Annex
TO THE TRIPS AGREEMENT
1.For the purposes of Article 31bis and
this Annex:
(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
on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2). It
is understood that active ingredients necessary for its manufacture
and diagnostic kits needed for its use would be included;[66]
(b) "eligible importing Member"
means any least-developed country Member, and any other Member
that has made a notification[67]
to the Council for TRIPS of its intention to use the system set
out in Article 31bis and this Annex ("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 as
importing Members[68]
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; and
(c) "exporting Member" means a
Member using the system to produce pharmaceutical products for,
and export them to, an eligible importing Member.
2.The terms referred to in paragraph 1 of Article
31bis are that:
the eligible importing Member(s)[69]
has made a notification2 to the Council for TRIPS, that:
(iv) specifies the names and expected quantities
of the product(s) needed;[70]
(v) 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 Appendix to this Annex; and
(vi) confirms that, where a pharmaceutical product
is patented in its territory, it has granted or intends to grant
a compulsory licence in accordance with Articles 31 and 31bis
of this Agreement and the provisions of this Annex;[71]
(d) the compulsory licence issued by the
exporting Member under the system 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 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[72]
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;
(e) the exporting Member shall notify[73]
the Council for TRIPS of the grant of the licence, including the
conditions attached to it.[74]
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.
3.In order to ensure that the products imported
under the system 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.
4.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 and diverted
to their markets inconsistently with its provisions, using the
means already required to be available under this 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.
5.With a view to harnessing economies of scale
for the purposes of enhancing purchasing power for, and facilitating
the local production of, pharmaceutical products, it is recognized
that the development of systems providing for the grant of regional
patents to be applicable in the Members described in paragraph
3 of Article 31bis should be promoted. To this end, developed
country Members undertake to provide technical cooperation in
accordance with Article 67 of this Agreement, including in conjunction
with other relevant intergovernmental organizations.
6.Members recognize the desirability of promoting
the transfer of technology and capacity building in the pharmaceutical
sector in order to overcome the problem faced by Members with
insufficient or no manufacturing capacities in the pharmaceutical
sector. To this end, eligible importing Members and exporting
Members are encouraged to use the system 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 this Agreement, paragraph 7 of the Declaration
on the TRIPS Agreement and Public Health and any other relevant
work of the Council for TRIPS.
7.The Council for TRIPS shall review annually
the functioning of the system with a view to ensuring its effective
operation and shall annually report on its operation to the General
Council.
66 This subparagraph is without prejudice to subparagraph
1(b). Back
67
It is understood that this notification does not need to be approved
by a WTO body in order to use the system. Back
68
Australia, Canada, the European Communities with, for the purposes
of Article 31bis and this Annex, its member States, Iceland, Japan,
New Zealand, Norway, Switzerland, and the United States. Back
69
Joint notifications providing the information required under this
subparagraph may be made by the regional organizations referred
to in paragraph 3 of Article 31bis on behalf of eligible importing
Members using the system that are parties to them, with the agreement
of those parties. Back
70
The notification will be made available publicly by the WTO Secretariat
through a page on the WTO website dedicated to the system. Back
71
This subparagraph is without prejudice to Article 66.1 of this
Agreement. Back
72
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 the system. Back
73
It is understood that this notification does not need to be approved
by a WTO body in order to use the system. Back
74
The notification will be made available publicly by the WTO Secretariat
through a page on the WTO website dedicated to the system. Back
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