1. Findings and Recommendations on HIV, the
law and Treatment Access:
HIV/AIDS practice Meeting
Dubai, 12 January 2012
Tenu Avafia
HIV/BDP, NY

2. Finding 1:TRIPS Flexibilities have
increased generic competition
Source: MSF (2010), Untangling the Web of Antiretroviral Price Reductions, 13th ed.

3. Finding 2: Generic Competition has resulted in
increased treatment scale up
• 22-fold increase in
treatment in 7 years
• At end of 2010,
6 650 000 PWA were
receiving treatment
globally, about 47% of
those in need
• Only 23% of children
have access to ART
• 2011 HLM
commitment of 15
million by 2015

4. Finding 3: There is an Impending Treatment Crisis
• India produces >85% of generic
ARVs used by low and middle
income countries globally
• 2005 Indian Patents Act was
amended to comply with TRIPS
Agreement
• 2010 UNDP study shows that
more medicine patents being
granted in India
• Patenting of new medicines in
India will affect availability of
2nd and 3rd generation ARVs in
developing countries

5. Finding 4: Countries will have to use Flexibilities to
Sustain and increase Treatment Levels
• Up to 95% of PWA on ART still on first
generation treatment
• Because of resistance, switch to second
generation ARVs: some under patent
3.4x times more expensive, 3rd
generation up to 23.4 times more
expensive
• TRIPS flexibilities can reduce cost of
treatment for Hep C, and NCDs e.g.
Cancers, cardiovascular diseases
• Recommendation: Countries
should adopt and utilize the
TRIPS public health flexibilities
• Explore new TRIPS flexibilities
and modalities e.g. South-south

6. Indonesia
Oct 2004
GU (manufacture)
-lamivudine, nevirapine
7-8 years
(remaining patent
term)
0.5% of the net
selling value of
ARVs to patent
holder
Malaysia
Oct 2003
GU to import: didanosine;
zidovudine;
didanosine+zidovudine
2 years Offered 4%
Thailand
Nov '06
GU: to import/manufacture
Efavirenz
until 31 Dec. 2011 0.5%
Thailand
Jan '06
GU to import/manufacture:
clopidogrel
Patent expiry or
no longer needed
0.5%
Thailand
Jan 2007
GU to import/manufacture :
lopinavir/ritonavir
Until 31st January
2012
0.5% of total sale
value of the
imported/locally
produced
Thailand
Jan 2008
3 Government Use licence
for cancer drugs
Patent expiry or
no longer needed
3-5%
Brazil
May 2007
GU to import efavirenz 5 years 1.5%

7. Finding 5:The Emergence of IP enforcement
agenda is impeding access to treatment
• Several TRIPS+ FTAs involving US,
EU, Japan and EFTA countries
• TRIPS + measures can impede the
use of TRIPS flexibilities, often
resulting in higher drug costs
• UNDP model shows US CAFTA FTA
resulting in 40% increase a year
• DE resulted in 2 generic versions of
LPV/r being de-registered in
Ukraine
• Recommendation: Countries
should avoid signing TRIPS+ FTAs
that impedes access to treatment

8. Finding 5 continued: IP Enforcement Agenda
• Initiatives to use TRIPS Flexibilities could be endangered by
proliferation of “anti-counterfeiting” legislation:
– Tanzania, Subsidiary Merchandise Marks Act, 2008;
– Kenya , Anti-Counterfeiting Act ,2008;
– Uganda, discussing a Counterfeit Goods Bill since 2008, Revived
in Parliament in late 2011
– Reports of Legislation being deliberated in some southern African
countries
• Draft EAC Anti-counterfeit Act being discussed
• Several stakeholders have expressed concerns about impact
• Recommendation: Countries when passing domestic
legislation should not adopt measures that could impede
access to treatment

9. Finding 6: Current IP system does not Stimulate
innovation for ARVs, Communicable diseases, NTDs
• Despite the global increase in patenting in recent
years, there has been a decrease in innovation pipeline
• Current IP system is not stimulating innovation for ARVs
(FDCs and Pediatric) and NTDs
• Recommendation: Countries should explore systems
outside of current IP system to stimulate innovation in
pharmaceutical products
• IP system should only reward genuine innovation
• Possibilities include patent pools, R&D treaty, open
source innovation platforms

10. What can UNDP do in terms of:
• Legislative review and reform
• Judicial sensitization
• Parliamentary training
• Coordinating national working groups
• Working with Patient groups/treatment
advocates
• Providing technical assistance