The international harmonization of human tissue regulation: Regulatory control over human tissue use and tissue banking in select countries and the current state of international harmonization efforts

Food and Drug Law Journal

Volumn 55, Issue 3, 2000, Pages 343-372

  Indech, Barbara ^a  

^a NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONSUMER; DISEASE CONTROL; HEALTH CARE; HUMAN TISSUE; INDUSTRIALIZATION; INDUSTRY; LAW; MEDICAL ETHICS; MEDICAL RESEARCH; ORGAN TRANSPLANTATION; QUALITY CONTROL;

ETHICS, MEDICAL; EUROPE; EUROPEAN UNION; FORECASTING; HUMAN; INTERNATIONAL AGENCIES; INTERNATIONAL COOPERATION; PRACTICE GUIDELINES; TISSUE BANKS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0033808818     PISSN: 1064590X     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (279)

1. For the purposes of this paper, "human tissues" are defined as constituent parts of the human body including, but not limited to, bones, skin, heart valves, tendons, corneas, arteries, veins, dura mater, and cells intended for grafting. While fetal tissue generally falls within the scope of this definition, this paper does not address the myriad of ethical considerations associated with the use of human fetal tissue. Whole organs, blood, and blood products (including fetal cord blood) are deemed beyond the parameters of this definition. See, e.g., Robin Elizabeth Margolis, Should Human Tissue Transplants be Regulated?, HEALTHSPAN, Dec. 1992, at 17.
2. This paper does not examine the ethical and legal aspects of human tissue stored in biological banks for medical research purposes, including DNA examination. Some ethics questions generated in this area do bear mentioning, including: 1) to what extent should biomedical storage be allowed, and what use of such material is permissible; 2) must the donor give consent for such preservation and use, and to what degree must the donor be informed of any use (i.e., must donor consent be secured for every different use of his/her tissue, even years after donation); 3) may old biomaterials which were retrieved without donor consent (i.e., residual tissues from surgery) be used for research purposes; 4) who is the owner of the biomaterial - the person who donated the tissue, the research institution, the individual researcher, society as a whole; 5) as a corollary, should human tissue, an intrinsic part of the human body, even be considered as property; and 6) to what degree must confidentiality be maintained. In essence, the protection of a donor's autonomy, privacy, and human dignity must be balanced against the fundamental societal interests of freedom of research and efficiency of medical care. Where DNA analysis of a donor's tissue may reveal his genetic profile and future health and by extension relevant medical information on his biological family, yet another ethical consideration is what obligation, if any, researchers bear to inform the donor of any genetic concerns (i.e., diseases or disease markers) discovered. See Linda Nielsen, Legal and Ethical Aspects of Further Use of Human Tissue, 20 EUR. J. HEALTH L. 109, 109-110, 112 (1995).
3. Introduction: Human Tissues; Health Care and the Rights of Patients, 2 EUR. J. HEALTH L. 101, 101-02 (1995).
4. In tissue engineering, human cells or tissues maybe combined with biodegradable synthetic polymers to create a "neo-tissue."
5. Linda Horton, Mutual Recognition Agreements and Harmonization, 29 SETON HALL, L. REV. 692, 693 (1998).
6. Lori Andrews & Dorothy Nelkin, Whose Body is it Anyway? Disputes Over Body Tissue in a Biotechnology Age, 351 LANCET 53, 53-57 (Jan. 3, 1998).
7. Id.
8. Id.
9. Id.
10. Id.
11. Id.
12. Jason T. Corsover, The Logical Next Step? An International Perspective on the Issues of Human Cloning and Genetic Technology, 4 ILSA J. INT'L & COMP. L. 697, 715 (Spring 1998).
13. James F. Childress, Organ and Tissue Procurement: Ethical and Legal Issues Regarding Cadavers: Religious and Humanistic Beliefs, Attitudes, and Practices, 4 ENCYCLOPEDIA OF BIOETHICS 1854, 1863 (Warren Thomas Reich ed., 2d ed. 1995).
14. Id.
15. Id.
16. Id.
17. Id.
18. Id.
19. Id.
20. Id.
21. Id.
22. Childress, supra note 13, at 1854. Those opposed to donating tissue often cite a mistrust of the medical establishment and the donation process, including the fear that a commitment to donation will compromise the care or prolong the suffering of a relative. Id.
23. Id. at 1856. There is great ethical concern about the "donation" of tissues and organs by persons in dire economic need, particularly in developing countries, who receive some financial compensation for their donation. Peter A. Ubel & Mary B. Mahowald, Ethical and Legal Issues Regarding Living Donors, 4 ENCYCLOPEDIA OF BIOETHICS 1865, 1869 (Warren Thomas Reich ed., 2d ed. 1995).
24. Childress, supra note 13, at 1856.
25. Id.
26. Id. at 1857.
27. Id.
28. Id. at 1862.
29. Ubel & Mahowald, supra note 23.
30. Id. at 1866.
31. Id.
32. Id. at 1866-68.
33. Id. at 1867-68.
34. See, e.g., The Commission Sets Up a European Group on Ethics in Science and New Technologies, Ethical Legal and Social Aspects of the Life Sciences and Technologies, Press Release No. IP/97/1196 (Dec. 31, 1997) (last visited Aug. 1999) 〈www.europa.eu.int/comm/dg12/life/elsa/pr311297.html〉.
35. Human Tissue Intended for Transplantation, 62 Fed. Reg. 40,429, 40,444 (1997) (codified at 21 C.F.R. pt. 1270 (1999)).
36. 42 U.S.C. § 264 (1994).
37. 21 C.F.R. pts. 16, 1270; 62 Fed. Reg. at 40,430-31.
38. 62 Fed. Reg. at 40,431. Section 361 of the PHSA is enforced in part under the authority of the Act's section 368 (42 U.S.C. § 271), which provides penalties for those individuals violating section 361 provisions. Id.
39. Martha A. Wells, Overview of FDA Regulation of Human Cellular and Tissue-Based Products, 52 FOOD & DRUG L.J. 401 (1997); Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
40. Martha A. Wells, Overview of FDA Regulation of Human Cellular and Tissue-Based Products, 52 FOOD & DRUG L.J. 401 (1997); Pub. L. No. 75-717, 52 Stat. 1040 (1938) (codified as amended 21 U.S.C. §§ 301 et seq. (1994)).
41. Dura mater is the outer meningeal tissue covering the brain. Marc O. Williams, The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis, 52 FOOD & DRUG L.J. 409, 415 (1997). It is extracted from cadavers and used to patch the brain sacs of live human beings. FDA Investigating Firm Making Device Implicated in CJD Case, INSIDE WASH.'S FDA WK., Dec. 11, 1998, at 12.
