Drug-Testing on Seropositive Pregnant Women in the Developing World: Moral and Legal Implications

See AIDS Epidemic Update: December 1999, (1999), Geneva: UNAIDS/WHO, p. 4. HIV stands for the Human Immunodeficiency Virus; and AIDS stands for the Acquired Immune Deficiency Virus. UNAIDS is a joint cosponsored programme which was set up in 1995 to focus and strengthen the response of the United Nations agencies most active in the field of HIV/AIDS. Currently, the cosponsors are: the United Nations Children's Fund (UNICEF); the United Nations Development Programme (UNDP); the United Nations Educational, Scientific and Cultural Organization (UNESCO); the United Nations Population Fund (UNFPA); the United Nations International Drug Control Programme (UNDCP); the World Health Organization (WHO); and the World Bank. UNAIDS became fully operational in January 1996.

During 1999 alone, some 5.6 million people became infected with the virus and some 2.6 million lost their lives to AIDS; see AIDS Epidemic Update: December 1999, (1999), Geneva: UNAIDS/WHO, p. 4.

Ibid., p.6. Note that in 1998, the rate of HIV infected women stood at 43 per cent; see HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed), Geneva: UNAIDS, p. 4.

HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, pp. 1–3.

See Mofenson L.M. (1997), ‘Mother-Child HIV-1 transmission: Timing and Determinants’ Obstetr Gynecol Clin North Am 24(4), p. 759; and Fowler, M.G. (1997) ‘Update: Transmission of HIV-1 from Mother to Child’, Curr Opin Obstet Gynecol, 9(6), p.343.

Administration of Oral ZDV to the mother starting between the 14th and 34th weeks of pregnancy (median 26 weeks), intravenous ZDV during labour and oral therapy to the newborn for six weeks after birth; see HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, p. 19.

See Newell M-L , Gray G , & Bryson Y.J. (1997), ‘Prevention of Mother-to-Child Transmission of HIV-1 Transmission’ AIDS 11 (Suppl A), S165; and Connor, E et al, (1994), ‘Reduction of Maternal-infant Transmission of Human Immunodeficiency Virus Type 1 with Zidovudine Treatment’, New England Journal of Medicine, 311, p. 1173.

The trials have involved numerous developing countries, including Botswana, Burkina Faso, Cambodia, Côte d'Ivoire, Dominican Republic, Ethiopia, Haiti, Honduras, Kenya, Malawi, Rwanda; South Africa, Tanzania, Thailand, Uganda, Zambia and Zimbabwe; see HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, pp 21–27; and de Bruyn, M. (1998), ‘Prevention of Perinatal HIV Transmission’ in Gómez, A. & Meacham, D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p.82.

For discussion on problematic aspects of clinical trials in industrialised countries, see for example, McNeil P. (1993), The Ethics and Politics of Human Experimentation, Cambridge University Press: Cambridge; and D. Sprumont (1999), ‘Legal Protection of Human Research Subjects in Europe’, Journal of Health Law, 6, p.25.

This is especially problematic since many ethical codes and guidelines throughout the world explicitly exclude pregnant women from medical research; thus leading many to argue that the women in such trials are being used as reproductive vessels and vectors; see for example, Faden R. , Kass N. , & McGraw D. (1996), ‘Women as Vessels and Vectors: Lessons from the HIV Epidemic’ in Wolf S. (ed.), Feminism & Bioethics-Beyond Reproduction, New York: Oxford University Press, p. 252.

Note that it is not the purpose of this article to evaluate the current ARV trials per se, but rather to use them as examples to inform the analysis in respect of these dilemmas.

See AIDS Epidemic Update: December 1999, (1999), Geneva: UNAIDS/WHO, p. 4.

This is albeit the fact that Africa accounts for only ten per cent of the world's population; see HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed), Geneva: UNAIDS, p. 6.

For example, in parts of Zimbabwe, the rates of infection among pregnant women, tested anonymously in antenatal clinics, reached a high of 59 per cent and even 70 per cent in some cases; ibid.

Ibid.

