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The Right to Health and the Nevirapine Case in South Africa

George J. Annas, J.D., M.P.H.
New England Journal of Medicine
Volume 348:750-754 February 20, 2003 Number 8

* Date: Tue, 25 Feb 2003 19:57:21 +0200
FW: [CCS-l] Academic article on TAC & health rights
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> From: "Centre for Civil Society Centre for Civil Society"
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> Subject: [CCS-l] Academic article on TAC & health rights
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> The Right to Health and the Nevirapine Case in South Africa
> George J. Annas, J.D., M.P.H.
>
> New England Journal of Medicine
> Volume 348:750-754 February 20, 2003 Number 8
>
> Thanks to activists in South Africa, the right to health as a human
> right has returned to the international stage, just as it was being
> displaced by economists who see health through the prism of a globalized
> economy and by politicians who see it as an issue of national security
> or charity. The current post-apartheid debate in South Africa is not
> about race but about health, and in this context, the court victory by
> AIDS activists in the nevirapine case has been termed not only, as
> stated in one British newspaper, "the greatest defeat for [President
> Thabo] Mbeki's government" but also the opening of "legitimate
> criticism" of the government "over a host of issues from land rights to
> the pursuit of wealth."1 Using the nevirapine case as a centerpiece, I
> will explore the power of the human right to health in improving health
> generally.
>
> Jonathan Mann rightly observed that "health and human rights are
> inextricably linked,"2 and Paul Farmer has argued that "the most
> important question facing modern medicine involves human rights."3
> Farmer noted that many poor people have no access to modern medicine and
> concluded, "The more effective the treatment, the greater the injustice
> meted out to those who do not have access to care."3 Access to treatment
> for infection with the human immunodeficiency virus (HIV) and AIDS has
> been problematic in most countries, but especially in South Africa,
> where almost 5 million people are infected with HIV and the government's
> attitude toward the epidemic has been described as pseudoscientific and
> dangerous.4 Political resistance by the South African government to
> outside funders who want to set the country's health care agenda is, of
> course, understandable in the context of racism and colonialism.5 But
> even understandable politics cannot excuse the government's failure to
> act more decisively in the face of an unprecedented epidemic.
>
> HIV Infection and the Right to Health
>
> One of the most controversial actions of the South African government
> was its restriction of the use of nevirapine to prevent the transmission
> of HIV from mothers to infants. Only two government hospitals per
> province were allowed to use the drug. The Treatment Action Campaign was
> formed in 1998 as a coalition of South African AIDS-related
> organizations to promote affordable treatment for all people with HIV
> infection or AIDS. This group (and others) scored a victory in 2001,
> when 39 multinational pharmaceutical companies withdrew their lawsuit
> against the South African government, which sought to enforce their
> patents on drugs for the treatment of HIV infection or AIDS, in order to
> prevent the government from purchasing generic versions of the drugs.6
>
> At about the same time, the Treatment Action Campaign brought a suit
> against the South African government itself, alleging that its
> restrictions on the availability of nevirapine (limiting it in the
> public sector to hospitals involved in a pilot study) and its failure to
> have a reasonable plan to make the drug more widely available violated
> the right to health of HIV-positive pregnant women and their children
> guaranteed in the South African constitution. The use of nevirapine
> remains controversial in Africa, even after a study in Uganda, published
> in 1999, suggested that administering the drug to a pregnant woman at
> the onset of labor and to her newborn immediately after birth could
> result in a 50 percent reduction in the rate of transmission of HIV.7
> This is the basis for the claim that failure to use nevirapine condemns
> 35,000 newborns a year to HIV infection in South Africa.1
>
> The Treatment Action Campaign prevailed in the trial court, which ruled
> that restricting nevirapine to a limited number of pilot sites in the
> public sector "is not reasonable and is an unjustifiable barrier to the
> progressive realization of the right to health care."8 In July 2002, the
> Constitutional Court of South Africa, the country's highest court,
> affirmed the ruling, stating that the government's nevirapine policy
> violated the health care rights of women and newborns under the South
> African constitution.9 Section 27 of the post-apartheid constitution
> states, "(1) Everyone has the right to have access to (a) health care
> services, including reproductive health care; (b) sufficient food and
> water; and (c) social security. . . . (2) The state must take reasonable
> legislative and other measures, within its available resources, to
> achieve the progressive realization of each of these rights. (3) No one
> may be refused emergency medical treatment." Section 28 states, "(1)
> Every child has a right . . . (b) to family care or parental care, or to
> appropriate alternative care when removed from the family environment;
> (c) to basic nutrition, shelter, basic health care services and social
> services. . . . (2) A child's best interests are of paramount importance
> in every matter concerning the child."9
>
> These rights are part of the bill of rights in the South African
> constitution, which the constitution itself requires the state to
> "respect, protect, promote and fulfill." These provisions are modeled on
> those in the International Covenant on Economic, Social and Cultural
> Rights (which has been signed, but not yet ratified, by South Africa).10
> Under the covenant, the right to health includes not only appropriate
> health care, but also the underlying determinants of health, including
> clean water, adequate sanitation, safe food and housing, and
> health-related education.11 South Africa's constitutional health
> obligations apply to every branch of government. The Constitutional
> Court considered two questions: what actions the government was
> constitutionally required to take with regard to nevirapine, and whether
> the government had an obligation to establish a comprehensive plan for
> the prevention of HIV transmission from mother to child.
