¹ Albert Einstein, 1930 California Institute of Technology Pasadena, California.

² The United States Department of Health and Human Services (DHHS) issued a formal definition of the term “xenotransplantation.” The DHHS's most recent guideline on xenotransplantation, PHS Guideline on Infectious Disease Issues in Xenotransplantation at http://www.fda.gov/cber/gdlns/xeno0500.pdf (visited Sept. 14, 2000) [hereinafter PHS Guideline], defines “xenotransplantation” as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.” Id. at 4.

³ See F. Barbara Orlans Et Al., The Human use of Animals: Case Studies in Ethical Choice 57 (1998); Robert E. Michler, Commentary, Xenotransplantation: Risks, Clinical Potential and Future Prospects, *4-5, 1996, al http://www.cdc.gov/ncidod/EID/vol2nol/michler.htm (describing the history of xenotransplantation since the early 20 111 century).

⁴ See Orlans, supra note 3, at 57-58; see also Frank Morgan, Babe the Magnificent Organ Donor? The Perils and Promises Surrounding Xenotransplantation, 14 J. Contemp. Health L. & Pol'Y 127, 140 (1997) (addressing the problem of “hyperacute rejection,” which is the “total rejection of the organ almost immediately”). To prevent rejection in any transplant (and especially with xenotransplants), recipients must normally undergo immunosuppression, since “[ojrdinarily, the body's immune system fights infections by recognizing foreign protein strains.” Id. at 138. The risk of rejection also increases when the donor organ originates from a non-human source animal; even more dangerous is when the donor animal is less similar to humans. Id.

⁵ In particular, two recent breakthroughs involving the genetic alteration of pigs made the science of xenotransplantation more viable and hopefully less dangerous. See BioTransplant Breeds Miniature Swine That Do Not Produce Porcine Endogenous Retrovirus (PERV) Capable of Replicating in Human Cells; Presented Today at the XVIII Meeting of the International Congress of the Transplantation Society in Rome, Italy, Pr Newswire, Aug. 28, 2000, available in Lexis, News Group File (discussing the August 28, 2000 announcement by BioTransplant Incorporated (BioTransplant) that it might be able to breed pigs whose organs will not transmit the porcine endogenous retrovirus (PERV) to humans, if those organs were to be used as transplants). BioTransplant achieved this discovery by inbreeding several pigs of a defined genetic line. “All nine animals failed to transmit [a] virus that replicated in human kidney cell line 293, the most permissive human cell line for PERV replication.” Id. Furthermore, “[t]he results of this study suggest that the non-transmitter animals do not contain copies of replication-competent PERV.” Id.; PPL Produces World's First Cloned Pigs at http://xenotransplant.ineu.org/xenotrans/news/ 20000314.htm (visited Sept. 27, 2000) (discussing the March 5, 2000 announcement by PPL Threrapeutics that it cloned five piglets from adult cells). In an effort similar to BioTransplant's scientific and commercial objectives, PPL plans to continue this research in order to produce cloned pigs that lack the alpha 1-3 gal transferase gene, which constitutes a sugar group within pig cells. See id. The presence of this sugar group within the human body can lead to hyperacute rejection, since the human body recognizes the sugar group as being a foreign substance. PPL is perfecting the process of “targeted gene knockout,” which would inactivate the alpha 1-3 gene and possibly other genes that would lead to the human body's rejection of xenotransplants. The goal of this research is to create a “'knock-out' pig” that would have certain incompatible genes inactivated—allowing scientists to then clone that pig and harvest the cloned pigs' organs for transplanting. See id. For further discussion of Perv and genetic issues, see infra Part I.A.2.

⁶ See Pr Newswire, supra note 5.

⁷ See, e.g., Orlans, supra note 3, at 59 (stating that in 1992 an estimated 15,000 people on the transplant waiting list would not receive an organ).

⁸ See, e.g., Morgan, supra note 4, at 141-142 (discussing three categories of viruses that pose some threat to the success of xenotransplantation). First, retroviruses such as PERVs are quite threatening. Retroviruses “are named for reverse transcriptase, an enzyme that transcribes the viral RNA into the [host's] DNA.” Id. A retrovirus such as PERV could affect a human's DNA, and remain dormant for an extended period of time before manifesting any symptoms. This process is similar to the effects of AIDS. Second, herpesviruses may present an even greater challenge to xenotransplantation, because such viruses are “benign in the host but become malevolent when they cross species.” Id. Third, filoviruses also present some risk to organ recipients, but not nearly as much so as with retroviruses and herpesviruses. Id. The reason or this reduced risk is that filoviruses are short-lived, and researchers could prevent the spread of filoviruses within a colony with proper isolation prior to the xenotransplant procedure.

