(TRANSVAAL PROVINCIAL DIVISION) CASE NO: 4183/98 In the matter between :- THE PHARMACEUTICAL MANUFACTURERS' ASSOCIATION OF SOUTH AFRICA First Applicant AND OTHERS Second to Forty Second Applicants and THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA, THE HONOURABLE MR N.R. MANDELA N.O. First Respondent AND OTHERS Second to Tenth Respondents and TREATMENT ACTION CAMPAIGN Amicus Curiae HEADS OF ARGUMENT ON BEHALF OF THE TREATMENT ACTION CAMPAIGN 1 INTRODUCTION Overview of the submissions by the Treatment Action Campaign 1.1 The Treatment Action Campaign ("TAC") has been admitted as an amicus = curiae in these proceedings. The TAC addresses submissions only on the = constitutionality of sections 15C, 22F and 22G of the Medicines and Relat= ed Substances Control Act 101 of 1965 as amended by Act 90 of 1997 ("the = Act"). 1.2 The TAC submits that these provisions violate neither the fundamental= rights of the applicants, nor the rule of law guarantee against arbitrar= iness. In advancing this submission, these heads of argument will addr= ess the following issues: 1.2.1 the proper approach to the interpretation of the relevant sections = of the Act; 1.2.2 the constitutional obligation resting on the State to provide cheap= access to drugs, particularly in the context of the HIV/AIDS epidemic; 1.2.3 the nature and ambit of the fundamental rights relied upon by the a= pplicants: the rights to property (s 25 of the Constitution), equality (s= 9(1) of the Constitution) and free choice of occupation, trade and profe= ssion (s 22 of the Constitution); 1.2.4 the scope of rationality review under sections 9(1), 22 and 25(1) o= f the Constitution and under section 1(3) which entrenches the rule of la= w as a founding value. 1.3 It will be submitted that there is no substance to the following cons= titutional challenges made by the applicants to provisions of the Act: 1.3.1 the challenges to section 15C based on the fundamental right to pro= perty and the non-arbitrariness requirement of the rule of law; 1.3.2 the challenges to section 22F based on the fundamental rights to pr= operty, equality and free choice of profession and the non-arbitrariness = requirement of the rule of law; and 1.3.3 the challenges to section 22G based on fundamental rights to equali= ty and free choice of profession and the non-arbitrariness requirement of= the rule of law. 1.4 In relation to the fundamental rights challenges brought by the appli= cants to sections 15C, 22F and 22G, the TAC submits that the provisions i= n question: 1.4.1 do not limit any fundamental rights of the applicants; alternativel= y 1.4.2 having particular regard to the imperatives of combatting the HIV/A= IDS epidemic, can be justified in terms of section 36(1) of the Constitut= ion. 1.5 At the heart of the challenges based upon the rule of law, property, = equality and free choice of profession is the concept of rationality revi= ew. Irrespective of who bears the onus of demonstrating that the provi= sions in question are arbitrary or irrational (and it will be submitted t= hat the applicants bear the onus) there is clearly a rational basis for t= he legislation. Hence it will be submitted that these challenges fall = at the first hurdle. 1.6 The TAC does not address the applicants "void for vagueness" and "del= egation doctrine" challenges to sections 15C, 22F and 22G because these a= re canvassed fully in the responddents' heads of argument and are, in any= event, issues in respect of which the amicus has no direct interest. 1.7 These heads of argument will consolidate all the submissions that the= TAC wishes to advance. They replace the heads of argument filed at th= e previous hearing. The interest of the Treatment Action Campaign and the facts relevant to t= hat interest 1.8 The Treatment Action Campaign is a voluntary association with broad l= ocal and international support, campaigning inter alia for: 1.8.1 affordable treatment for all people with HIV/AIDS; 1.8.2 the prevention and elimination of all new HIV infections; 1.8.3 a regulatory framework to ensure equal access and equal treatment o= f all people with HIV/AIDS; and 1.8.4 affordable and quality access to health care for all people in Sout= h Africa 1.8.4=20 Founding Affidavit of Steele p 3434 para 4 1.9 The legislation under challenge in these proceedings has the professe= d aim to make all medicines affordable, but the scale of the HIV/AIDS epi= demic and its impact create an urgency and immediacy in this regard which= is not applicable to any other illnesses. The TAC therefore represent= s a constituency with a particular interest in these proceedings. 2 HIV/AIDS AND THE CONSTITUTIONAL OBLIGATION TO PROVIDE ACCESS TO DRUGS 2.1 The HIV/AIDS epidemic presents a health crisis that is unparalleled i= n South African history. Official estimates in October/November 1999 p= laced the number of HIV positive people in South Africa at 4.2 million. = The most recent estimates now place the number at 4.7 million. The Dep= artment of Health projects that by 2002 a quarter of a million South Afri= cans could die of AIDS each year and that by 2008 this figure will have r= isen to over a million. Founding Affidavit of Steele: p 3450 para 41;=20 p 3451 para 44 p 3451 para 45 Supplementary Answering Affidavit of Steele: p 4249 para 13 2.2 The affidavits of individual deponents living with HIV/AIDS personali= se the effect of these national statistics and illustrate the extent to w= hich the HIV/AIDS epidemic compromises the ability of the millions of Sou= th Africans behind the statistics to live a dignified life. Achmat Amicus Application Annexure AA11 p 3537 Dubula Amicus Application Annexure AA12 p 3541 Impali Amicus Application Annexure AA13 p 3544 Mthathi Amicus Application Annexure AA14 p 3547 Makebesana Amicus Application AA15 p 3550 Kwaza Amicus Application Annexure AA16 p 3552 Mantshi Amicus Application Annexure AA17 p 3554 Feni Amicus Application Annexure AA18 p 3557 Dove Amicus Application Annexure AA19 p 3560 Ogle Amicus Application Annexure AA20 p 3563 Mohapi Amicus Application Annexure AA21 p 3565 Ogle Amicus Application Annexure A22 p 3567 To these personal case studies, the applicants have offered no answer. 2.3 It is not disputed that anti-retroviral drugs have now been developed= which target HIV directly and significantly reduce the replication of th= e virus, thereby preventing illness and the onset of AIDS. Founding Affidavit of Steele: p 3542 para 51 Johnson Amicus Application Annexure AA3 p 3493 para 19 - p 3494 para 24 2.4 However, the cost of these anit-retroviral drugs in South Africa, (be= tween R2000 and R4000 per person per month) remains beyond the means of m= ost persons living with HIV/AIDS. Thus, most South Africans living wit= h HIV/AIDS are condemned to follow a path towards inevitable death over a= n average period of ten years from their infection. Steele Amicus Application p 3453 para 52 Reuter Amicus Application Annexure AA9 p 3533 para 13 Johnson Amicus Application Annexure AA3 p 3487 para 8.3 and p 3494 para 2= 4 =09 Goemaere Amicus Application Annexure AA4 p 3511 para 23 - p 3512 para 26 2.5 The high price of these life saving anti-retroviral drugs is not inev= itable. Dr Goemaere shows how the promotion of generic substitution in= Brazil has led to a 70% reduction in the price of the anti-retroviral dr= ugs. This reduction in anti-retroviral drug prices (which, incidentall= y, corresponds almost exactly to the average differential between anti-re= troviral wholesale prices in Brazil and South Africa) has enabled the Bra= zilian government to put approximately 100 000 people onto anti-retrovira= l treatment and thereby to extend their lives. Goemaere Amicus Application Annexure AA4 p 3512 paras 28-29 and p 3513 pa= ra 32 2.6 It is not only anti-retrovirals which have been placed beyond the rea= ch of patients living with HIV/AIDS by drug prices. For example, Fluco= nazole, which is used effectively to treat or prevent a range of serious = and invasive fungal infections commonly associated with HIV/AIDS, was sol= d to the government at a tender price of R28 per pill and retailed at R12= 5 per pill when a generic equivalent cost R2 per pill. Johnson Amicus Application Annexure AA3 p 3492 para 15 Founding Affidavit of Steele: p 3453 para 53 Geffen Amicus Application Annexure AA8, p 3530 paras 7-8 2.7 In the original answering affidavit filed by the applicants, Deeb con= ceded that "the HIV/AIDS epidemic poses severe challenges to the health c= are system and to research-based pharmaceutical industry". She profess= ed to be "alive to the personal suffering caused by the ravages of diseas= e, not only HIV,". However, she claimed that her omission to deal with= "such tragedy in these papers is simply that it would not contribute to = the resolution of the narrow issues which call for adjudication in this a= pplication". Deeb Original Answering Affidavit: p 3659 para 3 2.8 In the supplementary answering affidavit, Deeb, once again, studiousl= y avoids any engagement with the impact of HIV/AIDS and contents herself = with conceding that "the extent of the HIV/AIDS infections in South Afric= a has reached epidemic proportions and has catastrophic effects". Deeb Supplementary Answering Affidavit: p 3810 para 2.2.2 p 3813 para 2.4 2.9 In asserting its interest in these proceedings, the TAC essentially a= dvanced three propositions: 2.9.1 First, the nature and extent of the health risks posed by HIV are o= f such a magnitude that such risks are unparalleled in our history and ar= e simply not comparable to any other incurable disease. The HIV/AIDS e= pidemic threat constitutes the greatest health risk ever faced by South A= frica. The epidemic has the potential to decimate the population on an= unprecedented scale. Its effects are being felt daily. 2.9.2 Second, the costs of medicines to treat HIV/AIDS are simply beyond = the reach of the majority of South Africans and that ss 15C, 22F and 22G = will if implemented, reduce the costs of medicines used in treating HIV/A= IDS. 2.9.3 Third, there are medicines currently available which can substantia= lly relieve suffering and prolong the lives of people living with HIV. 2.10 The applicants do not dispute the first and third contentions advanc= ed. Moreover, they do not dispute that the costs of anti-retroviral medi= cines are unaffordable for many people. They contend, however, that a d= istinction must be drawn between the public and the private sector and th= at it is, in essence, only the private sector which is touched by the que= stion of affordability. Even an acceptance of the applicants' contenti= ons in this regard (which, in any event, are disputed) indicates that "th= e number of HIV positive people seeking medical assistance in the private= sector cannot be more on current demographics than 0,84 million". Thi= s, according to the applicants, represents a maximum figure and the "real= figure of patients with HIV/AIDS actually seeking or receiving medical t= reatment in the private sector probably stands at well below 1% of the po= pulation". On this basis (and given the most recent figures), this wo= uld represent approximately 500 000 people. =20 Deeb Supplementary Answering Affidavit p 3823 para 4.2.5(d) 2.11 The applicants' contentions in this regard, however, are demonstrabl= y misconceived in a number of respects. The applicants' argument rests = essentially on three contentions: 2.11.1 First, while conceding that the costs of HIV/AIDS medicines are in= accessible to many patients, the applicants contend that this is true for= many patients who are unable to pay for the medicines at any cost level.= Deeb Supplementary Answering Affidavit: p 3821para 4.1 2.11.2 Second, the applicants contend, however, that 70% by volume of the= medicines sold in South Africa is bought and supplied for patients by th= e State or public sector and in respect of these medicines the public sec= tor "obtains supplies at costs comparable to the cheapest available in th= e world". The submission is advanced that no saving will be brought ab= out in the public sector by the process catered for in section 22F (gener= ic substitution) because "the State sector operates on a tender system in= terms of which it gets what it orders by the awarding of the tender." Deeb Supplementary Answering Affidavit: p 3821 para 4.2.1 p 3824 para 5.3 2.11.3 Third, the applicants make great play of the initiatives of member= s of the PMA "by projects aimed at providing greater access to the medici= nes which they produce and which are useful in the treatment of HIV/AIDS"= =2E Deeb Supplementary Answering Affidavit: pp 3832 para 8.1 2.12 Irrespective of the manner in which the State purchases medicines, t= hey ultimately come at a cost which is dependent upon the willingness of = the manufacturers to tender at all, and, if they do so tender, to tender = at a particular price. The decision to tender and the price of such te= nder are exclusively matters within the preserve of the manufacturer. = There is no obligation upon a manufacturer to tender or, to tender at a= particular price. The fallacy of the applicants' argument emerges clea= rly from the reply by Dr Ntsaluba who states that the State does not supp= ly anti-retrovirals because they are not affordable. Ntsaluba Replying Affidavit: p 4895 para 14 p 4899 para 19.4 p 4910 para 34.2 p 4918 para 40 p 4929 para 61.1 - 61.2 See also: p 4924 para 47.2 p 4928 para 58 The applicants' approach also ignores the inter-relationship between the = public and private sectors. Van den Heever Amicus Reply: pp 4353-4356 paras 39 - 47 2.13 One of the initiatives to which reference is made by both the TAC an= d the applicants concerns Pfizer Laboratories' product, Diflucan. In re= lation to this product, there is no dispute that the Memorandum of Unders= tanding between the Minister of Health and Pfizer Laboratories was entere= d into because the Government could not afford to purchase sufficient qua= ntities to meet demand for the medicine at the current tender price to th= e public sector of R28 per pill. The price of the bioequivalent generi= c version is R2 per pill. It is not disputed that this agreement is an = explicit confirmation that at the current price this particular drug is n= ot affordable. This and other medicines are therefore either not purch= ased on State tender or purchased and prescribed in the Public Health Ser= vice in insufficient volumes to meet a public need. Founding Affidavit of Steele: pp 3453 paras 53-56 Annexure AA25 p 3614 =20 Deeb Supplementary Answering Affidavit: p 3833 para 8.2 Ntsaluba Replying Affidavit: p 4911 paras 35.4 - 35.5 2.14 The applicants contend that sections 22F and 22G will not bring abou= t savings in the cost of medicines to any significant degree in the publi= c sector. The argument in this regard appears to be that the State sec= tor operates on a tender system in terms of which it gets what it orders = by the awarding of the tender. The product so bought by and delivered = to the State is thereupon dispensed to patients at State facilities. =20 2.14=20 Deeb Supplementary Answering Affidavit: pp 3824 - 3926 para 5.3 - 5.