Lessons across the pond: Assisted reproductive technology in the United Kingdom and the United States

American Journal of Law and Medicine

Volumn 31, Issue 4, 2005, Pages 419-446

  Ouellette, Alicia ^a,b   Caplan, Arthur ^c   Carroll, Kelly ^d   Fossett, James W ^e   Bjarnadottir, Dyrleif ^f   Shickle, Darren ^g,h   McGee, Glenn ^b  

^a ALBANY LAW SCHOOL   (United States)

^b ALBANY MEDICAL COLLEGE   (United States)

^c UNIVERSITY OF PENNSYLVANIA   (United States)

^d AMERICAN MEDICAL ASSOCIATION   (United States)

^e Rockefeller Institute of Government   (United States)

^f STATE UNIVERSITY OF NEW YORK   (United States)

^g UNIVERSITY OF LEEDS   (United Kingdom)

^h EuroPHEN Program   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

ACT; BIOETHICS; BIRTH RATE; DATA BASE; EVALUATION; FERTILIZATION IN VITRO; FOOD AND DRUG ADMINISTRATION; FREEDOM; FUNDING; GOVERNMENT REGULATION; HEALTH CARE FACILITY; HEALTH CARE POLICY; HEALTH CARE QUALITY; HUMAN; INFERTILITY THERAPY; LAW; LICENSING; MANDATORY REPORTING; MEDICAL RESEARCH; MEDICAL TECHNOLOGIST; MONEY; MORALITY; MULTIPLE PREGNANCY; PATIENT RIGHT; PERCEPTION; PUBLIC HEALTH SERVICE; REGISTER; REPRODUCTION; REPRODUCTIVE RIGHTS; REVIEW; STANDARD; STANDARDIZATION; TOTAL QUALITY MANAGEMENT; UNITED KINGDOM; UNITED STATES;

EID: 33645362723     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885880503100402     Document Type: Review

References (276)

