Banning private stem cell banks: A human rights analysis

South African Journal on Human Rights

Volumn 25, Issue 1, 2009, Pages 126-151

  Jordaan, Donrich W ^a,b   Woodrow, Christopher ^b   Pepper, Michael S ^a,c  

^a UNIVERSITY OF PRETORIA   (South Africa)

^b High Court of South Africa ^*  (South Africa)

^c UNIVERSITY OF GENEVA   (Switzerland)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 84864981057     PISSN: 02587203     EISSN: 19962126     Source Type: Journal    
DOI: 10.1080/19962126.2009.11865195     Document Type: Article

References (124)

1. This is a Persian proverb, recently employed in the context of the Iranian nuclear problem by Ali Larijani, Iran's top nuclear negotiator. 'US "Digs Its Own Hole". Interview with Ali Larijani' Newsweek (2 July 2007) 19.
2. GJ Annas 'Waste and longing - the legal status of placental-blood banking' (1999) 340 N Engl J Med 1521.
3. M Zilberstein, M Feingold & MM Seibel 'Umbilical-cord-blood banking: lessons learned from gamete donation' (1997) 349 Lancet 642
4. GR Burgio, E Gluckman & F Locatelli 'Ethical reappraisal of 15 years of cord-blood transplantation' (2003) 361 Lancet 250.
5. JL Ecker & ME Greene 'The case against private umbilical cord blood banking' (2005) 105 Obstet Gynaecol 1282
6. J Gunning Umbilical Cord Cell Banking: A Surprisingly Controversial issue (2004),
7. FL Johnson 'Placental blood transplantation and autologous banking - caveat emptor' (1997) 19 J Pediatr Hematol Onco 183.
8. Government Gazette (4 May 2007).
9. The reason why the draft Regulations constitute an effective ban is set out below in part IV 'Private stem cell banks and the draft Regulations'.
10. See for instance Annas (note 2 above)
11. N Kirby 'Treatment or crime? The status of stem cell therapies and research in South African law' (2007) 26 Med Law 95
12. C Witte 'Cord blood storage: property and liability issues' (2005) 26 J of Legal Medicine 275
13. T McIntire 'Legal issues of stem cell transplantation and the family' (2002) 32 Univ of Memphis LR 3
14. JD Munzer & FO Smith 'Limited property rights in umbilical cord blood for transplantation and research' (2001) 23 J Pediatr Hematol Oncol 203.
15. Regulations regarding the use of human DNA, RNA, cultured cells, stem cells, blastomeres, polar bodies, embryos, embryonic tissue and small tissue biopsies for diagnostic testing, health research and therapeutics were published for public comment in the Government Gazette (5 January 2007). From one perspective there seems to be support for the fact that such umbilical cord blood and stem cells belong to the child, since they contain the DNA of the baby and not the mother; from another perspective this may belong to the mother, as the placenta is seen as part of the mother's body. Regulations 9(c) and 10(c) provide that the ownership of umbilical cord blood and the stem cells derived from umbilical cord blood vest in the parents. The Regulations appear therefore to create parental co-ownership. Ambiguous situations may result from situations in which children are born from rape, for example, or in which the father cannot be identified. This is an area that needs further deliberation.
16. PJ Gokhale & PW Andrews 'Human embryonic stem cells: 10 years on' (2009) 89 Lab Invest 259.
17. N Siva 'US stem cell climate improves raising concerns elsewhere' (2009) 15 Nature Med 224.
18. MR Alison & S Islam 'Attributes of adult stem cells' (2009) 217 J Pathol 144.
19. J Kurtzberg 'Update on umbilical cord blood transplantation' (2009) 21 Curr Opin Pediatr 22.
20. RK Burt, Y Loh, W Pearce et al 'Clinical applications of blood-derived and marrow-derived stem cells for nonmalignant diseases' (2008) 299 J Am Med Assoc 925.
21. VFM Segers & TL Lee 'Stem-cell therapy for cardiac disease' (2008) 451 Nature 937.
22. MC Pasquini, BR Logan, F Verter, MM Horowitz & JJ Nietfeld 'The likelihood of hematopoietic stem cell transplantation (HCT) in the United States: implications for umbilical cord blood storage' (2005) 106 Blood 1330.
