IN THE HIGH COURT OF SOUTH AFRICA
	TRANSVAAL PROVINCIAL DIVISION

In the matter between

TREATMENT ACTION CAMPAIGN (TAC)	First Applicant

HAROON SALOOJEE	Second Applicant

CHILDREN'S RIGHTS CENTRE	Third Applicant

and

MINISTER OF HEALTH	First Respondent

MECS FOR HEALTH	Second to Tenth Respondents



	
	FOUNDING AFFIDAVIT




I, the undersigned

	SIPHOKAZI MTHATHI

do hereby affirm and say:



1.	I am an adult woman of full legal capacity residing at 7 Rorita Court, 
Strubens Road, Mowbray, Cape.

2.	I am the Deputy Chairperson of the Treatment Action Campaign, which is the 
First Applicant in this matter.  I am duly authorised by a resolution of the 
Executive Committee of the Treatment Action Campaign, on 17 August 2001, 
to bring this application and make this affidavit on its behalf.  I attach marked 
A a copy of that resolution.

3.	Except where the context indicates otherwise, the facts stated in this affidavit 
are within my personal knowledge.  To the best of my knowledge and belief 
the contents of this affidavit are true and correct.

THE APPLICANTS

4.	The First Applicant is the TREATMENT ACTION CAMPAIGN (TAC), a 
voluntary association with legal personality and the capacity to sue and be 
sued, located at Town One Properties, Sulami Drive Site B, Khayelitsha, 
Western Cape.  I attach marked B a copy of the Constitution of the TAC.

5.	A number of organisations and individuals are associated with the TAC.  
They include the AIDS Law Project, the AIDS Consortium, the Congress of 
South African Trade Unions, the New Women's Movement, the South 
African Catholic Bishops Conference, and a range of individuals with 
HIV/AIDS and organisations of people with HIV/AIDS.



6.	The principal objectives of TAC are set out in paragraph 4 of Annexure B.  
They include the following:

1.	to campaign for affordable treatment for all people with HIV/AIDS; 
and

2.	to campaign for the prevention and elimination of all new HIV 
infections.

7.	The Second Applicant is HAROON SALOOJEE, an adult male 
paediatrician who is the Head of the Division of Community Paediatrics in the 
Department of Paediatrics and Child Health at the University of the 
Witwatersrand, Johannesburg.

8.	The Third Applicant is the CHILDREN'S RIGHTS CENTRE, a trust of 
First Floor, 480 Smith Street, Durban.

THE RESPONDENTS

9.	The First Respondent is the MINISTER OF HEALTH in the Government 
of the Republic of South Africa. She is the member of the national executive 
who is responsible for developing and implementing national policy with 
regard to health services.  She is cited in her official capacity and as a 
representative of the Government of the Republic of South Africa care of the 
State Attorney, 4th Floor South Tower, Fedsure Forum Building, 268 Van der 
Walt Street, Pretoria.



10.	The Second Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF THE EASTERN CAPE.  He is the member of the provincial executive 
who is responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  He is cited in his official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

11.	The Third Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF THE FREE STATE.  She is the member of the provincial executive 
who is responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  She is cited in her official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

12.	The Fourth Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF GAUTENG.  She is the member of the provincial executive who is 
responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  She is cited in her official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.



13.	The Fifth Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF THE KWAZULU-NATAL.  He is the member of the provincial 
executive who is responsible for implementing national and provincial 
legislation, and developing and implementing provincial policy, with regard to 
health services.  He is cited in his official capacity and as a representative of 
the provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

14.	The Sixth Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF MPUMALANGA.  She is the member of the provincial executive who 
is responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  She is cited in her official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

15.	The Seventh Respondent is the MEC FOR HEALTH IN THE 
NORTHERN PROVINCE.  He is the member of the provincial executive 
who is responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  He is cited in his official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

16.	The Eighth Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF THE NORTHERN CAPE.  She is the member of the provincial 
executive who is responsible for implementing national and provincial 
legislation, and developing and implementing provincial policy, with regard to 
health services.  She is cited in her official capacity and as a representative of 
the provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.



17.	The Ninth Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF NORTH-WEST.  He is the member of the provincial executive who is 
responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  He is cited in his official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

18.	The Tenth Respondent is the MEC FOR HEALTH IN THE PROVINCE 
OF THE WESTERN CAPE.  He is the member of the provincial executive 
who is responsible for implementing national and provincial legislation, and 
developing and implementing provincial policy, with regard to health 
services.  He is cited in his official capacity and as a representative of the 
provincial government, care of the State Attorney, 4th Floor South Tower, 
Fedsure Forum Building, 268 Van der Walt Street, Pretoria.

THE ISSUES

19.	There are two issues in this case.

20.	The first issue is whether the Respondents are entitled to refuse to make 
Nevirapine (a registered drug) available to pregnant women who have HIV 
and who give birth in the public health sector, in order to prevent or reduce 
the risk of transmission of HIV to their infants, where in the judgment of the 
attending medical practitioner this is medically indicated.



21.	The second issue is whether the Respondents are obliged, as a matter of law, 
to implement and set out clear timeframes for a national programme to 
prevent mother-to-child transmission of HIV, including voluntary counselling 
and testing, antiretroviral therapy, and the option of using formula milk for 
feeding.


22.	In summary, the Applicants' case is as follows:

22.1	The HIV/AIDS epidemic is a major public health problem in our 
country, and has  reached catastrophic proportions.

22.2	One of the most common methods of transmission of HIV in children 
is from mother to child at and around birth.  Government estimates are 
that since 1998, 70 000 children are infected in this manner every year.

22.3	The Medicines Control Council has the statutory duty to investigate 
whether medicines are suitable for the purpose for which they are 
intended, and the safety, quality and therapeutic efficacy of medicines.

22.4	The Medicines Control Council has registered Nevirapine for use to 
reduce the risk of mother-to-child transmission of HIV.  This means 
that Nevirapine has been found to be suitable for this purpose, and that 
it is safe, of acceptable quality, and therapeutically efficacious.

22.5	The result is that doctors in the private profession can and do prescribe 
Nevirapine for their patients when, in their professional judgment, it is 
appropriate to do so. 

22.6	In July 2000 the manufacturers of Nevirapine offered to make it 
available to the South African government free of charge for a period 
of five years, for the purposes of reducing the risk of mother-to-child 
transmission of HIV.

22.7	The government has formally decided to make Nevirapine available 
only at a limited number of pilot sites, which number two per province.

22.8	The result is that doctors in the public sector, who do not work at one 
of those pilot sites, are unable to prescribe this drug for their patients, 
even though it has been offered to the government for free.

22.9	The Applicants are aware of the desirability of a multiple-strategy 
approach to the prevention of mother-to-child transmission.  However, 
they cannot and do not accept that this provides a rational or lawful 
basis for depriving patients at other sites of the undoubted benefits of 
Nevirapine, even if at this stage the provision can not be done as part 
of a broader integrated strategy – a point that is not conceded.

22.10	To the extent that there may be situations in which the use of 
Nevirapine is not indicated, this is the situation in both the private and 
the public sector.  Whether or not to prescribe Nevirapine is a matter 
of professional medical judgment, which can only be exercised on a 
case-by-case basis.  It is not a matter which is capable of rational or 
appropriate decision on a blanket basis. 

22.11	There is no rational or lawful basis for allowing doctors in the private 
sector to exercise their professional judgment in deciding when to 
prescribe Nevirapine, but effectively prohibiting doctors in the public 
sector from doing so.

22.12	In addition to refusing to make Nevirapine generally available in the 
public health sector, the government has failed over an extended 
period to implement a comprehensive programme for the prevention of 
mother-to-child transmission of HIV.

22.13	The result of this refusal and this failure is the mother-to-child 
transmission of HIV in situations where this was both predictable and 
avoidable.

22.14	This conduct of the government is irrational, in breach of the Bill of 
Rights, and contrary to the values and principles prescribed for public 
administration in section 195 of the Constitution.  Furthermore, 
government conduct is in breach of its international obligations as 
contained in a number of conventions that it has both signed and 
ratified.

23.	On 17 July 2001 the Applicants' attorney wrote to each of the Respondents 
setting out this case in summary form, and requiring that within fourteen days 
they:

(a)	provide legally valid reasons why they will not make Nevirapine available to 
patients in the public health sector, except at the designated pilot sites, or 
alternatively undertake forthwith to make Nevirapine available in the public 
health sector.



(b)	undertake to put in place a programme which will enable all medical 
practitioners in the public sector to decide whether to prescribe Nevirapine 
for their pregnant patients, and to prescribe it where in their professional 
opinion this is medically indicated.

24.	I attach marked C a copy of the letter to the First Respondent, which was sent 
in identical terms to each of the other Respondents.

25.	The Tenth Respondent replied by writing to the Applicants attorney on 27 
July 2001.  He attached to his letter (Annexure D) copies of

25.1	a letter he had written to the First Respondent (Annexure D1)

25.2	a circular from his Department describing its mother-to-child 
transmission prevention programme (Annexure D2), and

25.3	a recent article from the South African Medical Journal, describing the 
pilot programme in Khayelitsha (Annexure D3).

26.	It appears from D1 that the First Respondent advised the other Respondents 
that she believed it appropriate that a single response from her should serve 
as a response from all of the Respondents.

27.	The Second to Ninth Respondents have not responded at all to the letter 
addressed to them, except that the Third Respondent and the Seventh 
Respondent have acknowledged receipt.



28.	On 6 August 2001 the First Respondent replied to the letter from the 
Applicants'?attorney.  I attach a copy of her reply marked E.  I deal below 
with the contents of that reply.  I say at this stage, though, that it does not 
appear that the First Respondent denies the correctness of any of the 
statements of fact set out in paragraphs 22.1 to 22.8 of this affidavit, which 
are specifically set out in the letter from the Applicants' attorney.

29.	In this affidavit, I have therefore not set out detailed evidence in support of 
certain of those facts.  Detailed evidence in this regard is however contained 
in the annexures to this affidavit.

STANDING OF THE APPLICANTS

30.	TAC has standing in this matter on the following bases:

30.1	it acts in its own interest, in order to achieve the purposes set out in its 
Constitution

30.2	it acts on behalf of pregnant women with HIV/AIDS and women of 
reproductive age, who are being or will be treated in the public health 
sector, and who can not act in their own name because of poverty, 
stigma, discrimination or a lack of knowledge of their HIV status or of 
the risk to their infants to be born, or of what can be done to reduce 
this risk.

30.3	it acts on behalf of the group consisting of pregnant women with HIV, 
who are being or will be treated in the public health sector, and who 
are or will be unable to obtain treatment with Nevirapine for 
themselves or (in due course) for their babies in the public health 
sector.

30.4	it acts in the public interest.  There is a public interest in the effective 
enforcement of the constitutional rights that are at issue in this matter, 
and in ensuring that the government takes all reasonable measures to 
prevent or reduce HIV infection as a result of mother-to-child 
transmission. 

30.5	it acts in the interests of its members, who include individuals with 
HIV and organisations which are themselves committed to achieving 
the purposes of this application.

31.	The Second Applicant has standing on the following bases:

31.1	he acts in his own interest as a medical practitioner who is responsible 
for the treatment of children born to women with HIV, who wishes to 
be able to treat his patients with Nevirapine where in his professional 
opinion this is medically indicated, and who is ethically obliged to treat 
his patients in this manner.

