EXCERPT FROM JUDGMENT TAC AND OTHERS V MINISTER OF HEALTH AND OTHERS "Against this background I shall now deal with the issue of whether the respondents have fulfilled their constitutional obligations in terms of section 27(2). "Section 27(2) clearly presupposes a situation where there is not yet a full realisation of the right to health care. No doubt that is in recognition of a host of historical and socio economic realities. It equally imposes the duty to achieve a progressive realisation of the right to health care as an ongoing obligation. It obviously does not impose the duty to achieve the realisation of access to health care overnight. The pace is dictated by a vailable resources. Yet, in my view the inexorable goal is a realisation of the right, even through it may be achieved progressively. "What is in issue in this case is not the general implementation of health care. This case concerns merely an aspect of it, namely a programme for the prevention of MTCT of HIV. Although it is only a facet of health care. This case concerns merely an aspect of it, namely a programme for the prevention of MTCT of HIV. Although it is only a facet of health care, in view of what is at stake, it is a very important aspect of health care. "Mr Marcus conceded, correctly I think, that there is nothing wrong per se with a gradual geographical roll out of a comprehensive programme of health care relating to MTCT. It is in keeping with the duty to provide achieve a progressive realization of the right to health care within the state's available resources. "In that context I am also of the view that the respondents cannot be faulted for having decided to establish two research and training sites, or pilot sites, in each province. With a recently registered drug it cannot be denied that it is a prudent precaution to have centers where track is kept of its performance so that counter-indications can be picked up. "Furthermore the research and training sites also provide valuable information about the logistical and operational problems that can be encountered in the implementation of a programme for the prevention of MTCT of HIV. "Having said that, it must not be forgotten that the phased implementation of a health care programme is discriminating, that it causes inequality and that it denies access to those who find themselves outside the reach of the sites where implementation is being effected. "Much was made of the conditional registration of Nevirapine and its possible side effects. The evidence was that the side effects are associated with long-term use, not with the once-off use for the prevention of intrapartum MTCT of HIV. The evidence was also that the mutations that lead to resistance are transient and disappear when Nevirapine is not longer in the body. "The evidence is also that the conditional registration, or accelerated registration, is a mechanism to make a drug immediately available where the available evidence is that it is safe and efficacious. It is a procedure that is resorted to where the health authorities are faced with a crisis of the first magnitude, such as HIV/AIDS. The approach is to provide the public with immediate access to the drug for the good it can do whilst at the same time imposing conditions to ensure the collection of long term data relating to its effect. In view of all this evidence there is in my view no justification to suggest, if there is such a suggestion, that Nevirapine should not be made generally available to the South African public because of its conditional registration or because of reservations about side effects or resistance. It can be made available for general use. The fact that its use may have to be monitored does not detract from the fact that it is available for general and large scale use. "Another subject that enjoyed much attention was breast feeding. Dr Ntsaluba stated that it would be irresponsible for the first to ninth respondents to make Nevirapine available in the entire public sector where it is common knowledge that a percentage of babies who are born HIV negative subsequently become HIV positive as a result of breast feeding. The point is that if a baby is born HIV negative because Nevirapine was administered during delivery and subsequently becomes HIV positive as a result of breast feeding , it is the breast feeding, and not the Nevirapine that has caused him to become HIV positive. It would be irresponsible to administer Nevirapine to the mother without counseling her as to the risks of breast feeding. As it is, the evidence shows that breast feeding does not necessarily reverse the effect of an intrapartum application of Nevirapine. It is of note that according to dr Guay the Ugandan study was conducted in a breast feeding population without substitute feed being made available. According to a study cited by Dr Wood and apparently accepted by dr Ntsaluba, the avoidance of breast feeding can reduce MTCT by 44%. Obviously, to optimize the effect of Nevirapine, or rather to avoid reversals, it is the better option to provide formula food for those mothers who are prepared not to