The document discusses how intellectual property rights and trade policies can impact access to medicines in developing countries. It summarizes key issues including how patents extend drug company monopolies and raise drug prices, the flexibilities in international trade agreements like TRIPS that aim to promote access to generics, and ways powerful countries like the US have attempted to undermine these public health safeguards through additional trade agreements and political pressure on other nations.

1. Access to Medicines:
Trade and Intellectual Property Rights
Jennifer Flynn Amirah Sequeira
Managing Director Coordinator
Health GAP SGAC
02/07/13 www.healthgap.org 1

2. The Greatest Tool on Earth: The
Midwest Academy Strategy Chart
Goals Resources Allies Targets Tactics
Long-Term
Goal
Mid Range
Goal
Short-Term
Goal
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3. Accountable Global
Accountable Global
Economic & Health
Economic & Health
that is focused on
Power Analysis Market driven economy
Market driven economy
Deregulation
Deregulation
that is focused on Privatization
human rights Privatization
human rights US Nationalism
US Nationalism
10
Decisive
Decision
making Power
or Influence
Who are
decision makers?
8
Active How are decisions made?
Participant in
Decision-
making
Who is our opposition?
6
Power to have
Major Influence
on decision-
making Who are our allies?
4
Taken
into
Account
3
Can Get
Attention
6. What opportunities are there for us to exercise power?
SGAC
2
Not on
Radar
Die Hard Active Support Inclined Towards Inclined Towards Active Support Die Hard

4. What do we mean by
access to medicines?
 Access to essential medicines in developing countries is
primarily dependent on price.
 Patented, brand-name drugs are usually much more
expensive than generic drugs.
 Why? A patent is a government-conferred monopoly (usually
20 years).
 Monopoly = No competitors = Higher prices
 Access to medicines in developing countries requires
access to low-cost generic drugs.

5. Trade and Development Policy and
HIV: Things you need to know
• IMF Policies
• DOHA Declaration
• WTO
• TRIPS
• Free Trade Agreements
• Drug Seizures
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6. Intellectual Property
• Political in nature
• Competing demands
from the developed and
developing worlds
• The rights of companies
against the rights of
society
• Decisions about IP are
not about simply finding
ways to stimulate &
reward innovation
• Profits over people

7. Loans from the International Monetary
Fund Create Barriers to Access to
Medicines
• The IMF should exit the development business
• Eliminate the IMF's mission creep
• Debt cancellation
• No financial sector liberalization
• Let developing countries pursue expansionary
macroeconomic policies
• The IMF should not impede public spending through budget
caps
• IMF policies need to generate decent work
• Transparency and access to information at the IMF is vital
• Participation must open up
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8. Patent Hegemony:
The WTO TRIPS Agreement
• 1994 WTO TRIPS Agreement:
– Uniform global standards (the floor)
– 20-year patent protection for pharmaceutical
products
– Non-discrimination: fields of technology, imports
• Important flexibilities
– Standards of patentability, exclusions, and
limited exceptions, e.g., early working and
research
– Parallel importation
– Compulsory licenses
– Transition periods & patent mailbox
8

9. TRIPS Agreements (cont)
 The World Trade Organization’s (WTO) Agreement on Trade-
Related Aspects of Intellectual Property (TRIPS), adopted in
1995, sets the international minimum standard for intellectual
property (IP) rules, which includes patent rules.
 Most developing countries signed TRIPS, agreeing to adopt US-
style patent rules for the first time.
 “Flexibilities” allowing exceptions to patents (which allow the
introduction of generic competition during the life of a patent)
were also enshrined in TRIPS.

10. Common TRIPS-plus IP
provisions in U.S. FTAs
 Data Exclusivity: Provisions establishing special 5-10
year monopoly protections for pharmaceutical test data
required to demonstrate drug safety and efficacy and to
authorize a drug for use.
 May effectively bar compulsory licensing or generic
competition for drugs that are not patent protected. A
priority of Big pharma that is in most agreements.
 Patent extensions: These provisions extend the 20
years of monopoly protection mandated by TRIPS.
 Evergreening provisions: Obligations to extend
patent protection to minor improvements in, or new
uses of, older products (like Novartis attempted in
India).

11. Doha Declaration
• 2001: crisis in access to AIDS medicines, African
countries fight back.
• 9/11 anthrax scare.
• Doha Declaration on the TRIPS Agreement and Public
Health (Nov. 14, 2001)
– “We agree that the TRIPS Agreement does not and should
not prevent Members from taking measures to protect
public health. … [W]e affirm that the Agreement can and
should be interpreted and implemented in a manner
supportive of WTO Members' right to protect public
health and, in particular, to promote access to medicines
for all.”
• Paragraph 6 Decision (2003) – production for export.11

12. The Doha Declaration (cont)
 The Doha Declaration on the TRIPS Agreement and
Public Health emphasizes was adopted unanimously in
2001 by all 150 WTO members.
 TRIPS had left developing countries uncertain of their
right to promote access to essential medicines. It was
clear that there were conflicting understandings as to
how developing countries could implement the sections
relating to the “flexibilities” or exceptions to
pharmaceutical patents.
– The Doha Declaration "affirm[s] that the [TRIPS] agreement
can and should be interpreted and implemented in a manner
supportive of WTO members' right to protect public health
and, in particular, to promote access to medicines for all.”

