IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION) Case No: 21182/01 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 Ninth Respondent MEC FOR HEALTH, WESTERN CAPE Tenth Respondent REPLYING AFFIDAVIT I the undersigned SIPHOKAZI MTHATHI hereby affirm as follows: 1 I wish to reply as follows to the affidavits filed on behalf of the First to Ninth Respondents. I am duly authorised by the Applicants to do so. 2 Except where the context indicates otherwise, the facts stated in this affidavit are within my personal knowledge. To the best of my knowledge and belief the contents of this affidavit are true and correct. 3 A number of the allegations made on behalf of the First to Ninth Respondents are repeated in numerous affidavits, and also repeated at numerous places within some of the affidavits. In order to avoid repetition, I first set out in this affidavit my general response to the allegations made in the affidavits filed on behalf of the First to Ninth Respondents. As will appear from that response, I deny the correctness of many of the statements made on their behalf. In order to avoid unnecessarily burdening the papers in this matter, I do not repeat those denials at each and every place where a contrary statement is made in the affidavits filed on behalf of the First to Ninth Respondents. 4 Where I refer to 'the Respondents', I refer to the First to Ninth Respondents unless the context indicates otherwise. 5 Where the allegations made on behalf of the Respondents are inconsistent with the statements in the founding affidavits on behalf of the Applicants, I do not repeat what is said in the founding affidavits. The Applicants stand by what is said in the founding affidavits. 6 I submit that the Respondents have not shown a lawful, reasonable or rational basis for: 6.1 preventing medical practitioners or health professionals in the public health sector from making Nevirapine available to their patients, in accordance with the terms of the registration of the drug by the Medicines Control Council, where in their professional opinion this is in the interest of their patients. 6.2 refusing to make Nevirapine available in the public health sector where it is practicable to provide it either immediately or in the short term, because the places at which it would be so provided do not fall within the policy sites. 6.3 failing and refusing to decide upon, plan and implement (reasonably or at all) an effective national programme to prevent or reduce the mother-to-child transmission of HIV, including the provision of voluntary counselling and testing, and where appropriate Nevirapine or other appropriate medicine, and formula milk for feeding. 7 At various points in the affidavits filed on their behalf, the Respondents fundamentally misrepresent the case of the Applicants. It is not and never has been the case of the Applicants that Nevirapine can and should be provided today or tomorrow to every pregnant woman with HIV who gives birth in the public health sector. It is our case that a programme has to be designed and implemented to provide appropriate treatment on a comprehensive and nationwide basis. That programme must be reasonable, and must be reasonably implemented. Our complaint is that: 7.1 the respondents have not resolved to institute such a programme; 7.2 the respondents have not designed such a programme; 7.3 the respondents have not implemented such a programme. 8 I respectfully submit that nothing in the affidavits of the Respondents contradicts this fundamental cause of complaint. 9 I submit that the conduct of the Respondents is in breach of their duties under the Constitution and the law as alleged in the founding affidavit. I deny that the programmes which they have instituted are 'reasonable' in the sense in which that is required by the Constitution. I also deny that, to the extent that there is a theoretically reasonable programme, that programme has been reasonably implemented. 10 The contents of certain of the annexures to the affidavits filed by the Respondents materially contradict the averments in the affidavits. As this evidence is already before the Court, I do not refer to it in this affidavit, but the matter will be dealt with in argument as the hearing of this matter. AD THE AFFIDAVIT OF AYANDA NTSALUBA 11 Ad Paragraph 3 I deny that all of the facts in Dr Ntsaluba's affidavit are true and correct. 12 Ad paragraph 4 12.1 I deny that Dr Ntsaluba is qualified to express an expert opinion on matters relating to the prevention and treatment of HIV/AIDS, or on the economics of health care. He has not alleged that he is an expert on such matters. He is not a clinician, a paediatrician, a virologist, or an economist. He is (like the Dean of a medical school) a manager, policy-maker and administrator. 12.2 I respectfully point out that every one of the deponents on behalf of the Respondents is either employed by them, or by an institution which is accountable to them. The Respondents have not produced evidence of any genuinely independent experts, and neither have they produced evidence of any clinician, virologist, or economist in order to dispute the allegations made by the applicants. 13 Ad Paragraph 18 13.1 It is not correct that the Applicants contend that the mere prescription of Nevirapine by the attending medical practitioner or health professional would ensure the safe and effective administration of the medicine. We are well aware that treatment to prevent or reduce MTCT of HIV at the time of birth should involve elements other than the provision of Nevirapine alone. 13.2 It is not the complaint of the Applicants that medical practitioners or health professionals in the public sector should not be required to function within a 'well established and generally acceptable policy and fiscal framework' when it comes to Nevirapine. It is our contention 'that policy and fiscal framework' is inconsistent with the Constitution and also unlawful on other grounds, and that it is not 'generally acceptable'. 13.3 The Applicants do not request the Court to make a policy choice. They request the Court to compel the Respondents to comply with their Constitutional and legal obligations. 13.4 It is not our case that Nevirapine has to be made 'immediately and comprehensively available in all public health care facilities'. That is simply a misrepresentation of the contentions of the Applicants. 14 Ad Paragraph 19 The Applicants do not seek a 'hasty and precipitate approach'. The approach which we seek, and which we submit is a legal obligation of the government, will not exacerbate the problem or lead to a catastrophe. On the contrary, it will help to address the problem and avoid the catastrophe which is facing our country. 15 Ad Paragraph 22 15.1 In relation to the registration of Nevirapine by the Medicines Control Council, I refer to the affidavit of Professor Peter Folb (Annexure A). 15.2 Nevirapine has been registered by the Medicines Control Council for various purposes. The only purpose which is relevant to this application is for the reduction of intrapartum transmission of the HIV. This is the major mode of mother-to-child transmission of HIV. It is therefore, as a matter of simple logic, correct that Nevirapine is registered in order to reduce the risk of (one of the causes of) mother-to-child transmission of HIV. 15.3 The fact that the MCC has registered Nevirapine subject to certain conditions is neither an unusual matter, nor relevant to the question whether the MCC has determined that the Nevirapine is suitable for this purpose, and that it is safe, of acceptable quality, and therapeutically efficacious. The MCC may not register a drug unless it is satisfied that the registration is the public interest. In determining whether the registration or availability of a medicine is in the public interest, it may have regard only to the safety, quality and therapeutic efficacy of the drug. 15.4 It follows that the registration of the drug is an authoritative determination that Nevirapine is safe, of acceptable quality, and therapeutically efficacious. 15.5 The conditions have been imposed on the manufacturer of the drug, in order to enable the Medicines Control Council to remain informed of new information as and when it becomes available. They do not go to the question of when or how a medical practitioner may prescribe or administer the drug. 15.6 The Medicines Control Council has determined that if the drug is prescribed or administered in the circumstances for which it has been registered, then it is safe, of acceptable quality and therapeutically efficacious. 15.7 It is not clear whether Dr Ntsaluba denies that Nevirapine is safe, of acceptable quality and therapeutically efficacious when it is used as a short-term measure for the prevention or reduction of mother-to-child transmission of HIV. If that is his view, then he seeks to contradict the authoritative determination of the Medicines Control Council. In that event, he should immediately have taken steps to have the MCC registration set aside. He plainly has not done so. 15.8 The statement by Dr Ntsaluba that it is not 'quite safe' to expose a largely breastfeeding populace to Nevirapine is simply not true. There is no medical evidence to support that statement, and the Respondents have not produced any medical evidence to that effect. What is true is that the efficacy of Nevirapine may be reduced if a mother with HIV breastfeeds her infant. 15.9 I do not dispute that there are differences between the public and private health sectors. The point of my statement is that doctors in the private sector can and do prescribe Nevirapine for their patients when they consider that this is indicated. 16 Ad Paragraph 24 The letter annexure AN5(b) is not attached to Dr Ntsaluba's affidavit, and I am therefore not able to comment on it. However, it is remarkable that it appears that the government has still not taken up the offer of Boehringer Ingelheim to make the drug available for free, even at the pilot sites. This belies the Respondents' repeated expressions of concern about resources and limited budgets. 17 Ad Paragraph 25 17.1 It is not 'largely true' that the Respondents have only made Nevirapine available at the pilot sites. It is true. The implication of the decision by the Respondents is that they have decided to deny Nevirapine to patients in the public health sector, other than at the pilot sites. I say that this is unconstitutional and otherwise unlawful. 17.2 I deal below with the question of resources and alleged safety issues. 18 Ad Paragraph 28 I do not deny that the Respondents are entitled to make policy on the provision of services in the public health sector. The complaint of the Applicants is that this policy is inconsistent with the Constitution and unlawful. 19 Ad Paragraph 22.10 19.1 I am astonished by the statement that a reason for refusing to make Nevirapine available in the public health sector is that the Respondents would be liable to delictual claims if they permitted qualified medical practitioners to prescribe a drug which has been registered for the purpose, and which their colleagues in the private sector are permitted to prescribe. 19.2 The true risk of delictual claims is brought about by the failure of Respondents to make available drugs which are readily available, inexpensive, and can save lives. I am aware that the First Respondent is already being sued in the High Court by a mother on behalf of her child who was born in the public health sector, was denied access to Nevirapine, and was born HIV positive. 