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their universal accessibility, the acceptability of the treatment with respect to the culture and ethics of the individual and an appropriate quality of the available medication’.150
The links between patents, the price of medicines, and access to drugs have been considered by various countries in developing their health sector legal and policy frameworks. India, regarded as the pharmacy of the developing world, offers a good example. The country adopted patent legislation prohibiting product patents for medicines, and this constituted one of the major incentives for the development of a vibrant pharmaceutical industry. 151
The legal arguments surrounding the relationship between human and IP rights, and the practical debates on access to medicines in DCs both point to the existence of potential conflicts between the introduction of patents on drugs in DCs and the realisation of the right to health. While states must endeavour as far as possible to reconcile their various international obligations, there appear to be some cases where the implementation of the TRIPS Agreement implies a reduction in access to medicines and so represents a retrogressive step in the realisation of the right to health.152 This appears to be unacceptable under the ICESCR, and countries in this situation are expected to prefer their human rights obligations.153
This solution, which accords primacy to human rights, is unlikely to meet with the approval of all states or to succeed in adjudication in a WTO context. It nevertheless appears adequate from a legal and ethical point of view.154
3.7 Analysis of the courts’ approach to cases relevant to access to medicines in South Africa.
There are ‘internal modifiers’ in the South African Constitution which limit the extent to which socio-economic rights can be enforced. These ‘internal modifiers’ or internal limitations appear in sections 26(2), 27(2) and section 36 of the Constitution. For the purpose of this thesis I intend
150‘General Comment No 14’para 12.
151Jean O Lanjouw ‘The introduction of pharmaceutical product patents in India: Heartless exploitation of the poor and suffering?’ NBER Paper 6366 (1999).
152General Comment 14 n 115 above..
153ICESCR IP Statement para 12, where it is specifically stated that ‘any intellectual property regime that makes it more difficult for a state party to comply with its core obligations in relation to health, food, education or any other right set out in the Covenant, is inconsistent with the legally binding obligation of the state party.’
154Cullet n 35b above 139-160.
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to show that the courts have been reluctant to apply the general limitations in section 36 in most of the cases that have come before them, relying instead on the internal modifiers in sections 26(2) and 27(2).
In Khosa v Minister of Social Development,155 the court among several primary issues had to make a decision on the ‘reasonableness’ government actions as part of the investigation into the internal limitation in section 27(2). Alternatively, the court had to decide if the investigation should rotate around section 36 – the general limitation clause which governs the limitation of rights under the Constitution. The court was of the view that since there were no arguments on this issue, it refused to decide the issue. The majority, held that if an assumption could be made on the approach of reasonableness as is required under section 36 differs from that in sections 26 and 27, they were still not convinced that the exclusion of permanent residents from the programme was ‘neither reasonable nor justified within the meaning of section 36.156
Consequently it remains unclear whether the section 27 and section 36 ‘reasonableness’ tests are identical and how exactly section 36 operates in relation to socio-economic rights under the Constitution.
In Minister of Health v Treatment ActionCampaign 2002 SA 721 (CC), the court considered the reasonableness of government’s measures in realising socio-economic rights in relation to medical care. The case arose from government’s failure to provide the antiretroviral drug, Nevirapine, to all HIV positive mothers in government hospitals. In delivering its judgment the court stated that:
‘This court has had to consider claims for the enforcement of socio-economic rights on two occasions. On both occasions it was recognised that the state is under a constitutional duty to comply with the positive obligations imposed on it by sections 26 and 27 of the Constitution. It was stressed, however that the obligations are subject to the qualifications expressed in sections 26(2) and 27(2). On the first occasion, in Soobramoney,157 the claim was dismissed because the applicant failed to establish that the state was in breach
1552004 (6) SA 505 (CC).
156www.escr-net.org › Caselaw Database para 136 of courts judgment.
157Soobramoney v Minister of Health, KwaZulu-Natal (1997) ZACC 17; 1998(1) SA 765 (CC); 1997 (12) BCLR 1696 (CC).
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of its obligations under section 26 in so far as the provision of renal dialysis to chronically ill patients was concerned. In Grootboom,158 the claim was upheld because the state’s housing policy in the area of the Cape Metropolitan Council failed to make reasonable provision within available resources for people in that area who had no access to land and roof over their heads and were living in intolerable condition.’159
The court went on to point out that in both Soobramoney and Grootboom the socio-economic rights of the applicants and the corresponding obligations of the state were interpreted in their social and historical contexts.160In this light, the question in the TAC case was whether the applicants had shown that the measures adopted by the government to provide access to health care services for HIV-mothers and their newborn babies, fell short of its obligations under the Constitution.161
The court held that section 27(1) and (2) of the Constitution requires that within its available resources, the government devise and implement a comprehensive and coordinated programme progressively to realise the rights of pregnant women and their newborn infants to access to health services to combat the mother-to-child transmission of HIV.162
The court further held: ‘Government is ordered without delay to … remove the restrictions that prevent Nevirapine being made for the purpose of reducingthe risk of mother to child transmission of HIV at public hospitals and clinics that are not researchand training sites.’163 In accordance with the provisions of sections 26(2) and 27(2), the state must take reasonable, legislative and other measures, within its available resources, to achieve the progressive realisation of the socio-economic rights enshrined in the Constitution. The general limitation clause in section 36, however, allows for the limitation of the rights in the Bill of Rights provided that the limitation is, inter alia, ‘reasonable and justifiable in an open and democratic society’.
