Treatment or crime? The status of stem cell therapies and research in South African law

Medicine and Law

Volumn 26, Issue 1, 2007, Pages 95-115

  Kirby, Neil ^a  

^a BALLBLLM ^*

Author keywords

Human Tissue Act (1983) S.A.; Informed consent; South Africa; Stems cells; Umbilical cord blood

Indexed keywords

ARTICLE; BIRTH; CORD BLOOD STEM CELL TRANSPLANTATION; ETHICAL DECISION MAKING; HEALTH CARE POLICY; INFORMED CONSENT; LAW; MEDICAL ETHICS; MEDICAL RESEARCH; MEDICOLEGAL ASPECT; PATIENT RIGHT; SOUTH AFRICA; UMBILICAL CORD BLOOD;

EID: 34247537931     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (70)

1. Advertising pamphlet for NetCell Therapeutics (Proprietary) Limited
2. A J Klotzke A Clone of Your Own? (2004) at page 79
3. Dr H Marcovitch (ed) Black's Medical Dictionary 41st ed
4. See Black's Medical Dictionary, quoted above.
5. P J Badenhorst, J M Pienaar, H Mostert Silberberg & Schoeman's: The Law of Property 4th ed
6. No. 65 of 1983
7. No. 63 of 2001
8. See Proclamation No. R19, dated 18 April 2005 published in Government Gazette No. 27503 dated 18 April 2005.
9. Section 14 of the Constitution
10. Ibid
11. Section 12(2) of the Constitution
12. See Washington University v Catalona, Case No. 4-03-CV010655NL and L Andrews "Who Owns Your Body? A Patient's Perspective on Washington University v Catalona" 34 Journal of Law, Medicine & Ethics 398 (2006) and S F Terry and P F Terry "A Consumer Perspective on Forensic DNA Banking" 34 Journal of Law, Medicine & Ethics 408 (2006).
13. 793 P.2d 479 (Cal. 1990), cert denied 499 US 936 (1991)
14. J A Bovenberg Property Rights in Blood, Genes & Data: Naturally Yours? (2006) at pages 123 to 126
15. See sections 6, 7, 8 and 9 of the National Health Act, quoted above.
16. See section 6(1)(a) of the National Health Act.
17. See section 6(1)(c) of the National Health Act.
18. See section 7(1) of the National Health Act.
19. Treatment, as contemplated in section 7 of the National Health Act, in circumstances of the severing of an umbilical cord, is not applicable to the treatment requiring informed consent. The term "health services" is defined in section 1 of the National Health Act to mean:
20. "(a) health care services, including reproductive health care and emergency medical treatment, contemplated in section 27 of the Constitution;
21. basic nutrition and basic health care services contemplated in section 28(1)(c) of the Constitution;
22. medical treatment contemplated in section 35(2)(d) of the Constitution; and
23. municipal health services."
24. However, see decision in C v Minister of Correctional Services 1996 (4) SA 292 (T)
25. and section 1.2.1.2 of M A Dada and D J McQuoid-Mason Introduction to Medico-Legal Practice (2001) at page 8
26. and Castell v De Greeff 1994 (4) SA 408 (C) at 425.
27. The term is defined to mean "human blood".
28. The term is defined to mean "any product derived or produced from blood".
29. See section 18 of the Human Tissue Act.
30. See sections 19(a) to (c) of the Human Tissue Act.
31. See section 19(a) of the Human Tissue Act.
32. See section 19(b) of the Human Tissue Act.
33. See section 20 of the Human Tissue Act read together with sections 23 and Chapter 3 of the Human Tissue Act.
34. See section 18(b)(ii) of the Human Tissue Act as read together with sections 23 and Chapter 3 of the Human Tissue Act.
35. L Altenroxel "State, scientists set to clash over stem cells" The Star 30 April 2002
36. D Caelers "Stem cells are 'the future'" Cape Argus 29 May 2002,
37. "Hu-mice have human embryonic stem-cells" Business Day 24 June 2003
38. "Stem cells used to culture form of sperm" Citizen 11 December 2003
39. "Stem cells are the new waive in a child's life assurance" This Day 23 February 2004,
40. "Stem cells lift weak hearts" Citizen 25 August 2005
41. "Sister's stem cells aid her brother's fight against leukaemia" Cape Times 9 November 2004
42. "South Africans harvesting their newborns' stem cells" Natal Witness 10 September 2005
43. "Foreign firm keen to try stem cells on AIDS patients" Cape Times 17 December 2001
44. No. 101 of 1965, as amended
45. Section 1 of Act No. 101 of 1965, as amended
46. This examination is required in light of the objects of the Medicines Act. These objects were set out in Administrator, Cape v Raaths Röntgen & Vermeulen (Proprietary) Limited 1992 (1) SA 245 (A)
47. Mistry v Interim Medical and Dental Council of South Africa 1998 (7) BCLR 880 (CC)
48. and in Reitzer Pharmaceuticals (Proprietary) Limited v Registrar of Medicines, quoted below, and "that the Minister of Health and the Registrar of Medicines were public authorities charged with the duty of promoting and protecting the public interest, through the mechanisms of (the Medicines] Act. It was both necessary and desirable that the public interest should be protected by the regulation and control of medicines. In addition, the respondents were 'not only charged to protect the public against the use of unsafe or harmful substances, but also to protect the public against in effect substances of which the quality is not properly controlled'." in N Nadasen Public Health Law in South Africa (2000) at page 54.
49. See section sections 14 and 19 of the Medicines Act.
50. Also see the decision in Reitzer Pharmaceuticals (Proprietary) Limited v Registrar of Medicines & Another 1998 (4) SA 660 (T).
51. The definition of "biologic" in the Merriam Webster Dictionary is "a substance used as a medication or in the preparation of medication... according to the Food, Drug and Cosmetic Act (1): a substance recognized in an official pharmacopoeia or formulary (2): a substance intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease (3): a substance other than food intended to affect the structure or function of the body (4(): a substance intended for use as a component of a medicine but not a device or a component, part, or accessory of a device."