19.3 The Applicants do not say that medical practitioners in the public health sector should be permitted to prescribe whatever drug they wish to. They say that doctors in the public health sector should be permitted to prescribe Nevirapine, a free medicine, for the purposes for which it has been registered. 19.4 If the government has implemented a comprehensive plan for the prevention of mother-to-child transmission of HIV, it has failed to disclose this plan in these proceedings. A comprehensive plan would necessarily include a plan for the provision of Nevirapine or other appropriate drugs to all pregnant women with HIV who are to give birth in the public health sector, where this is medically indicated. There is plainly no plan to do this. On the contrary, the Respondents prevent this provision where it is readily possible. 20 Ad Paragraph 22.13 I accept that Nevirapine is not completely effective in preventing intrapartum HIV transmission, and that intrapartum HIV transmission is not totally avoidable. I do not allege that mother-to-child transmission of HIV is caused only by the fact that the Respondents have not made Nevirapine available at all the public health facilities in the country. That has never been the case of the Applicants. The case of the Applicants, which Dr Ntsaluba does not in fact deny, is that the failure to provide Nevirapine results in the mother-to-child transmission of HIV in situations where this was both predictable and avoidable. 21 Ad Paragraph 44 It is true that the MCC placed conditions on the registration of Nevirapine. These are not conditions imposed on the medical practitioner who wishes to prescribe or administer Nevirapine, and they do not contradict the fact that the MCC has determined that Nevirapine is safe, of acceptable quality and therapeutically efficacious for this purpose. They are not 'very stringent' conditions. The conditions are reporting conditions which are imposed on the manufacturer. In this regard I refer to the affidavit of Professor Folb (Annexure A). 22 Ad Paragraph 56 22.1 I regret to say that Dr Ntsaluba misrepresents the reactions to the use of Nevirapine. The serious negative responses to which he refers in paragraph 56.3 all relate to the prolonged use of Nevirapine. They are not 'worse with' prolonged use of Nevirapine - they have been sometimes reported with prolonged used of Nevirapine. Nowhere in the affidavits filed by the Respondents is it suggested that there is any evidence of such severe responses to Nevirapine when used as a single dose for the prevention of intrapartum transmission of HIV. I do not know what he means by saying that 'some of them especially skin reactions' have the 'potential ' to occur with short term use of Nevirapine in MTCT of the HIV. I note that Dr Ntsaluba does not actually say that these reactions have occurred under these circumstances. The simple reason for his reticence is that there is no evidence that they have done so. 22.2 I refer in this regard to the affidavit of Professor Robin Wood (Annexure B) and a statement of Professor Laura Guay, an investigator in the HIVNET 012 trial in Uganda. The Guay statement includes a summary of the results of the HIVNET 012 trial of intrapartum and neonatal Zidovudine versus Nevirapine for the prevention of mother-to-child HIV transmission in Uganda, including the updated final 18 month follow-up results. In additions discussions of the safety and efficacy of Nevirapine in this and other trials completed to date, discussion of the information available about Nevirapine resistance, the impact of infant feeding practices on the overall efficacy of perinatal antiretroviral therapy for the prevention of HIV infection in infants, and the currently accepted international guidelines and recommendations for the prevention of mother-to-child transmission of HIV. 22.3 I deal below with the question of resistance. 23 Ad Paragraph 56.14 I deny that it has been established that there are negative side effects in mothers from the provision of Nevirapine for this purpose, except for skin rashes. 24 Ad Paragraph 64 Despite the formal denial by Dr Ntsaluba, he does not say what scientific or clinical evidence there is which shows that Nevirapine used in this manner (as a once off dose) causes illness in either the mother or the child. None of the deponents for the Respondents produces any such evidence. The development in some cases of a short lived Nevirapine-resistant strain of the HIV is entirely irrelevant in this regard. There is no evidence that this causes any illness in the mother or child. 25 Ad Paragraph 67 Dr Ntsaluba is playing with words. I do not understand the difference between refusing to make Nevirapine generally available in the public health sector, and deciding only to provide it at selective sites. A decision only to provide it at selective sites obviously implies a refusal to provide it at other sites. 26 Ad Paragraph 70.2 Annexure AN10 does not state that Boehringer Ingelheim has actually made this donation available to NGOs, charitable institutions and academic institutions. It lists parties which might be interested in benefiting donations of this kind. 27 Ad Paragraph 70.3 It is remarkable that despite the Respondents' complaint about the lack of resources, they have plainly still not taken up an offer of free supply of Nevirapine. NEVIRAPINE RESISTANCE 28 Ad Paragraph 71 It is not clear what response Dr Ntsaluba would have liked the Applicants to make to the letter from the First Respondent. The Applicants made a demand on the Respondents, and the Respondents refused to comply with that demand. The First Respondent gave the reasons for that refusal. That is the cause of this application. The history of this matter demonstrates that further correspondence in this regard would not have served any purpose, but would have led to the continued unnecessary death of infants while a fruitless correspondence took place. 29 Ad Paragraph 74.2 29.1 The statement that the resistance may cause certain drugs to become ineffective on a long term basis, or that resistant strains of the HIV may be transmitted to sexual partners, is contradicted by the contents of paragraph 90 of my affidavit (which is not denied by Dr Ntsaluba), and by the clear view of the World Health Organisation. 29.2 In this regard I refer to the affidavits of Professor Wood and Dr Pierre Schoeman (Annexure C), both of whom are expert in this field. 29.3 I respectfully submit that those expert affidavits demonstrate that this Nevirapine resistance occurs only in some cases; that it is short-lived; and that it is no threat either to the health of the mother or child, or to public health. 29.4 I refer too to the view of Professor Mark Wainberg (set out below) that the monitoring of this resistance does not provide a reason for denying this treatment, and that to deny treatment on this basis is in fact unethical. 30 Ad Paragraph 75.2 Dr Ntsaluba has seriously misrepresented the opinions of Professor Wainberg, by selective quotation from the article AN 11. What Professor Wainberg also says, which Dr Ntsaluba omits, is the following: 'The question is, then, whether the development of such resistance overshadows the benefits of using NVP in the maternal off-spring setting. The answer is that the use of NVP should continue to be encouraged.' 30.1 I attach marked D a statement by Professor Wainberg, in which he confirms this view and says further that in his opinion, to withhold effective therapy and particularly effective and affordable prevention of MTCT until the infrastructure for monitoring resistance is in place would appear to be unethical, and would constitute a major step backwards in the fight against AIDS in Africa and other resource-poor settings. 30.2 Dr Wainberg is in Canada. In the time available for the submission of this reply I have not been able to obtain the original copy of Dr Wainberg's statement. An original sworn and attested copy of this statement will be filed at court and delivered to the Respondents as soon as it is received from Canada. 31 The statements which I made in the section of my affidavit dealing with Nevirapine resistance were based on the expert opinion of Professor Wood. I respectfully point out that Dr Ntsaluba has not provided any expert evidence whatsoever in support of the generalised assertions which he makes about resistance. He does not suggest that he is an expert on HIV/AIDS or on virology, and neither could he do so. He is a senior public health official whose views I respect in that capacity. However, he is not an expert on the matters with which he deals in this section of the affidavit. He quite rightly does not claim to be such an expert. Yet he produces no expert evidence to justify his position. 32 By contrast, the Applicants rely on the genuinely expert opinions of (amongst others) the World Health Organisation, Professor Wood, Professor Wainberg, Professor Laura Guay and Dr Schoeman. 33 It will be submitted in argument on behalf of the Applicants that the Respondents have wilfully ignored the expert scientific opinion which is readily available. For reasons which are obscure, they are simply not willing to make and implement a policy which will result in the provision of Nevirapine to babies who need it as a matter of survival. They then seek to justify this through assertions which lack any scientific basis or support, and for which they can not produce any scientific evidence. 34 Ad Paragraph 79 I submit that it is unreasonable and in fact irrational to contend that it would be 'irresponsible' to make available Nevirapine in the public sector, when 'a percentage' of the babies who are born HIV negative will subsequently become HIV positive as a result of such breastfeeding. 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. 35 Ad Paragraph 80 35.1 If there is any evidence that babies who are born HIV negative and subsequently become HIV positive are any worse off through having received Nevirapine at the time of their birth, or suffer any adverse affect, Dr Ntsaluba has failed to uncover or reveal it. The truth is that there is simply no such evidence. 35.2 Annexure 'AN12' is not the letter by Marseille to which Dr Ntsaluba refers, apparently published in The Lancet of 20 November 1999. Paragraph 80.2. of his affidavit is therefore a piece of unsupported hearsay, for which no context is provided. It should therefore be ignored. However, annexure 'AN12(a)', also by Marseille and others concludes that 'single dose Nevirapine administered to mothers and neonates in the intrapartum period and soon after birth represents a deliverable and cost effective regimen for prevention of mother-to-child transmission of HIV-1 in sub Saharan Africa, especially under the universal treatment scenario'. 36 Ad Paragraph 81 I do not understand Dr Ntsaluba's statement that the First to Ninth Respondents have not refused to provide Nevirapine. They have refused to provide it except at the pilot sites. And when public sector doctors manage to provide their patients with Nevirapine, Dr Ntsaluba accuses them of being irresponsible. 37 Ad Paragraph 83 Some mothers do not breastfeed. Their children will receive the benefits of Nevirapine, which Dr Ntsaluba does not dispute. Yet the Respondents refuse even to provide Nevirapine to these mothers and their babies unless they are treated at the pilot sites. This is unreasonable and irrational in the extreme. And the evidence shows that in relation to the mothers who do breastfeed, at least some of their babies will retain the benefits of having received Nevirapine. 38 Ad Paragraph 85 I deny that it is 'almost certain' that the provision of breast milk substitute is essential for the benefits of the prevention of intrapartum transmission. This matter is dealt with in the affidavit of Professor Wood. I do not know to which document marked AN12, or which part of that document, Dr Ntsaluba refers, and I am therefore not able to deal with whatever support (if any) he alleges that he has for his statement. 