IN THE HIGH COURT OF SOUTH AFRICA (TRANSVAAL PROVINCIAL DIVISION) CASE NO: 4183/98 In the matter between THE PHARMACEUTICAL MANUFACTURERS' ASSOCIATION OF SOUTH AFRICA First Applicant ALCON LABORATORIES (S.A.) (PROPRIETARY) LIMITED Second Applicant BAYER (PROPRIETARY) LIMITED Third Applicant BRISTOL-MYERS SQUIBB (PROPRIETARY) LIMITED Fourth Applicant BYK MADAUS (PROPRIETARY) LIMITED Fifth Applicant ELI LILLY (SOUTH AFRICA) (PROPRIETARY) LIMITED Sixth Applicant GLAXO WELLCOME (SOUTH AFRICA) (PROPRIETARY) LIMITED Seventh Applicant HOECHST MARION ROUSSEL LIMITED Eighth Applicant INGELHEIM PHARMACEUTICALS (PROPRIETARY) LIMITED Ninth Applicant JANSSEN-CILAG PHARMACEUTICA (PROPRIETARY) LIMITED Tenth Applicant KNOLL PHARMACEUTICALS SOUTH AFRICA (PROPRIETARY) LIMITED Eleventh Applicant LUNDBECK SOUTH AFRICA (PROPRIETARY) LIMITED Twelfth Applicant MERCK (PROPRIETARY) LIMITED Thirteenth Applicant MSD (PROPRIETARY) LIMITED Fourteenth Applicant NOVARTIS SOUTH AFRICA (PROPRIETARY) LIMITED Fifteenth Applicant NOVO NORDISK (PROPRIETARY) LIMITED Sixteenth Applicant PHARMACIA & UPJOHN (PROPRIETARY) LIMITED Seventeenth Applicant RHONE-POULENC RORER SOUTH AFRICA (PROPRIETARY) LIMITED Eighteenth Applicant ROCHE PRODUCTS (PROPRIETARY) LIMITED Nineteenth Applicant SCHERING (PROPRIETARY) LIMITED Twentieth Applicant SCHERING-PLOUGH (PROPRIETARY) LIMITED Twenty-First Applicant S.A. SCIENTIFIC PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Second Applicant SMITHKLINE BEECHAM PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Third Applicant UNIVERSAL PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Fourth Applicant WYETH (PROPRIETARY) LIMITED Twenty-Fifth Applicant XIXIA PHARMACEUTICALS (PROPRIETARY) LIMITED Twenty-Sixth Applicant ZENECA SOUTH AFRICA (PROPRIETARY) LIMITED Twenty-Seventh Applicant BAYER AG Twenty-Eighth Applicant BOEHRINGER-INGELHEIM INTERNATIONAL GmbH Twenty-Ninth Applicant BOEHRINGER-INGELHEIM KG Thirtieth Applicant BRISTOL-MYERS SQUIBB COMPANY Thirty-First Applicant BYK GULDEN LOMBERG CHEMISCHE FABRIK GmbH Thirty-Second Applicant DR. KARL THOMAE GmbH Thirty-Third Applicant ELI LILLY AND COMPANY Thirty-Fourth Applicant F. HOFFMANN-LA ROCHE AG Thirty-Fifth Applicant MERCK KGaA Thirty-Sixth Applicant MERCK & CO., INC. Thirty-Seventh Applicant RHONE-POULENC RORER S.A. Thirty-Eighth Applicant SMITHKLINE BEECHAM plc Thirty-Ninth Applicant OLIVER CORNISH Fortieth Applicant and THE PRESIDENT OF THE REPUBLIC OF SOUTH AFRICA, THE HONOURABLE MR N.R. MANDELA N.O. First Respondent THE SPEAKER OF THE NATIONAL ASSEMBLY, THE HONOURABLE DR. F.N. GINWALA N.O. Second Respondent THE CHAIRPERSON OF THE NATIONAL COUNCIL OF PROVINCES, THE HONOURABLE MR M.G.P. LEKOTA, N.O. Third Respondent THE MINISTER OF HEALTH, THE HONOURABLE DR. N.C. DLAMINI ZUMA N.O. Fourth Respondent THE CHAIRPERSON OF THE PORTFOLIO COMMITTEE ON HEALTH (NATIONAL ASSEMBLY), THE HONOURABLE DR. A.S. NKOMO N.O. Fifth Respondent THE CHAIRPERSON OF THE SELECT COMMITTEE ON SOCIAL SERVICES (COUNCIL OF PROVINCES), THE HONOURABLE DR. S.C. CWELE N.O. Sixth Respondent THE CHAIRPERSON OF THE MEDICINES CONTROL COUNCIL, PROFESSOR P.I. FOLB N.O. Seventh Respondent THE PREMIER OF THE GAUTENG PROVINCE, THE HONOURABLE MR. M. MOTSHEKGA N.O. Eighth Respondent THE MEMBER OF THE EXECUTIVE COMMITTEE FOR HEALTH OF THE GAUTENG PROVINCE, THE HONOURABLE MR. A. MASONDO N.O. Ninth Respondent THE REGISTRAR OF PATENTS, MR. C. BURTON-DURHAM N.O. Tenth Respondent In the application to be admitted as an amicus curiae TREATMENT ACTION CAMPAIGN Amicus Applicant FOUNDING AFFIDAVIT I, the undersigned THEODORA STEELE Do hereby make oath and say that: 1. I am an adult female. I was born in 1957 and am married with three children. Since May 2000, I have been a member of the national executive committee of the Treatment Action Campaign (TAC). I am employed as the Campaigns Coordinator of the Congress of South African Trade Unions (COSATU), and have been actively involved in the South African trade union movement since 1984. I am duly authorized to depose this affidavit and to bring this application on behalf of the TAC. A resolution of the National Executive Committee of the Treatment Action Campaign, dated 15-16 January 2001, is annexed hereto marked AA1. 2. The facts contained herein are to the best of my knowledge true and correct and are, unless otherwise stated or indicated by the context, within my personal knowledge. THE INTEREST OF THE TREATMENT ACTION CAMPAIGN (TAC) IN THE SUBSTANTIAL ISSUES COVERED IN THESE PROCEEDINGS 3. The TAC is a voluntary association with the capacity to institute legal proceedings. The Constitution of the TAC is annexed hereto marked AA2 4. The objectives of the TAC are set forth in its Constitution. They include, to: 4.1. Campaign for affordable treatment for all people with HIV/AIDS; 4.2. Campaign for the prevention and elimination of all new HIV infections; 4.3. Promote and sponsor legislation to ensure equal access and equal treatment of all people with HIV/AIDS; 4.4. Challenge by means of litigation, lobbying, advocacy and mobilisation, all forms of discrimination relating to treatment of HIV/AIDS in the private and public sector; 4.5. Educate, promote and develop an understanding and commitment within all communities of developments in HIV/AIDS treatment and care; 4.6. Campaign for affordable and quality access to health care for all people in South Africa; 5. The TAC was founded on December 10th 1998. Its creation arose from a call made by the current TAC Chairperson, Mr Zackie Achmat, to improve public access to essential HIV/AIDS medicines. This plea was made at the memorial service of Mr Tseko Simon Nkoli, a Delmas Treason Trialist, anti-apartheid and gay rights activist who died of an AIDS related illness on November 30th 1998. 6. A central aim of the TAC is to save the lives of people who are infected with the Human Immuno-deficiency Virus (HIV). The TAC does this by campaigning for medicines, that are of proven efficacy in treating illnesses caused by HIV and the Acquired Immune Deficiency Syndrome (AIDS), to be made accessible through the South African public and private health service. An affidavit on the efficacy of these medicines is annexed hereto marked AA3. 7. An affidavit by Dr. Eric Goemaere, Mission Head of Médecins Sans Frontières (MSF) on the pricing of HIV/AIDS medicines, the importance of the case for access to medicines and the rights to life for many people with HIV/AIDS, and a description of the Brazilian state's role in the provision of anti-retroviral treatment for people with HIV/AIDS is also annexed hereto as AA4. 8. The TAC has won broad support for its objectives amongst organisations of civil society in South Africa. Amongst these are the Congress of South African Trade Unions (COSATU), the South African National NGO coalition (SANGOCO), the South African Catholic Bishop's Conference, the Anglican Church, the debt-cancellation campaign known publicly as Jubilee 2000, the Children's Rights Centre, the Coalition for Children Living in an HIV Positive World, the New Women's Movement, the Women's Health Project and the Reproductive Rights Alliance. The Amicus Applicant is able to provide additional confirmatory affidavits from duly authorised officers of these organisations to confirm these statements. 9. TAC has also established formal and informal relationships with organisations that share its objectives internationally. Amongst these are the International Confederation of Free Trade Unions (ICFTU) - which has 45 million members worldwide - and Médecins Sans Frontières, which won a Nobel peace prize for its humanitarian work in 1999. Other organizations include Action for Southern Africa (ACTSA) based in the United Kingdom; the Southern African Development Fund, based in the United States of America, Oxfam, and the Voluntary Services Organisation (VSO). 