Legal Enforcement of Xenotransplantation Public Health Safeguards

U.S. Food and Drug Administration, PHS Guideline on Infectious Disease Issues in Xenotransplantation, at <http://www.fda.gov/cber/gdlns/xenophs0101.htm> (last visited January 21, 2004).

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Allen J.S. , “Understanding Xenotransplantation Risks from Nonhuman Primate Retroviruses,” Current Topics in Microbiology and Immunology 278 ((2003): 101–123.

Id. See also, Butler D. , “Last Chance to Stop and Think on Risks of Xenotransplantation,” Nature 391 (1998): 320–24;

Chapman L.E. Bloom E.T. , “Clinical Xenotransplantation,” JAMA 285 (2001): 2304–06.

The public health risks associated with xenotransplantation are also reviewed in Florencio P.S. Ramanathan E.D. , “Are Xenotransplantation Safeguards Legally Viable?,” Berkeley Technology Law Journal 16: Suppl. (2001): 937–77.

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Chapman , supra note 2, at 1499.

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McNeill W.H. , Plagues and Peoples (New York: Anchor Press, 1976);

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U.S. Food and Drug Administration, PHS Guideline on Infectious Disease Issues in Xenotransplantation, at <http://www.fda.gov/cber/gdlns/xenophs0101.htm> (last visited January 21, 2004);

Health Canada, Proposed Canadian Standard for Xenotransplantation, at <http://www.hc-sc.gc.ca/hpb-dgps/therapeut/zfiles/english/bgtd/xeno_std_e.html> (last visited January 21, 2004);

United Kingdom Xenotransplantation Interim Regulatory Authority (UKXIRA), Draft Report of the Infection Surveillance Steering Group of the UKXIRA, at <http://www.doh.gov.uk/pub/docs/doh/surveil.pdf> (last visited January 21, 2004).

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Florencio P.S. Caulfield T , “Xenotransplantation and Public Health: Identifying the Legal Issues,” Canadian Journal of Public Health 90 (1999): 282–84;

Caulfield T.A. Robertson G.B. , “Xenotransplantation: Consent, Public Health and Charter Issues,” Medical Law International 5 ((2001): 81–99.

Daar A.S. , “Ethics of Xenotransplantation: Animal Issues, Consent, and Likely Transformation of Transplant Ethics,” World Journal of Surgery 21 (1997): 975–82;

Bach F. , “Uncertainty in Xenotransplantation: Individual Benefit Versus Collective Risk,” Nature Medicine 4 (1998): 1998–141;

Cooper D.K.C. Lanza R.P. , Xeno: The Promise of Transplanting Animal Organs Into Humans (New York: Oxford University Press, 2000): At 218.

Supra note 1.

Id.

Id.

Id.

Florencio Ramanathan , supra note 3.

Beauchamp T.L. Childress J.F. , Principles of Biomedical Ethics, 4th ed. (New York: Oxford University Press, 1994): At 120;

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Ciarlariello v. Schacter [1993] 2 S.C.R. 119 (Can.);

Reihl v. Hughes [1980] 2 S.C.R. 880 (Can.);

Salgo v. Leland Stanford Jr. University Board of Trustees, 317 P.2d 170 (Cal. 1957);

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972).

Malette v. Shulman [Ont. Ct. App. 1990] 67 D.L.R. (4th) 321 (Can.);

Nancy B v. Hotel-Dieu de Quèbec [Que. Sup. Ct. 1992] 86 D.L.R. (4th) 385 (Can.);

Cruzan v. Director, Missouri Dept. of Health, 497 U.S. 261 (1990).

Daar , supra note 23;

Bach ., supra note 23;

Cooper Lanza , supra note 23.

Fitzpatrick v. Micheal, 9 A.2d 639 Md. (1939);

American Broadcasting Companies, Inc. v. Warner Wolf, 420 N.E.2d 363 (N.Y. 1981).

Warner Bros. Pictures Inc. v. Nelson [1937] 1 K.B. 209 (Can.);

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For additional reasoning on this point, see Florencio Ramanathan , supra note 3, at 949–53.

Canadian Charter of Rights and Freedoms, Part I of the Constitution Act, 1982, being Schedule B to the Canada Act 1982 (U.K.), 1982, c. 11, s. 7;

U.S. Constitution, Amendment XIII; Universal Declaration of Human Rights, Art. III, U.N. Res. 217A(III) (1948).

Health Protection and Promotion Act, R.S.O. ch. H-7, § 22(2) (1990) (Can.); Cal. Health and Safety Code § 120175 (West 2000).

Model State Emergency Health Powers Act (2001), available at <http://www.publichealthlaw.net/MSEHPA/MSEHPA2.pdf> (last visited July 24, 2002).

Id. at § 502(a).

Id. at § 301.

Florencio Ramanathan , supra note 3.

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45 C.F.R. § 46.1l6(a)(8) (2001); 21 C.F.R. § 50.26(8) (2001).

Regarding the need for federal legislation, see Florencio Ramanathan , supra note 3 at 953–63.

United States v. Estate of Romani, 523 U.S. 517 (1998).

Canadian Charter of Rights and Freedoms ch. 11, §§ 7-& 8

U.S. Constitution, Amendment IV (the “Search and Seizure Clause”); U.S. Constitution, Amendment XIV (the “Due Process Clause”).

Canadian Charter of Rights and Freedoms, ch. 11, § 15

U.S. Constitution, Amendment XIV (the “Equal Protection Clause”).

Florencio Ramanathan , supra note 3, at 963–75.

Id.

Id.

Bach , supra note 23

Somerville M. , The Ethical Canary: Science, Society and the Human Spirit (Toronto: Penguin, 2000): At 104.

In addition to the issue of how to assure that societal consent is informed, other issues needing further erudition include how to effectively disseminate information to the public (e.g., mailed information packages, televised debate); how to collect consent (e.g., referendum, online polls); quorum requirement — what percentage of a nation's citizenry must vote for the societal consent or refusal to be considered effective and binding (e.g., 15%; 30%; 50%); level of consent required (e.g., regular majority; two thirds majority); scope of the research to which consent is being provided (e.g., cell and tissue xenotransplantation, whole organ xenotransplantation); effect of societal refusal (i.e., particularly in countries already engaged in clinical trials of cell and tissue xenotransplantation).

Defoe D. , A Journal of the Plague Year (Oxford: Oxford University Press, 1990): At 35–36.