1. See THE PRESIDENT'S COUNCIL ON BIOETHICS, REPRODUCTION AND RESPONSIBILITY: THE REGULATION OF NEW TECHNOLOGIES, at ch. 9-10 (2004) available at http://www.bioethics.gov/reports/reproductionandresponsibility/index.html (criticizing patchwork framework for regulation of ART in U.S. and suggesting comprehensive regulation, including permanent monitoring and oversight arrangements);
2. Erik Parens & Lori Knowles, Reprogenetics and Public Policy: Reflections & Recommendations, HASTINGS CTR. RPT. (Supp. Jul. - Aug. 2003), available at http://www.thehastingscenter.org/publications/reports.asp (advising creation of commission, Reprogenetics Technology Advisory Committee, to propose legislation to Congress).
3. See, e.g., Lori Andrews, et al., Cloning Position Paper of the UT Institute for Science, Law, and Technology Working Group On Reproductive Technologies, 8 S. CAL. INTERDISC. L.J. 87, 99 (1998) (advocating the U.S. ban human cloning and explaining that the loss of possible benefits of cloning as a result of such a ban could be avoided by crafting legislation similar to that of the United Kingdom's licensing of clinics involved in reproductive technologies);
4. James F. Childress, An Ethical Defense of Federal Funding for Human Embryonic Stem Cell Research, 2 YALE J. HEALTH POL'Y L. & ETHICS 157, 163 (2001) (stating that a public body similar to that used in the U.K. may be needed in the U.S. for regulating embryonic stem cell research);
5. Cynthia B. Cohen, Unmanaged Care: The Need to Regulate New Reproductive Technologies in the United States, 11 BIOETHICS 348 (1997);
6. Weldon E. Havins & James J. Dalessio, The Ever-Widening Gap Between the Science of Artificial Reproductive Technology and the Laws Which Govern that Technology, 48 DEPAUL L. REV. 825 (1999);
7. Robert L. Stenger, The Law and Assisted Reproduction in the United Kingdom and the United States, 9 J.L. & HEALTH 135, 159 (1994-1995) (arguing that Britain's Human Fertilization and Embryology Act of 1990 can offer guidance to states within the U.S. in their attempts to formulate legislation on assisted reproductive technology);
8. Kara L. Belew, Comment, Stem Cell Division: Abortion Law and its Influence on the Adoption of Radically Different Embryonic Stem Cell Legislation in the United States, the United Kingdom, and Germany, 39 TEX. INT'L L.J. 479, 519 (2004) (stating that the U.S. and Germany will have to change their laws and regulations concerning stem cell research to something similar to the U.K. framework if either country wants "to stay on the forefront of biomedical technology.");
9. Melissa S. Burchell, Note, America's Struggle to Develop a Consistent Legal Approach To Controversial Human Embryonic Stem Cell Research and Therapeutic Cloning: Are the Politics Getting in the Way of Hope?, 32 SYRACUSE J. INT'L L. & COM. 133, 158-61 (2004) (arguing that the U.S. should revise its regulations on stem cell research and therapeutic cloning, modeling them after the U.K.'s);
10. Sherri A. Jayson, Comment, "Loving Infertile Couple Seeks Woman Age 18-31 to Help Have Baby. $6,500 Plus Expenses and a Gift": Should We Regulate the Use of Assisted Reproductive Technologies by Older Women?, 11 ALB. L.J. SCI. & TECH. 287, 311 (2001) (discussing legislation regulating age of women undergoing ART).
11. Compare Suzanne H. Rhodes, Comments, The Difficulty of Regulating Reproductive and Therapeutic Cloning: Can the United States Learn Anything From the Laws of Other Countries?, 21 PENN. ST. INT'L L. REV. 341, 355 (2003) (recommending that the U.S. "follow the lead" of the U.K. and other countries and place a ban on reproductive cloning),
12. with Arthur C. D'Andrea, Note, Federalizing Bioethics, 83 TEX. L. REV. 1663 (2005) (arguing that regulation of human cloning should be done on a state, not national level).
13. The publication of the reports is considerably delayed. The 2002 data was not published until 2004. See Div. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION, & SOC'Y FOR ASSISTED REPROD. TECH., AM. SOC'Y FOR REPROD. MED., 2002 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS (2004), available at http://www.cdc.gov/ART/ART02/ index.htm [hereinafter 2002 ART RATES].
14. The existing federal regulation limits federal funding for embryo research. On August 9, 2001, President Bush announced that federal funds for human embryonic stem cell research would be limited to 64 stem cell lines that were in existence as of the date of the announcement. In May 2005, The U.S. House of Representative approved a bill to expand federal financing for embryonic stem cell research to permit financing studies involving human embryos in frozen storage at fertility clinics if they would otherwise be discarded. To date, the Senate has not passed comparable legislation. The States have been more active in regulating assisted reproduction. In particular, fourteen states have laws pertaining to human cloning. See National Conference of State Legislatures, State Human Cloning Laws, (2005), available at http://www.ncsl.org/programs/health/genetics/rt-shcl.htm (charting state laws regulating the cloning of human embryos as of June 21, 2005).