42. Dura mater is the outer meningeal tissue covering the brain. Marc O. Williams, The Regulation of Human Tissue in the United States: A Regulatory and Legislative Analysis, 52 FOOD & DRUG L.J. 409, 415 (1997). It is extracted from cadavers and used to patch the brain sacs of live human beings. FDA Investigating Firm Making Device Implicated in CJD Case, INSIDE WASH.'S FDA WK., Dec. 11, 1998, at 12.
43. Corneal lenticules, a human tissue product derived from the human cornea, is applied to the cornea to correct vision problems. Williams, supra note 40, at 415.
44. Margolis, supra note I.
45. D. Michael Strong, Tissue Banks: Drafting New Rules for Grafting, BUS. & SOC'Y REV., Sept. 22, 1991, at 42. FDA defended this classification as necessary in light of the agency's findings that there was little tissue bank consistency in new processing techniques affecting human heart valves and that not all heart valves were subjected to state-of-the-art donor screening and testing. Margolis, supra note 1, at 18.
46. Id. This potential commercialization of human tissue banks was perceived as likely to negatively impact tissue bank donations, as altruistic donors and their families would be disinclined to donate tissues under such circumstances. Id.
47. Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, 63 Fed. Reg. 26,744 (to be codified at 21 C.F.R. pts. 207, 807, 1271). In the late 1980s and early 1990s, several alarming instances of transmission of serious illness (including AIDS and tuberculosis) from tissue donors prompted federal government efforts to pass comprehensive legislation regulating human tissue banks. Lynn Wagner, Tough Rules Urged for Tissue Banks, MOD. HEALTHCARE, Oct. 12, 1992, at 17. The proposed legislation (i.e, Senator Paul Simon's (D-IL) suggested "Human Tissue Transplantation Act of 1992"), however, never achieved the necessary accord for passage into law. See, e.g., Margolis, supra note I, at 18. Concerns over the safety of human tissues used in transplants have remained. In a December 1997 report to Congress on the matter, the General Accounting Office (GAO) evaluated FDA oversight of different transplanted human tissue. The GAO concluded that, despite the passage of a 1997 FDA rule regulating human tissue intended for transplantation (effective January 1998), a number of safety issues remained unaddressed or inadequately addressed by existing regulations. FDA Must Improve Human Tissue Oversight, GAO Says, ANDREWS HEALTH L. LITIG. REP. 15 (Jan. 1998).
48. Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, 63 Fed. Reg. 26,744 (to be codified at 21 C.F.R. pts. 207, 807, 1271). In the late 1980s and early 1990s, several alarming instances of transmission of serious illness (including AIDS and tuberculosis) from tissue donors prompted federal government efforts to pass comprehensive legislation regulating human tissue banks. Lynn Wagner, Tough Rules Urged for Tissue Banks, MOD. HEALTHCARE, Oct. 12, 1992, at 17. The proposed legislation (i.e, Senator Paul Simon's (D-IL) suggested "Human Tissue Transplantation Act of 1992"), however, never achieved the necessary accord for passage into law. See, e.g., Margolis, supra note I, at 18. Concerns over the safety of human tissues used in transplants have remained. In a December 1997 report to Congress on the matter, the General Accounting Office (GAO) evaluated FDA oversight of different transplanted human tissue. The GAO concluded that, despite the passage of a 1997 FDA rule regulating human tissue intended for transplantation (effective January 1998), a number of safety issues remained unaddressed or inadequately addressed by existing regulations. FDA Must Improve Human Tissue Oversight, GAO Says, ANDREWS HEALTH L. LITIG. REP. 15 (Jan. 1998).
49. Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, 63 Fed. Reg. 26,744 (to be codified at 21 C.F.R. pts. 207, 807, 1271). In the late 1980s and early 1990s, several alarming instances of transmission of serious illness (including AIDS and tuberculosis) from tissue donors prompted federal government efforts to pass comprehensive legislation regulating human tissue banks. Lynn Wagner, Tough Rules Urged for Tissue Banks, MOD. HEALTHCARE, Oct. 12, 1992, at 17. The proposed legislation (i.e, Senator Paul Simon's (D-IL) suggested "Human Tissue Transplantation Act of 1992"), however, never achieved the necessary accord for passage into law. See, e.g., Margolis, supra note I, at 18. Concerns over the safety of human tissues used in transplants have remained. In a December 1997 report to Congress on the matter, the General Accounting Office (GAO) evaluated FDA oversight of different transplanted human tissue. The GAO concluded that, despite the passage of a 1997 FDA rule regulating human tissue intended for transplantation (effective January 1998), a number of safety issues remained unaddressed or inadequately addressed by existing regulations. FDA Must Improve Human Tissue Oversight, GAO Says, ANDREWS HEALTH L. LITIG. REP. 15 (Jan. 1998).
50. The Regulation of Human Tissue and Organs, 46 FOOD DRUG COSM. L.J. (special issue) 1, 47 (1991).
51. Id. at 50.
52. Lynn Wagner, Tough Rules Urged for Tissue Banks, MOD. HEALTHCARE, Oct. 12, 1992, at 17.
53. The Regulation of Human Tissue and Organs, supra note 46, at 56.
54. Human Tissue Intended for Transplantation; Interim Rule, 58 Fed. Reg. 65, 514 (1993) (codified at 21 C.F.R. pt 1270).
55. Id.; 42 U.S.C. § 264.
56. 21 C.F.R. § 1270.1(a).
57. Id. § 1270.3(b).
58. Wells, supra note 39, at 404.
59. Id.
60. Id.
61. 62 Fed. Reg. at 40,429.
62. Id. at 40,439-40.
63. Id. at 40,439.
64. Id.
65. Id.
66. Wells, supra note 39, at 405.
67. 62 Fed. Reg. at 40,430.
68. FDA Issues Final Rule on Human Tissue In tended for Transplantation; New Regulations Effective Jan. 26, 1998, 7 TRANSPLANT NEWS, Aug. 11, 1997, available in 1997 WL 8941086.
69. A Proposed Approach to the Regulation of Cellular and Tissue-Based Products, FDA, Feb. 28, 1997, at 3. At the same time, FDA also published a less detailed analysis of the proposed regulations entitled, Reinventing the Regulation of Human Tissue, as a Component of Vice President Al Gore's National Performance Review for Streamlining Government Regulation, FDA, DHHS, NATIONAL PERFORMANCE & REV.: REINVENTING THE REG. OF HUMAN TISSUE (1997) [hereinafter Reinventing the Regulation of Human Tissue].
