still considering different types of legislation for adoption).

43 Britain to Ban Human Cloning, CNN.Com, at http://www.cnn.com/2001/WORLD/europe/UK/04/19/cloning. legislation/index.html (Apr. 19, 2001). See also Human Reproductive Cloning Act 2001, U.K. Stat. 2001, ch. 23, Enactment Clause (Eng.). (stating that the law “prohibit[s] the placing in a woman of a human embryo which has been created otherwise than by fertilisation”).

44 4Ministry Bans Cloning Technology for Humans, Daily Yomiuri, July 29, 1998, at 2.

45 Gesetz zum Schutz von Embryonen (Embryonenschutzgesetz), v.13.12.1990 (BGBI. I S.2747). [Federal Embryo Protection Law].

46 Manipulacion Gentica y Reproduccion [Genetic Manipulation and Reproduction]; Victoria Infertility Treatment Act, 2000; Human Reproductive Technology Act, 1991, § 7(l)(d)(i) (W. Austl.).

47 See, e.g., The Logical Next Step? An International Perspective on the Issues of Human Cloning and Genetic Technology, 4 Ilsa J. Int'l & Comp.L. 697, 721-25 (1998).

48 See, e.g., Valerie S. Rup, Human Somatic Cell Nuclear Transfer Cloning, the Race to Regulate, and the Constitutionality of the Proposed Regulations, 76 U. Det. Mercy L. Rev. 1135, 1138-39 (1999); Christine Willgoos, Note, FDA Regulation: An Answer to the Questions of Human Cloning and Germline Gene Therapy, 27 Am. J.L. & Med. 101, 103 (2001).

49 Human Fertilisation and Embryology Act, 1990, ch. 37, Enactment Clause (Eng.). See generally Ruth Deech, The Legal Regulation of Infertility Treatment in Britain, in Crosscurrents:Family Law and Policy in the U.S. and England 165-86 (Sanford Katz et al., eds, 2000).

50 Human Fertilisation and Embryology Act. ch. 27, §§ 3, 12.

51 Id. ch. 37, §41 .

52 Id. ch. 37, Enactment Clause.

53 The Act also had a ban, predating Dolly, on the replacement of the nucleus of a human embryo cell with that of any person or embryo, but that prohibition does not cover somatic cell nucleus transfer into a human egg.

54 Pro-Life Alliance v. Sec'y State for Health, CO/4095/2000 (Q.B. 2001), available at 2001 WL 1347031.

55 Human Reproductive Cloning Act, 2001, U.K. Stat. 2001 ch. 23 § 1.

56 R (Quintavalle) v. Sec'y of State for Health, 2 WLR 550 (C.A. 2002), reprinted at Cell Nuclear Replacement Organism is “Embryo," The Times (London), Jan. 25, 2002.

57 Federal Embryo Protection Law, 1990 (Eng.)

58 Victoria Infertility Treatment Act, 1995.

59 Federal Embryo Protection Law, 1990 (Eng.), at Part 5, § 39(1).

60 Federal Embryo Protection Law, 1990 (Eng.), at Part 5, § 39(2).

61 Human Reproductive Technology, 1991, § 7(1 )(j) (Austl.).

62 The Act Relating to the Application of Biotechnology in Medicine, ch. 7.

63 Law No. 115 of March 14, 1991, Act Concerning Measures for the Purposes of Research or Treatment in Connection with Fertilized Human Oocytes (1993).

64 Law No. 94-654 of July 29,1994, on the Donation and Use of Elements and Products of the Human Body, Medically Assisted Procreation, and Prenatal Diagnosis.

65 Decree No. 24029-S: A Regulation on Assisted Reproduction, Feb. 3, 1995.

66 See Memorandum on the Prohibition on Federal Funding for Cloning of Human Beings, 33 Weekly Comp. Pres. Doc. 281 (Mar. 4, 1997); see also Transcript of Clinton Remarks on Cloning, U.S. Newswire, Mar. 4, 1997, available at 1997 WL 5711155.