31.2	he acts in his capacity as a member of, as representative of the 
members of, and in the interests of Save Our Babies, which is an 
unincorporated group of health professionals consisting mainly of 
paediatricians and maternal and child health practitioners.  The 
purpose of Save Our Babies is to press for implementation of an 
effective programme for reduction of mother to child transmission of 
HIV.  Approximately 150 health professionals have expressed their 
support for these proceedings, and have mandated him to represent 
them in these proceedings.  They include Professor Hoosen (Jerry) 
Coovadia, who is Victor Daitz Professor of HIV/AIDS Research at the 
Nelson Mandela School of Medicine at the University of Natal, and 
who I verily believe is South Africa's pre-eminent medical scientist in 
this area, whose expertise is internationally recognised.  Save Our 
Babies and the mandate Dr Saloojee has been given are more fully 
described in the affidavit of the Second Applicant. 

31.3	he acts on behalf of new-born babies who are under his care or who in 
due course will be under his care, who in the nature of things, are not 
able and will not be able to act in their own name. 

31.4	he acts in the public interest, on the same basis as the First Applicant.

32.	As appears from the affidavit of Cati Vawda, the Third Applicant has 
standing on the following bases:

32.1	it acts in its own interest, in order to achieve the purposes set out in its 
Constitution.

32.2	it acts on behalf of children, who are being or will be born in the public 
health sector to mothers with HIV, and who in the nature of things can 
not act in their own name.

32.3	it acts in the public interest.  There is a public interest in the effective 
enforcement of the constitutional rights of children, and in ensuring 
that the government takes all reasonable measures to prevent or reduce 
the transmission of HIV to children from their mothers.



JOINDER AND JURISDICTION IN RESPECT OF RESPONDENTS

33.	The Respondents are joined because they have jointly taken the decision 
which gives rise to this litigation, namely not to make Nevirapine generally 
available to pregnant women in the public health sector, even where in the 
view of the attending medical practitioner this is medically indicated.  This is 
a national policy for which all of the Respondents (alternatively the First 
Respondent) are responsible.  It is being implemented by the First 
Respondent on a national basis, and (save for what I say below with regard to 
the Tenth Respondent) by the other Respondents in their respective 
provinces.

34.	I have been advised, and respectfully submit that this Honourable Court has 
jurisdiction over those Respondents who do not reside or carry on business 
within the area of jurisdiction of the Court, on the following bases:

34.1	in terms of section 19(1)(b) of the Supreme Court Act, because they 
are joined as parties to the application against the First Respondent, on 
the grounds set out above.

34.2	because the case against each of the Respondents is one and the same 
case, to avoid a multiplicity of processes, to avoid the possibility of 
conflicting judgments on the same cause of action, and to provide for 
the convenient disposition of the issue.

THE NATURE OF HIV / AIDS



35.	As appears from the affidavit of Professor Robin Wood (F), HIV/AIDS is a 
progressive disease of the immune system that is caused by the Human 
Immunodeficiency Virus (HIV).  HIV-1 is the predominant and virulent form 
of HIV.

36.	When left untreated, HIV profoundly depletes the immune system and may 
prove fatal because of the inability of the body to fight opportunistic 
infections such as tuberculosis, pneumonia and meningitis.

37.	The scientific evidence indicates that without effective treatment, the majority 
of people with HIV/AIDS die prematurely of illnesses that further destroy 
their immune systems, quality of life and dignity.

38.	Early diagnosis, clinical management, medical treatment of opportunistic 
infections and the appropriate use of anti-retroviral therapy prolongs and 
improves the quality of life of people with HIV/AIDS.

39.	Anti-retroviral drugs are a class of drugs which, operating through various 
mechanisms,  suppress HIV viral activity and replication.  When used 
effectively they reduce volumes of HIV to levels which are undetectable in 
the blood.  This prevents and delays the destruction of a person's normal 
immune system.  AZT (zidovudine) and Nevirapine (viramune), to which I 
refer below, are such anti-retroviral drugs.



40.	In its HIV/AIDS Policy Guideline, entitled Prevention and Treatment of 
Opportunistic and HIV-related diseases in Adults?(August 2000), the 
Department of Health (which operates under the direction of the First 
Respondent) has recognised the efficacy of anti-retroviral treatment, stating 
as follows at page 9: "Current research also strongly indicates that 
suppressing HIV viral activity and replication with anti-retroviral therapy 
(ART) or Highly Active Anti-Retroviral Therapy (HAART) combinations 
prolongs life and prevents opportunistic infections."

41.	I have been advised that the Medicines Control Council (MCC) was 
established in terms of the Medicines and Related Substances Control Act 
101 of 1965.  It has the statutory duty to investigate and determine whether 
medicines are suitable for the purpose for which they are intended, and 
whether their safety, quality and therapeutic efficacy is such that they should 
be made available in South Africa.   Registration by the MCC is a 
prerequisite for the lawful prescription and administration of medicines.

42.	The MCC has registered various anti-retroviral drugs for the treatment of 
people who have HIV.

43.	By April 2000 Nevirapine was registered by the MCC for the treatment of  
HIV in adults, adolescents and children with HIV/AIDS.

THE EPIDEMIOLOGY OF HIV/AIDS



44.	As appears from the affidavits of Professor Wood and Dr Abdool Karim (G), 
the Health Department has conducted annual ante-natal surveys at clinics 
across the country.  These surveys show a 24.5% national HIV prevalence 
rate among women attending antenatal clinics in the public health services in 
South Africa for 2000.   On the basis of the information obtained in the 
survey, it has been projected that there are approximately 4.68 million people 
in South Africa living with HIV/AIDS.  This is more than 10% of the 
population of South Africa.

45.	The scale and continued growth of the number of people with HIV/AIDS is a 
national crisis.

46.	During his closing address to the XIII International AIDS Conference in 
Durban on 14 July 2000, former President Nelson Mandela referred to the 
epidemic as a "tragedy of unprecedented proportions" and stated that 
"something must be done as a matter of the greatest urgency".  He concluded: 
"We need bold initiatives to prevent new infections among young people, and 
large-scale actions to prevent mother-to-child transmission". A copy of his 
speech is attached marked H.

47.	The HIV/AIDS & STD Strategic Plan for South Africa 2000-2005 (Strategic 
Plan - Annexure I) compiled by the Respondents suggests that the HIV 
epidemic in South Africa is one of the fastest growing epidemics in the world. 
 Young women aged 20-30 have the highest prevalence rates.  Young women 
under the age of 20 had the highest percentage increase in infection.

MOTHER TO CHILD TRANSMISSION

48.	The Human Immunodefiency Virus (HIV) is transmitted in a very few basic 
ways: through unprotected sexual intercourse, from infected blood and blood 
products, from a pregnant woman in utero during delivery, and from 
breastfeeding from an infected mother.

49.	The subject matter of this application is the transmission of HIV from an 
infected mother to her infant, around the time of birth (intrapartum 
transmission) and thereafter through breastfeeding. Mother-to-child 
transmission is also known as vertical transmission.



50.	In South Africa, of the women with HIV who give birth to a child, 
approximately one third of women will give birth to a child with the virus.  It 
is estimated that approximately 70 000 new infections occur each year in 
South Africa as a result of mother-to-child transmission of HIV.  Most of this 
infection takes place during and around the time of the birth of the infant, 
through intrapartum transmission.  This is the most common way in which 
HIV is transmitted to children.

51.	The 2000 report does not indicate how many babies will be born with HIV.  
However, the 1999 survey stated that during that year, between 94 608 and 
102 000 babies would have been born with HIV.

ANTI-RETROVIRAL DRUGS AND MOTHER-TO-CHILD 
TRANSMISSION
 
52.	The affidavit of Professor Wood describes the studies which have been done 
of the use of various anti-retroviral drugs in order to prevent or reduce 
mother-to-child transmission of HIV.

53.	The Bangkok Perinatal AZT Study (also known as the Thai Study), the 
results of which were announced in February 1998, tested the safety and 
efficacy of short-course AZT therapy.  The Thai Study demonstrated a 
reduction of mother-to-child HIV transmission by 50%, by using 300mg twice 
daily from the 36th week of pregnancy, and 300mg every two hours during 
labour.



54.	The Thai study offered hope to people in developing countries because this 
relatively short course AZT regimen was much cheaper than the regimens that 
had previously been tested, and could be incorporated into the prevention 
programmes of those countries.  Thailand introduced a country-wide mother-
to-child HIV prevention programme in 1999.  According to the World Health 
Organisation, Thailand has halved HIV infection in newborn children.  That 
country is now providing technical assistance to other countries in the 
Mekong Region.  As Professor Nattrass and many other economists have 
shown, even the Thai regimen is cost-effective and cost-saving to the South 
African government.

55.	Whilst the Thai Study indicated that AZT reduces the rate of vertical 
transmission of HIV in non-breastfed populations, studies in Côte d'Ivoire 
and Burkina Faso showed significant reductions in breastfeeding populations. 
 Results published in March 1999 indicated that short course AZT given 
before birth was well accepted and tolerated, and provided a 38 percent 
reduction in vertical transmission despite breastfeeding.

56.	At Khayelitsha in the Western Cape, significant reductions of approximately 
50% in mother-to-child HIV transmission have been recorded since January 
1999 by using the short-course Thai AZT programme.

NEVIRAPINE

57.	Nevirapine is a fast-acting and potent antiretroviral with a long half-life.  This 
means that it takes long to be eliminated from the body.  It is considered to be 
a valuable option for reducing the risk of mother-to-child transmission of 
HIV, for various reasons.  It is absorbed quickly in the body, and passes 
readily through the placenta.  Only a limited dose is needed .  It remains 
active in the body of both mother and infant for a period which could limit 
HIV infection.



58.	Various studies were accordingly performed to test the effectiveness and 
safety of Nevirapine for use in the prevention of mother-to-child transmission 
of HIV.

59.	The initial study was the ACTG 250 study, which was carried out in seven 
hospitals in the USA and Puerto Rico.  This was followed by the HIVNET 
006 trial, which was conducted in Uganda.

60.	The positive results of pharmacokinetic and safety studies of Nevirapine 
prompted larger clinical trials to evaluate the efficacy of Nevirapine for the 
prevention of mother-to-child transmission.

61.	The HIVNET 012 study was a randomized controlled trial conducted in 
Uganda.  It compared short-course use of AZT and Nevirapine as a means of 
preventing mother to child transmission.  The Nevirapine treatment was a 
maternal single 200mg oral dose of Nevirapine during labour and an infant 
2mg/kg dose of Nevirapine within 72 hours of birth.  The study was 
conducted in a breastfeeding population.

62.	The results showed lower rates of HIV infection in infants treated with 
Nevirapine, than in those who had been treated with AZT.

63.	The HIVNET 012 researchers cited as advantages of Nevirapine, its 
simplicity, low cost and potential for widespread use because of the ease of 
administration of the drug.  Compared with other antiretroviral treatment, it 
achieves a similar reduction of transmission in a single dose.  Mother-infant 
pairs continued to confirm that Nevirapine was safe and significantly reduced 
the mother-to-child transmission rate by comparison with AZT.



64.	After the publication of the HIVNET 012 results, the World Health 
Organisation placed Nevirapine on its Essential Drug List for the prevention 
of mother-to-child transmission of HIV.

65.	In South Africa, the South African Intrapartum Nevirapine Trial (SAINT 
study) was carried out.  1306 HIV-infected women participated in this study.  
They were assigned to 2 arms, comparing 200mg of Nevirapine during labour 
and 1 dose to mother and infant 24-48 hours after delivery, with multiple 
doses of AZT and 3TC during labour and for 1 week after delivery to mother 
and infant.

66.	The SAINT study demonstrated that HIV transmission from mother to child 
could be reduced by more than 50% through the administration of Nevirapine 
in this manner.  The cost of the Nevirapine would be less than R30.00 per 
mother and child.

NEVIRAPINE REGISTRATION BY THE MEDICINES CONTROL 
COUNCIL FOR PREVENTING MTCT

67.	During November 1999 Boehringer Ingelheim, the manufacturers of 
Nevirapine, submitted the drug to the Medicines Control Council for 
registration for the prevention or reduction of mother-to-child transmission of 
HIV.



