IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS
AGREEMENT AND PUBLIC HEALTH
Decision of [date]
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:
- For the purposes of this Decision:
- "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 would be included;1
- "eligible importing Member" means any least-developed country
Member, and any other Member that has made a notification
2 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 uswe 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
3 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.
- "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.
- 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 license 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:
- the eligible importing Member(s) 4
has made a notification 2
to the Council for TRIPS, that
- specifies the names and expected quantities of the product(s) needed;5
- 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
- confirms that, where a pharmaceutical product is patented in its territory, it has granted or intends to grant a compulsory license in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision;6
- the compulsory license issued by the exporting Member under this
Decision shall contain the following conditions:
- only the amount necessary to meet the needs of the eligible importing Member(s) may be manufactured under the license and the entirety of this production shall be exported to the Member(s) which has notified its needs to the Council for TRIPS;
- products produced under the license shall be clearly identified as being produced under the system set out in this Decision through specific labeling 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
- before shipment begins, the licensee shall post on a website7 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;
- the exporting Member shall notify8
the Council for TRIPS of the grant of the license, including the
conditions attached to it.9 The
information provided shall include the name and address of the licensee,
the product(s) for which the license 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 license. The
notification shall also indicate the address of the website referred
to in subparagraph (b)(iii) above.
- Where a compulsory license 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 license 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.
- 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.
- 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.
- With a view to harnessing economies of scale for the purposes of
enhancing purchasing power for, and facilitating the local production
of, pharmaceutical products:
- 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 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 license 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;
- 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.
- 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
- 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 fulfill the
review requirements of Article IX:4 of the WTO Agreement.
- 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 license can be exported under the present
provisions of Article 31(f) of the TRIPS Agreement.
- 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.
- 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
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:
- the Member in question has established that it has no manufacturing capacity in the pharmaceutical sector;
- 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.
1 This subparagraph is without prejudice to subparagraph 1(b).
2 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.
3 Australia, Austria, Belgium, Canada, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Japan, Luxembourg, Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom and United States of America.
4 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.
5 The notification will be made available publicly by the WTO Secretariat through a page on the WTO website dedicated to this Decision.
6 This subparagraph is without prejudice to Article 66.1 of the TRIPS Agreement.
7 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.
8 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.
9 The notification will be made available publicly by the WTO secretariat through a page on the WTO website dedicated to this Decision.