See ‘Recommendations on the Safe and Effective Use of Short-course ZDV for Prevention of Mother-to-child Transmission of HIV (1998), WHO Weekly Epidemiological Record, 73(41), p. 313.

Breastfeeding, which is now known to be a significant source of infection, is more common and usually practised for a longer period in developing countries than in the industrialised world; see HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed.), Geneva: UNAIDS, p. 6.

Ibid., p. 7.

Ibid., p. 8.

Note that other types of trials and studies have been undertaken in the developing world, such as those in respect of HIV vaccine, micronutrients supplementation, delivery by Caesarian section, cleansing of the birth canal, and so forth. These, however, are outside the scope of this article; for details, see HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, pp. 24–26.

This study was a collaboration between the Thai Ministry of Public Health and the US Centers for Disease Control and Prevention; see HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed), Geneva: UNAIDS, p. 7.

This study concluded in 1998 that this regimen could reduce MTCT by approximately 50 per cent, provided that the baby is not breastfed; see Centers for Disease Control and Prevention, (1998), ‘Administration of Zidovudine During Late Pregnancy to Prevent Perinatal HIV Transmission—Thailand 1996-1998’, Morbidity and Mortality Weekly Report, 47, p. 151; and ‘Recommendations on the Safe and Effective Use of Short-course ZDV for Prevention of Mother-to-child Transmission of HIV’, (1998), WHO Weekly Epidemiological Record, 73(41), p. 313.

See also randomised trial in Côte d'Ivoire wherein women received either oral ZDV (300mg) twice a day from week 36 of pregnancy until the onset of labour or matching placebo, and at the onset of labour ZDV (300mg) every three hours until delivery versus placebo (over 95 per cent of the infants were breastfed); HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, p. 21.

In this study, over 85 per cent of infants were breastfeed for longer than three months; see Dabis F. (1999), ‘6-month Efficacy, Tolerence, and Acceptability of a Short Regimen of Oral Zidovudine to Reduce Vertical Transmission of HIV in Breastfed Children in Côte d'Ivoire and Burkina Faso: A Double-blind Placebo-controlled Multicentre Trial’, Lancet, 353, p. 786.

The PETRA study, commencing in 1995, is WHO/UNAIDS multi-centred. It is partly funded by UNAIDS. Other sources of support come from the Dutch, Australian, Swedish and Italian governments respectively and the drugs are donated by Glaxo-Wellcome, interview with Dr J. Perriens (UNAIDS, Geneva), and Mr G. Haverkamp (National AIDS Therapy Evaluation Centre—NATEC, Amsterdam), January 2000.

Note that initially this study compared the various regimens to placebo, but following the results of the Thai study, the placebo Arm was discontinued in March 1988, interview with Dr J. Perriens (UNAIDS, Geneva) and Mr. G. Haverkamp (NATEC), January 2000; see also de Bruyn M. (1998) ‘Prevention of Perinatal HIV Transmission’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women. Vulnerability and HIV/AIDS. Santiago: Latin American and Caribbean Women's Health Network, p. 86.

see HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, p 22.

The Nevirapine regimen is much cheaper (approximately US $4) than that of ZDV and 3TC. Note that the placebo Arm was discontinued in March 1998 following the results of the Thai Study. The Nevirapine study is sponsored by the HIV Prevention Trials Network (HIVNET) of the National Institute of Allergy and Infectious Diseases (NIAID)—a US Government agency, supported by researchers from Makerere University—Kampala, conducted by the Johns Hopkins University—Baltimore, and the drugs were donated by Glaxo-Wellcome (ZDV) and Boehringer-Ingellreim (Nevirapine); see HIVNET 012: Questions and Answers, (8 July 1999), National Institute of Allergy and Infectious Diseases: www.niaid.nih.gov.

See Mother-To-Child Transmission of HIV: Questions and Answers, (5 August 1999), UNAIDS: www.unaids.org. In real terms, Nevirapine could reduce the risk of transmission by approximately 50 per cent; interview with Achom, M., Nevirapine study coordinator, Kampala, March 2000.

