IN THE HIGH COURT OF SOUTH AFRICA

	(TRANSVAAL PROVINCIAL DIVISION)

	CASE NO: 21182/2001

In the matter between :-

TREATMENT ACTION CAMPAIGN	First Applicant

DR HAROON SALOOJEE	Second Applicant

CHILDREN’S RIGHTS CENTRE	Third Applicant

and

MINISTER OF HEALTH	First Respondent
MEC FOR HEALTH, EASTERN CAPE	Second Respondent
MEC FOR HEALTH, FREE STATE	Third Respondent
MEC FOR HEALTH, GAUTENG	Fourth Respondent
MEC FOR HEALTH, KWAZULU-NATAL	Fifth Respondent
MEC FOR HEALTH, MPUMALANGA	Sixth Respondent
MEC FOR HEALTH, NORTHERN CAPE	Seventh Respondent
MEC FOR HEALTH, NORTHERN PROVINCE	Eighth Respondent
MEC FOR HEALTH, NORTH WEST PROVINCE	Ninth Respondent
MEC FOR HEALTH, WESTERN CAPE	Tenth Respondent

	APPLICANTS’ HEADS OF ARGUMENT  
	PART I: THE FACTS

Explanatory Note:	These heads of argument are in two parts.   Part I deals with the facts.   Part II deals with the applicable legal principles.

1	INTRODUCTION: OVERVIEW OF APPLICANTS’ CASE

1.1	The HIV/AIDS epidemic has reached catastrophic proportions in South Africa.    According to the Department of Health, by the end of 2000 it was estimated that there would be 4,7 million South Africans infected with HIV.  This represents a figure of 1 in 9 South Africans.    The scale and continued growth of the number of people with HIV/AIDS is a national crisis.    

1.2	One of the most common methods of transmission of HIV is from mother  to child (“MTCT”) at or around birth.    This results in approximately 70 000 babies being infected each year.

1.3	MTCT can be effectively and substantially reduced by a single dose to the mother and child of a drug known as Nevirapine.    Nevirapine is a registered drug.    It has been offered to the South African government free of charge by the manufacturer for five years for use in the public health sector.   The South African government has not yet accepted this offer.      In any event, the cost of Nevirapine is negligible.

1.4	Notwithstanding the admitted efficacy of Nevirapine, the Department of Health has laid down a policy limiting the availability of Nevirapine.   To this end it has designated two sites per province where pregnant HIV positive mothers may be administered the drug.   Outside of the designated sites, Nevirapine may not be prescribed even where in the opinion of the treating doctor this is medically desirable.

1.5	Nevirapine is available in the private health sector without restriction.    It is also available, free of charge, to patients in the public health sector who are fortunate enough to give birth at a designated site.    The rest of the patients who are forced to use the public health care system by reason of poverty or geographical location are denied access to medication which offers real hope of reducing the risk of mother-to-child transmission of HIV and thereby saving the lives of their children.    

1.6	The Western Cape stands out in marked contrast to the other provinces.  It has a substantial and expanding programme to make Nevirapine available throughout the province.    By 30 June 2002, it is estimated that 90% of the HIV infected mothers in that province will have been reached by the programme.   By March 2003, it is anticipated that coverage will approach 100%.    The applicants have settled their dispute with the Western Cape, but the example of the Western Cape conclusively demonstrates the feasibility of making Nevirapine accessible to all in the public health care system.   (In these heads of argument, all references to “the respondents” must be understood as excluding the tenth respondent unless otherwise indicated).

1.7	The criteria for the selection of the designated sites is arbitrary.  Major urban hospitals, like the Johannesburg Hospital, were excluded from the original designation.  Doctors, however eminently qualified, who happen to work in non-designated sites are precluded by the respondents’ policy from dispensing Nevirapine even when this is medically indicated, and irrespective of the availability of back-up resources to ensure the effective implementation of the drug regimen.

1.8	The real possibility of life for the many thousands of children born to HIV positive mothers is thus made dependent upon two factors: First, the extent to which they are able to afford treatment in the private health care system. Second, the random and arbitrary designation of a limited number of sites per province in the public health care system at which it is permissible for doctors to dispense the drug.    It is this irrational and arbitrary policy which is the subject matter of the present application.

1.9	The applicants accordingly seek redress from this Court to address the anomaly in two ways:

1.9.1	The first method of relief is to declare that the respondents are obliged to make Nevirapine available to pregnant women with HIV who give birth in the public health sector and to their babies, where in the judgment of the attending medical practitioner or health professional this is medically indicated.  Related to this declaration, the applicants seek an order requiring the respondents to make Nevirapine available in the circumstances postulated.
1.1.1	
1.9.2	The second avenue of redress is to require the respondents to plan and implement an effective national programme to prevent or reduce mother-to-child transmission of HIV, including through the provision, where appropriate, of Nevirapine or other appropriate medicine. 

1.10	It will be submitted that the relief sought by the applicants is modest and narrowly tailored to meet the exigencies of a pressing social need.   Contrary to the impression created by the respondents, it is not and has never been the case for the applicants that Nevirapine can and should be provided instantaneously to every pregnant women with HIV who gives birth in the public health sector.    The applicants’ case is aimed at ensuring that a programme is designed and implemented to provide appropriate treatment on a comprehensive and nationwide basis.    That programme must, in terms of the Constitution, be both reasonable and reasonably implemented.

1.11	These heads of argument accordingly address the following contentions:

1.11.1	By Government Notice 657, Government Gazette 15817 of 1 July 1994 the Government decreed that pregnant women and children under the age of 6 years were entitled to free health services rendered at State healthcare facilities.   The free health services are defined to include “the rendering of all available health services ... including the rendering of free health services to pregnant women for conditions that are not related to the pregnancy”.  The respondents are acting ultra vires their own policy by the selective denial of health services to pregnant women and their children outside the designated sites.

1.11.2	Section 7(3) of the Constitution places a duty on the State to “respect, protect, promote and fulfil the rights in the Bill of Rights”.  Section 237 of the Constitution requires that “all constitutional obligations must be performed diligently and without delay”.

1.11.3	The policy adopted by the respondents in selectively making Nevirapine available only at designated sites is not only unreasonable, arbitrary and irrational, but creates an untenable inequality which discriminates against the poor.  Inevitably this amounts to discrimination on grounds of race as well.

1.11.4	In so acting, the State has ensured that efficacious drugs for the prevention of HIV infection are placed beyond the reach of most people in this country.  This constitutes a profound threat to the fundamental rights of South Africans to:

1.11.4.1	access to health care services, including reproductive health care (section 27);
1.1.1.1	
1.11.4.2	basic health care services for children (section 28(1)(c)); 

1.11.4.3	life (section 11);

1.11.4.4	human dignity (section 10);

1.11.4.5	equality (section 9); and

1.11.4.6	psychological integrity, including the right to make decisions regarding reproduction (section 12(2)(a)).

1.11.5	Section 195 of the Constitution requires, inter alia, that public administration must be governed by the democratic values and principles enshrined in the Constitution including the principle that a high standard of professional ethics must be promoted and maintained.    It also requires that people’s needs must be responded to and that services be provided impartially, fairly, equitably and without bias.    The system provided by the respondents not only violates these principles, but places health professionals in the public sector at non-designated sites in the untenable position of being compelled to act unethically.   They are precluded from prescribing a potentially life-saving medication in circumstances where this is medically indicated.

1.12	These legal contentions will be addressed in Part II.   The facts supporting them will be dealt with in detail below.

1.13	Throughout the papers, various abbreviations are constantly used.   For the sake of convenience, the most prevalent abbreviations are as follows:
AIDS - Acquired Immune Deficiency Syndrome
ARV - Anti-retroviral medication
AZT - Zidovudine, an anti-retroviral medication
HIV - Human Immuno-Deficiency Virus
MCC - Medicines Control Council
MTCT - Mother-to-Child Transmission
NVP - Nevirapine
PMTCT - Prevention of Mother- to-Child Transmission
VCT - Voluntary Counselling and Testing
WHO - World Health Organisation

Several of the documents contain a full list of abbreviations.  See, for example, 

Founding Affidavit Annexure “RW3", p 168
Founding Affidavit Annexure “RW7", p 227
Answering Affidavit Annexure “AN6", p 898
Answering Affidavit Annexure “AN17", p 1011

2	THE INTEREST OF THE APPLICANTS

2.1	The standing of the applicants is not put in issue.   

Founding Affidavit: Mthathi, pp 19-22 paras 30-32
Answering Affidavit: Ntsaluba, p 651 para 36

2.2	The Treatment Action Campaign (“TAC”) brings this application on several bases:

2.2.1	It acts it its own interest in order to achieve the purposes set out in its Constitution;

2.2.2	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 cannot 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;

2.2.3	It acts on behalf of the group consisting of pregnant women with HIV who are being or will be treated in the public health care 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;
1.1.1	

2.2.4	It acts in the public interest in ensuring 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;

2.2.5	Finally, 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.

Founding Affidavit: Mthathi, pp 19 - 20 para 30

2.3	A number of organisations and individuals are associated with the TAC.  They include -

2.3.1	The AIDS Law Project;

2.3.2	The AIDS Consortium;

2.3.3	The Congress of South African Trade Unions;

2.3.4	The New Women’s Movement;

2.3.5	The South African Catholic Bishops’ Conference.

Founding Affidavit: Mthathi, p 10 para 5
Answering Affidavit: Ntsaluba, p 631 para 8

2.4	Dr Haroon Saloojee acts in three capacities:

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

2.4.2	Second, he acts as a member and representative of Save our Babies, an unincorporated group of health professionals consisting mainly of pediatricians 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.

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

Founding Affidavit: Mthathi, pp 20-22 para 31  

2.5	Approximately 150 health professionals have expressed their support for these proceedings and have mandated Dr Saloojee to represent them in these proceedings.

2.6	The Children’s Rights Centre brings this application on the following basis:

2.6.1	It acts in its own interest in order to achieve the purposes set out in its Constitution;

2.6.2	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 cannot act in their own name;

2.6.3	It acts in the public interest to ensure 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.

Founding Affidavit: Mthathi, p 22 para 32

3	THE FACTS: GENERAL OVERVIEW

3.1	We address below, in detail, the facts which are common cause or not disputed.    By way of overview, we deal with the following topics:

The HIV/AIDS epidemic

3.1.1	The evidence will demonstrate that the HIV/AIDS epidemic has reached catastrophic proportions.    Without urgent intervention the mortality rate is going to be overwhelming.   Approximately 70 000 HIV positive children are born each year.    

Nevirapine

3.1.2	Nevirapine has been registered by the Medicines Control Council.  It is effective in reducing mother-to-child transmission of the HIV.  It holds out the very real prospect of saving vast numbers of lives of children born of HIV positive mothers.

The Cost of Nevirapine

3.1.3	Nevirapine has been offered to the South African Government free of charge.   The Government has yet to accept that offer.  At current market prices, the cost of the drug is negligible.   It is presently available at R10 per dose.

The Choice of Sites

3.1.4	The Government has designated two sites per province at which Nevirapine may be prescribed.    It justifies the selection of sites on the basis that these are pilot sites at which research is being conducted.    The consequence of the limited number of sites is that the availability of life-saving medication is limited to the designated sites only.  Doctors in the public health sector outside of the designated sites are precluded from prescribing Nevirapine even where this is medically indicated and even where the necessary support services for the administration of the drug are available.  There are no restrictions on the prescription of the drug in the private sector.

The Attitude of Health Professionals

3.1.5	There is widespread support among health professionals for the prescription of Nevirapine where medically indicated.  The respondents accept that health professionals in the public health sector are as qualified as their counterparts in the private sector.   Yet, the effect of the policy of the respondents is to preclude health professionals at non-designated sites from prescribing Nevirapine even where this is medically indicated.   

The 1994 Notice on Children and Pregnant Mothers

3.1.6	Since 1994 there has been in place a binding policy promulgated in GN 657 of 1994 which affords free medical treatment to pregnant women and children under the age of six.    The effect of the respondents’ policy on mother-to-child transmission is in direct conflict with GN 657 and makes access to health services arbitrary and discriminatory.

The Cost and Benefits of Nevirapine

3.1.7	The evidence of health economists reveals that the nationwide implementation of a programme for the administration of Nevirapine and related services is cost effective and will result in the saving of money to the State.

3.2	These issues will be addressed in detail below.

4	THE HIV/AIDS EPIDEMIC

4.1	The HIV/AIDS epidemic is a major health problem in South Africa and has reached catastrophic proportions.
1.1	

Founding Affidavit: Mthathi, p 15 para 22.1
Answering Affidavit: Ntsaluba, p 635 para 19

4.2	In a document compiled by the Department of Health entitled “HIV/AIDS AND STD STRATEGIC PLAN FOR SOUTH AFRICA 2000 - 2005" the epidemic is described in the following terms:

“During the past two decades, the HIV pandemic has entered our consciousness as an incomprehensible calamity.   HIV/AIDS has claimed millions of lives, inflicting pain and grief, causing fear and uncertainty, and threatening the economy.”

Founding Affidavit: Mthathi, p 26 para 47

Answering Affidavit: Ntsaluba, p 656 para 48

Strategic Plan, Annexure “I”, p 275

4.3	HIV/AIDS is a progressive disease of the immune system that is caused by the human immuno-deficiency virus (HIV).    HIV-1 is the predominant and virulent form of HIV.    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.

Founding Affidavit: Mthathi, pp 23 - 24 paras 35 - 36

Answering Affidavit: Ntsaluba, p 651 para 37

4.4	Without antiretroviral therapy, the majority of people with HIV/AIDS die prematurely of illnesses that destroy their immune systems, quality of life and dignity.    Early diagnosis, clinical management, medical treatment of opportunistic infections and the appropriate use of antiretroviral therapy prolongs and improves the quality of life of people with HIV/AIDS.   This is explicitly recogised by the Department of Health.  In its “HIV/AIDS Policy Guideline” it states:

“Current research strongly indicates that suppressing HIV viral activity and replication with antiretroviral therapy combinations prolongs life and prevents opportunistic infections.”