breast feed, but who cannot afford formula feed. That is also why it is quite correct that where the respondents have implemented a programme for the prevention of MTCT of HIV, they have done so with formula feed as part of the package. All that does not mean, however, that before full implementation, it would be irresponsible after proper counseling, to prescribe Nevirapine without the availability of formula feed. "I shall now deal with the relief claimed in prayers 1 and 2. "There is in my view incontrovertible evidence that there is a residual or latent capacity in the public sector outside the 18 pilot sites to prescri be Nevirapine. The experience in the Western Cape is evidence of it. Dr C ook testified to it in relation to the Johannesburg Hospital. Dr Grant tes tified to it in respect of a rural hospital in KwaZulu Natal. The suggesti on that he is in favour of prescribing Nevirapine to women regardless of th eir HIV status is wrong. He merely cited an Africa Centre report which sug gested it as a cheaper alternative. Further support of the residual capaci ty in the public sector to prescribe Nevirapine is to be found in the affid avits of nurses Matebula and Mahlonoko. The evidence of the number of hosp itals in the provinces also points to such a capacity. Then there is the e vidence of prof Schneider which cannot be denied. The very fact that in Ga uteng it was possible to effect such a rapid extension of the programme sho ws that there is an existing capacity that can be harnessed. "The arguments against allowing doctors in the public sector to prescribe Nevirapine are mainly that it would throw the system in disarray, that it w ould cause budgeting distortions, and that it would set a precedent for the prescription of expensive drugs for the most esoteric conditions. I canno t agree with these arguments. We are not concerned with the prescription o f an expensive drug. Its cost is minimal, if it is to have a price at all. If the respondents are ordered to make it available, it enters, as it wer e, the Essential Drug List, and its prescription can set no precedent. The re is no evidence that the prescription of Nevirapine in this way has cause d any chaos or disarray in the Western Cape. What it has done, as pointed out by dr Abdullah, was to avoid so-called missed opportunities. In other words it mitigated the harsh and discriminating effect of the decision to s tart the programme at two pilot sites in the province. To that extent it w as also a means of the progressive realization of the right to health care, in this case by means of access to Nevirapine, in the province. I agree t hat state doctors should not be allowed to prescribe Nevirapine indiscrimin ately or irresponsibly. That is also not what is asked. It can only be pr escribed after proper testing and counseling. "Mr Marcus has indicated that he has no objection to a further qualificati on, along the lines of the Western Cape practice, that such prescription be done after consultation with the medical superintendent in charge of the f acility concerned. "Access to Nevirapine in this manner is in my view a vital element that is lacking in the programme of the first to nine respondents. It would add a n element of flexibility and pragmatism. It will allow a capacity that hit herto has been inhibited to manifest and develop itself. It need not in an y way detract from the integrity of the pilot sites and the valuable work d one there. It merely provides another means of access, less structured, le ss perfect, but infinitely to be preferred to the choice between all or not hing. "In this respect therefore I am of the view that the policy of the first t o nine respondents in prohibiting the use of Nevirapine outside the pilot s ites in the public health sector is not reasonable and that it is an unjust ifiable barrier to the progressive realization of the right to health care. It is a breach of their negative obligation (see Grootboom's case supra a t para 34) to desist from impairing the right to health care. The breach c an be remedied by relief as prayed in prayers 1 and 2, appropriately amende d as suggested above. "I shall now deal with the relief claimed in paragraphs 3 to 8. "It is necessary to refer to the various pronouncements of dr Ntsaluba on what the programme of the first to nine respondents. At p 656 it is stated that the said respondents had embarked on a research and training program me before making Nevirapine available at every public health facility. At p 652 it is stated that the complete support services and products required for the effective use of Nevirapine are not fully known. It is necessary to investigate these before Nevirapine is made available at every public si te. The question of breast feeding must also be investigated in this conte xt. At p 696 he says that it is necessary that the drug be released in con trolled settings with the object of gathering as much data as possible in o rder to extend the programme to the greater public as resources allow. At p 698 he refers to the affidavit of dr Simelela for greater detail concerni ng the