In many parts of the developing world, especially sub-Saharan Africa, the epidemic has led, inter alia, to a significant decline in life expectancy, a rapid increase in child mortality rates, a dramatic increase in health care costs, a devastating impact on education with many teachers losing their lives to the virus, and a staggering decrease in economic output; see UNAIDS Report, (1999), Geneva: UNAIDS, pp.44-51.

See Jayasuriya D.C. (1995), HIV Law, Ethics and Human Rights, New Delhi: UNDP, p. 27; and Abdussalam, M. & Osuntokun, B.O. (1991), ‘Capacity Building For Ethical Consideration of Epidemiological Studies: Perspective of Developing Countries’, in Bankowski, Z., Bryant, J.H. & Last, J.M. (eds), Ethics and Epidemiology: International Guidelines, Geneva: CIOMS, p.130.

For instance, a well known South African oncologist, who has recently admitted faking the results of clinical trials on breast cancer treatment, was found to have conducted the study in South Africa without the approval nor the knowledge of the local ethics committee; Daily Mail & Guardian, South Africa, 18 and 25 February 2000.

This statement in no way implies that local ethical review committees in the developing world are unable to judge the ethics of clinical trials properly, but is rather an indication of the difficult choices that such committees have to make in situations of this kind; that is either approve the study protocol (even when ethically inadequate) so that some benefit, albeit limited, may accrue on the population, or reject it and suffer the consequences.

See Cook R.J. (1994), Women's Health and Human Rights, Geneva: WHO, pp. 47–48.

The Declaration of Helsinki, ‘Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects’, was adopted by the World Medical Association in 1964 both to incorporate the principles of the Nuremberg Code 1947 and to provide additional ethical principles for issues which the Nuremberg Code had not addressed. The declaration has been revised on four occasions, in 1975, 1983, 1989 and 1996 respectively; see Ramsay, S. (1999), ‘More developments in developing world research ethics’, Lancet, 354, p. 1405; Dunne, J. (1995), ‘Drug and Vaccine Trials’, in Jayasuriya, D. C. (ed.), HIV Law, Ethics and Human Rights, New Delhi: UNDP; and Levine R. J. (1988), Ethics and Regulation of Clinical Research, (2nd ed), New Haven: Yale University Press.

These guidelines were first adopted in 1982 and were subsequently revised in 1993; see Bankowski Z. , & Levine R.J. (1993), Ethics and Research on Human Subjects—International Guidelines, Geneva: CIOMS. Note also the Guidelines for Good Clinical Practice for Trials on Pharmaceutical Products promulgated by WHO in 1995.

Guideline 15, International Guidelines for Biomedical Research Involving Human Subjects 1993.

See, for example, Osuntokun B.O. (1993), ‘Individual Consent: A Perspective of Developing Countries’ in Bankowski Z. , & Levine R.J. (ed.), Ethics and Research on Human Subjects: International Guidelines, Geneva: CIOMS, p. 25; and Gostin, L.O. (1991), ‘Macro-Ethical Principles for the Conduct of Research on Human Subjects: Population-Based Research and Ethics’, in Bankowski, Z., Bryant, J.H. & Last, J.M. (eds), Ethics and Epidemiology: International Guidelines, Geneva: CIOMS, p.29.

Gostin L.O. ibid.

See Scholle Connor S. (1992), ‘International Legal and Ethical Aspects of Developing and Distributing an HIV Vaccine’ in Fuenzalida-Puelma H. , Linaires Parada A.M. , & Serrano LaVertu D. (eds), Ethics and Law in the Study of AIDS, Washington DC: Pan American Health Organization, p. 162.

See CIOMS Guideline 13.

Note that randomisation is another constituent of these principles. Since the conduct of randomised trials is an ethically controversial topic in both parts of the world with its own huge literature, this article cannot present that material without substantially going over the word limit. It suffices to indicate that in the context of ARV trials for the reduction of MTCT in the developing world this issue had provoked extensive ethical debates, but following encouraging preliminary results on the Bangkok study, the placebo Arm was discontinued in all the trials; on the ethical dilemmas in this context, see for example Angell, M. (1997), ‘The Ethics of Clinical Research in the Third World’, New Eng. J. of Medicine, 337(12), p 847; and Grady, C. (1998), ‘Science in the Service of Healing’, The Hastings Center Report. 28(6), p.34.