70. Wells, supra note 39, at 406. The Medical Device Amendments to the FDCA, enacted on May 28, 1976, establish the basic framework governing the regulation of medical devices. Further legislation relevant to medical device regulation includes the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and sections of the FDA Export Reform and Enhancement Act of 1996 and the Food and Drug Administration Modernization Act of 1997. FDA Center for Devices and Radiological Health (CDRH) (last visited Aug. 1, 1999) 〈www.fda.gov/cdrh/devadvice/371.html#global〉.
71. Wells, supra note 39, at 406. The Medical Device Amendments to the FDCA, enacted on May 28, 1976, establish the basic framework governing the regulation of medical devices. Further legislation relevant to medical device regulation includes the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and sections of the FDA Export Reform and Enhancement Act of 1996 and the Food and Drug Administration Modernization Act of 1997. FDA Center for Devices and Radiological Health (CDRH) (last visited Aug. 1, 1999) 〈www.fda.gov/cdrh/devadvice/371.html#global〉.
72. Wells, supra note 39, at 406.
73. Id.
74. Reinventing the Regulation of Human Tissue, DHHS, February 28, 1997 (last visited Aug. 1, 1999) 〈www.medscape.com/govmt/DHHS/1997/mar/RegulationOfHumanTissue.html〉 (Medscape site is free to use but requires user to register for password).
75. Id.
76. Id.
77. Id.
78. Wells, supra note 39, at 406.
79. All product labeling and promotion must be accurate, clear, balanced, and non-misleading. Reinventing the Regulation of Human Tissue, supra note 65.
80. Wells, supra note 39, at 406.
81. Nancy Chew, Agony and Ecstasy in Biopharmaceutical Regulation, BIOPHARM 20, Sept. 1, 1997, available in 1997 WL 9637433.
82. 63 Fed Reg. 26,744 (1998).
83. Id. at 26,746.
84. Id.
85. Id. at 26,745. See also 21 C.F.R. §§ 1271.21, 1271.22, 1271.25, 1271.26.
86. Supporting Statement for Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products, OMB No. 0910-0372.
87. Id.
88. 63 Fed. Reg. at 26,747.
89. Registration and listing requirements are not contingent on the human tissue product entering into interstate commerce. Id. at 26,754.
90. Id. at 26,754 (to be codified at 21 C.F.R. § 1271.10).
91. Id. at 26,745-46.
92. Id. at 26,745.
93. All Tissue/Cell Product Firms Must Register With CBER Under Proposed Rule, F-D-C REP. ("The Pink Sheet"), May 25, 1998, available in 1998 WL 8441307.
94. Id.
95. 63 Fed. Reg. at 26,753.
96. Telephone Interviews with Steve Falter, Director of Regulations, Policy Staff, Center for Biologics Evaluation & Research (CBER), FDA, Rockville, MD (Aug. 2, 1999) and Jennie Butler, Administrative Proceedings Officer of FDA, Rockville, MD (July 1999).
97. Falter, supra note 91.
98. Id.
99. Adoption of an Opinion on Human Tissue Banking: Legislations and Ethical Guidelines with Regard to Human Tissue Banking in the Member States of the EU, European Group on Ethics in Science and New Technologies to the European Commission (July 21, 1998) [hereinafter Opinion on Human Tissue Banking].
100. Id. It would appear that the dominant legislation governing organ and tissue removal for diagnostic and research purposes is Resolution (78) 29 on the harmonization of member state legislation relating to removal, grafting, and transplantation of human substances, which was adopted by the Committee of Ministers of the Council of Europe on May 11, 1978. Herman Nys, Therapeutic Use of Human Organs and Tissues Under Belgian Law, 12 MED. L. 131, 132 (1993). As this paper is limited to discussion of the therapeutic use of human tissue, that legislation is not now addressed.
101. Law of 13 June 1986 on the Removal and Transplantation of Organs (Article 6), Moniteur Belge, 14 February 1987, No. 32, at 2192-2132, reprinted in 38 INT'L. DIG. HEALTH LEGIS. 523, 524 (1987).
102. Id. art. 7.
103. Id.
104. B. Van Haelewicjck et al., How to Improve the Public Image of Organ Donation, ORGAN AND TISSUE TRANSPLANT IN THE EUROPEAN UNION: MANAGEMENT OF DIFFICULTIES AND HEALTH RISKS LINKED TO DONORS 180, 181-82 (Yvon Englert ed., 1995).
105. Nys, supra note 95, at 134-35.
106. Opinion on Human Tissue Banking, supra note 94.
107. Id. Brain death must be established by three doctors who are independent of the organ retrieval or transplantation team. Van Haelewicjck, supra note 99, at 182.
108. Id. In order to guard against profit from organ/tissue donation, the Belgian Minister of Health sets the prices for delivery of homografts, with publication of the prices in the Belgian official Gazette. Id.
109. Id.
110. Opinion on Human Tissue Banking, supra note 94.
111. Id. As noted earlier, the Belgian Minister of Health fixes prices for each allograft in order to guarantee the nonprofit operation of human tissue banks in Belgium.
112. Id.
113. Id.
114. L.F. Markenstein, An Analysis of the State of the Debate on Further Use of Human Tissue in Various European Countries, 2 EUR. J. OF HEALTH L. 125, 130 (1995).
115. C. Delloye, Specific Difficulties in Widespread Tissue Banking, ORGAN AND TISSUE TRANSPLANT IN THE EUROPEAN UNION: MANAGEMENT OF DIFFICULTIES AND HEALTH RISKS LINKED TO DONORS 145 (Yvon Englert ed., 1995).
116. L. Muylle, Origin and Circulation of Tissues for Grafting, ORGAN AND TISSUE TRANSPLANT IN THE EUROPEAN UNION: MANAGEMENT OF DIFFICULTIES AND HEALTH RISKS LINKED TO DONORS 134 (Yvon Englert ed., 1995).
117. Id.
118. Tara Patel, France's Troubled Transplant Trade, NEW SCIENTIST, July 3, 1993, at 12-13. A 1992 French decree mandated that all tissue donors be tested for transmissible diseases. However, a 1993 report on tissue banks by France's Inspector General of Social Affairs revealed that when some orthopedic units requested that patients who donated bone undergo blood tests for HIV screening three months later (and were refused by some), the tissues were nonetheless reused. Id.
