Treatment Action Campaign v. Minister of Health (No. 1)

2002(4) BCLR 356 (T)
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Applicants sought an order that the respondents (the Minister of Health and the members of the executive council for health) make Nevirapine available to pregnant women with HIV who give birth in public health institutions and “produce and implement an effective national program to prevent or reduce mother to child transmission (MTCT) of HIV, including the provision of voluntary counseling and testing (VCT) and, where appropriate, Nevirapine, or other appropriate medicine, as well as formula milk for feeding.”

Nevirapine was a drug administered to an HIV+ mother during labor or to the infant within 72 hours after birth to reduce the risk of intrapartum transmission. The cost of the drug was minimal. Nevirapine was administered at testing sites along with counseling regarding the role of breast feeding in MTCT, because Nevirapine did not eliminate the risk of transmission through breast feeding.

The respondents had made Nevirapine available for the prevention of MTCT at a limited number of pilot sites in order to test its implementation. Affidavits submitted in connection with the case confirmed, inter alia, that many public health facilities other than the initial pilot site were able to provide the necessary testing and counseling that go along with the administration of Nevirapine and that the cost of providing Nevirapine would be less than the cost of treating HIV+ children; that certain safety issues with Nevirapine had been identified, that it would not have been safe to expose a breast-feeding population to Nevirapine without further measures being taken, and that ultimately, it was a policy decision to implement the MTCT prevention program at pilot sites in order to understand the package of care for mothers and babies; that the health department was unable to implement a comprehensive program outside of the pilot sites immediately due to limited budgetary and human resource constraints; and that, with regard to a similar test done in Uganda, that avoiding breast feeding was not a prerequisite for the success of Nevirapine.

The Court determined that the issues must be approached from the perspective of South Africa’s constitutional obligation under section 27(3) to progressively realize the right to health care services and noted that, in determining whether the measures that had been taken were reasonable, it was relevant that fundamental rights in addition to the right to health were at stake (namely, the rights afforded by sections 9, 10, 11, 12(2)(a) and 28(1)(c) of the South African Constitution). The Court further confirmed that the State’s progressively realizable obligation was justiciable and that the Court was entitled to adjudicate the reasonableness of the steps taken by the executive to fulfill such constitutional obligation.

The Court agreed that a gradual roll out of a comprehensive health care program related to MTCT was acceptable, however noted that the phased implementation of a health care program was discriminating. The Court also noted that the evidence of Nevirappine’s side effects were not associated with the one-off use of the drug to prevent intrapartum MTCT.

Ultimately, the Court held that there was “no justification” that Nevirapine should not be made available to the public, based on concerns of side effects or resistance and that simply because the drug should be monitored was not a reason to prevent it being widely rolled out.  The Court also debunked the argument that it would be irresponsible to prescribe Nevirapine without availability of formula feed because, even if it was correct to include formula feed as part of the Nevirapine package, “breast feeding [did] not necessarily reverse the effects of an intrapartum application of Nevirapine.”

Moreover, the Court found that there was “incontrovertible evidence that there [was] residual or latent capacity in the public sector outside the 18 pilot sites to prescribe Nevirapine.” Considering that the cost of Nevirapine was minimal, allowing doctors in the public sector to prescribe the drug was unlikely to “throw the system into disarray. . . cause budgeting distortions . . . set a precedent for the prescription of expensive drugs for the most esoteric conditions.” Rather, allowing the widespread prescription would mitigate the “harsh and discriminating effect of the decision to start the programme at two pilot sites in the province.”

Reviewing the affidavits, the Court also found that there was “no comprehensive and coordinated plan for a roll out of the MTCT prevention program . . . There is no unqualified commitment to reach the rest of the population in any given time or at any given rate.” Considering the fundamental rights at stake, the Court thus concluded that the steps taken by the state to give the public access to a MTCT prevention program were unreasonable.

“I am in agreement with Mr. Moerane that the matter should be approached from the perspective of section 27(2) of the Constitution. The question is whether the first to ninth respondents have taken reasonable legislative and other measures within their available resources to achieve the progressive realization of the right to health care services, including reproductive health care.

In determining whether such measures as have been taken are reasonable, it will be a relevant factor that other fundamental rights are involved.” Page 36.

“The court does not assume the task of the executive when it pronounces on the reasonableness of the steps taken by the executive in the fulfillment of a constitutional obligation of the State.” Page 37.

“I shall accept that the respondents had to make policy decisions, and that there need not be one objectively determinable road to the progressive realization of the right to health care, but in the end the court has to determine whether the steps taken by the respondents were, in the circumstances, reasonable. That is the constitutional imperative.” Page 38.

“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.” Page 42.

“In this respect therefore I am of the view that the policy of the first to nine respondents in prohibiting the use of Nevirapine outside the pilot sites in the public health sector is not reasonable and that it is an unjustifiable barrier to the progressive realization of the right to health care. It is a breach of their negative obligation (see Grootboom case supra at para 34) to desist from impairing the right to health care.” Page 44.

“A programme that is open-ended and leaves everything for the future cannot be said to be coherent, progressive and purposeful.” Page 45.

“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 maintain the momentum of progression. It must be goal driven.  As stated in  Grootboom case supra at para 71 there is a balance between goals and means. Sometimes the goal will enforce the creation of the means. Sometime the attainment of the foal will be delayed for lack of means. What I find unacceptable in the respondents’ approach is the formulation that once the lessons have been learnt from the test and research sites, the roll out will follow as the means allow. That does not justice to the exigency of the case.

About one thing there must be no misunderstanding: a countrywide MTCT prevention programme is an ineluctable obligation of the State. . . . To the extent that the impression was created in the affidavits filed on behalf of some of the respondents that the further roll out of the programme will depend on the availability of resources, it must be dispelled. The resources will have to be found progressively. The availability or resources can only have an influence on the pace of the extension of the programme. But there must be a plan for a further roll out. Only if there is a coherent plan will it be possible to obtain the further resources that are required for a nationwide programme, whether in the form of a reorganization of priorities or by means of further budgetary allocations.” Page 46.