67 Yet despite the risks, only six states—California, Iowa, Louisiana, Michigan, Rhode Island and Virginia—have passed legislation that prohibits human reproductive cloning. Cal. Health & Safety Code Ann. § 24185 (West 2002); Iowa Code § 707B, CSB 218 (S.F. 2118) (2002); LA. Rev. STAT. 40:1299.36.2 (West 2002); Mich. Comp. Laws Ann. § 750.430a (West 2001); R.I. Gen. Laws § 23-16.4 (2001); VA. Code Ann. §§ 32.1-162.21, 162.22 (Michie 2002). In addition, Missouri prohibits the use of any state funds to bring about the birth of a child via cloning techniques. Mo. Ann. Stat. § 1.217 (West 2002). The U.S. House of Representatives in July 2001 voted to ban human cloning. See The Human Cloning Prohibition Act of 2001, H.R. 2505, 107th Cong. (2001). See also Sheryl Gay Stolberg, House Backs Ban on Human Cloning for any Objective, N.Y. Times, Aug. 1, 2001, at Al . At the time of this writing, the U.S. Senate was scheduled to consider this issue in 2002.

68 Fla. Stat. Ann. § 390.0111(6) (West 2002); LA. Rev. Stat. Ann. § 9:121-129 (West 2002); Me. Rev. Stat. Ann. tit. 22, § 1593 (2002); Mass. Gen. Laws Ann. ch. 112, § 12J West (2002); Mich. Comp. Laws Ann. § 333.2685-.2692 (West 2002); Minn. Stat. § 145.421 (2001); N.D. Cent. Code § 14-02.2-01 (2001); N.H. Rev. Stat. Ann. § 168-B:15 (2002); 18 Pa. Cons. Stat. § 3216 (2001); R.I. Gen. Laws § 11-54-1 (2001). A South Dakota law bans research that destroys an embryo, when such research has not been undertaken to preserve the life and health of the particular embryo. S.D. Codified Laws § 34-14-18 (Michie 2001).

69 Minn. Stat. Ann. § 145.421.

70 Mich. Comp. Laws Ann. § 333.2685.

71 Fla. Stat. Ann. § 390.0111(6); Me. Rev. Stat. Ann. tit. 22, § 1593; Mass. Gen. Laws Ann. ch. 112, § 12J; Mich. Comp. Laws Ann. § 333.2685-.2692; N.D. Cent. Code § 14-02.2-01; R.I. Gen. Laws § 11-54-1.

72 18 Pa. Cons. Stat. § 3216.

73 See Ronald M. Green, The Ethical Considerations, 286 Scientific Am. 4850, 4850 (Jan. 2002) (arguing that when Advanced Cell Technology created what the company called the “world's first human cloned embryo,” all it had really done was create an “activated egg”). The company's president, Michael West, had previously argued that the company's work did not violate the Massachusetts Federal Research statute, and we believe he is correct in this argument.

74 Four states' fetal research bans—those of Arizona, Illinois, Louisiana, and Utah—have already been struck down on those grounds. Forbes v. Napolitano, 236 F.3d 1009 (9th Cir. 2000); Margaret S. v. Edwards, 794 F.2d 994, 998-99 (5th Cir. 1996); Jane L. v. Bangerter, 61 F.3d 1493, 1499-1502 (10th Cir. 1995); Lifchez v. Hartigan, 735 F. Supp. 1361, 1363-66 (N.D. 111. 1990).

75 N.H. Rev. Stat. Ann. § 168-B:15(II) (2002).

76 LA. Rev. Stat. Ann. § 40:1299.36.2 (West 2002); Mich. Comp. Laws Ann. §§ 333.16275, 750.430(a) (West 2001); R.I. Gen. Laws § 23-16.4-2 (2001).

77 Me. Rev. Stat. Ann. tit. 22, § 1593 (2002).

78 See, e.g., Fla. Stat. Ann. § 390.0111(6) (West 2002); Mass. Gen. Laws Ann. ch. 112, § 12J (West 2002); Mich. Comp. Laws Ann. § 333.2685-.2692 (West 2002); Minn. Stat. § 145.421 (2001); N.D. Cent. Code § 14-02.2-01 (2001); 18 Pa. Cons. Stat. § 3216 (2001); R.I. Gen. Laws § 11-54-1.

