Annex
WORLD TRADE ORGANIZATION 20 NOVEMBER 2001
Ministerial Conference
Fourth Session
Doha, 9—14 November 2001
DECLARATION ON
THE TRIPS
AGREEMENT AND
PUBLIC HEALTH
Adopted on 14 November 2001
1. We recognize the gravity of the public
health problems afflicting many developing and least-developed
countries, especially those resulting from HIV/AIDS, tuberculosis,
malaria and other epidemics.
2. We stress the need for the WTO Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS
Agreement) to be part of the wider national and international
action to address these problems.
3. We recognize that intellectual property
protection is important for the development of new medicines.
We also recognize the concerns about its effects on prices.
4. We agree that the TRIPS Agreement does
not and should not prevent Members from taking measures to protect
public health. Accordingly, while reiterating our commitment to
the TRIPS Agreement, we affirm that the Agreement can and should
be interpreted and implemented in a manner supportive of WTO Members'
right to protect public health and, in particular, to promote
access to medicines for all.
In this connection, we reaffirm the right of
WTO Members to use, to the full, the provisions in the TRIPS Agreement,
which provide flexibility for this purpose.
5. Accordingly and in the light of paragraph
4 above, while maintaining our commitments in the TRIPS Agreement,
we recognize that these flexibilities include:
(a) In applying the customary rules of interpretation
of public international law, each provision of the TRIPS Agreement
shall be read in the light of the object and purpose of the Agreement
as expressed, in particular, in its objectives and principles.
(b) Each Member has the right to grant compulsory
licences and the freedom to determine the grounds upon which such
licences are granted.
(c) Each Member has the right to determine
what constitutes a national emergency or other circumstances of
extreme urgency, it being understood that public health crises,
including those relating to HIV/AIDS, tuberculosis, malaria and
other epidemics, can represent a national emergency or other circumstances
of extreme urgency.
(d) The effect of the provisions in the TRIPS
Agreement that are relevant to the exhaustion of intellectual
property rights is to leave each Member free to establish its
own regime for such exhaustion without challenge, subject to the
MFN and national treatment provisions of Articles 3 and 4.
6. We recognize that WTO Members with insufficient
or no manufacturing capacities in the pharmaceutical sector could
face difficulties in making effective use of compulsory licensing
under the TRIPS Agreement. We instruct the Council for TRIPS to
find an expeditious solution to this problem and to report to
the General Council before the end of 2002.
7. We reaffirm the commitment of developed-country
Members to provide incentives to their enterprises and institutions
to promote and encourage technology transfer to least-developed
country Members pursuant to Article 66.2. We also agree that the
least-developed country Members will not be obliged, with respect
to pharmaceutical products, to implement or apply Sections 5 and
7 of Part II of the TRIPS Agreement or to enforce rights provided
for under these Sections until 1 January 2016, without prejudice
to the right of least-developed country Members to seek other
extensions of the transition periods as provided for in Article
66.1 of the TRIPS Agreement. We instruct the Council for TRIPS
to take the necessary action to give effect to this pursuant to
Article 66.1 of the TRIPS Agreement.
WORLD TRADE ORGANIZATION 1 JULY 2002
Council for Trade-Related Aspects of Intellectual
Property Rights
EXTENSION OF
THE TRANSITION
PERIOD UNDER
ARTICLE 66.1 OF
THE TRIPS
AGREEMENT FOR
LEAST-DEVELOPED
COUNTRY MEMBERS
FOR CERTAIN
OBLIGATIONS WITH
RESPECT TO
PHARMACEUTICAL PRODUCTS
Decision of the Council for TRIPS of 27 June 2002
The Council for Trade-Related Aspects of Intellectual
Property Rights (the "Council for TRIPS"),
Having regard to paragraph 1 of Article 66 of
the TRIPS Agreement;
Having regard to the instruction of the Ministerial
Conference to the Council for TRIPS contained in paragraph 7 of
the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2)
(the "Declaration");
Considering that paragraph 7 of the Declaration
constitutes a duly motivated request by the least-developed country
Members for an extension of the period under paragraph 1 of Article
66 of the TRIPS Agreement;
Decides as follows:
1. Least-developed country Members
will not be obliged, with respect to pharmaceutical products,
to implement or apply Sections 5 and 7 of Part II of the TRIPS
Agreement or to enforce rights provided for under these Sections
until 1 January 2016.