10. In July 2000 a 'Global march for access to HIV/AIDS treatment', led by the TAC, and co-hosted by the HealthGAP Coalition of the United States of America attracted endorsement of over 250 organisations from outside South Africa. 11. The TAC's submissions as amicus curiae would reflect the interests, expertise and opinions of these groups, who are humanitarian groups that derive their understanding from international human rights covenants such as the Universal Declaration of Human Rights, the International Covenant on Economic, Social and Cultural Rights and the International Covenant on Civil and Political Rights. These are areas of international law and international customary law that have a direct bearing on this case. THE RELEVANCE OF THE QUESTION OF ACCESS TO HIV/AIDS MEDICINE TO THE KEY CONSTITUTIONAL ISSUES BEFORE THE COURT 12. On 26 January 2001 the Amicus Applicant wrote to the legal representatives of the Applicants and Respondents seeking their permission to be admitted as an amicus curiae in these proceedings. A copy of the letter is annexed marked AA5. Permission has been granted by the respondents and a copy is annexed marked AA6. In a letter from the Applicants' attorney of record, which is attached hereto as annexure AA7, it is stated that "the issues before the Court are of a constitutional nature and do not relate, in any way, particularly to access to Aids medication." 13. It is my contention, and that of the TAC, that the ability of many persons with HIV to purchase and take medicines that treat HIV and its attendant illnesses, has a profound and inseparable bearing on their constitutional rights to human dignity and life and access to health care. In this respect people with HIV are directly dependent on the State's ability to fulfill its constitutional duty to bring about the progressive realisation of their rights of access to health care services. 14. In this regard, the ability of the Respondents to implement the proposals contained in the White Paper for the Transformation of the Health System in South Africa (Government Gazette No. 17910, 16 April 1997) is of interest to the TAC. In particular, the TAC has an interest in one of the White paper's objectives, being to "ensure the universal availability of high quality, low-cost essential drugs." 15. The TAC has a direct interest in supporting reasonable legislative and other measures, taken by the state, to improve access to health care services and to promote the achievement of equality. The TAC believes that Medicines and Related Substances Control Amendment Act (90 of 1997) represents an attempt by the respondents to perform their constitutional obligations diligently and without delay, and that the HIV/AIDS epidemic creates a unique and historically unparalleled necessity to ensure that this is done with the minimum of delay. 16. The TAC is concerned that the rights of its members are being directly threatened by the action of the applicants. The constitutional rights to equality, dignity, life, access to health care services, and the rights of children, of many people living with HIV/AIDS and in particular, TAC volunteers will be directly affected by the outcome of these proceedings. 17. The Applicants' attorney asserts in his response to the TAC's request for the applicant's permission to participate in this matter as amicus curiae, that the TAC "should not be allowed to seize on an opportunity in a related matter to have a hearing in its own issue raised in its own affidavits but not raised as an issue in the proceedings as it is already before the Court." 18. In response the TAC states that as amicus curiae its standing and contribution to the Court's finding derive from the fact that it would be acting: 18.1. On behalf of many people who cannot act in their own name. According to the Department of Health there are 4,2 million South Africans infected with the Human Immuno-deficiency Virus (HIV), but most are unaware of this. This class of people have a direct interest in improved access to health care services. 18.2. On behalf of people with HIV or AIDS, who, as a result of stereotyping, stigma and discrimination, are afraid to act in their own names. 18.3. On behalf of many children with HIV/AIDS who cannot be represented and are not represented in this case, including children who have parents with HIV, and who desire to see their parents live longer and productive lives, and children who have been prematurely orphaned. 18.4. On behalf of professional health care workers who have an ethical and legal duty to provide health care services to people with HIV or AIDS, but find themselves unable to provide vital curative and palliative medicines, because these medicines are frequently too expensive. Affidavits for Dr. Leon Geffen and Dr. Hermann Reuter, registered medical practitioners, explaining this dilemma are attached hereto as annexures AA8 and AA9. 19. As evidence of the standing of TAC, and the urgency of its concerns, I draw your attention to the fact that in October and November of 2000 the following TAC activists died as a result of AIDS related illnesses: Mr Christopher Moraka, Mr Sbu Mkhize, Ms Farida Abrahams and Ms. Queenie Qiza. Each lived in a major city. Each was able to seek treatment and care at a public hospital. But none of them could afford treatment. In this regard we draw your attention to an article in The Cape Times, 30th November 2000, attached hereto as Annexure AA10. 20. We also annex hereto affidavits from twelve (12) TAC volunteers and staff members as Annexures AA11-AA22. They include: Mr. Zackie Achmat, Ms. Nomfundo Dubula, Mr. Mkhanyiseli Mpalali, Ms. Siphokazi Mthati and others. These affidavits demonstrate the need for health care and in particular, access to affordable anti-retroviral medicines. They also demonstrate the desperation and indignity faced by poor people who have no access, or those who rely on clinical trials as their only means of access, to medicines. I am aware that drug companies, both brand name companies and generic companies, have made offers of discounts and reduced their prices after international public opinion and activist pressure. This is not sufficient. Should such pressure cease, people with HIV/AIDS and broader society need a legal framework enforced by the state that contains high prices of medicines. 21. I hope that these affidavits can demonstrate to this Honourable Court the links between the issues before the Court and the question of access to AIDS medication. 22. Finally, the TAC acts in the public interest. There is no dispute that, up to this point, the cost of many medicines that are essential in the treatment of HIV/AIDS has been considered prohibitive in both the private and public health sectors. Medicines have therefore not been widely provided. Without access to medicines, there is very little incentive for members of the public to voluntarily seek HIV counseling and testing. Without diagnosis, many people inadvertently transmit HIV during sexual intercourse. This chain of events contributes to the failure of the South African government to contain the epidemic. THE HISTORY OF THE TAC'S ENGAGEMENT WITH THE ISSUES BEFORE THE COURT 23. Under its description of "logistical considerations" for declining consent to the TAC's request for permission to act as amicus the Applicants' attorney of record states that the TAC "should have come to the matter at an earlier time. It could clearly have done so since it knew of it, on its own version, for at least 25 months." 24. Since early 1999 the TAC has attempted to engage both the Applicants and the Respondents on the specific issue of the contested Act as well as on the general questions of the affordability and availability of essential medicines. 25. The request to the Court for permission to act as amicus curiae comes as the last stage in a multi-dimensional process to resolve these issues by other constitutional means, particularly exercising rights to assemble, to demonstrate, to picket and to present petitions. These activities are listed below, and should serve to illustrate that the TAC has always had a keen interest in the issues. 