1. HIV/AIDS and ART in South Africa –
The Importance of generic ARTs
IES Health and Community Development 2013 Fall
Rachel Park
2. HIV/AIDS in South Africa – Quick Stats
• HIV/AIDS: very young disease; SA’s first recorded HIV/AIDS case in
1985
• 34 millions of people suffer world-wide; 5.7 million in SA.
• HIV/AIDS prevalence in SA: 17.3% (2013)
3. History of ARV treatment in South Africa
• Antiretroviral drugs can effectively
help HIV patients to live a normal life
• SA have been one of the biggest buyers
of ARV drugs in the world
• Greatest obstacle of providing ARV
medicines to the patients has been
money
• Pharmaceutical company = business
minded
• SA Healthcare system takes all the
burden of drug cost
4. Heavy cost of ART pressuring the government
• Under the formal President Thabo Mbeki :
• Zidobudin was declared to be “toxic.”
Resulted in 330,000 lives claimed by
HIV/AIDS and 35,000 children born with
HIV.
• Alternative and completely ineffective
treatments like garlic and lemon juice
were promoted
5. Why Generics ARVs?
• Help reduce the cost
• In average, generic ARVs cost
about 1/3 of the brand name
ARVs
• Creates competition in the
market
• Equally potent and effective as
the brand name drugs
• PEPFAR case – saved $320 million
• More 3rd line drugs available
6. So What’s stopping SA from getting more
generic ARVs?
1. South Africa’s Patent Law
- 20 years of patent protection
- Patents automatically obtained unless an objection raised
2. WTO: Agreement on Trade-Related Intellectual
Property Rights (TRIPS)
3. Strong opposition from the pharmaceutical
companies
7. Is there a way through the obstacles?
• There are a number of possible ways to go around – but South
Africa has not been utilizing those opportunities
• TRIPS
• Compulsory License: a permission to manufacture or import generic drugs without
the consent of the patent owner; only given when the general public’s well-being is
threatened
• South Africa Patent Law
• Revise the law to prevent “evergreening”
• Improve the infrastructure and the workers; patents too easily given in the
current system
8. Case study: India v. Novartis
• Lawsuit filed in 2006 by Novartis when
India rejected the reapplication for
Gleevec, a drug for chronic myloid
leukemia
• Example of “evergreening” practice
• India decided in 2013 that the new
version of the drug was not adequate
for another patent
• Generic drug cost: $2500
• Gleevec cost: $25,000-70,000
9. SA’s ARV treatment – its hopeful future and
other concerns
• Current efforts include
• Government’s revision of the patent Law; draft made
public in September 2013
• Doctors without borders, Treatment Action Campaign,
Section 27 actively calling for a reform
• Project Ketlaphela: government’s joint project to
manufacture active pharmaceutical inredients of ARVs
• R1.6 billion investment
• Drug price already lowered from several years ago
with new tender deal
• 80% treatment rate for those who are eligible
10. Personal Experience
• The benefits of HIV/AIDS generics will most likely come in a form
of:
• Greater access to the patients in Eastern Cape, where funding is not as
sufficient as Western Cape
• Saving money on drugs = more money to spend on other aspects of
healthcare (ex) prevention campaign, education, etc)
• Cheaper 3rd line drugs
• Positive outcomes in government effort: there are much support
for the eligible patients