WORLD TRADE
ORGANIZATIONIP/C/W/416
21 November 2003
(03-6231)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
IMPLEMENTATION OF THE GENERAL COUNCIL DECISION
ON PARAGRAPH 6 OF THE DOHA DECLARATION ON
THE TRIPS AGREEMENT AND PUBLIC HEALTH
Communication from the European Communities
The following communication, dated 17 November 2003, is being circulated at the request of
the Delegation of the European Commission.  It was circulated as an advance copy for the Council'smeeting on 18 November 2003.
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I. INTRODUCTION
1. The European Communities (hereinafter "the EC") warmly welcome the adoption by the
General Council on 30 August of the long-awaite d Decision on the Implementation of Paragraph 6 of
the Doha Declaration on the TRIPS Agreement and Public Health ("the Decision").
1
2. The  Decision now allows WTO Members to issue compulsory licences with a view to
exporting patented medicines to countries with no or insufficient manufacturing capacity in the
pharmaceutical sector.  The Decision fulfils the mandate given by the Doha Declaration on the TRIPSAgreement and Public Health.
2
3. The EC will fully contribute to the implementation of this Decision.  In this spirit, the present
Communication spells out the EC's views on two cruc ial issues for the follow-up of the Decision, i.e.
its domestic implementation by Members and its transposition into an amendment of the TRIPS
Agreement.
4. In terms of domestic implementation, the Communication insists on the need to fully respect
the terms of the Decision, and on the availability of appropriate technical assistance.  With regard to
the amendment, it takes the view that work on the amendment should take place according to the
schedule set out in paragraph 11 of the Decision, without yet making proposals on language.
                                                     
1 Implementation of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health -
Decision of 30 August 2003,  WT/L/540 of 2 September 2003.
2 WT/MIN(01)DEC/W/2 of 14 November 2001.IP/C/W/416
Page 2
II. DOMESTIC IMPLEMENTATION OF THE 30 AUGUST DECISION AND
TECHNICAL ASSISTANCE
5. All Members of the WTO now have the responsibil ity to ensure that the right conditions are
put in place which will allow the system set up by the Decision to operate efficiently.  The most
immediate and important efforts will have to be made by those countries with manufacturingcapacities in the pharmaceutical sector which are prepared to participate in the system as
manufacturers and exporters, if so requested.  These countries will have to create a new legal basis in
their patent law to grant compulsory licences for e xport, according to the conditions set out in the
Decision.
6. Other Members have responsibilities too.  Importing Members will have to examine which
reasonable measures may have to be taken, within their means and proportionate to their
administrative capacities and to the risk of trade diversion, to prevent re-exportation of the productsthat have been imported into their territories under the system.  Members (this applies in particular to
rich country markets or transit countries) must ensure the availability of effective legal means, as
already required to be available under Part III of the TRIPS Agreement, to prevent the importation or
diversion into, and sale in, their territories of products produced under the system.
7. In addition, to make the system really work, Members will have to refrain from overly
restrictive interpretations of the Decision which could affect its efficiency.  Likewise, abuse of the
system for reasons other than those stated in the Decision, leading to an erosion of the confidence
among Members, would equally affect the workability of the system.
8. In June of this year, the EC submitted a Communication to the TRIPS Council on the
implementation of the Doha Declaration.
3  In this Communication, the EC highlighted that, in
establishing intellectual property laws and related policies, and in particular in implementing the
TRIPS Agreement, developing countries must be enabled to (a) ensure that an appropriate balance is
found between the need to protect research and development, through intellectual property, and public
health policy issues, in accordance with Articles 7 and 8 of the TRIPS Agreement, and (b) adequately
take into account the safeguards and flexibilities available under the Agreement as identified in theDoha Declaration.
9. The EC further took the view that, in view of structural challenges faced by developing and
least-developed countries in acting on the implications of the Doha Declaration, and in particular the
legal and administrative measures to be taken, technical assistance and capacity building are
paramount.  For many Members, balanced, transparent and unbiased technical assistance on how to
best integrate the Doha Declaration into intellectual property policies and practices will be key.
10. In this spirit, the EC reiterated its commitment to fully take the Doha Declaration into account
in their trade policy, in particular in the context of technical assistance for the implementation of the
TRIPS Agreement.  It called upon all technical assistance providers, and in particular multilateral
organizations, to join them in taking up this commitment, and to fully integrate the Doha Declaration
in their policies and practices.
11. It goes without saying that the adoption of the Decision reinforces the case for appropriate
technical assistance, and that the position expressed by the EC in its Communication of June 2002
fully applies to the implementation of the Decision as well.
                                                     
3 Communication by the European Communities on the Implementation of the Doha Declaration on the
TRIPS Agreement and Public Health, IP/C/W/402 of  24 June 2003.IP/C/W/416
Page 3
12. The EC therefore propose that the TRIPS Counc il instructs the Secretariat to take the
necessary steps to ensure that the WTO-WIPO "Joi nt Initiative" on technical assistance in the area of
intellectual property rights for least-developed countries effectively addresses the public health
dimension, and to closely involve the World Health Organization in this process.
III. THE AMENDMENT OF THE TRIPS AGREEMENT
13. Paragraph 11 of the Decision states that "(t)his Decision, including the waivers granted in it,
shall terminate for each Member on the date  on which an amendment to the TRIPS Agreement
replacing its provisions takes effect for that Member.  The TRIPS Council shall initiate by the end of
2003 work on the preparation of such an amendment with a view to its adoption within six months, on
the understanding that the amendment will be based, where appropriate, on this Decision and on the
further understanding that it will not be part of the negotiations referred to in paragraph 45 of the
Doha Ministerial Declaration (WT/MIN(01)/DEC/1)".
14. The EC takes the view that work on the amendment should take place according to the
schedule set out in paragraph 11 of the Decision, which means that the process must be initiated in
December 2003 and be terminated by end-June 2004 at the latest.
15. The nature of this process should remain essentially technical.  The amendment should
faithfully reflect what was agreed in the Decision.  In any event, the fact that the TRIPS Agreementshould be amended means that textual changes will have to be made to the TRIPS Agreement itself, in
order to transpose the relevant paragraphs of the Decision into TRIPS language.
16. To this effect, the EC propose that the Chai r of the TRIPS Council takes the necessary steps
to establish a work programme after consultation with the Membership.
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