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HIV/AIDS and ART in South Africa –
The Importance of generic ARTs
IES Health and Community Development 2013 Fall
Rachel Park
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)
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
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
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
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
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
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
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
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
Questions?

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Hiv and art

  • 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