= 6 2.15 It is submitted that the contentions are both factually and legally = misconceived: 2.15.1 From a factual point of view, the contentions simply ignore the ev= idence, referred to above, in relation to Diflucan as well as the evidenc= e of Dr Ntsaluba. Ntsaluba Replying Affidavit: pp 4889 - 4892 paras 10.1 - 10.10 Ntsaluba Main Answering Affidavit: pp 1409 - 1411 para 49 2.15.2 There is nothing in section 22F which confines its operation to th= e private sector. =20 2.15.3 Save for section 22G(3)(a), there is nothing in section 22G which = confines its operation to the private sector. 2.15.4 The State's obligations in relation to the procurement of goods fl= ow from section 217 of the Constitution, the relevant provision of which = provides: "217 (1) When an organ of State in the national, provincial or local sphe= re of government, or any other institution identified in national legisla= tion, contracts for goods or services, it must do so in accordance with a= system which is fair, equitable, transparent, competitive and cost-effec= tive." 2.15.5 The fact that the COMED system is presently in operation does not = mean that this system is the only system for the procurement of medicines= nor does it mean that its operation will continue either at all, or in i= ts present form. Moreover, the capacity of the State to meet all of i= ts constitutional obligations is ultimately dependent upon the revenue it= generates and the extent of its costs. Hence, the price at which medi= cines are purchased is a crucial determinant in the capacity of the State= to meet its obligations, inter alia, to provide access to health care se= rvices. This clearly emerges from the evidence of Dr Ntsaluba. Ntsaluba Replying Affidavit: pp 4892 - 4894 paras 12.1 - 12.2 Gray Amicus Reply: p 4817 para 8 Ntsaluba Main Answering Affidavit: pp 1409 - 1411 para 49 2.16 As for the initiatives by certain members of the PMA to provide medi= cines at cheaper rates, these initiatives are entirely at the whim of the= manufacturers concerned and reduce patients to the recipients of charity= =2E Initiatives of this sort can as easily be withdrawn as they are ma= de. Hence, powers of parallel importation and generic substitution, as = well as price control are legitimate means to achieve price reduction and= other legitimate objectives. Perez-Casas Amicus Reply: pp 4299 - 4300 paras 9.1 - 9.3 pp 4301 - 4302 paras 10.1 - 10.6 pp 4302 - 4303 paras 11.1 - 11.2 Van den Heever Amicus Reply: pp 4349-4350 paras 26 - 30 pp 4352 - 4353 paras 35 - 38 pp 4358 - 4360 paras 47 -57 2.17 It is not without significance that all the initiatives referred to = by the applicants were made substantially after the institution of these = proceedings. 2.18 The applicants also fail to address the principle contentions advanc= ed by Dr Goemaere of Medecins Sans Frontiers ("MSF"), an international hu= manitarian medical aid agency operating in many countries, including Sout= h Africa. MSF comprises a group of physicians who offer emergency assi= stance wherever humanitarian disasters occur. It was the recipient of = the Nobel Peace Prize in 1999. MSF South Africa is based in Khayelitsh= a. In April 2000 it began infectious disease clinics to provide treatm= ent for people with HIV/AIDS. It is pointed out that "hundreds of pati= ents under the care of our doctors are in need of treatment that they can= not afford". Dr Goemaere states the following: "23 The experience in the MSF clinics in Khayelitsha forms the basis of t= hese comments. These clinics are among the few in the Western Cape ded= icated to the provision of treatment for people with HIV/AIDS. The cli= nics also dispense free treatment for the opportunistic infections that a= re common in people with HIV/AIDS. As a result, on a daily basis, peop= le with HIV/AIDS who cannot afford the high cost of medicines visit the M= SF clinics. The need is such that even patients with little income wil= l pay hefty sums to travel from the surrounding areas in the hopes of rec= eiving treatment in the MSF clinics. =20 24 At the moment our doctors and nurses are able to provide the medicine= s necessary for the treatment of opportunistic infections, the complicati= ons that arise as a result of the damage HIV causes to the immune system.= =20 25 However, the medical indication for many of the patients visiting the= MSF clinics is antiretroviral therapy, which directly inhibits HIV from = replicating and so can prevent the development of opportunistic infection= s. Our doctors and nurses cannot provide out patients with the anti-re= troviral therapy because the high price of these drugs makes this an unsu= stainable option (once begun, antiretroviral therapy is life-long). 26 Thus as a result of the high price of medicines, our doctors and nurs= es are regularly unable to offer the antiretroviral treatment needed by o= ur patients." Goemaere Amicus Application: pp 3511 - 3512 paras 23-26 2.19 The applicants' response to this affidavit is curious. It goes sc= arcely further than raising the irrelevant question of whether or not Dr = Goemaere and the MSF volunteers are qualified and registered to practice = as such in South Africa. Deeb Supplementary Affidavit: p 3851 paras 9.1.10 - 9.1.11 The implicit attack is, in any event, refuted. Goemaere Amicus Reply: pp 4856 - 4857 paras 3 - 9 2.20 The affidavit of Susan Roberts also refutes the implicit suggestion = of the impermeable barrier between the private and the public health sect= or. It is made clear that even patients treated at State hospitals rec= eive prescriptions for drugs which may not be dispensed at the hospital c= oncerned and hence must be attended to privately by the patient concerned= =2E Roberts Amicus Reply: pp 4332 - 4338 =20 2.21 Furthermore, simple logic dictates that the public and private healt= h care sectors are not hermetically sealed from one another. Drug prices= in the private sector affect the degree to which private patients are ab= le to cover their health care expenses from their private funds, and henc= e the degree to which these private patients are obliged to seek care in = State facilities. =20 Steele Amicus Reply p 4259 para 32 2.22 Finally, it must be pointed out that even taking their arguments abo= ut the public sector / private sector divide at face value, the applicant= s concede that 30% of the total volume of drugs presently sold in South A= frica are sold in the private sector. A figure this high amply justifies= the taking of measures designed specifically to lower prices in the priv= ate sector. Furthermore, the applicants' figures are figures based on hi= storical sales and do not reflect the effect of recent legislative and po= licy changes designed to shift the focus of public health care expenditur= e onto primary health care and generally to increase the private sector's= share of the burden of health care expenditure. See for example: Sections 24(2)(e), 29(1)(n), 29(1)(p) and 29(1)(t) of th= e Medical Schemes Act 131 of 1998 Paragraphs 3.8.2, 3.10.4 and 3.10.5 of the White Paper for the Transforma= tion of the Health Care System in South Africa Government Gazette 17910, = 16 April 1997 2.23 It is accordingly submitted that the evidence clearly establishes th= e three central propositions advanced by the TAC referred to in paragraph= 2.9 above. 3 THE PROPER APPROACH TO THE INTERPRETATION OF THE RELEVANT SECTIONS OF T= HE ACT The Relevant Sections of the Act 3.1 For the sake of convenience, the three sections which the TAC seeks t= o defend are reproduced below: 3.1.1 "15C Measures to ensure supply of more affordable medicines The Minister may prescribe conditions for the supply of more affordable m= edicines in certain circumstances so as to protect the health of the publ= ic, and in particular may - (a) notwithstanding anything to the contrary contained in the Patents Act= , 1978 (Act 57 of 1978), determine that the rights with regard to any med= icine under a patent granted in the Republic shall not extend to acts in = respect of such medicine which has been put onto the market by the owner = of the medicine, or with his or her consent; (b) prescribe the conditions on which any medicine which is identical in = composition, meets the same quality standard and is intended to have the = same proprietary name as that of another medicine already registered in t= he Republic, but which is imported by a person other than the person who = is the holder of the registration certificate of the medicine already reg= istered and which originates from any site of manufacture of the original= manufacturer as approved by the Council in the prescribed manner, may be= imported; (c) prescribe the registration procdure for, as well as the use of, the m= edicine referred to in paragraph (b)." 3.1.2 "22F Generic substitution (1) Subject to sub-sections (2), (3) and (4) a pharmacist shall - (a) inform all members of the public who visit his or her pharmacy with a= prescription for dispensing, of the benefits of the substitution for a b= randed medicine of an inter-changeable multi-source medicine; and (b) dispense an inter-changeable multi-source medicine instead of the med= icine prescribed by a medical practitioner, dentist, practitioner, nurse = or other person registered under the Health Professions Act, 1974, unless= expressly forbidden by the patient to do so. (2) If a pharmacist is forbidden as contemplated in sub-section (1)(b), t= hat fact shall be noted by the pharmacist on the prescription. (3) When an inter-changeable multi-source medicine is dispensed by a phar= macist he or she shall note the brand name or where no such brand name ex= ists, the name of the manufacturer of that inter-changeable multi-source = medicine in the prescription book. (4) A pharmacist shall not sell an inter-changeable multi-source medicine= - (a) if the person prescribing the medicine has written in his or her own = hand on the prescription the words 'no substitution' next to the item pre= scribed; (b) if the retail price of the inter-changeable multi-source medicine is = higher than that of the prescribed medicine; or (c) where the product has been declared not substitutable by the Council.= " 3.1.3 "22G Pricing Committee (1) The Minister shall appoint such persons as he or she may deem fit to = be members of a committee to be known as the pricing committee. (2) The Minister may, on the recommendation of the pricing committee, mak= e regulations - (a) on the introduction of a transparent pricing system for all medicines= and scheduled substances sold in the Republic;=20 (b) on an appropriate dispensing fee to be charged by a pharmacist or by = a person licensed in terms of section 22C(1)(a). (3) (a) The transparent pricing system contemplated in sub-section (2)(a)= shall include a single exit price which shall be published as prescribed= , and such price shall be the only price at which manufacturers shall sel= l medicines and scheduled substances to any person other than the State. (b) No pharmacist or person licensed in terms of section 22C(1)((a) shall= sell a medicine at a price greater than the price contemplated in paragr= aph (a). (c) Paragraph (b) shall not be construed as preventing a pharmacist or pe= rson licensed in terms of this Act to charge a dispensing fee as contempl= ated in sub-section (2)(b). (4) To the members of the pricing committee who are not in the full-time = employment of the State may be paid such remuneration and allowances as t= he Minister, with the concurrence of the Minister of Finance, may determi= ne." The Purpose of the Sections 3.2 In S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) Chaskal= son P dealt with the manner in which the purpose of particular legislativ= e provisions is to be ascertained. He did so, in the context of sectio= n 26 of the interim Constitution which dealt with the right freely to eng= age in economic activity. He stated at para 52: "The purpose of particular legislative provisions has ordinarily to be es= tablished from their context, which would include the language of the sta= tute and its background. Where the purpose is one sanctioned by sectio= n 26(2) the question whether that purpose is justifiable in an open and d= emocratic society based on freedom and equality is essentially a question= of law; so too is the question whether there is a rational basis for the= means used to achieve the legislative purpose. That is not to say tha= t evidence will not be relevant to these enquiries; it may well be. Th= e evidence, however, is more likely than not to consist of 'legislative f= acts'. Professor Hogg ... says: 'The US literature draws a distinction between 'adjudicative' facts and '= legislative' facts, terminology originally coined by Professor Kenneth Cu= lp Davis, the author of the major US treatise on Administrative Law. A= djudicative facts are facts about the immediate parties to the litigation= - 'who did what, where, when, how, and with what motive or intent'; legi= slative facts are facts of a more general character concerning the social= or economic milieu which gave rise to the litigation'. Legislative facts do not have to be proved as strictly as adjudicative fa= cts and as Professor Hogg says: 'In constitutional cases in the United States there has been a substantia= l relaxation of the limits of judicial notice for findings of legislative= facts.'" In footnote 46, which deals with the question whether there is a rational= basis for the means used to achieve the legislative purpose, the followi= ng is stated: "In the United States the courts do not require evidence on this issue. = 'A legislative choice is not subject to courtroom fact finding and may b= e based on rational speculation unsupported by evidence or empirical data= ' (FCC v Beach Communications Inc ....). See also Cabinet for the Terr= itory of South West Africa v Chikane and Ano. 1989 (1) SA 349 (A) at 368 = A - 369 D and 382 H - 383 F. As the Beach Communications case shows ..= =2E.. the United States Supreme Court requires those challenging the cons= titutionality of legislation under a rational basis review 'to negative e= very conceivable basis which might support it'." 