15. Legislation that would regulate ART and the use of frozen embryos has been introduced in ten states. See National Conference of State Legislatures, Genetics Legislation Database, available at http://www.ncsl.org/programs/health/ genetics/geneticsDB.cfm (last visited Oct. 26, 2005).
16. See 2002 ART RATES, supra note 2, at 5-6 (stating that clinics known to be in existence without reporting success rate data were merely listed as nonreporters, in compliance with U.S. law).
17. The Human Fertilisation and Embryology Authority, About the Human Fertilisation and Embryology Authority, http://www.hfea.gov.uk/AboutHFEA (last visited Oct. 23, 2005).
18. See Human Fertilisation and Embryology Act, 1990, c. 37, § 11, sched. 2 (Eng.), available at http://www.opsi.gov.uk/acts/acts1990/ Ukpga_19900037_en_l.htm#end (Select "Schedule 2" link).
19. Gladys B. White, Crisis in Assisted Conception: The British Approach to an American Dilemma, 7 J. WOMEN'S HEALTH 321, 327 (1998).
20. On file with author (Glenn McGee).
21. See generally Human Fertilisation and Embryology Act, 1990, c. 37 (Eng.).
22. Id. §§ 3-15.
23. HUMAN FERTILISATION & EMBRYOLOGY AUTH., FACING UP TO THE CHALLENGE: HFEA ANNUAL REPORT 2003/04 (Thirteenth Annual Report) at 5 (2004), available at http://www.hfea.gov.uk/HFEAPublications/AnnualReport [hereinafter FACING UP TO THE CHALLENGE].
24. Id.
25. HUMAN FERTILISATION AND EMBRYOLOGY AUTH. CODE OF PRACTICE 6TH EDITION (2003), available at http://www.hfea.gov.uk/HFEAPublications/CodeofPractice.
26. The Human Fertilisation and Embryology Authority, supra note 5.
27. Id.
28. See, e.g., Burchell, supra note 1, at 139-42 (describing federal regulation of embryonic stem cell research in the U.S. as inconsistent and contradictory);
29. Childress, supra note 1, at 162-63 (contrasting the U.K.'s "strict regulation of reproductive technologies" with the "limited and uneven" regulation in the U.S.).
30. But see PRESIDENT'S COUNCIL ON BIOETHICS, supra note 1, at 47-50 (discussing extensively current regulation of ART).
31. Fertility Clinic Success Rate and Certification Act of 1992, Pub. L. No. 102-493, 106 Stat. 3146 (codified at 42 U.S.C. §§ 263a-1 to a-7 (2000)).
32. 42 U.S.C. §§ 263a-1 to a-5 (2000).
33. Id. §§ 263a-2(a)(1), 263a-5(1)(A).
34. See PRESIDENT'S COUNCIL ON BIOETHICS, supra note 1, at 50.
35. For a list of state laws regulating the cloning of human embryos, see NATIONAL CONFERENCE OF STATE LEGISLATURES, STATE HUMAN CLONING LAWS (2005), http://www.ncsl.org/programs/health/genetics/rt-shcl.htm (charting state laws regulating the cloning of human embryos as of June 21, 2005).
36. Legislation that would regulate ART and the use of frozen embryos has been introduced in nine states. See NATIONAL CONFERENCE OF STATE LEGISLATURES, GENETICS LEGISLATION DATABASE, http://www.ncsl.org/programs/health/genetics/ geneticsDB.cfm (select "ART/Frozen Embryos"; then enter search) (last visited Oct. 26, 2005).
37. See PRESIDENT'S COUNCIL ON BIOETHICS, supra note 1, at 51-54 (outlining state regulation of ART and concluding that "There are few state laws that bear directly on assisted reproduction.").
38. FACING UPTOTHECHALLENGE, supra note 11, at 12, 41.
39. Twelfth Annual Report And Accounts 2002/03, 2003 HUMAN FERTILISATION AND EMBRYOLOGY AUTH. 16, http://www.hfea.gov.Uk/HFEAPublications/AnnualReport/ Twelfth%20HFEA%20Annual%20Report.p df [hereinafter Twelfth Annual Report].
40. FACING UP To THE CHALLENGE, supra note 11, at 5.
41. Human Fertilisation and Embryology Auth., http://www.hfea.gov.uk (last visited Oct. 20, 2005).
42. Eleventh Annual Report And Accounts 2002, 2002 HUMAN FERTILISATION AND EMBRYOLOGY AUTH. 7, http://www.hfea.gov.uk/HFEAPublications/AnnualReport/ 2002%20HFEA%20Annual%20Report.pdf [hereinafter Eleventh Annual Report].
43. Id.
44. FACING UP To THE CHALLENGE, supra note 11, at 9.
45. Eleventh Annual Report, supra note 27, at 18.
46. Id.
47. FACING UP TO THE CHALLENGE, supra note 11, at 9.
48. Id.
49. Id.
50. Id.
51. 42 U.S.C. § 263a-1 (2005).
52. The Homepage for SART is located at http://www.sart.org/home.html.
53. ASRM is a professional society. The Homepage for the ASRM is located at http://www.asrm.org.
54. Med. Research Int'l, In vitro Fertilization/Embryo Transfer in the United States: 1985 and 1986 Results from the National IVF/ET Registry, 49 FERTILITY & STERILITY 212 (1988).
55. See generally Centers for Disease Control and Prevention, Assisted Reproductive Technology: All Reports, at http://www.cdc.gov/ART/ARTReports.htm (showing links to published ART reports beginning with the 1995 ART report through the 2002 ART report).
56. See American Society for Reproductive Medicine, The ASRM Invites You To Apply For Membership, http://www.asrm.org/Professionals/Membership/member.html (showing that affiliations with like organizations is a benefit of membership in ASRM);
57. American Society for Reproductive Medicine, Specialty Societies, http://www.asrm.org/Professionals/Membership/member.html (showing that SART is affiliated with ASRM).
58. See also Society for Assisted Reproductive Technology, What Does Sart Do Anyway?, at http://sart.org/whatis.html (demonstrating close affiliation with ASRM).
59. E-mail communication from Joyce Zeitz to author Alicia Ouellette (October 5, 2005) (on file with author).