79 N.H. Rev. Stat. Ann. § 168-B.15(II).

80 LA. Rev. Stat. Ann. § 9:122 (West 2002).

81 The right to make decisions about whether or not to bear children is constitutionally protected under the constitutional right to privacy. See, e.g., Eisenstadt v. Baird, 405 U.S. 438 (1972); Griswold v. Connecticut, 381 U.S. 479 (1965/ The constitutional right to liberty also affords such protection. See Planned Parenthood of S.E. Pa. v. Casey, 505 U.S. 833, 857 (1992). The U.S. Supreme Court in 1992 reaffirmed the “recognized protection accorded to liberty relating to intimate relationships, the family, and decisions about whether to bear and beget a child.” Id. at 857. Early decisions held that the right to privacy protected married couples' ability to make procreative decisions, but later decisions focused on individuals' rights as well. The U.S. Supreme Court has stated, “If the right of privacy means anything, it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.” Eisenstadt, 405 U.S. at 453.

A federal district court has indicated that the right to make procreative decisions encompasses the right of an infertile couple to undergo medically-assisted reproduction, including IVF and the use of a donated embryo. Lifchez v. Hartigan, 735 F. Supp. 1361, 1367-69. (N.D. 111. 1990). Lifchez held that a ban on research on conceptuses was unconstitutional because it impermissibly infringed upon a woman's fundamental right to privacy. Id. at 1363. Although the Illinois statute banning embryo and fetal research at issue in the case permitted IVF, it did not allow embryo donation, embryo freezing or experimental prenatal diagnostic procedures. Id. at 1365-70. The court stated, “It takes no great leap of logic to see that within the cluster of constitutionally protected choices that includes the right to have access to contraceptives, there must be included within that cluster the right to submit to a medical procedure that may bring about, rather than prevent, pregnancy.” Id. at 1377. The court also held that the statute was impermissibly vague because of its failure to define “experiment” or “therapeutic.” Id. at 1376.

Some commentators argue that the Constitution similarly protects the right to create a child through cloning. See John Robertson, Views on Cloning: Possible Benefits, Address Before the National Bioethics Advisory Commission (Mar. 14, 1997), available at http://bioethics.georgetown.edu /nbac/transcripts/index.html. This seems to be a reversal of Robertson's earlier position that cloning “may deviate too far from prevailing conception of what is valuable about reproduction to count as a protected reproductive experience. At some point attempts to control the entire genome of a new person pass beyond the central experiences of identity and meaning that make reproduction a valued experience.” John Robertson, Children of Choice: Freedom and the New Reproductive Technologies 169 (1994).

However, cloning is sufficiently different from normal reproduction and the types of assisted reproduction protected by theLifchez case that constitutional protections should not apply. In even the most high-tech reproductive technologies available, a mix of genes occurs to create an individual with a genotype that has never before existed. In the case of twins, two such individuals are created. Their futures are open and the distinction between themselves and their parents is acknowledged. In the case of cloning, however, the genotype already exists. Even though it is clear that the individual will develop into a person with different traits because of different social, environmental and generational influences, there is evidence that the fact that he or she posses an existing genotype will affect how the resulting clone is treated by himself, his family and social institutions.

In that sense, cloning is sufficiently distinct from traditional reproduction or alternative reproduction to not be considered constitutionally protected. It is not a process of genetic mix, but of genetic duplication. It is not reproduction, but a sort of recycling, where a single individual's genome is made into someone else. This change in kind in the fundamental way in which humans can “reproduce” represents such a challenge to human dignity and the potential devaluation of human life (even comparing the “original” to the “copy” in terms of which is to be more valued) that even the search for an analogy has come up empty handed. Testimony on Scientific Discoveries and Cloning: Challenges for Public Policy, Before the Sen. Subcomm. on Public Health and Safety, Sen. Comm. on Labor and Human Resources, 105th Cong. 25 (1997) (statement of George J. Annas), available at http://www.bumc.bu.edu/www/sph/lw/pvl/Clonetest.htm. Gilbert Meilaender, in testifying before NBAC, pointed out the social importance of children's genetic independence from their parents: “They replicate neither their father nor their mother. That is a reminder of the independence that we must eventually grant to them and for which it is our duty to prepare them.” Cloning Human Beings, supra note 12, at 81.

