Debunking ‘Conglomo-talk’: A Case Study of the Amicus Curiae as an Instrument for Advocacy, Investigation and Mobilisation 1
By Mark Heywood
Head: AIDS Law Project (ALP),
Centre for Applied Legal Studies (CALS),
University of the Witwatersrand, Johannesburg
“The resolution of this court case only confirms our view that international markets, which play an increasingly important role in all our lives, have no inbuilt conscience. But governments and ordinary people acting collectively have a precious responsibility to make the huge companies that dominate the markets accountable for how they respond to the most critical issues of our times.”
Media Statement, Dr Manto Tshabalala-Msimang, Minister of Health, 19 April 2001
Abstract: In 1998 the Pharmaceutical Manufacturers Association (PMA) in South Africa launched legal action against an amendment to an Act, passed by the South African parliament in 1997, that was intended to make essential medicines more affordable.th The PMA claimed in Court papers that the Act violated a range of its members’ rights, citing particularly rights to property contained in Chapter 2 of the South African Constitution.2 On the international arena the PMA’s affiliates unleashed a barrage of ‘conglomo-talk’, alleging that the actions of the South African government threatened the international patent regime, encapsulated in the TRIPS agreement, and that the government’s action made it a pariah state acting contrary to its obligations as a member of the World Trade Organization (WTO). Initially this lobbying had some success, particularly in the USA where it led to SA being placed on a US Trade Representative (USTR) ‘watch list’. It became one of the subjects of bi-lateral discussions between the SA and US governments. This action was contested, particularly by activist groups in the United States such as ACT-UP and the Health-Gap Coalition. In South Africa, the ‘conglomo-talk’ of the PMA began to suffer a reversal when in January 2001 the Treatment Action Campaign (TAC) announced that it would seek permission from the Pretoria High Court to join the case as amicus curiae. The legal papers filed by the TAC as amicus applicant, became the new focus of the case. In TAC’s hands the litigation brought by the PMA became an instrument for progressive and people-driven advocacy and mobilisation. Its legal papers offered an opportunity, in the glare of international media, to investigate and debunk the ‘conglomo-talk’. Despite PMA opposition, TAC was admitted as amicus curiae on March 6 2001, and the PMA was instructed to respond to the allegations and arguments about ‘justification’ made in the TAC Founding Affidavit. The case collapsed on April 19thth 2001, leaving the South African government free to implement the Act.
The relationship between law and social and political issues in South Africa has a long and rich history. Much of this history relates to the abuse of law and law-making to serve segregationist ends and the response of ‘progressive’ lawyers to this.3 Between 1907 and 1908, Mahatma Gandhi tried to use defiance of the law, and his position as an admitted advocate, to resist racist legal reforms being planned by the colonial government (the so-called Black Act). Then in the 1950s and 1960s the African National Congress (ANC) engaged legal strategies to try to resist and justify defiance of unjust laws.4 This culminated in 1964 when Nelson Mandela and his co-accused used their defence in the Rivonia Trial to debunk some of the main tenets of apartheid and as a platform for advocacy and much of the international mobilisation against apartheid that took place during the 1970s, 1980s and 1990s.5
For a decade after the imprisonment of Mandela and most of the rest of the ANC’s senior leadership internal opposition that used the law to challenge apartheid shriveled, in tandem with the collapse of most political opposition. It never died entirely and a number of lawyers, amongst them post-apartheid South Africa’s first Minister of Justice Dullah Omar, remained in South Africa in what Omar described as “very dark years” using the law routinely to defend “hundreds and hundreds of people over the years on charges of contravening Pass Laws or workers who were charged with having gone on strike.” However, in the dying days of apartheid, on the crest of an enormous social mobilization revitalized by the industrial working class and urban youth, law was again used extensively this time to defend a new generation of detainees from arbitrary arrest and torture, as well as more boldly to challenge some of the fundamental tenets of apartheid law and practice, such as the Pass Laws and the Group Areas Act. One of the most significant developments during this period was the beginning of the use of law pro-actively to challenge injustices and to mobilise public opinion. Ironically, public impact litigation in the 1980s and early 1990s found ways to turn defence into attack and thereby to turn apartheid’s own laws on itself, exploit loopholes, and turn into de jure legal decisions what had often been made de facto by political struggle.6 This tradition of pro-active use of law is the subject of this paper. It is linked to a perspective that -- whilst not diminishing its core content and core value -- imbibes law with extra legal purpose and potential. However, it differs from descriptions of law against apartheid in that it refers to the use of law in a different social and political environment. In SA today non-state actors, such as privately owned monopolies, are emerging as concurrent violators of human rights. There is increasing recognition that ‘civil’ rights, such as the rights to dignity and equality, are heavily dependent on the realization of ‘socio-economic’ rights, such as access to health care services. This requires both a redistribution and equalisation of access to resources. However, in many spheres of life access to resources is dependent on the co-operation of non-state actors, such as multi-national companies, that are not governed by traditional human rights legislation. In this context international law, as much as national law, becomes the subject of contestation.