68.	Early this year, the MCC resolved that Viramune (Nevirapine) is indicated for 
the reduction in risk of intrapartum transmission of HIV-1 from mother to 
child in patients who have been tested for HIV and appropriately counselled. 
It registered Nevirapine accordingly.  I attach marked J a letter from the 
Department of Health to the South African Human Rights Commission, 
setting out the terms of this registration.

69.	The MCC found that Viramune (Nevirapine) may be used alone, as a single 
oral dose of 200 mg to the mother during labour, preferably more than 2 hours 
before delivery, and a single dose of 2 mg/kg to the infant within 48 to 72 
hours after birth or before discharge, whichever is earlier.

70.	The MCC concluded that to reduce the risk of intra-partum transmission of 
HIV-1 from  mother to child in pregnant women who are not taking anti-
retroviral therapy at the time of labour, patients should be counselled before 
initiating therapy that breast-feeding is a contra-indication.  Patients should 
also be counselled on the advisability and appropriate use of alternative 
feeding.

71.	The fact that the Medicines Control Council has registered Nevirapine for use 
to reduce the risk of mother-to-child transmission of HIV means that it has 
authoritatively been found to be suitable for this purpose, and that it is safe, of 
acceptable quality, and therapeutically efficacious.

72.	After ten years of use of Nevirapine as daily, lifelong treatment, there have 
been reports of serious adverse effects including reports of five deaths in 
women in Europe, the US and South Africa who had used Nevirapine on a 
daily basis as chronic medication together with other antiretrovirals.  The 
European Medicines Evaluation Agency issued a public statement in April 
2000 drawing attention to the risk of liver disease from the use of Nevirapine.



73.	These adverse effects have always related to a very small percentage of 
people who use the medication for sustained treatment.  They have not been 
observed after the use of a once-off dose of Nevirapine to prevent mother-to-
child transmission.

74.	There is no scientific or clinical evidence which shows that Nevirapine used 
in this manner causes any illness in either the mother or the child.

75.	The First Respondent acknowledges in her letter (Annexure E) that there is 
evidence that Nevirapine is effective in the prevention of intra-partum 
transmission.

76.	The result of the registration of Nevirapine for this purpose is that doctors in 
the private profession can and do prescribe Nevirapine for their patients 
when, in their professional judgment, it is appropriate to do so.

77.	However, doctors in the public sector are generally not able to do this.  The 
reason for this is that the Respondents have refused to make Nevirapine 
generally available in the public health sector, despite its acknowledged 
effectiveness.  I deal further with this below.

THE BOEHRINGER INGELHEIM OFFER

78.	On 7 July 2000, Boehringer Ingelheim announced that it would make 
Viramune (Nevirapine) available to governments in developing economies 
(including South Africa) free of charge for a period of five years, for use to 
reduce mother-to-child transmission of HIV.



79.	The company stated in a press release that its donation was motivated by 
research that indicated that if all pregnant women in South Africa took a short 
course of Nevirapine, 110 000 infant HIV infections could be prevented over 
a period of five years.  A copy of the press release is attached marked K.

80.	This offer was an offer only to governments.  Regrettably it is not open, for 
example, to private health providers and health care providers in the social 
sector.

81.	Because the Respondents have refused to make Nevirapine generally 
available in the public health sector for this purpose, they have not yet 
accepted the offer by Boehringer Ingelheim.   However, the offer remains 
open to them.

82.	The result is that although Nevirapine is potentially available for free in South 
Africa, this has not materialised.



NEVIRAPINE RESISTANCE

83.	In her letter to the Applicants' attorney (E), the First Respondent states that a 
"concern that pre-occupies us in relation to the use of NVP [Nevirapine] for 
the prevention of MTCT [mother-to-child transmission] relates to resistance".

84.	As is pointed out by Professor Wood, an early study found that 3 of 15 
women receiving a single-dose of Nevirapine in the HIVNET 006 study had 
the K103N Nevirapine resistant mutation identified at 6 weeks postpartum.



85.	There is a continuing process of mutation of this virus.  As a consequence, 
some variants containing anti-retroviral reststant mutations occur naturally, ie 
in the absence of drug pressure, at low frequency.  These variants are rapidly 
selected in the presence of drug selection pressure.

86.	The mutations cause no harm to the mother, except that they may make her 
resistant to treatment with that class of anti-retrovirals for as long as they 
remain there.  Where the mother is receiving anti-retroviral treatment, 
treatment options for her may need to be tailored to avoid certain classes or 
combinations of drugs.  Triple drug therapy would be expected to be effective 
even in the presence of Nevirapine-resistant mutations.  There is no evidence 
that Nevirapine negatively affects the health of the mother after a single or 
double dose.

87.	The mutations are transient and short-lived, after which it can be assumed that 
that class of anti-retrovirals will again be effective.  This suggests that the 
disease may be susceptible to a second exposure to Nevirapine during a 
subsequent pregnancy, or as part of the subsequent treatment of the mother.

88.	Since the majority of women do not have access to anti-retroviral treatment, 
the impact on mothers of resistance is small.  It is far outweighed by the 
positive results Nevirapine has in preventing mother-to-child transmission of 
HIV.

89.	There is no evidence that Nevirapine accelerates progression of the HIV 
disease or increases transmissibility of HIV.



90.	There is no evidence that the transient appearance of these mutations causes 
any public health risk.  The apparently Nevirapine-induced mutations which 
were observed in mothers and babies in the Ugandan studies were different.  
This indicates that they arose de novo in mothers and infants and were not 
transmitted.  In any event, they are transient and short-lived.

91.	The fact that relatively short-lived Nevirapine-resistant mutations develop in 
some cases after treatment with Nevirapine, does not affect the efficacy of the 
treatment.  It does not provide any reason not to prescribe Nevirapine in 
appropriate cases.



BREAST FEEDING AND FORMULA FEEDING

92.	Breastfeeding is the cheapest and nutritionally most desirable way to feed 
infants.  In general, breastfeeding remains one of the most effective strategies 
to improve chances of child survival.  This is because breast milk provides for 
the infant's fluid and nutritional requirements, as well as growth factors and 
antibacterial and antiviral agents that protect the infant from disease.

93.	HIV can be transmitted from mother to child through breastmilk.  As the First 
Respondent points out in her letter to the Applicants' attorney (E), "a 
percentage of the babies who, as a result of the use of NVP, are born HIV 
negative, nevertheless sero-convert and become HIV positive in the months 
that follow their birth....  the most compelling reason for this sero-conversion 
is the fact that the HIV positive mothers were breast-feeding their babies."

94.	I wish at the outset to make two points in this regard.



95.	First, as pointed out by Professor Wood, the evidence does not show any 
"catch-up" in this regard.  That is, in a breastfeeding population of infants 
born to mothers with HIV, there will be a steady increase in HIV among the 
infants who did not receive Nevirapine treatment at the time of birth.  
Similarly, there is a steady increase in HIV among the infants who did receive 
Nevirapine treatment at the time of birth.  But at all times, those who received 
the treatment have a substantially lower rate of HIV-positivity than those who 
did not do so.  In other words, the benefits of the treatment are retained in a 
breast-feeding population.

96.	Secondly, the fact that "a percentage" of the babies who are born HIV 
negative will subsequently become HIV positive as a result of breast-feeding, 
is no reason to deny the unquestioned benefits of this treatment to all of the 
babies.

97.	There is no evidence, nor is there any suggestion, that babies who are born 
HIV-negative and subsequently become HIV-positive are any worse-off 
through having received Nevirapine at the time of their birth, or suffer any 
adverse affects.

98.	There is also no evidence, nor is there any suggestion, that the health of the 
mother is prejudiced in any way through the provision of a single dose of 
Nevirapine at the time of the birth.

99.	It is true that the avoidance of breast-feeding will reduce the risk of 
transmission of HIV after the infant's birth.  There is also some evidence that 
breast-feeding may be potentially harmful to the health of a mother who has 
HIV.  None of this is any argument for failing to provide Nevirapine at the 
time of birth.  It does raise issues about what measures should be taken to 
prevent or reduce mother-to-child transmission through breast-feeding.



100.	Alternative feeding options such as formula feed reduce this risk.  Since 1992, 
it has therefore been recommended that where feasible, women with HIV be 
counseled to formula feed.  Formula feed has been shown to be the most 
effective way to reduce the risk of mother to child transmission after 
childbirth.  The high cost of formula feed could be alleviated through bulk 
buying by the government and providing it for free to mothers who choose to 
breast-feed, or through negotiations with the manufacturers.  However, the 
choice must be that of the pregnant woman.

101.	In poor communities women sometimes do not have access to clean water or 
to high-cost formula feed.  In all contexts, it is desirable that women should 
be given clear information to enable them to make informed choices, and 
provided with formula feed when they choose alternative feeding and cannot 
afford to provide this themselves.

102.	The cost of formula feed and access to safe drinking water are factors in 
deciding whether to recommend formula feed to mothers. Counseling 
regarding the risks and benefits of available infant feeding methods and how 
to make the chosen method as safe as possible is the only way to resolve the 
dilemma until clean water is provided to all poor communities. The World 
Health Organisation has advised that HIV positive women in resource-poor 
areas should be encouraged to make an informed choice about infant feeding, 
weighing both its relative risks and its potential benefits.  Women should be 
given full information, and supported in their choice to breast-feed or formula 
feed, where such a decision is made.



103.	But whether or not mothers with HIV breast-feed, a significant percentage of 
their children will receive permanent benefits through having had Nevirapine 
administered at birth. 

104.	In her letter to the Applicants' attorney (E), the First Respondent states that 
the  government has decided "to provide breast milk substitutes for women 
who use NVP during delivery as part of our prevention of MTCT programme. 
 This is comparatively easy to manage in the urban environment but it is 
considerably more difficult to organise outside of the cities…"

105.	As I have pointed out above, the provision of breast milk substitutes is not 
essential in order to obtain substantial benefit from the provision of 
Nevirapine.  The provision of breast milk substitutes in appropriate cases 
would further reduce mother to child transmission.  The provision of breast 
milk substitutes can be relatively easily managed in some situations.  Yet the 
attitude of the Respondents is apparently that

105.1	they will not provide Nevirapine unless they can also provide breast 
milk substitutes; and 

105.2	they will not provide breast milk substitutes in those areas where it is 
relatively easy, until they can do it in all areas.



 	
106.	 What this amounts to is refusing to make Nevirapine available to someone 
who is able to use it highly effectively, because people in some other areas 
can only use it less effectively.
  
107.	I respectfully submit that such a policy is irrational in the extreme.  It leads 
inevitably to avoidable mother-to-child transmission of HIV.

WORLD HEALTH ORGANISATION RECOMMENDATIONS

108.	 The World Health Organisation (the WHO) is a specialised agency of the 
United Nations Organisation.  It is an inter-governmental organisation.  It is 
the most highly authoritative international organisation on public health 
issues.  On this particular issue it forms part of the Joint United Nations 
Programme on HIV/AIDS, which is known as UNAIDS.

109.	A recent UNAIDS/WHO Report, entitled "New Data on the Prevention of 
Mother to Child Transmission of HIV and their Policy Implications", was 
released in January 2001.  In this Report a Technical Consultation - consisting 
of expert scientists and programme managers fom different regions, UN 
agencies, governments, HIV-infected mothers, and non-governmental 
organisations implementing MTCT-prevention programmes - made known its 
conclusions and recommendations on the use of antiretroviral drugs.  South 
Africa was represented at this Consultation by the Chief Director of 
HIV/AIDS and Sexually Transmitted Diseases in the Department of Health, 
Dr. Nono Simelela.

110.	I set out below some of the key findings and recommendations of this 
authoritative Consultation on the prevention of mother to child transmission of 
HIV.  A copy of the Report is attached marked L.