programme. At p 713 he says that it is the aim of the first to nint h respondents to make Nevirapine available to the general population gradua lly. "At p 715 he states that an incrementalist approach is to be preferred. A t p 717 he says that the respondents are obliged to have a full grasp of th e full requirements for a successful MTCT prevention programme before they can make Nevirapine available at all public health facilities. At p 729 he denied that there was no clear plan for a comprehensive roll out. In resp ect of this issue, he referred to the affidavit of dr Simelela. At p 733 h e says that as information is gathered, and more is learnt about the operat ional challenges, it is envisaged that the programme will be rolled out to other sites. At p 734 he says that the respondents are keen to implement a nd deliver an integrated programme as soon as is reasonably feasible, as so on as their concerns as outlined in the first respondents letter have been sufficiently addressed. Those concerns, it will be remembered, relate to r esistance and breast feeding. At p 788 he says that it is envisaged that t he programme will be extended as lessons are learnt from the research and t raining sites and as more resources are realized. At p 808 he says that th e respondents have already embarked on a carefully planned programme in all provinces aimed at providing an infrastructure for counseling and testing of affected mothers. Due to a dearth of resources it is impossible to impl ement it immediately in all public sector facilities. "It is sufficient to say that dr Simelela in her affidavit nowhere gave pa rticulars of a clear plan for a comprehensive roll out. At p 1974 she says that the cost of a MTCT prevention programme has to be assessed in order t o perform a progressive extension of the programme. "All this leads only to one conclusion: that there is no comprehensive and co-ordinated plan for a roll out of the MTCT prevention programme. At bes t the intention, even the keenness, to extend the programme to the whole po pulation is expressed. There is no unqualified commitment to reach the res t of the population in any given time or at any given rate. "Where section 27(2) obliges the state to take reasonable measures to achi eve the progressive realisation of the right to health care, I do not think , if one has regard to the fundamental rights at stake, that the steps take n by the state to give the whole affected population access to a MTCT preve ntion programme can be regarded as reasonable. "A programme that is open-ended and that leaves everything for the future cannot be said to be coherent, progressive and purposeful. The programme fa lls to be criticized for much the same considerations that were mentioned i n the Grootboom case. "The plan of the tenth respondent has all the elements of a co-ordinated a nd programmatic plan. It is driven by a time scale. It allows of access out side the pilot sites. The respondents have tried to make capital of the st atement of dr Abdullah that it is not possible to do detailed planning more than 12 months in advance. That may be so. If dr Abdullah is not doing det ailed planning in 2001 for 2003, he knows that he will have to do that plan ning at some later stage so that he would be able to meet his target of 100 % coverage by the end of March 2003. The programme of the respondents lacks the impetus that is required for a programme that must move progressively. If there is no time scale, there must be some other built-in impetus to ma intain the momentum of progression. It must be goal driven. As stated in Gr ootboom case supra at p 71 there is a balance between goal and means. Somet imes the goal will enforce the creation of the means. Sometimes the attainm ent of the goal will be delayed for lack of means. What I find unacceptable in the respondent's' approach is the formulation that once the lessons hav e been learnt from the test and research sites, the roll out will follow as the means allow. That does no justice to the exigency of the case. "About one thing there must be no misunderstanding: a countrywide MTCT pre vention programme is an ineluctable obligation of the State. The respondent s alleged that it was unaffordable with AZT. It is clear that with Nevirapi ne it is affordable. That is the reason why the respondents have adopted Ne virapine as their drug of choice and launched the 18 pilot projects. To the extent that the impression was created in the affidavits filed on behalf o f some of the respondents that the further roll out of the programme will d epend on the availability of resources, it must be dispelled. The resources will have to be found progressively. The availability or resources can onl y have an influence on the pace of the extension of the programme. But ther e must be a plan for a further roll out. Only if there is a coherent plan w ill it be possible to obtain the further resources that are required for a nationwide programme, whether in the form of a reorganisation of priorities or by means of further budgetary allocations. "The provinces have given figures of