52. As is the case in terms of Federal Regulations in the USA, more particularly, Title 42 of the United States Code, more particularly, sections 262(i) and section 262(a)(iii) and Title 21, Code of Federal Regulations, section 601.21, read together with Title 21 USC: sections 321(g), 321G1(B)(C), 331(a), 352(f)(1) and Title 42 USC: at section 262(a). Also see the following: The brief of Amici Curiae in Genentec Incorporated and Biogen Idec Incorporated in support of the petitioner in the matter of Merck KGAA v Intergrow Life Sciences I, Limited and the Burnam Institute, Supreme Court of the United States Case No. 03-1237 dated 22 February 2005, at page 7, at which it is stated that "biologics are fundamentally different from traditional chemically-synthesized drugs, sometimes known as 'small molecule drugs'. The active ingredient of a biologic usually is a large, complex molecule derived from a living organism, a biologic, typically a protein, can be a chain of hundreds of amino acids with complex three-dimensional structures. As the FDA has explained, biologics are 'complex mixtures of molecular species that [are] difficult to characterise as individual entities. In some cases, the specific active moiety could not be identified, or the active moiety is existed in the milieu of other components that had the potential to affect many of its characteristics'."
53. See section 12 of the Guidelines for Registration of Medicines in South Africa published by the Medicines Control Council on 29 April 2003 read together with Regulation 42 of the General Regulations promulgated in terms of the Health Act No. 63 of 1977, as amended, and Volume 21, first re-issue, at paragraph 402, of the Law of South Africa.
54. See Moore's case, quoted above
55. See Moore's case, quoted above
56. Bovenberg, quoted above, at page 194
57. A reference to "prescribed", is a reference to regulations to be promulgated in terms of Chapter 8 of the National Health Act.
58. "Progenitor cells that can produce more than one type of mature cell. An example is the myeloid progenitor cell which can give rise to mature blood cells, including blood, granulocytes, monocytes, red blood cells, platelets, basophiles, eosinophiles and dendritic, but not T lymphocytes, or natural killer cells."
59. "Hematopoietic stem cells are present in the blood of the umbilical cord during and shortly after delivery. These stem cells are in the blood at the time of delivery, because they move from the liver, where blood formation takes place during foetal life, to the bone marrow, where blood is made after birth. Umbilical cord stem cells are similar to stem cells that reside in bone marrow, and can be used for the treatment of leukaemia, and other diseases of the blood. Efforts are now being undertaken to collect these cells and store them in freezers for later use. However, one problem is that there may not be enough umbilical cord stem cells in any one sample to transplant into an adult."
60. "Stem cells found in different tissues of the developed, adult organism that remain in an undifferentiated, or unspecialised, state. These stem cells can give rise to specialised cell types of the tissue from which they came, i.e.: a heart stem cell can give rise to a functional muscle cell but it is still unclear whether they can give rise to all different cell types of the body."
61. "Stem cells that can become all the cell types that are found in an implanted embryo, foetus, or developed organism, but not embryonic components of the trophoblast and placenta (these are usually called extra-embryonic)."
62. "Stem cells that can give rise to all cell types that are found in an embryo, foetus, or developed organism, including the embryonic components of trophoblast and placenta required to support development in birth. The zygote and the cells at the very early stages following fertilization (ie the two-cell stage) are considered totally potent."
63. "Stem cells whose progeny are of multiple differentiated cell types, but all within a particular tissue, organ or physiological system. For example, blood-forming (hematopoietic) stem cells are single multi potent cells but can produce all cell types that are normal components of the blood."
64. Stem cells that self-renew as well as give rise to a single mature cell type; eg, spermatogenic stem cells."
65. "The precursors of mature blood cells that are defined by their ability to replace the bone marrow system following its obliteration (for example by g-irradiation) and can continue to produce mature blood cells."
66. "Also known as bone marrow stromal cells, mesenchymal stem cells are rare cells, mainly found in the bone marrow, that can give rise to a large number of tissue types such as bone, cartilage (the lining of joints), fat tissue, and connective tissue (tissue that is between organs and structures in the body)."
67. "A type of stem cell that resides in the brain, which can make new nerve cells (called neurons) and other cells that support nerve cells (called glia). In the adult, neural stem cells can be found in very specific and very small areas of the brain where replacement of nerve cells is seen."
68. The definition of "tissue", in section 1 of the National Health Act, is identical to the definition of "tissue" in section 1 of the Human Tissue Act quoted above.
69. See the Guidelines for Good Practice in Medicine, Dentistry and the Medical Sciences (Booklet 14): Confidentiality: Protecting and Providing Information, as published in July 2002 by the Health Professions Council of South Africa
70. See sections 14, 15 and 16 of the National Health Act