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

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

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

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

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

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

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 ….”

Seminar on patent reform: 17th/18th 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

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

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

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

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)

Annual cost per patient per drug (exclusive of VAT & markup) Product Price 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 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

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

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?

Contact details Fatima Hassan Teboho Motebele Jonathan Berger 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