[Ip-health] The Right to Health and the Nevirapine Case in South Africa (New England Journal of Medicine)

[Alexander Tsai]

http://content.nejm.org/cgi/content/full/348/8/750

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.

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