111.	Short-term efficacy of antiretroviral prophylactic regimens:  The 
Consultation concluded that the simplest effective regimen includes single 
dose intrapartum/postpartum Nevirapine. The mechanisms by which these 
regimens provide protection against the mother-to-child HIV transmission 
include decrease of viral replication in the mother and/or prophylaxis in the 
infant during and after exposure to the virus.

112.	Long-term efficacy of antiretroviral prophylactic regimens:  The 
Consultation concluded that the long-term efficacy of short-term Nevirapine 
regimens has been demonstrated by infant status through 12 to 24 months.  
This shows that the early reduction in HIV transmission persists despite 
continued exposure to HIV during breastfeeding.

113.	Safety of antiretroviral prophylactic regimens:  The Consultation 
concluded that the short-term safety and tolerance of the effective 
antiretroviral prophylactic regimens has been demonstrated in all of the 
controlled clinical trials.  The effective antiretroviral prophylaxis regimens 
have not been associated with an excess of severe adverse events (including 
mortality).  They concluded that the benefit of these drugs in reducing mother-
to-child HIV transmission greatly outweighs any potential adverse effects of 
drug exposure.

114.	Selection of resistant viral populations:  The Consultation concluded that 
the benefit of decreasing mother-to-child HIV transmission with these 
antiretroviral drug prophylaxis regimes greatly outweighs concerns related to 
development of drug resistance. 



115.	Breastfeeding and alternative feeding:  The Consultation recommended 
avoidance of all breastfeeding by HIV-infected mothers when alternative 
feeding is acceptable to the woman, and it is feasible, affordable, sustainable 
and safe.  Otherwise, exclusive breastfeeding is recommended during the first 
months of life.  Decisions in this regard must be based on counselling the 
woman.

116.	The Consultation further concluded that:

116.1	the implementation of the antiretroviral drug regimens (including 
Nevirapine) could be recommended for general implementation;
116.2	the safety and effectiveness of antiretroviral (ARV) regimens which 
prevent HIV transmission from mother to child warrant their use 
beyond pilot projects and research settings; and
116.3	the prevention of mother-to-child transmission should be part of the 
minimum standard package of care for women who are known to be 
HIV infected and their infants.

CONCLUSIONS ON NEVIRAPINE

117.	I submit that the use of antiretroviral therapy, such as Nevirapine, in the 
prevention of mother-to-child transmission of HIV significantly reduces the 
risk of HIV transmission from mother to child, is safe for both mother and 
infant, and is a critical public health care measure.  The use of Nevirapine for 
this indication is simple, cheap and consistent with the recommendations of 
international health authorities.



118.	I submit that it is clear from the above that there is a national and international 
scientific and medical consensus that Nevirapine is a safe, effective and 
affordable option for resource poor settings such as many parts of South 
Africa.

119.	In any event, as Nevirapine is registered for this purpose by the Medicines 
Control Council, it has authoritatively been found to be safe and effective for 
this purpose by the body designated by Parliament to make such decisions in 
South Africa.

THE AVAILABILITY AND USE OF NEVIRAPINE IN SOUTH AFRICA

120.	As appears from the affidavit of Professor Keith Bolton and Professor Peter 
Cooper (M), private medical practitioners in South Africa now regularly 
prescribe Nevirapine for pregnant women with HIV and their infants, when in 
their view this is medically indicated.

121.	However, Nevirapine is not generally available in the public sector.  The 
reason for this is that the Respondents have decided to limit its availability in 
the public sector to two pilot sites in each of the nine provinces.  I describe 
the pilot programme more fully below.

122.	There is a national tender system though which medicines are purchased for 
the public health system.



123.	In principle it is possible for a hospital to buy a medicine that is not on the 
tender.  However, in the case of Nevirapine this has not generally happened 
because of the policy, adopted by the Respondents, who are the political 
heads of the Departments under which those facilities fall, that Nevirapine 
should not be made available in the public health sector outside the 18 pilot 
sites.  In addition, tight financial constraints discourage the use of a hospital's 
budget in order to buy medicines off-tender.

124.	Despite this, some medical practitioners in the public health sector have made 
every effort to make Nevirapine available to their patients when in their 
professional judgment this is desirable.

125.	The result has been that in some cases, this has been achieved by one of the 
following methods.  Some patients are referred from a hospital to another 
hospital in the district, which has been designated as a pilot site.  Some 
hospitals have sought donations of funds to enable them to buy Nevirapine.  
In other cases, the institution has bought Nevirapine.

126.	This has alleviated the consequences of the Respondents' policy to a limited 
extent.  However, it has not solved the problem, for the following reasons:

126.1	The Nevirapine has to be paid for when it could be available for free in 
terms of the offer made by Boehringer Ingelheim.  This naturally limits 
the willingness and ability of administrators to use scarce resources for 
this purpose. 

126.2	Referral to other hospitals is only possible where there is a pilot site in 
the district.  Even where that is possible, the time and money of 
patients is wasted by their having to travel to a less conveniently 
situated hospital. 

126.3	It is fundamentally inequitable that whether a patient receives the 
medicine which she needs, and which could be available for free, 
depends on where the hospital or facility treating her is located, and 
whether the medical practitioners or the hospital administrators are 
willing to act in a manner which is perceived to be contrary to the 
official policy of the Respondents.

127.	On 17 July 2001 Mark Heywood, Project Head of the AIDS Law Project 
based at the University of the Witwatersrand, wrote to Mr Sagie Pillay, Chief 
Executive Officer of the Johannesburg Hospital, asking whether that hospital 
has a programme for the prevention of mother-to-child HIV transmission, and 
particularly, whether Nevirapine is provided to women who are pregnant and 
who know that they are HIV-infected.  Mr Heywood asked Mr Pillay if 
Nevirapine was not available, to explain why and to provide him with a copy 
of any policy prohibiting its use at the hospital.

128.	 I attach marked N a copy of Mr Pillay's reply of 23 July 2001.  While parts 
of the letter are not entirely clear, what is clear is that:

128.1	the Johannesburg hospital has no programme for the prevention of 
mother-to-child transmission with the use of Nevirapine, because it is 
not a pilot site;

128.2	the hospital is keen to see the implementation of a cost effective and 
affordable prevention programme of mother-to-child HIV transmission 
in the immediate future. 

128.3	the Johannesburg Hospital "works within the frame work of National 
and Provincial policies and guidelines".

129.	In the experience of the TAC, this attitude of the Chief Executive Officer of 
one of South Africa's largest hospitals is typical of the attitude of hospital 
administrators.

130.	The exception to this is the Western Cape.  As appears from Annexures D1 
and D2, there, the provincial Minister of Health has put in place an extensive 
mother-to-child transmission programme which, the Tenth Respondent 
estimates, currently reaches an estimated 50% of all HIV positive women in 
the province.  That Ministry advises that Nevirapine should be provided as 
part of a package of services including voluntary counselling and testing in the 
antenatal period and formula feed (for those who choose it), cotrimoxazole 
prophylaxis and infant testing in the follow-up period.  In areas where this 
package is not yet available, if a practitioner is of the opinion that Nevirapine 
is indicated in an individual situation, he or she is free to exercise his or her 
discretion.

131.	This demonstrates that such a policy is feasible and workable, and can be 
reasonably implemented.

132.	The First to Ninth Respondents have not, in response to the letter from the 
Applicants' attorney, given any reason why this policy could not be followed 
nationally or in their respective provinces.

THE ATTITUDE OF THE HEALTH PROFESSIONALS


133.	Many doctors in the public sector wish to prescribe Nevirapine for their 
patients, but are unable to do so, because of the policy of the Respondents. 

134.	As appears from the affidavit of Professor Bolton and Professor Cooper, the 
South African Paediatrics Association (SAPA) has approximately 250 
members.  SAPA represents about half of the paediatricians in South Africa.

135.	The Executive Committee of SAPA is of the opinion that it is essential that 
Nevirapine be made generally available in the public sector for the prevention 
of mother-to-child HIV transmission, to be prescribed where in the 
professional judgment of the relevant health professional, this is in the best 
interests of his or her patient.

136.	In the experience of the Executive Committe of SAPA, there are many 
paediatricians in the public sector who wish to prescribe Nevirapine for their 
patients in order to prevent or reduce mother-to-child HIV transmission, but 
are unable to do so because in accordance with the policies of the 
Respondents, Nevirapine is generally only made available at the pilot sites.

137.	As appears from the affidavit of Dr Saloojee (the Second Applicant), in 
November 2000 he, along with a number of concerned paediatricians, 
launched a campaign called "Save Our Babies".  The purpose was to declare 
their stance as paediatricians on HIV/AIDS issues, particularly in relation to 
children.  The campaign arose from their perception that although 
paediatricians dealt with the effects of the HIV/AIDS epidemic on a daily 
basis, their opinions on these issues were not being effectively voiced, and 
where they had been communicated to the Ministry of Health, their 
suggestions had been ignored.



138.	"Save Our Babies" organised a petition campaign during two weeks in 
November 2000.  In those two weeks, they collected 273 signatures from 
paediatricians and child health practitioners around the country in support of 
the implementation of a mother to child transmission reduction programme.  
This petititon was formally handed over to a representative of the Minister of 
Health at Chris Hani Baragwanath on World AIDS Day 2000.  No response 
was received.

139.	On 6 July 2001 the co-ordinators of the Save Our Babies campaign (including 
the Second Applicant) distributed by e-mail a letter describing this litigation 
by TAC and inviting recipients to indicate their support for it.

140.	Approximately 150 health professionals have, in reply, indicated their support 
for this litigation.  A list of their names is attached to the affidavit of Dr 
Saloojee.  The majority of the signatories are working in the public health 
sector.

141.	Professor Max Price is the Dean of the Faculty of Health Sciences of the 
University of the Witwatersrand.  This is a leading institution for the training 
of medical practitioners in South Africa.  It undertakes research, teaching and 
the provision of medical services to patients.  In Professor Price's capacity as 
Dean of the Faculty, part of his responsibility is to ensure that he is well 
informed on major public health issues in South Africa, such as HIV/AIDS.

142.	As appears from Annexure O, according to Professor Price:



142.1	the medical evidence, as confirmed by the registration by the MCC, 
demonstrates that Nevirapine is an effective and safe means of 
preventing or reducing mother to child transmission of HIV.

142.2	it is regularly used by practitioners in private practice, who prescribe it 
when they consider that the circumstances are appropriate.

142.3	what are appropriate circumstances is a matter best left to the judgment 
of the individual practitioner in individual cases.  This is not a matter 
on which it is appropriate to make a general rule applying throughout a 
sector of the health system. 

142.4	the interests of equity require that Nevirapine be made available in the 
public sector on the same basis as the private sector.  This is 
particularly so given that the manufacturer has offered to make it 
available for free for five years for this purpose.

142.5	it is desirable in the public interest and the interests of patients that 
Nevirapine be made available in the public health sector when the 
qualified health professional attending the patient considers this 
appropriate, and that a programme be instituted to make it possible for 
health professionals to prescribe the drug whenever they consider this 
to be in the interests of their patients.

THE 'PILOT' SCHEME



143.	As I have stated above, in July 2000 the researchers on the SAINT study 
released the preliminary findings on the efficacy of Nevirapine to reduce 
mother to child transmission.  These results showed that the administration of 
a double dose Nevirapine to mother and child reduced HIV transmission by 
50%.

144.	On 12 and 13 August 2000, representatives of the Respondents attended a 
Strategic Planning Meeting on HIV/AIDS in Benoni.  A report compiled by 
the Department of Health was presented, summarising the information 
presented on various issues, including mother to child transmission, at the July 
2000 International AIDS Conference in Durban.  This included the results of 
the SAINT study.