3.3 The basis of rationality review, will be considered in more detail be= low. For present purposes, it suffices to state that with regard to th= e sections presently under review, the purpose is readily ascertainable f= rom the sections themselves. In broad terms, all have in common the ov= erriding objective of obtaining cheaper access to medicines. As the a= pplicants themselves point out, however, the legislation has its genesis = in the National Drug Policy published by the Department of Health in 1996= =2E PMA Heads of Argument: pp 201-204 para 20.1.2.2 3.4 The National Drug Policy deals with concerns beyond those catered for= by section 15C, 22F and 22G. Of relevance to the purpose of these sect= ions, however, the following emerges from the National Drug Policy: 3.4.1 "The pharmaceutical sector, as a component of the health sector, re= flected its deficiencies, most notably the lack of equity in access to es= sential drugs, with a consequent impact on quality of care. Furthermor= e, rising drug prices, already high in international terms, gave increasi= ng cause for concern, as did evidence of irrational use of drugs, losses = through mal-practice and poor security, and cost-ineffective procurement = and logistic practices. Most of these problems are interlinked. The Government of South Africa= decided to tackle them systematically through the development and implem= entation of a National Drug Policy that would be consonant with and an in= tegral part of the new National Health Policy, which aims at equity in th= e provision of health care for all. The goal of the National Drug Policy is to ensure an adequate and reliabl= e supply of safe, cost-effective drugs of acceptable quality to all citiz= ens of South Africa and the rational use of drugs by prescribers, dispens= ers and consumers." Annexure "M21" p 706 3.4.2 The specific objectives of the National Drug Policy include "to ens= ure the availability and accessibility of essential drugs to all citizens= ", "to lower the cost of drugs in both the private and public sectors" an= d "to promote the cost-effective and rational use of drugs". Annexure "M21" p 707 3.4.3 Dealing with the aim of promoting the availability of safe and effe= ctive drugs at the lowest possible cost the policy states, inter alia, th= at "this aim will be achieved by monitoring and negotiating drug prices a= nd by rationalising the drug pricing system in the public and private sec= tors, and by promoting the use of generic drugs." Rationalisation of t= he pricing structure reflects the intended establishment of "a pricing c= ommittee with clearly defined functions to monitor and regulate drug pric= es". It is envisaged that there will be "total transparency in the pri= cing structure of pharmaceutical manufacturers, wholesalers, providers of= services, such as dispensers of drugs, as well as private clinics and ho= spitals". It is pointed out that "where the State deems that the retai= l prices of certain pharmaceuticals are unacceptable and that these pharm= aceuticals are essential to the wellbeing of any sector of the population= , the State will make them available to the private sector at acquisition= cost plus the transaction costs involved." Part of the aim of promotin= g the availability of safe and effective drugs at the lowest possible cos= t is the availability of generic drugs. It is envisaged that generic su= bstitution would be allowed in the public and the private sector and that= it would be incumbent on the pharmacist, prior to dispensing a prescript= ion to inform the patient of the benefits of generic substitution. Annexure "M21" pp 711-712 3.4.4 With regard to the aim of ensuring an adequate supply of effective = and safe drugs of good quality to all people in South Africa the policy s= tates that "the objective is to develop a system of joint responsibility = between the government and the patient for the financing of drugs" and th= at "the government will ensure that essential drugs are available to all = people in need. To this end, drugs will be provided free of charge at t= he point of service at the primary care level". Annexure "M21": p 715 3.4.5 With regard to the aim of promoting the rational prescribing, dispe= nsing and use of drugs, the policy indicates that "the public will be pro= vided with access to objective, validated and practical information on dr= ugs and their proper use, written in lay language and including appropria= te self-diagnosis and treatment." Annexure "M21": p 720 3.5 Sections 15C, 22F and 22G give explicit expression to these policy ob= jectives. As will be argued below, there is manifestly a rational conn= ection between the means employed and the objectives pursued. =20 The Abstract Nature of the Applicants' Attack 3.6 In the present case, although the legislation has been enacted, it is= not yet in force. The applicants correctly point to the fact that the= Constitutional Court follows the objective theory of invalidity. =20 PMA's Heads of Argument: pp 20 - 23 para 3.1.8.5 3.7 In this regard, the Constitutional Court has recognised that notwiths= tanding the objective approach to the issue of constitutionality, the imp= lementation of an Act "may well give rise to a constitutional complaint, = if, as a result of circumstances which become apparent later, its impleme= ntation would infringe a constitutional right." New National Party of South Africa v Government of the Republic of South = Africa and Others 1999 (3) SA 191 (CC) at 205 B - C para 22 That case concerned the mechanisms which had been put in place in anticip= ation of the general election. The election had not yet occurred and h= ence, there was no certainty as to whether or not the mechanisms would re= sult in a substantial denial of the right to vote, as contended by the ap= plicants. Yacoob J, on behalf of the majority observed at para 23: "It is necessary to apply an objective test in deciding whether the Act o= f Parliament which makes provision for the electoral scheme challenged in= the present case, is valid. Parliament is obliged to provide for the m= achinery, mechanism or process that is reasonably capable of achieving th= e goal of ensuring that all persons who want to vote, and who take reason= able steps in pursuit of that right, are able to do so. I conclude, th= erefore, that the Act would infringe the right to vote if it is shown tha= t, as at the date of the adoption of the measure, its probable consequenc= e would be that those who want to vote would not have been able to do so,= even though they acted reasonably in pursuit of the right. Any schem= e which is not sufficiently flexible to be reasonably capable of achievin= g the goal of ensuring that people who want to vote will be able to do so= if they act reasonably in pursuit of the right, has the potential of inf= ringing the right. That potential becomes apparent only when a concret= e case is brought before a court. The appellant bears the onus of esta= blishing that the machinery or process provided for is not reasonably cap= able of achieving that purpose. As pointed out in the previous paragra= ph, it might well happen that the right may be infringed or threatened be= cause a governmental agency does not perform efficiently in the implement= ation of the statute. This will not mean that the statute is invalid. = The remedy for this lies elsewhere." (emphasis added) 3.8 Applying this approach to the present matter, and confining the argum= ent to the attacks based upon the Bill of Rights, it would be incumbent u= pon the applicants to show that the impugned sections would probably enta= il an unjustified violation of their rights. In the case of section 15= C, it is submitted that this cannot be demonstrated. Section 15C is an e= mpowering provision which vests the Minister with the discretion to presc= ribe conditions for the supply of more affordable medicines. It cannot= be said a priori that the exercise of that discretion will probably enta= il a violation of any of the applicants' rights. The same is true of t= he appointment of the Pricing Committee and the making of regulations for= the pricing system contemplated by section 22G. 3.9 It must be assumed that the discretionary powers conferred will be "p= roperly and lawfully" exercised. =20 Cf. President of the Republic of South African and Others v South African= Rugby Football Union and Others 2000 (1) SA 1 (CC) at 83 C para 186 The Requirements of Section 39(2) of the Constitution 3.10 In their heads of argument the applicants place considerable relianc= e upon section 39(1) of the Constitution. See: PMA Heads of Argument: pp 61 - 62 para 9 3.11 The applicants pay little, if any, attention to section 39(2) which = provides: "39 (2) When interpreting any legislation, and when developing the common= law or customary law, every court, tribunal or forum must promote the sp= irit, purport and objects of the Bill of Rights." 3.12 The injunction contained in section 39(2) of the Constitution is par= ticularly important. The Constitutional Court has recently underscored= this importance in the following way: "[21] ... This means that all statutes must be interpreted through the pr= ism of the Bill of Rights. All law-making authority must be exercised = in accordance with the Constitution. The Constitution is located in a = history which involves a transition from a society based on division, inj= ustice and exclusion from the democratic process to one which respects th= e dignity of all citizens, and includes all in the process of governance.= As such, the process of interpreting the Constitution must recognise t= he context in which we find ourselves and the Constitution's goal of a so= ciety based on democratic values, social justice and fundamental human ri= ghts. This spirit of transition and transformation characterises the c= onstitutional enterprise as a whole. [22] The purport and objects of the Constitution find expression in secti= on 1 which lays out the fundamental values which the Constitution is desi= gned to achieve. The Constitution requires that judicial officers read= legislation, where possible, in ways which give effect to its fundamenta= l values. Consistently with this, when the constitutionality of legisl= ation is in issue, they are under a duty to examine the objects and purpo= rt of an Act and to read the provisions of the legislation, so far as is = possible, in conformity with the Constitution." (emphasis added) The Investigating Directorate: Serious Economic Offences and Others v Hyu= ndai Motor Distributors (Pty) Ltd and Others=20 2001 (1) SA 545 (CC) 3.13 In practice, this means that the provisions of the Act presently und= er attack must be interpreted in the manner which promotes the spirit, pu= rport and objects of the Bill of Rights. In this regard, the applicant= s focus only on those aspects of the Bill of Rights which, they contend, = are violated by the provisions in question. At issue, for present purp= oses, are not simply rights to property, equality and the regulation of a= trade, occupation or profession, all of which have internal limitations.= Also to be considered are the rights to life, dignity and access to h= ealth care services. =20 The Right to Life 3.14 Section 11 of the Constitution provides: "11 Life Everyone has the right to life." 3.15 In S v Makwanyane and Ano 1995 (3) SA 391 (CC) Chaskalson P observed= at para 83: "An individual's right to life has been described as 'the most fundamenta= l of all human rights' ..... ". He observed further at para 144: "The rights to life and dignity are the most important of all human right= s, and the source of all other personal rights in Chap 3. By committin= g ourselves to a society founded on the recognition of human rights we ar= e required to value these two rights above all others. And this must be= demonstrated by the State in everything that it does, including the way = it punishes criminals." (emphasis added) In similar vein, Langa J observed at para 222: "Implicit in the provisions and tone of the Constitution are values of a = more mature society, which relies on moral persuasion rather than force; = on example rather than coercion. In this context, then, the role of the= State becomes clear. For good or for worse, the State is a role model= for our society. A culture of respect for human life and dignity base= d on the values reflected in the Constitution, has to be engendered and t= he State must take the lead. (emphasis added) O'Regan J observed at paras 326 - 327: "The right to life is, in one sense, antecedent to all the other rights i= n the Constitution. Without life, in the sense of existence, it would = not be possible to exercise rights or to be the bearer of them. But th= e right to life was included in the Constitution not simply to enshrine t= he right to existence. It is not life as mere organic matter that the = Constitution cherishes, but the right to human life: The right to live as= a human being, to be part of a broader community, to share in the experi= ence of humanity. The concept of human life is at the centre of our co= nstitutional values. The Constitution seeks to establish a society whe= re the individual value of each member of the community is recognised and= treasured. The right to life is central to such a society. The right to life, thus understood, incorporates the right to dignity. = So the rights to human dignity and life are entwined. The right to li= fe is more than existence - it is a right to be treated as a human being= with dignity: Without dignity, human life is substantially diminished. = Without life, there cannot be dignity." 3.16 These observations were made in the context of the constitutionality= of the death penalty. Nevertheless, they seek to underscore two import= ant propositions: 3.16.1 First, the centrality of the right to life in the constitutional s= cheme; and 3.16.2 Second, the duty resting upon the State to protect the right to li= fe. 3.17 The Constitutional Court has not dealt with the wider reaches of the= right to life. It has nevertheless alluded to the fact that the Indian= Supreme Court, "basing itself on the right to life ... has made orders r= equiring the State to provide medical treatment to those needing it, to p= rovide legal aid to those who cannot afford it themselves, and to provide= access between isolated areas and more developed areas." Soobramoney v Minister of Health, KwaZulu-Natal =09 1998 (1) SA 765 (CC) at para 15, fn 4 The Right to Dignity 3.18 Section 10 of the Constitution provides: 3.18=20 "10 Human Dignity Everyone has inherent dignity and the right to have their dignity respect= ed and protected." 