This article focuses on the legal action brought by the PMA to test the constitutionality of an amendment to South Africa’s Medicines and Related Substances Control Act of 1965.7 It traverses some of the history of a case rich in irony, insofar as the PMA utilized rights in a Constitution that is primarily intended to protect vulnerable people against vested interests. The irony was compounded when the TAC – a late joiner to the litigation - used the same rights-protections in the Constitution to turn the PMA’s case against itself, eventually contributing to the cessation of the litigation by the PMA. The TAC’s appropriation of the PMA case illustrates how legal action can be used to catalyse both national and international political mobilization. Interestingly, the case acquired international significance without even culminating in a judgment. It shows how the discipline demanded of litigators can provide impetus for legal and social investigation. It can assist with the uncovering of facts that contest – and undermine – arguments of powerful vested interests that consciously masquerade as objective ‘truths’ and ‘rules’ but whose origin often lies in political manipulation, power-broking and self-interest, rather than in reality or indeed in law.
At the heart of the PMA case is the manner in which international law can be appropriated and written by forces with no formal law-making power, and then imposed upon governments.As well as how this can be reversed. How the TAC and its allies achieved this is important to unpack and understand, because it offers a key to defence against one of the major strategies of human rights violators in the ‘new world order’ – dressing rights-incursions in the language of rights-protection and using unlimited economic power to pursue legal strategies to consolidate this.
This is not a new strategy. Summarising some of the uses of law against apartheid Richard Abel cautioned;
“As a sword, however, law may be ornamental or two-edged. Many victories, legislative or judicial, are largely symbolic, difficult or impossible to implement in practice. And vested interests may be better situated to invoke rights, derived from the Constitution or natural law, in opposition to legislative or executive reforms …”8 In a similar vein, in May 1997 Dullah Omar, then the Minister of Justice used the first conference of the SA Human Rights Commission (SAHRC) to warn:
“Because of the imbalances we have inherited, only a few people have the capacity to enjoy their rights and the danger we face is that the Bill [of Rights] will be the sole preserve of the rich and powerful.”9
Public-impact litigation should evolve with changing socio-political circumstance. Thus, TAC’s intervention in the PMA case, rather than attempting to emasculate state power, aimed to assist the government to defend its right to pass legislation to fulfill its constitutional obligations to progressively realize rights of access to health care services. It represented a strategic intervention into circumstances where although the new democratic government has political power, a great deal of economic power remains in non-state hands, limiting the ability of the state to address scarcity in health.
The full history of the case, and the legal issues it traversed, is lengthy and complex. Therefore, scrutiny will begin with the point when the TAC began to seek admission as amicus curiae in January 2001. However, before this, it is necessary to first provide a context for the court drama.
De-constructing apartheid: Improving Access to Health care Services Making health care more accessible to South Africa's poor is a constitutional duty facing the government. At Section 27 the South African Constitution states:
(1) “Everyone has the right to have access to –
health care services, including reproductive health care;
(2) “The state must take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of each of these rights.” 10
This is not an easy responsibility to fulfill. As with so many other spheres of life, the health system that the new South African government inherited in 1994 was racially divided and unequal. On the one hand there was/ is a private health sector, composed of highly paid doctors and modern medical facilities. This sector serves 20% of the population (mostly white) -- but accounts for 80% of national spending on health. On the other hand there is the public health sector, where 80% of the population seek care (mostly black) -- but where only 20% of health expenditure takes place.
In South Africa, as well as in the rest of the world, systems of private and public health care operate along parallel lines. But they are not independent of each other. If private care is excessively expensive more people are dependent on public hospitals. Similarly, if doctors and nurses are highly paid in the private sector, then health workers are sucked away from public facilities.11 The Constitutional duty to improve access to health care services thus dictates not only that government invest in public health but also that it address distortions in the private sector. In essence, making public health care more accessible means making private health care more affordable and efficient.