25.1. The TAC founding press statement on 9 December 1998 called for a fast on Human Rights Day, 21 March 1999, to "pressure the government and the pharmaceutical sector to seriously address the need for equitable and affordable access to treatment and care for all people with HIV/AIDS". 25.2. On 21st March 1999, TAC members conducted a national "Fast to Save Lives". The Cape Town fast at St. George's Cathedral attracted at least 200 people. They were addressed by Gender Commissioner Farid Esack and the ANC's provincial health secretary - Dr. Saadiq Kariem. In Soweto more than 500 people representing trade unions, religious bodies, AIDS organisations, the South African Communist Party, the National Coalition for Gay and Lesbian Equality gathered outside Chris Hani Baragwanath Hospital where they were addressed by Mark Heywood of the AIDS Law Project, Zackie Achmat (NCGLE), Dr. Glenda Gray of Baragwanath Hospital, Bishop Paul Verryn of the Methodist Church, Ms Florence Ngobeni (NAPWA) and Gauteng Provincial Health Department's Dr. Liz Floyd -Director of HIV/AIDS, STDs and Infectious Diseases. 25.3. On 28 April 1999, TAC members demonstrated outside the premises of the Seventh Applicant, Glaxo Wellcome, in Midrand, Gauteng. A letter to Glaxo Wellcome was presented by Ms Sharon Ekambaram, TAC's co-ordinator in Gauteng, and received by Mrs Vikki Ehrich, Director Corporate Affairs, and Dr Peter Moore, Chief Medical Officer. 25.4. On 30th April 1999, TAC Chairperson Mr Zackie Achmat and other TAC representatives met with the then Minister of Health, Dr Nkosazana Zuma. Minister Zuma called on TAC to actively support measures taken by the government to lower the price of essential medicines. 25.5. On 5th July 1999, the TAC held a protest outside the Consulate of the United States of America in Johannesburg. The picket was led by TAC Executive member Mr Mazibuko Jara and called for an end to US government interference with SA law making and specifically questioned US government support for the litigation of the Applicants against the Amendment Act. A Memorandum was handed over to a US official, Mr Fred Kaplan. 25.6. On 26th July 1999, TAC representatives, led by Mr Randall Howard, the General Secretary of the Transport and General Workers Union, met with representatives of the US Government to receive a response to the TAC Memorandum. 25.7. On 13th September 1999, TAC issued a press release in response to the announcement by the Pharmaceutical Manufacturers' Association (PMA), the First Applicant in this matter, that it had "suspended" its legal action. The press release described the suspension as a "public relations exercise" and demanded the "unconditional withdrawal of the legal action by the PMA." 25.8. On 22 September 1999, TAC held a demonstration outside the offices of the First Applicant, (PMA) calling for the unconditional withdrawal of the court action to provide the basis for a negotiated settlement. The TAC delegation was led by TAC Chairperson Mr Zackie Achmat and a Memorandum was handed over to Ms. Maureen Kirkman, Head of Scientific and Regulatory Affairs at the PMA. In Cape Town, the TAC demonstrated at the offices of the Seventh Applicant, Mr. Ben Plumley and Ms. Vicki Ehrich received a memorandum from the TAC. Dr. Hermann Reuter of the TAC was present as was Professor Greg Hussey of Red Cross Children's Hospital. 25.9. On 30th September 1999, TAC Executive members including, Zackie Achmat, Mark Heywood and Phumi Mtetwa held a meeting with the Minister of Health, Dr Manto Tshabalala-Msimang, and the Director General of Health, Dr Ayanda Ntsaluba, where the need for a rapid resolution of the court case was discussed. 25.10. On 30th November 1999, TAC Executive members Zackie Achmat, Mark Heywood and Sharon Ekambaram met with the Chief Executive Officer of the First Applicant, PMA, Mrs Miryeena Deeb, Mrs Maureen Kirkman of the PMA, and a representative from Abbott Laboratories. The TAC again requested the withdrawal of the Court action and discussed the contested section 15C. Mrs Deeb offered to revert to the TAC before January 15th 2000 with what the PMA considered to be a suitable re- wording of Section 15C of the Medicines Act. At the same time a prayer vigil was held outside the PMA offices to commemorate those who had died of AIDS related illnesses in 1999. 25.11. On 1st December 1999, Mrs Vicki Ehrich of the Seventh Applicant, Glaxo Wellcome, accepted a petition from TAC members in Khayelitsha calling for a lowering of the price of their patented medicine AZT (Zidovudine). Dr. Hermann Reuter, TAC Western Cape Executive member, was present. 25.12. On 13th March 2000, a group of twenty TAC representatives, led by Mr Mark Heywood, met with Mr Barry Smith, the Chief Executive Officer of the pharmaceutical company Pfizer (SA). The purpose of the meeting was to request a price reduction of Pfizer's patented medicine Diflucan (Fluconazole) or alternatively for Pfizer to issue TAC or the South African Government with a voluntary licence for the use of this medicine 25.13. On 3rd April 2000, TAC members led by Mr Mark Heywood demonstrated outside Pfizer offices in Johannesburg. Simultaneously TAC members led by Midi Achmat and Deena Bosch demonstrated outside the offices of Warner Lambert (formerly the Twenty-fifth Applicant) in Cape Town. My legal representative has advised me that Warner-Lambert has since withdrawn from this matter. 25.14. On 6th April 2000, TAC executive members Zackie Achmat, Mark Heywood and myself met with Minister of Health, Dr Manto Tshabalala- Msimang, to discuss the affordability of essential medicines. 25.15. On 9th & 10th May 2000, TAC members, led by Siphokazi Mthati and including Christopher Moraka, (a TAC member who died of AIDS related illnesses on 27th July 2000) made presentations to a public hearing of the Parliamentary Health Portfolio Committee. TAC members called for measures to be taken to gain access to medicines and for the resolution of the court case. The First Applicant was represented by Mrs. Deeb and the Seventh Applicant was represented by Mrs. Ehrich. 25.16. On June 20th 2000, a mediation between the TAC and First Applicant and its members was due to take place in Johannesburg, facilitated by Justice Edwin Cameron and Dr John Matjila. The resolution of the court case was one of the matters that had been tabled for discussion. After initially formally agreeing to take part in the mediation, the PMA's representatives unilaterally withdrew from this meeting, without explanation, on June 18th. 25.17. On June 26th 2000, a demonstration was held outside the Pfizer (Pfizer is a member of the First Applicant) plant in Pietermaritzburg led by TAC member Mr Zamokhule Zwane. The purpose of the demonstration was to highlight issues of access to essential medicines. 25.18. On July 9th 2000, the TAC organized a Global March for Access to HIV/AIDS treatments. Over 6000 people participated. A Memorandum was addressed to the South African government and the International Federation of Pharmaceutical Manufacturers Association (IFPMA). This Memorandum called for an end to the litigation. It was handed over by the Vice-President of COSATU, Ms Joyce Phekane, to the Minister of Health, Dr Manto Tshabalala-Msimang, the Executive Director of the Joint United Nations Programme on AIDS (UNAIDS), Dr Peter Piot, and the President- elect of the International AIDS Society (IAS), Dr Stephano Vella. 