WORLD TRADE  
ORGANIZATION  IP/C/W/444 
18 March 2005 
 
 (05-1149) 
Council for Trade-Related Aspects 
of Intellectual Property Rights Original:   English 
 
 
 
COMMENTS ON IMPLEMENTATI ON OF THE 30 AUGUST 2003 
AGREEMENT (SOLUTION) ON THE TRIPS AGREEMENT 
AND PUBLIC HEALTH 
 
Communication from the United States  
  
 The following communication, dated 9 March 2005, is being circulated at the request of the 
delegation of the United States.  It was circulat ed as an advance copy for the Council's March 2005 
meeting. 
  
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 This paper sets forth the position of the Unite d States with respect to the implementation of 
the 30 August 2003 solution pursuant to paragr aph 6 of the Doha Declaration on the TRIPS 
Agreement and Public Health and its transformation into an amen dment to the TRIPS Agreement. 
 
I. THE AGREEMENT 
1. On 14 November 2001, at the Doha Ministerial Conference, Members adopted  the Doha 
Declaration on the TRIPS Agreement and Public Hea lth.  Paragraph 6 of the Declaration instructed 
the TRIPS Council to find, before the end of 2002, an  expeditious solution to the problem that "WTO 
Members with insufficient or no manufacturing capacities in the pharmaceutical sector could face difficulties in making effective use of compulso ry licensing under the TRIPS Agreement."  The 
December 2002 deadline was missed due to a failure to reach consensus on an appropriate solution.  It 
was not until 30 August 2003, almost two years after the Doha Declaration was adopted, that 
consensus was finally obtained.  The solution reached that day w as comprised of both a General 
Council Decision (WT/L/540) and a Statement of the Chair of General Council (found in 
WT/GC/M/82). 
2. As we consider the task before us of tran sforming the solution into  an amendment to the 
TRIPS Agreement, we must keep in mind both how  agreement was reached and the purpose of that 
agreement so we may better position ourselves to move  forward in a productive and efficient fashion. 
3. The solution was reached after long and inten se negotiations from 2001 to 2003.  From the 
perspective of the United States, the difficulties were not due to differences among the Members in 
the goals we were seeking to achieve.  All Members agreed that there was a need to address the public 
health problems facing many developing countries.  Specifically, all Members recognized that if 
countries could not produce drugs for themselves, th ey could not in that special circumstance 
effectively use the compulsory licensing flexibilities.  All Members agreed on the need to remove that 
obstacle.  All Members agreed that we were engage d in this exercise as a unique response to the grave 
public health problems faced by certain devel oping and least-developed countries, and not for IP/C/W/444 
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 commercial purposes.  All Members agreed that, in order to fulfil those objectives, the solution we 
were seeking to devise must ensure that the drugs  covered by the solution would reach the intended 
populations in need and must not be diverted to other markets.  This w as how the United States 
viewed the positions of the Membership, and it is the view of the United States that all Members remain committed to these goals. 
4. For nearly two years, the WTO Membership  focused on devising a comprehensive and 
balanced package to meet these objectives.  In th e end, the August 2003 solution put in place a system 
that was transparent and non-burdensome;  that effe ctively eliminated the export restriction in TRIPS 
Article 31(f), when applicable, so medicine could be supplied to countries most in need that cannot 
manufacture their own pharmaceuticals;  that contained essential elements to meet our common 
objective of ensuring that the system is employed to help those most in need;  and that ensured that 
the system would be used for the purposes for which it was intended.  This was the agreed solution - 
the solution that met the objectives we were seeki ng to achieve and garnered support from all WTO 
Members. 
II. UTILIZATION OF THE SOLUTION 
5. The United States strongly supports the solution that was agreed in August 2003 and 
encourages and will support a Member's effective a nd appropriate use of that solution.  If some 
Members encounter difficulties in implementing or utilizing the solution, the United States would be 
pleased to discuss the need for technical assistance .  Furthermore, the United States remains fully 
committed to reaching consensus expeditiously on an amendment to the TRIPS Agreement that 
reflects the solution. 
6. If Members feel that they need to make imme diate use of the solution, they need not and 
should not wait for the amendment process to run its course before doing so.  The solution is already 
in force and will remain in force until such time as it is replaced by an amendment.  This situation is 