60. Society for Assisted Reproductive Technology, supra note 41 (last visited Sept. 23, 2005).
61. Id. SART requires all its member laboratories to be accredited by a SART approved program. All laboratory accreditation programs approved by SART follow the Clinical Laboratory Amendments of 1988 (CLIA). CLIA requires certification at least every two years. BROOKS A. K. EEL & TAMMIE K. SCHALUE, Quality Control and Accreditation, in A COLOR ATLAS FOR HUMAN ASSISTED REPRODUCTION 277-78 (Pasquale Patrizio et al. eds., 2003);
62. Clinical Laboratory Amendments of 1988, 100 Pub. L. No. 578, 102 Stat. 2903 (1988) (codified at 42 U.S.C. § 263(a)).
63. Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 70 Fed. Reg. 5187, 5188 (Feb. 1, 2005).
64. Angenlique Lopez, RLT PG Representative to SART, REPRODUCTIVE TECHNOLOGIST PROFESSIONAL GROUP NEWSLETTER (American Society of Reproductive Medicine), Summer 2005 at 3, available at http://www.asrm.org/Professionals/PG- SIG-Affiliated_Soc/rltpg/rItpg_summer2005 newsletter.pdf.
65. Id.
66. 2002 ART RATES, supra note 2, at 4.
67. Victoria Clay Wright, et al., Assisted Reproductive Surveillance - United States 2001, MORBIDITY AND MORTALITY WEEKLY REPORT (April 30, 2004), at http://www.cdc.gov/mmwr/preview/mmwrhtml/ss5301a1.htm.
68. See also PRESIDENT'S COUNCIL ON BIOETHICS, supra note 1, at 47-50.
69. Soc'y for Assisted Reprod. Tech. & The Am. Soc'y for Reprod. Med., Assisted Reproductive Technology in the United States: 1999 Results Generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry, 78 FERTILITY & STERILITY 918, 919 (2002).
70. Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (June 25, 2003); E-mail communication from Joyce Zeitz to author Ouellette dated October 5, 2005 (on file with author).
71. Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 65 Fed. Reg. 53,310, 53,311 (Sept. 1, 2000).
72. Id.
73. See Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, 70 Fed. Reg. 5187, 5188 (Feb. 1, 2005).
74. Soc'y for Assisted Reprod. Tech. & The Am. Soc'y for Reprod. Med., Assisted Reproductive Technology in the United States and Canada: 1995 Results Generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry, 69 FERTILITY & STERILITY 389 (1998).
75. DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 2000 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 71 (2002), available at http://www.cdc.gov/ reproductivehealth/ART/ARTReports.htm [hereinafter 2000 RATES].
76. 2002 ART RATES, supra note 2, at 69.
77. See, e.g., 2002 ART RATES, supra note 2, at 71, 509-510. Out of 428 total listed clinics, approximately 91% of them submitted data.
78. See Reporting of Pregnancy Success Rates From Assisted Reproductive Technology Programs, supra note 52, at 53,312-13.
79. DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1999 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 6, 469-70 (2001), available at http://www.cdc.gov/ reproductivehealth/ART/ARTReports.htm [hereinafter 1999 RATES].
80. DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1998 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 5, 445-46 (2000), available at http://www.cdc.gov/ reproductivehealth/ART/ARTReports.htm [hereinafter 1998 RATES].
81. 1999 RATES, supra note 60, at 6, 469-70.
82. 2000 RATES, supra note 56, at 6, 501-02.
83. 1999 RATES, supra note 60, at 469-70.
84. 1998 RATES, supra note 61, at 445-46.
85. DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1997 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 404-05 (1999), available at http://www.cdc.gov/ reproductivehealth/ART/ARTReports.htm [hereinafter 1997 RATES].
86. 2000 RATES, supra note 56, at 501-02.
87. 1999 RATES, supra note 60, at 469-70.
88. DIV. OF REPROD. HEALTH, CTRS. FOR DISEASE CONTROL & PREVENTION ET AL, 1996 ASSISTED REPRODUCTIVE TECHNOLOGY SUCCESS RATES: NATIONAL SUMMARY AND FERTILITY CLINIC REPORTS 359 (1998), available at http://www.cdc.gov/ reproductivehealth/ART/ARTReports.htm.
89. 1997 RATES, supra note 66, at 405.
90. 1998 RATES, supra note 61, at 446.
91. 1999 RATES, supra note 60, at 470.
92. 2000 RATES, supra note 56, at 502.
93. Gina Kolata, Researchers Report Success in Method to Pick Baby's Sex, N.Y. TIMES, Sept. 9, 1998, at A1.
94. See Claudia Kalb & Karen Springen, Brave New Babies, NEWSWEEK, Jan. 26, 2004, at 45.
95. Interview with Richard J. Sherins, M.D., Director of the GIVF Division of Andrology, The Genetics & IVF Institute (April 2003).
96. SART members may lose their membership, but SART is "not a punitive society." See Sandra Carson, President ASRM, Keynote Address at the Meeting of the President's Council on Bioethics (March 7, 2005), available at http://www.bioethics.gov/transcripts/march03/mar7full.html.
97. See, e.g., 2002 ART RATES, supra note 2, at 5-6.
98. Id. at 5.
99. Compare 2002 ART RATES, supra note 2, at 509-510 (listing 37 non-reporting clinics),
100. with 2000 RATES, supra note 56, at 501-502 (listing 25 non-reporting clinics).
101. Human Fertilisation and Embryology Act, 1990, c. 37, § 11(1)(b) (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.
102. Id. sched. 2.
103. Id.
104. Id. §§ 39-40.
105. ELEVENTH ANNUAL REPORT, supra note 27, at 6-7.