Founding Affidavit: Wood, p 137 para 10

Annexure “RW3" - “Prevention and Treatment of Opportunistic and HIV-related Diseases in Adults”, p 165 at 170

Answering Affidavit: Simelela, p 1091 para 75

4.5	Dr Onyebujoh, a member of the Medicines Control Council, who deposed to an affidavit on behalf of the respondents, states:
“The increasing HIV pandemic has informed the need to develop new interventions aimed at decreasing transmission of HIV.   Prime among those interventions is the prevention of MTCT of HIV to impact on childhood disease.”

Answering Affidavit: Onyebujoh, p 1521 para 5

4.6	In an article written by Dr Onyebujoh and others in the South African Medical Journal in May 2000, which is referred to in his curriculum vitae, he says the following:

“South Africa is currently in the grip of a catastrophic epidemic with 22,8% of pregnant women HIV-positive in 1998. ... Out of 1.2 million South African live births, nearly 300 000 are to HIV-positive women and therefore approximately 100 000 HIV-positive babies are born each year, most of whom die by the age of five.”

The article goes on to suggest that “anti-retrovirals for mother-to-child transmission should form part of an integrated approach to maternal and infant health care.”

Replying Affidavit: Mthathi, p 1833 para 128
Annexure “I”, pp 1992-1994

4.7	A survey relied upon by the Department of Health and annexed to the answering affidavit reveals the extent of the catastrophe.     This survey reveals the following:

4.7.1	It is estimated that “nationally 24.5% of the women who presented at the public health facilities (for the first time during that current pregnancy) were infected with HIV by the end of the year”.

“National HIV and Syphylis Sero-Prevalence Survey of Women Attending Public Antenatal Clinics in South Africa 2000"

Answering Affidavit, Annexure “AN2" p 859 para 4.1.1

4.7.2	Provincially, the highest rate of infection is KwaZulu-Natal (36.2%) followed by Mpumalanga (29.7%) and Gauteng (29.4%).

Answering Affidavit: Annexure “AN2" p 860 para 4.1.2

Founding Affidavit: Karim: pp 234-235 para 18
Answering Affidavit: Makubalo: pp 1496-1497 para 10.5

4.7.3	Between 1999 and 2000, HIV prevalence increased significantly among women in their twenties.

Answering Affidavit: Annexure “AN2" p 861 para 4.1.3

4.7.4	Extrapolating the estimates of HIV prevalence among pregnant women to non-pregnant women, men, new born babies and children, and adopting the necessary caution flowing from the methodology adopted, the Report stated:
1.1.1	

“Projections of the estimated number of infected people infected with HIV in South Africa at the end of 2000 are as follows: Women aged 15 - 49 years (2,5 million), men aged 15 - 49 years (2,2 million) and babies (106 109). This results in a total of 4,7 million South Africans being infected with HIV at the end of 2000.    These estimates suggest that approximately 1-in-9 South Africans are infected with HIV.”

Annexure “AN2", p 863 para 4.1.4

Founding Affidavit: Mtathati, pp 25-26 para 44

Answering Affidavit: Ntsaluba, p 654 para 44

Founding Affidavit: Wood, pp 137-8 para 11

Answering Affidavit: Simelela, p 1091 para 76

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

Founding Affidavit: Mthathi, p 26 para 45 - 46
Answering Affidavit: Ntsaluba, p 655-6 para 46 - 47

4.9	A vaccine, the best long term solution, is not going to be available for at least a decade given the most optimistic scenario.

Founding Affidavit: Karim, p 243, para 42
Answering Affidavit: Makubalo, p 1508, para 12.10

4.10	There is a disproportionately severe impact of the HIV/AIDS epidemic on women:

4.10.1	Sub-Saharan Africa is unique in having more women infected with HIV than men.

Founding Affidavit: Karim, p 232, para 6
Answering Affidavit: Makubalo, p 1493 paras 9.1-9.2

4.10.2	In the past ten years, HIV seroprevalence among first time antenatal clinic attendees has risen from 0,76% in 1990 to 10,44% in 1995 to 24,2% in 2000.

Founding Affidavit: Karim, p 234 para 17
Answering Affidavit: Makubalo, p 1496 para 10.4

4.10.3	Women “can be particularly vulnerable to HIV/AIDS partly because of the patriarchic nature of our society”.

Answering Affidavit: Makubalo, p 1499 para 11.5

4.10.4	Physiologically women are at greater risk than men for HIV transmission.

Founding Affidavit: Karim, p 239 para 27 
Answering Affidavit: Makubalo, p 1500, para 11.6

4.11	One of the most common methods of infection of HIV is from mother to child at and around birth.   This results in the infection of approximately 70 000 children each year.   Most of this infection takes place during and around the time of birth through intrapartum transmission.  

Founding Affidavit: Mthathi, p 15 para 22.2
Answering Affidavit: Ntsaluba, p 635 - 6 para 20
Founding Affidavit: Mthathi, p 27 para 50
Answering Affidavit: Ntsaluba, p 656 para 51

4.12	In a document published by the Department of Health upon which the respondents rely, entitled “Prevention of Mother-to-Child HIV Transmissions and Management of HIV-Positive Pregnant Women” (May 2000) it is stated:

“Mother-to-child transmission (MTCT) is the overwhelming source of HIV infection in young children.   In the absence of preventive intervention, the probability that an HIV positive woman’s baby will become infected is approximately 25% to 35%.  HIV may be transmitted during pregnancy, labour, delivery or after the child’s birth during breastfeeding.”

Answering Affidavit: Ntsaluba, p 648 para 30.2

Annexure “AN6", at p 899

4.13	The devastating health consequences of infection with HIV are self-evident.  But HIV infection also carries with it “discrimination and stigma associated with disclosure of HIV status”.   

Answering Affidavit: Ntsaluba, p 703 para 108.7

4.14	Ntsaluba accepts that “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.”   He disputes, however, that these admitted consequences are avoidable.  (Whether or not these consequences are indeed avoidable is the subject of the present application).

Founding Affidavit: Mthathi, p 80 para 238
Answering Affidavit: Ntsaluba, p 769 para 197.5

4.15	The devastating impact of HIV is borne out by the accounts of women who have been unable to obtain treatment to reduce the risk of transmission to their children and now have to live with the knowledge of the impending deaths of their offspring.    There is an apparent acceptance of the plight of these women.    Ntsaluba recognises that from these accounts “it is clear that a number of the elements of the health care system need attention”.

Answering Affidavit: Ntsaluba, p 794 para 228

4.16	Busisiwe Maqungo tested positive for HIV in May 1999.    At that time her daughter, aged one month, was very sick, suffering from pneumonia, diarrhoea and dehydration.    She too tested positive for HIV.    At the time of her pregnancy she was aware that the drug AZT would reduce the risk of mother-to-child transmission of HIV.    Notwithstanding the existence of this drug she gave birth to an HIV positive child without the advantage of this medication.     In consequence, her baby is always sick and she has been told that her baby will die and that nothing can be done.

Founding Affidavit: Maqungo: pp 472 - 474

4.17	Ntsaluba offers, in essence, two responses:

4.17.1	First, he points out that at the time in question, there was no affordable treatment available.   He concedes, however, that “Nevirapine has the potential to reduce the risk of MTCT of the HIV in children and it is generally regarded as a more cost-effective form of treatment for developing countries.”   He adds that there are nevertheless “concerns surrounding its immediate full scale implementation”.   
1.1.1	
4.17.2	His second response is that it was the Western Cape which was responsible for the treatment of Maqungo.

Answering Affidavit: Ntsaluba, p 795-6 paras 233 - 234

4.18	What has escaped Ntsaluba, however, is that the programme presently in place in the Western Cape would obviate a repetition of the tragedy which befell Maqungo.    By contrast, the plight of people in the position of Maqungo in other provinces will simply remain unredressed in the absence of the relief sought in the present application.

Replying Affidavit: Mthathi, p 1816 paras 70-71

4.19	The plight of SH is particularly telling.   She gave birth to a son on 18 July 2001 having been diagnosed with HIV in 1997.    She was aware of Nevirapine for reducing the risk of transmission of HIV.    She was referred by an NGO (Bambanani) to Chris Hani Baragwanath Hospital where she was given a Nevirapine tablet and advised to take drops for the baby when it was born.    She went into premature labour and was taken to Sebokeng Hospital by ambulance.    She told the doctor that she was HIV positive but was informed that she could not be given Nevirapine because it was not available. She gave birth but still wanted her baby to have the Nevirapine.  Because the baby was so small he could not be taken to Chris Hani Baragwanath.  He  did not receive the medicine.
1.1	

Founding Affidavit: SH, pp 476-479

Ntsaluba’s answer is callous to say the least.    He first denies that the version given by SH is true and correct yet, inexplicably, does not offer any facts in contradiction.    He also accuses SH, notwithstanding what was obviously a premature labour, of being “to some extent neglectful of her health and the health of her baby”.

Answering Affidavit: Ntsaluba, pp 797-8 para 239
      p 800 para 242.1

Replying Affidavit: Mthathi, p 1816 para 72
  p 1822 para 87

4.20	Ntsaluba’s approach to the plight of SH is one of obfuscation.    He argues that by reason of the premature birth, Nevirapine may not have been medically indicated in any event.

Answering Affidavit: Ntsaluba, pp 799-800 para 241.5

4.21	What Ntsaluba does not come to grips with, however, is that absent questions of prematurity and the like, there is simply no rational basis to refuse the prescription of Nevirapine to a person in the position of SH.

5	NEVIRAPINE

5.1	Nevirapine has been described as follows:

 “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.”

Founding Affidavit: Mthathi, p 29 para 57

Answering Affidavit: Ntsaluba, p 660 para 56.8

5.2	Nevirapine has been registered for use by the Medicines Control Council (“MCC”).   The MCC has a statutory duty to investigate whether medicines are suitable for the purpose for which they are registered.

Founding Affidavit: Mthathi, p 15 para 22.3
Answering Affidavit: Ntsaluba p 636 para 21

5.3	The MCC has registered Nevirapine for use to reduce the risk of MTCT of HIV.    It has been registered for “intrapartum transmission of HIV”.

Founding Affidavit: Mthathi, p 15 para 22.4
Answering Affidavit: Ntsaluba, p 636 - 639 para 22

5.4	The MCC found that Nevirapine (also known as “Viramune”) may be used alone, as a single oral dose of 200 mg to the mother during labour, preferably more than two 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.

Founding Affidavit: Mthathi, p 32 para 69
Answering Affidavit: Ntsaluba, p 664 para 59

5.5	The administration of Nevirapine is straightforward.    In terms of the respondents’ “Protocol for Providing a Comprehensive Package of Care for the Prevention of mother-to-child Transmission of HIV in South Africa”, all pregnant women who are HIV positive will receive an intra-partum pack after 28 weeks of gestation of Nevirapine 200 mgs and “be advised to self-administered (sic) the medication at the onset of labour or rupture of membranes... All infants born to HIV infected women will receive a single dose of Nevirapine between 12-72 hours after birth.”

Protocol, Annexure “Q”, p 353-354

5.6	The administration of Nevirapine, together with support services (testing, counselling, formula feed and monitoring) is intended to have as its end result “ensuring that the outcome of the intervention is a live HIV-negative infant at 24 months”.
1.1	

Answering Affidavit: Ntsaluba, p 707 para 110.1.4 and 110.1.7

5.7	There is no dispute that Nevirapine is effective in reducing intrapartum transmission of HIV from mother-to child:

5.7.1	The Minister herself acknowledges the efficacy of Nevirapine in relation to intrapartum transmission.

Letter: 6 August 2001, Annexure “E”, p 131

5.7.2	Ntsaluba  merely contends that it is not “completely effective”.

Founding Affidavit: Mthathi, p 17 para 22.13
Answering Affidavit: Ntsaluba, pp 649 - 650 para 31

5.7.3	Ntsaluba acknowledges that Nevirapine by admission of a single dose to the mother and a single dose to the child, reduces the risk of MTCT.  He contends that “in order to be effective” it additionally requires other support services.

Answering Affidavit: Ntsaluba, p 652 para 40

5.7.4	In the words of Simelela, Nevirapine has been found “to be effective for the prevention of intrapartum transmission of HIV”.   She states that this is not the same as prevention of MTCT.

Founding Affidavit: Wood, p 139 paras 17 - 18
Answering Affidavit: Simelela, p 1097 paras 81 - 82

5.7.5	The efficacy of Nevirapine has been clinically proven.    Dr Levin, a member of the Medicines Control Council, confirms its efficacy.  This flows from the HIV NET O12 trial in Uganda.    He states:

“The efficacy of intrapartum and neonatal single dose Nevirapine (NVP) in the prevention of mother-to-child transmission (PMTCT) of the HIV was established by the HIV NET 012 randomised trial in Uganda.    This trial randomly assigned mothers to receive 200 mg NVP orally at onset of labour and 2 mg/kg to babies within seventy-two hours of birth or AZT 600 mg orally to the mother at onset of labour and 300 mg every three hours until delivery and 4 mg/kg orally twice daily for babies for seven days after birth.  The primary efficacy endpoints were the rates of HIV infection and HIV-free survival at 6-8 weeks and 14-16 weeks.   In the results presented in the Lancet paper by Guay et al, the rates of HIV infection or death were at week 6 - 8 NVP 12,8% v AZT 23,1% and at week 14-16 NVP 14,4% v AZT 27,6%.    This represents a relative improvement of 47% for NVP, which was statistically significant (P = 0,00021) ie this difference was real and could not have arisen by chance.    It is important to note that the Lancet results were published in the interests of public health at a time that not all babies had reached the 14-16 week follow up.