no different than other cases where Members can rely  upon WTO waivers.  Domestic implementation 
of the relevant procedures will be identical whether the country acts now to implement or waits for an 
amendment.  Indeed, some Members such as Canada have already implemented the August 2003 
solution through domestic legislation, and other Members are in the process of doing so. 
7. In the meantime, Members should continue to wo rk to try to convert the solution into an 
amendment.  This task should be a technical exer cise and should not reopen substantive issues.  As 
noted above, all substantive issues were debated at length for nearly two years, and the Membership 
reached a consensus solution in Au gust 2003.  It is essential that the amendment preserve the entire 
agreement and therefore must expressly reference both the Decision and the Chairman's Statement. 
III. ANY AMENDMENT MUST REFLECT THE SOLUTION IN ITS ENTIRETY 
8. Reaching an agreement for an amendment that  will preserve all aspects of the consensus 
August 2003 solution will be a very difficult task if  Members seek to change  the content of that 
solution.  The United States appreciates the African  Group's efforts to move the discussion forward on 
this issue with its proposal for an amendment s ubmitted in December 2004.  However, the proposal 
presented a position quite different than the consen sus solution agreed in August 2003.  For example, 
it makes no reference whatsoever to the Chairman's Statement or the concepts in the Statement, and 
omits many key safeguards on notification and divers ion.  Consequently, we do not believe that the 
African Group Proposal meets the basic objective of formulating an amendment that preserves the 
consensus and delicate balance struck  after a long and intense debate.  IP/C/W/444 
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 9. The United States is willing to work with  the African Group and all WTO Members on 
moving ahead to reach a consensus agreement on an  amendment.  The United States remains open to 
how this technical exercise to implement the solution can be best and most expeditiously 
accomplished.  Toward this end, the United States be lieves that a footnote approach that references 
both the General Council Decision and the Chai rman's Statement would be an easy and 
straightforward exercise, and therefore an optimum solution.  The use of this approach in no way 
diminishes the legal significance of the amendment.  We are also willing to consider any other options 
for placement of an amendment that references bot h the General Council Decision and the Chairman's 
Statement, including a new section in Article 31 of the TRIPS Agreement itself. 
IV. US POSITION ON THE CHAIRMAN'S STATEMENT 
10. The United States seeks nothing more than to preserve all aspects of the August 2003 
solution.  We recognize, however, that some Member s have expressed concerns that, in fact, we are 
seeking to alter the solution by elevating the legal st atus of the Chairman's Statement.  Perhaps this 
misunderstanding was due to a lack of clarity in  our explanation or to misinformation about our 
intentions.  Clarification is, therefore, important. 
11. The United States does not  seek to elevate the legal status of the Statement.  We are open to 
discussion of how best to describe the relationshi p between the content of the Statement and the 
content of the decision.  Whatever description we settle upon, however, it is essential to preserve 
explicitly in the amendment a reference to the Statement or the principles included therein. 
12. As we consider this issue, we s hould also bear in mind the realities before us.  It is certain that 
the solution would not have been reached without  the Chairman's Statement.  To preserve the 
consensus, the principles included in the Statement must be preserved.  The Statement made the 
consensus solution possible by a ddressing and resolving questions concerning aspects of the Decision 
that were unclear or were not addressed.  It thus is  an essential part of the so lution, and provides value 
for all WTO Members.  If elements of the consen sus are eliminated, it will be difficult or impossible 
to transform the solution into an amendment.  It also will undermine the sense of urgency that seized 
this body at the beginning of this debate in Doha and prompted us to grapple with these serious policy 
issues in a serious way - treating it as an issue too important to be wrapped into the politicized give 
and take of the broader trade negotiations. 
V. CONCLUSION 
13. The United States looks forward to working w ith other Members to implement the solution 
and to find an appropriate way to transform the so lution in its entirety into an amendment to the 
TRIPS Agreement.  If approached properly, with a si ncere appreciation of the work that came before 
and the need to deal with pressing health problem s facing the world, we can complete this task 
expeditiously. 
 
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