158Government of the Republic of South Africa & others v Grootboom& others (2000) ZACC 19; 2001 (1) SA 46 (22); 2000 (11) BCLR 1169 (CC).
159Minister of Health v TreatmentAction Campaign 2002 SA 721 (CC)para 23.
160Id para 24.
161Id para 25.
162Id para 135 2(a).
163Id para 135 3(a).
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It is necessary to examine the form and content of the ‘reasonableness assessment’ under section 27(2), and then under the section 36 enquiry.
First, the court is required to interpret the scope and content of the right in order to establish whether it has been infringed. If there has been no infringement the inquiry ends. However, if the court finds that the right in question has been infringed, it must embark upon a ‘limitation analysis’. At this stage the court applies the factors listed in section 36 to determine whether the limitation of the right in question is constitutionally justifiable.
There are two general requirements that the limitation must meet in order to satisfy section 36: it must qualify as a law of general application, and it must be ‘reasonable and justifiable’ in an open and democratic society based on human dignity, equality and freedom.
Although, the Constitutional Court has not outlined the criteria for what would qualify as a law of general application, it has indicated that original and delegated legislation, the common law, and exercises in executive rule-making can all constitute ‘a law of general application’ provided that they are ‘accessible and precise’.164 Administrative action taken under the authority of legislation, does not satisfy this requirement, and legislation conferring ‘unconstrained discretionary power’165 on administrators has likewise been found not to qualify as a law of general application.166
This requirement is necessary to prevent arbitrary limitations on rights and to enable citizens to understand exactly when their rights may be limited. The consequence of a finding that the contested conduct does not qualify as a law of general application is that it simply cannot justifiably limiting rights. As the limiting measures do not constitute a law of general application, they will be declared unconstitutional.
However, if it is confirmed that the infringement is effected through a law of general application, the courts are required to conduct an enquiry to determine whether it ‘[took] place for a reason that is accepted as a justification for infringing rights in an open and democratic
164Ian Currie & Johan de Waal The Bill of Rights Handbook 5 ed (2005) 171. What is the case/s in which this was held – refer to original sources where possible??Khosa v Minister of Social Development 2004 (6) 505 (CC).Residents of Bon Vista Mansions v Southern Metropolitan Local Council’ (2003) 120 SALJ 41.
165Id 175.
166Dawood v Minister of Home Affairs 2000(3) SA 936 (CC).
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society based on human dignity, equality and freedom’.167 If it does, the infringement will be constitutional. Currie and de Waal168 explainthat the purpose of the inquiry is to ensurethat rights are not limited more than is required, and that the limitation serves a constitutionally acceptable purpose. This is in accordance with the constitutional imperative of justification and ensuring that actors are accountable for their actions that infringe on constitutionally protected rights.169 In State v Makwanyane,170 the Constitutional Court held that the nature of the analysis required under section 36 is one of proportionality.171 The court is required to put the nature and importance of the right and the impact that the limiting legislation would have on that right on one side, and the aim and importance of the legislation on the other. The court then weighs up these two considerations and determines whether the aim the limiting provision seeks to achieve is of greater import than the effect it has on the right in question.172
The important thing to note, however, is that the emphasis must be on the justifiability of the limitation in an open and democratic society. Therefore, the democratic values of human dignity, equality, and freedom are the guiding principles in the analysis. Accordingly, when respect for the right infringed is essential to ensure a society based on democratic values, there must be an especially compelling need for the limitation.173
Justice Richard Goldstone, reflecting on judicial interpretation of limitation clauses, noted as follows:
‘The result is that I earn my living doing a judicial balancing act. Perhaps three out of four of our cases involve balancing. When competing claims and interests are involved, we are compelled to engage in proportionality exercise against the background of the values that the constitution requires us to promote.’174
3.8 Conclusion
167Currie & de Waalsupra page164.
168Ibid.
169See M Pieterse ‘Towards a useful role for section 36 of the Constitution in social rights cases? Residents of Bon Vista Mansions v Southern Metropolitan Local Council’ (2003) 120 SALJ 41.
1701995 (3) SA 391 (CC).
171Id para 352.
172Id para 352.
173Id paras 368 – 370.
174See Richard J Goldstone ‘The South African Bill of Rights’ (1997) 32 Texas International Law Journal 451.
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In this chapter of the thesis, I have tried to show that access to treatment forms an integral part of the right to health which is guaranteed in so many international human rights instruments. The inability of the poor people in DCs to have access to life-saving medications compromises their right to health. I have discussed the conflict between patents and access to medicines and why it is necessary for governments to restrict basic rights through limitation clauses. I have also argued that it is necessary for the courts in South Africa to undertake an analysis of section 36 in socio-economic right cases before them. This will ensure that the infringement of rights is examined in terms of the required standards and foundational values and ensure respect for the transformed society the Constitution aspires to achieve.
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