39 Ad Paragraphs 90 - 93 The proper interpretation of the recommendations of the World Health Organisation consultation will be dealt with in argument on behalf of the Applicants. 40 Ad Paragraph 96 The international consensus also appears clearly from an editorial in The Lancet of September 2001. Dr Ntsaluba clearly reads The Lancet, as he has annexed to his affidavit a number of articles and letters from it. I have been advised and believe that The Lancet is arguably the best known and most prestigious medical journal published anywhere in the world. 40.1 The editorial of The Lancet (Annexure E) states as follows: In South Africa approximately 70 000 infections occur by mother-to-child transmission around birth each year. Two drugs, zidovudine and nevirapine, can prevent mother-to-child transmission and the manufacturer of nevirapine, Boehringer Ingelheim, has offered to supply the drug free of charge to governments for 5 years. However, the South African government says more studies are needed, and it has limited the use of Nevirapine in the public sector to a few study sites. But in the private sector in South Africa doctors can, and do, prescribe nevirapine if indicated. The health minister justifies this situation by saying that the government has concerns about resistance to nevirapine, that despite using nevirapine transmission to the child can occur with breastfeeding, and that it is only appropriate to prescribe nevirapine in the setting of an overall plan for the care of women with HIV. The government is also known to be worried about the toxicity of anti-retroviral drugs. None of these reasons justifies the government's position. As the coalition states in their affidavit: 'whether or not to prescribe nevirapine is a matter of professional medical judgment ... it is not a matter which is capable of rational or appropriate decision on a blanket basis'. They accept the urgent need for an overall plan for the care of women with HIV, but waiting until this is in place will cause many children to be infected.... 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. 41 Ad Paragraph 102 41.1 The individual medical practitioner who is treating a patient is better qualified and in a better position than the Respondents, who are politicians (many of them not medically qualified), to determine whether the administration of Nevirapine is or is not in the best interests of a particular patient. It is precisely the refusal of the Respondents to allow the medical practitioners to make these judgements, and to implement them, which may lead to delictual liability on the part of the Respondents. 41.2 Doctors who do not act in the best interest of the their patients are not 'flaunting' the programme or acting 'irresponsibly'. They are acting in the best interest of their patients, as medical ethics and the ordinary rules of law require them to do. 41.3 I refer in this regard to the affidavit of Professor Cooper (Annexure F). His affidavit reveals that: 41.3.1 as a result of a donation, he and his colleagues at the Johannesburg Hospital were enabled provide Nevirapine to their patients when they have considered this to be in the interests of their patients 41.3.2 they did this after carrying out voluntary counselling and testing 41.3.3 since 1 October 2001, and after the launch of these proceedings the Fourth Respondent has made Nevirapine available at the Johannesburg Hospital 41.3.4 the Fourth Respondent has not made any additional staff resources available to the Johannesburg Hospital for this purpose 41.3.5 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 interests of their patients 41.3.6 there has been no change to the nature or quality of the service provided to the patients. 41.4 Dr Ntsaluba apparently regards what was previously done as 'irresponsible', even though it has probably saved lives, and even though he would presumably now regard it as responsible to provide exactly the same service in exactly the same manner to the patients. 41.5 I do not know whether Dr Ntsaluba would contend that before 1 October 2001 it was not in the best interests of the babies at the Johannesburg Hospital to be treated with Nevirapine, but that now it is in their best interests. 41.6 I submit that the true irresponsibility lies in refusing to permit or encourage qualified practitioners to provide the treatment which is in the best interests of their patients. 41.7 The contrast between the Tenth Respondent and the other Respondents is particularly striking here. The Tenth Respondent has made special provision to minimise what he calls 'missed opportunities', which arise at places which his comprehensive roll-out programme has not yet reached. He has done by enabling the medical practitioners in those places to exercise their professional judgment as to whether it is in the interests of their patients to prescribe and administer Nevirapine. The other Respondents not only have no policy to cater for these 'missed opportunities': they actually object when medical practitioners exercise their professional judgment in order to minimise the missed opportunities. 41.8 The Respondents are well aware of this serious issue. The minutes of the Department of Health MTCT Steering Committee on 13 December 2000 (page 1493 of the papers) state: Meeting with the Treatment Action Campaign (TAC) A cordial meeting was held with TAC where treatment issues were raised. Critical issues raised regarded HIV positive women in areas where pilot sites would not be available. 41.9 The Respondents have done simply nothing to address this problem. This is neither reasonable nor rational. It leads to substantial inequity and unfairness. It leads to avoidable deaths. 41.10 There will be no 'chaos' or 'inequity' if a public hospital, using its authorised budget, purchases registered drugs and uses them for the purposes which they have been registered. It is lawful for them to do so. Yet Dr Ntsaluba appears to suggest that this is impermissible. 42 Ad Paragraph 106 Dr Ntsaluba seems to suggest that because the HIV/AIDS problem is more severe in other parts of the country than in the Western Cape, that is a justifiable basis for implementing a less comprehensive programme in those places than has been done in the Western Cape. I submit that this is truly turning logic on its head, and is irrational. 43 Ad Paragraph 108 Dr Ntsaluba appears not to understand the position of SAPA, or to have deliberately misrepresented it. The clearly expressed view of SAPA is that where in the professional judgment of the relevant health professional it is in the best interests of the patient for Nevirapine to be made available, this should be done. This obviously implies that in that particular case, the operational requirements can be met. The fact that operational requirements cannot be met in another case, is not a reasonable or rational basis for refusing to provide a drug where the operational requirements can be met. 44 Ad Paragraph 110 44.1 There is no evidence that the extreme reactions to long term use of Nevirapine are 'likely to occur' with short term use of that medicine. I refer to the expert affidavit of Professor Wood, which is directly to the contrary. 44.2 Dr Ntsaluba has not produced any evidence in support of his statement, nor has he suggested that any such evidence exists. 44.3 This is another example of the Respondents giving reasons for their decision which are simply unreasonable and unsupported by any evidence. It shows again that Respondents are grasping at straws to justify their decision, which they must have taken for some other reasons, which are obscure. 45 Ad Paragraph 110.3 I do not deny that the government is entitled and in fact obliged to make policy with regard to public health matters. That policy must be consistent with its constitutional and other legal obligations. 46 Ad Paragraph 118 46.1 Dr Ntsaluba has not in fact provided any evidence of the supposed 'catastrophic consequences' which may result from the provision of Nevirapine to pregnant women with HIV and their babies, where in the opinion of the medical practitioner this is indicated. I refer again to the affidavits of Professor Wood and Dr Schoeman, who show that there will not be any such consequences. 46.2 The public is suffering the consequences of the HIV/AIDS epidemic, which are genuinely catastrophic. The policies and actions of the Respondents will deepen this catastrophe, by leading to avoidable HIV infections and deaths. 46.3 I am aware that there is already one case in which the First Respondent is being sued for a failure to provide Nevirapine. Cases of this kind are likely to multiply. 47 Ad Paragraph 119 47.1 A doctor in the private sector has to do precisely what the Applicants wish the doctors in the public sector to be able to do, namely to consider whether it is in the interest of the patient and her baby to receive Nevirapine, having regard to all of the circumstances. The doctor in the private sector therefore also has to consider matters such as counselling and the best method of feeding the baby. 47.2 The Applicants have never suggested that the public health sector should simply provide Nevirapine and 'leave it at that', and Dr Ntsaluba misrepresents our position by suggesting that we do. 48 Ad Paragraph 120 I submit that the statement 'once one public practitioner is allowed to prescribe Nevirapine [a free drug], there is no way the First to Ninth Respondents can prevent another public practitioner from prescribing an extremely expensive drug to treat a heart condition' is, with due respect, self-evidently absurd. The same applies to the statement that there is then no logic in having drug dispensing policy. There must obviously be a policy with regard to which drugs may be dispensed. But that policy must be consistent with the requirements of the Constitution and the law, and it may not be based on irrational or unreasonable positions such as this. 49 Ad Paragraph 127 49.1 I refer to the affidavit of Professor Nattrass (Annexure G), who replies to various of the matters raised by Dr Ntsaluba. I will not repeat here everything which she says. 49.2 As I understand Dr Ntsaluba, in his view it is not possible to determine the cost-effectiveness of the provision of Nevirapine until babies have been treated at the pilot projects for between 18 - 24 months. I deal below with whether this is reasonable. What it means, however, is that the Respondents have not yet taken any decision to institute a national programme to prevent or reduce the mother-to-child transmission of HIV through methods which include the provision of Nevirapine or other appropriate medicine. 49.3 I submit that the evidence in the Wilkinson and Hensher studies (and in the numerous studies on which their work is based) is more than adequate to determine that the provision of Nevirapine will be cost effective, and particularly if it is backed up by the provision of milk substitutes. This information has been available for nearly 3 years in the case of the Wilkinson study, and for 1½ years in the case of the Hensher study. Despite this, the Respondents apparently take the view that they will not make any decision in this regard for another 18 - 24 months at least, and perhaps for longer, depending on the period for which they require results from the pilot sites before they make any decisions. 49.4 I point out in this regard that the Respondents apparently require the babies who have been treated at the pilot sites to reach the age of 18-24 months before they (the Respondents) will be willing to make a judgement 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. 