145.	Following the meeting, the First Respondent announced that Nevirapine could 
not be used outside approved research environments, and added that 
provinces would select two sites each for further research on Nevirapine.  She 
stated further that that Nevirapine should not be used outside an approved 
research site.

146.	When they are all fully operational, these sites will each year enable 90 000 
pregnant women to be tested and, if necessary, to obtain Nevirapine through 
the public health system.  This amounts to only 10% of the women who give 
birth each year.

147.	In a press statement released following the meeting, the First Respondent 
announced that the purpose of the pilot projects was to improve understanding 
of the operational challenges attendant on providing antiretrovirals in the 
public health system. A copy of the press release following this meeting is 
attached marked P.



148.	It is clear from documentation produced by the government that the purpose 
of the pilot projects is to assess the "operational challenges inherent in the 
introduction of anti-retroviral regimen for the reduction of vertical 
transmission in rural settings as well as in urban settings" in South Africa, and 
not to investigate the efficacy and safety of Nevirapine.  In this regard I 
respectfully refer to the "Protocol for Providing a Comprehensive Package of 
Care for the Prevention of Mother to Child Transmission of HIV (PMTCT) in 
South Africa", which is attached marked Q.   This document was produced by 
the national Department of Health and researchers associated with its work.

149.	The document acknowledges that "there is sufficient scientific evidence 
confirming the efficacy of various anti-retroviral (ARV) drug regimens in 
reducing the transmission of HIV from mother to child".  Indeed, the 
government could hardly contend otherwise, given that the MCC has 
registered the drug for this purpose.

150.	The Applicants recognise that the most effective way of preventing mother to 
child transmission is through an integrated and national programme, and that 
it is essential that such a programme be devised and implemented.

151.	However, the Applicants cannot and do not accept that this provides a 
rational or lawful basis for depriving patients at places other than the pilot 
sites, of the undoubted benefits of Nevirapine, even if at this stage the 
provision can not be done as part of a broader integrated strategy.

152.	Many facilities outside the pilot projects in urban and rural areas are already 
able to provide counselling, testing, and the administration of Nevirapine 
where appropriate.



153.	Ensuring the wide availability of Nevirapine is the most efficient means to 
provide the broadest protection against HIV transmission, while a nationwide 
programme is devised, implemented and improved.

154.	That this is so, is demonstrated by the fact that in the private medical sector, 
there is no constraint on doctors exercising their professional judgment to 
decide whether the use of Nevirapine is indicated in particular cases.  It is 
further demonstrated by the fact that this is already being done in the Western 
Cape.

155.	 Public health professionals in the public sector are every bit as qualified and 
competent as their colleagues in the private sector to decide, on a case-by-
case basis, whether the prescription of Nevirapine is in the interests of their 
patients.

156.	The effect of the decision not to provide Nevirapine except at the pilot sites is 
to prevent women and children at other places, who in the professional 
opinion of their medical practitioners need Nevirapine, from obtaining it until 
the two-year pilot programme has been completed.  By then, it will be too late 
for the unfortunate children who have been infected with HIV because they 
were unable to obtain Nevirapine.

157.	I attach marked R a copy of a presentation on the pilot projects by Celicia 
Serenata, who is Deputy Director in the HIV/AIDS and Sexually Transmitted 
Diseases Directorate of the national Department of Health.

158.	The fifth page of that presentation, headed "The Rough Figures", states as 
follows:



		-	Currently, 77 175 infants will be infected each year through mother to 
child transmission if Nevirapine is not provided

		-	If Nevirapine is provided for this purpose, 28 665 infants will be 
infected each year.

159.	What this means is that on the figures provided by the Department of Health, 
without the provision of Nevirapine almost 100 000 babies will unnecessarily 
contract HIV during the next two years.  The pilot projects will provide 
Nevirapine to about 10% of those babies.  Approximately 90 000 babies not 
covered in the pilot sites will not receive Nevirapine, and a very substantial 
number of them will die as a result of having contracted HIV.

160.	Whatever the precise statistics may be, the failure to provide Nevirapine will 
result in the unnecessary and avoidable death of many infants.  Those infants 
will die because they and their mothers have not been treated with Nevirapine 
at the time of their birth.  This is clearly a violation of the rights of the child 
including its right to life.

161.	The Applicants submit that there is no rational reason why doctors in public 
hospitals that do not fall within the pilot projects are not permitted and 
encouraged to prescribe Nevirapine to those of their patients to whom they or 
their colleagues can offer advice and an appropriate level of care.

162.	The policy of the Respondents effectively substitutes a blanket official 
decision for decisions made by medical practitioners who are well qualified to 
make those decisions in the light of the circumstances of their individual 
patients.  This has catastrophic results for the people affected, and for the 
country.



COST AND BENEFITS OF NEVIRAPINE

163.	The SAINT study confirmed that the drug costs for Nevirapine would be less 
than R30.00 per woman and child.

164.	As I have pointed out, the manufacturers of the drug have offered to make it 
available to the government for free for five years, for this purpose.  So even 
that modest cost of R30.00 would not arise if the government were to make 
Nevirapine generally available through the public health system.  In addition 
to making a free offer for the prevention of mother-to-child HIV transmission, 
the price of Nevirapine has been reduced by more than two-thirds making the 
cost of the drug R10.00 since 08 January 2001.  

165.	The cost of enabling medical practitioners simply to prescribe Nevirapine for 
pregnant women who already know they have HIV would therefore be 
entirely nominal.  However, the Respondents' policy prevents medical 
practitioners from doing this.

166.	As a matter of urgency, our country needs a comprehensive and integrated 
programme for preventing mother to child HIV transmission.   This requires 
testing, counselling, the provision of anti-retroviral therapy such as 
Nevirapine and the provision of infant milk formula where this is the choice of 
the mother after she has been properly informed.

167.	As appears from D1, the Tenth Respondent has already put this in place.  He 
estimates that the programme already reaches 50% of pregnant women with 
HIV in his province, and will reach 90% in the next phase of the roll-out.



168.	By contrast, the other Respondents have no clear plan for a comprehensive 
roll-out.  They will still be testing implementation for the next two years.  
During that period, practitioners in the public health sector will not even be 
able to prescribe Nevirapine for their patients.

169.	In January 1999, the Medical Research Council released a costing study by 
Professor David Wilkinson, Ms Katherine Floyd and Dr. Charles F. Gilks on 
preventing mother-to-child HIV transmission though the provision of short 
course zidovudine, infant milk formula and counselling.  The results of the 
study (Annexure S) may be summarised as follows:

169.1	An estimated 64 398 paediatric HIV infections occurred from mother-
to-child transmission in South Africa in 1997.  This represents 11% of 
the estimated global total of new infections. 

169.2	Approximately 37% of infections from mother to child could be 
prevented through a national programme which included short course 
zidovudine, infant milk formula and counselling. 

169.3	The estimated total cost of the national programme would be R160.54 
million, which is less than 1% of the national health budget or R3.73 
per capita

169.4	The study concluded that a national programme to reduce mother-to-
child transmission of HIV infection in SA would be an affordable, 
cost-effective and potentially cost-saving public health intervention.



170.	This study was conducted at a time when it was not known that short course 
Nevirapine, which is significantly less expensive than zidovudine even if one 
has to pay for it, is an effective means of prevention.

171.	The Respondents have commissioned their own costing study, which was 
conducted by Martin Hensher, a consultant in health economics.  This study 
(Annexure T) was completed in April 2000.  The Hensher study had regard to 
the cost savings which would result from such a programme, through avoiding 
the need for HIV-related care for infants for whom the programme 
successfully prevented infection.  It concluded that the Nevirapine 
programme might actually achieve an overall saving of R270 million - that 
is, additional savings after paying for its own cost.  While it expressed 
caution as to the extent of savings which would be achieved in reality, 
because of operational factors, it appeared likely that there would be a 
substantial net saving.

172.	Professor Nicoli Nattrass, of the School of Economics of the University of 
Cape Town, is Director of the Centre for Social Science Research and 
founder of the AIDS and Society Research Unit at the University of Cape 
Town.  She has undertaken an extensive and detailed analysis of the 
economics of mother to child transmission of HIV in South Africa.  I attach 
marked U an affidavit by her, in which she sets out in detail her analysis and 
methodology.

173.	Professor Nattrass concludes that unless the government is planning to deny 
health care to all children with HIV, an integrated programme to reduce 
mother to child transmission will save the government money.



174.	She finds further, on examining various treatment options, that a mother to 
child transmission reduction programme using Nevirapine has the greatest 
potential to save lives, and saves the government the most money.

175.	Professor Nattrass concludes, on the basis of a detailed examination of the 
economic factors, that there are "no credible economic arguments to the effect 
that the South African government cannot afford a programme to reduce 
MTCT of HIV.  This is particularly the case with regard to the Nevirapine 
intervention which entails a single dose to the mother and child."

176.	The significance of these programmes is that they provide a costing of an 
integrated programme for the prevention of mother-to-child transmission of 
HIV.  In other words, they include the cost of voluntary counselling and 
testing, the provision of medicines, and the provision of formula feed in 
appropriate cases.

177.	I respectfully submit that even in the absence of the Boehringer Ingelheim 
offer to which I have referred, an integrated programme involving the 
provision of Nevirapine to pregnant women with HIV is affordable for the 
Respondents, and will actually save costs.

THE APPROACH OF THE GOVERNMENT

178.	I have already referred to the continued and continuing refusal of the 
government to make even a minimalist intervention to prevent mother-to-child 
transmission through making a free drug available on the prescription of a 
qualified health professional.



179.	In this section of this affidavit, I deal with the government's continued failure 
to put in place a policy and to implement a programme that will in due course 
result in integrated programme on a comprehensive basis, despite repeated 
undertakings to that effect.

180.	In August 1992, the National AIDS Convention of South Africa (NACOSA) 
was launched.  NACOSA had its origins in discussions between the Health 
Secretariat of the African National Congress and the then Department of 
National Health and Population Development.  It was a broadly-based body 
which included representatives of business, trade unions, churches, and civil 
society organisations.

181.	On 23 and 24 October 1992 a National Conference "South Africa United 
Against AIDS" was held.  It was attended by 442 delegates, and was focused 
on designing a programme of action for the development of a National AIDS 
Strategy.

182.	In July 1994, after extensive consultation, NACOSA produced "A National 
AIDS Plan for South Africa, 1994-5".  The NACOSA Strategy Committee 
consisted of three members.  One of them was the previous Minister of 
Health, Dr Nkosazana Zuma.  The First Respondent, the current Minister of 
Health, was another of the members of that Committee.

183.	This National AIDS Plan is a lengthy document, and I am therefore not 
annexing it to this affidavit.  However, I wish to draw attention to some of the 
conclusions which were reached some seven years ago.

184.	The Plan provided that the steps which had to be taken to prevent perinatal 
transmission of HIV included the following:



184.1	Activity area 3 was to provide access to appropriate advice on breast 
feeding and HIV. 

184.2	Activity area 4 was to provide information about methods to prevent or 
reduce perinatal transmission and to assist in providing such measures. 

184.3	Activity area 2 included "Offer HIV testing to pregnant women at 
antenatal clinics on a voluntary basis".

185.	In 1994, the findings of the Paediatric AIDS Clinical Trials Group (PACTG) 
trial PACTG076 were published.  They established beyond doubt that the 
provision of AZT (zidovudine) after the first fourteen weeks in pregnancy 
reduced the rate of mother-to-child transmission by 67.5%.  As Professor 
Wood points out, this has become the standard of care in many developed 
countries.  However, then, the cost of the drug at 100mg five times daily was 
beyond the reach of the vast majority in the developing countries.  Since then, 
the price of AZT has been substantially reduced.