25.19. On 14th October 2000, after all entreaties to lower the price of fluconazole had failed - people were continuing to die because of lack of access to fluconazole and not a single tablet of the Pfizer "donation" promised in March 2000 had reached the public sector hospitals, TAC chairperson, Zackie Achmat brought a safe, effective and good quality generic into the country to defy the patent abuse by Pfizer. In November the Medicines Control Council (MCC) granted Brooklyn Medical Centre in Cape Town a conditional exemption for use of the unregistered medicine, under Section 21 of the Medicines and related Substances Control Act 101 of 1965. Both TAC and the MCC agreed that section 21 exemptions do not offer a lasting solution to this crisis of availability of affordable medicines. 25.20. On 28th October 2000, TAC Deputy Chairperson, Mr Mark Heywood, made a presentation to the Human Rights, Law and Ethics Committee of the South African Medical Association (SAMA) on the subject of the affordability of essential HIV/AIDS medicines in South Africa. Members of the First Applicant and the Thirteenth and Fourteenth Applicant were present. 25.21. On November 16th 2000, TAC Deputy Chairperson, Mark Heywood, met with Ms Kathleen Laya, Public Policy Manager, Vicki Ehrich, Director, Corporate Affairs and Simon Sargent, Head of Government and Industry Affairs - all senior representatives of Glaxo Wellcome in London and discussed the need to resolve the court case. The meeting was also attended by a Labour Party Member of Parliament, MP Barbara Follett. According to Mr Heywood, although the litigation was discussed the representatives of Glaxo Wellcome did not indicate that the First Applicant had by then caused the matter to be set down for hearing. 25.22. On 1st December 2000, Mr Mark Heywood joined Mrs Miryeena Deeb of the First Applicant as presenters at a seminar hosted by the South African Human Rights Commission. The purpose of the seminar was to discuss the question of human rights versus property rights, and the pending litigation was extensively discussed. According to Mr. Heywood, Mrs Deeb did not indicate that the PMA had by then caused the matter to be set down for hearing. 25.23. On 1st December 2000, TAC members held a demonstration outside the offices of the PMA led by the General Secretary of COSATU, Mr Zwelinzima Vavi. A Memorandum calling for the withdrawal of the legal action was handed to Mrs Kirkman. Once again, the First Applicant failed to inform the TAC that the matter had been set down for a hearing. 25.24. On 13th January 2001, TAC members led by Executive member Nathan Geffen and TAC Chairperson Mr Zackie Achmat, gathered at Cape Town International Airport to welcome home Mr Morne Visser, a local actor, who was returning from holidaying in Thailand, bringing with him a batch of the generic medicine fluconazole for prescription to patients registered with the Brooklyn Medical Centre. 26. The Amicus Applicant has consistently highlighted patent abuse, profiteering and the unnecessary loss of lives due to HIV/AIDS in South Africa, poor countries and communities across the globe. For instance, TAC regularly condemned the pressure of the Fourth Applicant - Bristol-Myers Squibb for its unlawful pressure on Thailand for the manufacture of drugs - stavudine (D4T) and didanosine (DDI) that are not patented there and which the Fourth Applicant had not discovered. 27. Confirmatory affidavits and copies of all documentation referred to in paragraphs 25.1 to 25.24 can be made available to this Honourable Court, should it be so requested. SUBMISSIONS TO BE ADVANCED BY THE TREATMENT ACTION CAMPAIGN, THEIR RELEVANCE TO THE PROCEEDINGS AND THE REASONS FOR BELEIVING THE SUBMISSIONS WILL BE USEFUL TO THE COURT AND DIFFERENT FROM THOSE OF OTHER PARTIES 28. The TAC wishes to intervene as amicus curiae to support the constitutional principles of access to essential medicines as they are contained in the following provisions of the Medicines and Related Substances Control Amendment Act, No. 90 of 1997 (Amendment Act) 28.1 Section 10 - introducing section 15C "Measures to ensure supply of more affordable medicines" or the principle of parallel importation. 28.2 Section 14 - introducing section 22F on "Generic Substitution". 28.3 Section 14 - introducing section 22G on "Pricing Committee". 29. The scale of the HIV/AIDS epidemic and its impact on society, together with the constitutional issues pertaining to access to life-saving essential medicines for people living with HIV/AIDS, form the basis of the organisation's interest in the above proceedings. The TAC respectfully submits that its participation will assist the Court in coming to a just resolution of the issues at stake THE LINK BETWEEN THE HIV/AIDS EPIDEMIC AND THE ISSUES TO BE DECIDED BY THIS COURT 30. In their response to the TAC's request for permission to act as amicus curiae the Applicants' attorney states that "No issues specific to the interests presented by TAC and not equally applicable to other incurable diseases arise for decision in this application." 31. The TAC respectfully submits that this is not the case. The HIV/AIDS threat has been consistently singled out by the Government as a health threat that deserves special attention. This is evident from a range of government publications and policies that can be made available to the Court, if requested. The nature and extent of the health risks posed by HIV are of such a magnitude that such risks are unparalleled in our history and are simply not comparable to any other incurable disease. I respectfully submit that the Applicants in these proceedings are acutely aware of the scale and impact of the HIV/AIDS threat and that none would dispute that it constitutes the greatest health risk ever faced by South Africa. The epidemic has the potential to decimate the population on an unprecedented scale. Its effects are being felt daily. 32. Further, epidemiologists agree that HIV infection is a nodal point for many other opportunistic infections that threaten to assume epidemic proportions if HIV is not managed and controlled. Tuberculosis, which has once again run out of control largely because of HIV, is a case in point. 33. The Medicines and Related Substances Control Amendment Act is one of general application. It is clearly intended to make all medicines more affordable (not just medicines for 'incurable diseases'). This is the purpose of the amendments introducing generic substitution and a pricing committee. 34. However, it is also clear that the wording of sections of the Act envisages "certain circumstances" where specific measures may be warranted to make medicines more affordable "so as to protect the health of the public." 35. I believe that the HIV/AIDS epidemic is precisely one of the "circumstances" envisaged by the legislature, where a public health imperative justifies measures by the Minister of Health to prescribe conditions for the supply of more affordable medicines. It would therefore benefit this Court to elaborate why. 36. Further, the TAC believes the decision of this court on the issues before it will establish a far-reaching precedent that will impact profoundly on the ability of poor people to have access to essential medicines and thus their prospects for dignity and life, not only in South Africa but in developing and resource constrained countries world-wide. 37. As its Constitution indicates, the TAC believes that the Constitution of the Republic of South Africa bestows the legislature with a definite role in improving access to essential medicines. TAC believes that the Medicines and Related Substances Control Amendment Act will reduce the price of medicines in the public and private health sectors. THE SCALE OF THE HIV/AIDS EPIDEMIC IN SOUTH AFRICA 38. South Africa faces a health crisis on a scale that is utterly unparalleled. 39. In many respects the HIV epidemic constitutes a public emergency. Indeed, many commentators have described it as such. The duty to protect public health falls squarely on the state, and managing these epidemics requires both preventative and medical strategies. Access to medicines is essential. 