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The right to health and the nevirapine case in south africa

The new england journal of medicine l e g a l i s s u e s i n m e d i c i n e The Right to Health and the Nevirapine Case in South Africa
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 economistswho see health through the prism of a globalized One of the most controversial actions of the Southeconomy and by politicians who see it as an issue African government was its restriction of the useof national security or charity. The current post-apart- of nevirapine to prevent the transmission of HIVheid debate in South Africa is not about race but from mothers to infants. Only two government hos-about health, and in this context, the court victory pitals per province were allowed to use the drug. Theby AIDS activists in the nevirapine case has been Treatment Action Campaign was formed in 1998termed not only, as stated in one British newspaper, as a coalition of South African AIDS-related organi-“the greatest defeat for [President Thabo] Mbeki’s zations to promote affordable treatment for all peo-government” but also the opening of “legitimate ple with HIV infection or AIDS. This group (andcriticism” of the government “over a host of issues others) scored a victory in 2001, when 39 multina-from land rights to the pursuit of wealth.”1 Using tional pharmaceutical companies withdrew theirthe nevirapine case as a centerpiece, I will explore lawsuit against the South African government, whichthe power of the human right to health in improv- sought to enforce their patents on drugs for theing health generally.
treatment of HIV infection or AIDS, in order to pre- Jonathan Mann rightly observed that “health vent the government from purchasing generic ver- and human rights are inextricably linked,”2 and sions of the drugs.6 Paul Farmer has argued that “the most important At about the same time, the Treatment Action question facing modern medicine involves hu- Campaign brought a suit against the South Africanman rights.”3 Farmer noted that many poor peo- government itself, alleging that its restrictions onple have no access to modern medicine and con- the availability of nevirapine (limiting it in the pub-cluded, “The more effective the treatment, the lic sector to hospitals involved in a pilot study) andgreater the injustice meted out to those who do its failure to have a reasonable plan to make thenot have access to care.”3 Access to treatment for drug more widely available violated the right toinfection with the human immunodeficiency vi- health of HIV-positive pregnant women and theirrus (HIV) and AIDS has been problematic in most children guaranteed in the South African constitu-countries, but especially in South Africa, where tion. The use of nevirapine remains controversialalmost 5 million people are infected with HIV and in Africa, even after a study in Uganda, publishedthe government’s attitude toward the epidemic in 1999, suggested that administering the drug to ahas been described as pseudoscientific and dan- pregnant woman at the onset of labor and to hergerous.4 Political resistance by the South African newborn immediately after birth could result in agovernment to outside funders who want to set 50 percent reduction in the rate of transmission ofthe country’s health care agenda is, of course, un- HIV.7 This is the basis for the claim that failure toderstandable in the context of racism and colo- use nevirapine condemns 35,000 newborns a yearnialism.5 But even understandable politics can- to HIV infection in South Africa.1not excuse the government’s failure to act more The Treatment Action Campaign prevailed in decisively in the face of an unprecedented epi- the trial court, which ruled that restricting nevira-demic.
pine to a limited number of pilot sites in the public Downloaded from nejm.org at EBSCO INFORMATION SERVICES - EJS on March 27, 2013. For personal use only. No other uses without permission. Copyright 2003 Massachusetts Medical Society. All rights reserved. l e g a l i s s u e s i n m e d i c i n e sector “is not reasonable and is an unjustifiable bar- as the number infected in the absence of preventiverier to the progressive realization of the right to treatment with nevirapine). These views have beenhealth care.”8 In July 2002, the Constitutional Court articulated by the minister of health, who along withof South Africa, the country’s highest court, affirmed President Mbeki, continues to take positions on HIVthe ruling, stating that the government’s nevirapine infection and its treatment that scientists in thepolicy violated the health care rights of women and rest of the world find baffling.4,5newborns under the South African constitution.9 In January 2001, after a meeting of southern Af- Section 27 of the post-apartheid constitution states, rican countries, the World Health Organization rec-“(1) Everyone has the right to have access to ommended the administration of nevirapine to(a) health care services, including reproductive HIV-positive women who are pregnant and to theirhealth care; (b) sufficient food and water; and (c) so- children at the time of birth. In April 2001, the Med-cial security. . . . (2) The state must take reason- icines Control Council, South Africa’s equivalent ofable legislative and other measures, within its avail- the Food and Drug Administration, formally ap-able resources, to achieve the progressive realization proved nevirapine as safe and effective. Shortlyof each of these rights. (3) No one may be refused thereafter, in July 2001, the government decided toemergency medical treatment.” Section 28 states, do the pilot study of nevirapine that was at issue in“(1) Every child has a right . . . (b) to family care the lawsuit; this study limited the drug’s availabilityor parental care, or to appropriate alternative care to two sites in each province. The result was thatwhen removed from the family environment; (c) to physicians who worked at other facilities in the pub-basic nutrition, shelter, basic health care services lic sector were unable to prescribe this drug for theirand social services. . . . (2) A child’s best interests patients, even though the manufacturer of the drug,are of paramount importance in every matter con- Boehringer Ingelheim, had agreed to make it avail-cerning the child.”9 able at no cost for a five-year period.