Even if a constitutional right to clone were to be recognized, any legislation which would infringe unduly upon this fundamental right would be permissible if it furthered a compelling interest in the least restrictive manner possible in order to survive this standard of review. See Lifchez, 735 F. Supp. at 1377. Along those lines, the NBAC raised concerns about physical and psychological risks to the offspring, as well as about “a degradation of the quality of parenting, and family if parents are tempted to seek excessive control over their children's characteristics, to value children according to how well they meet every detailed parental expectation, and to undermine the acceptance and openness that typify loving families.” Cloning Human Beings, supra note 12, at 77. The NBAC also noted how cloning might undermine important social values, such as opening the door to a form of eugenics, or by tempting some to manipulate others as if they were objects instead of persons, and exceeding the moral boundaries of the human condition. Id.

The potential physical and psychological risks of cloning an entire individual are sufficiently compelling to justify banning the procedure. The notion of replicating existing humans seems to fundamentally conflict with our legal system, which emphatically protects individuality and uniqueness. Banning procreation through nuclear transplantation is justifiable in light of common law and constitutional protection of the sanctity of the individual and personal privacy. Francis C. Pizzulli, Note, Asexual Reproduction and Genetic Engineering: A Constitutional Assessment of the Technology of Cloning, 47 S. Cal. L. Rev. 476, 502 (1974).

In the United States, couples' constitutional arguments regarding a privacy right or liberty right to use inheritable genetic interventions would appear to be stronger than those regarding access to cloning. In decisions construing the Americans with Disabilities Act, including one before the U.S. Supreme Court, individuals with AIDS were judged to be disabled because their disease was seen as interfering with a major life function—reproduction. Bragdon v. Abbott, 524 U.S. 624, 631 (1998). The argument seems to be that “normal” reproduction involves the creation of children without diseases.

Couples who both have sickle cell anemia or some other recessive genetic disorder might argue that a ban on germline interventions deprives them of reproductive liberty because it is the only way they can have healthy children. (There are several fallacies in that argument. The children born may have other diseases. And the genetic modification intervention itself might harm the children or be ineffective.) Forbidding the use of the techniques, it would be argued, forces them to go childless.

The couple might bolster their argument with a reference to another aspect of theLifchez holding. The court in that case also held the ban on embryo research unconstitutional because it forbade parents from using experimental diagnostic techniques to learn the genetic status of their fetus. See Lifchez, 735 F. Supp. at 1366-67. The court reasoned that, if the woman has a constitutional right to abort, she has a right to genetic information upon which to make the decision. See id. Using an expansive interpretation, Lifchez could be understood as saying that it was understandable that couples would choose to have only children of a certain genetic makeup and that such a decision was constitutionally protected. However, even if there were a constitutional right to use inheritable genetic interventions, such interventions could be banned if they posed compelling physical, psychological or social risks. To be constitutional, the ban would also need to be narrowly focused to operate in the least restrictive manner possible.

82 See Kaiser Family Found., Lawmakers Vow to Introduce Cloning Restrictions, Bush Signals He Will “Work to Pass” Ban, Kaiser Daily Reprod. Health Rep., Mar. 29, 2001, available at http://report.kff.org/archive/repro/2001/3/ kr010329.2.htm.

