1. Law and Treatment Access AIDS Law Project briefing Portfolio Committee on Health Friday, 21 st February 2003 Jonathan Berger Law and Treatment Access Unit AIDS Law Project Centre for Applied Legal Studies University of the Witwatersrand

2. Law & Treatment Access Unit  Collaborate with and act on behalf of the Treatment Action Campaign (TAC)  Use law as a tool in removing barriers to treatment access  Play a key role in the development and implementation of an appropriate legislative and regulatory framework  Directly target high costs of essential medicines— including antiretroviral drugs (ARVs)—and laboratory diagnostic and monitoring services

3. Overview of presentation  Basic principles underpinning work  Setting the legal context  Rights implicated  Key sources of rights  Developing the existing legal framework to increase access to essential medicines and medical products  Using the existing legal framework to increase access

4. Basic principles  Access to treatment is a human right  Accessing treatment is dependant upon an appropriate human rights framework  Civil and political rights  Social and economic rights  Prevention and treatment of HIV/AIDS are inextricably linked

5. Setting the legal context  Rights implicated  Life, dignity and equality  Access to health care services  Enjoyment of the benefits of scientific progress  Key sources of rights  Constitution of the Republic of South Africa, 1996  Universal Declaration of Human Rights  International Covenant on Economic, Social and Cultural Rights

6. Developing existing legal framework to increase access  Doha Declaration on TRIPS Agreement and Public Health, November 2001  TRIPS “can and should be interpreted and implemented in a manner … to promote access to medicines for all”  Regulatory flexibility clarified and confirmed  States can determine the grounds for issuing compulsory licenses  States can determine what constitutes a public health emergency for purposes of using streamlined procedures

7. Developing existing framework (continued)  International Guidelines on HIV/AIDS and Human Rights: Revised Guideline 6  “States should enact legislation to provide for the regulation of HIV-related goods, services and information, so as to ensure … safe and effective medication at an affordable price.”  “States should also take measures necessary to ensure for all persons, on a sustained and equal basis, the availability and accessibility of quality goods … including antiretroviral and other safe and effective medicines ….”

8. Seminar on patent reform: 17 th /18 th March 2003  “Implementing Doha, Increasing Access: Rethinking Patent Law in the Context of a Right of Access to Essential Medicines”.  Twofold purpose:  Explore the regulatory options available under international law to reduce the prices of essential medicines and medical products under patent protection  Explore implications for the state’s positive constitutional obligations

9. Using existing laws and statutory institutions  Hazel Tau and Others v GlaxoSmithKline SA and Boehringer Ingelheim (Competition Commission)  Multinational drug companies abusing monopoly power by—  Charging the private sector  Excessive prices  For ARVs  To the detriment of consumers

10. The complainants  People living openly with HIV/AIDS (PWAs)  Hazel Tau; Isaac Skosana; Matomela Ngubane; Nontsikelelo Zwedala; and Sindiswa Godwana  Health care workers treating PWAs  Sr Sue Roberts; Dr William Mmbara; Dr Francois Venter; and Dr Steve Andrews  Labour and civil society  COSATU; CEPPWAWU; TAC; and the AIDS Consortium

11. The companies  GlaxoSmithKline South Africa (Pty) Ltd  The Glaxo Group, United Kingdom  Boehringer Ingelheim (Pty) Ltd  Ingelheim Pharmaceuticals (Pty) Ltd  The Boehringer Ingelheim Group, Germany  All related companies

12. Their drugs  Zidovudine (AZT)—GlaxoSmithKline’s Retrovir ®  Lamivudine—GlaxoSmithKline’s 3TC ®  AZT/lamivudine—GlaxoSmithKline’s Combivir ®  Nevirapine—Boehringer’s Viramune ®  Capsules and tablets (for adults) and solutions (for children)

13. Annual cost per patient per drug (exclusive of VAT & markup) ProductPrice sold to private sector International Best Price Offer— branded product WHO pre- qualified generic International Best Price Offer— generic AZT (300mg) ZAR 7 082,46 (US$ 674,52) (ZAR 4 599,00) US$ 438,00 (ZAR 1 890,00) US$ 180,00 (ZAR 1 470,00) US$ 140,00 Lamivudine (150mg) ZAR 7 786,67 (US$ 741,59) (ZAR 2 457,00) US$ 234,00 (ZAR 1 050,00) US$ 100,00 (ZAR 693,00) US$ 66,00 AZT/lamivudine (300mg/150mg) ZAR 9 733,33 (US$ 926,98) (ZAR 6515,25) US$ 620,50 (ZAR 2 782,50) US$ 265,00 (ZAR 2 142,00) US$ 204,00 Nevirapine (200mg) ZAR 4 380,00 (US$ 417,14) (ZAR 4 599,00) US$ 438,00 (ZAR 1 743,00) US$ 166,00 (ZAR 1 176,00) US$ 112,00 AZT solution (100ml: 50mg/5ml) ZAR 5 545,52 (US$ 528,14) —(ZAR 1 290,42) US$ 122,86 — Lamivudine solution (100ml: 10mg/ml) ZAR 4 288,90 (US$ 408,47) —(ZAR 919,80) US$ 87,60 —

14. How do these prices limit access?  People who pay for their own treatment  No treatment or substandard treatment  Limited options for second and third-line regimens  Workplace treatment programmes; clinical trials; community programmes  Limited time-period  In case of workplace, often limited to employees  Medical schemes  Limited coverage and capped medication cover  Concerns about sustainability of medical schemes

15. What is Commission asked to do?  Treat complaint as matter of urgency  Use full powers of investigation  Search, seize and summons (if necessary)  Drug companies notorious for non-disclosure of information  Refer matter to Competition Tribunal  Stop charging excessive prices  Impose substantial administrative penalty—up to 10% of total annual turnover in SA possible  Declaration for damages claims—class action?

16. Contact details  Fatima Hassan  hassanf@law.wits.ac.za  Teboho Motebele  motebelet@law.wits.ac.za  Jonathan Berger  bergerj@law.wits.ac.za  AIDS Law Project  (011) 717-8600 (T)  (011) 403-2341 (F)  www.alp.org.za