2. This decision is made without prejudice
to the right of least-developed country Members to seek other
extensions of the period provided for in paragraph 1 of Article
66 of the TRIPS Agreement.
WORLD TRADE ORGANIZATION 12 JULY 2002
LEAST-DEVELOPED
COUNTRY MEMBERS—OBLIGATIONS
UNDER ARTICLE
70.9 OF THE
TRIPS AGREEMENT
WITH RESPECT
TO PHARMACEUTICAL
PRODUCTS
Decision of 8 July 2002[55]
The General Council,
Having regard to paragraphs 1, 3 and 4 of Article
IX 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 decision of the Council for TRIPS
on the Extension of the Transition Period under Article 66.1 of
the TRIPS Agreement for Least-Developed Country Members for Certain
Obligations with respect to Pharmaceutical Products (IP/C/25)
(the "Decision"), adopted by the Council for TRIPS at
its meeting of 25-27 June 2002 pursuant to the instructions of
the Ministerial Conference contained in paragraph 7 of the Declaration
on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2) (the
"Declaration");
Considering that obligations under paragraph
9 of Article 70 of the TRIPS Agreement, where applicable, should
not prevent attainment of the objectives of paragraph 7 of the
Declaration;
Noting that, in light of the foregoing, exceptional
circumstances exist justifying a waiver from paragraph 9 of Article
70 of the TRIPS Agreement with respect to pharmaceutical products
in respect of least-developed country Members;
Decides as follows:
1. The obligations of least-developed
country Members under paragraph 9 of Article 70 of the TRIPS Agreement
shall be waived with respect to pharmaceutical products until
1 January 2016.
2. This waiver shall be reviewed by
the Ministerial Conference not later than one year after it is
granted, and thereafter annually until the waiver terminates,
in accordance with the provisions of paragraph 4 of Article IX
of the WTO Agreement.
WORLD TRADE ORGANIZATION 2 SEPTEMBER 2003
IMPLEMENTATION OF
PARAGRAPH 6 OF
THE DOHA DECLARATION
ON THE
TRIPS AGREEMENT
AND PUBLIC
HEALTH
Decision of 30 August 2003[56]
The General Council,
Having regard to paragraphs 1, 3 and 4 of Article
IX 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) (the "Declaration")
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 and to report
to the General Council before the end of 2002;
Recognizing, where eligible importing Members
seek to obtain supplies under the system set out in this Decision,
the importance of a rapid response to those needs consistent with
the provisions of this Decision;
Noting that, in the light of the foregoing,
exceptional circumstances exist justifying waivers from the obligations
set out in paragraphs (f) and (h) of Article 31 of the TRIPS Agreement
with respect to pharmaceutical products;
Decides as follows:
1.2 For the purposes of this Decision:
(a) "pharmaceutical product" means
any patented product, or product manufactured through a patented
process, of the pharmaceutical sector needed to address the public
health problems as recognized in paragraph 1 of the Declaration.
It is understood that active ingredients necessary for its manufacture
and diagnostic kits needed for its use would be included;[57]
(b) "eligible importing Member"
means any least-developed country Member, and any other Member
that has made a notification[58]
to the Council for TRIPS of its intention to use the system as
an importer, it being understood that a Member may notify at any
time that it will use the system in whole or in a limited way,
for example only in the case of a national emergency or other
circumstances of extreme urgency or in cases of public non-commercial
use. It is noted that some Members will not use the system set
out in this Decision as importing Members[59]
and that some other Members have stated that, if they use the
system, it would be in no more than situations of national emergency
or other circumstances of extreme urgency;
(c) "exporting Member" means a
Member using the system set out in this Decision to produce pharmaceutical
products for, and export them to, an eligible importing Member.