119. Opinion on Human Tissue Banking, supra note 94.
120. Id.
121. Id. On July 31, 1998, Circular DGS/DH/EFG No. 98-489 was issued, putting into service the national computerized register of refusals with regard to tissue/organ removal from deceased persons. The Circular mandates consultation of the register by health establishments prior to any removal. Circular DGH/DH/EFG No. 98-489 of 31 July 1998 On the Putting Into Service of the National Computerized Register of Refusals With Regard to the Removal of Organs, Tissues, and/or Cells from Deceased Persons, and on the Consultation of This Register by Health Establishments Prior to Any Removal, Bulletin Officiel, 5 Sept. 1998, No. 98/34, Vol. I, Text No. 22206, pp. 127-131, reprinted in INT'L DIG. HEALTH LEGIS. 635 (1998).
122. Tara Patel, French Law Clamps Down on Tissue Traders, NEW SCIENTIST, July 2, 1994, at 6.
123. Law No. 193 of July 24, 1996, J.O., Aug. 20, 1996, pp. 12543-44; 47 INT'L DIG. HEALTH LEGIS. 464 (1996) (on the nature of the examinations to be carried out for the detection of biological markers of infection by the human immunodeficiency virus (HIV-1 and HIV-2) and by the hepatitis-C virus prior to any therapeutic use in human beings of elements and products of the human body for the purposes of transplantation, with the exception of gametes and blood and blood products). The July 24, 1996 Order was made pursuant to Decree No. 92-174 of Feb. 25, 1992 on the prevention of the transmission of certain infectious diseases. Id.
124. Law No. 193 of July 24, 1996, J.O., Aug. 20, 1996, pp. 12543-44; 47 INT'L DIG. HEALTH LEGIS. 464 (1996) (on the nature of the examinations to be carried out for the detection of biological markers of infection by the human immunodeficiency virus (HIV-1 and HIV-2) and by the hepatitis-C virus prior to any therapeutic use in human beings of elements and products of the human body for the purposes of transplantation, with the exception of gametes and blood and blood products). The July 24, 1996 Order was made pursuant to Decree No. 92-174 of Feb. 25, 1992 on the prevention of the transmission of certain infectious diseases. Id.
125. Tissue bank monitoring is "foreseen" by Law No. 95-116 of Feb. 4, 1995, with infringements penalized. Opinion on Human Tissue Banking, supra note 94.
126. Decree No. 94-416 of May 24, 1994, J.O., May 28, 1994, pp. 7654-7655; 45 INT'L DIG. HEALTH LEGIS. 316 (1994) (amending Decree No. 92-174 of Feb. 25, 1992, on the prevention of the transmission of certain infectious diseases).
127. Decree No. 94-416 of May 24, 1994, J.O., May 28, 1994, pp. 7654-7655; 45 INT'L DIG. HEALTH LEGIS. 316 (1994) (amending Decree No. 92-174 of Feb. 25, 1992, on the prevention of the transmission of certain infectious diseases).
128. Opinion on Human Tissue Banking, supra note 94.
129. Id.
130. Id.
131. Id.
132. Draft Report of Presentations and Discussion, Regulation: The Present and the Future; Answer to Expectations, ETABLISSEMENT FRANCAIS DES GREFFES MEETING ON TISSUE AND CELL ALLOGRAPHIS REGULATION IN EUROPE (International Association of Prosthesis Manufacturers) (June 8, 1998) [hereinafter Present and Future].
133. Opinion on Human Tissue Banking, supra note 94.
134. Decree No. 97-928 of Oct. 9, 1997, J.O., Oct. 12, 1997, pp. 14865-14866; 49 INT'L DIG. HEALTH LEGIS. 312, 312-14 (1998) (on the health safety rules applicable to all removals of elements or all collection of products of the human body and their use for therapeutic purposes, with the exception of gametes, blood and blood components and their derivatives, and reagents, made for the implementation of Articles L. 665-10 and 665-15 of the Public Health Code and amending that Code (Second Part: Decrees made after consulting the Conseil d'Etat)).
135. Decree No. 97-928 of Oct. 9, 1997, J.O., Oct. 12, 1997, pp. 14865-14866; 49 INT'L DIG. HEALTH LEGIS. 312, 312-14 (1998) (on the health safety rules applicable to all removals of elements or all collection of products of the human body and their use for therapeutic purposes, with the exception of gametes, blood and blood components and their derivatives, and reagents, made for the implementation of Articles L. 665-10 and 665-15 of the Public Health Code and amending that Code (Second Part: Decrees made after consulting the Conseil d'Etat)).
136. Law No. 302 of Dec. 29, 1998, J.O., Dec. 30, 1998, pp. 19824-19843; 50 INT'L DIG. HEALTH LEGIS. 32 (1999) (approving the rules of good practice with regard to the storage, processing, and transportation of tissues of human origin used for therapeutic purposes).
137. Law No. 302 of Dec. 29, 1998, J.O., Dec. 30, 1998, pp. 19824-19843; 50 INT'L DIG. HEALTH LEGIS. 32 (1999) (approving the rules of good practice with regard to the storage, processing, and transportation of tissues of human origin used for therapeutic purposes).
138. Law No. 248 of Oct. 16, 1996, J.O., Oct. 23, 1996, p. 15496; 48 INT'L. DIG. OF HEALTH LEGIS. 12 (1997) (prohibiting the manufacture, import, export, distribution, supply, and use, and ordering the withdrawal, of dura maters of human origin and products containing them). Use of dura mater has been associated with the contraction of Creutzfeldt-Jakob disease, a rare and fatal human neurodegenerative condition.
139. Law No. 248 of Oct. 16, 1996, J.O., Oct. 23, 1996, p. 15496; 48 INT'L. DIG. OF HEALTH LEGIS. 12 (1997) (prohibiting the manufacture, import, export, distribution, supply, and use, and ordering the withdrawal, of dura maters of human origin and products containing them). Use of dura mater has been associated with the contraction of Creutzfeldt-Jakob disease, a rare and fatal human neurodegenerative condition.
140. Present and Future, supra note 125.
141. Decree No. 96-327 of Apr. 16, 1996, J.O., Apr. 18, 1996, pp. 5954-5957; 47 INT'L DIG. HEALTH LEGIS. 331 (1996) (on the import and export of organs, tissues, and cells of the human body, with the exception of gametes, and amending the Public Health Code (Second Part: Decrees made after consulting the Conseil d'Etat)).
142. Decree No. 96-327 of Apr. 16, 1996, J.O., Apr. 18, 1996, pp. 5954-5957; 47 INT'L DIG. HEALTH LEGIS. 331 (1996) (on the import and export of organs, tissues, and cells of the human body, with the exception of gametes, and amending the Public Health Code (Second Part: Decrees made after consulting the Conseil d'Etat)).