⁹ In 1994, the Center for Biologies Evaluation Research (CBER) at the Food and Drug Administration (FDA) received the first investigational new drug applications for xenotransplantation-related products. See Susan L. Smith, Xenotransplantation Action Plan: US Food and Drug Administration Approach to the Regulation of Xenotransplantation, at http://transplantation.medscape.com/Medsc.2000/v01.n02/mt0214.smit/mt0214.smit.html (visited March 21, 2001). Currently, there are various xenotransplantation clinical trials that are being monitored by the FDA. See id. FDA and CBER published an industry guidance document, Public Health Issues Posed by the Use of Non-Human Primate Xenographs in Humans, in the April 6, Federal Register. See id.

¹⁰ Several months after its initial discovery (see supra note 5), BioTransplant entered into a joint venture with Novartis Pharmaceuticals, now named “Immerge Therapeutics.” BioTransplant JV with Novartis Renamed, Marketletter, Feb. 5, 2001, available in 2001 WL 9077394. During the next two years, this new company seeks to “conduct pig-to-primate transplants, focusing on the transplantation of the major organs, including kidneys, hearts and possibly lungs….” Pig Breeding for Xenotransplant Advances with Grant, Med. Indus. Today, Aug. 29, 2000, available in Lexis, News Group File. It is the hope of Immerge Therapeutics “to start testing pig organs in humans in 2004. [However], [s]uch testing, and later commercial transplants, would require approval from the Food and Drug Administration.” BioTransplant, Novartis Team Up on Transplants: New Firm Will Seek to Commercialize Use of Pig Organs, Boston Globe, Sept. 27, 2000, at E4.

¹¹ See, e.g., Alix Fano et al., Of Pigs, Primates, and Plagues: A Layperson's Guide to the Problems With Animal-to-Human Organ Transplants, at http://www.mrmcmed.org/pigs.html (visited Dec. 29, 2000) (arguing against xenotransplantation for several reasons, such as the excessive costs of xenotransplants, the threat of another viral epidemic similar to AIDS, researcher's inability to screen for unknown animal viruses, the environmental problems posed by the disposal of genetically modified source animal carcasses, and the availability of alternatives such as preventative health and the increase of human organ donations). For a detailed list of articles exploring the problems of xenotransplantation, see Campaign for Responsible Transplantation: Publications and Resources, at http://www.crt-online.org/jrnlarts.html.

¹² Hendrik A. Verfaillie, President and CEO Monsanto Company, Nov 27, 2000, Washington DC.

¹³ As a side note to this discussion, the DHHS addresses public concern and information in the PHS Guideline. See PHS Guideline, supra note 2, at §§ 5.1-5.3. The PHS Guideline proposes three methods of keeping relevant information available to the public: a National Xenotransplantation Database, biologic specimen archives, and the Secretary's Advisory Committee on Xenotransplantation (SACX). The National Xenotransplantation Database would be designed to “collect data from all clinical centers conducting trials in xenotransplantation and all animal facilities,” and would record the rates and clusters of adverse reactions, would link such events to exposures, and would notify individuals and clinical centers of adverse reactions. Id at § 5.1. The biologic specimen archives would store specimens from source animals and organ recipients. It is possible that DHHS may contract with a private organization to establish one central archive. Id. at § 5.2. The SACX would consider “ongoing and proposed protocols, and make recommendations to the Secretary on policy and procedures. The SACX will also provide a forum for public discussion of issues when appropriate.” Id. at § 5.3.

¹⁴ See also PHS Guideline, supra note 2, at § 2.5 (suggesting, in addition to compliance with regulatory requirements, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research's clinical practice guidelines, and the National Bioethics Advisory Board's recommendations, that informed consent procedures should address the following issues: (a) the potential of infection with known and unknown non-human agents; (b) possible risk of transmission of infectious agents to family or close contacts; (c) the recipient's responsibility to educate family and close contacts about possible transmission of infectious agents; (d) the possible necessity of isolation during any hospitalization; (e) the need for precaution regarding contact with animals of the same species from which the organ was procured; (f) long-term surveillance of the recipient, including routine evaluations; (g) the need for an autopsy after the recipient's death; (h) public health agencies' access to the recipients medical records, while maintaining some confidentiality; (i) the prohibition against any close contact's donating bodily fluids or parts; and (j) the dangers inherent in reproduction).