49.5 I submit that in the light of the evidence which is already available, this is unreasonable and unlawful. It means that for more than two years, babies will continue to die unnecessarily when effective treatment could have been provided on a cost-effective basis. 50 Ad Paragraph 130 50.1 The Hensher study was commissioned by the Department of Health. The report was produced in April 2000. If the Respondents had acted reasonably, they would by now have taken a view on the outcome of the Hensher study ,and if necessary have asked Hensher for further information as to his methodology. 50.2 However, Dr Ntsaluba's response to the Hensher study is not to deal at all with its merits, but simply to state that the methodology 'is not adequately described to bear proper scrutiny'. This can only mean that the Respondents have themselves not engaged in a proper analysis of the results of the study, which they themselves commissioned and which was produced for them more than a year and a half ago. 50.3 I respectfully submit that this shows that the Respondents are not genuinely concerned about cost effectiveness, but raise it merely as a smokescreen to justify their continued failure to decide to implement a comprehensive programme, plan it, and implement it. The apparent failure of the Respondents, for more than 1½ years, to raise any questions in the methodology of the study which they themselves commissioned, is frankly incomprehensible on any other basis. 51 Ad Paragraph 133 51.1 I do not know whether Dr Ntsaluba is seriously suggesting that because mothers have to purchase and sterilise bottles, and have to travel to facilities to receive formula milk, the programme is therefore not affordable - or, for that matter, whether he is suggesting that to the extent that the programme would not be affordable for some very poor people, therefore it should not be provided to any because it is not cost effective as far they are concerned either. I submit that on any basis this is an insupportable reason for declining to provide a comprehensive programme. 51.2 In any event, as Professor Nattrass points out, the costs of having a sick child are much greater than the costs of purchasing and sterilising bottles, and travelling to fetch formula feed. 52 Ad Paragraph 134 Professor Nattrass has pointed out, and Dr Ntsaluba has not denied, that the programme would actually save the government money. It would therefore not require additional funding - it would release money for other purposes. In the affidavit attached to this reply, she points out that even the start-up costs would be covered in the first year of the programme, or at worst in the second year. 53 Ad Paragraph 136 This amount was based on the actual cost of Nevirapine. As I have pointed out in my previous affidavit, the cost of the medicine has now been reduced to R10,00 per woman and child - and it is of course available for free to the Respondents. 54 Ad Paragraphs 137 and 138 I acknowledge that the cost of the medicine is one part of the cost of providing the service. The studies to which I have referred conclude that having regard to all costs, the programme is cost effective and will in fact result in a net saving to the government. As I understand Dr Ntsaluba's affidavit, he does not dispute this. In Prof Nattrass's affidavit in reply, she points out that her calculations show that the government will save substantial funds even if formula milk is provided for twelve months, and even if the mothers are provided with free bottles. 55 Ad Paragraph 139 The Applicants do not seek an order for the 'immediate provision of Nevirapine throughout the public health system'. We seek immediate availability of Nevirapine where in the judgment of the attending medical practitioner or health professional this is medically indicated (obviously with reference to all relevant circumstances including full informed consent), and a reasonable programme for comprehensive provision, which is reasonably implemented. The Respondents refuse to provide either. 56 Ad Paragraphs 140 and 141 56.1 The Tenth Respondent has created a comprehensive plan which is reasonable, and is implementing it in a reasonable manner. 56.2 The other Respondents, however, have no clear plan for a comprehensive roll out. Dr Simelela does not even say that there is such a plan, let alone say what it is. If there was such a plan, Dr Ntsaluba or Dr Simelela could easily have placed it before the Court. 57 Ad Paragraph 147 The Respondents' documents, attached to the affidavit of Dr Simelela, demonstrate that obtaining informed consent is not a particularly complex matter, requiring great expertise. Any reasonably educated person can use the documents prepared by the Respondents for this purpose. 58 Ad Paragraph 154 The statement concerned appears in the report prepared by Dr Ntsaluba's Department. Dr Ntsaluba does not dispute that this statement appears in his Department's report, or suggest that it is incorrect. 59 Ad Paragraph 162 In error, the correct letter was not attached to my affidavit. This does not make it 'not possible ' for the First Respondent to deal with this averment. I take it that she keeps the letters which she receives, and that they are filed in a manner which makes it possible to find them. Dr Ntsaluba does not deny that the letter was in fact received. He also does not suggest that the First Respondent replied to the letter. 60 Ad Paragraph 165 I deny that the results of the SAINT Study were 'inconclusive'. The deaths to which the First Respondent referred were the result of ongoing and long term treatment. Those trials are irrelevant to the present proceedings. 61 Ad Paragraph 169 The Applicants seek an order for the provision of Nevirapine or other appropriate medicine. 62 Ad Paragraph 171 It is true that the First to Ninth Respondent have placed no restrictions on health care professionals in the private sector. The fact that they have nevertheless placed unreasonable and unnecessary restrictions on professionals in the public sector is precisely the complaint of the Applicants. 63 Ad Paragraph 173 63.1 The dissemination of information to women outside the pilot sites does not assist them, if they are not able to implement the decisions which they make on the basis of that information. It is of no assistance to a pregnant woman with HIV, who is dependent on the public sector, to tell her that her baby is at risk of intrapartum transmission of HIV, and that there are drugs such as Nevirapine which can reduce or prevent this risk, if she is not given the means to implement a decision in this regard. Such women are not enabled to care for their infants in a manner that reduces the risk of HIV transmission, except to the extent that they are themselves able to provide milk substitutes. Even where women can provide milk substitutes for themselves, the Respondents deny them an essential part of what they need, namely a drug which is available to the Respondents for free. 63.2 The Tenth Respondent's programme does not differ 'to a degree' from that of the other Respondents. On the contrary, he has announced their intention to make AZT or Nevirapine or other drugs available to all pregnant women with HIV in the public sector; he has made a plan to achieve this goal; and he is implementing that plan. The other Respondents have taken none of these steps. 64 Ad Paragraph 174 If it is true as Dr Ntsaluba in effect alleges, that pregnant women are counselled about the effects of HIV on their reproductive choices, and that they are in a position to make effective personal health choices, then there is no real impediment to the provision of Nevirapine where it is medically indicated. The women concerned will have been adequately counselled and will be in a position to make appropriate choices. 65 Ad Paragraph 176 Again, if it is true that the Respondents had already (prior to the introduction of the pilot programmes) introduced 'an extensive VCT programme throughout South Africa', then there is no reason at all why Nevirapine can not be offered to pregnant women with HIV throughout South Africa, and why they can not make informed choices on the basis of that counselling. Certainly, there is no reason why they should wait for 2 years before this is offered. At the very least, there must be very many women outside the pilot sites who are in a position to make that choice. 66 Ad Paragraph 178 And if it is true that the Respondents have gone to great lengths to ensure that women who are HIV positive are aware of the dangers of breastfeeding their infants, then there is no reason why the women who are so aware can not be offered Nevirapine to prevent or reduce intrapartum transmission of HIV. If 'health workers looking after any HIV-positive woman are clearly told what to do', then there must be very many situations outside the pilot sites, where the provision of Nevirapine is entirely appropriate on any basis. 67 Ad Paragraph 181 If counselling has already been implemented on a comprehensive basis, then there can be no problem with offering Nevirapine to the women concerned . 68 Ad Paragraph 182 It has never been suggested by any scientist , and it is apparently not suggested by Dr Ntsaluba, that the effect of Nevirapine on the dominant strain of HIV in South Africa will be any different from the effect on the dominant strain of HIV in Uganda. Dr Ntsaluba raises this issue as though it was of some relevance, but does not say what relevance (if any) attaches to it. In fact, it has no significance. 69 Ad Paragraph 189 I of course accept that there is a difference between the rights of health-service users to be given full information, and the right to be given Nevirapine. According to Dr Ntsaluba, pregnant women who are HIV positive are fully informed about treatments for opportunistic infections, modes of delivery, breastfeeding and other information which would impact on their health and the health of the infant. If this is so, then it is a simple matter to provide Nevirapine where this is indicated, as the women concerned have already been informed about matters relevant to breastfeeding. 70 Ad Paragraph 197.6 The situation of Busisiwe Maqungo and her infant does not illustrate the difficulties which occur as a result of lack of resources and skills. It illustrates the consequences of the failure to put in place a comprehensive programme of voluntary counselling and testing, and provision of appropriate medicine. 71 Ad Paragraph 197.7 If Ms Maqungo had given birth in Khayelitsha, she and her daughter could have been treated with AZT, and her daughter might well still be alive today. This arbitrariness in the policy of the Respondents is unlawful. The same arbitrariness persists today: if her child were today born at one of the pilot sites, she would be treated with Nevirapine, but if she were born elsewhere, she would not receive Nevirapine and her prospects of survival would be considerably undermined. This arbitrariness is both unlawful on its own face, and also unlawful because of its discriminatory nature. 72 Ad Paragraph 197.8 I must say that I am astonished by Dr Ntsaluba's attitude to Ms Hlalele, who took steps to protect her baby from transmission of HIV. To suggest that the tragedy which has befallen her is because she was 'neglectful of her health and the health of her baby', and not because of the failure of the Respondents to provide her with a free medicine which is readily available, is simply heartless and an attempt to deny where the obvious responsibility lies. It is unworthy of Dr Ntsaluba. 