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Free trade agreements, intellectual property and access to medicines


Free Trade Agreements, Intellectual Property, and Access to Medicines

Health GAP, Médecins Sans Frontières, Oxfam, Third World Network, TNP+,
EATG, GAT, SGAC, Solidarite Sida, Canadian HIV/AIDS Legal Network

13 August 2006

Patent and data protection rules in free trade agreements have a profound
impact on the ability of developing countries to access life saving
medicines of assured quality. When drug sales were tightly controlled by
large pharmaceutical companies, patented, highly active antiretroviral
therapy cost $10,000 a year. Bypassing and annulling patent rules allowed
generic producers to manufacture and sell the same medicines in preferred
fixed-dose combinations for as little as $140 year.

Wealthy countries imposed a global baseline of intellectual property
protections with the 1994 WTO TRIPS Agreement. Developing countries fought
back against patent hegemony and in 2001 won the historical Doha Declaration
on the TRIPS Agreement and Public Health, which reaffirmed that TRIPS
supports governments’ right to protect public health and promote access to
medicines to all. It took two years (until August 30, 2003) for the WTO to
adopt a flawed Decision that partially addresses the problem of permitting
export of low-cost generics to developing countries that do not have the
capacity to produce these medicines domestically.

However, the U.S. government continues to pursue ever-higher intellectual
property protections in regional and bilateral free trade agreements,
thereby restricting developing countries’ ability to purchase affordable
versions of newer medicines. In the past five years the U.S. has concluded
negotiations with Australia, Bahrain, Chile, Central American countries and
the Dominican Republic, Colombia, Peru, Jordan, Morocco, Oman and Singapore.
It is currently negotiating bilateral free trade agreements with Thailand,
Malaysia, South Korea, the United Arab Emirates, Ecuador and Panama, and
attempted to pursue regional negotiations in Southern Africa and the entire
Western Hemisphere (the FTAA). In each negotiation, the U.S. tries to impose
U.S.-style intellectual property protections on other nations, which exceed
TRIPS standards, and in some instances even exceed U.S. law. These
TRIPS-plus intellectual property protections dramatically undermine
flexibilities guaranteed in the Doha Declaration and the August 30th

They include provisions to:
- expand the scope of pharmaceutical patents to include new indications, new
formulations, and other minor changes;
- limit grounds for issuing compulsory licenses to emergencies, government
non-commercial use, and competition cases only;
- bar parallel trade of on-patent drugs sold more cheaply elsewhere where
prohibited by contract;
- extend patent monopolies for administrative delays by patent offices and
drug regulatory authorities;
- enhance protections for clinical trial data by providing at least five
years of data exclusivity and by linking drug registration rights to patent
status, thereby preventing registration and sale of generics;
- enforce patent violations and grant drug companies investor-based rights
to sue, including for improvidently granted compulsory licenses.

In sum, the U.S.’s negotiation objectives completely eviscerate the Doha
flexibilities, dramatically increase IP protection, and threaten to reduce
trade in affordable generic medicines.

- A moratorium on intellectual property/patent/data protections in bilateral
and regional trade agreements;
- Adoption of a more streamlined procedure for producing generic
- Drug companies waive their patent rights on HIV and AIDS medicines in
highly affected regions and permit access to their registration data so that
inexpensive generic drugs of assured quality can be quickly approved for
- Enjoin drug companies to adopt systematic tiered pricing that enables
low-priced drugs in middle income countries.

Contacts: Brook Baker, Health GAP 1-617-259-0760
Mohga Kamal-Yanni, Oxfam 44-777-625-5884