The market for medicines in South Africa became grossly distorted under apartheid. A first-world regulatory authority oversaw the registration of medicines and guaranteed their safety and efficacy – but it had no control over prices.12 The emergence of a substantial ‘whites-only’ private health sector, funded largely by medical insurance schemes, meant that medicine sold to this part of the market could be highly priced – and highly profitable. Even during the years of apartheid this was recognized to be a problem, particularly by health providers: several commissions were set up to investigate the barriers to wider use of quality generic medicines – but their recommendations for legal reforms to permit wider use of generic medicines were thwarted by the pharmaceutical industry.13 For example, in 1984 the South African Pharmacy Board amended its ethical rules and Government Notice R2525 gave pharmacists permission to substitute items on a medical prescription without the prior permission of the prescribing doctor. This was challenged in Court by the drug companies and the SA Pharmacy Board lost the case. Ten years later, in 1995, the South African Pharmacy Council repeated its support for generic substitution of brand name medicines on the grounds that it would “undoubtedly assist the community pharmacist to provide a more affordable pharmaceutical service to the public, thereby improving the accessibility of community pharmacy without compromising quality…” – a position that was supported by the Pharmaceutical Society of South Africa (PSSA).
The historic absence of regulation of medicine prices, and perverse practices that evolved in the dispensing and supply of medicines, permitted very high prices to be set for medicines sold by private doctors, clinics and hospitals. This fuelled general medical inflation which reinforced barriers to wider access to private care.
In the public sector most patented medicines were unaffordable. Further, generic medicines, although sold at prices greatly lower than to the private sector, were still sold at prices that the SA government would allege in its legal papers to be substantially above what was normal in many other countries.14
Racial discrimination in access to health care services was thus exacerbated by economic discrimination that favoured the wealthy. This situation was carried over into post-apartheid society and, some surveys suggest, has got worse. For example in 1999, 66% of people survey by the Community Agency for Social Enquiry (CASE) said “cost” was their main reason for not seeking health care when they were sick. In the same survey 40% of African respondents said that access to medicines had “got worse”.15
Tackling these distortions and their consequences requires a variety of strategies. To this end a range of policies and laws have been introduced since 1994.16 For example, one objective of government health policy is to try to make private hospital care more affordable and thereby reduce the patient-load and the resource drain on the public sector. Thus the Medical Schemes Amendment Act (131 of 1998) aimed to make private health care more widely available by removing unfair barriers to membership of medical schemes and strengthening the regulations governing the industry.17
Another area of focus was on the affordability and availability of medicines. A tight-rope had to be constructed requiring careful balance. A National Drug Policy was published in 996. Its aim is to rationalize the prescription and use of medicines through a variety of mechanisms, including a pared down Essential Drug List (EDL). Several legal mechanisms to reduce the drugs bill were also suggested, including encouraging generic substitution of off-patent medicines, the use of parallel importation and possibly compulsory licensing.18
It was hoped that the combination of these strategies would reduce the costs incurred in the purchase (by the state) and the prescription (by the public provider) of medicines. The objectives: lowering the State medicines bill – whilst increasing medicine availability; decreasing the amount spent on medicines by private providers – so as to increase affordability of private care; increasing the amount of money available for other health services whilst simultaneously increasing the volume and public health value of medicines.19
It was with these obligations in mind that, on 31 October 1997, the National Assembly passed the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (hereafter referred to as the Medicines Act).20 This law amended the Medicines and Related Substances Control Act, No. 101 of 1965 and contained a range of measures that aimed to make medicines more affordable and improve the functioning of the Medicines Control Council (MCC).
The Act was fiercely opposed by the then Democratic Party (DP), New National party (NNP) and representatives of the pharmaceutical industry. On 18 February 1998, the PMA and forty multinational drug companies filed a Notice of Motion and Founding Affidavit with the Pretoria High Court and sought an interim interdict to prohibit the President and Minister of Health from bringing into operation crucial sections of the Amended Act, and declaring the sections unconstitutional. Many of the contested measures were already standard practice in developed countries and, prima facie, in compliance with international agreements such as that on Trade Related Aspects of Intellectual Property (TRIPS). In effect, the legal action was an attempt by the PMA to use the constitution to annex additional powers and safe-guards for intellectual property that are not part of TRIPS; to fill in some of the ambiguities in TRIPS, particularly its vagueness around ‘parallel importation’; and to warn other developing countries off a similar path.th The Act was thereby stopped in its tracks.