23. Johnson (note 2 above).
24. Phase I non-randomised study in progress at Duke University (NCT00593242), .
25. MJ Sullivan 'Banking on cord blood stem cells' (2008) 8 Nature Rev Cancer 555
26. MJ Sullivan 'Banking on cord blood stem cells' (2008) 8 Nature Rev Cancer 823 (author reply).
27. JJ Nietfeld 'Opinions regarding cord blood use need an update' (2008) 8 Nature Rev Cancer 823
28. DT Harris 'Cord blood stem cells: worth the investment' (2008) 8 Nature Rev Cancer 823.
29. N Maherali & K Hochedlinger 'Guidelines and techniques for the generation of induced pluripotent stem cells' (2008) 3 Cell Stem 595.
30. P Martin, N Brown & A Turner 'Capitalizing hope: the commercial development of umbilical cord blood stem cell banking' (2008) 27 New Genetics and Society 127, 138
31. see also .
32. Ibid 138.
33. Ibid 136.
34. Ibid 140.
35. Royal Decree 1301/2006 (Spain), .
36. See also G Garrido 'Debate: is there a place for autologous cord blood banking?' Webcast from the International Conference on Biology and Clinical Applications of Cord Blood Cells online curriculum on Cord Blood Technology & European School of Haematology (EUROCOR-ED & ESH), .
37. .
38. Martin et al (note 23 above) 141.
39. Cf European Group on Ethics in Science and New Technologies Ethical aspects of umbilical cord blood banking Opinion No 19 to the European Commission (2004), .
40. Martin S. et al (note 24 above) 130.
41. Statement by the Do H National Health Act proclaimed by the President (19 April 2005), .
42. Section 56(2)(a)(iv) presents an ambiguity that can be grounds for an argument that s 56 is not applicable to stem cell banks: Withdrawal of 'stem cells and umbilical cord' requires authorisation, but removal of 'umbilical cord progenitor cells' does not. The latter are in fact cord blood-derived stem cells. The wording of this s 56(2)(a)(iv) should thus be clarified through amendment. Also see note 84 below.
43. It is common practice in South Africa for the stem cell bank to contract the doctor present at the birth to perform the withdrawal for a fee. This raises the question of whether every independent doctor who withdraws umbilical cord blood for stem cell banking would need ministerial authorisation.
44. The conditions for the use of stem cells per reg 2(1) are unclear and confusing, and evidently impractical - a few examples will suffice: the labelling of stem cells is made conditional upon the prior testing of these stem cells for certain infectious agents and genetic diseases. How will stem cell units be identified prior to such testing if they cannot be labelled? In an apparent circular reference the very testing of stem cells (per reg 2(1)(b)) is made conditional upon the testing of these stem cells for certain infectious agents and genetic diseases (per reg 2(1)(c)(ii)). Regulation 2(1)(c)(ii) requires that each stem cell must be tested prior to storage, distribution, etc. It is clearly impractical and unnecessary to test each stem cell in a typical cord blood unit. The conditions for the use of stem cells are in clear need of complete reconceptualisation and reformulation to save them from being void for vagueness.
45. The conditions contained in reg 2(1)(d)(iii) and (iv) regarding written informed consent and voluntariness both refer to the 'donors' of stem cells, hence rendering them not applicable to private stem cell banks, since stem cells are not donated to private stem cell banks.
46. D Schaub, S Marrs, D Thompson, MS Pepper & DW Jordaan (comps) Report: Bioethics Forum on Stem Cell Banking, held at the Innovation Hub, Pretoria, on 15 June 2007 (2007) 7, .
47. The Regulations define 'storage' as follows: 'storage' means maintaining the product under appropriate controlled conditions until distributed.
48. See ss 60(4) and (5).
49. R v Milne and Erleigh (7) 1951 (1) SA 791 (A) 823
50. R v Sachs 1953 (1) SA 392 (A) 399
51. R v Sisilane 1959 (2) SA 448 (A) 454