83 As of June, 2002, the Senate had three bills to consider. S. 790, introduced by Senator Brownback of Kansas, is substantially the same as the Weldon bill passed by the House of Representatives in August, 2001. Human Cloning Prohibition Act, S. 790, 107th Cong. (2001). It would ban both the creation of human embryos by cloning as well as attempts to create a human child by cloning. Id. at § 3. S. 1758, introduced by Senator Dianne Feinstein of California bans attempts at human cloning, defined as “asexual reproduction by implanting or attempting to implant the product of nuclear transplantation into a uterus.” Human Cloning Prohibition Act, S. 1758, 107th Cong. (2001). It also specifically permits certain activities, including “nuclear transplantation to produce human stem cells.” Id. at § 4. It was slightly modified on May 1 and reintroduced as S. 2439 with the endorsement of Senator Orin Hatch. 148 Cong. Rec. S36.633 (2002) Finally, S. 1893, introduced in late January, 2002 by Senator Harkin of Iowa would simply ban cloning as defined as “asexual human reproduction by implanting or attempting to implant the product of nuclear transplantation [defined as “introducing the nuclear material of a human somatic cell into a fertilized or unfertilized oocyte from which the nucleus has been or will be removed or inactivated"] into a woman's uterus or a substitute for a woman's uterus.” S. 1893, 107th Cong. § 498C (2002). For more details, see George J. Annas, Cloning and the U.S. Congress, 346 New Eng. J. Med. 1599 (2002).

84 The outstanding question is whether abortion politics will permit members of Congress to outlaw so-called reproductive cloning (which they all agree should be done) without also outlawing research cloning (a prohibition included in the Weldon and Brownback bills because some supporters object to any creation of human embryos in the laboratory, and others believe that once created by cloning, it is inevitable that a cloned human embryo will be introduced into a woman's uterus and eventually result in the birth of a cloned child). The slippery slope from research to reproductive cloning is real, of course, but could be made much less likely by adding restrictions to what physicians involved in infertility treatment could do (e.g., no creation or use of cloned embryos by infertility specialists). Three further steps would virtually eliminate the danger: creation of a federal oversight panel that would have to approve any research projects involving the creation of cloned embryos; outlawing the purchase and sale of human eggs (as is done now for organs and tissues for transplant); and outlawing the freezing or storage of cloned human embryos, eliminating the potential for stockpiling human embryos, and making it almost impossible for a research embryo to be used for reproduction in practice. George J. Annas, Cell Division, Boston Globe, Apr. 21, 2002, El.

85 Gene Weingarten, Strange Egg, Wash. Post, Jan. 25, 1998, at Fl.

86 Radical Scientist to Help Open Cloning Clinics in Japan, Japan Sci. Scan, Dec. 7, 1998, available at 1998 WL 8029927.

87 Thomas Hirenee Atenga, Africa: Biotech Firms Have Their Eyes on Africa, Euro MPS Say, Int'l Press Serv., Oct. 14,1998.

88 See supra notes 39 to 56 and accompanying text.

89 Brit. Med. Ass'n, The Medical Profession and Human Rights 205-40 (2001), see also sources citedsupra note 32.

90 Most Doctors, Academics Oppose Human Cloning, Japan Econ. Newswire, Nov. 7, 1998.

91 Conselho Nacional de Etica para as Ciencias de Vida [National Council on Ethics for the Life Sciences], Opinion on Embryo Research and the Ethical Implications of Cloning, No. 21/CNEV/97(1997).

92 Resolution on Human Cloning, European Parliament, Jan. 15, 1998, O.J. (C 34) 164 (1998).

93 See Ian Wilmut, Cloning for Medicine, Scientific Am., Dec. 1998, at 58:

None of the suggested uses of cloning for making copies of existing people is ethically acceptable to my way of thinking, because they are not in the interests of the resulting child. It should go without saying that I strongly oppose allowing cloned human embryos to develop so that they can be tissue donors.

Id. Wilmut has testified around the world against human cloning. See, e.g., Christine Corcos et al., Double-Take: A Second Look at Cloning, Science Fiction and Law, 59 La. L. Rev. 1041, 1051 (denouncing cloning human beings at a talk at Princeton University); Creator of Dolly Stresses Benefits of Further Research on Cloning, Daily Yomiuri, June 7, 1997, available at 19997 WL 1211052 (advocating a worldwide prohibition against human cloning); Cult in the First Bid to Clone Human, Express, Oct. 11, 2000, available at 2000 WL 24217743 (responding to a British couple's plan to clone their deceased daughter, stating that “it is absolutely criminal to try this [cloning] in a human.”); Curt Suplee, Top Scientists Warn Against Cloning Panic; Recreating Humans Would Be Unethical Experts Say, Wash. Post, Mar. 13, 1997, at A03 (testifying against human cloning before the NBAC).