106. Human Fertilisation and Embryology Act, 1990, c. 37, § 41(1) (Eng.), available at http://www.opsi.gov.uk/acts/ acts 1990.htm.
107. Id. §§ 12-13.
108. Id. §§ 23-24.
109. New Embryo Research Regulations, HUMAN FERTILISATION AND EMBRYOLOGY AUTHORITY UPDATE (London), Feb. 2001, at 2, available at http://www.hfea.gov.uk/ HFEAPublications/HFEAUpdate.
110. HUMAN FERTILISATION AND EMBRYOLOGY AUTH., NINTH ANNUAL REPORT AND ACCOUNTS 2000 25 (2000), available at http://www.hfea.gov.uk/HFEAPublications/ AnnualReport [hereinafter NINTH ANNUAL REPORT].
111. New Embryo Research Regulations, supra note 89, at 2.
112. Andy Coghlan & Emma Young, Landmark vote clears the way for stem cell research in Britain, NEW SCIENTIST, Jan. 6 2001, at 99.
113. HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, § 10.6, at 93.
114. FACING UP To THE CHALLENGE, supra note 11, at 13.
115. HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, § 10.10, at 94.
116. ELEVENTH ANNUAL REPORT, supra note 27, at 11.
117. FACING UP To THE CHALLENGE, supra note 11, 20 apps. 4-5.
118. Id. at 14.
119. See Id.
120. Human Fertilisation and Embryology Act, 1990, c. 37, §§ 2-3, sched. 2 (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.
121. ELEVENTH ANNUAL REPORT, supra note 27, at 6.
122. Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (June 25, 2003).
123. Society for Assisted Reproductive Technology, supra note 43, at ¶ 9.
124. Fertility Clinic Success Rate and Certification Act of 1992, 42 U.S.C. § 263a-2(a) to (b) (2005).
125. Implementation of the Fertility Clinic Success Rate and Certification Act of 1992: A Model Program for the Certification of Embryo Laboratories, 64 Fed. Reg. 39,374, 39,386 (July 21, 1999).
126. The President's Council on Bioethics, Discussion Document, U.S. Public Policy and the Biotechnologies that Touch the Beginnings of Human Life: A Detailed Overview, at text accompanying notes 85-86 (June 3, 2003), available at http://www.bioethics.gov/background/biotechnology.html.
127. See 2002 ART RATES, supra note 2, at 69.
128. See also THE NEW YORK STATE TASK FORCE ON LIFE AND THE LAW, EXECUTIVE SUMMARY OP ASSISTED REPRODUCTIVE TECHNOLOGIES: ANALYSIS AND RECOMMENDATIONS FOR PUBLIC POLICY, at Certification and Licensure (Oct. 2001), http://www.health. state.ny.us/nysdoh/taskfee/execsum.htm.
129. 2002 ART RATES, supra note 2, at 69-70.
130. 2002 ART RATES, supra note 2, at 69-70; Society for Assisted Reproductive Technology, supra note 43, at f9.
131. 2002 ART RATES, supra note 2, at 71.
132. 1998 RATES, supra note 61, at 47.
133. White, supra note 7, at 323.
134. Press Release, Society for Assisted Reproductive Technology, Society for Assisted Reproductive Technology Embarks on New, Aggressive Campaign Aimed at Setting Higher Standards, Greater Awareness of Reproductive Medicine (Oct. 25, 2000) (on file with authors), available at http://www.obgyn.net/infertility/ infertility.asp?page=/infertilily/articles/sart.
135. Society for Assisted Reproductive Technology, supra note 43, at ¶ 9.
136. See COLL. OF AM PATHOLOGISTS, STANDARDS FOR LABORATORY ACCREDITATION (2000), available at http://www.cap.org/apps/docs/laboratory_accreditation/ lapstandards.pdf.
137. Id. at 1-3.
138. Id.
139. Id. at 5.
140. Id.
141. Id. at 4-5.
142. See FACING UP TO THE CHALLENGE, supra note 11, at 7.
143. See HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, at 9-10;
144. Human Fertilisation and Embryology Act, 1990, c. 37, § 3(1) (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.
145. See HUMAN FERTILISATION AND EMBRYOLOGY AUTH., supra note 13, at 9-10.
146. See Id. at 10.
147. The HFEA maintains all six editions of the Code of Practice on its website. HFEA, http://www.hfea.gov.uk/HFEAPublications/CodeofPractice (last visited October 26, 2005).
148. Human Fertilisation and Embryology Act, 1990, c.37, § 11, sched. 2 (Eng.), available at http://www.opsi.gov.uk/acts/acts1990.htm.
149. See ELEVENTH ANNUAL REPORT, supra note 27, at 16-17.
150. See FACING UP TO THE CHALLENGE, supra note 11, at 15.
151. See id. at 19.
152. K.C. Zoon, Human Cells Used in Therapy Involving the Transfer of Genetic Material, FDA Center for Biologies Evaluation and Research Letter to Sponsors/Researchers (July 6, 2001), available at http://www.fda.gov/cber/ltr/ cytotrans070601.htm.
153. 42 U.S.C. §§263a-1-263a-5.
154. See, e.g., Katherine Seligman, License Revoked for Embryo Mix-Up, S.F. CHRON., March 3, 2005, at B4 (reporting that the Medical Board of California revoked the license of San Francisco-based fertility specialist Dr. Steven Katz, who implanted the wrong embryo in a patient and failed to inform her of the mistake until more than two years later).
155. See Kathryn Venturatos Lorio, The Process of Regulating Assisted Reproductive Technologies: What We Can Learn from Our Neighbors - What Translates and What Does Not, 45 LOY. L. REV. 247, 266 (1999).
156. Jennifer L. Rosato, The Children of ART (Assisted Reproductive Technology): Should the Law Protect them From Harm?, 2004 UTAH L. REV. 57, 73-74 (2004) (arguing that the politics of abortion preclude meaningful regulation of ART in the United States).