40. However, I believe that the barriers of cost associated with denial of access to medicines for HIV/AIDS will assist the Court to understand many of the broader questions, as well as the defence of the respondents. 41. The results of the 10th Annual Survey of HIV Prevalence in Pregnant Women attending public ante-natal clinics, conducted by the Department of Health in October/November 1999, revealed that there were 4,2 million people infected with HIV in South Africa. This report is annexed as Annexures AA23. 42. A resolution of the Medicines Control Council (MCC) in November 2000 "noted the serious challenge posed by the HIV/AIDS to the health sector, and the profound suffering that the disease inflicted on those infected." 43. HIV infection usually has a long period of asymptomatic wellness, usually between 7 and ten years. After this period a person's immune system has been sufficiently weakened by HIV as to make her vulnerable to illness. Acquired Immune Deficiency Syndrome (AIDS) is the end-stage of HIV infection. It is diagnosed when a person's immune system is so seriously damaged that the body is no longer able to fight off illness. Without medical intervention and treatment an AIDS diagnosis is followed in months, or at most after one or two years, by death. 44. Unless there is access to appropriate medicines most of the four million people living with HIV in South Africa will become ill and die within ten years of infection. 45. In its current HIV/AIDS & STDs Strategic Plan for South Africa (2000-2005) the Department of Health estimates that in 1998 there were approximately 165,000 people living with AIDS and 120,000 AIDS deaths. The Department of Health projects that by 2002 a quarter of a million South Africans could die of AIDS per annum, and that this figure will rise to more than a million by 2008. A copy of the Strategic Plan will be available at the hearing. 46. Recognising the scale of this threat, in December 1999, Dr Kofi Anan, the Secretary-General of the United Nations (UN) described the AIDS epidemic in Africa as "a humanitarian emergency ... beyond the imagination of those who do not live there". A copy of Dr Anan's speech containing this comment is annexed as Annexure 24 . 47. The South African Minister of Health has described the HIV/AIDS epidemic as the most important challenge facing South Africa since the birth of our new democracy. 48. The Medicines and Related Substances Control Amendment Act, in so far as it is intended to improve access to safe and affordable medicines, therefore has a very direct bearing on the rights to dignity, life and access to health care services of people with HIV. It also has a bearing on the State's ability to respond to this emergency. 49. Whilst the Act intends to make all medicines more affordable, a measure TAC supports, the scale of the HIV/AIDS epidemic and its catastrophic impact, creates an urgency and immediacy that is simply not equally applicable to other incurable illnesses as suggested in the letter from the Applicants' attorney. THE LINK BETWEEN HIV AND THE AFFORDABILITY OF ESSENTIAL MEDICINES 50. During the 1990s there were major scientific breakthroughs in understanding and treating HIV. Today, many HIV-related illnesses (known as 'opportunistic infections') can be prevented and treated. Members of the First Applicant produce a range of drugs for the prevention and treatment of opportunistic infections, both patented and off-patent. Pfizer (fluconazole and azithromycin), Bristol-Myers Squibb (amphotericin B), Bayer (ciprofloxacin), Roche (ceftriaxone, cotrimoxazole and gancyclovir), Abbott (foscarnet), Merck (ivermecktin), and Abbott's (clarithromycin) are some of the Applicants or members of the First Applicant in the current case that produce these drugs. 51. Since 1987, a new therapeutic class of drugs (known as anti-retrovirals) were developed. By 1996, a specific class of anti-retrovirals called protease inhibitors were developed. These drugs target HIV directly and massively slow down its replication. By doing this they prevent the destruction of the human immune system and thereby prevent illness and AIDS. To be effective several drugs must be taken at the same time. This is known as 'combination therapy.' A copy of an expert affidavit explaining the efficacy of these medicines, has already been referred to and is attached hereto as item AA3. I assume that none of the Applicants would dispute the efficacy of these drugs. 52. At current prices these medicines cost between R2000 and R4000 per patient per month. Consequently, they are prescribed predominantly to patients in the private health sector. 53. On December 1st 2000 a Memorandum of Understanding between the Minister of Health and Pfizer Laboratories was signed. The Memorandum refers to a legal agreement by the company Pfizer to donate an essential medicine, Diflucan, to the SA Government for two years. The reason for the donation is because the government cannot afford to purchase sufficient quantities to meet demand for the medicine at the current tender price to the public sector of R28 per pill. The price of a bioequivalent generic version is R2.00 per pill. 54. The Memorandum, which is annexed hereto as Annexure 25, recognizes that "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 because of the limited nature of the resources available to it." 55. Annexure A of the Memorandum states that 80% of HIV/AIDS patients are treated in the public sector. 56. The Agreement is an explicit confirmation that at the current price, this particular drug, and many others, is not affordable. This and other medicines are therefore either not purchased on state tender, or purchased and prescribed in the public health service in insufficient volumes, to meet public need. 57. The fact that the price of medicines is a barrier to access to health care services is unambiguously stated by a range of reputable and authoritative sources. For example, Annexure "M53", supplied by the applicants, show that Professor Peter Folb, the former Chairman of the Medicines Control Council, told the Parliamentary Portfolio Committee on Health that in South Africa " there is an inordinately high cost of medicines". CONSTITUTIONAL DUTIES COMPELLING THE GOVERNMENT OF SOUTH AFRICA TO TAKE MEASURES TO CONTROL THE PRICE OF ESSENTIAL MEDICINES 58. Taking reasonable legislative and other measures to improve access to health care services, in this instance medicines, is a constitutional obligation, intimately linked to the duty on the state to protect human dignity and life. 59. I believe that the following rights are adversely affected by a failure to make medicines affordable, alternatively the following rights enhance the duty on the State to take reasonable measures to progressively realize the right to have access to health care services: THE RIGHT TO EQUALITY 60. The right to equality includes the full and equal enjoyment of all rights and freedoms, including equal rights to dignity, life and access to health care services. Presently there is a profound inequality, based on race and socio- economic conditions, in access to medicines. THE RIGHT TO HUMAN DIGNITY 61. The denial of access to affordable medicines leads to unnecessary pain and suffering that undermines the dignity and quality of life of people living with HIV/AIDS. Family life is an inherent part of dignity; but normal family life is removed from people whose illness leaves them debilitated, and unable to care for themselves. 62. The ability of people with HIV, AIDS or other serious illnesses to retain inherent dignity is inextricably linked to their ability to afford essential medicines. THE RIGHT TO LIFE 63. HIV is a life-threatening virus. The Department of Health estimates that it has led to the deaths of over 500,000 people in South Africa. However, in countries where medications for HIV or AIDS are affordable HIV has evolved into a chronic, but manageable condition. Access to medications has led to decreases in AIDS related deaths in the United States, Canada and Europe of over 50%. 