On-line version ISSN 1609-073X
Afr. hum. rights law j. vol.9 n.2 Pretoria 2009
Associate Professor, Faculty of Law, University of Pretoria, South Africa
The article investigates the protection by the African regional human rights system of participants in HIV-related human experimentation. It assesses the scope of the protection afforded by the system, and draws upon the jurisprudence of the African Commission on Human and Peoples' Rights in the communication of Zimbabwe Human Rights NGO Forum v Zimbabwe in order to argue that a failure on the part of African states to act to prevent the abuse of research participants will render those states liable for a finding by the African Commission of a violation of their obligations under regional human rights law.
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* BA (Hons) (Witwatersrand), LLB LLM LLD (Pretoria); email@example.com
1 See eg A Nienaber 'The utility of international human rights law on informed consent in the protection of clinical research participants in Africa: "The road less travelled"' (2007) 2 SA Public Law 422 (Nienaber (A)); [ Links ] A Nienaber 'The protection of participants in clinical research in Africa: Does domestic human rights law have a role to play?' (2008) 8 African Human Rights Law journal 138 (Nienaber (B)); [ Links ] and AG Nienaber 'Ethics and human rights in HIV-related clinical trials in Africa with specific reference to informed consent in preventative HIV vaccine efficacy trials in South Africa' unpublished LLD thesis, University of Pretoria, 2007 (Nienaber (C)). [ Links ]
2 Traditionally, international and domestic clinical research ethics or bioethics documents are relied upon to protect the interests of participants in clinical research. One such document is the Declaration of Helsinki, issued by the World Medical Association (WMA), and is an international code of ethics overseeing biomedical research involving human participants. It was adopted by the WMA's 18th Assembly, held in Helsinki, Finland, in 1964, and has been revised several times, most recently in October 2000. Clinical research ethics or bioethics is criticised for not adequately protecting the interests of research participants - they are non-binding guidelines which cannot be enforced effectively other than by professional sanction and a refusal to publish research which is considered to be in violation of the guidelines - see the sources quoted in n 1 above.
3 Zimbabwe Human Rights NGO Forum v Zimbabwe (2006) AHRLR 128 (ACHPR 2006).
4 See Nienaber (B) (n 1 above) for an examination of the role of domestic human rights law in the protection of participants in human experimentation in Africa.
5 OAU Doc OAU/CAB/LEG/67/3/Rev 5.
6 OAU Doc CAB/LEG/153/Rev 2.
7 AHG/Res.240 (XXXI).
8 The Universal or UN system is not discussed here. In this regard, see Nienaber (A) (n 1 above).
9 The [United Nations] Convention on the Rights of the Child (CRC), adopted in November 1989, years after the first HIV cases were reported, makes no mention of HIV/AIDS. See generally in this regard S Gumedze 'HIV/AIDS and human rights: The role of the African Commission on Human and Peoples' Rights' (2004) 4 African Human Rights Law Journal 181.
10 Art 4 African Charter.
11 Art 5 African Charter.
12 See eg the sources referred to in n 14 and n 51 below.
13 No person is treated with dignity if that person is not respected as an individual capable of making his or her own decisions. The right to dignity, therefore, implies autonomy, and the right not to be subjected to clinical research without having given informed consent.
14 For a discussion of the events in Kano, see eg WHO (19 February 1996) Disease Outbreak News http://www.who.int/disease-outbreak-news/n1996/feb/n19feb1996c.html (accessed 31 January 2008); DM Carr 'Pfizer's Trovan trials in Nigeria' (2003) 35 Case Western Reserve journal of International Law 15; J Ford & J Tomossy 'Clinical trials in developing countries: The claimant's challenge' (2004) 1 Law, Social justice and Global Development 4; and see S Bosely 'New drug "illegally tested on children": Pfizer accused of irregularities during clinical trial in Nigeria' The Guardian 17 January 2001 19. Parents of the children participating complained that they did not know that the drug that was being given to their children was experimental.
15 See sources referred to in n 14 above.
16 The control group was given the antibiotic Ceftriaxone, a drug already approved for use with children in the United States, and which drug was the existing proven treatment for the illness. During a clinical trial of this nature, the experimental drug (Trovan) is compared to the existing treatment (Ceftriaxone) to see whether the experimental drug is as effective or more effective in treating the disease. However, because they were short-staffed, Pfizer researchers injected Ceftriaxone into the children's buttocks, rather than administering it intravenously. More importantly, they administered only one-third of the regular dose of Ceftriaxone to the children; see F Kelleher 'The pharmaceutical industry's responsibility for protecting human subjects of clinical trials in developing nations' (2004) 38 Columbia journal of Law and Social Problems 68 fn 1.