1.3 The obligations of an exporting Member
under Article 31(f) of the TRIPS Agreement shall be waived with
respect to the grant by it of a compulsory licence to the extent
necessary for the purposes of production of a pharmaceutical product(s)
and its export to an eligible importing Member(s) in accordance
with the terms set out below in this paragraph:
(a) the eligible importing Member(s)[60]
has made a notification2 to the Council for TRIPS, that:
(i) specifies the names and expected quantities
of the product(s) needed;[61]
(ii) confirms that the eligible importing Member
in question, other than a least-developed country Member, has
established that it has insufficient or no manufacturing capacities
in the pharmaceutical sector for the product(s) in question in
one of the ways set out in the Annex to this Decision; and
(iii) confirms that, where a pharmaceutical product
is patented in its territory, it has granted or intends to grant
a compulsory licence in accordance with Article 31 of the TRIPS
Agreement and the provisions of this Decision;[62]
(b) the compulsory licence issued by the
exporting Member under this Decision shall contain the following
conditions:
(i) only the amount necessary to meet the needs
of the eligible importing Member(s) may be manufactured under
the licence and the entirety of this production shall be exported
to the Member(s) which has notified its needs to the Council for
TRIPS;
(ii) products produced under the licence shall
be clearly identified as being produced under the system set out
in this Decision through specific labelling or marking. Suppliers
should distinguish such products through special packaging and/or
special colouring/shaping of the products themselves, provided
that such distinction is feasible and does not have a significant
impact on price; and
(iii) before shipment begins, the licensee shall
post on a website[63]
the following information:
— the quantities being supplied to each
destination as referred to in indent (i) above; and
— the distinguishing features of the product(s)
referred to in indent (ii) above;
(c) the exporting Member shall notify[64]
the Council for TRIPS of the grant of the licence, including the
conditions attached to it.[65]
The information provided shall include the name and address of
the licensee, the product(s) for which the licence has been granted,
the quantity(ies) for which it has been granted, the country(ies)
to which the product(s) is (are) to be supplied and the duration
of the licence. The notification shall also indicate the address
of the website referred to in subparagraph (b)(iii) above.
1.4 Where a compulsory licence is granted
by an exporting Member under the system set out in this Decision,
adequate remuneration pursuant to Article 31(h) of the TRIPS Agreement
shall be paid in that Member taking into account the economic
value to the importing Member of the use that has been authorized
in the exporting Member. Where a compulsory licence is granted
for the same products in the eligible importing Member, the obligation
of that Member under Article 31(h) shall be waived in respect
of those products for which remuneration in accordance with the
first sentence of this paragraph is paid in the exporting Member.
1.5 In order to ensure that the products
imported under the system set out in this Decision are used for
the public health purposes underlying their importation, eligible
importing Members shall take reasonable measures within their
means, proportionate to their administrative capacities and to
the risk of trade diversion to prevent re-exportation of the products
that have actually been imported into their territories under
the system. In the event that an eligible importing Member that
is a developing country Member or a least-developed country Member
experiences difficulty in implementing this provision, developed
country Members shall provide, on request and on mutually agreed
terms and conditions, technical and financial cooperation in order
to facilitate its implementation.
1.6 Members shall ensure the availability
of effective legal means to prevent the importation into, and
sale in, their territories of products produced under the system
set out in this Decision and diverted to their markets inconsistently
with its provisions, using the means already required to be available
under the TRIPS Agreement. If any Member considers that such measures
are proving insufficient for this purpose, the matter may be reviewed
in the Council for TRIPS at the request of that Member.