See, in general, HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, pp 27–31.

This is in line with Basic Principle 6 of the Declaration of Helsinki and Guideline 12 of the CIOMS International Ethical Guidelines for Biomedical Research on Human Subjects.

In respect of the Thai study, see for example, ‘Recommendations on the Safe and Effective Use of Short-course ZDV for Prevention of Mother-to-child Transmission of HIV’ (1998), WHO Weekly Epidemiological Record, 73(41), p. 314.

This emerged from interviews with counsellors involved with these sites (March 2000).

See Jackson H. (1998), ‘Key Problems Facing Women in the Context of HIV/AIDS in Southern Africa’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, at.68.

Interview with J. Matuvo, PETRA, Kampala, Uganda, March 2000.

See de Bruyn M. (1998), ‘Prevention of Perinatal HIV Transmission’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 86.

See Cohen B. , & Trustell J. (1996), Preventing and Mitigating AIDS in Sub-Saharan Africa, Washington DC: National Academy Press, p. 103.

See speech by Peter Piot, Executive Director of UNAIDS, presented to the Commission on the Status of Women (Panel on Women and Health, United Nations, New York) during its forty-third Session, on 3 March 1999: www.unaids.org.

See Women and AIDS: Agenda for Action, (1994), Geneva: WHO/GPA/DIR, p. 14.

See Shuster E. (1997), ‘Fifty Years Later: The Significance of the Nuremberg Code’, New England Journal of Medicine. 338, p. 1436; for a full history of the principle of informed consent, see Beauchamp, T.L. & Faden, R.L. (1995), ‘History of Informed Consent’ in Reich, W.T. (ed.), Encyclopedia of Bioethics, New York: Macmillan Press.

Basic Principle 9.

Guidelines 1 to 3. Note that the concept of informed consent is also incorporated as a basic human right in the International Covenant on Civil and Political Rights, adopted by the United Nations General Assembly in 1966, which is discussed later in this article. It suffices to note at this stage that Article 7 of the Covenant states that: ‘No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his free consent to medical or scientific experimentation.’

Guideline 3.3.

Dunne J. (1995), ‘Drug and Vaccine Trials’ in Jayasuriya D.C. (ed), HIV Law, Ethics and Human Rights, New Delhi: UNDP, p. 213.

See Cook R.J. (1994), Women's Health and Human Rights, Geneva: WHO, pp 25–26.

See Hogg C. (1999), Patients, Power and Politics, London: SAGE, p. 68.

See Grady C. (1998), ‘Science in the Service of Healing’, The Hastings Center Report, 28(6), p. 36; and Cook, R.J. (1994), Women's Health and Human Rights. Geneva: WHO, pp. 25-26.

See, for example, HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed), Geneva: UNAIDS; and ‘Recommendations on the Safe and Effective Use of Short-course ZDV for Prevention of Mother-to-child Transmission of HIV’ (1998), WHO Weekly Epidemiological Record, 73(41), pp.313-320.

See Last J.M. (1991), ‘Epidemiology and Ethics’ in Bankowski Z , Bryant J.H. , & Last J.M. (eds), Ethics and Epidemiology: International Guidelines, Geneva: CIOMS, p. 17; and Grady, C. (1998), ‘Science in the Service of Healing’, The Hastings Center Report, 28(6), p.34.

See Peters D. (1999), Health Expenditures, Services, and Outcomes in Africa, Washington DC: The World Bank, wherein it was reported that the hypothetical median African country had an adult female illiteracy rate of 53 per cent.

Dunne J. (1995), ‘Drug and Vaccine Trials’ in Jayasuriya D.C. (ed), HIV Law, Ethics and Human Rights, New Delhi: UNDP, p. 214.

Ibid.