Between February 1998, when the PMA initiated legal action and 10 November 2000, when it set the matter down for hearing in 2001, a great deal happened politically.th Although litigation had commenced, much of the substance of the dispute was thrashed out outside of the courts. For example, in 1998 pharmaceutical company lobbying was successful in having South Africa placed on the United States Trade Representatives’ (USTR) 301 Watch List. A year later it was removed as a result of activist pressure, primarily in the United States, that led to then US President Bill Clinton signing an ‘Executive Order’ that recognized the rights of countries in Africa to pass legislation without interference from the United States, as long as it was TRIPS-compliant.21 AIDS activism helped to catalyse an international activist movement that challenged the impact of international trade law on social and economic rights (such as health).
In South Africa, the froth in international politics, masked a stasis around the court papers. The pharmaceutical companies benefited by this inertia. The Ministry of Health lacked capacity to respond timeously to the PMA’s papers and this led to requests for postponements by the State Attorney, which were readily agreed to. The consequence of these postponements was that measures which would have drastically brought down the price of many medicines (as well as their profitability) were delayed, saving the pharmaceutical companies many millions of dollars and delaying the advent of affordable health care in South Africa.22
This period had also seen the rapid emergence of an AIDS activist movement in South Africa with the launch of the TAC in December 1998. Between 1999 and 2001, the TAC was aware of the issues in the court case and frequently engaged the PMA through demonstrations with demands to withdraw the case.23 However, a lack of capacity delayed TAC’s ability to tackle the issue squarely. Other campaigns were more aggressively pursued and alliances constructed. This helped prepare civil society in South Africa for the kind of mobilization that would be required in the PMA matter.24 In 2000, TAC waged a campaign against Pfizer Inc. to demand a price-reduction of its anti-fungal medicine, Diflucan/ Fluconazole. The campaign reached a high-point in October 2000 when TAC chairperson, Zackie Achmat, returned to South Africa from a trip to Thailand with 5000 tablets of a bio-equivalent generic fluconazole (Biozole) – and TAC held a press conference to announce the commencement of its patent abuse defiance campaign. This action led to intense public discussion about the morality of patent abuse and pricing of medicines. It dominated the news headlines for a week, and led to television and radio discussions. Its effect was to educate the public and build sympathy and support for TAC across the social and political spectrum.25 The campaign undoubtedly influenced the decision of Pfizer to donate Diflucan for use in the public sector by people with certain AIDS-related opportunistic infections.
By early 2001 in the wake of successful advocacy to highlight the price differentials between essential generic and patented medicines, particularly Fluconazole, the TAC was ready to intervene in the court case. On 10 November 2000, the PMA had quietly set the matter down for hearing in March 2001. Strangely, the South African government had not drawn public attention to this. This changed on January 11thth 2000 when the PMA’s Head of Scientific and Regulatory Affairs, Maureen Kirkman, informed TAC of the dates. Early in January a discussion was held with senior lawyers about whether the TAC should aim to join as a party. TAC was advised that this would seriously delay the hearing. Therefore, it was decided seek permission from the parties and the Court for leave to intervene as amicus curiae.26
The TAC’s first objective was to break the two year inertia and to draw international attention to the dates of the case. This it did on January 16 at a press conference where TAC announced that it would seek to join as amicus curiae and simultaneously mobilize an international campaign to call on the pharmaceutical companies to withdraw from the matter. Thereafter, these two strategies were pursued separately -- but at all times in close parallel to each other. Each benefited the other.
Advocacy: In one important respect the TAC intervention in the PMA case differs from public impact law under apartheid. After the Soweto uprising in 1976 the social movement against apartheid revived independently of the law, but took advantage of the law and progressive lawyers to consolidate and catalyse change. After the political defeats of the early 1960s very few lawyers were prepared to take on apartheid in the absence of a political movement. Many went into exile or were imprisoned. Their courage returned with the return of political opposition. By contrast, although on an infinitely smaller scale at this stage, the TAC has used law and mobilization concurrently, and has often been responsible for both. It has been aided in this by a Constitution with a clear Bill of Rights, and a legal tradition that encourages the use of litigation as a way of colouring in and defining its principles.