64. In developing countries such as Brazil, legal measures, similar to those contemplated by the Medicines Act, have caused a drop in the price of medicines. THE RIGHTS TO HEALTH CARE, FOOD, WATER AND SOCIAL SECURITY 65. Health care services include physical facilities such as clinics and hospitals; human resources, such as doctors, nurses, pharmacists and dentists; and palliative or curative medicines. If any of these ingredients are removed, access to health care, or the prospect of progressively improving access to health care is removed. 66. I believe that the national health policy of the Government, which is set out in detail in the White paper for the Transformation of the Health System in South Africa, seeks to address each of these ingredients. THE RIGHTS OF CHILDREN 67. Every child has the right to basic health care services and a child's best interests are of paramount importance in every matter concerning the child. These rights create a number of duties on the government. 67.1. Approximately 70,000 children are born with HIV as a result of mother to child transmission of HIV. Scientists have accumulated significant research-generated evidence to show that with appropriate and affordable treatment this number could be cut by between 30 and 50%. 67.2. Most children who are born with HIV usually live for several years, before succumbing to AIDS. During this time access to effective and affordable medicines is important. Not only does it reduce the suffering of the child and its parents, but it can lead to cost-savings for the health system, as hospitalization is avoided. 68. The duty to act in the best interests of the child creates a duty on the State to take measures to provide access to health care services for parents that can delay and prevent children being orphaned. According to the United Nations Report of the Global HIV/AIDS epidemic (June 2000) South Africa already has approximately 420 000 children orphaned as a result of AIDS. Unless essential medicines, that can prevent the premature death of parents, are made accessible, this number will increase dramatically in the years ahead. LIMITATION OF RIGHTS 69. The amicus applicant submits that the principles of parallel importation, generic substitution and price control as envisaged by the respondents in the Medicines and Related Substances Control Amendment Act (90 of 1997) do not infringe upon the constitutional rights of the applicants. 70. Alternatively, if they do, the Amicus Applicant would argue that Section 36(1) of the Constitution is applicable. The Amendment Act is a law of general application. Secondly, the infringements are reasonable and justifiable. South Africa faces an epidemic which is killing over 100 000 people per year. Economically active adults, students, parents and babies are dying because the treatment for HIV is unaffordable at the current prices charged by the patent-holders. 71. 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. LEGAL FRAMEWORK 72. In the context of all the aforegoing, and taking into consideration the purpose of the Act, the Amicus Applicant will advance arguments to support the constitutionality of three provisions in the Amendment Act. The supported provisions are generic substitution, parallel importation and price control. These provisions cannot be seen in isolation as they constitute the building blocks of a legal framework for the provision of affordable medicines. 73. A legal framework that will contain costs and make medicines more affordable is essential to fulfill the constitutional obligations of the state towards all people in South Africa and in particular towards people living with HIV/AIDS. PARALLEL IMPORTATION AND MEASURES TO MAKE MEDICINES AFFORDABLE 74. The Amicus Applicant submits that section 14 of the Amendment Act introducing section 15C into the Principal Act empowers the Fourth Respondent to make regulations to reduce the prices of medicines and to increase their affordability to protect public health. The powers allocated to the Fourth Respondent are circumscribed by two factors: under certain circumstances and to protect the health of the public. Here, the section gives effect to the principles of TRIPS (The Agreement on Trade Related Aspects of Intellectual Property Rights), in particular, Article 8 of the agreement. Article 8 of TRIPS: Principles "1. Members may in formulating or amending either their laws and regulations, adopt measures necessary to protect public health and nutrition, and to promote the public interest in sectors of vital importance to their socio-economic and technological development, provided that such measures are consistent with the provisions of this agreement. "2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology. (TRIPS Text Annexure M19) 75. When read with Articles 30 and 31 that allow members the right to override patent rights in limited circumstances, it is clear that this international agreement envisages situations where signatories may have to introduce laws, regulations or policies that may conflict with a strict application of TRIPS. Such exemptions are allowed in the interest of public health, also within the broad category of nutrition and to promote public interest in sectors of vital importance to a country's socio-economic and technological development. There can be little doubt that TRIPS agreement does not prevent countries from taking measures to protect public health including technology transfer, parallel importation and compulsory licencing. Then, World Health Organisation authors, German Velasquez and Pascale Boulet recognised that a range of possible measures to alleviate burdens imposed by intellectual property protection can be adopted by a member state to ensure that countries have access to health care services, and in particular, access to medicines. Apart from the conditions for issuing compulsory licences, Velasquez and Boulet identify a broad scope for action by Member States. "Five kinds of [patent] use without authorization of the right holder are expressly envisaged by the Agreement: ? licences for public non-commercial use by the Government; ? licences granted to third parties authorized by the Government for public non-commercial use; ? licences granted in conditions of emergency or extreme urgency; ? licences granted to remedy a practice determined after administrative or judicial process to be anti-competitive; ? licences arising from a dependent patent. "However, [they continue], the Agreement does not state that these are the only cases authorized. Thus Member States are not limited in regard to the grounds on which they may decide to grant a licence without the authorization of the patent holder. " (Globalization and Access to Drugs: Perspectives on the WTO/TRIPS Agreement; 1997/1999 WHO Geneva) 76. In particular, it is sub-section 15C (a) that introduces the concept of parallel importation or the exhaustion of intellectual property rights. I have read the affidavits of the First Applicant and that of Dr. Ayanda Ntsaluba on behalf of the Respondents. The Amicus Applicant concurs with the Respondents' reading of 15C as set out in the answering affidavit of Dr. Ntsaluba at paragraph 77 to paragraph 88. 