Transcript Law and Treatment Access

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—
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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
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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 prequalified
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