There is also an important overlap between the two periods. The TAC draws much inspiration from the work of Edwin Cameron, one of the pioneers of public impact law in the 1980s. Senior Counsel for the TAC in the PMA case was Advocate Gilbert Marcus, who has had long involvement with public interest law and in 1985 argued as amicus curiae in a case that led to the unbanning of the Freedom Charter.
On 15thth and 16th of January 2001 the TAC national executive committee (NEC) met in a clinic run by MSF in Khayelitsha in Cape Town. Spirits and confidence were high, in the light of the importation of another batch of Fluconazole tablets from Thailand (this time declared at customs by Morne Visser, a local TV actor), which were handed over to cheering activists at Cape Town International Airport in the glare of television cameras. TAC knew that this was testing the legal boundaries of the exemption that it had received from the Medicines Control Council (MCC) in 2000 to import the generic medicine for use by a clinic in Cape Town. A resolution to try to intervene as amicus was unanimously passed by the NEC27. TAC called for a Global Day of Action against the pharmaceutical companies on March 5 2001, the first day of the Court case.th This call received significant attention from the local and international media.28
Between January and March mobilization in South Africa and internationally was intense. The start of the Court case was a focal point, but the legal process engaged in by TAC to try to gain admission as amicus gave it a day-to-day reality, and allowed the legal questions to be teased out into the public domain and to provide valuable public education around the issues.
On March 5 5000 people, led by religious and trade union leaders, marched past the Pretoria High Court and handed a Memorandum over at the US Embassy. On March 4thth , COSATU and the TAC staged an all night vigil in a tent outside the Court, and TAC leaders seized the rare opportunity to workshop the most senior officials of COSATU until 2am in the morning on legal and political issues posed by the case.
Internationally TAC formed alliances with Oxfam, MSF, Action for Southern Africa (ACTSA) in Britain and the Health-GAP coalition in the USA – several of these organisations were already campaigning against the pricing practices and abuse of patents by pharmaceutical companies. These allies were able to mount pressure directly against the companies as well as on the governments of industrialized countries. When the case began on March 5th demonstrations were held in 30 cities world-wide, including in Brazil, the Philippines, the USA, Britain, Kenya, Thailand, France, Italy, Denmark, Australia, and Germany. By this point over 250 organisations from 35 countries had signed a petition opposing the legal action.29 The civil society mobilization, supported by international luminaries such as John Le Carre, left the companies increasingly isolated. After the postponement of the case on March 6 MSF initiated an international petition which collected 250 000 signatures, and during this time played a crucial part in persuading the European Union and Dutch government to pass resolutions calling for the case to be dropped.
During this period the media made great play of the ‘alliance’ between the TAC and the government – an alliance that drew criticism from some quarters on the left. It is important, therefore, to note the tensions behind this mobilsation.
In reality there was little contact between TAC and the government. On February 1thst a TAC/ALP delegation had met with the Director General of the Health Department, Dr Ayanda Ntsaluba, and discussed the case. The TAC received a positive response to its request to join as amicus, although Ntsaluba explained that the final government position would depend on consent from all the Respondents. This had to include the Office of the President, with whom the TAC has a very poor relationship, largely as a result of the President’s destructive public flirtation with the ‘AIDS dissidents’ and their views. Thereafter there was no direct contact. Although the press were generally unable to grasp the point, the Ministry of Health understood that the amicus intervention was but a stage in TAC’s campaign for treatment access, that would lay the foundations for intensified criticism of on the government’s policy concerning access to treatments for HIV.30 Unlike COSATU, the African National Congress (ANC) kept its distance from the TAC campaign. After victory had been secured the ANC excluded the TAC entirely from acknowledgement. A ‘victory rally’ held in Church Square in Pretoria on April 19 left out the TAC completely and tried to elevate organizations that had engaged very little with the case. Similarly, whilst the Minister of Health congratulated the TAC’s international allies, such as Oxfam and ACTSA, she privately chided them for working with TAC.th
Leaders of the ANC and some Ministers expressed concern that the TAC had hijacked the case and turned all attention onto the question of access to anti-retroviral drugs. Whilst the media might have contributed to this impression, a study of what the TAC actually said and wrote will not support this.