143. Id. at 332-34.
144. Id. at 332-35.
145. France Calls for European Medical Device Agency, CLINICA: WORLD MED. DEVICE & DIAGNOSTIC NEWS, May 19, 1997, at 1. Extra French Device Controls Against EU Directives, EUR. DRUG & DEVICE REP., July 7, 1997, at 7.
146. France Calls for European Medical Device Agency, CLINICA: WORLD MED. DEVICE & DIAGNOSTIC NEWS, May 19, 1997, at 1. Extra French Device Controls Against EU Directives, EUR. DRUG & DEVICE REP., July 7, 1997, at 7.
147. Opinion on Human Tissue Banking, supra note 94.
148. Id.
149. Id. In contrast, Belgium and Spain regulate human tissue donation under a presumed consent-with-opt-out theory, as previously discussed. British Organ Donor Society (last visited July 26, 1999) 〈www.argonet.co.uk/ body/index.html〉.
150. Siobhan Deehan, The Gift of Life, 144 NEW L.J. 1143 (1994).
151. Id.
152. In 1986, the United Kingdom's Department of Health issued a guideline document on the microbiological safety of human tissues and organs. Present and Future, supra note 125. It is unclear whether this guideline document applies to cadaveric donors, living donors, or both. However, living tissue donors are required to undergo repeat testing for HIV antibodies and other markers mandatorily tested in blood donors, 180 days or more after donation. D. Fehily & R.M. Warwick, Safe Tissue Grafts, 314 BRIT. MED. J. 1141 (1997).
153. In 1986, the United Kingdom's Department of Health issued a guideline document on the microbiological safety of human tissues and organs. Present and Future, supra note 125. It is unclear whether this guideline document applies to cadaveric donors, living donors, or both. However, living tissue donors are required to undergo repeat testing for HIV antibodies and other markers mandatorily tested in blood donors, 180 days or more after donation. D. Fehily & R.M. Warwick, Safe Tissue Grafts, 314 BRIT. MED. J. 1141 (1997).
154. Deehan, supra note 138.
155. Id.
156. Id.
157. In 1996, the United Kingdom issued a guideline on serological testing of donors. A social and medical risk questionnaire for the assessment of lifestyle risks also has been issued. Present and Future, supra note 125.
158. Andrew Grubb, The Nuffield Council Report on Human Tissue, 3 MED. L. REV. 235 (1995).
159. Id. at 236.
160. Present and the Future, supra note 125.
161. Opinion on Human Tissue Banking, supra note 94.
162. Current member states of the European Union include Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden, and the United Kingdom. Professor Linda Horton, Int'l Food, Drug, and Medical Device Law, Georgetown University Law Center 1028-1029 (Summer 1999) (class materials on file with author).
163. The ABC of the European Union - Citizenship (last visited July 1999) 〈www.europa.eu.int/abc-en.htm〉.
164. The European Commission maintains exclusive power to draft EU legislation, while the European Council acts as the principal lawmaking body of the EU (with the political interests of member state countries represented accordingly), and the European Parliament serves as a "significant voice for the ideological blocs of Europe." Horton, supra note 149, at 1028. On October 2, 1997, the Treaty of Amsterdam was signed by European Union member states. This treaty amends previous EU treaties, and includes provisions on consumer protection, health, increased transparency, and the European Parliament's enhanced role in Community decisions. The new Article 129 provides in part: 4. The Council, acting in accordance with the procedure referred to in Article 189b and after consulting the Economic and Social Committee and the Committee of the Regions, shall contribute to the achievement of the objectives referred to in this Article through adopting; (a) measures setting high standards of quality and safety of origin and substances of human organ, blood and blood derivatives; these measures shall not prevent any Member State from maintaining or introducing more stringent protective measures; (b) by way of derogation from Article 43, measures in the veterinary and phytosanitary fields which have as their direct objective the protection of public health; (c) incentive measures designed to protect and improve human health, excluding any harmonization of the laws and regulations of the Member States. The Council, acting by a qualified majority on a proposal from the Commission, may also adopt recommendations for the purposes set out in this Article. Treaty Of Amsterdam, Oct. 2, 1997, art. 129.
165. Horton, supra note 149.
166. Id. at 1030-31.
167. Id. at 1031.
168. Id. In the European Union, a medical device has been defined as: any instrument, apparatus, appliance material or other article, whether use[d] alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of: -diagnosis, prevention, monitoring, treatment, or alleviation of disease, -diagnosis, monitoring, treatment, or alleviation of or compensation for an injury or handicap, -investigation, replacement or modification of the anatomy or of a physiological process, -control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. Information About the EC Medical Device Directives, Medical Devices Agency, Bulletin No. 8 (June 1998) (electronic copy on file with author) [hereinafter Bulletin No. 8]. As in the United States, the European Union has a risk-based medical device classification system, consisting of four categories. Unlike the medical device regulations administered by FDA in the United States, which include review for safety and effectiveness, the EU medical device regulatory system reviews only for safety and performance as the manufacturer intended. Moreover, it is the EU member state manufacturer, not the EU regulatory body, who determines the appropriate class for a new device, based on classification rules in the directives (although that classification may be subject to change if the final regulatory authority disagrees with it). Medical Device Regulation: Too Early to Assess European System's Value as Model for FDA, U. S. General Accounting Office (GAO/HEHS-96-65), Report to the Chairman, Committee on Labor and Human Resources 2, 6, 10 (Mar. 1996).
169. Bulletin No. 8, supra note 155.
170. Id.
171. Id.
172. Id.
173. Horton, supra note 149, at 1032.
174. Id.
175. CEN is the European Committee for Standardization, whose mission is to "promote voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe." About CEN and European Standardization (last visited Aug. 1999) 〈www.cenorm.be/AboutCEN/AboutCEN.htm〉. One of CEN's partners is CENELEC, the European Committee for Electrotechnical Standardization. General Information (last visited Aug. 1999) 〈www.cenelec.be/generalinfo/hp_general_info.htm〉.
176. CEN is the European Committee for Standardization, whose mission is to "promote voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe." About CEN and European Standardization (last visited Aug. 1999) 〈www.cenorm.be/AboutCEN/AboutCEN.htm〉. One of CEN's partners is CENELEC, the European Committee for Electrotechnical Standardization. General Information (last visited Aug. 1999) 〈www.cenelec.be/generalinfo/hp_general_info.htm〉.