Results are available for 20 months follow-up.   The rates of HIV infection or death were roughly 20% for NVP versus 30% for AZT.  This translates as a relative reduction of 33% and an absolute risk difference of 10%, ie NVP would save 10 out of every 100 babies born to HIV positive mothers who agreed to participate in the programme as compared to the AZT regime. ....

Thus, HIVNET 012 provides conclusive evidence of the efficacy of NVP - it could be argued from a public health point of view that the month 20 result is more relevant than the week 14-16 result.    Thus, it would reduce the MTCT (or death) rate by one-third rather than by one-half.”

Answering Affidavit: Levin, p 1478 - 1479 paras 5 - 7

See also:	Founding Affidavit, Wood, pp 141 - 142, para 28

5.7.6	The MCC registered Nevirapine on the strength of the data obtained from the HIVNET 012 trial.    

Answering Affidavit: Onyebujoh, p 1521 paras 6 - 7

5.8	The efficacy of Nevirapine is supported by the World Health Organisation (“WHO”).    The WHO is a specialised agency of the United Nations.   It is the most highly authoritative international organisation on public health issues.    It forms part of the joint United Nations programme on HIV/AIDS, known as UNAIDS.    Ntsaluba accepts this but states that by reason of differences in resources and expertise, WHO recommendations have to be tailored to the circumstances and conditions of individual countries.

Founding Affidavit: Mthathi, p 41 para 108

Answering Affidavit: Ntsaluba, p 686 para 88
Answering Affidavit: Simelela , p 1049 para 13

5.9	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.    The report flowed from a consultation comprising expert scientists and programme managers from various regions, HIV infected mothers, and NGOs.   South Africa was represented at the consultation by its Chief Director of HIV/AIDS and STDs, Dr Simelela.

Founding Affidavit: Mthathi, p 41 para 109
Founding Affidavit: Wood, p 146, para 52
Answering Affidavit: Ntsaluba, p 686 para 89
Answering Affidavit: Simelela, p 1110 - 1111 para 110

5.10	One of the key findings on short term efficacy of Nevirapine was that “the simplest effective regimen includes single dose intrapartum/postpartum Nevirapine”.    

Founding Affidavit: Mthathi, p 42 para 111
Answering Affidavit: Ntsaluba, p 686 para 89

Founding Affidavit: Wood, pp 146-7 para 53
Answering Affidavit: Simelela, p 1111 para 111

Simelela does not dispute this finding.    She merely accuses Wood of ignoring issues of resistance and operational challenges that are posed by the administration of Nevirapine.

5.11	As to the long term efficacy of Nevirapine, the WHO concluded that “the long-term efficacy of short-term Nevirapine regimen has been demonstrated through 12-24 months.  This shows that the early reduction in HIV transmission persists despite continued exposure to HIV during breastfeeding.”

Founding Affidavit: Mthathi, p 42 para 112
Answering Affidavit: Ntsaluba, p 686 paras 90.1 - 90.2

Founding Affidavit: Wood, p 147 para 54
Answering Affidavit: Simelela, p 1111 para 112

5.12	As to safety, the WHO concluded that short-term safety and tolerance had been demonstrated in all the clinical trials.    There had been no association “with an excess of severe adverse events (including mortality)”.    The conclusion was that the benefits in reducing MTCT “greatly outweighs any potential effects of drug exposure”.     Neither Simelela nor Ntsaluba dispute this.   They merely make the point that this conclusion cannot be applied to the long-term safety of Nevirapine as there is no data yet available on long-term safety.
1.1	

Founding Affidavit: Mthathi, p 42 - 3 para 113
Answering Affidavit: Ntsaluba, p 686 - 688 paras 90.3 - 90.6

Founding Affidavit: Wood, p 147 para 55
Answering Affidavit: Simelela, p 1111-1113 para 113

5.13	The WHO consultation further concluded that -

5.13.1	Implementation of antiretroviral drug regimens (including Nevirapine) could be recommended for general implementation;

5.13.2	The prevention of MTCT should be part of the minimum standard package of care for women who are known to be HIV infected and their infants.    

Ntsaluba characterises these conclusions as “important and noteworthy” but states that the recommendations assume that other necessary components of programmes are in place.

Founding Affidavit: Mthathi, p 43 para 116
Answering Affidavit: Ntsaluba, p 691 para 93

5.14	The respondents argue that there are questions concerning the safety and efficacy of Nevirapine.    The evidence in this regard will be dealt with below.    It suffices to state, that such debate as exists about the safety and efficacy of Nevirapine is entirely misplaced in an application of the present sort.    Nevirapine has been registered for use.   This means that provided it is used in the manner indicated, it is recognised by the MCC as being suitable for the reduction of MTCT.    Such risks or questions concerning its efficacy apply to every mother and child to whom it is administered, whether in the private or the public sector and whether in designated sites or elsewhere.  The real issue with which this application is concerned is that those who by reasons of poverty or geographical location are unable to receive the drug are simply left with no choice at all.    The spectre is that their babies will be infected with HIV and will die a premature death.

5.15	In similar vein, the respondents seek to emphasise what they term the “conditional” registration of Nevirapine.    This is a misnomer and is irrelevant.   On the day that Nevirapine was registered it was available for use, as medically indicated, without restriction.    The central issue in this application is why its availability is confined to the designated sites.   In other words, there is no escape from the logical conclusion that whatever the conditions of registration, they apply generally in both the public and private sector.    Thus, the availability of the drug is wholly unconnected to issues concerning its safety or efficacy. 

5.16	The basis upon which the MCC registered Nevirapine is described by Onyebujoh as follows:

“The MCC considers the registration of an intervention for a mentioned indication on grounds of quality, safety, efficacy and in the public interest.   Whilst the process of registration rigorously investigates the claims of an applicant for registration of a new chemical entity in respect of quality, safety and efficacy, the public health interest is also considered.    This would mean that if the MCC is reasonably satisfied with the current safety and efficacy data of a product and the potential public health impact is considered to be great, provisional or conditional registration may be granted, with the requirement for further supporting data to monitor safety, quality and efficacy.   Thus, the magnitude and public health impact of HIV is a good example of the need to facilitate an intervention in the public sector with potential to decrease the disease burden.   This approach is consistent with the accelerated process of approval of antiretroviral drugs, which is usually accompanied by conditions including post-registration monitoring and reporting to the MCC adverse drug reactions.   .... Thus, the registration of Nevirapine for the indications applied for was granted more in response to the public health imperative of providing an intervention to decrease vertical transmission of HIV.”  (emphasis added)

Onyebujoh, p 1524 - 1525 para 11

5.17	Onyebujoh’s evidence in this regard is significant.    It underscores the fact that the HIV/AIDS epidemic is of such a magnitude as to justify immediate and drastic intervention.  But it simultaneously stresses that the MCC’s investigation was rigorous and that the yardstick for registration is quality, safety and efficacy and the public interest.

5.18	Since the efficacy of Nevirapine is potentially affected by breastfeeding, the MCC decided that the package insert should reflect that breastfeeding might alter the efficacy of the drug and that prospective mothers who are about to receive the intervention should be made so aware.

Answering Affidavit: Onyebujoh, p 1523, para 10.2
MCC Resolution, Annexure “PO3" p 1541

5.19	Although this is largely a question of law determined by the Medicines and Related Substances Control Act 101 of 1965, Professor Folb, Chairman of the Medicines Control Council between 1977 and 1998, puts the issue concerning the safety of Nevirapine and the alleged conditionality of its registration to rest.   His evidence may be summarised as follows:

5.19.1	The MCC is required by its statute to ensure that each and every one of its decisions taken in the registration approval of new medicines, and each and every indication that is approved, should meet the stringent standards of therapeutic efficacy, safety, quality and public interest.

Replying Affidavit: Folb, p 1853 para 14

5.19.2	It can reasonably and confidently be deduced that the MCC, in coming to the resolution that it did at its meeting of 30-31 March 2001 would have taken into account all relevant evidence and that such evidence would have been weighed against any risk posed by the known safety profile of Nevirapine.   In reaching its decision the MCC would have concluded that the quality of the medicine was assured and that making the drug available for the indications that were approved would be in the public interest.

Replying Affidavit: Folb, pp 1852 - 1853 paras 11-12

5.19.3	In setting conditions for safety and resistance monitoring to which the registration of Nevirapine is to be subjected, this would indicate the Council’s concern that should the evidence affecting its original decision change in any material way, the Council should be notified. If there has been no revision by the Council of the package insert since its meeting of 30-31 March 2001, it can confidently be stated that the Council has not revised in any material way its original decision.

Replying Affidavit: Folb, p 1853-1854 para 15

5.19.4	Registration of a drug by the MCC “amounts to an unequivocal determination that availability of the drug as specified is in the public interest, which means that the Council has determined that the drug is safe, of acceptable quality, and therapeutically efficacious.”

Replying Affidavit: Folb, p 1854 para 16
        p 1855 para 18

5.19.5	The attachment of conditions to the terms of registration by the MCC “is not an extraordinary event”.    Such conditions in no way qualify the MCC’s conviction that the availability of the drug would be in the public interest and that the Council was satisfied as to its safety, quality and therapeutic efficacy.

Replying Affidavit: Folb, p 1854-1855 para 17

5.20	Ntsaluba responds to Folb’s affidavit as follows, before making some statements of his own: “Folb’s comments correctly reflect both explicitly and implicitly the process of registration adopted by the MCC.”

Further affidavit: Ntsaluba, p 2107 para 12

5.21	It is important to appreciate that such conditions as have been imposed on the registration of Nevirapine are not conditions imposed on the medical practitioner who wishes to prescribe or administer Nevirapine.   The conditions are reporting conditions which are imposed on the manufacturer.

Replying Affidavit: Mthathi, p 1794-1795 para 21

5.22	The respondents’ case concerning the safety of Nevirapine serves merely to cloud the issues in the present matter.   On their own version they have embarked on an extensive programme of public education to enable pregnant women with HIV to make informed choices.    This applies to both the designated and non-designated sites.

Answering Affidavit: Ntsaluba, p 737 para 155.2
      pp 748-749 para 173
      pp 751-752 para 178

5.23	The respondents state that they have “embarked on a carefully considered programme of training counsellors and health care workers” for implementing their plan.   To this end, they have produced a manual for training health providers.    This manual, contends Simelela, shows that the respondents “had expended substantial resources towards developing a comprehensive long-term programme for the prevention of MTCT”.   
Answering Affidavit: Simelela, pp 1048-1049 para 11
     p 1054 para 25

Manual: Annexure “AN14", pp 946-980

5.24	The manual is revealing.    It exposes the exaggeration and misleading impression created by the respondents in these proceedings of the supposed risks associated with Nevirapine.   It reveals what the counsellors and health care workers are told about Nevirapine (and what they in turn impart to their patients).    Thus, the following emerges from the manual:

5.24.1	The aims of the training course are, inter alia, “to help to prepare health care workers and lay councillors for participation in the Department of Health National MTCT Prevention Project, ... and to share more information about the prevention of MTCT for HIV-positive women.”

Manual: p 948

5.24.2	The manual provides the following summary of the MTCT Prevention Project:

“The use of anti-retroviral therapy (ART) to reduce mother-to-child transmission (MTCT) of HIV has become standard treatment in developed countries.   Recent results showing that the use of both short course AZT or a single dose of Nevirapine administered in labour and to the infant can reduce transmission of HIV from mother to child.  These findings have led to recommendations for the widespread introduction of anti-retroviral interventions for this strategy in developing countries, in parallel with the provision of replacement feeds.”

Manual: p 949

5.24.3	It is stated that “women who test positive for HIV will be offered Nevirapine as an intervention to reduce vertical transmission of HIV-1.   Women who accept the intervention will be requested to consent in writing.”

Manual: p 950

5.24.4	The written consents envisaged are annexed to the affidavit of Simelela.

Answering Affidavit: Simelela, Annexure “NS7(c)” p 1256
Replying Affidavit: Mthathi, p 1812 para 57

5.24.5	The ‘”Information to Patient” to enable the patient to decide whether to provide this written consent, state the following with regard to side effects:

“There are side effects that can be expected from taking many tablets of Nevirapine.  These are skin rash, fever, nausea, headache, and abnormal liver function tests.  In this programme, you will receive only one tablet, and these side effects have not been commonly reported for one dose.”

Answering Affidavit: Simelela, Annexure “NS7(c)” p 1256

5.25	In answer to the relief sought by the applicants, the respondents adopt a contradictory stance.    In essence, they stress two factors.    First, they contend that the administration of Nevirapine in and of itself is not sufficient without the necessary support services.    Second, they raise a number of safety concerns surrounding the use of the drug.   

5.26	These concerns, even if legitimate (which is denied), are of no avail to the relief sought in prayers 1 and 2 of the notice of motion.    Those prayers pre-suppose the administration of the drug only if medically indicated.    In other words, such administration pre-supposes the necessary support services and a knowledge and appreciation of the risks involved.   However, the concerns in this regard are spurious, having regard to the fact that the drug is  available in the private sector without restriction.    The concerns raised also provide no justification for the limited availability of the drug only at designated sites in circumstances where it is clear that the support services and expertise are available at non-designated sites.