77. Velasquez and Boulet, correctly rely on Article 6 of TRIPS and footnote 6 attached to Article 28 to establish the right of any jurisdiction to authorise parallel imports. They hold that: "This provision of the Agreement is very important in so far as it allows the supply of the product to be increased and prices to be moderated through competition, in other words, improving accessibility through importation. Member States could improve the accessibility of products, including drugs, by establishing that the exclusive rights of the patent holder may not be claimed in cases where products marketed with that patent holder's consent in any other country are imported. No State may complain of a breach of the Agreement on this ground." (p23) 78. In addition to the exceptions provided in TRIPS itself, the Amicus Applicant submit that other international instruments on the rights to dignity, life and health care access, as well as children's and women's rights instruments and the South African Constitution, provide further support for legislation that allow measures such as compulsory licencing, parallel importation and technology transfer to access medicines and health care services. Further Legal argument on these issues will be addressed to the above Honourable Court. GENERIC SUBSTITUTION OF MEDICINES NOT UNDER PATENT 79. Generic substitution of off-patent medicines as envisaged in section 14 of the Amendment Act introducing section 22F into the Principal Act is essential to contain costs in the private medical sector. The private medical sector covers both people who have access to medical aid and those that do not have access to medical aid. All medical schemes are required by law to include people with HIV/AIDS. The state has a duty to make medicines and health care services accessible to everyone in the public and private sector. As demonstrated in all the affidavits by TAC volunteers and office bearers, medical practitioners and the record before this Honourable Court Court, high prices are a major obstacle to accessibility. In addition, high costs of medicines in the private sector will shift patients onto an already over- burdened public health sector. (See Annexure: AA8 Affidavit Dr. Leon Geffen). 80. Generic substitution will benefit all members of the public who rely on private sector care. However, people with HIV/AIDS who need treatment for opportunistic infections such as PCP pneumonia, shingles, fungal and bacterial infections, meningitis, chronic sinusitis and so on will benefit directly through accessing lower cost, good quality generics. In addition, over time, medical schemes will be able to sustain provision of good services to all their members because of lower priced generics. PRICE CONTROL AND PRICING COMMITTEE 81. Section 14 of the Amendment Act, introducing section 22F into the Principal Act makes provision for a pricing committee and the creation of regulatory mechanisms for transparent pricing. This is an essential safeguard against patent abuse and to keep prices lower. The South African Pharmacy Council in annexure R12.5 to the Respondents' papers notes that in most major markets, governments have introduced some form of direct or indirect price control of medicines. Direct price controls have been introduced in Britain, Germany, the Netherlands, Sweden and Denmark. 82. The Amicus Applicant submits that the research and development (R&D) costs of many of the antiretroviral drugs such as those produced by the Fourth Applicant (stavudine and didanosine) and those of the Seventh Applicant (zidovudine and lamivudine) used to treat HIV/AIDS were publicly funded in that the initial, most expensive stage of the R&D was carried by government agencies. The agencies concerned were Yale University and the National Institutes for Health in the United States of America. 83. The most expensive stage of R&D was carried out by government or public agencies. 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. The operation of a pricing committee and a transparent pricing mechanism would establish the facts and be able to prevent price gouging. 84. The Amicus Applicant submits that the formation of a pricing committee as envisaged by the Amendment Act will indeed lower prices for the consumer and is in line with the practice of major markets in the world. It will specifically assist in combating excessive prices for HIV/AIDS medications. INTERNATIONAL OBLIGATIONS AND DUTIES 85. The applicants base a substantial part of their argument on grounds that the Medicines Act is a violation of South Africa's legal obligations under the Trade Related Aspects of Intellectual Property Agreement (TRIPS) of the World Trade Organisation. 86. However, the Applicants' objection to the Amending Act ignores the government's obligations under international law. These obligations are consistent with the South African Constitution. I believe that as amicus curiae the TAC could bring a vital perspective that is currently missing in this area. 87. The duty to take reasonable legislative and other measures to improve access to health care services, is recognised internationally. 88. Since 1999, the international community, has given a special priority to measures to improve access to medicines for HIV, tuberculosis and malaria. Although tuberculosis and malaria are 'curable' illnesses, they are closely linked with HIV. People with malaria or TB are more likely to die if they also have HIV infection. 89. Unlike with other "incurable diseases" the United Nations (UN) has developed a specific focus on HIV. It has specifically published Guidelines which recommend that States should "enact legislation to provide for the regulation of HIV-related goods, services and information, so as to ensure widespread availability of qualitative prevention measures and services, adequate HIV prevention and care information and safe and effective medication at an affordable price." (United Nations, HIV/AIDS and Human Rights, International Guidelines, 1998 , Guideline 6, attached). 90. In particular I believe that no regard is given by the applicants to obligations imposed by the International Covenant on Economic, Social and Cultural Rights (CESCR), the Convention on the Elimination of all forms of Discrimination Against Women (CEDAW) and the Convention on the Rights of a Child (CRC). THE INTERNATIONAL COVENANT ON ECONOMIC, SOCIAL AND CULTURAL RIGHTS (ICESCR) 91. ICESCR came into force on 3 January 1976 and was signed by South Africa on 3 October 1994. It still awaits ratification. The preamble states parties' recognition of the inherent dignity of human beings being the source from which these rights are derived. The Covenant also recognises that conditions must be created for the enjoyment of freedoms and rights. 92. In particular, signatories are obligated to take steps, including the adoption of legislative measures, in order to achieve the progressive realisation of the rights recognised in the Covenant. For present purposes, the right recognised by the Covenant is the right to the highest attainable standard of health as contained in Article 12. 93. To achieve full realisation of this right, the states parties may take whatever steps necessary for the "reduction of the stillbirth-rate and of infant mortality and for the healthy development of the child" and the "prevention, treatment and control of epidemic, endemic, occupational and other diseases". In its general comment 14 (2000), the Committee on Economic, Social and Cultural Rights of the United Nations Economic and Social Council (ECOSOC) recognises that the right to health includes among other things, the right to affordable health facilities, goods and services. THE CONVENTION ON THE ELIMINATION OF ALL FORMS OF DISCRIMINATION AGAINST WOMEN (CEDAW) 94. CEDAW came into force on 3 September 1981 and was ratified by South Africa on 15 December 1995. In the context of HIV/AIDS, there is evidence linking women's vulnerability to HIV/AIDS and the inequalities in society. 95. It is against this background that the obligations under this convention must be read. In particular Article 12.1 of CEDAW provides that States Parties should take all appropriate measures to eliminate discrimination 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, including those related to family planning. By taking measures to increase access to affordable medicines, government has discharged this duty. THE CONVENTION ON THE RIGHTS OF A CHILD (CRC) 96. CRC came into force on 2 September 1990 and was ratified by South Africa on 16 June 1995. Article 6.2 provides that states parties must ensure to the maximum extent possible the survival and development of the child. 