These rights are part of the bill of rights in the The Treatment Action Campaign argued that in South African constitution, which the constitution the face of the HIV epidemic, which includes the in-itself requires the state to “respect, protect, promote fection of approximately 70,000 infants from theirand fulfill.” These provisions are modeled on those mothers annually, it was irrational and a breach ofin the International Covenant on Economic, Social the bill of rights for the government to prohibit phy-and Cultural Rights (which has been signed, but sicians in public clinics from prescribing nevirapinenot yet ratified, by South Africa).10 Under the cove- for preventive purposes when medically indicated.9nant, the right to health includes not only appro-priate health care, but also the underlying determi- e n f o r c i n g t h e o b l i g a t i o n nants of health, including clean water, adequate sanitation, safe food and housing, and health-relat-ed education.11 South Africa’s constitutional health This was the third case in which the Constitutionalobligations apply to every branch of government. Court had been asked to enforce a socioeconomicThe Constitutional Court considered two questions: right under the South African constitution. The first,what actions the government was constitutionally Soobramoney v. Minister of Health, was also a right-to-required to take with regard to nevirapine, and health case.12 It involved a 41-year-old man withwhether the government had an obligation to es- chronic renal failure and a history of stroke, hearttablish a comprehensive plan for the prevention of disease, and diabetes, who was not eligible for aHIV transmission from mother to child.
kidney transplant and therefore required lifelongdialysis to survive. The renal-dialysis unit in the re-gion where he lived, which had 20 dialysis machines m a k i n g n e v i r a p i n e a v a i l a b l e — not nearly enough to provide dialysis for every- As justification for its refusal to make nevirapine one who required it — had a policy of acceptinggenerally available in public clinics, the South Af- only patients with acute renal failure. The health de-rican government has argued that the drug’s safety partment argued that this policy met the govern-and efficacy have not been satisfactorily established ment’s duty to provide emergency care under theand that it is of limited benefit in a breast-feeding constitution. Patients with chronic renal failure, likepopulation (since the number of infants acquiring the petitioner, did not automatically qualify.