94 Press Release, Biotechnology Ind. Org., BIO Reiterates Unequivocal Opposition to Reproductive Cloning; Support for Therapeutic Applications, Nov. 25, 2001, available at http://www.bio.org/newsroom/news.asp. See also Frances Bishop, 11th Annual Bio Conference: Ethical Issues in Genetics Create Challenges for Biotech Industry, 8 BlOworld Today 112 (1997), available at 1997 WL 11130296.

95 Press Release, W.H.O., World Health Assembly, World Health Assembly States its Position on Cloning Human Reproduction (May 14, 1997), available at http://www.who.int/archives/ inf-pr-1997/en/97wha9.html.

96 W.H.O., World Health Assembly, 51st Sess., Ethical, Scientific and Social Implications of Cloning in Human Health, WHA51.10, (1998).

97 1) Croatia, 2) Cyprus, 3) Czech Republic, 4) Denmark, 5) Estonia, 6) Finland, 7) France, 8) Georgia, 9) Greece, 10) Hungary, 11) Iceland, 12) Italy, 13) Latvia, 14) Lithuania, 15) Luxembourg, 16) Moldova, 17) Netherlands, 18) Norway, 19) Poland, 20) Portugal, 21) Romania, 22) San Marino, 23) Slovenia, 24) Slovenia, 25) Spain, 26) Sweden, 27) Switzerland, 28) the former Yugoslav Republic of Macedonia and 29) Turkey. See also Additional Protocol (Explanatory Report) To the Convention on Human Rights and Biomedicine, Jan. 12,1998, available at http://conventions.coe.int/Treaty/en/ Reports/Html/168.htm.

98 Resolution on Human Cloning, Eur. Parliament, Jan. 15, 1998 O.J. (C34) 164 (1998).

99 Id.

100 Id.

101 U.N.E.S.C.O., Universal Declaration on the Human Genome and Human Rights, 29th Sess., 29 C/Res. 16 (1997), available at http://www.unesco.org/human_rights/hrbc.htm. The declaration was adopted by the General Assembly in 1999. G.A. Res. 152, U.N. Gaor, 53rd Sess., U.N. Doc. A/53/152 (1999).

102 Universal Declaration on the Human Genome and Human Rights, Introduction.

103 Id.

104 Id. art. 11.

105 id.

106 Request for the Inclusion of a Supplementary Item in the Agenda of the 56th Session, International Convention Against the Reproductive Cloning of Human Beings, U.N. Gaor, 56th Sess., U.N. Doc. A/56/192 (2001).

107 United Nations Calls for a Treaty to Ban Human Cloning, Birmingham Post, Nov. 21, 2001, at 8.

108 See supra note 84. The next meeting of the ad hoc committee is scheduled at the United Nations for September 23-27, 2002. It is anticipated that the mandate to guide subsequent treaty negotiations will be adopted at this meeting, and that treaty language may be agreed upon a year or so later.

109 Stephen P. Marks, Tying Prometheus Down: The International Law of Human Genetic Manipulation, 3 Chi. J. Int'L L. (forthcoming 2002). The other U.N. treaty method is known as a framework convention, which is used when countries agree that a particular field needs to be regulated (such as the environment), but do not yet agree on the specifics of how the regulation should work. Because there is basic international agreement on human reproductive cloning, the framework convention is inappropriate. See, e.g., Daniel Bodansky, The United Nations Framework Convention on Climate Change: A Commentary, 18 Yale J. Int'l L. 451, 494 (1993). See also Anthony Aust, Modern Treaty Law and Practice 97 (2000); Donald M. Goldberg, Negotiating the Framework Convention on Climate Change, 4 Touro J. Transnat'l L. 149 (1993); Lee A. Kimball, The Biodiversity Convention: How to Make it Work, 28 Vand. J. Transnat'l L. 763 (1995).

110 Convention on the Prohibition of the Use, Stockpiling, Production and Transfer of Anti-Personnel Mines and on their Destruction, G.A. res. 47/39, 47 U.N. GAOR Supp. (No. 49) at 54, U.N. Doc. A/47/49 (1992).