186.	In July 1997, the AIDS Law Project (which is an affiliate of the TAC) 
convened a seminar on "The Rights of Pregnant Women in the Context of 
HIV".  The seminar was attended by AIDS organisations, health care workers 
and a range of civil society organisations.  The HIV/AIDS and STD 
Directorate of the national Department of Health and the Gauteng Provincial 
Directorate were represented at the seminar.  A committee was formed to 
draft a Code of Best Practice on Pregnancy and HIV.  The Committee 
included a representative of the Department of Health.



187.	In October 1997, the AIDS Law Project published the Pregnancy and HIV: 
Recommended Code of Best Practice for comment.  Recommendations in 
section 6 on Medical and Therapeutic Interventions included the following:

Women should be informed of all available medical and therapeutic 
interventions for pregnant women living with HIV, including whether 
they are provided free of charge or not, costs and availability of such 
interventions, the efficacy of such interventions, and the advantages 
and disadvantages of such interventions.  Interventions should be 
concerned with the well-being of the woman's own health and that of 
her offspring.

A woman should be given information on and the option of undergoing 
antiretroviral therapy.  She should be accurately informed of the rates 
of success; the level of compliance required; and the potential side-
effects for both herself and the fetus, known and unknown, including 
the possibility of drug resistance developing and the lack of efficacy in 
future pregnancies and for one's own treatment.

188.	On 19 and 20 November 1997, the National AIDS Programme (part of the 
national Department of Health) and the Perinatal HIV Research Unit (based at 
Baragwanath Hospital) co-hosted a conference on "Affordable Options for 
the Prevention of Mother to Child Transmission of HIV-1: From Research to 
Clinical Care".  In a draft report of the Conference (Annexure V), prepared by 
the Department of Health, areas of "broad consensus" included the following:

* 	"All pregnant women should have VCT" [this refers to voluntary 
counselling and  testing]


*	"Short course ARV [anti-retroviral therapy] using AZT or AZT and 
3TC should be offered"

*	"Pilot studies need to be done"

189.	As further appears from the report prepared by the Department of Health, 
(which I have not attached in full because of its length), at that meeting Mark 
Heywood, Director of the AIDS Law Project, which is associated with the 
TAC, said the following:

"The AIDS Law Project has been approached by someone in the 
Johannesburg area to consider a civil action against a public hospital 
on behalf of a child born with HIV on the grounds that measures did 
and do exist that could have reduced the risk of HIV transmission to 
that child.  It is being discussed, but it's also being held [back] 
because of initiatives such as this conference and the commitment of 
the Department of Health to look at issues such as the provision of 
short course AZT if it works and simpler strategies such as subsidized 
milk formula."    

190.	Subsequent studies indicated that short-course treatments do indeed work.  
Despite these plans, agreements, scientific and social consensus – the 
government has unreasonably failed to budget for, or implement voluntary 
counseling and testing at all antenatal clinics; it has failed to provide pregnant 
women with HIV/AIDS information on their health, breast-feeding and 
antiretroviral therapies.

191.	On 19 February 1998 the results of the Bangkok Perinatal AZT Study (the 
Thai Study), which tested the safety and efficacy of short-course AZT 
therapy, were announced.  The Thai Study reduced mother-to-child HIV 
transmission by 50% and used only 300mg twice daily from the 36 week of 
pregnancy and 300mg.



192.	On that same day, the Gauteng Department of Health had a meeting at the 
Sizwe Tropical Diseases Hospital to plan pilot projects to implement short-
course AZT for pregnant women with HIV.  In order not to burden the record 
further, I am not attaching documents relating to that meeting and subsequent 
meetings, which are well known to the First and Fourth Respondents.

193.	On 18 May 1998 the Gauteng Task Team selected five sites to implement 
mtctp programmes.  They were Witkoppen; Coronation Hospital;  Zola Clinic 
and Chris Hani Baragwanath;  Empilisweni;  and Sebokeng.

194.	On 3 August 1998 it was reported to the Gauteng Task Team that the sites 
had identified pilot managers.  Storing of AZT, testing of protocols and 
training had commenced and site visits were under way.

195.	On 9 October 1998, the same day as the launch of the government's so-called 
"Partnership Against AIDS", the then Minister of Health, Dr Nkosazana 
Dlamini-Zuma withdrew national government sponsorship of these five pilot 
projects that would have provided short course AZT for pregnant women with 
HIV, as well as other pilot projects in other provinces such as KwaZulu-Natal 
and Western Cape.

196.	Despite this setback, the TAC has made sustained and repeated efforts to 
persuade the government to make appropriate treatment available to pregnant 
women with HIV and their infants.  I deal only with a few aspects of those 
efforts.



197.	On 29 September 1999 the TAC had a meeting with the First Respondent and 
the Director-General of her Department.  At that meeting the First 
Respondent stated that the government was committed to a programme on the 
prevention of mother to child transmission, but had concerns about the cost of 
drugs, sustainability, and unrealistic expectations that could be created if 
antiretroviral drugs were provided to pregnant women.  She also stated that 
there were concerns regarding the safety and efficacy of Nevirapine, but these 
would be dealt with when the results of the SAINT trials were published.

198.	On 16 November 1999, the First Respondent made a speech in the National 
Assembly, in which she indicated that the toxicity of AZT was a reason for 
the refusal of government to provide it to pregnant women.  A copy of her 
speech is attached marked W.  She also said the following:

We simply cannot afford AZT.  At current market prices the cost of 
triple therapy drugs alone for the treatment of four million South 
Africans would be 10 times the total South African health budget and 
140 times what we spend on pharmaceuticals in the public sector. 

So, before we can even begin to consider the appropriateness of the 
drugs, we fall at the hurdle of affordability....

Nivirapine [sic] was markedly more effective.  Nivirapine was also 
safer, less expensive and more practical than AZT or any other drug 
tested so far, in preventing mother-to-child transmission.  
Nevertheless, nivirapine is still not registered in Uganda for mass 
administration for the prevention of mother-to-child transmission.



In terms of affordability, the cost of the short course of AZT, as given 
in the Thai study that showed a 50% reduction in transmission, would 
be approximately R400 per mother.  By comparison, the cost of 
nivirapine would be approximately R30 per mother and child.  This 
will mean that many countries that could not adopt drug strategies 
that involved AZT because of the cost could now adopt a strategy that 
could lower the rate of mother-to-child transmission with nivirapine.

Comparative studies are currently underway in South Africa to look at 
nivirapine [sic] as compared to the short course in AZT given in the 
Thai study and the short course given in the Petra study.  The findings 
of these cost effectiveness studies are expected in March next year.  
They will provide critical information for policy making in respect of 
mother-to-child transmission in South Africa.

199.	On 11 January 2000, the TAC requested the First Respondent in writing to 
state whether the government had decided on a policy of provision of anti-
retroviral medication for pregnant women in order to reduce the risk of 
mother to child transmission.  A copy of this letter is attached marked X.  The 
First Respondent did not reply to this letter.

200.	On 5 April 2000 the First Respondent made a speech in parliament on 
Nevirapine, in which she stated the following (Annexure Y):

Studies on the safety and efficacy of nivirapine [sic] for mother-to-
child transmission in HIV-infected pregnant women have already been 
conducted in Uganda. These studies have not yet been concluded with 
respect to long-term safety.



In South Africa, a study known as Saint is currently comparing 
nivirapine with short course AZT and 3TC for safety and efficacy for 
mother-to-child transmission. We have been told by the scientists 
concerned that the results of this study will not be available until 
June/July of this year.  The Medicines Control Council has not yet 
registered nivirapine in South Africa for paediatric use. Before we can 
reach a policy decision on the use of nivirapine, we require the 
medicine to be registered, as well as the results of the same [SAINT] 
study.

It would be immoral and unethical for Government, despite the 
numerous requests that we are receiving and the demonstrations that 
have been staged, to attempt to make policy decisions regarding the 
use of nevirapine in our country until the full results of the clinical 
trials of the drug are available.

201.	As appears from these speeches, the First Respondent based her initial refusal 
to implement a comprehensive programme on the cost and alleged toxicity of 
AZT.  She indicated that Nevirapine was a cost-effective method of dealing 
with mother-to-child transmission, but that before making a decision she 
would await the outcome of the SAINT study.  She further indicated that 
Nevirapine would have to be registered with the MCC for paediatric use. This 
was not correct. By this time, Nevirapine had been registered for paediatric 
use but not for reducing mother-to-child transmission. 

202.	The results of the SAINT study have now been available for more than a year. 
 They show that Nevirapine administered to the mother and infant around the 
time of birth is effective in reducing mother-to-child transmission of HIV.  
Approximately five months ago, Nevirapine was registered by the MCC for 
this purpose.



203.	Private practitioners are now using Nevirapine where in their professional 
judgment it will benefit their patients.

204.	The manufacturers of Nevirapine have offered to make it available to the 
government for free.

205.	Despite this, the Respondents continue to persist in their refusal to make 
Nevirapine generally available in the public health sector on the prescription 
of a qualified medical practitioner.

206.	Therapeutically effective and highly cost-effective therapy is now available.  
But there is still not a comprehensive system of testing and counselling in 
place.  All that the Respondents currently propose is a two-year pilot phase at 
18 sites, after which the government will consider designing and 
implementing a comprehensive plan.

207.	Meanwhile, the rate of HIV infection in our country has escalated at an 
alarming rate during this past seven years.  It is, as Dr Abdool Karim says, an 
"explosive" epidemic which has had and will continue to have devastating 
consequences.


THE GOVERNMENT'S DUTY TO INSTITUTE A COMPREHENSIVE 
PROGRAMME



208.	Most of this affidavit deals with the government's duty to make Nevirapine 
available to pregnant women and their infants where in the professional 
opinion of the medical practitioner, this is in the interests of his or her patient.

209.	However, I respectfully submit that the legal duties of the government go 
beyond this.  In particular, for reasons which will be set out in the section 
headed "Submissions", the government is under a duty to

209.1	make it possible for all health care professionals to determine  
whether pregnant women patients should be given antiretroviral 
therapy to reduce mother-to-child HIV transmission.  

209.2	make it possible for women with HIV to make an informed 
choice about pregnancy and her own health.  

209.3	make it possible for women to care for their infants in a manner 
which reduces the risk of HIV transmission.   This requires 
counselling and the provision of formula feed where the 
circumstances and the informed choices of the mother warrant it, 
and the mother cannot afford to provide formula feed for her 
infant. 

210.	This was proposed by a group which included the First Respondent and her 
predecessor as much as seven years ago. 

211.	The position of the Respondents comes down to this: except at the pilot sites, 
they will not provide testing, counselling or any treatment to pregnant women 
with HIV.  The exception is the Tenth Respondent, who is already 
implementing an integrated programme on a significant scale.



212.	Pregnant women with HIV/AIDS are susceptible to opportunistic infections 
such as bacterial pneumonia, urinary tract infections and tuberculosis.  
Therefore, testing, counselling and offering women options related to their 
pregnancy and following their personal health is crucial to public health 
interests.  Because pregnant women are not counselled about the effect of 
HIV on their reproductive choices, they cannot make effective personal health 
choices.

213.	As I have pointed out above, HIV can be transmitted through breast milk.  In 
the scientific community, the majority of paediatricians advise women with 
HIV who have access to alternative feeding not to breastfeed.  Alternative 
feeding includes formula feed. However, where there is no alternative to 
breastfeeding because of cost or lack of clean water, it is generally agreed that 
women should continue to exclusively breastfeed.   In this context women 
should be advised about safer breastfeeding methods including avoiding 
infections and treating them.

214.	I submit that the Respondents are under a legal duty to offer testing to 
pregnant women, and counselling on what steps they should take if they are 
found to have HIV.  The government has now failed for more than seven 
years to implement a comprehensive programme to do this.

215.	Formula feed has been shown to be the most effective way to reduce the risk 
of mother to child transmission after childbirth.  The high cost of formula feed 
could be alleviated through bulk buying by the government and providing it 
for free to mothers who choose to breast-feed.  However, the choice must be 
that of the pregnant woman.