It should be noted that in some of the PETRA sites, there is available a counsellor whose time is fully dedicated to explain the study to the participants and ensure their proper understanding of the proposed intervention prior to giving their consent; interview with Dr J. Perriens (UNAIDS, Geneva), January 2000. A very good practice is that followed in both the PETRA and the HIVNET 012 sites in Kampala, where the consent form is translated into the local language in simple, clear and comprehensible terms. Once the form is read by the seropositive woman (or if illiterate it is read out to her), the counsellor explains the study thoroughly. She is then asked questions by the counsellor to ascertain whether she has understood everything before signing. Note also that in those sites, there are two separate consent forms. The first is signed before the performance of the HIV test, and this is preceded by educational talks on HIV/AIDS. The second is signed prior to the woman's participation in the study and is preceded by extensive counselling; interview with J. Matuvu and M. Achom, (Kampala, Uganda); March 2000.

On the social perception of a woman's role in the developing world see, for example, Cabral C.S. (1998), ‘HIV-Positive Women and their Social Representations of Motherhood’, in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 101.

For example women in the developing world find it extremely difficult to negotiate when or how to have sexual intercourse, demand condom use, or even reject sexual relations, for any such action may lead to violence, mistrust, recrimination, abandonment or withholding of financial support; see Gómez A. (1998), ‘Women and HIV/AIDS: A Gender Perspective’, ibid., at 5.

See general discussion on the low status of women in respect of HIV/AIDS in Facing the Challenges of HIV, AIDS, STDs: A Gender-Based Response (1998), Amsterdam and Harare: KIT and SAFAIDS, pp.7-9.

See Osuntokun B.O. (1993), ‘Individual Consent: A Perspective of Developing Countries’ in Bankowski Z. , & Levine R.J. (eds), Ethics and Research on Human Subjects: International Guidelines, Geneva: CIOMS, p. 29.

“See de Bruyn M. (1998), ‘Prevention of Perinatal HIV Transmission’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, pp. 91–92.

A good practice in this respect has been followed in the PETRA sites in Uganda, where counsellors have helped many seropositive women overcome some of these limitations, such as counselling the women on how to disclose their serostatus to their partner; interview with J. Matuvo, PETRA, Kampala (Uganda), March 2000.

See Dunne J. (1995), ‘Drug and Vaccine Trials’ in Jayasuriya D.C. (ed.), HIV Law, Ethics and Human Rights, New Delhi: UNDP, pp 218–219.

Commentary to Guideline 13, International Ethical Guidelines for Biomedical Research Involving Human Subjects 1993.

This is in line with Guideline 2, International Ethical Guidelines for Biomedical Research Involving Human Subjects 1993.

See de Bruyn M. (1998), ‘Prevention of Perinatal HIV Transmission’ in Gómez, A. & Meacham, D. (eds), A Human Rights Perspective: Women. Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p.86.

Two neonatal deaths in a study involving 200 women; see HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, p. 22.

See HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, p. 22.

Category C is defined as follows: ‘safety in human pregnancy has not been determined, animal studies are either positive for fetal risk or have not been conducted, and the drug should not be used unless the potential benefit outweighs the potential risk to the fetus’; see Augenbaum M. , & Minkoff H.L. (1997), ‘Antiretroviral Therapy in the Pregnant Woman, Obstet Gynocol Clin North Am, 24(4), p. 833.

See Cook R (1994), Women's Health and Human Rights, Geneva: WHO, p. 28.

On this point see generally, Sherr L. (1993), ‘HIV Testing in Pregnancy’ in Squire C. (ed.), Women and AIDS: Psychological Perspectives, London: Sage Publications, p. 42; and S.V. Rosser, (1991), ‘Perspectives: AIDS and Women’ AIDS Education and Prevention, 3(3), p.230.

Interview with Dr E. Madraa, Director of AIDS Control Programme, Ministry of Health, Kampala, Uganda, (March 2000).

A similar criticism was directed at the ACTG076; see for example, Faden R. , Kass N. , & McGraw D. (1996), ‘Women as Vessels and Vectors: Lessons from the HIV Epidemic’ in Wolf S. (ed.), Feminism & Bioethics—Beyond Reproduction, New York: Oxford University Press, p. 253, who argue that the sole focus of ACTG076 was on the prevention of pediatric AIDS and no attention was given to monitoring the effect of AZT on the disease progression in women.