>
> Making Nevirapine Available
>
> As justification for its refusal to make nevirapine generally available
> in public clinics, the South African government has argued that the
> drug's safety and efficacy have not been satisfactorily established and
> that it is of limited benefit in a breast-feeding population (since the
> number of infants acquiring HIV from breast-feeding would be almost as
> large as the number infected in the absence of preventive treatment with
> nevirapine). These views have been articulated by the minister of
> health, who along with President Mbeki, continues to take positions on
> HIV infection and its treatment that scientists in the rest of the world
> find baffling.4,5
>
> In January 2001, after a meeting of southern African countries, the
> World Health Organization recommended the administration of nevirapine
> to HIV-positive women who are pregnant and to their children at the time
> of birth. In April 2001, the Medicines Control Council, South Africa's
> equivalent of the Food and Drug Administration, formally approved
> nevirapine as safe and effective. Shortly thereafter, in July 2001, the
> government decided to do the pilot study of nevirapine that was at issue
> in the lawsuit; this study limited the drug's availability to two sites
> in each province. The result was that physicians who worked at other
> facilities in the public sector were unable to prescribe this drug for
> their patients, even though the manufacturer of the drug, Boehringer
> Ingelheim, had agreed to make it available at no cost for a five-year
> period.
>
> The Treatment Action Campaign argued that in the face of the HIV
> epidemic, which includes the infection of approximately 70,000 infants
> from their mothers annually, it was irrational and a breach of the bill
> of rights for the government to prohibit physicians in public clinics
> from prescribing nevirapine for preventive purposes when medically
> indicated.9
>
> Enforcing the Obligation to Respect Rights
>
> This was the third case in which the Constitutional Court had been asked
> to enforce a socioeconomic right under the South African constitution.
> The first, Soobramoney v. Minister of Health, was also a right-to-health
> case.12 It involved a 41-year-old man with chronic renal failure and a
> history of stroke, heart disease, and diabetes, who was not eligible for
> a kidney transplant and therefore required lifelong dialysis to survive.
> The renal-dialysis unit in the region where he lived, which had 20
> dialysis machines - not nearly enough to provide dialysis for everyone
> who required it - had a policy of accepting only patients with acute
> renal failure. The health department argued that this policy met the
> government's duty to provide emergency care under the constitution.
> Patients with chronic renal failure, like the petitioner, did not
> automatically qualify.
