9 November 2002
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON
THE TRIPS AGREEMENT AND PUBLIC HEALTH
DRAFT LEGAL LANGUAGE FOR GENERAL COUNCIL DECISION
[Preamble]
[To be drafted.]
[Definitional paragraph]
1. 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 referred to in paragraph 1 of the
Declaration, it being understood that active ingredients used in its
manufacture and diagnostic kits needed for its use would be included;
(b) "eligible importing Member" means any least-developed country Member,
and any other Member that has made a notification to the WTO of its
intention to use the system as an importer, it being understood that a
Member may notify 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. This
notification, which can be made at any time, will also serve to indicate an
acceptance by the eligible importing Member concerned of the provision
contained in paragraph 3 below; and
(c) "exporting Member" means a Member producing pharmaceutical products
for, and exporting them to, an eligible importing Member under paragraphs
1-4 of this Decision.
[Operative paragraph of waiver plus terms and conditions of waiver]
2. The obligations of an exporting Member under sub-paragraph (f) of
Article 31 of the TRIPS Agreement shall be waived with respect to the grant
by it of any compulsory license to the extent necessary for the purposes of
production of pharmaceutical products and their export to an eligible
importing Member(s) in accordance with the terms set out below:
(a) the eligible importing Member(s) has made a notification to the WTO that:
(i) specifies the names and quantities of product(s) needed and the
period of time for which it is needed ; and
(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 products
in question in at least one of the ways set out in an Annex to this Decision.
(b) the compulsory license issued by the exporting Member under
paragraphs 1-4 of this Decision shall contain the following conditions:
(i) only the amount needed by the eligible importing Member may be
manufactured under the licence and the entirety of this production shall be
exported to the Member which has notified its needs to the WTO;
(ii) products produced under the licence shall be clearly identified as
being produced under the system established by this Decision, for example
through specific labelling or marking. Suppliers would also be encouraged
to distinguish such products through special packaging and/or special
colouring/shaping of the products themselves; and
(iii) before shipment begins, the licensee shall post on a website
maintained by it 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 the WTO of the grant of the
licence, including the conditions attached to it. The information provided
shall include the name and address of the licensee, the product(s) for which
the licence 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 sub-paragraph
(b)(iii) above.
[Undertakings by importing Members and other Members]
3. It is understood that eligible importing Members will take reasonable
measures proportionate to their administrative capacities and to the risk of
trade diversion to prevent re-exportation of the pharmaceutical products
imported under the system.
4. It is understood that Members to which products produced under the
system might be diverted will ensure effective legal means to prevent their
importation and sale, using the means already required to be available under
the TRIPS Agreement and, if they prove insufficient, such other legal means
as may be necessary and proportionate to the problem.
[Interpretation of "domestic market"]
5. Where a developing or least-developed country Member is in a regional
trade agreement, the term "domestic market" used in Article 31(f) of the
TRIPS Agreement is understood for the purposes of this Decision to include
the markets of those other developing or least-developed country members of
the regional trade agreement that share the health problem in question. This
is without prejudice to the territorial nature of the patent rights in
question and the way in which the term "domestic" will be understood in any
other WTO agreement.
[Transfer of technology]
6. It is agreed that special attention will be paid to the transfer of
technology and capacity-building in the pharmaceutical sector in the further
work to be undertaken pursuant to Article 66.2, the outstanding
implementation issues and concerns and in the Working Group on Trade and the
Transfer of Technology.
[Review]
7. The Council for TRIPS shall keep the functioning of the system
established under this Decision under regular review with a view to ensuring
its effective operation and shall annually report on its operation to the
General Council. This shall be deemed to fulfill the review requirements of
Article IX:4 of the WTO Agreement.
[Safeguarding of existing rights and flexibilities under the TRIPS Agreement]
8. This Decision is without prejudice to the rights and flexibilities
that Members have under the other provisions of the TRIPS Agreement in
conjunction with the Doha Declaration on the TRIPS Agreement and Public
Health, 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.
[Moratorium on dispute settlement]
9. It is agreed that Members will not challenge any measures taken in
conformity with the provisions of the waiver contained in this Decision
under the dispute settlement mechanism of the WTO.
[Duration of the waiver]
10. Paragraphs 1-4 and 7-9 of this Decision shall remain in force until
an amendment to the TRIPS Agreement superseding their provisions is accepted
by all Members.
__________
ANNEX
Assessment of Manufacturing Capacities in the Pharmaceutical Sector
Least-developed country Members are deemed to have insufficient or no
manufacturing capacity.
For other eligible importing Members insufficient or no manufacturing
capacities for the product(s) in question may be established in any one of
the following ways:
(i) if the Member has made a public invitation for tenders for the
needed product(s) and no responsive offers have been received from domestic
producers on reasonable terms and conditions;
OR
(ii) the Member in question has established that it has no
manufacturing capacity in the pharmaceutical sector as a whole;
OR
(iii) where it has some manufacturing capacity in this sector, it
has examined this capacity and found that it is insufficient for the
purposes of meeting its needs on reasonable terms and conditions. Where
domestic manufacturing capacity would take some time to meet the Member's
needs on reasonable terms and conditions, the system would only be used for
this period.