73 Ad Paragraph 198 73.1 Dr Ntsaluba states that the Respondents 'do not decide which patients should be treated with Nevirapine'. But they do decide which patients should not be treated with Nevirapine, namely the overwhelming majority of patients in the public health sector, who are not situated at one of the pilot sites. They are in rural and urban areas, and this blanket rule is applied to them regardless of the facilities available at the institution at which the woman is treated, regardless of her knowledge of her own situation, regardless of the testing and counselling which is available to her, and regardless of her preferences as to the feeding of her child. 73.2 It is simply incomprehensible to me that where the health professional and the woman are competent to make a decision that she should be provided with Nevirapine, a free drug, this is in effect prohibited by the Respondents. This is not a question of an expensive cardiovascular service. It is a basic service which can be provided in at least some of the situations where it is not provided, at no cost or at a nominal cost. 74 Ad Paragraphs 211 -219 I refer to the affidavit of Professor Cooper attached to this affidavit (Annexure F), which responds to various statements made by Dr Ntsaluba. I do wish however to respond to some of the matters which he raises. 75 Ad Paragraph 212 Professor Bolton and Professor Cooper are chairman and secretary of the SA Paediatric Association, which has approximately 250 members, constituting approximately half of the specialist paediatricians in South Africa. I submit that it is obvious that Professors Cooper and Bolton can speak with expert knowledge of what is happening in the specialist paediatric profession in our country. 76 Ad Paragraph 212 Professor Cooper and Professor Bolton are themselves paediatricians working in the public sector. Their statement is obviously based on their knowledge derived from their own work and their work with their professional colleagues. If Dr Ntsaluba really does not know that many paediatricians in the public sector wish to prescribe Nevirapine for their patients in order to prevent or reduce mother-to- child HIV transmission, then he is startlingly ignorant of what is going in the profession which his department regulates, and on which it seek to impose conditions. 77 Ad Paragraph 216 I refer to the affidavits of Professor Cooper with regard to the use of Nevirapine obtained through donation. As fas as the matter of referral of patients from one hospital to another hospital which is a pilot site, this is not only a matter of the expert knowledge of Professor Cooper and Professor Bolton, but there is also direct evidence of this in the affidavits in this matter. 78 Ad Paragraph 217 The doctors in the public health sector who are outside the pilot sites, are exercising their professional responsibilities and duties when they seek to save the lives of their patients by providing a registered medicine which is available at a nominal price. I challenge Dr Ntsaluba to say that they have acted unprofessionally or unethically by doing so. I further invite him to request the bodies which are responsible for maintaining ethical standards in the medical profession, to say whether the doctors concerned acted in accordance with or contrary to their professional and ethical duties. I say that in fact they are acting responsibly, in accordance with the interest of their patients and their obligations and duties as members of the medical profession, of which Dr Ntsaluba is also a member. 79 Ad Paragraph 218 Dr Ntsaluba misrepresents the position of the Applicants. We do not 'expect the medical practitioners in the public sector to do everything to ensure the effective treatment with Nevirapine'. What we say is that they should be permitted to provide the treatment which they wish to provide, and which they believe is in the best interest of their patients. Professor Cooper states that they would welcome the opportunity to do so. The attitude of the Respondents is that they should not be permitted to do this, and that politicians should be the people who decide whether a particular treatment is in the best interests of a patient. 80 Ad Paragraph 219 Dr Ntsaluba here clearly acknowledges, contrary to what he has said elsewhere, that a comprehensive programme for the prevention and reduction of mother-to- child transmission of the HIV has not yet been instituted. 81 Ad Paragraph 220 The functions of the Dean of the Faculty of Health Sciences, like the functions of the Director-General of the Department of Health, are largely policy making, managerial and administrative. 82 Ad Paragraph 221 Dr Ntsaluba is also not an expert in HIV/AIDS treatment, and he is also neither a pediatrician nor a clinician. For that matter neither is any of the deponents on behalf of the Respondents a paediatrician or a clinician, and none of them is involved in the treatment of HIV/AIDS. The Applicants, on the other hand, have submitted expert evidence by people who are daily involved in the treatment of HIV/AIDS and who are paediatricians and clinicians. In this regard I refer to the affidavits of Professor Wood, Professor Cooper, Professor Bolton, and Dr Saloojee. 83 Ad Paragraph 222 Yet again, Dr Ntsaluba makes the semantic argument that the MCC has not registered Nevirapine for 'preventing or reducing mother-to-child transmission of HIV' because it is registered only for preventing or reducing one of the methods of mother-to-child transmission of HIV. If necessary, in argument it will be demonstrated that in numerous places in their own papers, the Respondents use the term 'preventing or reducing mother-to-child transmission of HIV', as a convenient shorthand. 84 Ad Paragraph 223 I assume that Dr Ntsaluba does not dispute that Nevirapine is regularly used by private practitioners to reduce the risk of intrapartum transmission of HIV, which (it is common cause) is the dominant mode of mother-to-child transmission of HIV. 85 Ad Paragraph 225 I can not respond to Dr Ntsaluba's criticism of Professor Price's use of the term 'equity', as he does not say what he himself means by this. What I do say is that it can not be equitable for the poorest members of the community, who are dependent on the government, to be denied access to a free drug which is readily available to wealthier people in the private sector, purely on the basis of decisions made by politicians and not on the basis of a considered medical professional opinion. This practice can not possibly constitute 'substantive equity', no matter how complex that concept may be. 86 Ad Paragraph 227 86.1 Dr Ntsaluba is not an economist or an expert in the field in which Professor Nattrass has given evidence. He is not competent to express an expert opinion on the matters on which she gives expert evidence. In her affidavit in reply Professor Nattrass responds directly to various statements made by Dr Ntsaluba. 86.2 I note that Dr Ntsaluba does not dispute the conclusions which Professor Nattrass has reached. He raises certain questions with regard to the model on which she has worked. 86.3 Each of the studies - by Wilkinson and others, by Hensher (on behalf of Dr Ntsaluba's department) and by Professor Nattrass - uses a different model. Each of them reaches basically the same conclusion, namely that a comprehensive programme for treatment and prevention of mother-to-child transmission of HIV would be affordable, cost effective, and in fact potentially cost saving. 86.4 The first of these studies was available in January 1999. The second, which was commissioned by Dr Ntsaluba's department, was completed in April 2000. I ask how many more studies Dr Ntsaluba would like to have done before he is satisfied as to their conclusions. 86.5 It will be submitted on behalf of the Applicants that the unwillingness of the Respondents to accept that it has been demonstrated that comprehensive treatment is cost effective is yet another example of their grasping at straws to justify their failure to institute a comprehensive programme for dealing with this matter, for reasons which are obscure. 87 Ad Paragraph 242 I submit that the attitude of Dr Ntsaluba, namely that SH was neglectful of her health and the health of her baby, is simply heartless, and unworthy of him. SH had received all of the necessary counselling to enable her to know that she needed Nevirapine. If Nevirapine had been available on the prescription of medical practitioners at the hospital where she gave birth, there is a real possibility that her baby would not have been born with HIV. This is not a question of 'operational glitches'. It is simply that Nevirapine is not generally available in the public health sector, because of the policies of the Respondents. The difficulties which SH experienced will not be addressed by the pilot programme, because women going to the hospital where she gave birth will still not be able to be treated with Nevirapine, even if they know that they are HIV positive, and even if they are able to provide breast milk substitutes for their babies. 88 Ad Paragraph 255 Dr Ntsaluba here apparently introduces a new reason for not providing Nevirapine at all public health facilities, namely that some people are situated far from those facilities, and making Nevirapine available at all public health facilities would not necessary alleviate the problems that arise because of these distances. I submit that this is truly far-fetched. What Dr Ntsaluba does not (and can not) explain is why it is reasonable for Ms Matebula to have to send her patients, who are HIV positive and need Nevirapine, to a hospital which is 60 kms away. 89 Ad Paragraph 256 It has never been the Applicants' case that a comprehensive programme must be implemented 'immediately in all public sector facilities'. What the Applicants require is that the Respondents should decide now to implement a comprehensive programme, should prepare a reasonable plan for its implementation, and should implement that plan reasonably. This is what they refuse to do. 90 Ad Paragraph 257 - 262 I am astonished that Dr Ntsaluba apparently either does not know, or does not care, what the availability is of Nevirapine from pharmacies, and how the drug is packaged and sold there. I can not understand why he does not say what his understanding of the position is, if he disagrees with the thrust of what is said by Ms Hardy. 91 Ad Paragraph 271 Dr Ntsaluba is being disingenuous when he says that he does not know what Ms Mahlonoko means when she says that the whole package is 'naked'. What she obviously means is that there is little purpose in undertaking testing and counselling, and informing women of what they should do to deal with the fact that they have HIV and there is a risk that they may transmit the virus to their babies, and then disabling them from doing anything about it because the Respondents refuse to provide any treatment for this. 92 Ad Paragraph 273 Dr Ntsaluba does not explain why it is not possible for someone like Ms Mahlonoko, if necessary under the supervision of a doctor, to provide Nevirapine to a patient who needs it. 93 Ad Paragraph 228 I can not deal with the statement by Dr Ntsaluba that he does not admit that Dr Saloojee is 'necessarily' qualified to express his views or opinions, because I do not know which views or opinions he is (or may be) unqualified to express, or why Dr Ntsaluba makes this denial - if in fact it is a denial. 94 Ad Paragraph 296 Dr Saloojee has stated that the difficulties which confront paediatricians in our work are accurately described in the article in question. He has adopted those views as his own. I note that Dr Ntsaluba does not deny their correctness. 