¹⁵ Carnerie, Fran, Crisis and Informed Consent: Analysis of a Law-Medicine Malocclusion, 12 Amj.L.& Med. 55(1986)Google Scholar.

¹⁶ See generally, e.g., Anne Fadiman, The Spirit Catches you and You Fall Down (1997) (chronicling the cultural conflicts and obstacles that arose between the family of a Hmong child and their American doctors).

¹⁷ On surrogate decision-making, see generally Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 170-181 (4^th Ed. 1994).

¹⁸ Superintendent of Belchertown v. Sarkewitz, 370 N.E.2d. 417, 431 (Mass. 1977). The Court adopted a substituted judgment doctrine in order to determine an incompetent person's actual interests, from the standpoint of a reasonable, competent person in the same position as the incompetent person. See id.

¹⁹ See also PHS Guideline, supra note 2, at § 4 (discussing clinical issues). Section 4 addresses several issues relevant to the transplant recipient's cooperation with and subordination to clinicians. The PHS Guideline proposes that since “[p]ost-xenotransplantation clinical and laboratory surveillance of xenotransplantation product recipients is critical, …surveillance of [recipients] is appropriate.” Id. at § 4.1.1. Regarding specimens from recipients, the DHHS recommends that specimens “be archived for 50 years beyond the date of the xenotransplantation,” and that additional specimens should be collected periodically during the recipient's lifetime. Id at § 4.1.2. Concerning medical records, the PHS Guideline states that the “sponsor should maintain a cross-referenced system that links the relevant records of the [recipient], xenotransplantation product, source animal(s), animal procurement center, and significant nosocomial exposures.” Id. at § 4.3. Nevertheless, “[t]o the extent permitted by applicable laws and/or regulations, the confidentiality of all medical and research records pertaining to human recipients should be maintained….” Id. Although the PHS Guideline does not advise keeping actual records of the recipient's close contacts, it does place responsibility upon the recipient to inform close contacts of any risks. For some discussion of the PHS Guideline's treatment of recipients' contacts, see supra note 14.

²⁰ Currently, the Canadian Council of Animal Care (CACC) has formulated special guidelines on transgenic animals and requires that genetic modifications performed on animals be approved by the Animal Care Committee. See CCAC guidelines on: transgenic animals, 1997, CCAC, at http://www.ccac.ca/english/gdlines/transgen/transgel.htm. See also PHS Guideline, supra note 2, at § 3 (discussing animal sources for xenotransplantation). Although § 3 substantially addresses the prevention of inter-species and cross-species infections and recordkeeping requirements, there is some mention of animal welfare. In particular, although source animals are to be “bred and reared in captivity,” procedures “should be in place to assure the humane care of all animals.” Id. at §§ 3.1.1, 3.2.3. In addition, “animal facilities should be subject to inspection by designated representatives of the clinical protocol sponsor and public health agencies. The sponsor is responsible for implementing and maintaining a routine facilities inspection program for quality control and quality assurance.” Id. at § 3.2.8.

²¹ Universal Declaration of Human Rights, G.A. Res. 217A, U.N. Gaor 3d Sess., (1948), at http://www.un.org/overview/rights.html [hereinafter UDHR].

²² Optional Protocol to the International Covenant on Civil and Political Rights, G.A. Res. 2200A, U.N. Gaor 21st Sess., (1966), at http://www.unhchr.ch/html/menu3/b/a_opt.htm.

²³ International Covenant on Civil and Political Rights, G.A. Res. 2200A, U.N. Gaor 21st Sess., (1966), at http://www.unhchr.ch/html/menu3/b/a_cescr.htm [hereinafter Icescr].

²⁴ Convention for the Protection of Human Rights and Fundamental Freedoms, Council of Europe, Ets no.005, Nov. 4,1950, at http:// conventions.coe.int/treaty/EN/Treaties/html/005.htm.

²⁵ Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data, Council of Europe, ETS no. 108, Jan. 28, 1981, at http://conventions.coe.int/treaty/en/Treaties/Html/108.htm.

²⁶ It should be noted that the United States is not a party to the Council of Europe conventions discussed.

²⁷ Declaration on the Use of Scientific and Technological Progress in the Interests of Peace and for the Benefit of Mankind, G.S. Res. 3384, U.N. Gaor 30th Sess., (1975), at http://diana.law.yale.edu/diana/db/81098-4.html.

²⁸ Strengthening the Coordination of the Mechanisms on the Commission for Science and Technology for Development, G.A. Res. 185, U.N. Gaor 55th Sess., (2000) at http://www.un.org/documents/ga/res/55/a55rl85.pdf.

