Annex
ASSESSMENT OF
MANUFACTURING CAPACITIES
IN THE
PHARMACEUTICAL SECTOR
Least-developed country Members are deemed to
have insufficient or no manufacturing capacities in the pharmaceutical
sector.
For other eligible importing Members insufficient
or no manufacturing capacities for the product(s) in question
may be established in either of the following ways:
(i)the Member in question has established that
it has no manufacturing capacity in the pharmaceutical sector;
OR
(ii)where the Member has some manufacturing capacity
in this sector, it has examined this capacity and found that,
excluding any capacity owned or controlled by the patent owner,
it is currently insufficient for the purposes of meeting its needs.
When it is established that such capacity has become sufficient
to meet the Member's needs, the system shall no longer apply.
WORLD TRADE ORGANIZATION 29 JULY 2005
IMPLEMENTATION OF
PARAGRAPH 6 OF
THE DOHA DECLARATION
ON THE
TRIPS AGREEMENT
AND PUBLIC
HEALTH
Decision of 30 August 2003
Corrigendum
The asterisked note at the bottom of page 1
should read as follows:
* Secretariat note for information purposes
only and without prejudice to Members" legal rights and obligations:
This Decision was adopted by the General Council in the light
of a statement read out by the Chairman, which can be found in
JOB(03)/177. This statement will be reproduced in the minutes
of the General Council to be issued as WT/GC/M/82.
WORLD TRADE ORGANIZATION 8 DECEMBER 2005
AMENDMENT OF
THE TRIPS
AGREEMENT
Decision of 6 December 2005
The General Council;
Having regard to paragraph 1 of Article X of
the Marrakesh Agreement Establishing the World Trade Organization
("the WTO Agreement");
Conducting the functions of the Ministerial
Conference in the interval between meetings pursuant to paragraph
2 of Article IV of the WTO Agreement;
Noting the Declaration on the TRIPS Agreement
and Public Health (WT/MIN(01)/DEC/2) and, in particular, the instruction
of the Ministerial Conference to the Council for TRIPS contained
in paragraph 6 of the Declaration to find an expeditious solution
to the problem of the difficulties that WTO Members with insufficient
or no manufacturing capacities in the pharmaceutical sector could
face in making effective use of compulsory licensing under the
TRIPS Agreement;
Recognizing, where eligible importing Members
seek to obtain supplies under the system set out in the proposed
amendment of the TRIPS Agreement, the importance of a rapid response
to those needs consistent with the provisions of the proposed
amendment of the TRIPS Agreement;
Recalling paragraph 11 of the General Council
Decision of 30 August 2003 on the Implementation of Paragraph
6 of the Doha Declaration on the TRIPS Agreement and Public Health;.
Having considered the proposal to amend the
TRIPS Agreement submitted by the Council for TRIPS (IP/C/41);
Noting the consensus to submit this proposed
amendment to the Members for acceptance;
Decides as follows:
1. The Protocol amending the TRIPS Agreement
attached to this Decision is hereby adopted and submitted to the
Members for acceptance.
2. The Protocol shall be open for acceptance
by Members until 1 December 2007 or such later date as may be
decided by the Ministerial Conference.
3. The Protocol shall take effect in accordance
with the provisions of paragraph 3 of Article X of the WTO Agreement.
Attachment
PROTOCOL AMENDING
THE TRIPS
AGREEMENT
Members of the World Trade Organization;
Having regard to the Decision of the General
Council in document WT/L/641, adopted pursuant to paragraph 1
of Article X of the Marrakesh Agreement Establishing the World
Trade Organization ("the WTO Agreement");
Hereby agree as follows:
1.13 The Agreement on Trade-Related Aspects of
Intellectual Property Rights (the "TRIPS Agreement")
shall, upon the entry into force of the Protocol pursuant to paragraph
4, be amended as set out in the Annex to this Protocol, by inserting
Article 31bis after Article 31 and by inserting the Annex to the
TRIPS Agreement after Article 73.
1.14 Reservations may not be entered in respect
of any of the provisions of this Protocol without the consent
of the other Members.
1.15 This Protocol shall be open for acceptance
by Members until 1 December 2007 or such later date as may be
decided by the Ministerial Conference.
1.16 This Protocol shall enter into force in
accordance with paragraph 3 of Article X of the WTO Agreement.
1.17 This Protocol shall be deposited with the
Director-General of the World Trade Organization who shall promptly
furnish to each Member a certified copy thereof and a notification
of each acceptance thereof pursuant to paragraph 3.
1.18 This Protocol shall be registered in accordance
with the provisions of Article 102 of the Charter of the United
Nations.
Done at Geneva this sixth day of December two
thousand and five, in a single copy in the English, French and
Spanish languages, each text being authentic.
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