Indeed, it has been reported that breastfeeding may double the transmission rate of infection and may be the major determinant for the difference in transmission rates between developed and developing countries; see HIV in Pregnancy: A Review, (1999), Geneva: UNAIDS/WHO, p. 26.

See HIV and Infant Feeding—A Review of HIV Transmission Through Breastfeeding, (1998), Geneva: WHO/UNAIDS/UNICEF, p. 15. Note, however, that a recent study on infant feeding patterns and HIV has suggested that exclusive breastfeeding (that is without any water, other fluids or food) carries a significantly lower risk of HIV transmission to the infant at 3 months than mixed feeding (that is breastfeeding with some water, other fluids or food) but a similar risk to formula feed; see Coutsoudis, A., et al. (1999), ‘Influence of Infant-Feeding Patterns on Early Mother-To-Child Transmission of HIV-1 in Durban, South Africa: A Prospective Cohort’, Lancet, (354), p. 471. Although such findings are very encouraging news, they may not be of much benefit in Africa where exclusive breastfeeding is not common and most women practice mixed feeding to their infants. Also, the infants in this study were assessed at 3 months of age and further research should be done to assess the risk of transmission beyond 3 months.

See de Bruyn M. (1998), ‘Prevention of Perinatal HIV Transmission’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women. Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 88.

Ibid.

See, for example, Cabral C. S. (1998), ‘HIV-Positive Women and Their Social Representations of Motherhood’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 98.

See de Bruyn M. (1998), ‘Prevention of Perinatal HIV Transmission’ in Gómez, A. & Meacham, D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 88.

Ibid.

See, for example, Glantz L.H. (1998), ‘Research in Developing Countries: Taking “Benefit” Seriously’, The Hastings Center Report. 28(6), p. 38.

Crouch R.A. , & Arras J.D. (1998), ‘AZT Trials and Tribulations’, The Hastings Center Report. 28(6), p 26, at 30.

HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed), Geneva: UNAIDS/WHO, p. 7.

Additionally, the efficacy of this regimen was established in an asymptomatic study population with relatively intact immune system. It was not known whether this regimen would be equally effective in more symptomatic women whose risk of transmitting HIV to the infant is greater. Accordingly, in 1998 WHO recommended the use of this regimen only in settings where practical and budgetary considerations precluded the use of ACTG076 and where adequate healthcare infrastructure was in place; see ‘Recommendations on the Safe and Effective Use of Short-course ZDV for Prevention of Mother-to-child Transmission of HIV (1998), WHO Weekly Epidemiological Record, 73(41), p. 313.

Editorial, (1999), Lancet, (353), p. 511.

HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants. (1999, 2nd ed), Geneva: UNAIDS/WHO, p. 8.

The proportion of people who lack access to any health care ranges from over 40 per cent in some parts of Latin America and Asia to almost 80 per cent in the poorest parts of Africa; see HIV/AIDS: Emerging Issues and Challenges for Women, Young People and Infants, (1999, 2nd ed.), Geneva: UNAIDS/WHO, p.8.

Ibid.

This also raises the question concerning the extent to which a state must ensure that its nationals enjoy the right to health, a basic right advocated in many international and regional human rights instruments, which is discussed in the next section.

See in general UNAIDS Report, (1999), Geneva: UNAIDS.

See Morris K. (1998), ‘Experts plan strategy to tackle mother-to-child HIV-1 transmission’, The Lancet, 351, p. 961; and HIV in Pregnancy: A Review, (1999) Geneva: UNAIDS/WHO, p.22.

Interview with Dr E. Madraa, AIDS Control Programme, Ministry of Health, Kampala, Uganda, March 2000; see also Partners in Prevention: International Case Studies of Effective Health Promotion Practice in HIV/AIDS, (1998) Geneva: UNAIDS, pp. 49–57.

Although the Universal Declaration is not a treaty signed by states, it is widely considered to be binding under customary international law; see for example, L. Gostin & L. Lazzarini (1997), Human Rights and Public Health in the AIDS Pandemic, New York: Oxford University Press, p.4; and Greenberg J. (1989), ‘Race, Sex, and Religious Discrimination in International Law’, in Claude R. Pierre , & Weston B.H. (eds), Human Rights in the World Community, Philadelphia: University of Pennsylvania Press, p. 87.