52. S v Fazzie 1964 (4) SA 673 (A) 680
53. S v Stessen 1965 (4) SA 131 (T) 134
54. SA Breweries Ltd v Food and Allied Workers Union 1990 (1) SA 92 (A) 97, 100
55. S v Martinez 1991 (4) SA 741 (Nm) 752-753
56. Hira v Booysen 1992 (4) SA 69 (A) 78, 81, 83.
57. Workshop on the draft Regulations relating to human stem cells, organised by the DoH, Pretoria (3 October 2007).
58. .
59. The proportion of families in Spain that chooses to bank their newborn's stem cells is 12 per cent. (M Kirwin 'Stem cell collection: The banking crisis' The Independent (Ireland) (6 April 2009), .)
60. See our calculations in VII(b) 'The diversion-of-resources argument' below.
61. Cryo-Save Group NV Acquisition of leading Spanish distributor press release (8 July 2008), .
62. Section 27(1).
63. Ex parte Chairperson of the Constitutional Assembly: in re Certification of the Constitution of the Republic of South Africa 1996 1996 (4) SA 744 (CC) para 78.
64. Section 27(2) of the Constitution.
65. Cf Soobramoney v Minister of Health (KwaZulu-Natal) 1998 (1) SA 765 (CC).
66. Jaftha v Schoeman 2005 (2) SA 140 (CC) paras 31, 33.
67. Cf Residents of Bon Vista Mansions v Southern Metropolitan Local Council 2002 (6) BCLR 625 (W).
68. The State's positive duty will be considered in VII(b) 'The diversion-of-resources argument' below.
69. The umbilical cord blood is referred to as the newborn's in the genetic sense, not necessarily the legal sense. Legal ownership of umbilical cord blood is a separate issue that we will not address in this article.
70. Refer to the discussion of the current use of stem cells in II(c) 'The likelihood of using stem cells' above.
71. Section 12(2).
72. I Currie & J de Waal The Human Rights Handbook 5 ed (2005) 308.
73. M Bishop & S Woolman 'Freedom and Security of the Person' in S Woolman & T Roux (eds) Constitutional Law of South Africa 2 ed (2002) 40.
74. Cf Castell v De Greef 1994 (4) SA 408 (C).
75. Section 28(1).
76. Minister of Welfare and Population Development v Fitzpatrick 2000 (3) SA 422 (CC) 428 para 17.
77. Section 28(2).
78. Section 28(3).
79. Section 6(1)(b).
80. Refer to the discussion of the current use of stem cells in II(c) 'The likelihood of using stem cells' above.
81. Cf Minister of Health v Treatment Action Campaign 2002 (5) SA 721 (CC).
82. This is in contrast with the broader formulation of the right's predecessor, s 26(1) of the interim Constitution, which provided that 'every person shall have the right to freely engage in economic activity and pursue a livelihood anywhere in the national territory'. There is clearly a difference in the wording of the current s 22 and its predecessor, from which it is clear that the current right is narrower in scope, inter alia as it only pertains to citizens of the Republic of South Africa.
83. JR 1013 Investments v Minister of Safety and Security 1997 (7) BCLR 925 (E)
84. City of Cape Town v Ad Outpost 2000 (2) SA 733 (C) at 747F
85. First National Bank of SA t/a Wesbank v Commissioner for the South African Revenue Service 2001 (3) SA 310 (C).
86. Note 57 above, 489-90.
87. Black v Law Society of Alberta [1989] 1 SCR 591.
88. Becket (TW) & Co v H Kroomer 1912 AD 324, 334
89. see however Dadoo v Krugersdorp Municipal Council 1920 AD 530.
90. Ferreira v Levin NO 1996 (1) SA 984 (CC).
91. Affordable Medicines Trust v Minister of Health 2006 (3) SA 247 (CC) 274.
92. Section 36 of the Constitution.
93. .
94. Royal College of Obstetricians and Gynaecologists, Scientific Advisory Committee Umbilical Cord Banking, Opinion Paper 2 (2006), .
95. LC Edozien 'Commercial banking of umbilical cord blood NHS maternity units should not encourage' (2006) 333 BMJ 801.
96. Donatio in Roman and Roman-Dutch law (Grotius, 3. 2. 1; Van Leeuwen, lib. iv. cap. xxx; Voet, 39.5.1.) as still applicable in contemporary South African law.
97. Cf Castell v De Greef (note 59 above)
98. D Welz 'The boundaries of medical-therapeutic privilege' (1999) SALJ 299