3.19 Justice Chaskalson in the Third Bram Fischer Lecture "Human Dignity = as a Foundational Value of our Constitutional Order" (2000) 16 South Afri= can Journal on Human Rights 193 observed at 201 - 202: "Respect for human dignity is crucial to accommodate conflicting interest= s; so to is respect for the other foundational values - democracy, equali= ty and freedom. There are, however, potential tensions between these val= ues which courts have to resolve. This is not a problem peculiar to So= uth Africa. It is a problem of constitutionalism and is experienced wh= erever constitutional government is in force. Lord Steyn refers to thi= s in a discussion of the constitutionalisation of public law. He illus= trates the problem by quoting Isaiah Berlin, who says: 'Both liberty and equality are among the primary goals pursued by human b= eings through many centuries; but total liberty for wolves is death to th= e lambs, total liberty of the powerful, the gifted, is not compatible wit= h the right to a decent existence of the weak and the less gifted. .... E= quality may demand the restraint of the liberty of those who wish to domi= nate; liberty - without some modicum of which there is no choice and ther= efore no possibility of remaining human as we understand the word - may h= ave to be curtailed in order to make room for social welfare, to feed the= hungry, to clothe the naked, to shelter the homeless, to leave room for = the liberty of others, to allow justice or fairness to be exercised.' = The result, according to Lord Steyn, is that: 'Courts will sometimes have to balance the protection of the fundamental = rights of individuals against the general interests of the community. I= ndividualised justice and the stability needed in any democratic society = may be in contention. .... Often courts will have to choose between com= peting values and make sophisticated judgments as to their relative weigh= t.' The balancing may be required in the application of the provisions of the= Constitution to concrete cases. An example is a case where a statute l= imits a constitutional right and the Government seeks to justify the limi= tation as being reasonable and justifiable in an open and democratic soci= ety. To decide the case the Court has to undertake a proportionality a= nalysis calling for a balancing of the conflicting rights and interests i= nvolved. But balancing can also take place at an anterior level by inter= preting rights and values in ways that avoid conflict." (emphasis added,= footnotes omitted) 3.20 This article was referred to by the Constitutional Court in Dawood a= nd Ano v Minister of Home Affairs and Others 2000 (3) SA 936 (CC) at para= 35, footnote 49. See also: Holomisa v Argus Newpapers Ltd 1996 (2) SA 588 (W) at 606 E and 607 I - 608 A Concorde Plastics (Pty) Ltd v NUMSA and Others 1997 (11) BCLR 1624 (LAC) at 1645 I - 1646 A Dagenais v Canadian Broadcasting Corporation 25 CRR (2d) 1 (SCC) at 32 - 34 3.21 In the article referred to above, Justice Chaskalson states the foll= owing: "There is also a close link between dignity and equality. No society can= promise equality of goods or wealth. Nor could it reasonably be though= t that this is what our Constitution contemplates. It recognises that = at the level of basic needs, such as housing, health care, food, water an= d society security, profound inadequacies require State intervention and = that the State is obliged to 'take reasonable legislation and other measu= res, within its available resources, to achieve the progressive realisati= on' of access to such goods." - at 202 He goes on to state: "Ours is an unequal society and the Constitution recognises that positive= action is necessary to establish conditions in which there is not only e= quality of rights but also equality of dignity. To this end the Constit= ution provides that the State must take action to achieve the progressive= realisation of socio-economic rights to housing, health care, food, wate= r and social security." - at 203 He states further: "As an abstract value, common to the core values of our Constitution, dig= nity informs the content of all the concrete rights and plays a role in t= he balancing process necessary to bring different rights and values into = harmony. It too, however, must find its place in the constitutional ord= er. Nowhere is this more apparent than in the application of the socia= l and economic rights entrenched in the Constitution. These rights are= rooted in respect for human dignity, for how can there be dignity in a l= ife lived without access to housing, health care, food, water or in the c= ase of persons unable to support themselves, without appropriate assistan= ce? But social and economic policies are pre-eminently policy matters = that are the concern of Government. In formulating such policies the G= overnment has to consider not only the rights of individuals to live with= dignity, but also the general interests of the community concerning the = application of resources. Individualised justice may have to give way = here to the general interests of the community." - at 204 (emphasis = added) 3.22 As indicated above, this article was cited by the Constitutional Cou= rt in Dawood and Ano v Minister of Home Affairs and Others 2000 (3) SA 93= 6 (CC). In that case, a unanimous Constitutional Court said the follow= ing concerning the right to dignity at para 35: "The value of dignity in our constitutional framework cannot therefore be= doubted. The Constitution asserts dignity to contradict our past in = which human dignity for black South Africans was routinely and cruelly de= nied. It asserts it too to inform the future, to invest in our democracy = respect for the intrinsic worth of all human beings. Human dignity ther= efore informs constitutional adjudication and interpretation at a range o= f levels. It is a value that informs the interpretation of many, possib= ly all, other rights. This Court has already acknowledged the importan= ce of the constitutional value of dignity in interpreting rights such as = the right to equality, the right not to be punished in a cruel inhuman or= degrading way, and the right to life. Human dignity is also a constitut= ional value that is of central significance in the limitations analysis. = Section 10, however, makes it plain that dignity is not only a value fu= ndamental to our Constitution, it is a justiciable and enforceable right = that must be respected and protected." (emphasis in the original) 3.23 It is submitted that the applicants are oblivious to the proper plac= e of dignity in the constitutional scheme. Indeed, the suggestion by D= eeb that somehow significance should be placed, for constitutional purpos= es, (as opposed to moral or ethical obligations) on the donations made by= various members of the PMA, misconceives the right to dignity. It dem= eans those who are poor and unable to afford medicines and relegates them= to the role of supplicants dependent upon the largesse of the wealthy an= d the powerful. The State cannot discharge its constitutional obligati= ons by relying on the charity of others. 3.24 The fact that donations have been made or significant price reductio= ns offered to the State would have potential relevance to the exercise of= the Minister's discretion in terms of section 15C. Clearly such donati= ons or reductions would be factors that the Minister would be obliged to = take into account. In this regard, two contentions are advanced: 3.24.1 First, the applicants misconceive the nature of discretionary powe= rs. They refer repeatedly to the Minister having an "unfettered discret= ion". See, for example, PMA's Heads of Argument p 40 para 5.2.2; p 44 = para 5.3.3 and p 52 para 5.4.2. At common law, all discretionary power= s are subject to legal limits. An "unfettered discretion" is a contradi= ction in terms. Ismail and Ano v Durban City Council 1973 (2) SA 362 (N) at 371 H - 372 B 3.24.2 Second, all discretionary powers must be exercised in accordance w= ith the Constitution. Metcash Trading Ltd v Commissioner for the South African Revenue Service = & Ano 2001 (1) BCLR 1 (CC) at paras 40 - 42 Access to Health Care Services 3.25 Section 27 of the Constitution provides: "27 Health Care, Food, Water and Social Security (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, including, if they are unable to support themselves = and their dependants, appropriate social assistance. (2) The State must take reasonable legislative and other measures within = its available resources, to achieve the progressive realisation of each o= f these rights. (3) No one may be refused emergency medical treatment." 3.26 Also of relevance is section 28(1)(c) of the Constitution which prov= ides: "28 Children (1) Every child has the right - (a) ... (b) ... (c) to basic nutrition, shelter, basic health care services and social se= rvices ...." 3.27 The introduction of the interim Constitution and the final Constitut= ion marked a decisive break with the past. The Constitution is not neu= tral on certain fundamental values. The Constitution contains a vision= for the transformation of society in which the State has positive obliga= tions. This has been reflected in several decisions of the Constituti= onal Court: 3.27.1 In S v Makwanyane 1995 (3) SA 391 (CC) Mahomed J observed at para = 262: "In some countries the Constitution only formalises, in a legal instrumen= t, a historical consensus of values and aspirations involved incrementall= y from a stable and unbroken past to accommodate the needs of the future= =2E The South African Constitution is different: It retains from the p= ast only what is defensible and represents a decisive break from, and a r= inging rejection of, that part of the past which is disgracefully racist,= authoritarian, insular and repressive, and a vigorous identification of = and commitment to a democratic, universalistic, caring and aspirationally= egalatarian ethos expressly articulated in the Constitution. The cont= rast between the past which it repudiates and the future to which it seek= s to commit the nation is stark and dramatic." 3.27.2 In Soobramoney v Minister of Health, KwaZulu-Natal 1998 (1) SA 765= (CC) Chaskalson P stated at para 8: "We live in a society in which there are great disparities in wealth. M= illions of people are living in deplorable conditions and in great povert= y. There is a high level of unemployment, inadequate social security, a= nd many do not have access to clean water or to adequate health services.= These conditions already existed when the Constitution was adopted an= d a commitment to address them, and to transform our society into one in = which there will be human dignity, freedom and equality, lies at the hear= t of our new constitutional order. For as long as these conditions conti= nue to exist that aspiration will have a hollow ring." 3.28 The most significant decision on the ambit and justiciability of soc= io-economic rights is Government of the Republic of South Africa and Othe= rs v Grootboom and Others 2001 (1) SA 46 (CC). That case concerned, int= er alia, section 26 of the Constitution which guarantees the right of "ac= cess to adequate housing". Section 26(2) is couched in almost identica= l terms to section 27(2) and imposes an obligation on the State to take r= easonable legislative measures, within its available resources, to achiev= e the progressive realisation of this right. Hence, the judgment is clo= sely analogous to the present case inasmuch as the legislation presently = under consideration is, in the TAC's submission, a consequence of the Sta= te's duties, inter alia, pursuant to section 27(2) of the Constitution. 3.29 Dealing generally with the place of socio-economic rights in our Con= stitution, Yacoob J, on behalf of a unanimous Court, observed at paras 23= - 24: "[23] Our Constitution entrenches both civil and political rights and soc= ial and economic rights. All the rights in our Bill of Rights are inter-= related and mutually supporting. There can be no doubt that human dign= ity, freedom and equality, the foundational values of our society, are de= nied those who have no food, clothing or shelter. Affording socio-econ= omic right to all people therefore enables them to enjoy the other rights= enshrined in Chapter 2. The realisation of these rights is also key to= the advancement of race and gender equality and the evolution of a socie= ty in which men and women are equally able to achieve their full potentia= l. [24] The right of access to adequate housing cannot be seen in isolation.= There is a close relationship between it and the other socio-economic= rights. Socio-economic rights must all be read together in the setting = of the Constitution as a whole. The State is obliged to take positive = action to meet the needs of those living in extreme conditions of poverty= , homelessness or intolerable housing. Their interconnectedness needs to= be taken into account in interpreting the socio-economic rights, and, in= particular, in determining whether the State has met its obligations in = terms of them." (emphasis added) The State's Positive Obligations 3.30 It is clear from the various constitutional provisions referred to a= bove, that the State is under a positive duty to adopt certain measures. = It is constitutionally required, for example, to take reasonable legislat= ive and other measures within its available resources to achieve the prog= ressive realisation of the right of access to health care services. The = Constitutional Court, however, has interpreted the State's obligations mo= re widely as appears from the extracts referred to above. 3.31 Section 7(3) of the Constitution places a duty on the State to "resp= ect, protect, promote and fulfil the rights in the Bill of Rights." If t= he State were to stand by when efficacious drugs for the treatment of HIV= /AIDS and associated infections are placed beyond the reach of most peopl= e in this country, it would ignore a profound threat to the fundamental r= ights of millions of South Africans to human dignity (s 10), health care = (s 27), basic health care services for children (s 28(1)(c)) and to life = itself (s 11). There is accordingly a pressing constitutional obligation= on the State to take all measures at its disposal to reduce the price of= these drugs.=20 3.32 It is in the context of these overarching constitutional obligations= that the constitutional claims of the applicants in relation to sections= 15C, 22F and 22G must be approached.=20 The State's Obligations under International Law 3.33 The applicants correctly refer to section 39(1) of the Constitution = which enjoins a court, when interpreting the Bill of Rights, to consider = international law. What is conspicuously absent from the applicants' h= eads of argument, however, is a conspectus of all the relevant treaties w= hich have a bearing upon the subject matter of the present case. Instead= , there is a singular focus on TRIPS. It is submitted that this focus = is far too narrow and avoids the many other relevant treaties referred to= below. The Universal Declaration of Human Rights 3.34 Article 25 of the Universal Declaration of Human Rights, 1948 provid= es: "Article 25 1 Everyone has the right to a standard of living adequate for the health = and well-being of himself and of his family, including food, clothing, ho= using and medical care and necessary social services, and the right to se= curity in the event of unemployment, sickness, disability, widowhood, old= age or other lack of livelihood in circumstances beyond his control. 2 Motherhood and childhood are entitled to special care and assistance. = All children, whether born in or out of wedlock, shall enjoy the same s= ocial protection." Article 22 provides: "Article 22 Everyone, as a member of society, has the right to social security and is= entitled to realisation, through national effort and international coope= ration and in accordance with the organisation and resources of each Stat= e, of the economic, social and cultural rights indispensable for his dign= ity and the free development of his personality." The International Covenant on Economic, Social and Cultural Rights, 1966 3.35 Article 12 of the International Covenant on Economic, Social and Cul= tural Rights, 1966 provides: "Article 12 1 The States' Parties to the present Covenant recognise the right of ever= yone to the enjoyment of the highest attainable standard of physical and = mental health. 2 The steps to be taken by the States' Parties to the present Covenant to= achieve the full realisation of this right shall include those necessary= for: (a) the provision for the reduction of the stillbirth-rate and of infant = mortality and for the healthy development of the child; (b) the improvement of all aspects of environmental and industrial hygien= e; (c) the prevention, treatment and control of epidemic, endemic, occupatio= nal and other diseases; (d) the creation of conditions which would assure to all medical service = and medical attention in the event of sickness." The Convention on the Rights of the Child, 1989 3.36 Article 24 of the Convention on the Rights of the Child, 1989 provid= es: 3.36=20 "Article 24 1 States' Parties recognise the right of the child to the enjoyment of th= e highest attainable standard of health and to facilities for the treatme= nt of illness and rehabilitation of health. States' Parties shall stri= ve to ensure that no child is deprived of his or her right of access to such health care services. 