95 Ad Paragraphs 297 - 301 I have already dealt elsewhere with the general allegations made in these paragraphs, and these matters are also dealt with in the annexures to this affidavit. I therefore do not repeat that material here. 96 Ad Paragraph 299 The Applicants do not seek an order requiring the Respondents to administer Nevirapine to all pregnant women and new born infants, regardless of the HIV status of the woman. I therefore do not understand the relevance of paragraph 299.2. 97 Ad Paragraph 305 I submit that the statement in paragraph 305.2 is disingenuous in the extreme. Dr Ntsaluba is very well aware that the overwhelming majority of the women who are treated in the public health sector are simply unable to obtain Nevirapine, even if they know that they need it. Women in that position obviously can not protect and exercise their rights. 98 Ad Paragraph 307.2 Dr Ntsaluba's argument is circular: doctors may only prescribe what is available in the public sector; the Respondents refuse to make Nevirapine available; and the doctors may therefore not prescribe it. That of course begs the very question at issue in this case, namely that Nevirapine should be made available in the public health sector. This would not lead to any difficulties in managing the public sector health care budget - it would save money. It would also not lead to any inequitable distribution of resources - on the contrary, it would lead to a more equitable distribution of resources. AD THE AFFIDAVIT OF PRINCESS NOTHEMBA SIMELELA 99 The affidavit of Professor Robin Wood (Annexure B) and the statement by Professor Laura Guay responds to a number of the assertions made by Dr Simelela. In general I do not repeat them here. Dr Simelela's assertions about the nature and results or Nevirapine resistance (which are not substantiated by any expert evidence) are in effect dealt with in the affidavit of Dr Schoeman (Annexure C), who explains the nature and consequences of Nevirapine resistance. 100 I also submit the affidavit of Dr Hermann Reuter in response to Dr Simelela's 'fault-finding' mission to the Western Cape. In particular, Dr Reuter annexes a paper co-authored by Dr. Saadiq Kariem, secretary of the African National Congress' Health Committee on the lessons of the Khayelitsha programme. 101 Ad Paragraph 29 The WHO conclusion is plainly that the provision of Nevirapine should be generally implemented, but the Respondents fail to accept this, citing questions about resistance and (although very faintly) effectiveness of the drug. This is not a question of 'operational and implementation issues'. The Respondents continue to refuse to make Nevirapine available in the public sector where this can be done without raising any 'operational and implementation issues'. 102 Ad Paragraph 37 The Applicants have from the outset stated that they endorse the benefit of developing 'learning sites'. What is objectionable is that everywhere else in the country (except the Western Cape and to some extent in Gauteng), no effective PMTCT will take place outside those sites for probably two years or longer, while there is already adequate knowledge and capacity to plan and implement activities which will save lives. 103 Ad Para 41.3 The statement that the purpose of the pilot sites is to assess 'the acceptability of anti-retroviral therapy for the prevention of MTCT' flies directly in the face of the World Health Organisation conclusions. This has nothing to do with operational and implementation issues. It also flies directly in the face of all of the science on the matter. 104 Ad Paragraph 49 You do not need 'learning sites', and you certainly do not need to prevent the provision of Nevirapine by qualified medical practitioners, to learn that the packaging of the syrup should be such that the syrup does not expire before it is used. 105 Ad Paragraph 62 It is indeed plain that other African countries face difficuilties in immediately implementing nationwide comprehensive MTCT prevention programmes. The difference between them and our country is that they have decided to do this, they have planned to do so, and they are implementing it. The Respondents have still not even made a decision to have a comprehensive MTCT prevention programme which includes the provision of Nevirapine or similar medicines; they have not planned to do so; and they are not implementing any such plan. Dr Simelela states at paragraph 64 (with apparent approval) that Uganda has prepared and documented a five-year 'roll-out' plan. That is precisely what the Respondents have refused to do. 106 Ad Paragraph 68 I am astonished by Dr Simelela's statement that the validity of the Respondents' approach 'has been confirmed by the concerns and findings of many eminent authors' who presented papers at the Uganda conference. This is the purest form of hearsay - not only does Dr Simelela not produce evidence by these 'eminent authors', she does not even say who they are. It speaks volumes that the Respondents can not produce any evidence at all in support of this assertion, which I deny. 107 Ad Paragraph 94 to 105 107.1 The allegations in these paragraphs demonstrate that Dr Simelela regrettably does not understand the nature and results of Nevirapine resistance. This will if necessary be demonstrated in argument. It is striking that she has apparently not been able to find any virologist or pathologist to support her assertions. 107.2 The affidavit of Dr Schoeman confirms Professor Wood's statements, and explains why these statements are correct, that 107.2.1 the phenomenon of Nevirapine resistance is inherently transient and short-lived 107.2.2 if subsequent anti-retroviral therapy is prescribed for persons who have Nevirapine resistant mutations, there are many other anti-retrovirals that can be substituted 107.2.3 there is no scientific basis for the fear that resistance resulting from the use of Nevripine as registered by the MCC for MTCT may lead to a public health catastrophe 108 Ad Paragraph 102 108.1 As appears from Professor Wainberg's article and affidavit, it is his view that the use of Nevirapine for this purpose should be encouraged; that the evidence of Nevirapine resistance does not undermine this conclusion; and that it would be unethical to withhold this therapy until infrastructure is in place for carrying out further monitoring in this regard. 108.2 In the article at NS15 Professor Wainberg also confirms that Nevirapine- resistant HIV strains are 'overgrown' by 'wild-type' virus in the absence of continued administration of Nevirapine. This further confirms the views of Professor Wood and Dr Schoeman. For this reason, Professor Wainberg expresses the view that Nevirapine should be made available to these women as a prophylactic agent during subsequent pregnancies, as well as for future therapy. 109 Ad Paragraph 113 As Professor Wood points out, the WHO recommendations are indeed based on research that includes Nevirapine studies. AD THE AFFIDAVIT OF JONATHAN BERNHARD LEVIN 110 Dr Levin has had access to unpublished material, and material in the possession of the MCC, which has not been made available to the Applicants. As I will explain below, the Applicants are seeking to obtain this information from the MCC, and to obtain the written authority of Dr Ntsaluba which is necessary before they can do this. 111 The Applicants reserve the right to seek to supplement their papers if and when this information is made available. 112 The Respondents do not dispute the efficacy of Nevirapine for the prevention or reduction of intrapartum transmission of HIV. In the words of Dr Levin, 'HIVNET 012 provides conclusive proof of the efficacy of NVP' (para 7). None of the deponents on behalf of the Respondents disputes this. The papers filed by the Respondents contain numerous statements that Nevirapine is efficacious for this purpose. The MCC has registered Nevirapine for this purpose, which means that it has been authoritatively found to be efficacious, by the body designated by Parliament for that purpose. 113 The only point in issue is whether the SAINT study confirms this finding (as the Applicants contend), or whether from that study 'there is nothing that can be concluded' with regard to efficacy, as Dr Levin contends (para 9.1.6). 114 The Applicants persist in their contention that the SAINT study confirmed the efficacy of Nevirapine. If we are given access to the information to which Dr Levin had access, we will if necessary seek to supplement our papers in this regard. However, as the efficacy of Nevirapine is plainly not in issue in these proceedings, I have been advised that it is not necessary to adduce further evidence with regard to the efficacy of Nevirapine. AD THE AFFIDAVIT OF LINDIWE MAKUBALO 115 I refer to the affidavit of Professor Karim (Annexure H) in response to what is said by Dr Makubalo. 116 I need only say that I find it truly extraordinary that Dr Makubalo can say (at paragraph 12.4.1) that '(t)he transmission of the HIV from mothers to their newly born babies has nothing to do with sexual activity'. AD THE AFFIDAVIT OF PHILIP CHUKWUKWA ONYEBUJOH 117 I refer to the affidavit of Professor Peter Folb (Annexure A), who was a member of the MCC for 21 years and chairman for 18 of those years. I submit that it is clear from his affidavit that Professor Folb is plainly a highly experienced expert of international repute. 118 Professor Folb states as follows: 'It is in the nature of science that knowledge is always subject to review, revision and correction in the light of new information and evidence which emerges. In this sense, any scientific conclusion is provisional. Registration of a drug by the Council 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. This determination, like any other scientific determination, can be revised or annulled in the light of any new scientific evidence which emerges. 'The attachment of conditions to the terms of registration by the Medicines Control Council (and indeed by national drug regulatory authorities in many other countries such as United States of America, United Kingdom, Switzerland, Australia, Zimbabwe and Uganda, among others) is not an extraordinary event. Such conditions in no sense qualify the earlier statement that the Council would unequivocally have reached its decision to make nevirapine available for the approved indications after having considered fully and carefully all the evidence, that such decision would reflect the council's conviction that the availability of the drug as specified would be in the public interest, and that this in turn means that the Council was satisfied as to the safety, quality and therapeutic efficacy of the drug.' 119 The 'conditions' attached to Nevirapine thus do not relate to the use of this medicine, and Dr Onyebujoh does not in fact suggest otherwise. It may be used without restriction for the purposes for which it has been registered, subject to the specific contra-indication of breast-feeding - not because breast-feeding will cause illness, but because it may reverse the positive effects of the medicine, or 'reverse the initial gains' (para 10.2). 120 The conditions relate to the desire of the MCC to be kept informed of new information as and when it becomes available. This does not and can not imply that the drug is not suitable for this purpose, safe, and therapeutically efficacious,. If it did not have these attributes, in terms of section 1 of the Medicines and Related Substances Control Act it could not have been registered for this purposes. 