216.	Women with HIV/AIDS are not made aware of the risk of breastfeeding their 
children, and are not given the alternatives to breastfeeding by the 
Respondents.  They are not provided with formula feed where this is indicated 
and necessary.



217.	In 1996, the Joint United Nations Programmes on HIV/AIDS (UNAIDS) 
advised that women with HIV/AIDS in resource-poor areas be encouraged to 
make an informed choice about infant feeding by weighing risks and benefits.

218.	Programmes that aim to reduce mother-to-child HIV transmission will use 
voluntary counselling as an instrument to gain informed consent for testing 
from women.  Experts are agreed that such counselling has inestimable value 
in educating women (both HIV negative and positive) of their options.  They 
may also assist in preventing further HIV transmission by promoting safer sex 
practices and the education of the sexual partners of women.  Most 
importantly, counselling can provide women with HIV/AIDS the opportunity 
to learn about treatment, care and support options.

219.	The Respondents have failed and continue to fail to implement such 
counselling on a comprehensive basis.


GOVERNMENT PROMISES AND POLICIES

220.	I respectfully submit that what the government has done, and more 
particularly not done, is inconsistent with various government promises and 
policies.  I have already referred to various statements by the Minister in 
which she indicated that in relation to Nevirapine, her concern was its safety 
and efficacy, and that she was awaiting (first) the outcome of the SAINT 
study, and (subsequently) registration of Nevirapine by the MCC.



221.	In his address to parliament on 24 May 1994, after his inauguration as the first 
democratically elected President, Nelson Mandela set out a policy on children 
and pregnant women that remains government policy to this day.  The policy 
states that "Children under the age of six and pregnant mothers will receive 
free medical care in every state hospital and clinic where such need exists."

222.	This policy statement was subsequently incorporated in Notice 657 of 1994, 
published in the Government Gazette of 1 July 1994 by the then Minister of 
Health.  I attach a copy of that Notice marked Z.

223.	This was therefore more than a political promise or a general statement of 
intent.  It was a formally promulgated policy.  Members of the public are 
entitled to rely on it, and to hold the government to it.

224.	The Respondents' continued refusal to make safe and effective anti-retroviral 
drugs, including Nevirapine, available in the public health sector for pregnant 
women and newborn infants, is inconsistent with that policy, particularly 
where it is available to the government for free.

225.	The same applies to the Respondents' failure to implement a comprehensive 
programme of testing, counselling and support.

226.	This refusal and failure are also inconsistent with the strategic plan of the 
Department of Health, and the National Patients' Rights Charter which it has 
issued.



227.	In May 2000, the Department of Health produced its HIV\AIDS strategic plan 
for 2000-2005.  The plan identifies various strategies to be pursued during the 
five-year period in order to bring about meaningful change in the spread of the 
HIV\AIDS epidemic in South Africa.

228.	The first priority identified is that of prevention, and the reduction of mother 
to child transmission of HIV is identified as a goal to be achieved.

229.	The Department issued the National Patients Rights Charter in 2001.  It states 
as follows:

Informed consent: Everyone has the right to be given full and accurate 
information about the nature of one's illnesses, diagnostic procedures, 
proposed treatment, and the cost involved, for one to make a decision 
that affects anyone of these elements.

Under the heading "Access to health care" the Charter promises

*	provision for special needs in the case of newborn infants, 
children, pregnant women, the aged, disabled persons, patients 
in pain, persons living with HIV or AIDS patients

*	counseling without discrimination, coercion or violence on 
matters such as reproductive health, cancer or HIV/AIDS 



230.	I submit that the Charter is binding on government as a public policy that 
requires pregnant women with HIV/AIDS to be given full information and 
counselling regarding all options including termination of pregnancy, anti-
retroviral treatment to reduce mother to child transmission, treatment for 
opportunistic infections, mode of delivery, breastfeeding and any other 
information that will impact on the health of the woman and her newborn 
infant.

231.	I submit that the effective failure to provide any information and treatment to 
pregnant women with HIV is in breach of the provisions of the Charter.

232.	From December 1998 to June 2001, TAC has made numerous and repeated 
efforts to persuade the government to deal with this matter effectively and in 
accordance with its obligations.  TAC's actions have included extensive 
submissions, protests, social mobilization and negotiations. Annexure AA 
submitted to the Minister of Health on 11 June 2001 sets out those efforts.  
They have been unsuccessful.

233.	The failure to provide this treatment is in breach of an undertaking which the 
First Respondent's predecessor made to the TAC after she had had a lengthy 
meeting with the TAC on 30 April 1999.  After that meeting, the parties 
issued a joint statement which included the following:

1.	The Minister of Health, Dr. Nkosazana Zuma and a delegation 
from the NAPWA Treatment Action Campaign agreed that 
affordable treatment for HIV/AIDS and all medical conditions is 
a basic human right.

2.	The Minister assured the Treatment Action Campaign that 
government would name an affordable price for the 
implementation of AZT to pregnant mothers and report within 
six weeks on the price and other issues pertaining to the 
prevention of mother-to-child transmission. 



3.	The Minister of Health calls on business, labour, religious 
bodies, women's organisations and all sectors of civil society to 
pressurise Glaxo Wellcome and all pharmaceutical companies 
to unconditionally lower the price of all HIV/AIDS medications 
to an affordable price for poor people and countries. The 
Treatment Action Campaign agrees with the Minister that 
pressure on the drug companies and the producers of formula 
feed such as Nestle is a key objective of all civil society bodies.  

234.	As I have said above, on 29 September 1999 the TAC had a meeting with the 
First Respondent and the Director-General of her Department.  The First 
Respondent stated that the government was committed to a programme on the 
prevention of mother to child transmission, but had concerns about the cost of 
drugs, sustainability, and unrealistic expectations that could be created if 
antiretroviral drugs were provided to pregnant women.  She also stated that 
there were concerns regarding the safety and efficacy of Nevirapine, but these 
would be dealt with when the results of the SAINT trials were published.

235.	The TAC stated that government support and leadership was essential to 
implement a programme, and that they would not pursue action against the 
Ministry.  They believed that the Minister would act in good faith on the 
SAINT studies, the results of which were then expected in March 2000.  The 
Minister promised to make a time-table on implementation available once the 
results of the studies were available.



236.	The TAC also stated that they did not believe that short-course AZT was 
unaffordable.  Given the very low cost of Nevirapine they would give the 
Minister the benefit of the doubt.  However, if Nevirapine were not to show 
the desired scientific results, the TAC then would expect the government to 
announce a phased-implementation plan of short-course AZT.

237.	As I have stated above, even though the SAINT study results were positive, 
and even though Nevirapine is now available for free, the Respondents still 
refuse to put in place and implement a programme for the provision of 
Nevirapine to pregnant women with HIV.


THE IMPACT ON WOMEN WITH HIV

238.	The current situation, in which women with HIV are unable to take 
appropriate measures to protect their health and that of their infants, has a 
devastating impact on their lives.  That situation is avoidable.  In this section 
of this affidavit I give some practical examples of this.

239.	I attach marked BB an affidavit by Busisiwe Maqungo, a 29-year old woman 
who has HIV, and whose daughter died as a result of HIV/AIDS.  Ms 
Maqungo was not tested for HIV until a month after the birth of her daughter. 
 It was then found that her daughter had HIV.  Her daughter died when she 
was nine months old.

240.	If Ms Maqungo had been counselled and tested before she gave birth, she and 
her daughter could have been treated with AZT, and her daughter might well 
still be alive today.



241.	In the experience of the TAC, Ms Maqungo's story is typical of those of 
many women whose children have died, when they could have been saved 
through counselling, testing, and the administration of antiretroviral therapy.  
This tragic and avoidable suffering and loss of human life is continuing today.

242.	I attach marked CC the affidavit of SH, a woman with HIV who lives in the 
Vaal area.  She is aware that she has HIV, and took steps to protect her baby 
from transmission of HIV.  The only way she could do this was to go to the 
Chris Hani Baragwanath Hospital, which is some distance from her home.

243.	However, SH unexpectedly went into premature labour.  In those 
circumstances of emergency her baby had to be delivered at the closest 
hospital, which is Sebokeng Hospital, and it was not possible for her to get to 
Chris Hani Baragwanath Hospital for the delivery.  Sebokeng Hospital is not 
a pilot site, and it therefore does not have access to Nevirapine.  As a result, 
her baby could not be treated with Nevirapine when he was born, even though 
this was plainly necessary, and she knew that it was necessary.

244.	SH's baby is very ill, in intensive care.  She could not take him to Chris Hani 
Baragwanath Hospital for the treatment immediately after his birth because he 
is so ill, and no ambulance was available.

245.	It is now too late for SH's baby to be treated with Nevirapine.  She does not 
yet know whether he has HIV.  SH has been denied her right to have her baby 
treated with Nevirapine, and her baby has been denied the right to proper 
medical treatment. This treatment could have been provided at no cost.  

246.	The impact on the dignity and quality of life of a child with HIV/AIDS and 
the emotional and economic costs of ill-health to poor families is illustrated in 
the affidavit of Ms. Thembisa Constance Mhlongo, a domestic worker 
(Annexure DD).  She is foster mother to her deceased sister's child Sibongile. 
 
247.	Ms. Mhlongo describes the pain, memory loss and illnesses of her child. She 
is woken in the middle of the night by health emergencies and pays between 
R50.00 and R250.00 in transport costs to get the child to hospitals.  Ms. 
Mhlongo has lost her previous employment because of constant absenteeism 
related to Sibongile's AIDS-related illnesses and is in danger of losing her 
current employment.

248.	Ms. Mhlongo supports the TAC court action because "It is sad that parents 
have to go through such experiences all the time. What makes it worse is that 
this situation can be prevented for most children with HIV/AIDS.  I want the 
government to introduce a programme to prevent mother-to-child HIV 
transmission to ensure that children and their families across the country do 
not suffer in the way that Sibongile suffers."  Ms. Mhlongo also hopes that 
children with AIDS like Sibongile and people with AIDS such as her sister 
should receive antiretroviral treatment.  

249.	The affidavit of Bongiwe Mkhutyukelwa (Annexure EE) tells the story of a 
woman with HIV who was lucky enough to be treated in the Khayelitsha 
programme when she was pregnant.  She was tested and counselled, she was 
given AZT, she was advised not to breastfeed her baby, and she was offered 
free formula milk.

250.	Ms Mkhutyelwa's daughter was born without HIV.  She tested negative for 
HIV after nine months and again after 18 months.

251.	If the Respondents were to make Nevirapine available in the public health 
system, and were to institute a comprehensive programme for the prevention 
of mother-to-child transmission, many more mothers and children would have 
the positive experience of Ms Mkhutyelwa.

252.	Vivienne Nokudza Matebula works as a senior nursing auxiliary at Kopanong 
Hospital in Vereeniging.  That hospital is not a pilot site.  Where pregnant 
women with HIV are about to give birth, they must therefore be referred to 
Chris Hani Baragwanath if they are to be treated.

253.	In Ms Matebula's affidavit (Annexure FF), she explains the lengths to which 
pregnant women who are in labour must go, if they and their babies are to be 
treated with Nevirapine which could save the lives of the babies.

254.	This human suffering and cost could easily be avoided through the simple 
remedy of making Nevirapine, a free drug, generally available in the public 
health sector.

255.	It is not practically possible for patients in the public health sector to obtain 
Nevirapine for themselves from pharmacies.  The reasons for this are the 
following:

256.	For a poor person, the medicine is very expensive and often unaffordable.

257.	As appears from the affidavit of Chloe Hardy (Annexure GG) most 
pharmacies do not stock the drug. Those that do stock it, most sell the tablet 
only in a pack of 60 tablets, which is very expensive. Very few stock the drug 
in suspension form, which is what the baby needs at the time of birth. All 
pharmacies that do stock the drug in suspension form, sell it only in volumes 
of more than 200 ml, which is very expensive. 