177. Horton, supra note 149, at 1033.
178. Id.
179. Id. Bulletin No. 8, supra note 155.
180. Horton, supra note 149, at 1034. Member states further bear responsibility for post-market surveillance of approved products, as well as for enforcement actions for removal of dangerous products from the market Additionally, member states are charged with taking actions to strip a notified body of its conformity assessment role under an EU directive if it has not followed requirements of eligibility. Id. at 1031-32.
181. Id. at 1033.
182. Id. at 1034. Article 36 of the Treaty of Rome states that: The provisions of Articles 30 to 34 [prohibiting quantitative restrictions on products exported between Member States] shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on grounds of public morality, public policy or public security; the protection of health and life of humans, animals or plants . . . . Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States. Treaty of Rome, art. 36,〈www.hrc.org/docs/Rome57/Part3Title01.html〉; Treaty of Rome, Mar. 25, 1957, art. 129,〈www.hri.org/docs/Rome57/Part3Title10.html〉. The revised Article 129a, § 5, of the Treaty of Amsterdam provides likewise: Measures adopted pursuant to paragraph 4 [EU measures designed to support, supplement and monitor the health safety and consumer protection policies of Member States] shall not prevent any Member State from maintaining or introducing more stringent protective measures. Such measures must be compatible with this Treaty. The Commission shall be notified of them. Treaty Of Amsterdam, Oct. 2, 1997, art. 129.
183. France Wants Registration to Replace EU Device Directives, EUR. DRUG & DEV. REP., June 9, 1997, at 7.
184. Id.
185. Id. Approval of pharmaceuticals within the European Union is achieved through complex systems which vary according to the type of drug (innovative medicines, biotechnology-based or conventional medicines) presented for evaluation. Basically, two processes govern market entry of a pharmaceutical product in the European Union: 1) the London-based EMEA, which spearheads the centralized procedure for innovative and biotechnology-based pharmaceuticals; and 2) the Mutual Recognition Process, a decentralized procedure that is applied to conventional medicines and involves drug approval by one EU member state (the reference country) with mutual recognition of the reference country's approval requested of the other fourteen EU member states. Thus, the decentralized Mutual Recognition Process operates similarly to the EU process for premarket medical device approval. Horton, supra note 149, at handout (European Medicine and Evaluation Agency).
186. France Wants Registration to Replace EU Device Directives, supra note 169.
187. Id.
188. Id.
189. Sara Lewis, Europe: Tissue Devices, 341 LANCET 684 (1993).
190. Bulletin No. 8, supra note 155.
191. Interestingly, until very recently, the EU apparently had not attempted to subject human tissue regulation to the centralized, pharmaceutical regulatory system, which is positively regarded by several member states (i.e.,France) as more rigorous and therefore more likely to ensure the protection of the public health. 178 Lewis, supra note 175.
192. Id.
193. Id.
194. Id.
195. Id.
196. The Active Implantable Medical Devices Directive covers all powered implants or partial implants which are left in the human body (i.e., heart pacemakers), and became effective on January 1, 1995. The Medical Devices Directive, which originally was proposed to cover medical devices incorporating human tissues, encompasses most other medical devices, such as ECG and heart values, hip prostheses, and first aid bandages. Bulletin No. 8, supra note 155. Implementation of the Medical Devices Directive was subject to a transitional period until June 14, 1998, during which time medical device manufacturers could choose to either follow the existing national controls in force as of December 31, 1994, or to follow the regulatory system created by the Directive. Id.
197. HEALTH: Council Nears Agreement on In Vitro Diagnostic Devices, EUR. REP., May 24, 1997.
198. Id.
199. Id.
200. Removal of Clauses Pertaining to Human Tissue May Revive IVD Directive, Oct. 29, 1997, (last visited July 1999) 〈www.devicelink.com/news/97/10/3172.html〉.
201. EU to Leave Many Human Tissue Devices Unregulated, EUR. DRUG & DEVICE REP., Nov. 9, 1998.
202. Directive on In Vitro Diagnostic Medical Devices, SPICERS CENTRE FOR EUROPE, Dec. 7, 1998, available in 1998 WL 857106 (C.E.A.). December 7, 1998, was the date set for mandatory compliance with the IVD Directive by member states.
203. Medical electronic mail interview with Victoria Ann Dedrick, Secretary and General, International Association of Prosthesis Manufacturers, Europe (Aug. 1999). Ms. Dedrick provided a copy of her "Published Statement Concerning the Status in the European Union."
204. Id.
205. EMEA Could Regulate Medical Devices Made From Human Substances, EUR. DRUG & DEVICE REP., Apr. 12, 1999.
206. Id.
207. Id.
208. Id.
209. Sara Lewis, EU Will Not Have Human Tissue Rules Until at Least 2000, EUR. DRUG & DEVICE REP., June 7, 1999.
210. Id.
211. Id.
212. Id.
213. Id.
214. A full assessment includes a risk analysis of a particular product, resulting in a scientific opinion. Sara Lewis, EU Consensus That EMEA to Approve Human Tissue Devices, EUR. DRUG & DEVICE REP., July 19, 1999.
215. Id.
216. Id.; Sara Lewis, EMEA Might Refuse Limited Human Tissue Device Approval, EUR. DRUG & DEVICE REP., July 5, 1999.
217. Id.; Sara Lewis, EMEA Might Refuse Limited Human Tissue Device Approval, EUR. DRUG & DEVICE REP., July 5, 1999.
218. Lewis, supra note 201.
219. Sara Lewis, EU Split Over EMEA Regulating Human Tissue Devices, EUR. DRUG & DEVICE REP., Aug. 2, 1999, at 6.
220. Id. A "human tissues directive" within the EU is not likely to appear in the near future. Electronic mail interviews with Alan Kent, Former (retired) Chief Executive, United Kingdom Medical Devices Agency (Aug. 6, 1999) and Karen Howes, the Directorate General III of the European Commission (Aug. 2, 1999).
221. With majority consensus, an EU proposal must be formally discussed by ministers at an Internal Market Council meeting. In contrast, a unanimously supported proposal allows EU officials to reach accord on the text, which then may be rubberstamped as approved "as an A point" by ministers at a council on any subject -without further discussion. Lewis, supra note 205.
222. Muylle, supra note 111.
223. Id.
224. Octavi Quintana, Human Tissue Banks in Europe, HUMAN DNA: LAW & POLICY: INTERNATIONAL AND COMPARATIVE PERSPECTIVES. PROCEEDINGS OF THE FIRST INTERNATIONAL CONFERENCE ON DNA SAMPLING AND HUMAN GENETIC RESEARCH: ETHICAL, LEGAL, AND POLICY ASPECTS, HELD IN MONTREAL, CANADA, 6-8 SEP 1996, 423-24 (Bartha Maria Knoppers ed., 1997). It should be noted, however, that certain human tissues have been subject to long-standing regulations. These tissues include blood and its derivatives, tissues related with reproductive functions (such as sperm, ova, and embryos) and corneas. Id. at 424. There also is an arguable understanding within the European Community that either the norms governing organs apply to tissues or that no norm is needed. Id. at 423.