>
> In considering whether the constitution required the health department
> to provide a sufficient number of machines to offer dialysis to everyone
> whose life could be saved by it, the court observed that under the
> constitution, the state's obligation to provide health care services was
> qualified by its "available resources." The court noted that offering
> extremely expensive medical treatments to everyone would make
> "substantial inroads into the health budget . . . to the prejudice of
> the other needs which the state has to meet."12 The Constitutional Court
> ultimately decided that the administrators of provincial health
> services, not the courts, should set budgetary priorities and that the
> courts should not interfere with decisions that are rational and made
> "in good faith by the political organs and medical authorities whose
> responsibility it is to deal with such matters."12
>
> Likewise, in South Africa v. Grootboom, a case involving the right to
> housing, the Constitutional Court determined that although the state is
> obligated to act positively to ameliorate the conditions of the
> homeless, it "is not obligated to go beyond available resources or to
> realize these rights immediately."13 The constitutional requirement is
> that the right to housing be "progressively realized." Nonetheless, the
> court noted, there is "at the very least, a negative obligation placed
> upon the state and all other entities and persons to desist from
> preventing or impairing the right of access to adequate housing."13,14
>
> Applying the rulings in these two cases to the nevirapine case, the
> Constitutional Court reasonably concluded that the right to health care
> services "does not give rise to a self-standing and independent
> fulfillment right" that is enforceable irrespective of available
> resources. Nonetheless, the government's obligation to respect rights,
> as articulated in the housing case, applies equally to the right to
> health care services.9
>
> Enforcing the Obligation to Protect Rights
>
> The Constitutional Court reframed the two questions it would answer in
> the light of the South African government's obligation to take
> "reasonable steps" for the "progressive realization" of the right to
> health as follows: "Is the policy of confining the supply of nevirapine
> reasonable in the circumstances; and does the government have a
> comprehensive policy for the prevention of mother-to-child transmission
> of HIV?"9
>
> The South African government argued that the real cost of delivering
> nevirapine is not the cost of the drug but the cost of the
> infrastructure of care: HIV testing, counseling, follow-up, and the
> provision of formula for parents who cannot currently afford it. The
> Constitutional Court agreed that the ideal is to make these preventive
> services universally available but restated the dispute as "whether it
> was reasonable to exclude the use of nevirapine for the treatment of
> mother-to-child transmission at those public hospitals and clinics where
> testing and counseling are available."9
>
> The South African government gave four reasons for its restriction of
> the use of nevirapine: its efficacy would be diminished in settings in
> which a comprehensive package of services, including breast-milk
> substitutes, was not available; administration of the drug might produce
> a drug-resistant form of HIV; the safety of nevirapine has not been
> adequately demonstrated; and the public health system does not have the
> capacity to deliver the "full package" of services.9
>
> The court addressed each point in turn. With respect to efficacy, the
> court found that breast-feeding does increase the risk of HIV infection
> "in some, but not all cases and that nevirapine thus remains to some
> extent efficacious . . . even if the mother breastfeeds her baby."9 The
> court conceded that drug resistance is possible but concluded, "The
> prospects of the child surviving if infected are so slim and the nature
> of the suffering [is] so grave that the risk of some resistance
> manifesting at some time in the future is well worth running."9 The
> safety issue was disposed of by reference to the World Health
> Organization's recommendation of nevirapine and the determination of the
> Medicines Control Council that the drug is safe. As for capacity, the
> court concluded that resources are relevant to the universal delivery of
> the "full package" but are "not relevant to the question of whether
> nevirapine should be used to reduce mother-to-child transmission of HIV
> at those public hospitals and clinics outside the research sites where
> facilities in fact exist for testing and counseling."9
>
> The Rights of Children and the Obligation to Fulfill Rights
>
> This case is a right-to-health case because it concerns the availability
> of a drug and the circumstances under which the government can
> reasonably restrict its use. Nonetheless, the case could have been
> decided solely on the basis of the rights of children. In the words of
> the Constitutional Court, "This case is concerned with newborn babies
> whose lives might be saved by the administration of nevirapine to mother
> and child at the time of birth."9 The court specifically cites the
> constitutional rights of children, including their right to "basic
> health care services." Parents have the primary obligation to provide
> these services to children but often cannot meet this obligation without
> help from the state.15 The court concluded that nevirapine is an
> "essential" drug for children whose mothers are infected with HIV, that
> the needs of these children are "most urgent," and that their ability to
> exercise all other rights is "most in peril."9 The court did not write
> about the certainty of the children becoming orphans if their mothers do
> not also have access to treatment, but treatment of HIV infection and
> AIDS was beyond the scope of this case, which concerned the prevention
> of HIV infection.
>
> On the basis of either the right to health or the rights of children,
> the court's answer to the first question was that the policy of
> restricting the availability of nevirapine is unreasonable and a
> violation of the government's obligation to take "reasonable legislative
> and other measures, within its available resources, to achieve the
> progressive realization" of the right to "access to health care
> services, including reproductive health care."9 In the court's words, "A
> potentially lifesaving drug was on offer and where testing and
> counseling facilities were available it could have been administered
> within the available resources of the state without any known harm to
> mother and child."9 The question of whether the cost of nevirapine
> mattered was not addressed, although the outcome almost certainly would
> have been different had nevirapine not been available at no or very low
> cost.