97. I respectfully submit that adopting legislative measures to bring affordable medicines to children infected with HIV/AIDS in order to prolong their lives and to HIV infected pregnant mothers in order to reduce mother to child transmission is consistent with the obligations of government as contained in this convention. 98. Furthermore, it is recognised in the convention that the family is the natural environment for the growth and well being of children. States parties are therefore required to protect the continuation of family life. By providing affordable treatment to parents infected with HIV, the ever-growing number of AIDS orphans can be reduced and more and more people living with HIV/AIDS will live longer. CONDONATION 99. I am advised that if Rule 16A applies, this application ought to have been brought within 20 days of the date on which the Notice of Set Down was lodged with the Registrar of this Honorable Court, pursuant to the Provisions of Rule 16A. I have been advised that applications concerning the admission of an amicus curiae are now governed by Rule 16A of the High Court which came into effect on 25 August 2000 substantially after the main application was launched. Accordingly I have been advised that Rule 16A probably does not govern the present application and that it falls to be dealt with in terms of this Court's inherent jurisdiction. Nevertheless I have attempted to follow Rule 16A as closely as possible and if it is held that this Rule applies to this application, I humbly seek condonation for not complying strictly with its terms. This application is out of time and I respectfully request this Honourable Court to condone the late filing thereof. 100. I respectfully submit, on the basis of the aforegoing considerations, that the Treatment Action Campaign has in this application set out sufficient interest and good cause for its admission as amicus curiae in these proceedings. 101. As set out above, during the past 25 months the TAC was actively engaged in proposing to both principal parties that the matter be settled expeditiously. 102. The TAC does not wish to unnecessarily add to already voluminous pleadings and will therefore not burden the court with all the documentation relating to TAC attempts to settle the matter. The documentation will be on hand should any of the parties require sight of them or dispute the engagements of the TAC with the main parties to the litigation. 103. In 1999, the first applicant publicised world-wide that this case had been suspended and the TAC assumed that this was still the state of the litigation until 11 January 2001 when Mrs Maureen Kirkman, Head of Scientific and Regulatory Affairs of the PMA telephonically informed Mark Heywood, Deputy Chairperson of the TAC, that the hearing in the above matter had been set down for the period 5 March 2001 to 13th March 2001. 104. Thereafter at the earliest opportunity, its National Executive Committee meeting held on 15th and 16th January 2001, the TAC sought and received from the committee members a mandate to seek permission from the court to intervene as an amicus curiae. The TAC then briefed the AIDS Law Project (ALP) to act as its attorneys of record. The TAC acted expeditiously as soon as it heard that the matter had been set down and made arrangements to obtain copies of the pleadings. 105. On 26 January 2001 the ALP sent letters to the attorneys of record for the applicants and respondents seeking permission to intervene as an amicus curiae in the matter and setting out their reasons for doing so. According to Rule 16A of the above Honourable court, an answer was due from the parties by 2 February 2001. 106. On 6 February 2001, a letter was received from the attorneys for the Applicants stating that they had been instructed to withhold consent for the reasons set out in the letter attached hereto as annexure "AA7". The attorneys for the Respondent have consented to the TAC intervening as an amicus in this matter and written consent is attached as Annexure AA6. 107. The TAC submits that it has not delayed unnecessarily in bringing this application as it has been actively involved, since it became aware of the matter, in attempting to mediate between the parties and proposing to both parties that the matter be settled expeditiously. The TAC also acted without delay as soon as it became aware that the matter had been set down and took immediate steps to intervene. The TAC therefore seeks condonation from the court for late filing of the application in terms of Rule 16A of the above Honourable court and a waiver of the time limits imposed by Rule 16A. 108. The TAC submits that it will not disrupt or delay the hearing by the introduction of additional evidence on the issues canvassed by the parties. It will confine itself to submissions on generic substitution, price control and parallel importation. The TAC, if allowed to intervene, has no wish to delay the hearing of this matter as this would clearly be contrary to the interests of its constituency. If the TAC is allowed to intervene, the presiding judge may direct an extra day or half day for hearing of the amicus' submissions, after hours if necessary and also the nature of the introduction of new matter into the record. 109. The presiding judge may also direct that the amicus submission be in writing and that only those portions which require clarification be argued orally so as to avoid any delay of the matter. In any case, it is entirely feasible that the matter may require extra time for argument even without the intervention of the amicus, as often happens when cases are not completed within the time set down. The presiding judge may also direct that the amicus presents written argument together with oral argument of limited duration or that the amicus confines itself to the filing of heads of argument only. 110. The TAC respectfully submits that its admission as an amicus curiae would be in the interests of justice as envisaged by Rule 16A. The TAC can offer a unique perspective entirely lacking on the papers and if admitted will assist the court by providing that absent but crucial perspective. 111. If at the outcome of the hearing, the matter goes on Appeal to the Constitutional Court, the TAC will also seek permission to intervene as an amicus curiae and therefore submits that the above Honourable Court should have the benefit of considering the TAC's submission at the outset of the hearing. 112. WHEREFORE THE TAC SEEKS THE FOLLOWING RELIEF: 112.1. Admission as an amicus curiae to these proceedings; 112.2. Permission to present oral and written argument subject to the directions of the Court. ________________________ DEPONENT SIGNED AND SWORN TO BEFORE ME AT JOHANNESBURG ON THIS THE 16TH DAY OF FEBRUARY 2001, THE DEPONENT HAVING ACKNOWLEDGED THAT SHE KNOWS AND UNDERSTANDS THE CONTENTS OF THIS AFFIDAVIT, THAT SHE HAS NO OBJECTION TO TAKING THE PRESCRIBED OATH AND THAT SHE CONSIDERS THE SAME AS BINDING ON HER CONSCIENCE. ________________________ COMMISSIONER OF OATHS DATED at JOHANNESBURG on this the 16TH day of February 2001. __________________________ APPLICANT'S ATTORNEYS AIDS LAW PROJECT Centre for Applied Legal Studies 1ST Floor, D J du Plessis Centre West Campus University of the Witwatersrand Cnr Jan Smuts & Yale Road Braamfontein Tel: (011) 717-8637 Fax: (011) 403-2341 Ref: A Kleinsmidt / M Heywood TO: The Registrar The Above Honourable Court PRETORIA AND TO: ___________________________ APPLICANTS' ATTORNEY D M Kisch Inc. 66 Wierda Road East Wierda Valley Tel: 884-8852 Fax: 884-8873 Ref: Mr N Vermaak AND TO: ___________________________ RESPONDENTS' ATTORNEY The State Attorney 4th Floor South Fedlife Forum Tower Van der Walt Street Pretoria Tel: (012) 310-2704 Fax: (012) 322-0177 Ref: Ms Behardien