157. See D'Andrea, supra note 1, at 1698 (noting that devolving law making powers to the states recognizes "the tension between the principle of One law for all' and the need to accommodate a 'bewildering variety of religious and belief systems.'").
158. See, e.g., Havins & Dalessio, supra note 1.
159. Havins & Dalessio, supra note 1, at 828-31;
160. R. Alta Charo, Children by Choice: Reproductive Technologies and the Boundaries of Personal Autonomy, NATURE CELL BIOLOGY & NATURE MEDICINE (Fertility Supp. 2002), available at www.nature.com/fertility.
161. LA. REV. STAT. ANN. § 9:129 (1991);
162. Havins & Dalessio, supra note 1, at 837-38.
163. Sandra Carson, President, American Society for Reproductive Medicine, Chief, Baylor University Assisted Reproductive Technology Program,. Remarks at the Meeting of the President's Council on Bioethics (March 7, 2003), available at http://www.bioethics.gov/transcripts/march03/mar7full.html.
164. See http://www.sart.org (The Benefits of Membership).
165. See generally ASRM/SART Statement on Responsibility and Reproduction, March 30, 2004, available at http://www.asrm.org/Washington/Bulletins/vol6no22. html.
166. See Mark. S. Frankel & Parisa Morris, A View From the Field on Food and Drug Administration Regulation: Report of a 2002 Survey of U.S. Fertility Clinics, 79 FERTILITY & STERILITY 1060 (2003).
167. Id. at 1061.
168. Id.
169. See Carson, supra note 139.
170. Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (Aug. 7, 2001).
171. Lorio, supra note 133, at 248.
172. See generally PCBE: Monitoring Stem Cell Research: Chapter 2 "Current Federal Law and Policy" (January 2004), THE PRESIDENT'S COUNSEL ON BIOETHICS, available at http://www.bioethics.gov/reports/stemcell/ chapter2.html (describing a history of federal policy in this area).
173. See, e.g., Rick Weiss, Bill Renews Fight on Stem Cells; House, Senate Measures Would Loosen Bush's Research Curbs, WASH. POST, Feb. 17, 2005, at A6;
174. Rick Weiss, Approved Stem Cells 'Potential Questioned, WASH. POST, October 29, 2004, at A3;
175. Ceci Connolly, 2 GOP Senators Defend Bush on Stem Cell Research, WASH. POST, August 13, 2004, at A2;
176. CNN.com Specials, The Stem Cell Debate, http://www.cnn.com/SPECIALS/2001/ stemcell/ (last visited Oct. 26, 2005).
177. The original amendment can be found in Section 128 of P.L. 104-99; it affected NIH funding for FY1996 contained in P.L. 104-91. For subsequent fiscal years, the rider is found in Title V, General Provisions, of the Labor, HHS and Education appropriations acts in the following public laws: FY1997, P.L. 104-208; FY1998, P.L. 105-78; FY1999, P.L. 105-277; FY2000, P.L. 106-113; FY2001, P.L. 106-554; FY2002, P.L. 107-116; FY2003, P.L. 108-7; FY2004, P.L. 108-199; and, FY2005, P.L. 108-447.
178. See CRS Report for Congress, Stem Cell Research, n.19, available at http://fpc.state.gOv/documents/organization/51131.pdf. The amendment states: (a) None of the funds made available in this Act may be used for -(1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). (b) For purposes of this section, the term 'human embryo or embryos' includes any organism, not protected as a human subject under 45 CFR 46 [the Human Subject Protection regulations] as of the date of enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes [sperm or egg] or human diploid cells [cells that have two sets of chromosomes, such as somatic cells].
179. See, e.g., JUDITH A. JOHNSON & ERIN D. WILLIAMS, CONG. RES. SERV., STEM CELL RESEARCH 8 (2005), available at http://fpc.state.gov/documents/ organization/51131.pdf;
180. George Q. Daley, Missed opportunities in Embryonic Stem-Cell Research, 351 NEW ENG. J. MED. 627 (2004);
181. NAT'L BIOETHICS ADVISORY COMM'N, ETHICAL ISSUES IN HUMAN STEM CELL RESEARCH 35 (1999), available at http://www.georgetown.edu/research/nrcbl/nbac/ stemcell.pdf.
182. See Clinton Administration NIH Guidelines for Embryonic Stem Cell Funding, 65 Fed. Reg. 51,975, (Aug. 25, 2000),
183. reprinted in President's Council on Bioethics, Monitoring Stem Cell Research, Appendix D, available at http://www.bioethics.gov/reports/stemcell/ appendix_d.html;
184. NAT'L BIOETHICS ADVISORY COMM'N, supra note 151, at 35.
185. Roger Noll, The Politics and Economics of Implementing State-Sponsored Embryonic Stem-Cell Research 21, http://siepr.stanford.edu/papers/pdf/04-28.pdf, (June 2005)(Stanford Institute for Economic Policy Research Discussion Paper 04-2820).
186. Sheryl Gay Stolberg, Senate's Leader Veers from Bush Over Stem Cells, N.Y. TIMES, July 29, 2005, at A6.
187. Ceci Connolly, Frist Breaks with Bush on Stem Cell Research, WASH. POST, July 30, 2005, at A1.
188. Senate Lacks Vote for Stem Cell Override, (August 1, 2005), available at http://www.boston.com/news/nation/washington/articles/2005/08/01/ senate_lacks_votes_for_stem_cel l_override?mode=PF (last visited Oct. 26, 2005).
189. Address to the Nation on Stem Cell Research, 37 PUB. PAPERS 32 (Aug. 13, 2001).
190. See generally Noll, supra note 153.
191. See National Council of State Legislatures, supra note 3, for an inventory of state legislative activities.
192. Id. For analyses of state legislation and subsequent court action, see Lori B. Andrews, Legislators as Lobbyists: Proposed State Regulation of Embryonic Stem Cell Research, Therapeutic Cloning, and Reproductive Cloning, available at http://www.bioethics.gov/reports/stemcell/appendix_e_html;