5.27	Pursuant to this contradictory stance advanced by the respondents, both Ntsaluba and Simelela contend that for Nevirapine to be effective in the prevention or reduction of the risk of MTCT of HIV, a number of other actions have to be taken and other services have to be provided.    It is contended that a comprehensive programme is required which includes counselling of pregnant women and their spouses, HIV antibody tests, services concerning breastfeeding and the monitoring of adverse reactions.   
Answering Affidavit: Ntsaluba, p 657 - 660 para 56.1 - 56.7

Answering Affidavit: Simelela, p 1099 para 89

5.28	Related to the need for the kind of programme envisaged is the role of breastfeeding in relation to the effect of Nevirapine.    Thus, the respondents contend that “many of the women that rely on the public sector for their and their children’s health care are forced to, or choose to, breastfeed.”   This, it is contended, could “result in the reversal of the gains made by administering Nevirapine.”  

Ntsaluba, p 674 - 5 para 75.4

5.29	It is common cause that HIV can be transmitted from mother to child through breast milk.    Alternative feeding options such as formula feed reduce this risk.    In poor communities women often do not have access to clean water or high cost formula feed.   Hence women need information to make informed choices and this is achieved through counselling.   The WHO recommends that HIV positive women in resource poor areas be encouraged to make an informed choice about infant feeding.    

Founding Affidavit: Wood, p 144 - 145 paras 45 - 48
Answering Affidavit: Ntsaluba, p 681 - 2 para 82
Answering Affidavit: Simelela, p 1107 - 9 para 106

5.30	Although breast feeding is a method of MTCT, it does not follow that a HIV positive mother who breastfeeds her infant will transmit the virus, although the chances of this occurring are significant.   The avoidance of breast milk was estimated, in one study, to reduce MTCT by 44%.

Founding Affidavit: Wood, p 146 para 49
Answering Affidavit: Simelela, p 1109 - 1110 para 107

5.31	However, the use of Nevirapine to reduce MTCT is beneficial even in an exclusive breastfeeding or mixed feeding population.    At worst, Simelela states that “there is also evidence to show that some of the gains can be reversed by prolonged breastfeeding and mixed feeding”.

Founding Affidavit: Wood, p 146, para 51
Answering Affidavit: Simelela p 1110 para 109

5.32	Ntsaluba advances a further spurious argument.    He contends that it would be “irresponsible” for the respondents “to make available Nevirapine to the entire public sector when it is common cause that ‘a percentage’ of the babies who are born HIV-negative would subsequently become HIV-positive as a result of breastfeeding.”    This contention defies logic.  It is not Nevirapine which will cause the babies to become HIV-positive, it is the breastfeeding.   What this amounts to, is a policy that no baby outside the pilot projects may receive Nevirapine because some may not retain the life-saving benefit which it provides.
1.1	

Founding Affidavit: Mthathi, p 38 para 96
Answering Affidavit: Ntsaluba, p 679 para 79
Replying Affidavit: Mthathi, p 1799 para 34

5.33	The respondents also purport to justify their decisions on the basis that there is a need to investigate drug-resistant mutations of HIV.   Absent such investigation, it is contended there is a danger to public health if a drug-resistant strain of HIV is developed and allowed to proliferate.

Founding Affidavit: Wood, p 143 para 35
Answering Affidavit: Ntsaluba, p 672 - 3 para 74
Answering Affidavit: Simelela, p 1102-3, para 97

5.34	At the outset it should be emphasised that to the extent that this is offered as a defence to the relief sought, it is spurious.   Such dangers as may exist apply across the board.    They apply equally in the private sector and in the public sector.    In any event, the concerns are overstated.

5.34.1	Wood states that “there is no evidence that the transient appearance of these mutations in the mother causes any public health risk.   It may not be transmitted at all and in any event it is transient.”

Founding Affidavit: Wood, p 144 para 39
See also:  Replying Affidavit: Schoeman, p 1956 para 66

5.34.2	Simelela criticises this approach as being speculative but nevertheless asserts that “the transient nature of the resistant strain may not preclude transmissibility.”    She does not dispute that there is no significant public health risk.

Answering Affidavit: Simelela, p 1104 -1106 para 101

5.35	Wood states further that “the fact that relatively short-lived Nevirapine-resistant mutations develop in some cases after use of Nevirapine, does not affect the safety or efficacy of the intervention”.

Founding Affidavit: Wood, p 144 para 43

The most that Simelela can offer to this is that “the development of resistant mutations does raise questions about the appropriateness of the drug in certain circumstances especially where its efficacy is undermined by practices such as breastfeeding”.

Answering Affidavit: Simelela, p 1107 para 104

6	THE COST OF NEVIRAPINE

6.1	After its registration, Nevirapine was made available at a cost of less than R30 per treatment.

Founding Affidavit: Mthathi, p 57 para 163
Founding Affidavit: Saloojee, p 527 para 17
Answering Affidavit: Ntsaluba, p 824, para 298.2

Ntsaluba does not dispute the cost of the medication.    He states, however, that there are other costs such as counselling and alternative feeding.

6.2	Since 8 January 2001, the price for Nevirapine has been reduced to R10. 

Founding Affidavit: Mthathi, p 57 paras 163-4
Answering Affidavit: Ntsaluba, pp 726-727 paras 136-137

6.3	The costs of the medication, excluding the cost of support services, is “entirely nominal”.

Founding Affidavit: Mthathi, p 57 para 165
Answering Affidavit: Ntsaluba, pp 727 - 728 para 138

6.4	It is clear that the cost of Nevirapine is no bar to its use.    The major costs, according to Ntsaluba, are costs involved in counselling and the provision of formula feeds.    

Answering Affidavit: Ntsaluba, p 750 para 175b

6.5	In July 2000, the manufacturer of Nevirapine, Boehringer-Ingelheim, offered to make the drug available to the South African Government free of charge for a period of five years.

Founding Affidavit: Mthathi, pp 15-16 para 22.6
Answering Affidavit: Ntsaluba, pp 642-643 para 24

Founding Affidavit: Mthathi, p 34 para 79
Answering Affidavit: Ntsaluba, pp 666-667 para 68

6.6	The offer was made only to governments and is not open to the private health sector, save, according to Ntsaluba, for NGO’s, charitable organisations and academic institutions.   It does not appear that the free offer has in fact been made to these latter institutions.

Founding Affidavit: Mthathi, p 34 para 80
Answering Affidavit: Ntsaluba, p 668 para 70.2
Replying Affidavit: Mthathi, p 1796 para 26

6.7	The Government has not yet accepted the offer and is in “discussions” with the manufacturer.

Founding Affidavit: Mthathi, p 34 para 81
Answering Affidavit: Ntsaluba, p 668 para 70.3

What those “discussions” entail is not disclosed and why the offer has not been accepted remains a mystery.   

Replying Affidavit: Mthathi, p 1792, para 16
  p 1797, para 27

6.8	Notwithstanding the fact that the offer of free medication remains open, the Government, save for the Western Cape, has formally decided to make Nevirapine available only at a limited number of sites.   

Founding Affidavit: Mthathi, p 16 para 22.7
Answering Affidavit: Ntsaluba, pp 643-4 para 25

6.9	Although Nevirapine is stocked at pharmacies, most sell the tablet in a pack of 60 tablets thus making it considerably more expensive.   In addition, very few pharmacies stock the drug in suspension form.    Those that do, sell it in volumes of more than 200 ml which, again, makes it very expensive.

Founding Affidavit: Mthathi, p 84 para 257
Answering Affidavit: Ntsaluba, pp 774-5 para 197.12

Founding Affidavit: Hardy, p 515 para 6
Answering Affidavit, Ntsaluba, pp 810-811 para 262
Replying Affidavit: Cooper, p 1970 para 11

7	THE CHOICE OF SITES

Introduction

7.1	According to figures furnished by the Department of Health, 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.  This means that on those figures, without the provision of Nevirapine, almost 100 000 babies will unnecessarily contract HIV during the next two years.

Founding Affidavit: Mthathi, p 55 para 158

7.2	The pilot projects at the designated sites will provide Nevirapine to about 10% of these babies and their mothers.  Approximately 90 000 babies, not covered in the pilot sites, will not receive Nevirapine.  A very substantial number of them will die as a result of having contracted HIV.
1.1	

Founding Affidavit: Mthathi, p 56 para 159

7.3	Ntsaluba, without offering any figures of his own, claims that this is an exaggeration.    The stark reality, however, is that the respondents’ programme will result in a substantial number of infections and deaths of babies not covered by the pilot sites.

Answering Affidavit: Ntsaluba, p 719 para 123

7.4	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”.

Founding Affidavit: Mthathi, p 56 para 160
Answering Affidavit: Ntsaluba, pp 719-720 para 124
See also:  Onyebujoh, Annexure “I”, pp 1992-1994

7.5	At issue in the present case, is the limited availability of a drug which, it is common cause, is effective in reducing MTCT.    This intervention gives the real hope of life to children born of HIV-positive mothers.   The drug is fully available in the private sector.    It is confined to designated sites in the public sector.   It may not be prescribed by doctors at non-designated sites even where this is medically indicated.

7.6	It will be submitted that the evidence demonstrates a complete absence of any rational basis -

7.6.1	for the selection of the designated sites;

7.6.2	for the exclusion of other sites where the necessary expertise and resources are available.

7.6.3	for the distinction between designated and non-designated sites.

The Selection of the Sites

7.7	Simelela explains the choice of sites as follows:

“The MinMec, ie a body composed of all the Respondents, have decided to introduce a MTCT prevention programme in two ‘learning sites’ per province.    There are several good underlying reasons and justifications to this approach.   It is important that appropriate research and monitoring is carried out so that the country as a whole can properly learn from these sites.    A scarcity of resources in the provinces also makes this the most feasible approach.”

Answering Affidavit: Simelela, p 1058 para 37

7.8	Following a meeting on 12 and 13 August 2000, the Minister announced that Nevirapine could not be used outside approved research environments.  The provinces would each select two sites and Nevirapine could not be used outside an approved site.

Founding Affidavit: Mthathi, p 52 paras 144-145
Answering Affidavit: Ntsaluba, p 712 paras 112-13
Minister’s Press Statement: p 340

7.9	The purpose of the pilot projects was stated to be 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” and not to investigate the safety and efficacy of Nevirapine. This is reflected in a document produced by the Department of Health entitled “Protocol for Providing a Comprehensive Package of Care for the Prevention of Mother-to-Child Transmission of HIV (PMTCT) in South Africa.”    Indeed, the document acknowledges that “there is sufficient evidence confirming the efficacy of various anti-retroviral (ARV) drug regimens in reducing the transmission of HIV from mother-to-child”.

Founding Affidavit: Mthathi pp 53-54 para 148 - 149
Answering Affidavit: Ntsaluba, p 713 para 115

7.10	According to the protocol referred to above, the method for the selection of sites is described as follows:

“Site Selection

In order to appreciate fully the operational challenges inherent in the implementation of these interventions, a rural and an urban site will be selected in each Province.    In addition to this pre-requisite, other criteria for the selection of sites include:

1 	A minimum of 3000 deliveries per year;

2 	Access to laboratory support services;

3 	On-site medical expertise to deal with any medical emergencies arising from the PMTCT interventions; and

4 	A well-functioning referral system.

.... depending on the situation in the Provinces, some of the sites are hospitals, others consist of hospitals and feeder clinics.  In case of the latter, ante-natal care visits and post-partum follow-up visits mainly take place at the feeder clinics whereas deliveries are done at the hospitals.”

Founding Affidavit: Annexure “Q” p 348

7.11	The basis upon which sites were chosen and, more particularly, the reasons for exclusion of hospitals, where the necessary expertise and support is available is simply not explained.  Attempts to obtain the MinMec minutes have met with refusal by the respondents.  An appropriate application to compel production will be made at the hearing of this application.

Replying Affidavit:  Mthathi, p 1841-1863 paras 153-167

7.12	The position in the provinces is as follows:

Eastern Cape

7.12.1	The Eastern Cape has two sites for implementation of the MTCT programme, an urban site in the East London hospital complex which includes its 47 surrounding clinics and a rural site at the Rietvlei hospital and its 12 surrounding clinics.

Second Respondent’s Answering Affidavit: p 1552 para 16

7.12.2	The second respondent blandly states that it is envisaged that as the programme at the various sites proceeds, as more lessons are learned and more resources become available, “the programme will be extended progressively to other areas which are not presently included in the programme”.

Second Respondent’s Answering Affidavit: p 1553 para 18

7.12.3	How this will be done and over what period is not stated.

7.12.4	It is claimed that the Eastern Cape is not in a position to commence with the comprehensive programme “principally due to a lack of resources”.    It is estimated that a comprehensive programme would cost the Department an additional R56,8m, far more than the R33m which was allocated for the entire HIV/AIDS programme.

Second Respondent’s Answering Affidavit: p 1553 para 19

7.12.5	It emerges, however, that the Auditor-General has reported that:

“It was found that an amount of R33 585 277.00 earmarked for HIV/AIDS spending was transferred by the Department to the Fort Hare Foundation on 30 March 2001.   No reasonable explanation could be given as to the purpose of the above mentioned action which appears to be irregular.    

While the amount was refunded by way of two payments during April 2001, no interest had been received.

HIV/AIDS related projects are regarded as high priority spending by the department, the province and the country as a whole, yet the department failed to utilise the money.    The amount unspent had not been ‘rolled forward’ to the new financial year by National Treasury and was therefore lost to the province.”

These facts were not disclosed in the answering affidavit.  As of November 2001, the Department had reportedly still not provided the Eastern Cape Legislature Standing Committee on Health with an explanation for the unspent R33m allocated for HIV/AIDS projects in 2000/2001.    It could also apparently not account for its plans to spend the additional amount allocated for HIV/AIDS programmes for 2001/2002.

Replying Affidavit: Mthathi, pp 1838-1839 paras 146-148

Replying Affidavit: Allan, pp 2019-2022

The Free State

7.12.6	The Free State province commenced with the implementation of the prevention of mother-to-child transmission programme in Virginia, Frankfort and their surrounding referral areas.   There are 20 access points in the project where Nevirapine is available.