2 States' Parties shall pursue full implementation of this right and, in = particular, shall take appropriate measures: (a) to diminish infant and child mortality; (b) to ensure the provision of necessary medical assistance and health ca= re to all children with emphasis on the development of primary health car= e; (c) to combat disease and mal-nutrition, including within the framework o= f primary health care, through, inter alia, the application of readily av= ailable technology and through the provision of adequate nutritious foods= and clean drinking-water, taking into consideration the dangers and risk= s of environmental pollution;=20 (d) to ensure appropriate pre-natal and post-natal health care for mother= s; (e) to ensure that all segments of society, in particular parents and chi= ldren, are informed, have access to education and are supported in the us= e of basic knowledge of child health and nutrition, the advantages of bre= ast-feeding, hygiene and environmental sanitation and the prevention of a= ccidents; (f) to develop preventive health care, guidance for parents and family pl= anning education and services. 3 States' Parties shall take all effective and appropriate measures with = a view to abolishing traditional practices prejudicial to the health of c= hildren. 4 States' Parties undertake to promote and encourage international cooper= ation with a view to achieving progressively the full realisation of the = right recognised in the present Article. In this regard, particular acc= ount shall be taken of the needs of developing countries." Convention on the Elimination of All Forms of Discrimination Against Wome= n, 1979 3.37 Article 12 of the Convention on the Elimination of All Forms of Disc= rimination Against Women, 1979 provides: "Article 12 1 States' Parties shall take all appropriate measures to eliminate discri= mination against women in the field of health care in order to ensure, on= a basis of equality of men and women, access to health care services, in= cluding those related to family planning. 2 Notwithstanding the provisions of paragraph 1 of this Article, States' = Parties shall ensure to women appropriate services in connection with pre= gnancy, confinement and the post-natal period, granting free services whe= re necessary, as well as nutrition during pregnancy and lactation." 3.38 In Government of the Republic of South Africa and Others v Grootboom= and Others 2000 (11) BCLR 1169 (CC), the Constitutional Court gave speci= fic consideration to the obligations resting upon the State under interna= tional law. Consideration was given to the obligations under the Inte= rnational Covenant on Economic, Social and Cultural Rights. Reference = was made, in that regard, to the United Nations Committee on Economic, So= cial and Cultural Rights. The Court referred to a report by this Commi= ttee in which the following was stated: "On the basis of the extensive experience gained by the Committee, as wel= l as by the body that preceded it, over a period of more than a decade of= examining States' Parties' reports the Committee is of the view that the= minimum core obligation to ensure the satisfaction of, at the very least= , minimum essential levels of each of the rights is encumbent upon every = State Party. Thus, for example, a State Party in which any significant= number of individuals is deprived of essential foodstuffs, of essential = primary health care, of basic shelter and housing, or of the most basic f= orms of education, is prima facie, failing to discharge its obligations u= nder the Covenant. If the Covenant were to be read in such a way as no= t to establish such a minimum core obligation, it would be largely depriv= ed of its raison d'etre. By the same token, it must be noted that any= assessment as to whether a State has discharged its minimum core obligat= ion must also take account of resource constraints applying within the co= untry concerned. Article 2(1) obligates each State Party to take the = necessary steps 'to the maximum of its available resources'. In order = for a State Party to be able to attribute its failure to meet at least it= s minimum core obligations to a lack of available resources it must demon= strate that every effort has been made to use all resources that are at i= ts disposition in an effort to satisfy, as a matter of priority, those mi= nimum obligations." Commenting on these observations, Yacoob J observed at para 30: "Accordingly, a State in which a significant number of individuals is dep= rived of basic shelter and housing is regard as prima facie in breach of = its obligations under the Covenant. A State Party must demonstrate tha= t every effort has been made to use all the resources at its disposal to = satisfy the minimum core of the right. However, it is to be noted that= the general comment does not specify precisely what the minimum core is.= " 3.39 In the context of a case such as the present, it is quite clear that= having regard to the nature and scale of the HIV/AIDS epidemic there is = a compelling case to be made that the State is under a duty both under th= e Constitution and at international law to ensure adequate access to heal= th care. That is precisely the objective sort to be achieved by the p= rovisions presently under consideration. 4 IRRATIONALITY AND ARBITRARINESS 4.1 At the core of the applicants' attacks is the necessity for demonstra= ting that the provisions in question are arbitrary or irrational. This = is central to the attacks based upon the rule of law, property, equality = and the regulation of a trade, occupation or profession. 4.2 The Constitutional Court has adopted the concept of "rationality revi= ew" in a variety of contexts. In so doing, it has expressly been influ= enced by the American jurisprudence in this field. This will be discus= sed in more detail below. The concept of "rationality review" has been= adopted by the Constitutional Court in the following contexts: 4.2.1 The rule of law. Pharmaceutical Manufacturers Association of South Africa and Ano: In re: = Ex Parte President of the Republic of South Africa and Others 2000 (2) SA 674 (CC) at paras 83-85 New National Party of South Africa v Government of the Republic of South = Africa and Others 1999 (3) SA 173 (CC) at para 24 Fedsure Life Assurance Ltd and Others v Greater Johannesburg Transitional= Metropolitan Council and Others 1999 (1) SA 374 (CC) at paras 56-57 4.2.2 Equality and discrimination. Prinsloo v Van der Linde and Ano 1997 (3) SA 1012 (CC) at para 25 Pretoria City Council v Walker 1998 (2) SA 363 (CC) at para 27 4.2.3 The regulation of economic activity. S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) at paras 42-44 4.3 With some minor exceptions, all of the applicants' challenges to sect= ions 15C, 27F and 27G of the Act with which the TAC engages resolve into = disputes over whether the provisions in question are rationally related t= o a legitimate government purpose. This is the test on which the applica= nts' case depends in so far as it relates to the fundamental rights to pr= operty (s 25(1)), equality (s 9(1)) and free choice of profession (s 22).= It is also the test which governs the applicants' case in respect of th= e founding value of the rule of law (s 1(c)) in so far as that case is ba= sed on the contention that sections 15C, 22F and 22G of the Act are arbit= rary. (There is a separate rule of law challenge to the relevant provisi= ons based on the "void for vagueness" doctrine, but that is not a challen= ge which concerns the TAC). 4.4 It is therefore crucial, at the outset, to clarify the scope of a cou= rt's rationality review jurisdiction. It is an extraordinarily narrow sc= ope, a fact which is reflected in the following: 4.4.1 In the seven years since the adoption of the interim Constitution t= here has not been a single case in which a law has been struck down by th= e Constitutional Court on the grounds that it fails to meet the standard = of rationality review. 4.4.2 Over this period there is only one case in which an executive or ad= ministrative act has been struck down by the Constitutional Court for fai= ling to meet the standard of rationality review: the first applicant's ca= se to set aside a presidential proclamation bringing into force the South= African Medicines and Medical Devices Regulatory Authority Act 132 of 19= 98. Pharmaceutical Manufacturers Association of SA and Another: in Re Ex Part= e President of the Republic of South Africa and Others 2000 (2) SA 674 (C= C) 4.4.3 Moreover, in the Pharmaceutical Manufacturers case it was common ca= use that the decision to bring the Act into force was irrational because = the schedules upon which the Act depended for its efficacy had not yet be= en promulgated. The president in fact approached the court together with= the first applicant to ask for his decision to be set aside and to expla= in that he had taken this decision on the basis of the mistaken belief th= at the relevant schedules were already in force. 4.5 The narrow scope of rationality review has been emphasized repeatedly= by the Constitutional Court. It has stated that 4.5.1 rationality review is a "deferential" standard of review; New National Party of South Africa v Government of the Republic of South = Africa and Others 1999 (3) SA 191 (CC) at para 122 (per O'Regan J dissent= ing, but not on this point) 4.5.2 a finding of irrationality is likely to be made only rarely; Pharmaceutical Manufacturers Association of SA and Another: in Re Ex Part= e President of the Republic of South Africa and Others 2000 (2) SA 674 (C= C) at para 90 4.5.3 a Court cannot in the name of rationality review strike down a deci= sion or law simply because it disagrees with it or considers that is inap= propriate or unreasonable; Pharmaceutical Manufacturers Association of SA and Another: in Re Ex Part= e President of the Republic of South Africa and Others 2000 (2) SA 674 (C= C) at para 90 New National Party of South Africa v Government of the Republic of South = Africa and Others 1999 (3) SA 191 (CC) at para 24 4.5.4 rationality review does not entitle a court to make policy choices,= because these must be left to the legislature; and Jooste v Score Supermarket Trading (Pty) Ltd (Minister of Labour Interven= ing) 1999 (2) SA 1 (CC) at para 17 S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) at paras 41-46= 4.5.5 rationality review does not entitle a court to strike down a statut= e because it believes that the legislature could have achieved its desire= d ends through better means or means that are less invasive of private ri= ghts. Prinsloo v van der Linde and Another 1997 (3) SA 1012 (CC) at para 36=20 East Zulu Motors (Pty) Ltd v Empangeni / Ngwelezane Transitional Local Co= uncil and Others 1998 (2) SA 61 (CC) at paras 24 and 30 S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) at paras 41-46= 4.6 All that rationality requires is that the legislation has a purpose t= hat is not unconstitutional and that it is rational to believe that the l= egislation will advance this purpose. The fact that the legislation migh= t, in the process of advancing its purpose, infringe private rights is no= t relevant in the rationality review enquiry. The existence of less inva= sive (or more reasonable) means to achieve the governmental purpose is, a= t constitutional law, a question of proportionality and not a question of= rationality. Prinsloo v van der Linde 1997 (3) SA 1012 (CC) at para 36 East Zulu Motors (Pty) Ltd v Empangeni / Ngwelezane Transitional Local Co= uncil and Others 1998 (2) SA 61 (CC) at paras 24 and 30 S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) at paras 41-46= New National Party of South Africa v Government of the Republic of South = Africa and Others 1999 (3) SA 191 (CC) at para 24 4.7 Thus the applicants are incorrect to suggest that issues such as "ove= rbreadth" (PMA's Heads of Argument p 200, para 20.1.2.1) and "overshootin= g the mark" (PMA's Heads of Argument p 266 para 21.4.2.2) are relevant to= the rationality enquiry. If Parliament uses a legislative sledgehammer = to kill a gnat, provided that killing the gnat is a legitimate government= al object, the law that Parliament enacts does not fail rationality revie= w. A law which is overbroad or which overshoots the mark may be dispropor= tional and may therefore fail the balancing test of the limitations claus= e enquiry but provided that, within its excessive ambit, part of what it= does is to promote a legitimate governmental purpose, the law is not ope= n to challenge at the level of rationality review. 4.8 This distinction demonstrates a weakness that lies at the heart of mu= ch of the applicants' case. For the most part the applicants depend on f= undamental rights which are afforded the weakest level of protection in t= he bill of rights. Sections 9(1), 22 and 25(1) are enforceable only by r= ationality review and therefore offer the applicants no more protection t= han the general rationality review they can invoke under section 1(c). I= n order to reach questions of proportionality, overbreadth and overshooti= ng the mark, the applicants have to reach the limitations clause, section= 36, and its requirement that limitations of fundamental rights be reason= able. However, if the applicant is unable to show that sections 15C, 22F= and 22G fail the low test of rationality review, the provisions in quest= ion cannot be said to limit any of the fundamental rights protected by se= ctions 9(1), 22 and 25(1) and questions of proportionality, overbreadth a= nd overshooting the mark simply do not arise. 