121 In other words, the use of Nevirapine for this purpose is not to undertake a large- scale trial of its suitability, safety or efficacy. If that had been the intention, the medicine would have had to act in terms of sec 21 of the Act, which provides for limited use under conditions determined by the Council. The MCC did not follow this route: it registered the medicine. That can only mean that it reached an 'unequivocal' conclusion, on the basis of all of the evidence before it, that the medicine is suitable, safe, and therapeutically efficacious. 122 I do not know what Dr Onyebujoh means when he says that the conditional registration was done 'to facilitate the acquisition of long-term safety data' (para 7'. I accept that the conditions were imposed for inter alia this purpose. But if he means that the purpose of registration was not to enable medical practitioners to prescribe it, but rather to obtain more information about long-term safety data, then I say that this can not possibly be true. It is also contradicted by other parts of his affidavit. If that had been the purpose, the Council would have acted under section 21, which would have prevented practitioners in the private sector, for example, making it available to their patients whenever they think it appropriate. 123 I submit that nothing which Dr Onyebujoh says can contradict this. It is not an 'oversimplification'. It is the law. The Act states quite clearly how the Council determines whether it is in the public interest to register a medicine. 124 Of course it is true that registration 'does not confer permanent safety and effectiveness' on a product (para 11). Nothing can do that. 125 Dr Onyebujoh has had access to unpublished material, and material in the possession of the MCC, which has not been made available to the Applicants. As I will explain below, the Applicants are seeking to obtain this information from the MCC, and to obtain the written authority of Dr Ntsaluba which is necessary before they can do this. 126 This material includes the record of the discussion of this matter by the MCC (which Professor Folb states will have been mechanically recorded), all reports to the Council by its committees, and all other materials on which the Council came to its conclusions. It will no doubt shed greater light on what Dr Onyebujoh says, to the extent that this may be necessary. 127 The Applicants reserve the right to seek to supplement their papers if and when this information is made available. 128 I wish to point out that Dr Onyebujoh seems to have no doubt that antiretroviral drugs should be provided for mother-to-child transmission. In an article in the South African Medical Journal in May 2000, which is referred to in his curriculum vitae, he says the following (Annexure I): '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. 'Zidovudine (AZT) has been demonstrated to reduce vertical transmission of HIV by 37-67% in several randomised controlled clinical trials. It had no serious side-effects in pregnancy or in infants born to these mothers (followed up for 4 years). The benefits far outweigh the risks, and AZT should be used in HIV-positive mothers wherever resources are available. 'Nevirapine reduces vertical transmission by 48% (CI 17-60%), and costs R30 per treatment compared with R300 for AZT. The results of the SAINT will be important .... Furthermore, resistance to Nevirapine (and AZT) may become a problem when it is used on a wide scale as a single agent regimen. Resistance could be countered by combination therapy ...' 'Antiretrovirals for mother-to-child transmission should form part of an integrated approach to maternal and infant health care ...' AD THE AFFIDAVITS ON BEHALF OF THE SECOND TO NINTH RESPONDENTS 129 It is not possible for the Applicants, in the limited time available for the preparation of this reply, to collect detailed information in rebuttal of the statements made in all of these affidavits. However, I have been advised and submit that this is not necessary, because: 129.1 the Applicants do not contend that the Respondents are required immediately to implement a comprehensive MTCT programme throughout South Africa: it is our contention that the Respondents are under a duty to plan and implement such a programme in a reasonable manner. To the extent that they currently suffer a lack of capacity, that is a matter to which such a plan would have to have regard 129.2 It has not been disputed that such a programme would be cost-effective, and would actually save the government money. It follows that it can not be contended that the government can not afford to implement such a programme. 130 However, I do wish to place before the Court information which demonstrates that there is in fact a solid platform in our country's health system for the implementation of such a plan. I will also seek to show that some of the statements made on behalf of the Respondents are simply without foundation. 131 The affidavit of Professor Helene Schneider (Annexure J) points out that: 131.1 94% of South African women make use of antenatal services during pregnancy 131.2 84.4% of women deliver under the supervision of a health professional 131.3 93.3% of children attend the health service for their first immunizations at 6 weeks after birth 131.4 56.2% of the 3000 fixed clinics in South Africa offer HIV testing 131.5 83% of fixed clinics provide HIV counselling 131.6 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 131.7 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 131.8 In 2000, 92% and 84.9% of fixed clinics had stocks of the two antibiotics essential for the management of HIV and sexually transmitted diseases 131.9 In 2000, 65.8% of fixed clinics had infant nutrition supplements in stock. 132 I submit that this demonstrates that there are very many opportunities and a good platform for the planned implementation of a comprehensive MTCT prevention programme. 133 Professor Schneider concludes that the best available evidence suggests that the health system has the immediate capacity to provide a PMTCT programme on a scale larger than the pilot sites, in at least 8 of the 9 provinces. 134 Of course, precisely where and when to implement such a programme would have to be determined. However, the Respondents refuse to plan and implement such a programme. Incompatibility of what is being done in some provinces, with the national policy 135 As I have pointed out, there is no national plan for the implementation of a comprehensive programme for PMTCT. On the contrary, it is a necessary implication of what Dr Ntsaluba and Dr Simelela say that it would be premature to prepare such a plan, because of outstanding questions about (for example) resistance. 136 However, the Western Cape Department of Health (under the auspices of the Tenth Respondent) has gone ahead and planned and implemented just such a programme. Dr Ntsaluba does not say that what they have done is wrong. 137 The same is now happening in Gauteng. That Department of Health is implementing what is plainly a roll-out of comprehensive provision at each of the major hospitals in Gauteng. I attach (K) a letter from that Department to Mark Heywood of the AIDS Law Project, which states: 'A provincial rollout plan has been approved by the Provincial Cabinet and is as follows 1) Carletonville Hospital / Leratong Hospital / Coronation Hospital - Operational since 31 July 2001 2) Johannesburg Hospital / Hillbrow clinic MOU - 30 September 2001 3) Sebokeng Hospital / Johan Heyns MOU - 30 November 2001 4) Garankuwa Hospital / Soschanguve MOU - 28 February 2002 .... There are plans by the PHRU (approved and supported by province) to roll out to the other MOU's (10 MOU's) in Soweto.' 138 This is consistent with what is said by the Chief Executive Officer of the Johannesburg Hospital in his letter of 23 July 2001 to Mr Heywood (Annexure N to my founding affidavit - page 335 of the papers) in which he states: We are expected to be part of the roll-out phase of this programme. 139 Dr Rispel (on behalf of the Fourth Respondent) attempts to suggest that this is simply part of the research process. However, this can not be so: 139.1 the roll-out includes every major facility in Gauteng 139.2 no reason is advanced why Gauteng should have so many 'research' sites, unlike the other provinces 139.3 the Department's own documents describe this as part of the 'roll-out' 139.4 Professor Cooper explains that at the Johannesburg Hospital, they are simply continuing to do what they previously did, namely to provide appropriate care for their patients. 140 The Applicants welcome what the Fourth Respondent is now doing. It is a sensible and humane approach to getting on with dealing with the problem, instead of waiting possibly for two years, possibly for longer, for the results of the pilot projects. 141 But if what Dr Ntsaluba says is correct, then both the Western Cape and Gauteng are acting in an irresponsible manner, without waiting for the outcome of the pilot projects. What they are doing is simply inconsistent and irreconcilable with what the Respondents say should be done. 142 The truth is that the Western Cape and Gauteng are acting in a responsible manner. It is the other Respondents who are acting irresponsibly, and unlawfully, by refusing to plan and implement a comprehensive programme. Available funding 143 As I have stated above, it has not been disputed that such a programme would be cost-effective, and would actually save the government money. It follows that it can not be contended that the government can not afford to implement such a programme. 144 However, it appears that the Respondents (or at least some of them) are not even spending the funds which have been made available to them for this purpose. 145 Annexure AN3 to the affidavit of Dr Ntsaluba is the Intergovernmental Fiscal Review for 2001, produced by the National Treasury. It shows that: 145.1 It is anticipated that during 2000/01 Mpumalanga spent only 85.9% of the funds available to it for Health (page 879) 145.2 It is anticipated that during 2000/01 Gauteng spent only 88.5% of the funds available to it for Health (page 879) 145.3 During 2000/01 the provinces spent only 66% (R10 million out of R15 million) of the conditional grants made to them by the national government for HIV/AIDS (page 882). 146 The situation in the Eastern Cape is far worse. As appears from the affidavit of Colm Allan (Annexure L), the Auditor-General has reported that 'It was found that an amount of R33 585 277 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.' 147 Dr Mjekevu conceals this fact in his affidavit, in which he claims that there is not enough money to run a comprehensive HIV/AIDS programme in the Eastern Cape. 148 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. ADDITIONAL INFORMATION NOT AVAILABLE TO (AND APPARENTLY WITHHELD FROM) THE APPLICANTS 149 By agreement, the Respondents delivered their answering affidavit to our attorney at his Johannesburg office on Tuesday 23 October 2001. These papers run to more than one thousand pages. 150 On Thursday 25 October 2001, having rapidly perused these papers, our attorney wrote to the State Attorney requesting certain information which he believed, I submit correctly, would assist the Court in its decision of this matter. 151 The relevant information relates to two matters: decisions of the MINMEC and information held by the Medicines Control Council. 152 For reasons which will appear below, at the time when I am signing this affidavit this information had not yet been provided to our attorney. The Applicants will persist in their efforts to obtain this information, if necessary through an order for its production. We reserve the right to seek to supplement our papers if necessary. The decisions of the MINMEC 153 MINMEC is a regular meeting of the Minister of Health (the First Respondent) and the Provincial Members of the Executive Committee for Health (The Second to Tenth Respondents). 