193. Havens & Dalessio, supra note 1.
194. The State Science and Technology Institute publishes weekly digests of State funded technology initiatives on its website, http://www.ssti.org/Digest/ Indices/indexstate.htm.
195. California Gives Go-Ahead to Stem Cell Research, http://www.msnbc.msn. com/id/6384390/ (last visited Oct. 27, 2005).
196. For descriptions of state initiatives, see What's New in State Stem Cell Legislation and Funding, http://www.grassrootsconnection.com/ state_stem_cell_resources.htm (last visited Oct. 27, 2005).
197. Letter from James Thomson, Professor, University of Wisconsin-Madison Medical School, to Rep. Steve Kestell, Representative, Wisconsin State Assembly, June 28, 2005, available at www.wisbusiness.com/1008/large/050627thomson.pdf.
198. California Gives Go-Ahead to Stem Cell Research, supra note 162.
199. Illinois Regenerative Medicine Institute Act, H. B. 3815, 94th Gen. Assemb. (Ill. 2005).
200. Stem Cell Research Bond Act, Assemb. B. 4013, 211th Leg., 2d Reg. Sess. (N.J. 2005).
201. Stem Cell Research Act, H. B. 864, 189th Gen. Assemb. (Pa. 2005);
202. Amy Worden, Spotlights on Biology and God, PHILA. ENQUIRER, Jun. 21, 2005, http://www.philly.com/mld/inquirer/news/local/states/pennsylvania/ 11943819.htm.
203. Jeana Anderson, Gov. Unveils $375m Stem-Cell Initiative, THE DAILY CARDINAL, Nov. 18, 2004, http://www.dailycardinal.com/article.php?storyid= 809385.
204. An Act Permitting Stem Cell Research and Banning the Cloning of Human Beings, S. B. 934, 2005 Gen. Assem., Jan. Sess. (Conn. 2005) (enacted), 2005 Conn. Act. 05-149.
205. The argument in this paragraph is largely drawn from Noll, supra note 153.
206. Id.
207. See Andrews, supra note 8.
208. See Jessica Reaves, The Great Debate Over Stem Cell Research, TIME ONLINE, July 11, 2001, http://www.time.com/time/health/article/0,8599,167245,00. html;
209. J.C. Wilke, I'm Pro-life and Oppose Embryonic Stem Cell Research, CULTURE OF LIFE FOUNDATION & INSTITUTE, June 27, 2001, http://sites.silaspartners. com/partner/Article_Display_Page/0,PTID4211[CHID102753]CIID578206,0 0.html.
210. See Noll, supra note 153.
211. For coverage of the implementation of the California initiative, see David Jensen, California Stem Cell Report, http://www.californiastemcellreport. blogspot.com/ (last visited Oct. 26, 2005).
212. For a description of the most recent suit filed against the stem cell program, see Terri Somers, Group Files Lawsuit to Halt Research at Stem Cell Institute, S.D. UNION TRIB., Aug. 6, 2005, at A4.
213. See Tina Kelley, In Race Toward Stem Cell Research Institute, New Jersey Stalls, N.Y. TIMES, July 31, 2005, at 25, § 1, col. 2.
214. See id.
215. The Human Fertilisation and Embryology Authority, Patients' Guides are available as pdf files at http://www.hfea.gov.uk/HFEAPublications/ PatientsGuides.
216. HUMAN FERTILISATION AND EMBRYOLOGY AUTH., NINTH ANNUAL REPORT & ACCOUNTS 2000 14 (2000), available at http://www.hfea.gov.uk/HFEAPublications/ AnnualReport;
217. ELEVENTH ANNUAL REPORT, supra note 27, at 13.
218. Fertility Watchdog "incompetent", BBC NEWS (Dec. 10 2004), http://news.bbc.co.uk /l/hi/health/4084365.stm;
219. Mark Henderson, An Embryo That Went on Growing, TIMES ONLINE, http://timesonline.co.uk/printFriendly/0,1-210-1524515-355,00,html.
220. See generally Havins & Dalessio, supra note 1.
221. See Jayson, supra note 1, at 299-302.
222. See generally Cohen, supra note 1, at 353.
223. Christine Willgoos, Comment, FDA Regulation: An Answer to the Questions of Human Cloning and Germline Gene Therapy, 27 AM. J.L. & MED. 101 (2001).
224. Lorio, supra note 133, at 253.
225. Human Cells, Tissues, and Cellular and Tissue-Based Products; Establishment Registration and Listing, 66 Fed. Reg. 5447 (Jan. 19, 2001) (codified at 21 C.F.R. pts. 207,807,1271).
226. See generally Willgoos, supra note 185, at 122.
227. 21 C.F.R. § 1271.1 (2005).
228. Id. § 1271.3.
229. Id. pt. 1271, subpt. C.
230. Id. pt. 1271, subpt. B.
231. 66 Fed. Reg. 5447 (Jan. 19, 2001) (codified at 21 C.F.R. pts. 207, 807, & 1271).
232. Id. pt. 1271, subpt. D.
233. Id. at 29949.
234. Human Cells, Tissues, and Cellular and Tissue-Based Products; Donor Screening and Testing, and Related Labeling, 70 Fed. Reg. 29949, 29949-29950 (May 25, 2005) (codified at 21 C.F.R. pt. 1271).
235. See Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, 66 Fed. Reg. 5447, 5448 (Jan. 19, 2001).
236. Id.
237. Id. at 5549.
238. Public Health Service Act, 42 U.S.C. § 264 (2005);
239. see also 21 C.F.R. § 1271.1 (2005).
240. Interview with Joyce Zeitz, Executive Administrator, Society for Assisted Reproductive Technology (August 8, 2001).
241. Id.
242. Id.
243. Id.
244. Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments: Inspection and Enforcement, 69 Fed. Reg. 68,612, 68,654 (Nov. 24, 2004).
245. 66 Fed. Reg. 1507, 1544 (January 8, 2001).
246. 69 Fed. Reg. 68,612.
247. See ELEVENTH ANNUAL REPORT, supra note 27, at 13.
248. Centers for Disease Control and Prevention, Contribution of Assisted Reproductive Technology and Ovulation-Inducing Drugs to Triplet and Higher-Order Multiple Births-United States, 1980-1997, 49 MORBIDITY & MORTALITY WKLY. REP. 535, 535, (June 23, 2000).
