[Ip-health] Free Trade Agreements and Intellectual Property doom Access to Medicines

[mkamalyanni@Oxfam.org.uk]

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NGO POLICY BRIEF=0D
 Free Trade Agreements and Intellectual Property doom Access to Medicines=
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  Health GAP, M=C3=A9decins Sans Fronti=C3=A8res, Oxfam International, Thir=
d World=0D
 Network, TNP+, EATG, GAT, SGAC, Solidarite Sida, Canadian HIV/AIDS Legal=
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                Network, Korean HIV/AIDS Wide Action, MTAG+=0D
                              16 August 2006=0D
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Patent  and  data protection rules in free trade agreements have a profound=
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impact  on  the  ability  of  developing  countries  to  access life saving=
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medicines  of  assured  quality. When drug sales were tightly controlled by=
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large  pharmaceutical  companies,  patented,  highly  active antiretroviral=
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therapy  cost  $10,000 a year. Bypassing and annulling patent rules allowed=
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generic  producers  to manufacture and sell the same medicines in preferred=
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fixed-dose combinations for as little as $140 year.=0D
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Wealthy  countries  imposed  a  global  baseline  of  intellectual property=
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protections  with the 1994 WTO TRIPS Agreement. Developing countries fought=
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back   against  patent  hegemony  and  in  2001  won  the  historical  Doha=
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Declaration on the TRIPS Agreement and Public Health, which reaffirmed that=
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TRIPS  supports  governments=E2=80=99  right  to  protect public health and=
 promote=0D
access  to medicines to all.  It took two years (until August 30, 2003) for=
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the  WTO to adopt a flawed Decision that partially addresses the problem of=
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permitting  export of low-cost generics to developing countries that do not=
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have the capacity to produce these medicines domestically.=0D
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However,  the  U.S. government continues to pursue ever-higher intellectual=
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property  protections  in  regional  and  bilateral  free trade agreements,=
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thereby  restricting  developing  countries=E2=80=99 ability to purchase af=
fordable=0D
versions  of newer medicines. In the past five years the U.S. has concluded=
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negotiations with Australia, Bahrain, Chile, Central American countries and=
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the   Dominican   Republic,  Colombia,  Peru,  Jordan,  Morocco,  Oman  and=
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Singapore. It is currently negotiating bilateral free trade agreements with=
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Thailand,  Malaysia,  South  Korea,  the  United Arab Emirates, Ecuador and=
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Panama,  and  attempted  to pursue regional negotiations in Southern Africa=
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and the entire Western Hemisphere (the FTAA). In each negotiation, the U.S.=
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tries  to  impose  U.S.-style  intellectual  property  protections on other=
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nations,  which  exceed  TRIPS standards, and in some instances even exceed=
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U.S.  law.  These TRIPS-plus intellectual property protections dramatically=
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undermine  flexibilities  guaranteed in the Doha Declaration and the August=
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30th Decision.=0D
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They include provisions to:=0D
=C2=B7 expand the scope of pharmaceutical patents to include new indication=
s,=0D
new formulations, and other minor changes;=0D
=C2=B7 limit grounds for issuing compulsory licenses to emergencies, govern=
ment=0D
non-commercial use, and competition cases only;=0D
=C2=B7 bar parallel trade of on-patent drugs sold more cheaply elsewhere wh=
ere=0D
prohibited by contract;=0D
=C2=B7 extend patent monopolies for administrative delays by patent offices=
 and=0D
drug regulatory authorities;=0D
=C2=B7 enhance protections for clinical trial data by providing at least fi=
ve=0D
years of data exclusivity and by linking drug registration rights to patent=
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status, thereby preventing registration and sale of generics;=0D
=C2=B7 enforce patent violations and grant drug companies investor-based ri=
ghts=0D
to sue, including for improvidently granted compulsory licenses.=0D
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In  sum,  the  U.S.=E2=80=99s negotiation objectives completely eviscerate =
the Doha=0D
flexibilities,  dramatically increase IP protection, and threaten to reduce=
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trade in affordable generic medicines.=0D
1.      Key recommendations:=0D
=C2=B7 A moratorium on intellectual property/patent/data protections in=0D
bilateral and regional trade agreements;=0D
=C2=B7 Adoption of a more streamlined procedure for producing generic=0D
medicines-for-export;=0D
=C2=B7 Drug companies waive their patent rights on HIV and AIDS medicines i=
n=0D
highly affected regions and permit access to their registration data so=0D
that inexpensive generic drugs of assured quality can be quickly approved=
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for sale.=0D
=C2=B7 Enjoin drug companies to adopt systematic tiered pricing that enable=
s=0D
low-priced drugs in middle income countries.=0D
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Contacts:  Brook Baker, Health GAP +1-617-259-0760=0D
        Mohga    Kamal-Yanni,    Oxfam    International    +44-777-625-5884=
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Mohga   -dictating  to  the  computer  so  please  forgive  silly  mistakes=
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Dr.                   Mohga                  M                  Kamal-Yanni=
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Senior          health         &         HIV         policy         advisor=
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