Third Respondent’s Answering Affidavit: p 1568 para 6

7.12.7	The province appears to be in the process of training counsellors to implement the Voluntary Confidential Counselling and Testing programme.    Lay counsellors have been trained and are working in 12 pilot facilities in Bloemfontein, Botshabelo and ThabaNchu.

Third Respondent’s Answering Affidavit: p 1572 para 15

7.12.8	The province is “not in a position to presently extend the programme beyond the two pilot sites and their access points”.

Third Respondent’s Answering Affidavit: p 1572 para 16

7.12.9	While “the progressive implementation of a comprehensive programme, where Nevirapine is being made available to everyone in the province is an ideal”, the pace of implementatin is determined by the availability of resources.

Third Respondent’s Answering Affidavit: p 1573 para 18

7.12.10	What plans there are, if any, to achieve this “ideal” and over what period, is not stated.

Gauteng

7.12.11	The two research sites established in terms of the MinMec decision in Gauteng are the Natalspruit hospital and the Kalafong/Pretoria West hospital.   A  MTCT programme at the Chris Hani Baragwanath Hospital was initiated in 1998.   

Fourth Respondent’s Answering Affidavit: pp 1586-7 para 5

7.12.12	Additional sites have been identified.    These are the Leratong and Carletonville hospitals (approved on 31 July 2001), the Coronation hospital (approved on 12 September 2001) and the Johannesburg Hospital and Hillbrow CHC (approved on 1 October 2001).  Research sites will be extended to the Sebokeng Hospital and Johan Heyns Community Health Care Centre on 30 November 2001 and the Garankuwa Hospital and Soshanguve Health Care Centre on 28 February 2002.   

Fourth Respondent’s Answering Affidavit: p 1587 para 6

7.12.13	While it is clear that there has already been a significant expansion of the programme, it is not possible “to implement a comprehensive mother-to-child transmission programme within a short period” for various reasons, including the need for training, limitations of accommodation and the like.

Fourth Respondent’s Answering Affidavit. Pp 1580-1590, para 10

7.12.14	Plans for the expansion of the programme and the period in which this is to be achieved are not given.

7.12.15	There is a logical inconsistency in the approach of Gauteng.   It is quite clear that this province has gone significantly beyond the MinMec decision of pilot sites.    Indeed, there has been a significant expansion.    However, among the reasons furnished for the inability to implement a comprehensive plan within a short period is what is described as “outstanding safety and resistance issues” (p 1590 para 10.7).    What is not explained, however, is on what basis the province embarked upon a significant expansion, notwithstanding the alleged concern for matters of safety and resistance.

Replying Affidavit: Mthathi, pp 1836-1838 para 135-142

KwaZulu/Natal

7.12.16	In KwaZulu/Natal there are presently ten access points at the sites pertaining to the MTCT programme in the province.    They are King Edward Hospital, Prince Mshiyeni Hospital, Kwa-Mashu Poly-Clinic, Section D and Section K Clinics at Umlazi Township, Edendale Hospital, Grey’s Hospital, Northdale Hospital, Church of Scotland Hospital and Imbalenhle Clinic.

Fifth Respondent’s Answering Affidavit: p 1610 para 11

7.12.17	There are 390 provincial clinics, 11 provincial health centres and 61 provincial hospitals in KwaZulu/Natal.

Fifth Respondent’s Answering Affidavit: p 1610 para 12

7.12.18	There are no public health care facilities outside the present pilot programme which have the capacity “to immediately implement a  comprehensive MTCT programme, which would include treatment with Nevirapine in order to prevent MTCT of HIV”. Such capacity “has to be developed” for which additional funds are required.

Fifth Respondent’s Answering Affidavit: p 1612-1613 para 17

7.12.19	It is stated that a “progressive roll out of the programme to other sites as and when resources become available and taking account that the issue of resources is being addressed urgently is the most rational and reasonable approach”.

Fifth Respondent’s Answering Affidavit: p 1613 para 19

7.12.20	No timetable for the expansion of the programme is furnished.

Mpumalanga

7.12.21	The pilot sites in Mpumalanga are situated at Shongwe and Evander.

Sixth Respondent’s Answering Affidavit: p 1627 para 13

7.12.22	There are 386 clinics and 25 hospitals in Mpumalanga.

Sixth Respondent’s Answering Affidavit: p 1624 para 7

7.12.23	It is not possible for the province “to immediately implement a comprehensive programme, outside of the pilot sites, where Nevirapine is administered in order to prevent MTCT of HIV.”

Sixth Respondent’s Answering Affidavit: p 1627-8 para 15

7.12.24	It is stated that the challenges presented by a comprehensive programme makes it reasonable for the province to embark on a pilot site programme “with a progressive roll out of the programme to other health care facilities in the province as resources allow”.

Sixth Respondent’s Answering Affidavit: 1628 para 17

7.12.25	Plans for the expansion of the programme and the period in which this is to be achieved are not given.

Northern Cape

7.12.26	The two sites in the Northern Cape are the Galeshewe Day Hospital in Kimberley and the De Aar Hospital.   These sites service 12% of the Northern Cape population.

Seventh Respondent’s Answering Affidavit: p 1633 para 5

7.12.27	Expansion of the programme is not possible due to “over-expenditure patterns”.

Seventh Respondent’s Answering Affidavit: p 1634 para 7

7.12.28	In order to expand the MTCT programme additional professional staff will have to be appointed.   This would require finance and professional staff.

Seventh Respondent’s Answering Affidavit: pp 1635-1636 para 9

7.12.29	No health care facility in the province is immediately able to take on a comprehensive MTCT programme.    Two of the facilities outside the present programme which would require “the least preparation” for the MTCT programme are the Kimberley and Upington Hospitals but this would require “extensive preparations”.

Seventh Respondent’s Answering Affidavit: pp 1637-1638 para 13

7.12.30	No plan for expansion of the programme and the period in which this is to be achieved is furnished.

Northern Province

7.12.31	Save for the pilot site at Makweng it is not clear if there is any other pilot site in the province.

Eighth Respondent’s Answering Affidavit : p 1649 para 14

7.12.32	There are 474 clinics in the province which provide ante-natal an post-natal services of which 169 provide 24 hours maternity services.

Eighth Respondent’s Answering Affidavit: pp 1645-6 para 6

7.12.33	The programme “will be extended as resources become available”. There is no public health care facility outside the pilot sites which have the capacity to “immediately, effectively, properly and safely  administer Nevirapine to prevent MTCT of HIV.”

Eighth Respondent’s Answering Affidavit: pp 1651-1652 paras
 20-21

7.12.34	No plan for expansion of the programme and the period in which this is to be achieved is furnished.

North West Province

7.12.35	The pilot sites in the North West Province are in Lehurutshe/Zeerust (rural) and Tlhabane in Rustenberg (urban).    These projects are intended to be run for 18 months and then the programme is to be rolled out to the whole of the North West province provided that the pilot sites are successful.

Ninth Respondent’s Answering Affidavit: pp 1667-1668 para 13

7.12.36	The Department is not refusing to provide Nevirapine to HIV-positive mothers.    The availability of resources determines the pace of extension of the programme to other sites.

Ninth Respondent’s Answering Affidavit: p 1670 para 18

7.12.37	It seems that the North West Province will simply wait for 18 months to determine whether the programme will be extended to the whole province.

The Western Cape

7.12.38	The Western Cape stands alone as the only province with a comprehensive plan to ensure that all HIV positive women in the province will have access to the provision of Nevirapine and other support services.   This province alone reflects a constitutionally defensible commitment to the rights in the Bill of Rights and, in particular, its obligation to provide access to health care services.   None of the other provinces have anything remotely resembling the programme in the Western Cape.

7.12.39	The Western Cape programme is described as follows:

“As stated, the tenth respondent already has in place an effective programme to substantially reduce the risk of  MTCT of HIV, including the provision of voluntary counselling and testing ... and, where appropriate, the provision of Nevirapine or other similar medicine, as well as the provision of mothers of formula milk for feeding. It is expanding its existing programme in a phased, planned manner with a view to achieving near-universal coverage throughout the Western Cape province within a reasonable time-span.   Health Department estimates are that the programme at present caters for approximately 50% of HIV-positive women in the province.  By 30 June 2002 estimates are that 90% of the HIV infected mothers in the province will have been reached by the programme.    The final phase of the programme is tentatively scheduled to be completed by March 2003, by which time it is believed that coverage will approach 100%.”

Tenth Respondent’s Answering Affidavit: p 1686-1687 para 8

7.12.40	While the other respondents point to the relatively low prevalence of HIV in the Western Cape, it is significant that the Western Cape began its first MTCT site in January 1999 in Khayelitsha using the AZT regime.    Khayelitsha is an impoverished area.   Some 70% of the residents live in shacks.   Although the prevalence of HIV in Khayelitsha is not known with precision, it is estimated to be between 15% and 25% of the adult population.    Over the 2½ year period during which the programme has run, some 19,2% of antenatal patients who participated in the programme tested HIV positive and were offered treatment with AZT.   Of 791 infants born to HIV positive mothers, 697, or 88.1% tested HIV negative.
Tenth Respondent’s Answering Affidavit: pp 1687-1689 paras 10-16

7.12.41	For the Western Cape, the only “significant obstacles to a full roll out” is the difficulty of providing a “complete service in the remote areas which are sparsely populated”.   (This is an issue which faces other provinces as well).   Unlike the other provinces, however, the Western Cape has recognised that remote areas can be “practically serviced by mobile clinics”.    It is looking at ways of providing counselling and testing and drug administration in these areas.

Tenth Respondent’s Answering Affidavit: pp 1693-1694 para 33

7.12.42	Again, in stark contrast to the other provinces, and indeed the national policy, the Western Cape has in place a programme to ensure access to Nevirapine even in facilities where the MTCT programme is not yet implemented.   This programme is in place to ensure that “missed opportunities” are avoided.

Tenth Respondent’s Answering Affidavit: pp 1701-1703 paras 51-57

Replying Affidavit: Mthathi, p 1804, para 41.7

7.13	What emerges from the affidavits of the provinces is an inconsistent and haphazard approach to the provision of a comprehensive programme.  
1.1	

7.13.1	At the one end of the spectrum is a province such as the North West Province which appears to have no plan for expansion at all.    At the other end of the spectrum is a province such as the Western Cape which has a comprehensive plan.

7.13.2	All the provinces, with the exception of the North West Province proclaim their intention of expanding the programme.    However, none of them furnish a plan for the achievement of this goal or a timetable within which it is to be achieved.  

7.14	What is clear is that all the provinces have taken their directions from the MinMec decision.   It is equally clear that all provinces have budgetry constraints.    However, the use of available resources is revealing.   Annexed to the affidavit of Ntsaluba is the Intergovernmental Fiscal Review for 2001 produced by the National Treasury.   It shows that:

7.14.1	It is anticipated that during 2000/01 Mpumalanga spent only 85,9% of the funds available to it for health (p 879);

7.14.2	It is anticipated that during 2000/01 Gauteng spent only 88,5% of the funds available to it for health (p 879);

7.14.3	During 2000/01 the provinces spent only 66% (R10m out of R15m) of the conditional grants made to them by the National Government for HIV/AIDS (page 882).

Answering Affidavit: Annexure “AN3" pp 874-894
Replying Affidavit: Mthathi, p 1838 para 145

7.15	What is conspicuously absent, however, is any form of national coordination from the Ministry to ensure the progressive realisation of access to a programme to prevent MTCT.

7.16	Ntsaluba contends that the first to ninth respondents “have not refused to provide Nevirapine”.   In truth, however, they have refused to provide it except at the pilot sites.    When public sector doctors at non-designated sites provide their patients with the drug, they are accused of being irresponsible (p 696 para 103.3)   He contends that the view has been taken that the provision of Nevirapine must be “carefully and cautiously undertaken”.  He constantly falls back upon what he describes as a “policy choice” made with regard to available resources and with regard to concerns “relating to safety and resistance”.

Answering Affidavit: Ntsaluba, p 681 para 81
      p 650 para 32

Replying Affidavit: Mthathi, p 1800 para 36

The concerns relating to “safety and resistance” cannot be squared, for example, with provinces such as Gauteng and the Western Cape.   In those provinces, the expansion has already occurred and will continue.

7.17	The decision to designate two sites per province in the public sector is contended to be “based on a well thought out, carefully prepared programme that was developed after having regard to the complex nature of the HIV/AIDS problem that besets our country”.    This is purportedly explained in the affidavit of Simelela and those filed on behalf of the provinces.    But Simelela does not explain the basis on which the sites were chosen and, more importantly, the basis on which sites (like the Johannesburg Hospital) were originally excluded.

Answering Affidavit: Ntsaluba, p 643 - 4 para 25

7.18	A persistent theme throughout the affidavits of the respondents, particularly those of Ntsaluba, Simelela and the deponents on behalf of the provinces, is the alleged lack of capacity for the implementation of a comprehensive programme.    There is, however, ample evidence to indicate that the foundations for such a programme are in fact in place.   Professor Schneider points out that:

7.18.1	94% of South African women make use of antenatal services during pregnancy;
1.1.1	
7.18.2	84.4% of women deliver under the supervision of a health professional;

7.18.3	93.3% of children attend the health service for their first immunisations at six weeks after birth;

7.18.4	56.2% of the 3000 fixed clinics in South Africa offer HIV testing;

7.18.5	83% of fixed clinics provide HIV counselling;

7.18.6	In 2000, the daily patient load of nurses in fixed clinics was reported to be 19,8, well below suggested norms of between 28-40 patients per day;

7.18.7	Over a one year period, 56.6% of fixed clinics had at least one person who underwent skills upgrading in the area of HIV/AIDS management;

7.18.8	In 2000, 84,9% of fixed clinics had stocks of the two antibiotics essential for the management of HIV and sexually transmitted diseases;

7.18.9	In 2000, 65,8% of fixed clinics had infant nutrition supplements in stock.
1.1.1	

Replying Affidavit: Mthathi, pp 1834-1835 para 131
Replying Affidavit: Schneider, pp 1995-2016

The non-designated sites

7.19	One of the inescapable consequences of the respondents’ approach is that “doctors in the public sector, who do not work at one of these pilot sites are unable to prescribe the drug for their patients even though it has been offered to the Government for free.”