4.9 In S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) Chaskal= son P specifically endorsed an approach consonant with the American juris= prudence on rationality review. The Court was there concerned with sec= tion 26 of the interim Constitution which guaranteed the right freely to = engage in economic activity but did not preclude "measures designed to pr= omote the protection or the improvement of the quality of life, economic = growth, human development, social justice, basic conditions of employment= , fair labour practices or equal opportunity for all, provided such measu= res are justifiable in an open and democratic society based on freedom an= d equality." The Court was invited to adopt a test for the legislative= purpose based upon an objective probability that the purpose would be ac= hieved. This was expressly rejected. Chaskalson P observed at paras= 42 - 44: "[42] In the passage relied upon by the appellants Professor Mureinik arg= ued for a more stringent test of legislative purpose - that there be an '= objective probability' that the purpose will be achieved. He was not, = however, dealing there with 'economic freedom'. To apply that test to = economic regulation would require a court to sit in judgment on legislati= ve policies on economic issues. Courts are ill-equipped to do this and in= a democratic society it is not their task to do so. In discussing legis= lative purpose Professor Hogg says: 'While a court must reach a definite conclusion on the adjudicative facts= which are relevant to the disposition of litigation, the court need not = be so definite in respect of legislative facts in constitutional cases. = The most that the court can ask in respect of legislative facts is whethe= r there is a rational basis for the legislative judgment that the facts e= xist. The rational-basis test involves restraint on the part of the court in fi= nding legislative facts. Restraint is often compelled by the nature of= the issue: For example, an issue of economics which is disputed by profe= ssional economists can hardly be definitively resolved by a court staffed= by lawyers. The most that can realistically be expected of a court is = a finding that there is, or is not, a rational basis for a particular pos= ition on the disputed issue. The more important reason for restraint, however, is related to the respe= ctive roles of court and legislature. A legislature acts not merely on = the basis of findings of fact, but upon its judgment as to the public per= ceptions of a situation and its judgments as to the appropriate policy to= meet the situation. These judgments are political, and they often do = not coincide with the views of social scientists or other experts. It i= s not for the court to disturb political judgments, much less to substitu= te the opinions of experts. In a democracy it would be a serious disto= rtion of the political process if appointed officials (the judges) could = veto the policies of elected officials.' [43] This accords with the approach of the United States Supreme Court t= o rational basis review. It has consistently held: 'This restriction upon the judicial function, in passing on the constitut= ionality of statutes, is not artificial or irrational. The State legisl= ature, in the enactment of laws, has the widest possible latitude within = the limits of the Constitution. In the nature of the case it cannot re= cord a complete catalogue of the considerations which move its members to= enact laws. In the absence of such a record courts cannot assume that= its action is capricious, or that, with its informed acquaintance with l= ocal conditions to which the legislation is to be applied, it was not awa= re of facts which afford reasonable basis for its action. Only by fait= hful adherence to this guiding principle of judicial review of legislatio= n is it possible to preserve to the legislative branch its rightful indep= endence and its ability to function.' [44] Section 26 should not be construed as empowering a court to set asi= de legislation expressing social or economic policy as infringing 'econom= ic freedom' simply because it may consider the legislation to be ineffect= ive or is of the opinion that there are other and better ways of dealing = with the problem. If section 26(1) is given the broad meaning for whic= h the appellants contend, of encompassing all forms of economic activity = and all methods of pursuing a livelihood, then, if regard is had to the r= ole of the courts in a democratic society, section 26(2) should also be g= iven a broad meaning. To maintain the proper balance between the roles= of the legislature and the courts section 26(2) should be construed as r= equiring only that there be a rational connection between the legislation= and the legislative purpose sanctioned by the section." The passage cited from the United States Supreme Court is from the case o= f Carmichael, Attorney-General of Alabama v Southern Coal and Coke Co. (1= 937) 301 US 495 at 510; 81 L ed 1245 at 1253. The Court, in footnote 3= 8, also referred to Federal Communications Commission v Beach Communicati= ons Inc (1993) 508 US 307; 124 L ed (2d) 211 and Lehnhausen v Lake Shore = Auto Parts Co. (1973) 410 US 356; 35 L ed (2d) 351. The Court stated in paragraph 66, footnote 53 the following: "In the United States, the burden of negativing a rational connection bet= ween the legislation and legitimate government purpose is on the person c= hallenging the validity of the legislation. 'Those attacking the ratio= nality of the legislative classification have the burden to negative ever= y conceivable basis which might support it.' FCC v Beach Communication= s Inc .... at 315. Whilst a section 26 analysis may call for a differe= nt approach, a rational basis review is one in which the legislature will= be allowed considerable lee-way." Regardless of the test, the onus is on the applicants to demonstrate the = absence of rationality. Prinsloo v Van der Linde and Ano 1997 (3) SA 1012 (CC) at para 36 and para 17 4.10 In Jooste v Score Supermarket Trading (Pty) Ltd (Minister of Labour = Intervening) 1999 (2) SA 1 (CC) the Court, at para 17 stated: "It is clear that the only purpose of rationality review is an enquiry in= to whether the differentiation is arbitrary or irrational, or manifests n= aked preference and it is irrelevant to this enquiry whether the scheme c= hosen by the legislature could be improved in one respect or another." 4.11 The concept of the prohibition on "naked preferences" was first arti= culated by the Constitutional Court in Prinsloo v Van der Linde and Ano. = 1997 (3) SA 1012 (CC) in the context of equality. The Court stated at = para 25: "It is convenient, for descriptive purposes, to refer to the differentiat= ion presently under discussion as 'mere differentiation'. In regard to= mere differentiation the constitutional state is expected to act in a ra= tional manner. It should not regulate in an arbitrary manner or manifest = 'naked preferences' that serve no legitimate governmental purpose, for th= at would be inconsistent with the rule of law and the fundamental premise= s of the constitutional state. The purpose of this aspect of equality = is, therefore, to ensure that the State is bound to function in a rationa= l manner. This has been said to promote the need for governmental acti= on to relate to a defensible vision of the public good, as well as to enh= ance the coherence and integrity of legislation." 4.12 The concept of "naked preferences", as appears from footnote 28, is = taken from the article by Cass Sunstein "Naked Preferences and the Consti= tution" (1984) 84 Columbia Law Review 1689. A "naked preference" is th= e "raw exercise of political power". Sunstein puts the matter thus at 16= 93 - 4: "When a naked preference is at work, one group or person is treated diffe= rently from another solely because of a raw exercise of political power; = no broader or more general justification exists. For example, State A = may treat its own citizens better than those of State B - say, by requiri= ng people from State B to pay more for the use of the local parks - simpl= y because its own citizens have the political power and want better treat= ment. Or a city may treat blacks worse than whites - say, by denying t= hem welfare benefits - because whites have the power to restrict State la= rgesse to themselves. Or a State may relieve a group of citizens from = a contractual obligation, thus benefiting them at the expense of another = group of contracting parties, simply because the first group and its alli= es seized the political power to dispossess the second group of the right= s that it previously had." Sunstein describes this conception as a weak form of constraint upon the = exercise of governmental power. He states at 1696: "If courts are willing to hypothesise a public value as the basis for gov= ernment action and do not require a close fit between the public value an= d the measure under review, all or almost all government action will be u= pheld. By contrast, if courts require a good reason to be believe that = a naked preference was not in fact at work, many statutes may be invalida= ted. This consideration raises the question of how courts are to deter= mine whether a public value accounts for legislation. Under a lenient = test, any legislation for which such a value can be hypothesised is autom= atically valid. The fact that the statute satisfies the formal requir= ements for legislation, together with a not implausible connection betwee= n a public value and the statute under review, would suffice to validate = it. A stricter test might focus on both the legislative process and th= e outcome in order to ensure against the possibility that even a formerly= unobjectionable enactment was the result of a naked preference." At 1697 - 8 Sunstein states: "Modern rationality review is also characterised by extremely deferential= means-ends scrutiny. The Supreme Court demands only the weakest link = between a public value and the measure in question, and it is sometimes w= illing to hypothesise legitimate ends not realistically attributable to t= he enacting legislature. As a result, few statutes fail rationality re= view." Sunstein's observations are reflected in the case law. See for example: Munn v Illionois 94 US 77 Williamson v Lee Optical Co. 348 US 483 Ferguson v Shrupa 372 US 726; 10 L ed 2d Whalen v Roe 429 US 589; 51 L ed 2 d 64 Minnesota v Clover Leaf Creamery Co 449 US 456 See also: Nyambirai v National Social Security=20 Authority and Ano 1995 (9) BCLR 1221 (ZSC) Irwin Toy Ltd v Quebec (A.G.) 39 CRR 193 (SCC) R v Ministry of Agriculture, Fisheries and Food: Ex Parte Hamble (Offshor= e) Fisheries Ltd [1995] 2 All ER 714 (GB) cited with approval in Durban Add-Ventures Ltd v Premier, KwaZulu-Natal a= nd Others (No. 1) 2001 (1) SA 384 (N) Poswa v The Member of the Executive Council Responsible for Economic Affa= irs, Environment and Tourism (Supreme Court of Appeal, Case No. 175/99, 22 March 2001, unreported) The author is critical of the weak approach of the Supreme Court to ratio= nality review and says that this phenomenon raises the question whether t= he court's commitment to the prohibition of naked preferences is merely r= hetorical. What seems clear, however, is that the South African Consti= tutional Court, in referring to Sunstein's conception of "naked preferenc= es" and in relying upon the American jurisprudence, has opted for a weak = form of constraint. See also: Tribe American Constitutijonal Law (2nd ed) at 1451 at 1446 - 1= 450 4.13 Indeed, the Constitutional Court has drawn a clear distinction betwe= en rationality and reasonableness. In New National Party of South Afri= ca v Government of the Republic of South Africa and Others 1999 (3) SA 19= 1 (CC) Yacoob J, on behalf of the majority observed at para 24: "Courts do not review provisions of Acts of Parliament on the grounds tha= t they are unreasonable. They will do so only if they are satisfied th= at the legislation is not rationally connected to a legitimate government= purpose. In such circumstances, review is competent because the legisla= tion is arbitrary. Arbitrariness is inconsistent with the rule of law = which is a core value of the Constitution. It was within the power of Par= liament to determine what scheme should be adopted for the election. I= f the legislation defining the scheme is rational, the Act of Parliament = cannot be challenged on the grounds of 'unreasonableness'. Reasonablen= ess will only become relevant if it is established that the scheme, thoug= h rational, has the effect of infringing the right of citizens to vote. = The question would then arise whether the limitation is justifiable und= er the provisions of section 36 of the Constitution and it is only as par= t of this section 36 enquiry that reasonableness becomes relevant." See also: Prinsloo v Van der Linde and Ano 1997 (3) SA 1012 (CC) at para 35 4.14 Even in the context of an enquiry into reasonableness at the stage o= f limitation, requires a deferential approach to the policy choices of th= e legislature. This is made explicit by Chaskalson P in S v Makwanyane= 1995 (3) SA 391 (CC) at para 104 where he stated that in the balancing p= rocess required at the stage of limitation "regard must be had to the pro= visions of section 33(1) and the underlying values of the Constitution, b= earing in mind that, as a Canadian judge has said, 'the role of the court= is not to second-guess the wisdom of policy choices made by legislators.= '" =20 4.15 The mere fact that legislation is actuated by issues of socio-econom= ic policy does not mean that it is beyond judicial scrutiny. To hold ot= herwise would negate the very concept of judicial review. In the realm = of legislation such as the present, however, the courts both here and abr= oad, rightly adopt a cautious approach for three reasons: 4.15.1 First, courts are ill-equipped to make choices of socio-economic p= olicy. 4.15.2 Second, courts are anxious to ensure a proper separation of powers= and are reluctant to intrude into the executive or legislative realm. = This is particularly important in a constitutional setting such as ours = where judges are unelected yet have the power to strike down the enactmen= ts of a democratically elected legislature. 4.15.3 Third, courts are anxious to ensure that effective government is n= ot paralysed by permitting indiscriminate challenges to matters of socio-= economic policy. Absent strict constraints, virtually every legislativ= e choice would be subject to attack. 5 THE CONSTITUTIONAL PROVISIONS RELIED UPON BY THE APPLICANTS The Right to Property 5.1 The right to property is protected by section 25 of the Constitution = which states the following: "Property=20 25 (1) No one may be deprived of property except in terms of law of gener= al application, and no law may permit arbitrary deprivation of property. = (2) Property may be expropriated only in terms of law of general applicat= ion -=20 (a) for a public purpose or in the public interest; and=20 (b) subject to compensation, the amount of which and the time and manner = of payment of which have either been agreed to by those affected or decid= ed or approved by a court.=20 (3) The amount of the compensation and the time and manner of payment mus= t be just and equitable, reflecting an equitable balance between the publ= ic interest and the interests of those affected, having regard to all rel= evant circumstances, including -=20 (a) the current use of the property;=20 (b) the history of the acquisition and use of the property;=20 (c) the market value of the property;=20 (d) the extent of direct state investment and subsidy in the acquisition = and beneficial capital improvement of the property; and=20 (e) the purpose of the expropriation." 5.2 Section 25 draws a distinction between "deprivation of property" and = "expropriation of property". =20 5.2.1 The only constitutional protection against for deprivation of prote= ction is that such deprivation must be non-arbitrary and must take place = in terms of law of general application. 