17 Art 2 African Charter.
18 Art 3 African Charter.
19 Art 2 African Charter.
20 Art 16(1) African Charter.
21 Art 16(2) African Charter.
22 According to art 45(4) of the African Charter, it must also perform any other tasks 'which may be entrusted to it by the Assembly of Heads of State and Government'. See also Gumedze (n 9 above).
23 Arts 30 & 45(1) African Charter.
24 Arts 30 & 45(2) African Charter; see paras 3 & 4 below.
25 Art 45(3) African Charter.
26 Purohit & Another v The Gambia (2003) AHRLR 96 (ACHPR 2003) para 80. The case was brought in regard to the legal and material conditions of detention in a Gambian mental health institution.
27 As above.
28 Para 84.
29 Para 84 (my emphasis).
30 See R Macklin Double standards in medical research in developing countries (2004).
31 This is an example of 'soft' law.
32 Adopted by the African Commission following the appointment of the Working Group on the Right to a Fair Trial per its 1999 Resolution on the Right to a Fair Trial and Legal Assistance. Reprinted in C Heyns & M Killander (eds) Compendium of key human rights documents of the African Union (2007) 288.
33 Issued by the First OAU Ministerial Conference on Human Rights, which held a meeting from 12-16 April 1999 in Grand Bay, Mauritius.
34 Para 7 Grand Bay (Mauritius) Declaration.
35 See paras 3 & 4 below.
36 http:/www.onusida-acoc.org/Eng/Abuja%20declaration.htm (accessed 31 January 2008).
37 Para 12 Abuja Declaration.
38 AHG/Res 254 (XXXII) 1996.
39 Para 1 African Bioethics Resolution.
40 Para 2 African Bioethics Resolution.
41 Para 3 African Bioethics Resolution.
42 As above.
43 As above.
44 As above.
45 Para 21(g) Guidelines for Initial Reports of State Parties under the African Charter on Rights and Welfare of the Child.
46 Art 14(1) African Children's Charter.
47 As above.
48 Arts 14(2)(a)-(j) African Children's Charter.
49 They have the further task of ensuring the development of preventive health care and family life education and provision of service, the integration of basic health service programmes in national development plans; that all sectors of the society, in particular parents, children, community leaders and community workers, are informed and supported in the use of basic knowledge of child health and nutrition, the advantages of breastfeeding, hygiene and environmental sanitation and the prevention of domestic and other accidents; the meaningful participation of non-governmental organisations, local communities and the beneficiary population in the planning and management of basic service programmes for children; and to support, through technical and financial means, the mobilisation of local community resources in the development of primary health care for children.
50 Art 14(1) African Children's Charter.
51 In the 1950s, an experiment at Willowbrook State School, in which researchers injected the Hepatitis B virus into mentally-retarded children in order to study the natural progression of the disease, aroused public concern. Participants were fed extracts from the stools of infected children, and participants who were 'enrolled' in the trial at an earlier point in time, and who were already ill, received injections of 'purified' virus. The parents of children were only able to have their children admitted to hospital upon their agreeing to the children being part of the research. In this regard, see RJ Levine Ethics and regulation of clinical research (1986) 70-72.
52 See para 2.1 above & n 14 above.
53 Art 15(2).
54 See paras 3 & 4 below.
55 The article reads: '1. State parties to the present Charter shall take all appropriate measures to eliminate harmful social and cultural practices affecting the welfare, dignity, normal growth and development of the child and in particular: (a) those customs and practices prejudicial to the health or life of the child; and (b) those customs and practices discriminatory to the child on the grounds of sex or other status. 2. Child marriage and the betrothal of girls and boys shall be prohibited and effective action, including legislation, shall be taken to specify the minimum age of marriage to be eighteen years and make registration of all marriages in an official registry compulsory.'
56 Viljoen points out that the use of 'the primary consideration' (instead of 'a primary consideration', as used in CRC) sets a higher level of protection for children under the African Children's Charter than under CRC. See F Viljoen 'Africa's contribution to the development of international human rights and humanitarian law' (2001) 1 African Human Rights Law Journal 18.
57 'Non-therapeutic' research aims to benefit people other than the research participant. Such research is aimed at the acquisition of knowledge, and as such may be of no immediate benefit to the participant. 'Therapeutic research' is undertaken to benefit the individual research participant or patient by treating or curing their condition. Therapeutic HIV-related research, eg, is research to develop an effective anti-retroviral agent against HIV infection. Importantly, participants in therapeutic HIV-related research will be living with HIV/AIDS, whereas participants in non-therapeutic HIV-related research will be HIV negative.
58 Art 31(b).
59 AHG/Decl 1 (XXX) 1994.
60 Para 2(1) Tunis Declaration.
61 As evidenced by the fact that at the 32nd ordinary session of the Assembly of Heads of State and Government in 1996, the Resolution on Regular Reporting of the Implementation Status of OAU Declarations on HIV/AIDS in Africa was adopted. Governments were urged to implement resolutions and declarations of the OAU, especially the Tunis Declaration.