Founding Affidavit: Mthathi, p 16 para 22.8

Ntsaluba’s answer is extraordinary.   He concedes the point and states that such doctors “can generally only prescribe medicines which are available”.    What appears to have been lost on Ntsaluba, is that it is the State’s decision that Nevirapine is not available and hence such doctors are deliberately disabled from prescribing the drug.   In the case of Nevirapine, cost is not an issue.

Answering Affidavit: Ntsaluba, p 644 para 26

7.20	The case for the applicants rests upon the following propositions:

7.20.1	To the extent that there are situations in which the use of Nevirapine is not indicated, this applies in both the private and public sectors alike and at designated and non-designated sites;

7.20.2	Whether or not Nevirapine is medically indicated is a matter of a professional medical judgment;

7.20.3	The requisite judgment can only be exercised on a case-by-case basis and is not capable of rational or appropriate decision by means of a blanket rule.

Founding Affidavit: Mthathi, p 16 para 22.10

7.21	Ntsaluba does not come to grips with any of these propositions.   Instead, he makes general averments about costs and infrastructure but conspicuously avoids the contentions advanced.    He argues that “allowing the doctors in the public sector to prescribe any drug which they wish to would result in chaos and uncertainty at public sector health sites”.   
Answering Affidavit: Ntsaluba, pp 645-657 para 28

7.22	This approach is disingenuous.   The very system of selective sites and the inability of doctors in non-designated sites to prescribe Nevirapine where this is medically indicated and where the necessary infrastructure exists is precisely the recipe for “chaos and uncertainty” which he ostensibly seeks to avoid.   Moreover, the spectre of chaos and uncertainty is utterly belied by the position in the Western Cape.   The Minister of Health in the Western Cape explains the position as follows:

“It is our intention to roll out the MTCT programme throughout the province as far as this can be achieved given the difficulties with implementing such a programme in areas where there are a very small number of ante-natal attendances per year or where ante-natal services are provided at mobile clinics.

The rate limiting steps for implementation of the MTCT programme is the recruitment employment and training of counsellors.   We would have liked to reach 100% coverage as soon as possible but estimate that at least 90% of HIV positive women will be reached by July 2002.   This we believe is comparable to the roll out of MTCT programmes in Thailand, Brazil and Botswana - the only developing countries that have embarked on the MTCT programmes aimed at reaching the total population.

We do not restrict the ‘right’ of medical practitiners in the private sector in the Western Cape.   Within the public sector, we advise that Nevirapine should be provided as part of a package of services including voluntary counselling and testing in the ante-natal period and formula feed (for those who choose this), Bactrim prophylaxis and infant testing in the follow up period.

However, should an individual practitioner be of the opinion that Nevirapine is indicated in an individual situation (say, where HIV status is already known and formula feed is affordable for the mother) he/she is free to exercise his/her discretion.    The medical superintendent or head of the clinical department at the hospital should be consulted in such situations.   Irresponsible dispensing of Nevirapine without other aspects of the programme being available is not supported by the Department.    In general terms, there has been no protest against or criticism of the above policy by health professionals participating in the programme.    Senior public sector clinicians have been consulted about the development and implementation of the current programme.”   

Founding Affidavit: Mthathi, p 18 para 25

Letter, Annexure “D1" at pp 119-120

7.23	Ntsaluba does not dispute that the Western Cape policy is “feasible and workable and can be reasonably implemented”.    His stance is to argue that merely because the Western Cape has a different plan “does not imply that it is the better one”.    

Founding Affidavit: Mthathi, p 48 para 131
Answering Affidavit: Ntsaluba, p 698 para 106.1

As will be argued below, where the existing plan creates intolerable ethical dilemmas for health professionals and allocates resources on an entirely arbitrary basis, it is specious to argue that the Western Cape plan is not “the better one”.    

7.24	The attitude of the respondents is that -

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

7.24.2	They will not provide breast milk substitutes in those areas where it is relatively easy to do so until they can make provision in all areas.

Founding Affidavit: Mthathi, p 40 para 105

Ntsaluba accuses Mthathi of an over-simplistic approach and poor understanding of the respondents’ attitude.    Yet he does not come to grips with the two propositions advanced.   On the contrary, there is no denial of these propositions but an implicit acknowledgement.  The standpoint of Ntsaluba is that the respondents “would like to establish the full requirements of an effective programme that sustains the benefits of the prevention of intra-partum transmission of the HIV.”

Answering Affidavit: Ntsaluba, pp 683-685 para 86

7.25	In consequence, the applicants contend that the approach adopted is irrational in that it -

“... amounts to ... 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.”

Founding Affidavit: Mthathi, p 41 paras 106-7

Again, there is a conspicuous absence of a clear denial of this logical proposition.   On the contrary, its logic is implicitly affirmed.   

Answering Affidavit: Ntsaluba, p 685 para 87

7.26	The evidence of Professor Bolton, the head of the Department of Pediatrics at Coronation Hospital and Professor Cooper, head of the Department of Pediatrics at the Johannesburg Hospital is instructive.    Professors Bolton and Cooper are respectively the Chairman and Secretary of the South African Pediatric Association (“SAPA”), comprising 250 specialist pediatricians and constituting approximately half the pediatricians in South Africa.

Founding Affidavit: Bolton/Cooper: p 331 para 1

7.27	The experience of the executive committee of SAPA is that there are “many pediatricians 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 Minister of Health and the provincial MEC’s, it is generally made available only at the pilot sites.”    Ntsaluba concedes that there are such pediatricians in the public sector.   The excuse for their inability to provide Nevirapine is twofold:

7.27.1	First, they are precluded from doing so because they are outside the designated sites; and

7.27.2	Second, the are bound to act within the policy framework of the respondent.

Founding Affidavit: Bolton/Cooper: p 331 para 4
Answering Affidavit: Ntsaluba, p 785 para 213

7.28	The contention that doctors may only prescribe what they are permitted to prescribe is merely an argument in circularity.   The crucial question is why a drug, potentially available free of charge, but, in any event available at a nominal price cannot be prescribed when this is medically indicated.

7.29	While there is a national tender system through which medicines are purchased for the public health system, it is possible for a hospital to buy a medicine outside of the tender system.   The policy of the respondents with regard to Nevirapine precludes this because their stance is that Nevirapine “should not be made generally available in the public health sector” outside the designated sites.    

Founding Affidavit: Bolton/Cooper: p 332 paras 5 - 6
Answering Affidavit: Ntsaluba, p 785 paras 214-215

7.30	The iniquity in the system is manifest.    Bolton and Cooper put the matter thus:

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

Ntsaluba has little more than a bare denial to offer in response.

Founding Affidavit: Bolton/Cooper: p 333 para 9.3
Answering Affidavit: Ntsaluba, p 788 para 217.3

7.31	The victims of this policy, namely, those who are forced to use the public health sector are those who, in the words of Ntsaluba, are “the very uneducated and impoverished persons”.

Answering Affidavit: p 695 para 103.2

7.32	It is little wonder that some doctors have done what common humanity compels them to do, namely, to purchase Nevirapine with their own money and to administer it to patients where this is medically indicated.

Replying Affidavit: Grant, pp 2095-2098

7.33	For doctors of conscience, the dilemmas are acute.   Some medical practitioners in the public health sector “have made every effort to make Nevirapine available to their patients when in their professional judgments this is desirable.”   This has been achieved by one of the following methods:

7.33.1	Some patients are referred to a hospital which has been designated as a pilot site;

7.33.2	Some hospitals have sought donations of funds to enable them to buy Nevirapine;

7.33.3	In some cases, the institution itself has bought Nevirapine.

Founding Affidavit: Mthathi, pp 45-46, paras 124-125

7.34	Ntsaluba does not deny that these expedients have occurred.   He complains that by reason of the lack of detail, he is not able “to comment in detail upon them”.    While acknowledging that these expedients occur, he accuses the doctors concerned of “acting contrary to the decision taken by the respondents”.    He further alleges that such actions “may be without the necessary support”.    He expresses the fear of vicarious liability for the conduct of such doctors.   He goes on to accuse these doctors of “flaunting” (sic) the respondents’ programme and “acting irresponsibly”.    

Answering Affidavit: Ntsaluba, pp 694-695 para 102
      p 696 para 103.3

Replying Affidavit: Mthathi, p 1803, para 41.2
  p 1818 para 78

7.35	Responding to Ntsaluba’s complaint of the absence of detail, Professor Cooper states that:

7.35.1	As a result of a donation, he and his colleagues at the Johannesburg Hospital were enabled to provide Nevirapine to their patients when they considered this to be in the interests of their patients;

7.35.2	They did this after carrying out voluntary counselling and testing;

7.35.3	Since 1 October 2001, and after the launch of these proceedings, the fourth respondent has made Nevirapine available at the Johannesburg Hospital;

7.35.4	The fourth respondent has not made any additional staff resources available to the Johannesburg Hospital for this purpose;

7.35.5	Since 1 October 2001 Professor Cooper and his colleagues have continued to do what they previously did, namely carry out voluntary counselling and testing, and provide Nevirapine where they consider this in the best interests of their patients;
1.1.1	

7.35.6	There has been no change to the nature or quality of the service provided to the patients.

Replying Affidavit: Mthathi, pp 1803-1804 para 41.3
Replying Affidavit: Cooper, pp 1969-1971 paras 8-19

7.36	Ntsaluba’s accusations against doctors of conscience is an untenable response to a dilemma of the respondents’ own creation.    The reasonable alternative followed by the Western Cape avoids recourse to expedience of this sort.   The stance adopted by doctors of conscience in South Africa enjoys support.   An editorial in the prestigious medical journal, The Lancet, states:

“This disease is a tragedy for every family that it affects, but in Africa there is no time to indulge the luxury of wondering about the side-effects of anti-retrovirals.    HIV does not discriminate in who it kills.   By refusing to allow doctors in the public sector the freedom to prescribe drugs to prevent mother-to-child transmission, the government of Thabo Mbeki is discriminating against African men, women and children who rely on public care.    Had this happened under apartheid governments they would - rightly - have been horrified.    AIDS is already wiping out one generation of South Africans; if the government does not act quickly, another generation will be lost.”

The Lancet, Replying Affidavit Annexure “E” p 1967

Replying Affidavit: Mthathi, pp 1801-1802 para 40

7.37	It is not simply doctors who find themselves confronted with an untenable ethical dilemma.   Nursing staff like Vivienne Matebula faced the same problems.    She counsels women who are pregnant but because she operates from a non-designated site, those in need of Nevirapine cannot receive it.  She states:

“Early in 2001 I learnt that Chris Hani Baragwanath was providing NVP for pregnant mothers who are HIV positive. ... I am aware of the existence of anti-retroviral drugs that can tret HIV infection and particularly those drugs like NVP that reduce the risk of mother-to-child transmission.   But we do not have these at Kopanong Hospital.   The result is that where a pregnant woman asks for these drugs I have to refer them to Chris Hani Baragwanath Hospital ... where I know they can get the medicine.    Chris Hani Baragwanath Hospital is sixty kms away and because women who come to our hospital are poor, getting there causes great difficulty.”

Founding Affidavit: Matebula, p 488 para 9

Answering Affidavit: Ntsaluba, pp 807-808 para 255

7.38	The evidence of Tshidi Mahlonoko, a professional nurse and HIV counsellor at Boipatong Clinic (a non-designated site) is to similar effect.   She states:

“Since May 2001 alone, I have referred three mothers who are HIV-positive and pregnant to the Chris Hani Baragwanath Hospital for Nevirapine.    These women ranged in ages from 22 years to their 30s.   This is very inconvenient and poor women have to pay a lot of money to get to Soweto from the Vaal.”

Founding Affidavit: Mahlonoko, pp 518 - 519 para 18

Answering Affidavit: Ntsaluba, p 813 para 272

7.39	The absurdity of the respondents’ policy is further illustrated by the example of Johannesburg Hospital.    The AIDS Law Project wrote to the CEO of Johannesburg Hospital asking whether that hospital had a programme for the prevention of MTCT and particularly whether Nevirapine is provided to pregnant women who know they are HIV infected.    The CEO, Mr Pillay, was asked if Nevirapine was not available, to explain why not.   The reply of Mr Pillay, dated 23 July 2001, makes it clear that at that stage -

7.39.1	Johannesburg Hospital had no programme for the prevention of MTCT with the use of Nevirapine because it is not a pilot site;

7.39.2	The hospital “works within the framework of national and provincial policies and guidelines”.

Founding Affidavit: Mthathi, p 47 paras 127-128
Answering Affidavit: Ntsaluba, p 697 para 104

7.40	Ntsaluba does not dispute that the attitude of Mr Pillay, the CEO of “one of South Africa’s largest hospitals is typical of the attitude of hospital administrators”.    Ntsaluba’s stance is that public hospitals “cannot act independently because as soon as that happens financial and other chaos will arise and inequity in the distribution of resources will result.”

