E-DRUG: FTAs and Intellectual Property doom Access to Medicines
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NGO POLICY BRIEF
Free Trade Agreements and Intellectual Property doom Access to Medicines
Health GAP, Medecins Sans Frontieres, Oxfam International, Third World
Network, TNP+, EATG, GAT, SGAC, Solidarite Sida, Canadian HIV/AIDS Legal
Network, Korean HIV/AIDS Wide Action, MTAG+
16 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 Decision.
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.A's negotiation objectives completely eviscerate the Doha
flexibilities, dramatically increase IP protection, and threaten to reduce
trade in affordable generic medicines.
1. Key recommendations:
· A moratorium on intellectual property/patent/data protections in
bilateral and regional trade agreements;
· Adoption of a more streamlined procedure for producing generic
medicines-for-export;
· 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 sale.
· 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 International +44-777-625-5884
Mohga
Dr. Mohga M Kamal-Yanni
Senior health & HIV policy advisor
Oxfam GB
Oxfam House, John Smith Drive, Cowley,
Oxford, OX4 2JY, UK
Tel: + 44 (0) 865 472290
Mobile + 44 (0) 7776255884
mkamalyanni@Oxfam.org.uk