13.  Despite signing the Doha Declaration and
ratifying the TRIPS Agreement , the U.S.
government has adopted the position of Big
Pharma and has sought to undermine public
health safeguards by negotiating trade
agreements that undermine these
safeguards, and by pressuring and
sanctioning countries that have used them.

14. How U.S. Undermines Doha
 The USTR’s Special 301 Report
 Under Special 301, the Office of the U.S. Trade
Representative (USTR) conducts an annual review of trading
partners' intellectual property rules (IPR), and highlights
those countries deemed to deny adequate protection for
patents, copyright, trademarks, and other forms of IP.
 Trade Sanctions can result from a Special 301 listing, but a
special 301 listing alone can have a chilling effect on
developing countries.
 USTR has placed countries on these various Special 301 lists
for pharmaceutical-related practices that are TRIPS
compliant.

15. Generics and HIV/AIDS
treatment
 In the case of HIV/AIDS, the average cost of
common first-line treatments just seven years ago was
between $10,000-15,000 per patient per year in
developing countries.
 Today, these treatments are available for as little as $89
per patient per year under certain circumstances.
 On average, generic competition for first-line AIDS
treatments has reduced their price in developing
countries by more than 98 percent.

16. India
Pharmacy of the Poor
• India is now the major supplier of good
quality generic medicines to developing
countries for all medical needs.
• 85+% of ARVs for developing countries
are sourced from India.
• Danger: industry concentration is
growing and there is increased
cooperation with Big Pharma.

17. U.S. Threatened India with Trade
Sanctions During TRIPS Negotiations
• India was part of a developing country coalition
trying to keep IPRs out of the General Agreement
on Tariffs and Trade (precursor to WTO)
negotiations.
• The U.S. used its Special 301 IPR Watch List to
threaten India and other developing countries
including Brazil and Thailand during the
negotiations.
• Despite losing the battle to exclude IPRs, India held
out for some key flexibilities and a 10-year
transition period.

18. S. Africa Medicines Case
• Medicines and Related Substances Control
Act of 1997.
• 39 drug companies sue Mandela government
• USTR Special 301 Watch List.
• International Campaign
– Treatment Action Campaign
– ACT UP/Health GAP zaps

19. Free Trade Agreements (FTAs)
 Negotiating Bilateral and Regional Free Trade
Agreements (FTAs)
 U.S. pursuing a strategy of entering “TRIPS-plus” FTAs
that generally work to delay competition from generic
drug companies - and to maintain higher prices for life-
saving medicines - for a longer period of time than
international minimum standards set by TRIPS.
 U.S. has entered into at least 27 such deals since 1991.
 Eg. CAFTA, U.S.-Jordan FTA, U.S.-Peru FTAm, U.S. S.
Korea FTA, Trans Pacific Partnership.
 Renewed Commitment by big PhARMA (and
big business) to use FTA’s to maximize profit

20. Trans Pacific Partnership
• Trans Pacific Partnership Free Trade Agreement being
negotiated right now;
• 11 countries: US, Vietnam, Malaysia, Singapore, Peru, Chile,
Australia, Brunei, New Zealand, Canada (Mexico and Japan
are negotiating)
• Deny people right to oppose patents before they’re granted;
• Make clinical trial data corporate property for 12 years so
generics can’t be approved;
• Allow drug companies to make minor changes to old
medicines to get new 20-year patent;
• Let drug companies sue government agencies that set
reimbursement rates for public health programs if drug
companies don’t like them.
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21. Customs Seizures of Medicines
Manufacturing Fiction in the Netherlands No Patent in India
No Patent in Nigeria
No Patent in Brazil

22. Dutch seizures of medicines
in-transit
• Almost twenty incidents where Dutch authorities have confiscated
generic medicines in transit through Dutch ports from India to Latin
America and Africa.
• One shipment included WHO prequalified ARVs purchased by
UNITAID and headed to Nigeria.
• Patent holders initiate the request for seizures which are thereafter
undertaken by untrained customs officials using the “manufacturing
fiction.”
• One seizure included a claim of a trademark infringement because
the drug used the name Amoxicillin which is the International
Nonproprietary Name, which was similar to GSK’s brandname
“Amoxil”.
• India and Brazil have brought a WTO complaint on these seizures.

23. What you can do!
• Engage in campus activism when targets come as speaker’s
come to campus (Yale students pressured Obama to fire
Zeke Emanuel!)
• Organize a rally outside your Member of Congress’ office.
• FEB. 20th Hearing by Trade Rep in DC on Special 301 Watch
List. Help write testimony (and deliver it)
• Meet with Congressmembers! So easy and no one does it.
• Write articles for blogs and student papers (Obama has
readers for student papers)
• Join an SGAC working group on fighting the TPP!
• Next “Round” of negotiations for the TPP is March 4-13 in
Singapore. Solidarity actions?
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24. Contact Info
Jennifer Flynn
Health GAP
jflynn@healthgap.org
Amirah Sequeira
SGAC
amirah@studentglobalaidscampaign.org
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