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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 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
—
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 [email protected]
Teboho Motebele [email protected]
Jonathan Berger [email protected]
AIDS Law Project (011) 717-8600 (T) (011) 403-2341 (F) www.alp.org.za
