1. Free Trade Agreements and Access to
Medicines
15
MILLION
BY 2015?
Global Fund Partnership Forum, June 2011
Manoj Pardesi, ITPC-India

2. India: Pharmacy of the Developing
World

3. India and TRIPS
• India had to comply with
TRIPS in 2005
• Indian Parliament included key
health safeguards
• Indian PLHIV and health
groups have filed patent
oppositions to ensure
continuing generic production
– Lamivudine/zidovudine
combination, nevirapine
syrup, tenofovir, darunavir
• Still key newer ARVs patented:
raltegravir, etravirine
• Hep-C treatment: pegylated
interferon: $15,000 per
person

4. EU-India FTA: making a bad
situation worse
• Negotiations started in 2007
• Complete secrecy
• EU not known as aggressive on IP as US
• However EU-South Korea FTA made
public
– Several TRIPS-plus provisions
• Growing concern and vague responses
from EU and Indian government officials

5. What does the EU want?
• Leaked text in 2009 and
2010 confirm aggressive
TRIPS-plus demands by
EU:
– Patent Term Extension:
Patent term to be greater
than 20 years
– Data Exclusivity: Monopoly
on off-patent medicines
– Enforcement measures:
Public money used to
enforce private rights;
hampering judges ability to
protect public health
– Investment provisions:
Allows MNCs to sue Indian
government over health
policies and laws

6. Indian groups protest; beaten up
• DELHI
• North-East
• South

7. Activists donate 5 ml blood to get
FTA message to Carla Bruni
• Global Fund ambassador
• As of 2009, the USFDA & WHO
Prequalification Programme approved
or pre-qualified 31 paediatric ARV
tablets produced by Indian generic
manufacturers but only eight adult
FDCs & 14 paediatric ARV tablets
produced by non-Indian & originator
manufacturers
• In 2008, Indian-produced generics
accounted for 91% of paediatric ARV
volume.
- A lifeline to treatment: the role of Indian generic
manufacturers in supplying antiretroviral medicines
to developing countries. Journal of the International
AIDS Society 2010;13:35.

8. Global Movement

9. MASS RALLY: Groups from India, Nepal,
Cambodia, Indonesia, Thailand, Malaysia in Delhi

10. EU-India FTA: Update
• Indian Prime Minister’s office: Nothing in FTA
beyond TRIPS/domestic law
• Concern on enforcement measures (EC trying to
argue that it is within Indian law)
• Investment provisions (allowing EU MNCs to sue
Indian government over health policies, drug
price control, etc.)
• EC and US bilateral pressure on India to
change domestic law to include TRIPS-plus
provisions outside of FTA
• India also negotiating FTA with EFTA
(Switzerland, Iceland, Norway, Lichtenstein)

11. What if India says no but others
countries sign FTAs?
• India could produce and export
• Importing countries can no longer import
• EU and US both negotiating FTAs across
developing world

12. EU negotiations across Asia
Country Status Details of FTA Negotiations
Cambodia LDC EU-ASEAN FTA
India Developing Country EU-India
EFTA-India
Indonesia Developing Country EU-ASEAN
EU-Indonesia
EFTA – Indonesia
Lao People's Democratic Republic EU-ASEAN
Malaysia Developing Country EU-ASEAN
EU-Malaysia
Myanmar LDC EU-ASEAN
Philippines Developing Country EU-ASEAN
EU-Philippines
Thailand Developing Country EU – ASEAN
EU-Thailand
Viet Nam Developing Country EU – ASEAN
EU-Vietnam

13. US re-joins the FTA party
• Trans-Pacific Partnership
Agreement: US, Australia, Brunei,
Chile, Malaysia, New Zealand, Peru,
Singapore, and Vietnam.
• What does the US want:
– Patents on new forms of old
medicines
• Exact opposite of Indian law
provision Section 3(d) because of
which there are no patents in India on
lamivudine/zidovudine combination,
tenofovir and nevirapine syrup
– No pre-grant oppositions
• Exact opposite of Indian law
provision that allows health and
PLHIV groups to challenge patent
applications
– Possible longer terms for patents
and for data exclusivity
– Investment provisions: Allows US • Even developed countries in
companies to sue governments over the deal worried: Australia,
health policies; in particular price New Zealand finding their
control and negotiation mechanisms medical programmes under
are under threat attack

14. Global Fund Statement on FTAs
• “Free Trade Agreements with the
developing world need to take into
account that the world’s major pandemics
predominantly affect the poorest people
and should recognize the role of India in
supplying quality low-cost medicines to the
developing world”, said Professor
Kazatchkine.
• Is it enough?

15. Bangkok Declaration demand of GF
• The GLOBAL FUND BOARD to:
– call attention to & condemn FTA negotiations that
include TRIPS-plus measures,
– to direct the Global Fund secretariat to assess the
financial impact of potential trade agreements, share
this analysis publicly,
– ensure the adoption of procurement systems that
make optimal use of TRIPS flexibilities including
encouraging countries to use compulsory licences to
ensure the GFATM does not pay excessive premiums
for patented medicines.

16. Global Fund and IP: A question of
transparency
• Has the Global Fund ever received letters or threats from
patent holders on their money used for generic procurement?
– Why not made public?
• Has Global Fund ever had to give emergency excess funds
for countries left out of voluntary licences?
– Why not made public?
– VLs will leave out Latin America, China Russia, Middle East,
Easter Europe
– Why open support for VLs with no concern on restrictive
conditions?
• Have developed countries held up Global Fund commitments
over trade or investment disputes?
– Why not made public?
– German government actions in Philippines

17. Global Fund and the “middle
income” game
• Lets get real about India:
– 1.4 billion live on less than $2 a day
– Nearly 40% get pushed back into poverty because of healthcare
spending
– From my own experience, those accessing the AIDS
programme are poor and lower middle class – and for whom
even with the free medicines, the cost of getting to the ART
centre is too much to bear.
• So-called middle-income countries are the ones:
– Struggling with TRIPS since 2005: newer ARVs patented
– Being left out of voluntary licence mechanisms
– Having to pay premium prices under so-called discount schemes
– Being left out of the Global Fund?