²⁹ Convention for the Protection of Human Rights and the Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine, Council of Europe, ETS no. 164, April 4, 1997, at http://conventions.coe.int/Treaty/en/Treaties/Html/164.htm.

³⁰ Declaration of Helsinki, World Medical Association, June 1964, adopted by the 18th World Medical Assembly, Helsinki, Finland.

³¹ Universal Declaration on the Human Genome and Human Rights, 1997, at http://www.unesco.org/opi/29gencon/egenkit.htm.

³² It charges the International Bioethics Committee of UNESCO with many responsibilities in these areas and is a useful pointer to the important role this committee can play in the xenotransplantation problem.

³³ Other issues also include the right to privacy, see UDHR, supra note 21, Article 12; social and cultural rights, see UDHR, supra note 21, Article 22, 27, the right to the highest attainable standards of health, see ICESCR, supra note 23, Article 12, and the right to medical services, see ICESCR, supra note 23, Article 12(2)(d).

³⁴ See UDHR, supra note 21, Article 3.

³⁵ See supra Part II.A.

³⁶ The problem of inequitable allocation in allotransplantation have been the subject of adverse comment in some treatises on medical ethics. See, e.g., Beauchamp & Childress, supra note 17, at 373.

³⁷ Declaration of Helsinki, World Medical Association, June 1964, adopted by the 18th World Medical Assembly, Helsinki, Finland

³⁸ See The Corfu Channel Case, 1949 I.C.J. 4, *22.

³⁹ Id. at *22-23.

⁴⁰ Indeed, in Corfu, Albania was found liable to Great Britain for not taking measures to notify approaching ships that a minefield existed in its territorial waters. Great Britain could not prove that Albania itself created the minefield, but it did prove that Albania knew of its existence and did not make efforts to warn approaching ships. See id.

⁴¹ See Request for an Examination of Situation in Accordance with Paragraph 63 of Court's Judgment of 20 December 1974 in Nuclear Tests (New Zealand v. France), 1995 I.C.J. 288, *341-342 (Sept. 22) (Weeramantry, J., dissenting) (“The starting proposition is that each generation is both a custodian and a user of our common natural and cultural patrimony. As custodians of this planet, we have certain moral obligations to future generations which we can transform into legally enforceable norms.”), quoting E. Brown Weiss, In Fairness to Future Generations: International Law, Common Patrimony and Intergenerational Equity, 1989, p. 21; Stockholm Declaration on the Human Environment, 1972, Principle 1 (“[member nations have] a solemn responsibility to protect and improve the environment for present and future generations.”).

⁴² See Legality of the Threat or Use of Nuclear Weapons (United Nations), 1996 I.C.J. 226, para.29 (“[the] Court also recognizes that the environment is not an abstraction but represents the living space, the quality of life and the very health of human beings, including generations unborn. The existence of the general obligation of States to ensure that activities within their jurisdiction and control respect the environment of other States … is now part of the corpus of international law relating to the environment.”)

⁴³ See supra notes 41 and 42.

⁴⁴ Legality of the Threat or Use of Nuclear Weapons (United Nations) 1996 I.C.J. 226, para.27.

⁴⁵ See, e.g., New Zealand v. France, 1995 I.C.J. 288, *342-44 (Weeramantry, J., dissenting); 1992 Maastricht Treaty Title XVI, Art. 130r(2); Rio Declaration on Environment and Development, 1992, Principle 15; Phillippe Sands, Principles of International Environmental Law I: Frameworks, Standards and Implementation, Vol. 1,208-10 (1995).

⁴⁶ Universal Declaration on the Human Genome and Human Rights, 1997, at http://www.unesco.org/opi/29gencon/egenkit.htm.

⁴⁷ The World Health Organization (WHO) offers an informative guideline somewhat similar to the PHS Guideline, although the document is not a formal publication of the WHO. See C.J. Witt et al., Xenotransplantation: Guidance on Infectious Disease Prevention and Management, at § 1, at http://www.who.int/emc-documents/zoonoses/whoemczoo981c.html (visited Dec. 29, 2000.

⁴⁸ Constitution of the World Health Organization, July 22, 1946, 14 U.N.T.S. 185, 187-8. Many of the articles of the WHO Constitution detail the organization's mission. See Article 2(a) “to act as the directing and coordinating authority on international health work;” Article 2(g) “to stimulate and advance work to eradicate epidemic, endemic and other diseases;” Article 2(j) “to promote cooperation among scientific and professional groups which contribute to the advancement of health;” Article 2(r) “to assist in developing an informed public opinion among all peoples on matters of health.”