In force in January 1976.

In force in March 1976.

See Claude R. Pierre , & Weston B.H. (1989), Human Rights in the World Community, Philadelphia: University of Pennsylvania Press, p. 7.

Adopted by the UN General Assembly in 1989 and entered into force in September 1990.

Adopted by the Organisation of African Unity in 1981 and entered into force in October 1986.

Adopted by the Organisation of American States in 1969 and entered into force in July 1976.

Adopted at the World conference on Human Rights in June 1993.

Note that Key human rights that are applicable to HIV/AIDS in general are: the right to life; the right to non-discrimination and equality before the law; the right to autonomy, liberty and security of the person; the right to health; the right to privacy; freedom from inhuman or degrading treatment; the right to marry and found a family; the right to education; the right to work; the right to social security, assistance and welfare; the right to seek and enjoy asylum; freedom of movement; freedom of expression; the right to share in scientific advancement and its benefits; and the right to participate in public and cultural life. See in general, HIV/AIDS and Human Rights - International Guidelines, (1998), Geneva/New York: UNHCHR/UNAIDS.

Articles 1 and 3, Universal Declaration on Human Rights 1948; Preambles to both the International Covenant on Civil and Political Rights 1966, and the International Covenant on Economic, Social and Cultural Rights 1966; and Article 5, African Charter on Human and People's Rights 1981.

The right to self-determination is proclaimed in Article 1(1) of the two 1966 International Covenants on Human rights.

See Fuenzalida-Puelma H. (1992), ‘Legal Norms regarding AIDS in Latin America and the Caribbean’, in Fuenzalida-Puelma H. (eds), Ethics and Law in the Study of AIDS, Washington DC: Pan American Health Organization, pp. 30–31.

See, for example, Article 19, Universal Declaration on Human Rights 1948; Article 19, International Covenant on Civil and Political Rights 1966; Article 9, African Charter on Human and Peoples's Rights 1981; and Article 13, American Convention on Human Rights 1969.

See also Article 12, Universal Declaration on Human Rights 1948; and Article 37, the Convention on the Rights of the Child 1989.

The UNAIDS Guide to the United Nations Human Rights Machinery, (1997), Geneva: UNAIDS, pp. 9–10.

See Calderón M.C. , & González- Vélez A.C. (1998), ‘Women and AIDS in Colombia —A Legal and Epidemiological Overview’, in Gómez A , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 43.

See HIV/AIDS and Human Rights—International Guidelines, (1998), Geneva/New York: UNHCHR/UNAIDS, p. 48.

See, for example, Article 25, Universal Declaration on Human Rights 1948; Article 12, International Covenant on Economic, Social and Cultural Rights 1966; Articles 12(1) and 14(2), International Convention on the Elimination of All Forms of Discrimination Against Women 1979; and Article 24, Convention on the Rights of the Child 1989.

Consitution of the World Health Organization. Preamble, Basic Documents, 38th ed., Geneva: WHO.

Calderón M.C. , & González- Vélez A.C. (1998), ‘Women and AIDS in Colombia—A Legal and Epidemiological Overview’, in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 42.

de Bruyn M. (1998). ‘Prevention of Perinatal HIV Transmission’ in Gómez A. , & Meacham D. (eds), A Human Rights Perspective: Women, Vulnerability and HIV/AIDS, Santiago: Latin American and Caribbean Women's Health Network, p. 91.

Article 15, International Covenant on Economic Social and Cultural Rights 1966; and Article 27, Universal Declaration on Human Rights 1948.

See Annas G.J. , & Grodin M.A. (1999), ‘Human rights and Maternal Fetal HIV Transmission Prevention Trials’, in Mann J.M. , Health and Human Rights—A Reader, New York & London: Routledge, pp. 374–375.

Schembri Orland L. S. (1998), ‘The rights of patients and legal aspects of informed consent, in Cauchi M.N. (ed.), Informed Consent: proceedings of a Symposium for Medical and paramedical Practitioners, Guardamangia: Medical School, p. 31.