US Policy toward Thailand with respect to the compulsory licensing of ddI
The United States Government (USG) presented the following set of talking points to the Royal Thai Government (RTG) on
Wednesday, January 19, 2000.
James Love's analysis of these talking points can be found in the pharm-policy archives
(US Talking Points on Thai ddi CL).
- We recognize your desire to address all health issues as
effectively as possible. This is a goal we fully endorse
and support. We believe that your goals can be achieved
while promoting adequate and effective intellectual property
protection, including patent protection for pharmaceutical
- We understand that negotiations continue between Thai health
officials and a U.S. pharmaceutical manufacturer (Bristol
Myer Squibb) over the cost of the anti-HIV drug Videx (often
identified by the active ingredient "ddI").
- We also understand the Thai Government is considering
issuance of a compulsory license to permit local manufacture
- We are hopeful that in choosing a course of action in this
matter your government will explore all opportunities to
obtain the lowest price possible for ddI, including through
negotiations with BMS.
- The USG has generally viewed compulsory licenses as being
undesirable because they may undermine intellectual property
rights. However, if the RTG determines a compulsory license
is necessary to obtain the lowest price for ddI, the TRIPS
Agreement establishes conditions that must be followed. For
example, such use may only be permitted if the proposed user
has made efforts to obtain authorization from the right
holder on reasonable commercial terms and conditions and
that such efforts have not been successful within a
reasonable period of time, any license granted must be
considered on a case-by-case basis and the government must
limit the authority to use that patented invention to acts
needed to address the given situation, and predominately to
supply the domestic market.
- Furthermore, the license must be terminated when the
circumstances that give rise to its necessity no longer
exist. The patent owner must be paid adequate compensation
under the license that takes into account the economic value
of the license. The license cannot be transferred to other
parties, and must not preclude the ability of the patent
owner to make, use, sell or import the patent product.
- Finally, the U.S. Department of Health and Human Services
would be interested in learning from the RTG its expected
outcomes from the use of ddI in the treatment of HIV.