225. A. Rejman, Legal Aspects of Tissue Banking in the EU - Current and Future, ORGAN AND TISSUE TRANSPLANT IN THE EUROPEAN UNION: MANAGEMENT OF DIFFICULTIES AND HEALTH RISKS LINKED TO DONORS 153 (Yvon Englert ed., 1995).
226. Quintana, supra note 210, at 424. As of June 1998, Ms. Octavi Quintana Trias was the Director at the Spanish Ministry for Public Health and the Vice-President of the European Group on Ethics in Science and New Technologies.
227. Id. While human tissue bank regulation is a major focus of this paper, it should be noted that this limited regulation is not the only problem in the area of organ and tissue transplants in the EU. Another issue facing EU organ and tissue transplant facilities and health administrations is the lack of a comprehensive, centralized communications network that can provide timely information on organ and tissue availability and need. The Transplant European ComputerNetwork(TECN), a fully integrated communication system in Europe supported by the Commission of the European Communities, has served to coordinate and disseminate information relevant to organ (and to a lesser extent, tissue) transplant, but is a voluntary consortium whose membership as of the mid-1990s included only two tissue banks: Bio Implant Services in Leiden, the Netherlands, and France Tissues in Marseilles, France. P. Romano & J. Hors, The Transplant European Computer Network Project, in ORGAN AND TISSUE TRANSPLANT IN THE EUROPEAN UNION: MANAGEMENT OF DIFFICULTIES AND HEALTH RISKS LINKED TO DONORS 1, 117-18 (Yvon Englert ed., 1995).
228. European Association of Tissue Banks, New Rules Proposed for Tissue Banks, BULL. MED. ETH., May 1994, 10-11.
229. Id. at 10.
230. Rejman, supra note 211.
231. Nielsen, supra note 2, at 113.
232. Quintana, supra note 210, at 424-25.
233. Henriette D.C. Roscam Abbing, New Developments in International Health Law, 5 EUR. J. HEALTH L. 155, 160-61 (1998).
234. The author's recounting of the preceding movements to facilitate regulation of human tissue and tissue banks is not intended to be comprehensive, but rather representative of EU efforts in that area in the 1990s.
235. The European Group on Ethics in Science and New Technology was organized by the European Commission in December 1997 as replacement of the Group of Advisors for the Ethical Implications of Biotechnology. The new Group was charged with a broader mandate - coverage of ethical implications of biotechnology and "science and new technologies" in the framework of the drafting and implementation of European Community Legislation. The Commission Sets Up a European Group on Ethics in Science and New Technologies, Ethical Legal and Social Aspects of the Life Sciences and Technologies, Press Release No. IP/97/1196 (Dec. 31, 1997) (last visited Aug. 1999) 〈www.europa.eu.int/comm/dg12/life/elsa/pr311297.html〉.
236. Opinion on Human Tissue Banking, supra note 94.
237. Press Notice of the European Group on Ethics in Science and New Technologies, Human Tissue Banks (hard copy on file with the author).
238. Health: Ethics Group Urges Regulating Human Tissue Banks, 23 EUR. REP., July 25, 1998, available in 1998 WL 8803077.
239. BBC Online Network, Health Controls Wanted on Sale of Human Tissue (last visited July 26, 1999) 〈www.news2.thls.bbc.co.uk/hi/english/health/newsid%5F116000/116047. stm〉.
240. Health: Ethics Group Urges Regulating Human Tissue Banks, supra note 224.
241. Id.
242. European Ethics Group Calls for Strict Rules on Use of Human Tissue, 8 TRANSPLANT NEWS (Aug. 31, 1998), available in 1998 WL 9525584.
243. Jane E. Henney, M.D., U.S. Food and Drug Administration Commissioner of Food and Drugs, Keynote Address at the Global Harmonization Task Force Meeting in Bethesda, Maryland (June 29, 1999) available in (test visited Aug. 9, 1999) 〈www.fda.gov/oc/speeches/globalharm.html〉.
244. Mutual Recognition Agreements (last visited Aug. 27, 1999) 〈www.europa.eu.int/comm/dg03/directs/dg3b/b1/indexb1.htm〉. If reliance upon another country's conformity assessments is not practical, a mutual recognition agreement also has been interpreted to encompass the exchange of conformity assessment results to assure that the requirements of the receiving country are met. Horton, supra note 5, at 716.
245. On June 24, 1998, Europe, Australia, and New Zealand signed a mutual recognition agreement that provides for the assessment (testing, inspection, and certification) of traded products in eight industry sectors (including medical devices and medicinal products, GMP inspection, and batch certification) to be undertaken in the exporting country rather than in the importing country. Australia Therapeutic Goods Administration, Mutual Recognition Agreement on Conformity Assessment Between the European Community & Australia: Frequently Asked Questions (as at December 1998). On May 18, 1998, the United States and the European Community signed an accord on the mutual recognition of pharmaceutical good manufacturing practice inspection reports, certain medical device product evaluation reports, and medical device quality system audit reports. 63 Fed. Reg. 60,122 (to be codified at 21 C.F.R. pt. 26). Under the agreement, the importing country authority may normally endorse GMP inspection reports for pharmaceuticals provided by the exporting authority determined by the importing authority to have an equivalent regulatory system. Likewise, the importing country authority may normally endorse medical device quality system evaluation reports and certain medical device product evaluation reports provided by conformity assessment bodies determined by the importing country authority to have equivalent assessment procedures. Id. The regulation became effective on December 7, 1998. Id. On May 18-19, 1999, the Joint Sectoral Committee, responsible for the implementation of the Pharmaceutical Annex of the U.S.-EC Mutual Recognition Agreement, met in plenary session, discussing such topics as the facilitation of coordination, monitoring, and communication between the participating parties "to ensure consistency and transparency in making equivalence determinations." U.S. Food and Drug Administration, Joint Summary of the Meeting of the Joint Sectoral Committee of the Pharmaceutical Good Manufacturing Practice Annex of the U.S.-EC Mutual Recognition Agreement (last visited July 29, 1999) 〈www.fda.gov/oia/jsmra.htm〉. The Committee also discussed the important issue of confidentiality of nonpublic documents, as the U.S. and the EU governments are subject to different requirements for disclosure of information (e.g., the U. S. Freedom of Information Act). Id
246. Horton, supra note 5, at 725.
247. Id. at 716, n. 118 (citing Richard A. Merrill, FDA and Mutual Recognition Agreements: Five Models of Harmonization, 53 FOOD & DRUG L.J. 133, 135 (1998)).