Founding Affidavit: Mthathi, p 48 para 129
Answering Affidavit: Ntsaluba, p 697 para 105

7.41	The fallacy of Ntsaluba’s charges of irresponsibility against doctors who prescribe Nevirapine at non-designated sites and his claim that hospitals, like the Johannesburg Hospital, cannot act independently without inviting chaos, is starkly exposed by what has in fact occurred in Gauteng:

7.41.1	From 1 October 2001, after the launch of these proceedings, the Gauteng MTCT programme has been extended to several other hospitals, including the Johannesburg Hospital;

7.41.2	This has occurred notwithstanding the fact that the respondents’ “well thought out and carefully prepared programme that was developed after having regard to the complex nature of the HIV/AIDS problem” and which took “full account of the resources - financial, infra-structural and human - that are available to the public health sector” precluded any expansion until such time as the research and training and the operational challenges that attend implementation of such a programme were “fully appreciated” (Ntsaluba, pp 643-644 para 25);

7.41.3	The expansion of the Gauteng programme to include, inter alia, the Johannesburg Hospital, merely permitted doctors to continue doing what they were doing before 1 October 2001;

7.41.4	The expansion of the programme to the Johannesburg Hospital has not been accompanied by the allocation of new resources to the doctors concerned to enable them now to do what they had always been doing.

Replying Affidavit: Cooper: p 1969-1971 paras 8-19

7.42	The inequity is  exacerbated by the fact that as envisaged, the pilot sites are to operate for two years.   (Certain provinces, seemingly contrary to this policy, are expanding the programme before the expiry of the two year period).   Mtathi states:

“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 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.”

Founding Affidavit: Mthathi, p 55 para 156

Ntsaluba has no legally or ethically tenable answer.    He states:

“I note the contents of this paragraph.    I repeat what I say earlier that it is most unfortunate that some pregnant women are not able, for one or other reason to have access to Nevirapine.”

Answering Affidavit: Ntsaluba, p 718 para 121

The Private Sector

7.43	A further consequence of the respondents’ policy is that it discriminates on the grounds of poverty.   Those who are wealthy enough may obtain Nevirapine in the private sector.   Hence, Ntsaluba is confronted with the dilemma of justifying the limited availability of Nevirapine in the public sector but its ready availability in the private sector.

Founding Affidavit: Mthathi, p 15 para 22.5

His answer is that there are differences between patients in the public and private sectors.    This may be conceded but the basis of the distinction points to a pernicious form of discrimination, namely, discrimination on grounds of poverty and, inevitably race.    Ntsaluba lists the following differences between the public and private sector:

7.43.1	Patients in the private sector are of a higher income and reside in areas with the necessary infrastructure;

7.43.2	There is less pressure on women in the private sector to breast feed;

7.43.3	The public sector serves 75% to 80% of the population.

Answering Affidavit: Ntsaluba, pp 639-642 para 23

7.44	By contrast with the public sector, the respondents “have placed no restrictions on health care professionals in the private sector concerning treatment with anti-retroviral therapy to reduce the risk of MTCT of the HIV”.    

Answering Affidavit: Ntsaluba, pp 745-6 paras 171.1 - 171.2

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

Founding Affidavit: Mthathi, p 51 para 142.2
Answering Affidavit: Ntsaluba, p 708 para 110.2
Replying Affidavit:  Cooper, p 1969 paras 3-7

7.46	For the private medical practitioner, there is no constraint on the exercise of his or her professional judgment to decide whether the use of Nevirapine is indicated in particular cases.   While stressing the differences between the public and private sectors, Ntsaluba does not dispute this.    Moreover, he states “a doctor in the private sector does not have to concern himself/herself with the availability of services such as for example counselling to support his/her decision to administer Nevirapine.”   This is fallacious.   The doctor in the private sector has to do precisely what is required of their counterparts in the private sector.

Founding Affidavit: Mthathi, p 54 para 154
Answering Affidavit: Ntsaluba, p 716 para 119
Replying Affidavit: Mthathi, p 1807 para 47.1

7.47	Ntsaluba accepts that 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 prescription of Nevirapine is in the best interests of their patients.”   On this basis, therefore, Ntsaluba is compelled to deny that Nevirapine is not being made available (at non-designated sites) because of the relative competence of public and private practitioners.    Having conceded the question of expertise, he nevertheless asserts that the public health professional must operate “within properly developed policies”.    He then advances the “slippery slope” argument:

“Once one public practitioner is allowed to prescribe Nevirapine, there is no way (the respondents) can prevent another public practitioner from prescribing an extremely expensive drug to treat a heart condition.”

Founding Affidavit: Mthathi, p 55 para 155 

Answering Affidavit: Ntsaluba, pp 717-718 para 120

The comparison between the capacity to prescribe Nevirapine which is potentially available free of charge or at negligible cost with “an extremely expensive drug to treat a heart condition” is a false comparison.

Replying Affidavit:  Nattrass, p 1984 para 42

7.48	The position then amounts to the following:

7.48.1	Public and private health practitioners are equally competent;

7.48.2	Private practitioners prescribe Nevirapine when, in their professional judgment, this is medically indicated;

7.48.3	A public health practitioner has the skill and competence to make the same professional judgment as his or her counterpart in the private sector;

7.48.4	When a public health practitioner is operating at a designated site, Nevirapine may be prescribed;

7.48.5	When the same public health practitioner operates at a non-designated site, Nevirapine cannot be prescribed even when medically indicated.

It is submitted that the distinctions drawn by the respondents are simply untenable.

Replying Affidavit: Mthathi, p 1808 para 48

7.49	The position of the respondents is all the more inexplicable having regard to Ntsaluba’s acceptance that the “ideal” is to extend the MTCT programme to every hospital in every province.    This is the “goal” that the respondents are working towards.

Answering Affidavit: Ntsaluba, pp 696-7 para 103.4

8	THE ATTITUDE OF HEALTH PROFESSIONALS IN THE PUBLIC SECTOR

8.1	Ntsaluba does not dispute that:

8.1.1	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;

8.1.2	The executive committee of the South African Pediatric Association (which has approximately 250 members representing about half the pediatricians in South Africa) is of the view that Nevirapine should be made generally available in the public sector for prevention of MTCT when in the professional judgment of the relevant health professional this is in the best interests of his or her patient.

Ntsaluba proclaims that he has “insight into the concerns and the views” of these health care professionals but does not “necessarily agree” with their views.

Founding Affidavit: Mthathi, p 49 paras 133-136
Answering Affidavit: Ntsaluba, p 700 paras 108.1 - 108.2

8.2	Dr Saloojee, the second applicant, is the head of the Division of Community Pediatrics and Child Health at the University of the Witwatersrand and a Principal Specialist at Chris Hani Baragwanath Hospital.    He has been a member of the Childhood HIV Working Group in Gauteng and part of the task team which has written the provincial guidelines for preventing and managing HIV in children.

Founding Affidavit: Saloojee, p 524 paras 6 - 7
Answering Affidavit: Ntsaluba, p 819 paras 289-290

8.3	In November 2000 Saloojee, together with a number of concerned pediatricians, launched a campaign called Save Our Babies in order to declare the stance of pediatricians on HIV/AIDS issues particularly in relation to children.    Their campaign arose out of their perception that although pediatricians dealt with the effect of the HIV/AIDS epidemic on a daily basis, their opinions on these issues were not being effectively voiced and when they had been communicated to the Minister of Health, had been ignored.    Ntsaluba denies only the latter contention.

Founding Affidavit: Saloojee, p 525 para 8
Answering Affidavit: Ntsaluba, p 820 para 291

8.4	During November 2000, 273 signatures from pediatricians and child health practitioners were obtained in support of a MTCT reduction programme.  Without motivation, Ntsaluba disputes that the signatures were collected and that each of the signatures are those of pediatricians and child health practitioners.    

Founding Affidavit: Saloojee, p 525 para 9
Answering Affidavit: Ntsaluba, p 820 para 292

8.5	In similar vein and again without motivation, Ntsaluba disputes that each of the signatures of doctors supporting a petition and memorandum on World Aids Day are “indeed” those of doctors or child health practitioners.

Founding Affidavit: Saloojee, p 525 para 10
Answering Affidavit: Ntsaluba, p 820 para 293

8.6	Irrespective of the petty dispute about numbers, Ntsaluba is simply unable to refute the dilemma articulated by Dr Saloojee:

“As a pediatrician, I care for the ever-increasing numbers of sick children with HIV/AIDS on a daily basis.   Pediatricians in South Africa have to deal with dying children at hospitals and clinics around the country.   I, and my colleagues, have to inform parents of their infant’s positive HIV status knowing that the risk of HIV infection may have been greatly reduced if the parents had been counselled and mothers offered anti-retroviral therapy such as Zidovudine (AZT) or Nevirapine (NVP), in the final stages of the pregnancy, and also if their infants had received the same drugs as prophylaxis after birth.”

Founding Affidavit: Saloojee, p 526 para 14

Answering Affidavit: Ntsaluba, p 822 para 296

8.7	Ntsaluba chooses to avert his eyes to the true horror of the dilemmas confronting health professionals by seeking refuge, wrongly it is submitted, in the hearsay rule.   Saloojee refers to an article which he specifically adopts as representing his own views.   He states:
1.1	

“The difficulties that confront us in our work are accurately described in an article by a pediatrician that appeared in the Mail and Guardian newspaper on 5 July 2001.”

It is clear, therefore, that the article is not hearsay but is advanced as reflecting Saloojee’s own views.	That article states, inter alia:

“For many hears it has been our daily bread to care for sick children most of whom we could cure.   But now we ordinary, unexceptional people are facing something extraordinary and exceptional; something that challenges the foundations on which our professional lives are built.

We have seen it coming but we did not know that it would have the power to remould our practice and our relationship with the children, to challenge the essence of our humanity (up to now we thought we had enough humanity in us to do our jobs), even our sense of self.   This extraordinary and unprecedented challenge is brought about by what HIV is doing to children. (That HIV causes AIDS is not something we argue about - we see the evidence daily).

AIDS comes upon most children like the poetic ‘wolf on the fold’.   It seizes them in a fast-forward caricature of the adult disease.   Years are telescoped into months, months into weeks. The final deadly expression of the immune deficiency is often also its first manifestation.   Sometimes parents hardly have time to take in the scent of the plague before their child is gone and they are left to face their own mortality.

These shocks are now our daily fare.   Like the steady reverberations from a pile-driver, they rattle the pillars on which, up to now, we have built our professional lives.”

Founding Affidavit: Saloojee, Annexure “HS6" p 576

8.8	The consequence of the respondents’ policy is unethical in itself but, more importantly, it compels health professionals to act unconstitutionally and unethically.    Saloojee reflects the inevitable ethical and constitutional dilemma which flows from the respondents’ policy:

“As doctors who place the health of our patients first, we would act against our constitutional right to freedom of conscience and against our ethical duty of clinical independence if we were to deny women the right to use anti-retroviral therapy to prevent mother-to-child transmission of HIV.    The current policy that restricts provision of anti-retroviral therapy to pregnant women to ‘pilot’ and ‘research’ sites deny women this right and undermines the doctor-patient relationship.”

Founding Affidavit: Saloojee, pp 531 - 532 para 31

In answer, Ntsaluba misses the point.    He argues that “it is a pity” that Saloojee sees the policy as undermining the doctor-patient relationship and proclaims that it has never been the “intention” of the respondents to do so.  He contends that the “intention was to enhance that relationship by ensuring effective administration of Nevirapine to reduce MTCT of the HIV”.   In so responding, he avoids the thrust of the complaint, namely, that the undermining of the relationship flows from the restriction imposed by the respondents confining prescription of Nevirapine to designated sites.

Answering Affidavit: Ntsaluba, p 836 para 309.2

8.9	Although the stance of the respondents is, at times, difficult to fathom, their position appears to be that save at the designated sites, they will not provide testing, counselling or any treatment to pregnant women with HIV.   Ntsaluba does not expressly refute this.   His response is that outside of the designated sites “information has been disseminated widely enabling women to make an informed choice about pregnancy and their own health”.   He claims that the respondents “have gone to great lengths to ensure that women who are HIV positive are aware of the dangers of breast feeding their infants” and that “counselling has been implemented on a comprehensive basis even before MTCT became an issue”.

Founding Affidavit: Mthathi, p 73 para 211
Answering Affidavit: Ntsaluba, pp 748 - 749 para 173
      pp 751 - 572 para 178
      pp 752 - 753 para 181

8.10	If this is indeed their standpoint, the case for the respondents is incoherent and indefensible.   It means that women treated at non-designated sites will, at least in some cases, have sufficient information to enable them to make informed choices.    They will be aware of the dangers of breast feeding and they will have access to counselling.   This being the case, there is no conceivable reason why they cannot receive Nevirapine where this is medically indicated.    This is precisely what is permitted in the Western Cape.

Replying Affidavit: Mthathi, pp 1813-1815 paras 63-67

9	THE 1994 NOTICE ON CHILDREN AND PREGNANT WOMEN

9.1	On 24 May 1994 President Mandela announced a programme of free access to health care by children and pregnant women.   That programme remains in place to this day.  It was promulgated in Government Notice 657, Government Gazette 15817 of 1 July 1994.    It provides:

9.1.1	As from 1 June 1994 free health services must be provided to pregnant women and children under the age of 6 years.

9.1.2	The free health services envisaged are to be provided at, inter alia, State health care facilities, including hospitals, community health centres, clinics, mobile clinics, satellite clinics and State-aided hospitals of which more than half their expenditure is subsidised by the State.

9.1.3	The free health services include “the rendering of all available health services to the persons mentioned ... including the rendering of free health services to pregnant women for conditions that are not related to the pregnancy”.

Founding Affidavit: Mthathi, p 75 paras 221-222

Government Notice, 657 p 467
Answering Affidavit: Ntsaluba, p 770 para 183

9.2	The respondents accept that this constitutes a formally promulgated policy upon which members of the public can rely.   They contend, wrongly it is submitted, that they are acting consistently with it.   

Founding Affidavit: Mthathi, p 76 paras 223-226
Answering Affidavit: Ntsaluba, p 760 paras 184 - 185

9.3	It is submitted that selective access to health care cannot conceivably constitute compliance with this Notice.   Moreover, as will be argued in relation to the applicable legal principles, this Notice pre-dates the final Constitution and hence operates independently of it.    