HIV from breast-feeding would be almost as large In considering whether the constitution required Downloaded from nejm.org at EBSCO INFORMATION SERVICES - EJS on March 27, 2013. For personal use only. No other uses without permission. Copyright 2003 Massachusetts Medical Society. All rights reserved. The new england journal of medicine the health department to provide a sufficient num- real cost of delivering nevirapine is not the cost ofber of machines to offer dialysis to everyone whose the drug but the cost of the infrastructure of care:life could be saved by it, the court observed that un- HIV testing, counseling, follow-up, and the provi-der the constitution, the state’s obligation to pro- sion of formula for parents who cannot currentlyvide health care services was qualified by its “avail- afford it. The Constitutional Court agreed that theable resources.” The court noted that offering ideal is to make these preventive services universal-extremely expensive medical treatments to every- ly available but restated the dispute as “whether itone would make “substantial inroads into the was reasonable to exclude the use of nevirapine forhealth budget . . . to the prejudice of the other the treatment of mother-to-child transmission atneeds which the state has to meet.”12 The Consti- those public hospitals and clinics where testing andtutional Court ultimately decided that the adminis- counseling are available.”9trators of provincial health services, not the courts, The South African government gave four reasons should set budgetary priorities and that the courts for its restriction of the use of nevirapine: its effica-should not interfere with decisions that are rational cy would be diminished in settings in which a com-and made “in good faith by the political organs and prehensive package of services, including breast-medical authorities whose responsibility it is to milk substitutes, was not available; administrationdeal with such matters.”12 of the drug might produce a drug-resistant form of Likewise, in South Africa v. Grootboom, a case in- HIV; the safety of nevirapine has not been adequate- volving the right to housing, the Constitutional ly demonstrated; and the public health system doesCourt determined that although the state is obligat- not have the capacity to deliver the “full package”ed to act positively to ameliorate the conditions of of services.9the homeless, it “is not obligated to go beyond avail- The court addressed each point in turn. With re- able resources or to realize these rights immedi- spect to efficacy, the court found that breast-feed-ately.”13 The constitutional requirement is that the ing does increase the risk of HIV infection “in some,right to housing be “progressively realized.” None- but not all cases and that nevirapine thus remainstheless, the court noted, there is “at the very least, to some extent efficacious . . . even if the mothera negative obligation placed upon the state and all breastfeeds her baby.”9 The court conceded thatother entities and persons to desist from prevent- drug resistance is possible but concluded, “Theing or impairing the right of access to adequate prospects of the child surviving if infected are sohousing.”13,14 slim and the nature of the suffering [is] so grave that Applying the rulings in these two cases to the the risk of some resistance manifesting at some nevirapine case, the Constitutional Court reason- time in the future is well worth running.”9 The safe-ably concluded that the right to health care services ty issue was disposed of by reference to the World“does not give rise to a self-standing and independ- Health Organization’s recommendation of nevir-ent fulfillment right” that is enforceable irrespec- apine and the determination of the Medicinestive of available resources. Nonetheless, the govern- Control Council that the drug is safe. As for capac-ment’s obligation to respect rights, as articulated in ity, the court concluded that resources are relevantthe housing case, applies equally to the right to to the universal delivery of the “full package” buthealth care services.9 are “not relevant to the question of whether nevir-apine should be used to reduce mother-to-childtransmission of HIV at those public hospitals and e n f o r c i n g t h e o b l i g a t i o n clinics outside the research sites where facilities in fact exist for testing and counseling.”9 The Constitutional Court reframed the two ques-tions it would answer in the light of the South Afri- t h e r i g h t s o f c h i l d r e n a n d t h e can government’s obligation to take “reasonable o b l i g a t i o n t o f u l f i l l r i g h t s steps” for the “progressive realization” of the rightto health as follows: “Is the policy of confining the This case is a right-to-health case because it con-supply of nevirapine reasonable in the circumstanc- cerns the availability of a drug and the circumstanc-es; and does the government have a comprehen- es under which the government can reasonably re-sive policy for the prevention of mother-to-child strict its use. Nonetheless, the case could have beentransmission of HIV?”9 decided solely on the basis of the rights of chil- The South African government argued that the dren. In the words of the Constitutional Court, “This Downloaded from nejm.org at EBSCO INFORMATION SERVICES - EJS on March 27, 2013. For personal use only. No other uses without permission. Copyright 2003 Massachusetts Medical Society. All rights reserved. l e g a l i s s u e s i n m e d i c i n e case is concerned with newborn babies whose lives department in deciding how money should be spentmight be saved by the administration of nevira- on health care? The court did not think so, pointingpine to mother and child at the time of birth.”9 The out that all branches of the government have thecourt specifically cites the constitutional rights of obligation to “respect, protect, promote and fulfill”children, including their right to “basic health care the socioeconomic rights spelled out in the con-services.” Parents have the primary obligation to stitution. The legislative branch is obligated to passprovide these services to children but often cannot “reasonable legislative” measures, and the executivemeet this obligation without help from the state.15 branch is obligated to develop and implement “ap-The court concluded that nevirapine is an “essen- propriate, well-directed policies and programs.”9 Ittial” drug for children whose mothers are infected is, of course, the role of the judiciary to resolve dis-with HIV, that the needs of these children are “most putes about whether a specific law or policy, or itsurgent,” and that their ability to exercise all other implementation, is consistent with the terms ofrights is “most in peril.”9 The court did not write the constitution. Since the initiation of the nevira-about the certainty of the children becoming or- pine lawsuit, three of the country’s nine provincesphans if their mothers do not also have access to — Western Cape, Gauteng, and KwaZulu-Nataltreatment, but treatment of HIV infection and AIDS — have publicly announced a plan to realize pro-was beyond the scope of this case, which concerned gressively “the rights of pregnant women and theirthe prevention of HIV infection.