>
> The answer to the second question - whether the government is required
> to have a reasonable, comprehensive plan to combat mother-to-child
> transmission of HIV - flowed directly from the answer to the first. The
> legal question was whether the government's plan of moving slowly from
> limited research and training programs to more available programs was
> reasonable. The court decided that because of the "incomprehensible
> calamity" of the HIV epidemic in South Africa, the government's plan was
> not reasonable.
>
> The Right to the Progressive Realization of Health
>
> Can the Constitutional Court be accused of taking on the role of the
> South African government's health department in deciding how money
> should be spent on health care? The court did not think so, pointing out
> that all branches of the government have the obligation to "respect,
> protect, promote and fulfill" the socioeconomic rights spelled out in
> the constitution. The legislative branch is obligated to pass
> "reasonable legislative" measures, and the executive branch is obligated
> to develop and implement "appropriate, well-directed policies and
> programs."9 It is, of course, the role of the judiciary to resolve
> disputes about whether a specific law or policy, or its implementation,
> is consistent with the terms of the constitution. Since the initiation
> of the nevirapine lawsuit, three of the country's nine provinces -
> Western Cape, Gauteng, and KwaZulu-Natal - have publicly announced a
> plan to realize progressively "the rights of pregnant women and their
> newborn babies to have access to nevirapine."9 The court expects the
> other six provinces to follow suit.
>
> The court was explicit both in defining the rights that were violated
> and in ordering a remedy. As to the rights, the court declared that
> "Sections 27(1) and (2) of the Constitution require the government to
> devise and implement within its available resources a comprehensive and
> coordinated program to realize progressively the rights of pregnant
> women and their newborn children to have access to health services to
> combat mother-to-child transmission of HIV."9 To implement this right,
> the court ordered the government to take four specific actions:
>
> Remove the restrictions that prevent nevirapine from being made
> available . . . at public hospitals and clinics that are not research
> and training sites.
>
> Permit and facilitate the use of nevirapine . . . at public
> hospitals and clinics when . . . this is medically indicated. . . .
>
> Make provision if necessary for counselors based at public hospitals
> and clinics . . . to be trained for counseling. . . .
>
> Take reasonable measures to extend the testing and counseling
> facilities at hospitals and clinics throughout the public health sector
> to facilitate and expedite the use of nevirapine.9
>
> Implementing the Right to Health
>
> The decision in the nevirapine case illustrates both the strength and
> the weakness of relying on courts to determine specific applications of
> the right to health. The strength is that the right to health is a legal
> right, and since there can be no legal right without a remedy, courts
> will provide a remedy for violations of the right to health. In this
> regard, it is worth noting not only that the right to health and access
> to health care articulated in the Universal Declaration of Human Rights
> has been given more specific meaning in the International Covenant on
> Economic, Social and Cultural Rights10,11 and other internationally
> binding documents on human rights, but also that these rights have been
> written into the constitutions of many countries, including South
> Africa. The widespread failure of governments to take the right to
> health seriously, however, means that we are still a long way from the
> realization of this right. Nonetheless, the recent activism of many new
> nongovernmental organizations, such as the Treatment Action Campaign, in
> the area of health rights, provides some ground for optimism that
> government inaction will not go unchallenged.16
>
> The weakness of relying on courts is that the subject matter of the
> right to health in a courtroom struggle is likely to be narrow,
> involving interventions such as kidney dialysis or nevirapine therapy.