their budgets, the amounts spent on H IV/AIDS, the cost of the pilot projects and the projected cost of a MTCT pr ogramme with 100% coverage. The figures show that the cost of a universal p rogramme is not beyond the means of the provinces. Obviously universal pro grammes cannot be afforded immediately. The Eastern Cape had a health budge t of R3,835 billion. Of that R33 million was allocated to HIV/AIDS (and no t spent). A comprehensive programme is estimated to require an extra R56,8 million. These figures show, in my view, that with proper planning, it shou ld be possible to achieve full implementation gradually. The Free State Pro vince estimates the cost of a full programme to be R23 million. KwaZulu Nat al's estimate is R36 million or R48 million. The Northern Province's estima te is R71 million. These figures, hypothetical as they are, are not without their discrepancies. They must be contrasted with the figures of the Weste rn Cape, which are the figures of a province actually engaged in a roll out . At present the Western Cape is rolling out its programme from 50% to 90% of the affected population. The cost will be R12 million. The cost for the year 2002 - 2003, with universal coverage in mind, is estimated at R21 mill ion. I repeat: a MTCT prevention programme with full coverage is affordable with proper planning. "For all these reasons I have reached the conclusion that the applicants h ave made out a case for relief in terms of prayers 3 to 8. I shall modify t he prayers slightly to make it quite clear that what is required is a plan that moves towards comprehensive coverage. Obviously there will be areas wh ere progress can be faster. The plan must have the flexibility to allow for that. "There was no dispute that the applicants would be entitled to an order fo r costs, including the costs attendant upon the employment of two counsel. "I shall bear in mind that this judgment is delivered at an awkward time, just before the holiday season. I shall therefore adjust the period within which compliance is to be effected. "The following order is granted: 1 It is declared that the first to ninth respondents are obliged t o make Nevirapine available to pregnant women with HIV who give birth in th e public health sector, and to their babies, in public health facilities to which the respondents' present programme for the prevention of mother-to-c hild transmission of HIV has not yet been extended, where in the judgment o f the attending medical officer, acting in consultation with the medical su perintendent of the facility concerned, this is medically indicated, which shall at least include that the woman concerned has been appropriately test ed and counselled. 2 The first to ninth respondents are ordered to make Nevirapine av ailable to pregnant women with HIV who give birth in the public sector, and to their babies, in public health facilites to which the respondents' pres ent programme for the prevention of mother-to-child transmission of HIV has not yet been extended, where in the opinion of the attending medical prac titioner, acting in consultation with the medical superintendent of the fac ility concerned, this is medically indicated, which shall at least include that the woman concerned has been appropriately tested and counselled. 3 It is declared that the respondents are under a duty forthwith t o plan an effective comprehensive national programme to prevent or reduce t he mother-to-child transmission of HIV, including the provision of voluntar y counselling and testing, and where appropriate, Nevirapine or other appro priate medicine, and formula milk for feeding, which programme must provide for its progressive implementation to the whole of the Republic, and to im plement it in a reasonable manner. 4 The respondents are ordered forthwith to plan an effective compr ehensive national programme to prevent or reduce the mother-to-child transm ission of HIV, including the provision of voluntary counselling and testing , and where appropriate, Nevirapine or other appropriate medicine, and form ula milk for feeding, which programme must provide for its progressive impl ementation to the whole of the Republic, and to implement it in a reasonabl e manner. 5 Each of the respondents is ordered to deliver, before 31 March 2 002, a report or reports which set out, under oath: 5.1 what he or she has done to implement the order in paragraph 4 5.2 what further steps he or she will take to implement the order in paragraph 4, and when he or she will take each such step. 6 The applicants may within a month of delivery of such reports de liver their replies, under oath, to the respondents' reports. 7 The respondents may within two weeks of delivery of such reports deliver their answers to the replies of the applicants. 8 The application is postponed to a date to be fixed by the regist rar for the consideration and determination of the said reports, replies an d answers. 9 The first to ninth respondents are ordered to pay the applicants ' costs, including the costs attendant upon the employment of two counsel. C BOTHA JUDGE OF THE HIGH COURT"