newborn babies to have access to nevirapine.”9 The On the basis of either the right to health or the court expects the other six provinces to follow suit.
rights of children, the court’s answer to the first The court was explicit both in defining the rights question was that the policy of restricting the avail- that were violated and in ordering a remedy. As toability of nevirapine is unreasonable and a violation the rights, the court declared that “Sections 27(1)of the government’s obligation to take “reasonable and (2) of the Constitution require the governmentlegislative and other measures, within its available to devise and implement within its available resourc-resources, to achieve the progressive realization” of es a comprehensive and coordinated program tothe right to “access to health care services, includ- realize progressively the rights of pregnant womening reproductive health care.”9 In the court’s words, and their newborn children to have access to health“A potentially lifesaving drug was on offer and where services to combat mother-to-child transmission oftesting and counseling facilities were available it HIV.”9 To implement this right, the court orderedcould have been administered within the available the government to take four specific actions:resources of the state without any known harm tomother and child.”9 The question of whether the Remove the restrictions that prevent nevira- cost of nevirapine mattered was not addressed, al- pine from being made available . . . at pub- though the outcome almost certainly would have lic hospitals and clinics that are not research been different had nevirapine not been available at The answer to the second question — whether Permit and facilitate the use of nevirapine the government is required to have a reasonable, . . . at public hospitals and clinics when comprehensive plan to combat mother-to-child . . . this is medically indicated. . . .
transmission of HIV — flowed directly from theanswer to the first. The legal question was whether Make provision if necessary for counselors the government’s plan of moving slowly from lim- based at public hospitals and clinics . . . to ited research and training programs to more avail- able programs was reasonable. The court decidedthat because of the “incomprehensible calamity” of Take reasonable measures to extend the test- the HIV epidemic in South Africa, the government’s ing and counseling facilities at hospitals and clinics throughout the public health sector tofacilitate and expedite the use of nevirapine.9 t h e r i g h t t o t h e p r o g r e s s i v e i m p l e m e n t i n g t h e r i g h t t o h e a l t h Can the Constitutional Court be accused of taking The decision in the nevirapine case illustrates bothon the role of the South African government’s health the strength and the weakness of relying on courts Downloaded from nejm.org at EBSCO INFORMATION SERVICES - EJS on March 27, 2013. For personal use only. No other uses without permission. Copyright 2003 Massachusetts Medical Society. All rights reserved. l e g a l i s s u e s i n m e d i c i n e to determine specific applications of the right to egy for combatting the AIDS epidemic requires thehealth. The strength is that the right to health is a engaged commitment of national leaders to providelegal right, and since there can be no legal right not only prevention but also treatment for everyonewithout a remedy, courts will provide a remedy for who needs it, “wherever they may be in the worldviolations of the right to health. In this regard, it and regardless of whether they can afford to pay oris worth noting not only that the right to health not.”20 Lack of leadership in addressing the HIVand access to health care articulated in the Univer- epidemic specifically and the right to health in gen-sal Declaration of Human Rights has been given eral is not, of course, confined to South Africa.
more specific meaning in the International Cove-nant on Economic, Social and Cultural Rights From the Health Law Department, Boston University School of and other internationally binding documents on 1. McGreal C. The shame of the new South Africa. The Guardian
human rights, but also that these rights have been (London). November 1, 2002:2.
written into the constitutions of many countries, 2. Mann JM. Human rights and AIDS: the future of the pandemic.
including South Africa. The widespread failure of In: Mann JM, Gruskin S, Grodin MA, Annas GJ, eds. Health and
human rights: a reader. New York: Routledge, 1999:216-26.
governments to take the right to health seriously, 3. Farmer P. The major infectious diseases in the world — to treat
however, means that we are still a long way from the or not to treat? N Engl J Med 2001;345:208-10.
realization of this right. Nonetheless, the recent ac- 4. Makgoba MW. HIV/AIDS: the peril of pseudoscience. Science
tivism of many new nongovernmental organiza- 5. Swarns RL. An AIDS skeptic in South Africa feeds simmering
tions, such as the Treatment Action Campaign, in doubts. New York Times. March 31, 2002(section 1):4.
the area of health rights, provides some ground for 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 coun- optimism that government inaction will not go un- tries. Kennedy Inst Ethics J 2002;12:159-74.