99. FFW Van Oosten 'Informed consent: patient rights and the doctor's duty of disclosure in South Africa' (1989) M&L 443
100. FFW Van Oosten 'The so-called "therapeutic privilege" or "contra-indication": Its nature and role in non-disclosure cases' (1991) M&L 31
101. FFW Van Oosten 'Castell v De Greef and the doctrine of informed consent: Medical paternalism ousted in favour of patient autonomy' (1995) De Jure 164.
102. Adopted by acclamation on 19 October 2005 by the 33rd session of the General Conference of UNESCO.
103. Article 6(a).
104. Section 6 specifies that 'health care providers' must inform the users of health services of, inter alia, the benefits, risks, costs and consequences of the treatment options. A 'health care provider' is defined by s 1 of the Act as a person providing health services 'in terms of any law', such as the Health Professions Act. Although a gynaecologist (who may discuss the matter of stem cell banking with a patient independent of a stem cell bank) is thus clearly a 'health care provider', it is debatable whether a stem cell bank qua legal person would qualify as such and therefore be subject to the provisions of s 6. It can be argued that a stem cell bank is indeed a person providing health services 'in terms of any law' - the relevant law being the National Health Act itself - and that a stem cell bank would therefore qualify as a health care provider. It can, however, be counter-argued that it is questionable whether it is the intention that a definition in the National Health Act referring to 'any law' would include the Act itself. This uncertainty can be addressed by an amendment of the Act.
105. These suggested regulations are amongst recommendations made by MS Cairo, J Kurtzberg, BH Lubin & WT Shearer 'Cord blood banking for potential future transplantation' (2007) 119 Pediatrics 165.
106. These guidelines as to what constitutes adequate information are amongst recommendations made by European Group on Ethics in Science and New Technologies (note 31 above).
107. These guidelines as to what constitutes adequate information are amongst recommendations made by E Salvaterra, L Lecchi, S Gobbi & P Rebulla 'The ethics of cord blood banking in light of ownership, informed consent, and solidarity' (2006) 4 Cell Preservation Technology 91.
108. Drawing the line at labour and also requiring post-delivery confirmation are recommendations made by American Academy of Pediatrics Working Group on Cord Blood Banking 'Cord blood banking for potential future transplantation' (1999) 104 Pediatrics 116.
109. J Sugarman, V Kaalud, E Kodish et al 'Ethical issues in umbilical cord blood banking' (1997) 278 JAMA 938.
110. Cf KJ Moise Jr 'Umbilical cord stem cells' (2005) 106 Obstet Gynecol 1393.
111. Section 36(1)(e) of the Constitution.
112. C Waldby 'Umbilical cord blood: from social gift to venture capital' (2006) 1 BioSocieties 55.
113. .
114. CV Fernandez, K Gordon, M van den Hof et al 'Knowledge and attitudes of pregnant women with regard to collection, testing and banking of cord blood stem cells' (2003) 168 CMAJ 695.
115. Section 36(1)(d) of the Constitution.
116. Section 36(1)(e) of the Constitution.
117. Section 27(2).
118. MS Pepper A model for the co-existence of public and private stem cell bank CIPS e-brief series no 44/2007 (31 July 2007).
119. Department of Health, South Africa Strategic Priorities for the National Health System, 2004-2009 (2004).
120. Minister of Home Affairs v Fourie (CCT 60/04) [2005] ZACC 19
121. 2006 (3) BCLR 355 (CC) para 149.
122. Although generally sceptical about private stem cell banking, the European Group on Ethics in Science and New Technologies has come to the conclusion that a strict ban would represent an undue restriction on the freedoms of enterprise and choice of individuals.
123. See European Group on Ethics in Science and New Technologies (note 31 above).
124. SASOG Policy Statement on Umbilical Cord Blood Banking, .