5.2.2 In cases of expropriation of property, section 25(2) imposes the ad= ditional requirements of a public purpose (or public interest) and paymen= t of just and equitable compensation. =20 5.3 In Harksen v Lane NO and others the Constitutional Court emphasised t= hat the constitutional protection given to property is premised on this "= distinction between expropriation (or compulsory acquisition as it is cal= led in some other foreign jurisdictions) which involves acquisition of ri= ghts in property by a public authority for a public purpose and the depri= vation of rights in property which fall short of compulsory acquisition"= =2E Harksen v Lane NO and Others=20 1998 (1) SA 300 (CC) at para 32 (emphasis added)=20 By casting the distinction between expropriation and deprivation in these= terms the Constitutional Court associated itself with a long line of Com= monwealth cases which have similarly held that interference with property= rights which does not result in a transfer of the property in question t= o the State is not compensable as of constitutional right. Government of Malaysia v Selangor Pilot Association 1978 AC 337 (PC) Vora, H D v State of Maharashtra 1984 AIR 866 (SC) Hewlett v Minister of Finance=20 1982(1) SA 502 (ZSC) Chairman of the Public Service Commission and others v Zimbabwe Teachers = Association and others 1997 (1) SA 209 (ZS) Davies and others v Minister of Lands, Agriculture and Water Development = 1997 (1) SA 228 (ZS) 5.4 The applicants contend that section 25 recognizes some doctrine of co= nstructive expropriation so that section 25(2) is implicated whenever a d= eprivation of property "goes too far" even if the deprivation does not re= sult in the acquisition of the property in question by the State. This c= ontention is unsustainable. It is based on the United States doctrine of= "inverse condemnation" which has not been adopted in any Commonwealth co= untry and which is inconsistent with the judgment of the Constitutional C= ourt in Harksen and all the Commonwealth authorities upon which the Const= itutional Court relied in Harksen. =20 5.5 The judgment of the Privy Council in Government of Malaysia v Selango= r Pilots, which is the leading case in the line of Commonwealth authoriti= es, illustrates that there is no scope for the doctrine of constructive e= xpropriations in our law. Selangor Pilots concerned a law which effectiv= ely precluded any private organisation from conducting the business of pr= oviding pilot services in Selangor. The applicant association had been c= onducting such a business and alleged that the law was unconstitutional i= nter alia for its failure to provide compensation for the goodwill of the= ir business which it had destroyed entirely. Viscount Dilhorne, speaking= for the majority of the Privy Council, dismissed their claim in the foll= owing terms: "It may be that the association by its enjoyment over a considerable peri= od of time of a monopoly in the provision of pilotage services had acquir= ed a goodwill, the value of which would be reflected on a sale by it of i= ts business and of which it was deprived by the amending Act. But, if tha= t were so, it does not follow that the goodwill was acquired by the port = authority from the association and in the opinion of the majority of thei= r Lordships it was not." Government of Malaysia v Selangor Pilot Association 1978 AC 337 (PC) at 348 See also Hewlett v Minister of Finance 1982(1) SA 502 (ZSC) 5.6 As is clear from the passage in Harksen quoted above, the Constitutio= nal Court has equated "expropriation" in section 25 with "compulsory acqu= isition" in the Commonwealth cases. There is, accordingly, no scope for = a doctrine of inverse condemnation as constructive expropriation in South= African Constitutional Law.=20 The Right to Equality 5.7 Section 9 of the Constitution protects the fundamental right to equal= ity. The applicants rely only on section 9(1) which states=20 "Everyone is equal before the law and has the right to equal protection a= nd benefit of the law. Equality includes the full and equal enjoyment of= all rights and freedoms." 5.8 The amicus accepts the correctness of the applicants' submission at p= 170 para 14.6.5 of their heads of argument that a law will fall foul of = section 9(1) if it differentiates in a manner which is not rationally rel= ated to any legitimate governmental purpose. The Right to Free Choice of Profession 5.9 Section 22 of the Constitution states the following: "Freedom of trade, occupation and profession=20 22 Every citizen has the right to choose their trade, occupation or profe= ssion freely. The practice of a trade, occupation or profession may be re= gulated by law."=20 5.10 Unlike most of the rights in the Bill of Rights, section 22 is veste= d not in "everyone" but in "every citizen." In City of Cape Town v Ad Ou= tpost (Pty) Ltd 2000 (2) BCLR 130 (C) Davis J commented on this distincti= on at 140F-G: "In my view section 22 introduces a constitutional protection to be enjoy= ed by individual citizens as opposed to juristic bodies. The right ensur= es that each citizen will have the right to choose how to employ his or h= er labour and skills without irrational government restriction. It is no= t a provision which should be extended to the regulation of economic inte= rcourse as undertaken by enterprises owned by juristic bodies which might= otherwise fall within the description of economic activity." In accordance with this reasoning, the right protected by section 22 is o= ne which vests only in natural persons who are South African citizens. I= t is not a right which vests in any of the applicants other than the 42nd= applicant. 5.11 Moreover, it is clear from the case law on section 22 and its predec= essor, section 26 of the interim Constitution, that the only constitution= al protection provided against legislation which restricts free choice of= trade, occupation or profession is a requirement that this legislation m= ust rationally pursue a legitimate government purpose. S v Lawrence; S v Negal; S v Solberg 1997 (4) SA 1176 (CC) City of Cape Town v Ad Outpost (Pty) Ltd 2000 (2) BCLR 130 (C) JR Investments CC and others v Minister of Safety and Security 1997 (7) B= CLR 925 (E) 6 SECTION 15C OF THE ACT 6.1 Section 15C(a) of the Act provides for the overriding of rights under= the Patent Act with respect to medicines that have been placed onto the = market by the owner of such medicines or with his or her consent. 6.1=20 6.2 Section 15C(b) of the Act vests in the minister the power to make reg= ulations governing the importation of medicines by a person other than th= e holder of the registration certificate of the medicine. 6.3 The applicants challenge the constitutionality of section 15C on vari= ous grounds. The amicus engages with the applicants only in respect of t= he challenges which are based on the fundamental right to property (s 25 = of the Constitution) and the non-arbitrariness requirement of the rule of= law (s 1(3) of the Constitution). Section 15C does not Expropriate Property 6.4 There is considerable debate between the applicants and the responden= ts on the full ambit of section 15C. For present purposes it is not nece= ssary for the amicus to enter that debate. Even assuming that section 15= C has the wide meaning contended by the applicants, the section does not = expropriate property. =20 6.5 Section 15C undoubtedly interferes with rights under the Patents Act = but it does not expropriate any property of the applicants because it mer= ely potentially renders the rights in question nugatory, it does not appr= opriate them for the State, or indeed for anybody else. All that=20 section 15C does is to permit certain competitors of a patentee to operat= e in ways that would ordinarily be considered to infringe the patentee's = rights. It does not vest the patentee's rights in the State or these com= petitors. The patentee retains his or her patent covering the patented m= edicine and neither the State nor the privileged competitors acquire a pa= tent for themselves over the medicine. The interference with the patente= e's rights therefore cannot amount to an expropriation of property which = is governed by section 25(2) of the Constitution. At best for the applic= ants it is a deprivation of property which is governed by section 25(1) o= f the Constitution. 6.6 As has been set out above, the only requirements imposed by section 2= 5(1) of the Constitution in respect of deprivation of property is that it= must be effected in terms of law of general application which is not arb= itrary. Section 15C of the Act is clearly a law of general application. = The section 25(1) case of the applicants must therefore stand or fall by= their contention that section 15C is arbitrary, in other words, that the= section will not pass rationality review. This is also the crucial test= for the purposes of the section 1(c) rule of law challenge to section 15= C with which the amicus engages. Section 15C is not Arbitrary 6.7 Section 15C clearly passes rationality review. The object pursued by= the government in respect of the section is to provide, inter alia, for = parallel importation of patented drugs so as to reduce the price of these= drugs. The constitutional obligation on the State to reduce drug prices= has been discussed above. The evidence shows that many drugs are sold in= South Africa at a far higher price than in other countries and that para= llel importation will serve to reduce drug prices. Ntsaluba p 1409-1411 para 49, pp 1423-1424 para 52(g) and pp 1449-1450 pa= ra 73(f) 6.8 The applicants do not dispute that section 15C will achieve its objec= t of facilitating the parallel importation of drugs. Their complaint is = that the measure is overbroad in that it will, in the process, interfere = with their intellectual property rights in respect of drugs and do so in = ways which are not necessary to promote parallel importation. =20 PMA's heads of argument p 209 para 20.1.3 - p 226 para 20.1.5.2.5=20 6.9 The amicus does not concede that section 15C, properly interpreted, i= nterferes with the intellectual property rights of the applicants in all = the ways they contend. However, even assuming for the purposes of argume= nt that the applicant's draconian interpretation of the section is correc= t, the applicant's case on the arbitrariness of the section must fail. O= nce it is clear that section 15C will, inter alia, provide for the parall= el importation of brand name drugs and thereby contribute to reducing pri= ces for these drugs, the section passes rationality review: it is ration= al to believe that, whatever else may or may not be unfortunate about the= provision, it will contribute to the achievement of the important govern= ment purpose of reducing drug prices through parallel importation. 6.10 The applicants' complaints about section 15C are complaints about ov= erbreadth. As has been shown above, these complaints have no place in a = rationality review enquiry, they can only be raised in a proportionality = enquiry under section 36 of the Constitution, the limitations clause. Bu= t the applicants never reach the limitations clause because they are unab= le to show that section 15C limits any fundamental right. 7 SECTION 22F OF THE ACT 7.1 Section 22F of the Act requires a pharmacist - 7.1.1 to inform members of the public holding a prescription for a brand = name medicine of the benefits of substituting a generic equivalent for th= at brand name medicine, and 7.1.2 if the generic equivalent is not more expensive than the brand name= medicine, to dispense it in place of the brand name medicine unless: 7.1.2.1 the patient expressly requires the pharmacist not to,=20 7.1.2.2 the prescribing doctor has inserted a written prohibition against= substitution on the prescription, or 7.1.2.3 the Medical Control Council has declared the medicine not to be s= ubstitutable.=20 7.2 The applicants challenge section 22F on various grounds. The amicus = engages only with the challenges which are based on the fundamental right= s to property (s 25 of the Constitution), equality (s 9(1) of the Constit= ution) and free choice of profession (s 22 of the Constitution) and the n= on-arbitrariness requirement of the rule of law (s 1(3) of the Constituti= on). Section 22F does not Expropriate Property =20 _ 7.3 It is doubtful that section 22F interferes with any property rights o= f the applicants. They contend that it violates their rights under secti= on 34 of the Trade Marks Act 194 of 1993 relating to the unauthorised use= of trade marks. The only case to which they refer in this regard is Abbo= tt Laboratories and Others V UAP Crop Care (Pty) Ltd and Others 1999 (3) = SA 624 (C), which concerned the wholly distinguishable situation of compa= rative advertising and does not support the applicants' contentions. =20 7.4 However, even assuming for the purposes of argument that section 22F = does cause an infringement of the applicants' trade mark rights, such an = infringement does not amount to a limitation of the applicants' rights un= der section 25 of the Constitution. Section 22F manifestly does not expr= opriate any property of the applicants. At best for the applicants, it r= enders certain of their trade mark rights nugatory. It does not appropri= ate them for the State, nor indeed for anybody else. All that section 22= F does is to permit certain competitors of the proprietor or holder of a = trade mark to be the trading beneficiaries of a prescription that identif= ies drugs by the trade mark. It does not vest the proprietor or holder's= trade mark rights in the State or in these competitors. The proprietor = or holder retains his or her trademark in respect of the drug and neither= the State nor the generic manufacturing competitors acquire that trade m= ark with its associated rights. =20 7.5 The only case open to the applicants is therefore to contend that thi= s alleged interference with trade mark rights amounts to a deprivation of= property which, in terms of section 25(1) of the Constitution, may not b= e arbitrary. Thus the applicant's case must stand or fall by their conte= ntion that section 22F is arbitrary, in other words, that the section wil= l not pass rationality review. This is also the crucial test for the purp= oses of the applicants equality and free choice of profession challenges = to section 22F and for the section 1(c) rule of law challenge to section = 22F with which the amicus engages. Section 22F is not Arbitrary=20 7.6 Section 22F is manifestly not arbitrary. The section assists to dis= charge the constitutional obligation resting on the State to promote chea= per access to drugs. It does so by requiring generic substitutes to be p= rescribed in place of brand name drugs which retail at a price which is n= ot cheaper than that of the generic substitutes. =20 7.6=20 Gray Amicus Reply: pp 4522-4527 paras 22-32.3 7.7 The general extent to which brand name drugs exceed the price of gene= ric substitutes is canvassed extensively on the papers. The relevant pas= sages are discussed in the respondents' heads of argument and will not be= repeated here. See Respondent's heads of argument p 143: para 208 - p 151 para 210 7.8 As has been pointed out above, in the specific context of HIV/AIDS me= dication, Dr Goemaere shows how the promotion of generic substitution in = Brazil has led to a 70% reduction in the price of the anti-retroviral dru= gs Goemaere Amicus Application p 3512 paras 28-29 and p 3513 para 32=20 7.9 Goemaere also describes an offer by Cipla Ltd, an Indian manufacturer= of generic anti-retrovirals to provide its drugs to Medicine Sans Fronti= ers at a price which is less than 10% of the wholesale price currently ch= arged for the same product in South Africa. Goemaere Amicus Application p 3513 para 34=20 Goemaere Amicus Reply: p 4859 paras 15 - 17 See also: Perez-Casas Amicus Reply: pp 4302-4303 paras 11.1 - 11.2 7.10 The generic substitutes ('interchangeable multi-source medicines') a= re defined in section 1 of the Act to mean - "medicines that contain the same active substances which are identical in= strength or concentration, dosage form and route of administration and m= eet the same or comparable standards, which comply with the requirements = for therapeutic equivalence as prescribed." 