Guay LA, Musoke P, Fleming T, et al. Intrapartum and neonatal The weakness of relying on courts is that the single-dose nevirapine compared with zidovudine for prevention of mother-to-child transmission of HIV-1 in Kampala, Uganda: subject matter of the right to health in a courtroom HIVNET 012 randomised trial. Lancet 1999;354:795-802.
struggle is likely to be narrow, involving interven- 8. Treatment Action Campaign v. Minister of Health, High Court
tions such as kidney dialysis or nevirapine therapy. of South Africa, Transvaal Provincial Div., 2002 (4) BCLR 356(T),
The HIV epidemic demands a comprehensive strat- 9. Minister of Health v. Treatment Action Committee, Constitu-
egy of treatment, care, and prevention, including tional Court of South Africa, 2002 (10) BCLR 1033.
education, adequate nutrition, clean water, and non- 10. Steiner HJ, Alston P, eds. International human rights in context:
law, politics, morals. 2nd ed. New York: Oxford University Press, discrimination.2,11,17 The government of South Af- 2000:1395-401.
rica has so far been unwilling to designate the HIV 11. United Nations, Economic and Social Council, Committee on
epidemic as a national emergency or to take steps Economic, Social and Cultural Rights. General comment no. 14: the
right to the highest attainable standard of health. New York: United to make the prevention and treatment of HIV in- Nations, 2000.
fection its highest health priority. This stance has 12. Soobramoney v. Minister of Health (KwaZulu-Natal), Constitu-
apparently changed little since the decision on ne- tional Court of South Africa, 1997 (12) BCLR 1696.
13. South Africa v. Grootboom, Constitutional Court of South
virapine was handed down. The South African gov- Africa, 2000 (11) BCLR 1169.
ernment, for example, has asked the Medicines 14. Tarantola D, Gruskin S. Children confronting HIV/AIDS: chart-
Control Council to review its approval of nevirapine ing the confluence of rights and health. Health Hum Rights 1998;3:
because of continued doubt about its safety and ef- 15. Ngwena C. The recognition of access to health care as a human
ficacy.18 Of course, if the council withdraws its ap- right in South Africa: is it enough? Health Hum Rights 2000;5:26-44.
proval of the drug, this action will effectively render 16. Torres MA. The human right to health, national courts, and
access to HIV/AIDS treatment: a case study from Venezuela. Chic J the Constitutional Court’s decision moot, since its Int Law 2002;3:105-15.
orders are based on the finding that nevirapine is 17. De Cock KM, Mbori-Ngacha D, Marum E. Shadow on the conti-
safe and effective. On the more positive side, South nent: public health and HIV/AIDS in Africa in the 21st century. Lan-
Africa’s cabinet has announced that it is considering 18. Baleta A. S Africa soaks up pressure to change HIV/AIDS policy.
universal access to antiretroviral drugs, and Ran- Lancet 2002;360:467.
baxy, the largest manufacturer of generic drugs in 19. Innocenti NG. Ranbaxy in link on AIDS drugs for Africa. Finan-
cial Times (London). October 18, 2002:29.
India, has formed a joint venture with Adcock Ingram 20. Mandela N. Care support and destigmatization. Plenary address
to distribute generic antiretroviral agents in South presented at the XIV International AIDS Conference, Barcelona,Africa.19 Spain, July 7–12, 2002. Copyright 2003 Massachusetts Medical Society. Former South African president Nelson Man- dela has persuasively argued that an effective strat- Downloaded from nejm.org at EBSCO INFORMATION SERVICES - EJS on March 27, 2013. For personal use only. No other uses without permission. Copyright 2003 Massachusetts Medical Society. All rights reserved.

Source: http://www.artsrn.ualberta.ca/amcdouga/Hist446_2013/Readings/The%20Right%20to%20Health.pdf

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