> The HIV epidemic demands a comprehensive strategy of treatment, care,
> and prevention, including education, adequate nutrition, clean water,
> and nondiscrimination.2,11,17 The government of South Africa has so far
> been unwilling to designate the HIV epidemic as a national emergency or
> to take steps to make the prevention and treatment of HIV infection its
> highest health priority. This stance has apparently changed little since
> the decision on nevirapine was handed down. The South African
> government, for example, has asked the Medicines Control Council to
> review its approval of nevirapine because of continued doubt about its
> safety and efficacy.18 Of course, if the council withdraws its approval
> of the drug, this action will effectively render the Constitutional
> Court's decision moot, since its orders are based on the finding that
> nevirapine is safe and effective. On the more positive side, South
> Africa's cabinet has announced that it is considering universal access
> to antiretroviral drugs, and Ranbaxy, the largest manufacturer of
> generic drugs in India, has formed a joint venture with Adcock Ingram to
> distribute generic antiretroviral agents in South Africa.19
>
> Former South African president Nelson Mandela has persuasively argued
> that an effective strategy for combatting the AIDS epidemic requires the
> engaged commitment of national leaders to provide not only prevention
> but also treatment for everyone who needs it, "wherever they may be in
> the world and regardless of whether they can afford to pay or not."20
> Lack of leadership in addressing the HIV epidemic specifically and the
> right to health in general is not, of course, confined to South Africa.
>
>
> Source Information
>
> From the Health Law Department, Boston University School of Public
> Health, Boston.
>
> References
>
> 1. McGreal C. The shame of the new South Africa. The Guardian
> (London). November 1, 2002:2.
> 2. Mann JM. Human rights and AIDS: the future of the pandemic. In:
> Mann JM, Gruskin S, Grodin MA, Annas GJ, eds. Health and human rights: a
> reader. New York: Routledge, 1999:216-26.
> 3. Farmer P. The major infectious diseases in the world -- to treat
> or not to treat? N Engl J Med 2001;345:208-210.[Full Text]
> 4. Makgoba MW. HIV/AIDS: the peril of pseudoscience. Science
> 2000;288:1171-1171.[ISI][Medline]
> 5. Swarns RL. An AIDS skeptic in South Africa feeds simmering doubts.
> New York Times. March 31, 2002(section 1):4.
> 6. Barnard D. In the high court of South Africa, case no. 4138/98:
> the global politics of access to low-cost AIDS drugs in poor countries.
> Kennedy Inst Ethics J 2002;12:159-174.[ISI][Medline]
> 7. Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal
> single-dose nevirapine compared with zidovudine for prevention of
> mother-to-child transmission of HIV-1 in Kampala, Uganda: HIVNET 012
> randomised trial. Lancet 1999;354:795-802.[ISI][Medline]
> 8. Treatment Action Campaign v. Minister of Health, High Court of
> South Africa, Transvaal Provincial Div., 2002 (4) BCLR 356(T), Dec. 12,
> 2001.
> 9. Minister of Health v. Treatment Action Committee, Constitutional
> Court of South Africa, 2002 (10) BCLR 1033.
> 10. Steiner HJ, Alston P, eds. International human rights in context:
> law, politics, morals. 2nd ed. New York: Oxford University Press,
> 2000:1395-401.
> 11. United Nations, Economic and Social Council, Committee on
> Economic, Social and Cultural Rights. General comment no. 14: the right
> to the highest attainable standard of health. New York: United Nations,
> 2000.
> 12. Soobramoney v. Minister of Health (KwaZulu-Natal), Constitutional
> Court of South Africa, 1997 (12) BCLR 1696.
> 13. South Africa v. Grootboom, Constitutional Court of South Africa,
> 2000 (11) BCLR 1169.
> 14. T arantola D, Gruskin S. Children confronting HIV/AIDS: charting
> the confluence of rights and health. Health Hum Rights
> 1998;3:60-86.[Medline]
> 15. Ngwena C. The recognition of access to health care as a human
> right in South Africa: is it enough? Health Hum Rights
> 2000;5:26-44.[Medline]
> 16. Torres MA. The human right to health, national courts, and access
> to HIV/AIDS treatment: a case study from Venezuela. Chic J Int Law
> 2002;3:105-15.
> 17. De Cock KM, Mbori-Ngacha D, Marum E. Shadow on the continent:
> public health and HIV/AIDS in Africa in the 21st century. Lancet
> 2002;360:67-72.[ISI][Medline]
> 18. Baleta A. S Africa soaks up pressure to change HIV/AIDS policy.
> Lancet 2002;360:467-467.[ISI][Medline]
> 19. Innocenti NG. Ranbaxy in link on AIDS drugs for Africa. Financial
> Times (London). October 18, 2002:29.
> 20. Mandela N. Care support and destigmatization. Plenary address
> presented at the XIV International AIDS Conference, Barcelona, Spain,
> July 7-12, 2002.
>
>
>
>
>
> www.nu.ac.za/ccs

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