TAC’s main arguments were that access to health is a human right that trumps rights to private property – particularly when these rights are being abused. Specifically, TAC argued that patented anti-retroviral medicines (needed by millions in Africa) bear out the main contentions of the Respondents: that patents were being used to gouge prices. Some of the measures in the Act, specifically section 15C, could be used to bring down prices of patented medicines. However, as important to TAC’s argument was the impact that S22F (the requirement for generic substitution of off-patent medicines) would have on making medicines that treat and prevent opportunistic infections more affordable – as well as the potential benefits for the health system as a whole.
The mobilization against the PMA and the other pharmaceutical company applicants was conscious and deliberate. Its success was not pre-ordained. It came about as a result of creative advocacy, skilful interaction with the local and international media, and research. Critically important was the ability of the TAC and its international allies to win the arguments.31
TAC’s approach to law: The PMA’s attack on the Act revolved around a handful of key issues. But as is the fashion of legal action whose objective is to delay and frustrate legislation (and where resources are limitless), the papers attacked almost every clause of the Act, as well as the procedures by which it passed through parliament.32 For an amicus applicant to be admitted, the amicus has to show that it can provide insight and argument that does not already exist in the Court papers – that its input is not erroneous, vexatious or repetitive. Unless special permission is sought, the amicus must confine itself to points of law and not introduce new evidence that might be disputed. Departing from the thrust of the international campaign which had rallied mainly around a defence of section 15C of the Act, TAC decided to focus on three key sections (including 15C) and to use the need for medicines created by the HIV/AIDS epidemic to highlight why each of these measures were necessary and justifiable.
The three areas were identified as sections 15C, 22F and 22G. They dealt with parallel importation, generic substitution and the establishment of a pricing committee.33
On January 26 2001 letters were sent to the Applicants and the Respondents, seeking their consent for TAC to act as amicus curiae.th The TAC offered not to “burden the Court .. with additional evidence” and only to use “uncontroversial scientific facts pertaining to the HIV/AIDS epidemic and the role of medicines in the management of this epidemic…”34 This offer formed part of TAC’s legal strategy which anticipated that neither party would dispute published epidemiological reports about the HIV epidemic, and that the companies were unlikely to question the efficacy of their products. If undisputed, these two admissions would help to build a legal argument to justify the contested sections of the Act.
For TAC limiting the amicus’ interest to three key provisions of the Act also helped with public education about the issues -- and forced the PMA to move into its terrain.
The response of the attorneys for the PMA might, arguably, have been the turning point in the case, or the point at which the pharmaceutical companies began to lose control over its direction. Consent was withheld on a number of technical and substantive grounds. TAC was advised to “reconsider, and thereupon abandon, [its] intended participation in the hearing of this matter” and “thereby avoid the expenditure of resources which could be better applied elsewhere.” According to the PMA’s attorney:
“The issues before the Court .. are of a constitutional nature and do not relate, in any way, particularly to access to Aids medication. The submissions which the TAC wish to advance, … , do not differ from the submissions of the other parties to the application. No issues specific to the interests presented by the TAC and not equally applicable to other incurable diseases arise for decision in the application.”35 This response set parameters for the core arguments that would be made in TAC’s legal papers, as well as in its advocacy. If the PMA’s contentions could be disproved, it also created the unique angle needed to justify admission as amicus. The challenge was to show (a) how the measures in the Act did have bearing on AIDS medicines and (b) how the constitutional questions were not limited to those being posed by the PMA. Neither challenge was too difficult. The TAC was also assisted when on 14 February 2001 the State Attorney wrote that “our clients have consented …”
Before looking at substantive legal arguments, it is important to draw attention to the manner in which, from the outset, the amicus application functioned simultaneously as legal argument and advocacy tool.th
One of TAC’s objectives was to turn a dry legal contest into a matter about human lives – this was important for education of the Court, as well as for public opinion. Thus, TAC’s main affidavits were deposed to by Ms Theodora Steele, the Campaigns Co-ordinator of South Africa’s largest trade union federation, the Congress of South African Trade Unions (COSATU), which has nearly two million members. This served two purposes: it made an ordinary person, with real interests in the legislation, the deponent, and it gave COSATU a sense of ownership in the Court battle. The ability to mobilize thousands of people depended very heavily on the close support of COSATU.