62 Art 2(1) African Women's Protocol.
63 Art 2(2) African Women's Protocol.
64 The African Women's Protocol came into effect in November 2005.
65 A violation of the requirement of informed consent for participation in clinical research is thus seen as a violation of ethical guidelines, instead of a violation of a human rights treaty.
66 Art 14(1)(d) African Women's Protocol.
67 Art 14(1)(e) African Women's Protocol.
68 Art 14(2)(a) African Women's Protocol.
69 Art 14(2)(b) African Women's Protocol.
70 (2000) AHRLR 66 (ACHPR 1995).
71 n 70 above, para 22.
72 Zimbabwe Human Rights NGO Forum v Zimbabwe (n 3 above) para 3.
73 n 3 above, paras 4- 5.
74 n 3 above, para 4.
75 n 3 above, para 8.
76 n 3 above, paras 10-11.
77 n 3 above, para 14.
78 As above.
79 As above.
80 Clemency Order 1 of 2000; as above.
81 Para 142.
82 Para 143.
83 The Inter-American Court of Human Rights, in looking at the obligations of the state of Honduras under the Inter-American Convention on Human Rights, first articulated this standard - Velásquez Rodriguez v Honduras (Ser C) No 4 (1988) 28 ILM (1989) ser C, No 4; Human Rights Law Journal 212.
84 n 3 above, para 143.
85 Velásquez Rodriguez v Honduras (n 83 above) para 176, quoted by the African Commission in Zimbabwe Human Rights NCO Forum v Zimbabwe (n 3 above) para 144.
86 Zimbabwe Human Rights NCO Forum v Zimbabwe (n 3 above) para 144.
87 As above.
88 In n 3 above, para 145, the Commission is quoting from Velásquez Rodriguez v Honduras (n 83 above) para 172.
89Zimbabwe Human Rights NCO Forum v Zimbabwe (n 3 above) para 146.
90 Para 147.
91 As above. Also see the jurisprudence of the African Commission in Social and Economic Rights Action Centre (SERAC) & Another v Nigeria (2001) AHRLR 60 (ACHPR 2001) and Free Legal Assistance Croup & Others v Zaire (2000) AHRLR 74 (ACHPR 1995).
92 Para 152. In this regard, also see, eg, P Alston (ed) Non-state actors and human rights (2005) 3-36 37-89; A Clapham Human rights obligations of non-state actors (2006) 25-83; and PT Muchlinski 'Human rights and multi-nationals: Is there a problem?' (2001) 77 International Affairs 31.
93 J Ford & G Tomossy (n 14 above) 3.
94 As above; eg Malawi, Tanzania and Zambia lack legally-binding informed consent procedures (see BM Meier ''International protection of persons undergoing medical experimentation: Protecting the right of informed consent' (2002) 20 Berkeley Journal of International Law 533 fn 124).
95 Kelleher writes: 'Because their impoverished governments would otherwise be unable to provide medical treatment to their citizens, host countries - African nations in particular - have no legislative protection for subjects of clinical trials. Researchers in such countries, faced with dire medical conditions, understaffed hospitals, language and cultural barriers, and research subjects who would otherwise have no access to medical treatment, thus find it expedient to violate the minimum ethical standards for the protection of human subjects' (Kelleher (n 16 above) 67).
96 Meier (n 94 above) 532.
97 Meier (n 94 above) 533.
98 In this regard, see Nienaber (C) (n 1 above) 168-177. This is true also in the case of Zimbabwe. Apart from non-binding international ethical guidelines governing clinical research relied upon by local university research ethics committees, there exists no binding regulatory framework governing clinical research in Zimbabwe. The development, importation and registration of drugs are governed by the Medicines and Allied Substances Control Act of 1997 (ch 15:03), which also established the Medicines Control Agency of Zimbabwe. However, the Act does not regulate the way in which clinical research is conducted in Zimbabwe. Clinical research participants have to rely on national tort and criminal law to institute claims for research-related injuries. See S Ratanawijitrasin & E Wondemagegnehu Effective drug regulation: A multicountry study (2002) 36.
99 Zimbabwe Human Rights NCO Forum v Zimbabwe (n 3 above) para 152 (my emphasis).
100 The consent requirement in the African Women's Protocol.
101 Clapham (n 92 above) 1 - 3. See also sources referred to in n 92 above.
102 Nowak points out that many of these multinational corporations are more powerful and financially stronger than many states. On that ground, it seems to him 'somewhat anachronistic that states should remain the only subjects of international law capable of signing and ratifying treaties under international law' (see M Nowak Introducing the international human rights regime (2003) 343).
103 See generally Clapham (n 92 above).