7.11 The effect of section 22F therefore is to ensure that where there ar= e available both a brand name drug and a generic substitute which is, in = the terms set out in the Act, identical to that drug, the cheaper of the = two identical drugs will be prescribed, unless the patient, his or her do= ctor, or the Medicines Control Council require otherwise. There is an ob= vious relationship between the Act and the laudable government purpose of= promoting cheaper access to drugs. Moreover, once it is conceded, as = it must be, that the section also has the effect of minimising perverse i= ncentives, a self-evident legitimate purpose, it is simply no answer to = say that the same result is achieved by other sections (ss 18A, B and C) = of the Act. Deeb Supplementary Answering Affidavit: p 3851 para 9.1.13 Geffen Amicus Application: p 3530 paras 7-8 Ntsaluba Replying Affidavit pp 4898-4899 paras 19.1-19.5 Van den Heever Amicus Reply: pp 4361-4363 paras 58-64 7.12 The applicants complain that generic substitutes are prescribed by t= he Act even where they retail at the same price as a brand name drug. Th= is is correct, but there is nothing per se offensive about such prescript= ion. It is open to the legislature to express this marginal preference f= or generic substitutes as a way of promoting the entry of generic substit= utes onto the market after a brand name has had a lengthy period of paten= t exclusivity in which to cultivate market links with pharmacists and pre= scribing doctors. The entry of generic substitutes has to be promoted in = terms of the scheme of the Act because, without the existence of competit= ion from generic substitutes there will be no incentive for drug companie= s to reduce the price of brand name drugs. =20 7.13 Section 22F also serves a range of other rational purposes: 7.13.1 The obligation upon the pharmacist to inform members of the public= of the benefits of the substitution for a branded medicine of an interch= angeable multi-source medicine serves the self-evident advantage of impar= ting information to a patient crucially relevant to the patient's physica= l and economic well being. In so doing, the section gives expression to= the constitutional rights of access to information and the right to rece= ive information. The obligation imposed upon the pharmacist assumes pa= rticular importance in an esoteric field in which the pharmacist has spec= ialised expertise and knowledge of which members of the public would gene= rally be ignorant. Ntsaluba Replying Affidavit: pp 4903-4 paras 29.1 - 29.3 Supplementary Answering Affidavit of Steele: pp 4255-6 paras 23.1 - 23.2 7.13.2 The further obligations imposed upon the pharmacist have the lauda= ble consequence of acting as a safeguard to ensure the clinical independe= nce of prescribing doctors and the reduction of the risk that pharmacists= and prescribing doctors may receive incentives to prescribe and dispense= particular medicines. The applicants do not dispute this. They mer= ely contend that this objective is achieved by other sections. This, h= owever, is no answer and cannot affect the validity of the section. 7.13.2=20 8 SECTION 22G OF THE ACT 8.1 Section 22G of the Act vests a delegated power in the Minister, actin= g on the recommendation of a pricing committee, to make regulations on th= e introduction of a transparent pricing system for drugs and maximum disp= ensing fees to be charged by pharmacists. In terms of section 22G(3)(a),= the transparent pricing system will provide for single exit prices for d= rugs to be published, and manufacturers selling drugs to anyone other tha= n the state, shall be obliged to do so at this exit price. A pharmacist = or other dispenser may then add a dispensing fee onto the exit price when= the drugs are sold on to the public. 8.2 The applicants challenge section 22G on the grounds that it is irrati= onal and therefore violates the fundamental value of the rule of law prot= ected by section 1(c) of the Constitution, the guarantee of equality befo= re the law (s 9(1)) and the protection of free choice of trade, occupatio= n and profession (s 22). This challenge is without foundation. 8.3 Section 22G is rationally related to two legitimate government purpos= es: 8.3.1 First, it ensures that, at least in so far as price is concerned, p= rivate persons have equal access to drugs throughout the Republic. A sin= gle exit price and a maximum dispensing fee ensure that no person's abili= ty to pay privately for the drugs on which their health depends will vary= according to the part of the country in which they live. That, in itsel= f, is sufficient to justify the provision in terms of rationality review.= 8.3.2 Section 22G does, however, have a second, less obvious purpose. =20 8.3.2.1 In the context of the broad range of measures introduced by the A= ct to promote access to cheaper drugs, section 22G eliminates the scope f= or drug companies to adopt a range of anti-competitive measures which hav= e been used to entice pharmacists and other dispensers to promote their d= rugs rather than lower priced drugs of competitors. The range and effect= of these incentives are discussed in the answering affidavit. Ntsaluba pp 1550-1554 para 187(b) They involved a variety of schemes (based on discounts, samples, and bonu= ses) in terms of which drug companies shared their broad profit margins w= ith some doctors and pharmacists at no benefit to the public, and in the = process provided the doctors and pharmacists with an obvious incentive to= continue prescribing their higher priced drugs in preference to those of= their competitors. See also Geffen Amicus Application Annexure AA8, p 3530 paras 7-8 8.3.2.2 By eliminating the scope for drugs to be sold to different doctor= s and pharmacists at different prices section 22G removes the scope for d= rug companies to "reward" doctors and pharmacists who sell their products= exclusively and to "punish" doctors and pharmacists who sell a competiti= ve range of products. In so doing, it promotes a competitive local marke= t in drugs. By limiting doctors and pharmacists to a maximum dispensing = fee and removing the scope for them to share profit margins on drugs with= drug companies, section 22G helps to reduce the cost of drugs. 8.3.2.3 This second broad purpose that is pursued by section 22G is accor= dingly independently sufficient for the provision to pass scrutiny in ter= ms of rationality review. 9 THE JUSTIFICATION FOR SECTIONS 15C, 22F AND 22G Section 15C 9.1 For the reasons set out above, it is submitted that sections 15C, 22F= and 22G of the Act do not limit any fundamental rights of the applicants= =2E In the event that these submissions are rejected, the amicus accepts= that section 15C of the Act cannot be justified in terms of section 36 o= f the Constitution because it lacks proportionality. In particular, the = amicus concedes that section 15C is insufficiently tailored to meet its p= urpose of providing for parallel importation to be saved under section 36= of the Constitution. (See PMA's Heads of Argument pp 201-209 paras 20.1= =2E2.2 - 20.1.2.2.3) However, section 15C can be saved by a process o= f severance or reading in. 9.1=20 9.2 It has been recognised by the Constitutional Court that there is some= thing akin to a presumption of constitutionality. This was expressly a= cknowledged in section 35(2) of the interim Constitution which provided: "No law which limits any of the rights entrenched in this Chapter, shall = be constitutionally invalid solely by reason of the fact that the wording= used prima facie exceeds the limits imposed in this Chapter, provided su= ch a law is reasonably capable of a more restricted interpretation which = does not exceed such limits, in which event such law shall be construed a= s having a meaning in accordance with the said more restricted interpreta= tion." 9.3 Section 35(2) was not repeated in the final Constitution. In De La= nge v Smuts NO and Others 1998 (3) SA 785 (CC) Ackermann J stated at para= 85 that this omission in no way altered the proper approach to constitut= ional adjudication. He stated: "The fact that the provisions of section 35(2) of the interim Constitutio= n have not been repeated in the 1996 Constitution is therefore irrelevant= to the decision in the present matter. In any event, they do no more t= han give expression to a sound principle of constitutional interpretation= recognised by other open and democratic societies based on human dignity= , equality and freedom such as, for example, the United States of America= , Canada and Germany, whose Constitutions, like our 1996 Constitution, co= ntain no express provision to such effect. In my view, the same interpret= ive approach should be adopted under the 1996 Constitution." 9.4 Striking down legislation is a drastic remedy. If there are remedi= al measures short of striking down, these should be adopted. If the app= licants' contentions concerning overbreadth have validity, the remedy, i= n a case such as the present, is actual or notional severance or reading = in. In this regard, Ackermann J in National Coalition for Gay and Lesb= ian Equality v Minister of Home Affairs 2000 (2) SA 1 (CC) stated at para= 63: "The device of notional severance can effectively be used to render inope= rative portions of a statutory provision, where it is the presence of par= ticular provisions which is constitutionally offensive and where the scop= e of the provision is too extensive and hence constitutionally offensive,= but the unconstitutionality cannot be cured by the severance of actual w= ords from the provision." 9.5 In Ferreira v Levin NO and Others 1996 (1) SA 984 (CC) an order of no= tional severance was made. The order in para 157 reflects the followin= g: "The provisions of section 417(2)(b) of the Companies Act 1973 are, with = immediate effect declared invalid, to the extent only that the words=20 'and any answer given to any such question may thereafter be used in evid= ence against him' in section 471(2)(b) apply to the use of any such answer against the pers= on who gave such answer, in criminal proceedings against such person, oth= er than proceedings where that person stands trial on a charge relating t= o the administering or taking of an oath or the administering or making o= f an affirmation or the giving of false evidence or the making of a false= statement in connection with such questions and answers or a failure to = answer lawful questions fully and satisfactorily." The Court also recognised the permissibility of reading words into a stat= ute in appropriate circumstances. Whether the remedy takes the form of= severance or reading in, the governing principle is to ensure that form = is not placed above substance so as to result in anomaly (at para 69). 9.6 Based on the aforegoing, three remedial possibilities present themsel= ves: 9.6.1 First, section 15C may be subject to actual severance by deleting s= ub-paragraph (a). 9.6.2 Second, section 15C(a) may be subject to notional severance along t= he following lines: Section 15C(a) is declared unconstitutional to the ex= tent that the words "notwithstanding anything to the contrary contained i= n the Patents Act, 1978" shall not be construed to permit any derogation = from the Patents Act other than parallel importation. 9.6.2=20 9.6.3 Third, words may be read into section 15C(a) along the following li= nes: "Notwithstanding anything to the contrary contained in the Patents Act, 1= 978, dealing with parallel importation ..." 9.7 It is submitted that the second and third alternatives offer the most= appropriate remedy should the applicants' argument on overbreadth succee= d. Sections 22F and 22G 9.8 If this Honourable Court should hold, contrary to the submission of t= he TAC, that sections 22F and 22G of the Act limit the fundamental rights= of the applicants, the TAC submits that any such limitation is justifiab= le under the limitations clause. 9.9 The application of the limitation clause involves a process, describe= d in S v Makwanyane 1995 (3) SA 391 (CC) at para. 104 as "the weighing up of competing values, and ultimately an assessment based = on proportionality ... which calls for the balancing of different interes= ts". This case was decided under the Interim Constitution. However, in the = National Coalition for Gay and Lesbian Equality v Minister of Justice the= Constitutional Court confirmed that - "the relevant considerations in the balancing process are now expressly s= tated in section 36(1) of the 1996 Constitution to include those itemised= in paragraphs (a) to (e) thereof. In my view this does not in any mater= ial respect after the approach expounded in Makwanyane, save that paragra= ph (e) requires that account be taken in each limitation evaluation of 'l= ess restrictive means to achieve the purpose [of the limitation]'. Altho= ugh section 36(1) does not expressly mention the importance of the right,= this is a factor which must of necessity be taken into account in any pr= oportionality evaluation" National Coalition for Gay and Lesbian Equality v Minister of Justice & O= thers 1999 (1) SA 6 (CC) at para 34 The Court stated further at para 35: "The balancing of different interests must still take place. On the one = hand there is the right infringed; its nature its importance in an open = and democratic society based on human dignity, equality and freedom; and = the nature and extent of the limitation. On the other hand there is the = importance of the purpose of the limitation. In the balancing process an= d in the evaluation of proportionality one is enjoined to consider the re= lation between the limitation and its purpose as well as the existence of= less restrictive means to achieve this purpose". 9.10 The purpose of sections 22F and 22G of the Act is, inter alia, to pr= omote cheaper access to drugs. As has been discussed above, this is a co= mmendable purpose, and, in the context of the HIV/AIDS epidemic, a consti= tutional obligation of the highest order linked to the duty of the State = to respect, protect, promote and fulfil a number of fundamental rights in= cluding the rights to human dignity and life which Chaskalson P in the Ma= kwanyane case held to be "the source of all other rights".=20 S v Makwanyane and Another 1995 (3) SA 391 (CC) at para 84 To the extent that sections 22F and 22G of the Act may be held, contrary = to the submissions of the TAC, to effect some limitations of the applican= ts' rights to property, equality or free choice of trade, occupation and = profession, any such limitation is clearly outweighed by the constitution= ally privileged purpose of the sections, and the sections are accordingly= justifiable under the limitations clause. 10 CONCLUSION 10.1 For the reasons set out above, it is submitted that there is no meri= t to the following challenges to the Act made by the applicants: 10.1.1 the challenges to section 15C based on the fundamental right to pr= operty (s 25 of the Constitution) and the non-arbitrariness requirement o= f the rule of law (s 1(3) of the Constitution), 10.1.2 the challenges to section 22F based on the fundamental rights to p= roperty (s 25 of the Constitution), equality (s 9(1) of the Constitution)= and free choice of profession (s 22 of the Constitution) and the non-arb= itrariness requirement of the rule of law (s 1(3) of the Constitution), a= nd 10.1.3 the challenges to section 22G based on fundamental rights to equal= ity (s 9(1) of the Constitution) and free choice of profession (s 22 of t= he Constitution) and the non-arbitrariness requirement of the rule of law= (s 1(3) of the Constitution). G J MARCUS S.C. MATTHEW CHASKALSON Counsel for Amicus Curiae Chambers Johannesburg 17 April 2001 --------------020006070805080501070409--