154 The case of the Respondents is in large measure based on a decision or decisions taken by the MINMEC with regard to the prevention of MTCT. 155 In this regard, I refer for example to the following affidavits: Simelela: Para 37 Nkjekevu: Para 16 Litlhakanyane: Para 6 Rispel: Para 5 Green-Thompson: Para 6 Charles: Para 17 Hendricks: Para 5 Gosnell: Para 13 and Para 18 This list is not exhaustive. 156 I believe that when the MINMEC makes a decision, that decision must be recorded in a resolution or another form of minute. 157 On 25 October 2001 our attorney wrote to the State Attorney (Annexure M) requesting that she furnish him with copies of 157.1 The MINMEC resolution to which reference is made, for example, in the affidavits of Simelela, Nkjekevu, Litlhakanyane, Rispel, Green-Thompson, Charles, Hendricks and Gosnell. 157.2 Copies of all other resolutions or decisions taken by MINMEC with regard to the prevention or reduction of mother-to-child transmission of HIV. 158 In that letter, our attorney asked the State Attorney whether she required a formal notice in terms of Rule 15 (which should have been a reference to Form 15), and when her clients would comply with this request. 159 On 26 October, when our attorney had not received a reply to this letter, he served a Notice to Produce on the State Attorney. 160 On 26 October, the State Attorney sent my attorney a letter which, for reasons which are not clear, he only received on 29 October. In that letter (Annexure N) she stated that she would have to take instructions from her clients in this regard. 161 On 29 October the State Attorney wrote to our attorney, asking in terms of what Rule of Court or procedure the notice was being filed. 162 That same day, our attorney wrote to the State Attorney (Annexure O), stating that the notice was a Form 15 notice, filed in terms of Rule 35(12), alternatively Rule 35(13), alternatively the inherent powers of the Court. Our attorney again asked the State Attorney to advise when her clients would comply with this request, or if they refused to do so, to advise him accordingly so that the appropriate steps could be taken. 163 On 31 October the State Attorney wrote to our attorney (Annexure P) asking him to 'please clarify in which affidavits and in which particular paragraph that term [MINMEC resolution] was used. Could you also clarify in which of the affidavits and in which particular paragraph(s) you have found reference to MINMEC "documents" that you are requesting'. The State Attorney said that she was 'busy taking instructions and looking into the matter'. 164 On that same day, our attorney replied to the State Attorney (Annexure Q), expressing his surprise that although the original letter of request had been sent on 25 October, and a Notice to Produce had been served on 26 October, after some days the only response he had was a request for further information with regard to the request and notice. Our attorney referred to eight affidavits in which reference was made to a MINMEC decision or resolution, and provided relevant paragraphs numbers. He again requested the State Attorney to advise him as a matter of urgency when her clients would comply with the request of 25 October and the notice of 26 October, or if they refused to do so, to advise him accordingly so that the appropriate steps could be taken. 165 At the time when I am signing this affidavit, approximately ten days after the original request was made, the Respondents have still not responded to it. 166 I respectfully submit that it is clear from the course of action which the Respondents have followed that they are deliberately delaying providing an answer to this request and the notice to produce, either in the hope that they will thereby not have to provide this information to the court, or in the hope that the matter will be postponed. 167 The attitude of the Respondents is inexplicable save on the basis that they have something to hide. It will be submitted on my behalf that the inference which should be drawn is the Respondents are deliberately withholding material from us and from the Court, and that by so doing they are deliberately thwarting our right under section 34 of the Constitution to a fair trial of this matter, and acting in breach of their duty under section 195 to act ethically. Information held by the Medicines Control Council (MCC) 168 The Respondents have filed affidavits by two persons who have disclosed information acquired by them in the exercise of their powers and performance of their functions with the MCC. They have done this with the written consent of the Director-General of the Department of Health. He is of course the principal deponent on behalf of the Respondents. 169 On 25 October our attorney wrote to the State Attorney (Annexure R) as follows: 'We are sure that you will agree that it would not be fair or proper for the Director-General to use his statutory powers to make relevant information which is held by a statutory body or its staff or officers, available to certain of the parties but not to others.... Although strictly speaking the Director-General is not your client with regard to his statutory powers under theAct in question, we do not wish to go behind your back in requesting that he give the necessary authority for us to obtain this information. We therefore request that the Director-General give an appropriate official of the Medicines Control Council written authority to disclose to us the full contents of the file of the Medicines Control Council relating to the application for registration of Nevirapine for the prevention or reduction of mother-to-child transmission of HIV, and all resolutions of the Medicines Control Council or its committees in this regard.' 170 The State Attorney replied on 26 October. In that letter (Annexure S) she stated as follows: 'We agree with you that the Director-General is not our client. Neither is the Medicines Control Council (MCC). We had to approach the MCC, and the Director-General, like any other litigant. It is, therefore, inappropriate for us to obtain the said information on your behalf from the MCC or the Director-General.' 171 On 29 October our attorney wrote to the State Attorney as follows: 'We would have thought that it was clear from our letter of 25 October that we were approaching the Director-General through you as a matter of professional courtesy. Would you kindly advise whether you have passed our request on to the Director-General, and if so, when this was done. 172 The State Attorney has not replied to this letter, or to our attorney's further letter of 31 October 2001 in this regard. 173 Meanwhile, our attorney had taken other steps to attempt to obtain this information. On 25 October 2001 he wrote to Professor Peter Eagles, the chairperson of the MCC, setting out the background to this matter and requesting that he instruct an appropriate member of the staff of the MCC to make this information available to our attorneys. Our attorney stated that he appreciated that Professor Eagles was not entitled to do so without the written authorisation of the Director-General of the Department of Health, and attached a copy of the letter of 25 October 2001 addressed to the State Attorney, for this authorisation. 174 On 29 October 2001 our attorney wrote to Dr Ntsaluba, the Director-General of the Department of Health, again setting out the background and asking that he give the necessary permission in this regard. Our attorney pointed out that he had initially directed this request to him through the State Attorney, but that she had apparently declined to pass this request on to him, and that he therefore now made the request directly to Dr Ntsaluba. 175 On 30 October 2001 our attorney again wrote to Professor Eagles, referring to his letter of 25 October 2001 and asking for an urgent reply. Our attorney stated that he appreciated that certain of the information on the MCC's file may be confidential for various reasons, namely of a proprietary nature. Our attorney stated that he would be happy to submit to any reasonable restriction in order to maintain this confidentiality, and to enter into any necessary agreement in this regard. 176 Our attorney has not received any response to these letters addressed to the MCC. 177 On 2 November 2001 the Director-General replied to our attorney (Annexure T) that he would not accede to the request because he considered it overbroad and would be likely to lead to a breach of confidentiality. However, he would reconsider his decision if the Applicants identified 'specific individuals who consent' and if the Applicants were more specific about the information which they require. 178 That day. my attorney replied (Annexure U) stating that we seek the information from the MCC through the Registrar of Medicines. He set out specific details of the information which we require, and set out proposed arrangements which would ensure confidentiality where appropriate. 179 Our attorney has obviously not had a reply to this letter at the time when I am signing this affidavit. 180 As appears from the affidavits of Dr Levin and Dr Onyebujoh, the Respondents have had access to information from persons who sit on relevant committees of the MCC, who have disclosed what transpired during the meetings of those committees, and who have sought to interpret the decisions of the MCC to which they were a party either directly or indirectly. The Respondents can do this only because the Director-General, who is their principal representative in this case, has given permission for this to happen. 181 The Director-General has used his statutory powers to make relevant information, which is held by a statutory body or its staff or offices, available to the parties for which he is the principal deponent. 182 As appears from the affidavit of Professor Folb, the meetings of the Council itself are recorded, and minutes are kept of those meetings, and of the expert and ad hoc committees. Those records will throw a clear light on what actually transpired at the MCC when Nevirapine was registered for the prevention of intrapartum transmission of HIV. The Respondents have placed before the court a version of what transpired, based on privileged access to this information obtained through the assistance of the their principal representative in this case. 183 The Applicants will continue to seek to obtain this information, and to have it placed before the Court if, on proper consideration, it appears to be relevant and helpful to the decision of this matter. The Applicants reserve their rights to seek to supplement their papers in this regard. 184 I wish to state that the Applicants do not wish to have this matter postponed. As was set out in my founding affidavit, this is a matter of the greatest urgency, literally involving questions of life and death. It will be submitted on our behalf that if the Respondents find themselves under time pressure in responding to the documents to which we believe we are entitled, and which we hope to obtain, that will be of their making because of the stonewalling tactics which they have adopted. AD THE AFFIDAVITS FILED ON BEHALF OF THE TENTH RESPONDENT 185 This matter has been settled between the Applicants and the Tenth Respondent, and the Applicants do not seek any relief against the Tenth Respondent. 186 The Applicants therefore do not reply to the affidavits filed on behalf of the Tenth Respondent. 187 The Applicants pray that an order be granted against the other Respondents as set out in the Notice of Motion. SIPHOKAZI MTHATHI SIGNED AND AFFIRMED BEFORE ME AT CAPE TOWN ON NOVEMBER 2001, THE DEPONENT HAVING TAKEN THE AFFIRMATION IN THE PRESCRIBED MANNER COMMISSIONER OF OATHS 2