9.4	In 2001, the Department of Health issued the National Patients’ Rights Charter.   It did so, according to Ntsaluba, “precisely because it considers that the issues raised therein could be of vital importance to the health of everyone in South Africa”.    Under the heading “Access to Health Care” the Charter promises:

“Provision for special needs in the case of new born infants, children, pregnant women, the aged, disabled persons, patients in pain, persons living with HIV or AIDS patients.

Counselling without discrimination, coercion or violence on matters such as reproductive health, cancer or HIV/AIDS.”

The Charter states further:

“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 any one of these elements.”

Founding Affidavit: Mthathi, p 77 para 229

Answering Affidavit: Ntsaluba, p 761 para 188

9.5	The respondents do not dispute that the Charter is binding on the Government.   Nor do they dispute that it requires pregnant women with HIV to be given full information and counselling regarding options for termination, treatment for opportunistic infections, mode of delivery and breast feeding.   They assert they have done all of this.   They deny that it includes anti-retroviral treatment to reduce MTCT.    Ntsaluba states that there is “a difference between the rights of health users to be given full information and the right of the user to be given Nevirapine.  The right to be given Nevirapine is subject, amongst others, to the resources available” to the respondents.

Founding Affidavit: Mthathi, p 77 para 230
Answering Affidavit: Ntsaluba, pp 761-2 para 189

9.6	Taken to its logical conclusion, therefore, the respondents would have it that fidelity to the precepts of the Charter would require of them to give pregnant women the information they require to make an informed decision concerning, inter alia, the admittedly beneficial effects of Nevirapine and the capacity of that drug to save the life of the unborn child.   Yet, in the same breath, the respondents deny to such women the means by which to give effect to such an informed decision.    The inhumanity of this approach is self-evident particularly having regard to the fact that the cheapest component of the entire process is the drug itself.   

10	THE COSTS AND BENEFITS OF NEVIRAPINE

10.1	The applicants have put up essentially uncontested expert evidence which reveals that the nationwide implementation of a programme for the administration of Nevirapine and related services is cost effective and will result in the saving of money to the State.    Three such analyses have been undertaken, namely:

10.1.1	The “Wilkinson” study.

D Wilkinson, K Floyd, and C Gilks “A National Programme to Reduce Mother-to-Child HIV Transmission is Potentially Cost-Saving: Evidence from South Africa”, Annexure “S” pp 367-380

10.1.2	The “Hensher” study.

M Hensher “The Costs and Effectiveness of Using Nevirapine or AZT for the Prevention of Mothr-to-Child Transmission of HIV - Current Best Estimates for South Africa”, Annexure “T”, pp 381-388

10.1.3	The “Nattrass” study.

N Nattrass, Annexure “U” pp 389 - 421

10.2	The respondents have elected not to put up the evidence of any economist of their own.   Ntsaluba is not an economist.   It is obviously for that reason that he chose not “to enter into any debate concerning the cost-effectiveness of interventions or the amounts of savings involved”

Answering Affidavit: Ntsaluba, p 725 para 135

10.3	Ntsaluba concedes (as he must) that “the argument that MTCT ARV programmes are cost-effective may well be sustained.”   He contends, however, that in order to arrive at a “firm view”, it is important to quantify the number of HIV infections averted and to have a “good sense” of the costs necessary to avert those infections.    

Answering Affidavit: Ntsaluba, pp 722-723 para 127.1

The Wilkinson Study

10.4	In January 1999 the Medical Research Council released a costing study by Professor David Wilkinson, Ms Katherine Floyd and Dr Charles Gilks on preventing mother-to-child HIV transmission through the provision of short course Zidovudine, infant milk formula and counselling.   The results of this study may be summarised as follows:
1.1	

10.4.1	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. 

10.4.2	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. 

10.4.3	The estimated total cost of the national programme would be R160,54m, which is less than 1% of the National Health Budget or R3,73 per capita.

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

Founding Affidavit: Mthathi, pp 58-9 para 169
Answering Affiavit: Ntsaluba, p 729 para 142
Wilkinson Study: Annexure “S” pp 367-380

10.4.5	Ntsaluba has little to say about this study.    He contends that Wilkinson assumed that formula milk is provided for four months whereas the Department of Health’s own study assumes that no formula milk is provided.     The fact that Wilkinson assumed that formula would be provided merely increases the costs of the programme and cannot, therefore, detract from its conclusions.

Answering Affidavit: Ntsaluba, pp 723-4 para 129
      pp 724-5 para 132	

10.5	Significantly, the Wilkinson study was done at a time when  Nevirapine was not registered.   Nevirapine is now available, potentially free of charge.   It is “significantly less expensive” than Zidovudine, on which the study was based.

Founding Affidavit: Mthathi, p 59 para 170
Answering Affidavit: Ntsaluba, p 730 para 143

10.6	In light of the negligible cost of Nevirapine, this study assumes all the more significance.    It emerges from the study that the cost of Zidovudine as a component of the national programme envisaged by Wilkinson came to some R47m representing 30% of the total costs.   Moreover, the provision of infant milk formula came to some R37m, comprising 23% of the component costs.

Wilkinson Study, Annexure “S”: p 375

The Hensher Study

10.7	The most significant feature of the Hensher study is that it was commissioned by the respondents themselves.    It was completed in April 2000.    The Hensher study had regard to the cost savings which would result from a MTCT 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 R270m, that is, additional savings after paying for its own costs.   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.    

Founding Affidavit: Mthathi, p 59 para 171
Answering Affidavit: Ntsaluba, p 730 para 144
Hensher Study: Annexure “T” pp 381-388

10.8	Confronted with the obvious embarrassment of the results of their own study, Ntsaluba, not surprisingly, has little to say.    In essence, he makes three points:

10.8.1	He states, correctly, that the study assumed that no formula milk is provided to mothers, with the result that the R270m savings calculated by Hensher would be significantly reduced.
1.1.1	
Answering Affidavit: Ntsaluba, pp 723-4 paras 129-30

10.8.2	He concedes that this study shows that a MTCT programme would be cost-effective.    But, he argues, the study assume that there would be a 50% reduction in transmission which is not confirmed in the studies conducted in breastfeeding populations.   

Answering Affidavit: Ntsaluba, p 725 para 135

10.8.3	Most surprisingly, he claims that the methodology is not adequately described “to bear proper scrutiny”.

Answering Affidavit: Ntsaluba, p 724 para 130

10.9	It is submitted that these criticisms scarcely detract from the significance of the study.   What Ntsaluba ignores is the fact that the study assumed costs of approximately R6.6m for Nevirapine and R54,4m for Zidovudine.  The costs of Nevirapine would be eliminated altogether if the free offer were accepted. 

Hensher Study: p 382

10.10	The complaint about the methodology is startling.  The Hensher study was commissioned by the Department of Health and produced in April 2000.  If, for purposes of these proceedings, a complaint is made about the methodology, this points inevitably to the fact that the respondents have themselves not engaged in a proper analysis of the results of the study which they commissioned.   It points also, it is submitted to the inference that the respondents are not genuinely concerned about cost-effectiveness but raise it merely as a smoke screen to justify their continued failure to implement a comprehensive programme.

Replying Affidavit: Mthathi, pp 1809-1810 para 50

The Nattrass Study

10.11	The Nattrass study is the most significant.  It was compiled by Professor Natrass whose expertise is neither questioned nor, it is submitted, questionable.    She holds five degrees, including a D.Phil.(Economics) from the University of Oxford.   She is a full professor in the School of Economics at the University of Cape Town and is the director of the Centre for Social Science Research and founder of the AIDS and Society Research Unit.  She has held academic positions at the University of Cape Town, the University Colleges of Galway and Dublin and Stellenbosh University.   She has consulted for the World Bank, the United Nations Development Programme, the International Labour Organisation and the Organisation for Economic Cooperation and Development.

Founding Affidavit: Nattrass, pp 389-90 paras 1-4

10.12	The conclusions reached by Nattrass may be summarised as follows:

10.12.1	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.  

10.12.2	An examination of various treatment options reveals that a mother-to-child transmission reduction programme using Nevirapine has the greatest potential to save lives and saves the government the most money.

10.12.3	On the basis of a detailed examination of the economic factors involved, she concludes 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.”

10.12.4	The programme envisaged includes the cost of voluntary counselling and testing, the provision of medicines and the provision of formula feed in appropriate cases.

Founding Affidavit: Mthathi, p 60-61 paras 173-176
Answering Affidavit: Ntsaluba, pp 730-731 para 145
Nattrass Study: Annexure “U”, pp 389-421

10.13	Ntsaluba says virtually nothing in response.    His only “criticism” is of the weakest sort:

10.13.1	He acknowledges that, unlike Wilkinson, Nattrass does address the logistical complexities arising from the use of substitute feeding by assuming increased mortality in children who use formula feed.    But, he contends, no studies have been done on costs of ensuring access to safe water.

Answering Affidavit: Ntsaluba, pp 724-5 para 132

10.13.2	He further contends that Nattrass and the others “focus only on the cost and savings to the health sector and not the individual mothers”.   This is a specious contention.  At issue is the cost to the State which is the only legitimate cost to be taken into account.

Answering Affidavit: Ntsaluba, p 725 para 133

10.14	A final criticism of Ntsaluba reveals a profound misconception of the role of the expert.    He contends that Nattrass’ work is “explicitly a model” and not “a calculation of data from directly observed research”.   He states:

“Nattrass attempts to take the best available data, and employs the data within the best theoretical framework which are then supported by assumptions because actual data is lacking.”
(emphasis added)

By contrast, he contends that the research and training programme will produce “hard essential data” which will replace the “speculative assumptions in models such as the one used by Nattrass.”

Answering Affidavit: Ntsaluba, p 792 para 227.1 (emphasis added)

10.15	Ntsaluba betrays a startling ineptitude in appreciating that forward planning is simply not possible without making certain assumptions.   The most accurate and reliable forecasts are precisely those based upon “the best available data” employed within “the best theoretical framework”, a method he concedes was adopted by Nattrass.    Taken to its logical conclusion, Ntsaluba would have it that the only basis upon which planning could take place is on the strength of historical data.   Not only is the MTCT programme itself based upon “speculative assumptions”, but if South Africa were to wait for the “hard essential data” to which Ntsaluba refers,
the infant mortality rate would increase.

10.16	The import of Ntsaluba’s standpoint betrays a fundamental contradiction in his approach.   Far from evidencing a comprehensive plan to prevent MTCT of the HIV, the respondents apparently require that the babies who have been treated at the pilot sites reach the age of 18-24 months before they will be willing to make a judgment on cost-effectiveness.   This necessarily implies that even longer than 18-24 months will have to elapse before the respondents are ready to make any decision about whether to institute a comprehensive plan.

Replying Affidavit: Mthathi, p 1809 para 49.4

10.17	Apart from the aforegoing, Nattrass refutes such criticisms as Ntsaluba is able to offer bearing in mind the fact that he has no expertise in the field of health economics.    She makes, inter alia, the following points:

10.17.1	With regard to Ntsaluba’s claim that none of the studies take into account the cost to mothers, such as travelling to health facilities and purchasing and sterilising bottles, etc, she responds that Ntsaluba fails to consider the cost to mothers of travelling to and from hospitals with their children, and the costs of missing work to look after their sick children.  Nattrass’s study was confined to the direct cost to the public health sector.    If it had included private/social costs, her conclusions would have been even stronger in favour of the cost-saving impact of this method of reducing MTCT.
Replying Affidavit: Nattrass, p 1976 paras 9-12

10.17.2	A modification of the model utilised by Nattrass to extend the period of substitute feeding from six months to twelve months still results in the conclusion that the government will save resources by introducing MTCT reduction programmes.

Replying Affidavit: Nattrass, pp 1976-1977 paras 13-17

10.17.3	Nattrass’s analysis demonstrates that if the government introduced a more comprehensive MTCT reduction programme there  would be fewer HIV-positive children in the paediatric wards and clinics and hence more resources (human and financial) available for other health needs.

Replying Affidavit: Nattrass, pp 1982-1983 para 37

10.17.4	Nattrass refutes Ntsaluba’s argument that like specialised cardiac and neuro-surgical care, MTCT programmes should only be available at specific (limited) sites.    She states:

“This argument lacks any economic foundation. A cost-saving MTCT reduction programme, which attends to the needs of very large numbers of people, cannot be compared with a far more complex intervention such as highly expensive neuro-surgical care, which attends to the needs of relative few people.    Providing highly expensive care to a relatively small number of people obviously does not produce the same cost-benefits as providing more basic care to a very large number of people, many of whom may require extended treatment by the health care system if this preventative measure is not adopted.”

Replying Affidavit: Nattrass, p 1984 para 42

11	CONCLUSION

11.1	Despite the volume of paper put up in answer, the evidential basis for the relief claimed by the applicants is clear:

11.1.1	The refusal to allow doctors at non-designated sites to provide Nevirapine where this is medically indicated, defies rational explanation.  The applicants are accordingly entitled to the relief in prayers 1 and 2.

11.1.2	The respondents’ MTCT programme suffers from a fatal conceptual flaw, namely, that it confines the prescription of Nevirapine to designated sites only.  A programme flawed at its inception simply cannot be reasonably implemented.  Apart from the conceptual flaw, however, there is no evidence of a reasonable plan of implementation.  The applicants are accordingly entitled to the relief in prayers 3-7.

11.2	The relief sought is supported by legal authority.  This is comprehensively addressed in Part II of the heads of argument.
1.1	

	GJ MARCUS S.C.

	B MAJOLA

Chambers
Johannesburg
16 November 2001

c:/win/gm/treatmentaction.hds