258.	The women who are treated in the public health sector are overwhelmingly 
poor, and unable to pay for the cost of private health care or to pay the cost of 
providing Nevirapine for themselves or their babies. 

259.	The vast majority of poor women who use the public sector health services 
are also African and coloured. Discrimination on the ground of socio-
economic status is compounded by indirect and unfair race discricimination.  

IMPACT ON HEALTH PROFESSIONALS

260.	The affidavit of the Second Applicant, Dr Saloojee, explains that because 
public sector doctors are not able to treat their patients in the most appropriate 
and effective way, they are not able to carry out their ethical duties.

261.	The decision by the respondents not to make Nevirapine generally available in 
the public health sector amounts to a decision that they, rather than the 
attending doctors, will decide which patients will be treated with this free 
drug.

262.	This is a breach of the professional independence of the doctors.

263.	The affidavit of Tshidi Mahlonoko (Annexure HH) describes the experience 
of a senior professional nurse whose job it is to provide care at a clinic to 
patients with HIV.

264.	Ms Mahlonoko explains that she counsels patients both before and after they 
are tested.  She submits that in the light of the way in which the clinic system 
works, it is possible to make Nevirapine at all levels of the health system.  
Nurses administer other drugs which have side effects.  They can be trained 
on possible side effects of this drug and how to deal with them.

265.	According to Ms Mahlonoko the inability of nurses to provide effective 
treatment, when it is in fact potentially available, is demoralising to them.  
The provision of drugs to manage HIV will "strengthen the confidence of the 
community in the government and the health sector".

SUBMISSIONS

266.	I respectfully submit that the continued failure and refusal of the Respondents 
to make Nevirapine generally available in the public sector in accordance with 
the decision of the relevant health professional as to the best interests of his or 
her patient, and their continued failure and refusal to plan and implement a 
nation-wide comprehensive programme to prevent mother-to-child 
transmission of HIV, is in conflict with the Constitution and unlawful, for the 
reasons set out above and more particularly for the reasons set out below.  

267.	It is irrational, for all the reasons set out above.

268.	It is in conflict with the constitutional rights of women and their babies to 
have access to health care services, including reproductive health care 
(section 27).

269.	It constitutes a failure to take reasonable measures to achieve progressive 
realisation of the right of access to health care services, including 
reproductive health care (section 27).  This is particularly so given that the 
babies and women affected are highly vulnerable, unable to assist themselves, 
and many are entirely dependent on the Respondents.

270.	It is in breach of the right of the babies concerned to basic health care 
services (section 28).  To the extent that the primary responsibility in this 
regard rests on their parents, in the nature of things their parents are unable to 
discharge this responsibility, and the babies are dependent on the 
Respondents for these services.

271.	It discriminates against poor people in breach of section 9 of the Constitution, 
as the effect of the policies of the government is that only people who are not 
poor are able to obtain effective protection against mother-to-child 
transmission of HIV. 

272.	The irrational policy of the Respondents indirectly and unfairly discriminates 
against black (African and coloured) women in breach of section 9 of the 
Constitution.

273.	The refusal of the Respondents to provide Nevirapine and where possible 
formula feed to all newly-born babies will lead to the transmission of HIV in a 
substantial number of them leading to unnecessary and premature death. This 
is in breach of the constitutional right to life (section 11) of the babies 
concerned.

274.	It is in breach of the right of the women concerned to make choices and 
decisions concerning reproduction, as they are given neither the information 
necessary to enable them to make those decisions, nor the advice, medicines 
or feeding substitutes necessary to enable them to implement such decisions 
(section 12).   

275.	The denial of counseling, testing, antiretroviral therapy to women and their 
newly-born infants is a violation of their rights to human dignity (section 10) 
and equality (section 9).

276.	In acting as they have, the Respondents have failed in their duty to respect, 
protect, promote and fulfill the rights to which I have referred. 

277.	The past planning, promises and policies which the First Respondent has 
made but not implemented, have created a legitimate expectation that the 
government will take all reasonable measures to prevent mother-to-child 
transmission of HIV, and more specifically that it will make voluntary 
counselling and testing, Nevirapine and other appropriate anti-retroviral 
drugs, and formula feed available to those who need this. The government is 
under a duty to give effect to that legitimate expectation, but has failed to do 
so.

278.	The history of this matter shows that the TAC and other interested parties 
have repeatedly, over many years, attempted to persuade the government to 
carry out its obligations in this regard.  The government has repeatedly made 
promises that it will do so, subject only to certain conditions.  When those 
conditions have been fulfilled, the government has imposed new conditions. 
This is also in breach of section 195 of the Constitution. 

279.	The current policy shows that the government has no intention of carrying out 
these legal obligations for at least another two years, when the pilot projects 
will have been completed.  In the light of the history of this matter, there is 
every reason to believe that even at that stage the government will seek new 
excuses to justify its failure to act, or will continue to drag its feet.  In the 
meantime, babies will unnecessarily die because necessary and feasible steps 
have not been taken to prevent the transmission of HIV to them from their 
mothers.   

280.	The government, and in particular the Respondents' acts and omissions are in 
violation of section 195 (1) and (2) of the Constitution that sets out the "basic 
values and principles governing public administration". 

281.	In particular, the Respondents' violate the rights of doctors and nurses in the 
public sector who have a duty to promote and maintain a high standard of 
professional ethics (s195(1)(a)).

282.	In addition, the failure to respond to the needs of women of reproductive age 
and their infants also violate the constitutional right to an accountable, 
development oriented, fair, equitable and impartial public administration.       

VIOLATION OF INTERNATIONAL OBLIGATIONS

283.	 The Government's failure to provide information, counselling, anti-
retrovirals, and, where requested, formula feed to pregnant women with 
HIV/AIDS violates various International Agreements which have been signed 
and or ratified by the South African government and places certain obligations 
on them:

UNIVERSAL DECLARATION OF HUMAN RIGHTS (UDHR)

284.	As outlined above, the dignity and equal rights of pregnant women with 
HIV/AIDS and their infants are violated by the Respondents (Article 1).  In 
addition, the Respondents deny pregnant women and their infants the right to 
a standard of living adequate for the health and well-being as individuals or 
families and ignore the provision of special care and assistance in  
"motherhood and childhood".  Although the declaration has no ratification 
process, I am advised that the UDHR forms part of international customary 
law. 



INTERNATIONAL COVENANT ON CIVIL AND POLITICAL RIGHTS 
(ICCPR)

285.	The ICCPR recognises the inherent dignity of every human being (article 10) 
and guarantees every human being the inherent right to life (article 6).  
Children born with HIV in the absence of mother-to-child prevention 
programmes suffer unnecessary illness that deny them inherent dignity. 
Children born with HIV will die unnecessarily and prematurely of AIDS-
related illnesses, denying them the right to life.  The Respondents' policies 
violate the right to life and dignity of children with HIV AIDS contained in 
the ICCPR, a covenant signed and ratified by the Respondents.

INTERNATIONAL COVENANT ON ECONOMIC, SOCIAL AND 
CULTURAL RIGHTS (ICESCR)

286.	Pregnant women with HIV/AIDS and their children are denied the right of 
everyone to the enjoyment of the highest attainable standard of physical and 
mental health. The Respondents pay lip-service to the special needs of women 
of reproductive age and their infants but their actions breach the requirement 
to take steps to achieve the full realisation of this right, including in particular 
a) provision for the reduction of infant mortality and for the healthy 
development of the child; and c) prevention, treatment and control of 
epidemic, endemic and other diseases in the case of pregnant women with 
HIV/AIDS and their infants (Article 12).   Although not ratified, this covenant 
has been signed by the Respondents.
AFRICAN CHARTER ON HUMAN AND PEOPLES' RIGHTS (ACHPR)

287.	Article 16 of the ACHPR provides that every individual shall have the right to 
enjoy the best attainable state of physical and mental health. State Parties to 
the Charter must take the necessary measures to protect the health of their 
people and to ensure that they receive medical attention.  The Respondents' 
policy violates the ACHPR, a charter that has been signed and ratified by the 
Respondents.

CONVENTION ON THE ELIMINATION OF DISCRIMINATION 
AGAINST WOMEN (CEDAW)

288.	The protection of pregnant women with HIV/AIDS granted by CEDAW is 
violated by the Respondents. This convention was signed and ratified by the 
Respondents. Article 12 states that States Parties shall take all appropriate 
measures to eliminate discrimination against women in the field of health care 
in order to ensure access to health care services, including access to family 
planning. States shall ensure further that women receive appropriate services 
in connection with pregnancy, confinement and post-natal period, granting 
free services where necessary, as well as adequate nutrition during pregnancy 
and lactation.




CONVENTION ON THE RIGHTS OF THE CHILD (CRC)

289.	Article 24 of the CRC requires that States Parties recognise the right of the 
child to the enjoyment of the highest attainable standard of health and to 
facilities for the treatment of illness and rehabilitation of health.  The CRC 
obliges States Parties to ensure that no child is deprived of his right of access 
to health care services. The Respondents' policies and actions violate the 
rights of children whose parents have HIV/AIDS without access to prevention 
and the rights of children with HIV/AIDS 

290.	It is further specified that States parties shall pursue full implementation of 
this right and, in particular, take appropriate measures including: to diminish 
infant and child mortality; to ensure the provision of necessary medical 
assistance and health care to all children with emphasis on the development of 
primary health care; and to ensure appropriate pre-natal and post-natal health 
care for mothers.  These rights of children with HIV/AIDS and those born to 
parents who have HIV are violated by the Respondents.

CONVENTION ON ELIMINATION OF ALL FORMS OF RACIAL 
DISCRIMINATION (CEAFRD)

291.	South Africa has signed and ratified the CEAFRD.  The indirect racial 
discrimination in the public health sector faced by pregnant women with HIV 
is a violation of Articles 2 and 5 of the CEAFRD.


CONCLUSION ON INTERNATIONAL INSTRUMENTS

292.	Denial of a national, comprehensive mother-to-child HIV prevention 
programme is a violation of the obligations of the above international human 
rights instruments. 
 
293.	Denial of Nevirapine appropriately prescribed by health care professionals to 
pregnant women with HIV/AIDS and their newly born infants who use the 
public sector health services constitutes a violation of the above international 
human rights instruments.

URGENCY

294.	Given the fact that the absence of the provision of Nevirapine and other 
preventative measures literally affects the lives of children yet to be born, and 
those born without the benefit of medication, this application is inherently 
urgent.  Although the Applicants have proceeded in accordance with the time 
limits prescribed by the rules of court, this is to enable the Respondents to put 
up such answer as they may choose.

295.	However, the Applicants hereby give notice that the Respondents will be held 
strictly to the timetable prescribed by the rules of court, and that the Judge 
President will be approached for a date for the hearing of this application. 

COSTS 
296.	The Applicants ask that any of the Respondents opposing this application be 
ordered jointly and severally to pay the Applicants' costs, and that these costs 
include the costs of two counsel.

RELIEF
297.	I accordingly ask that this Honourable Court grant an order as set out in the 
Notice of Motion.





SIPHOKAZI MTHATHI
DEPONENT

SIGNED AND AFFIRMED BEFORE ME IN THE PRESCRIBED MANNER 
AT CAPE TOWN ON THIS             DAY OF AUGUST 2001, THE 
DEPONENT HAVING STATED THAT SHE HAS NO OBJECTION TO 
AFFIRMING THE AFFIDAVIT AND THAT SHE REGARDS THE 
AFFIRMATION AS BINDING ON HER CONSCIENCE



COMMISSIONER OF 
OATHS
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