249. See Id. at 537.
250. Laura A. Scheive et al., Live-Birth Rates and Multiple-Birth Risk Using In-Vitro Fertilization, 282 JAMA 1832, 1832, 1837 (1999).
251. ELEVENTH ANNUAL REPORT, supra note 27, at 16-17.
252. HFEA CODE OF PRACTICE, supra note 13, at 84.
253. Press Release, Human Fertilisation & Embryology Auth., HFEA Strengthens Commitment to Reducing Multiple Births (Jan. 6, 2004), available at http://www.hfea.gov.uk/PressOffice/Archive/1073398264 (quoting Jane Denton, Director of The Multiple Births Foundation: "For some patients the prospect of twins or triplets may seem an ideal way to have the family they long for. But the reality can be very different. Multiple births are associated with premature and low birth-weight babies and the risk of death before birth or in the first week of life is significantly greater. Compared with one baby, long term disability like cerebral palsy is around five times higher for twins and 18 times higher for triplets.")
254. See The Am. Soc'y for Reproductive Medicine, 2002 Guidelines for Gamete and Embryo Donation: A Practice Committee Report, 77 FERTILITY & STERILITY S1 (Supp. 5 June 2002).
255. The Practice Committee of the Soc'y for Assisted Reproductive Technology & the Am. Soc'y for Reproductive Medicine, Guidelines on the Number of Embryos Transferred, 82 FERTILITY & STERILITY 773 (2004) [hereinafter SART & ASRM].
256. See id.
257. Id. at 773.
258. Id.
259. The guidelines recommended a maximum of three embryos for women 35-37, four for women 38-40, and five for women over 40. Id. at 773-774.
260. Id. at 774.
261. 1998 RATES, supra note 61, at 18.
262. SART & ASRM, supra note 216, at 773.
263. James Meek, IVF Doctor Loses Bid to Change Embryo Rule, THE GUARDIAN, April 25, 2001, available at http://education.guardian.co.uk/news/story/0,5500, 478170,00.html.
264. Rachel Ellis, Two-Embryo Limit For IVF as Triplet Births Soar, MAIL ON SUNDAY, July 8, 1996, available at 2001 WLNR 2726015;
265. Robert Verkaik, Judge Turns Down Woman 's Plea to Relax Embryo Limit, THE INDEPENDENT (London), Apr. 25, 2001, available at 2001 WLNR 6940416.
266. Meek, supra note 224.
267. Action to cut IVF multiple births, BBC NEWS, Aug. 7, 2001, http://news.bbc.co.Uk/1/hi/health/1476646.stm.
268. NINTH ANNUAL REPORT, supra note 90, at 14.
269. The most recent analysis is reported in Soc'y for Assisted Reprod. Tech. & The Am. Soc'y for Reprod. Med., Assisted Reproductive Technology in the United States: 2000 Results Generated from the American Society for Reproductive Medicine/Society for Assisted Reproductive Technology Registry, 81 FERTILITY AND STERILITY 1 207-20 (2004).
270. Robert Gatter, Faith, Confidence and Health Care: Fostering Trust in Medicine Through Law, 39 WAKE FOREST L. REV. 395, 424, 436-437(2004).
271. Id.
272. Human Fertilisation & Embryology Authority, Patients' Guide to Infertility: Issues to Consider: Will I Get NHS Funding?, http://www.hfea.gov. uk/ForPatients/Archivedinformation/PatientsGuidetoInfertility/Issuestoconsider (last visited Sept. 26, 2005). "Multiple births are associated with premature birth, low birth weight babies, a higher rate of stillbirth and neonatal death, and long-term disability such as cerebral palsy.. .. In addition to the health risks to the babies, there are also increased risks for the parents including complications at birth and the possible emotional strain of having to cope with more than one new baby in the family together with potential increased financial constraints."
273. "[T]he vast majority of courts have denied the wrongful life cause of action by focusing on the element of harm and holding that life itself cannot constitute injury. Such a holding assumes that life is always preferable to non-life and/or that it is impossible for a trier of fact to measure damages for the harm of life compared to the 'utter void of nonexistence.'" Deana A. Pollard, Wrongful Analysis in Wrongful Life Jurisprudence, 55 ALA. L. REV. 327, 328 (2004).
274. Charo points out that determination of a court challenge to regulation of ART procedures will depend upon the U.S. Supreme Court's view of ART: is the creation of a fetus in a dish entitled to the same special protection from government intrusion as the creation of a fetus through sexual intercourse? If [the special protection afforded human reproduction is] associated with intimate marital relations, then technologies using third party gametes or hired surrogates may not be protected .... If it is because the government ought not interfere with physical bodies and reproductive capabilities of its citizens, then there is a far weaker claim of any right to access medical services that depend on extra-uterine maintenance or diagnosis of embryos. But if it is because human reproduction is notable for the profound way in which it reflects individual choices, aspirations and self identity, then there may be a far broader range of reproductive decisions that are free from government intrusion. Charo, supra note 137, at 525.
275. Darren Shickle, "On a Supposed Right to Lie [to the Public] From Benevolent Motives": Communicating Health Risks to the Public, 3 MED., HEALTH CARE & PHIL. 241 (2000).
276. Id, at 246-247.