1.7 With a view to harnessing economies of scale
for the purposes of enhancing purchasing power for, and facilitating
the local production of, pharmaceutical products:
(i)where a developing or least-developed country
WTO Member is a party to a regional trade agreement within the
meaning of Article XXIV of the GATT 1994 and the Decision of 28
November 1979 on Differential and More Favourable Treatment Reciprocity
and Fuller Participation of Developing Countries (L/4903), at
least half of the current membership of which is made up of countries
presently on the United Nations list of least-developed countries,
the obligation of that Member under Article 31(f) of the TRIPS
Agreement shall be waived to the extent necessary to enable a
pharmaceutical product produced or imported under a compulsory
licence in that Member to be exported to the markets of those
other developing or least-developed country parties to the regional
trade agreement that share the health problem in question. It
is understood that this will not prejudice the territorial nature
of the patent rights in question; and
(ii)it is recognized that the development of
systems providing for the grant of regional patents to be applicable
in the above Members should be promoted. To this end, developed
country Members undertake to provide technical cooperation in
accordance with Article 67 of the TRIPS Agreement, including in
conjunction with other relevant intergovernmental organizations.
1.8 Members recognize the desirability of
promoting the transfer of technology and capacity building in
the pharmaceutical sector in order to overcome the problem identified
in paragraph 6 of the Declaration. To this end, eligible importing
Members and exporting Members are encouraged to use the system
set out in this Decision in a way which would promote this objective.
Members undertake to cooperate in paying special attention to
the transfer of technology and capacity building in the pharmaceutical
sector in the work to be undertaken pursuant to Article 66.2 of
the TRIPS Agreement, paragraph 7 of the Declaration and any other
relevant work of the Council for TRIPS.
1.9 The Council for TRIPS shall review annually
the functioning of the system set out in this Decision with a
view to ensuring its effective operation and shall annually report
on its operation to the General Council. This review shall be
deemed to fulfil the review requirements of Article IX:4 of the
WTO Agreement.
1.10 This Decision is without prejudice
to the rights, obligations and flexibilities that Members have
under the provisions of the TRIPS Agreement other than paragraphs
(f) and (h) of Article 31, including those reaffirmed by the Declaration,
and to their interpretation. It is also without prejudice to the
extent to which pharmaceutical products produced under a compulsory
licence can be exported under the present provisions of Article
31(f) of the TRIPS Agreement.
1.11 Members shall not challenge any measures
taken in conformity with the provisions of the waivers contained
in this Decision under subparagraphs 1(b) and 1(c) of Article
XXIII of GATT 1994.
1.12 This 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).
55 Adopted in accordance with the Decision-Making Procedures
under Articles IX and XII of the WTO Agreement agreed by the General
Council in November 1995 (WT/L/93). Back
56
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. Back
57
This subparagraph is without prejudice to subparagraph 1(b). Back
58
It is understood that this notification does not need to be approved
by a WTO body in order to use the system set out in this Decision. Back
59
Australia, Austria, Belgium, Canada, Denmark, Finland, France,
Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, the
Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland,
the United Kingdom and the United States. Back
60
Joint notifications providing the information required under this
subparagraph may be made by the regional organizations referred
to in paragraph 6 of this Decision on behalf of eligible importing
Members using the system that are parties to them, with the agreement
of those parties. Back
61
The notification will be made available publicly by the WTO Secretariat
through a page on the WTO website dedicated to this Decision. Back
62
This subparagraph is without prejudice to Article 66.1 of the
TRIPS Agreement. Back
63
The licensee may use for this purpose its own website or, with
the assistance of the WTO Secretariat, the page on the WTO website
dedicated to this Decision. Back
64
It is understood that this notification does not need to be approved
by a WTO body in order to use the system set out in this Decision. Back
65
The notification will be made available publicly by the WTO Secretariat
through a page on the WTO website dedicated to this Decision. Back
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