Similarly, reviving a tradition exploited by lawyers under apartheid of utilizing affidavits as legally sanctioned instruments to tell the stories of lives affected by apartheid,36 twelve poignant affidavits were collected from people living with or affected by HIV37, two from doctors treating people with HIV38, and one from the Head of Mission of Medicins Sans Frontieres (MSF) in South Africa.39 These affidavits offered personal testimony about living with HIV or AIDS in the shadow of medicines that are available but not affordable. They were all attached as annexures to the Founding Affidavit.
TAC’s Founding Affidavit was filed on February 162001. It aimed to establish that the AIDS epidemic did create an emergency in which the need for more affordable medicines is a matter of life and death for millions of people.th Even if the Act had not been devised with the AIDS epidemic specifically in mind (which it had not: its objective was to make all medicines more affordable) the epidemic created urgency and justification for legal measures to make medicines more affordable. Contrary to what was suggested in Vermaak’s letter the number of people with HIV, and the excessive price of HIV-related medicines meant that the amicusdid have issues to raise that were not “equally applicable to other incurable diseases.”40
The architecture of TAC’s Founding Affidavit is worth describing. An expert affidavit from a specialist HIV clinician, describing a range of the medicines that are used to fight HIV or its symptoms, was annexed in order to subtly challenge the applicants to dispute the efficacy of their products (which of course they did not). With the safety and efficacy of the medicines and the scale of the HIV epidemic placed beyond the realm of dispute, it would be possible to concentrate the Court’s attention on how the price of medicines was the major barrier to access, and thus the justification for the measures in the Act, should it be found that they did limit the rights to property of the pharmaceutical companies.
A Founding Affidavit is intended to convey evidence, rather than legal argument – which is saved (under South Africa law) for presentation in ‘Heads of Argument’ (submitted shortly before the hearing) and in oral argument on the papers before the Court. However, the Founding affidavit must, obviously, lay the evidentiary foundations for the legal argument.
The TAC’s legal argument was that none the three contested clauses were unconstitutional. Indeed, TAC argued that they were dictated by a positive duty on the Government to “progressively realize” rights of access to health care services and to protect rights such as dignity,41 life,42 equality43 and the duty to act in the best interests of the child44 – rights which are dependent on measures to improve socio-economic conditions.45 Poor people, the TAC alleged, were: “directly dependent on the State’s ability to fulfill its constitutional duty to bring about the progressive realization of their rights of access to health care services.” (FA, paragraph 13) However, in view of its limited resources, large epidemics such as HIV and TB, and the high price of medicines generally:
“the South African Government is constrained in its efforts to provide adequate and good quality treatment for its citizens who are dependent on government hospitals and clinics …..” (FA, paragraph 54, quoting from a ‘Memorandum of Agreement between the South African government and Pfizer Laboratories ltd’, 1 December 2000)
The law is an attempt to overcome these constraints. TAC argued that it was not a violation of TRIPS, pointing out that measures such as mandatory or incentivised generic substitution of off-patent medicines are common practice in industrialized countries. In the event that aspects of the Act might be found to be unconstitutional, TAC argued that under South Africa’s constitution certain rights may be limited as long as the infringements are “reasonable and justifiable in an open and democratic society based on human dignity, equality and freedom”46. TAC argued that should any of the Act’s measures be found to limit property rights, these could be justified on the grounds of the government’s obligations to improve access to health care services, as well as other duties arising from international treaties:
“The government of South Africa is justified in seeking to avoid the massive social and economic disruption caused by the HIV epidemic – and other causes of illness – by limiting the rights of the patent-holders to make excessive profits from the sale of the drugs in South Africa.” (FA, para 71)
Finally the TAC provocatively attacked one of the main tenets of the PMA’s legal and media case: that the Act was a violation of intellectual property rights that would rob private investors of just rewards for invention and research, and thereby undermine preconditions for future research into disease and medicine.
“The research and development costs borne by the applicants have been recouped many times over. The Amicus Applicant has on a number of occasions challenged, for example, Glaxo Wellcome, one of the applicants, and Pfizer, a member of the First Applicant to state what its R&D costs are in relation to antiretroviral and other drugs. The information was never provided.” (FA, para 83)
The Founding Affidavit listed a number of medicines essential for the treatment of HIV and its opportunistic infections, and tempted the PMA bear to come out of its lair and do battle on where they originated from, and how much public and private money was invested in them. They did just that.47