248. Id. at 722. U.S. regulatory authorities suggest that any agreements reached by the United States and another country under either model 4 or model 5 would require U.S. notice and comment rulemaking. Id. at 716. FDA derives its authority to conduct international activities (including entering into both mutual recognition and harmonization agreements) from several sources, including the Food and Drug Administration Modernization Act of 1997 (FDAMA) and sections 301, 307, 351, and 361 of the Public Health Service Act. Id. at 712. FDAMA provides a third objective to FDA's statutory mission, "participat[ion] through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements." 21 U.S.C.A. § 393(b)(3) (West Supp. 1998). FDAMA further 1) supplemented an internationally-oriented section of the Federal Food, Drug, and Cosmetic Appertaining to medical devices, with instruction that FDA "regularly participate in meetings with representatives of other foreign governments to discuss and reach agreements on
249. A Brief History of ICH, (last visited July 29, 1999) 〈www.ifpma.org/ich8.html〉. Europe, Japan, and the United States are the geographic areas where the vast majority of new medicines are developed.
250. Id.
251. Id.
252. Id.
253. CDER (Center for Drug Evaluation and Research) 1998 Report to the Nation, at 28.
254. Id. at 29.
255. Id.
256. International Conference on Harmonization Draft Guidelines and Adopted Guidelines (last visited Aug. 6, 1999) 〈www.eudra.org/humandocs/humans/ICH.htm〉.
257. CDER 1998 Report to the Nation, supra note 239.
258. Id. at 29.
259. Horton, supra note 5, at 720.
260. Global Harmonization Taskforce (last visited Aug. 2, 1999) 〈www.ghtf.org/general/prevsgl/ brussels0399.html〉 (site no longer active, hard copy of text on file with the author).
261. Proposed Memorandum of Understanding Between ISO/TC 210 and the Global Harmonization Task Force [210N135], June 1999, (last visited Aug. 19, 1999) 〈www.ghtf.org/meeting/ghtf-iso-tc210.html〉 (site no longer active, hard copy of text on file with the author).
262. Id.
263. Henney, supra note 229.
264. Id.
265. Matthias Burger, Designing for a Global Regulatory Environment (last visited July 2, 1999) 〈www.raps.org/previous.cfm?artid=318〉 (must be member to access the information, however, hard copy of text is on file with the author). The International Organization for Standardization (ISO) was established in 1947 with the goal of developing common international standards in many different areas. ISO 9000 Translated into Plain English (last visited Aug. 1999) 〈www.connect.ab.ca/~praxiom/index.htm〉. ISO 9000 quality assurance and quality management standards apply to a variety of disciplines, including manufacturing, processing, healthcare, pharmaceuticals, and biotechnology. Id. Certification of a quality system under the ISO 9000 guidelines serves as notification that the system has met internationally recognized quality assurance and quality management standards. Id.
266. Matthias Burger, Designing for a Global Regulatory Environment (last visited July 2, 1999) 〈www.raps.org/previous.cfm?artid=318〉 (must be member to access the information, however, hard copy of text is on file with the author). The International Organization for Standardization (ISO) was established in 1947 with the goal of developing common international standards in many different areas. ISO 9000 Translated into Plain English (last visited Aug. 1999) 〈www.connect.ab.ca/~praxiom/index.htm〉. ISO 9000 quality assurance and quality management standards apply to a variety of disciplines, including manufacturing, processing, healthcare, pharmaceuticals, and biotechnology. Id. Certification of a quality system under the ISO 9000 guidelines serves as notification that the system has met internationally recognized quality assurance and quality management standards. Id.
267. Transatlantic Cooperation on Medical Devices: FDA and EU Steps Toward Implementing the MRA (United States-European Union Mutual Recognition Agreement) (last visited Aug. 19, 1999) 〈www.fda.gov/ cdrh/mra/impmra.html〉.
268. WHO, founded in 1948 as a specialized agency of the United Nations, "promotes technical cooperation for health among nations, carries out programs to control and eradicate diseases and strives to improve the quality of human life." About WHO: Rapid Overview (last visited Aug. 27, 1999) 〈www.who.org/aboutwho/ en/rapid.htm〉. WHO's four principal functions are to 1) provide worldwide guidance in the health field, 2) set global standards for health, 3) work with governments to strengthen national health programs, and 4) develop and transfer appropriate health information, technology and standards. Id.
269. The May 1991 WHO endorsement appears to be WHO's most recent action in the arena of international regulation of human tissue intended for transplantation. Human Organ Transplantation: A Report on Developments Under the Auspices of WHO (1987-1991), I. Guiding Principles on Human Organ Transplantations, 42 INT'L DIG. OF HEALTH LEGIS. 390 (1991).
270. Id. at 392-94.
271. INSIDE WASH.'S FDA WK., June 28, 1996, at 1. Tissue engineering produces biological substitutes generally consisting of living cells or tissues and biomaterials. Id. at 2.
272. Id.
273. Id. at 2.
274. Telephone and electronic mail interviews with Dr. Elaine Esber, FDA's Center for Biologics Evaluation (Aug. 12, 1999) and Michelle Hoyte, Director of International Regulatory Affairs, the American Red Cross (Aug. 1999).
275. While noncommercialization of the entire process of human tissue donation is the ideal, this author believes it is an unrealistic goal and suggests that limited commercialization, with standardized payments to processing companies, is a more feasible prospect.
276. As harmonization of human tissue regulation extends beyond therapeutic purposes, there must be particular attention given to ensure that the potential tissue use comports with a "common level of decency." Civilized society should not be subject to such macabre human tissue use as lampshades made of human skin, as during the horror of the Holocaust in World War II.
277. In light of these considerations, and the EU's strong inclination for the EMEA to conduct primary evaluation of human tissue products at some future date, the International Conference on Harmonization appears to be the appropriate body to spearhead harmonization efforts.
278. See Horton, supra note 5, at 724.
279. Human tissue medical devices in a nonprofit environment raises a number of issues, including: 1) how can technology be promoted if research and development companies are not allowed to realize profits on their products, and 2) how should tissue-engineered products be valued, when they reflect a highly processed, transformed product, not the original, unprocessed tissue? Additionally, should there be international patent protection? Who controls the rights to these tissues, and how can these rights be uniformly exercised (i.e., what type of enforcement mechanism should be in place in the case of violations)?