E-drug: Implementation of par 6 of the Doha Declaration on TRIPS
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The WTO announces today the agreement has been reached
http://www.wto.org/english/news_e/pres03_e/pr350_e.htm
This is the approved text, as reported by the WTO at
http://www.wto.org/english/tratop_e/trips_e/implem_para6_e.htm
TRIPS: COUNCIL FOR TRIPS
Decision of 30 August 2003
IP/C/W/405
Implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement
and public health
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. 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; (1)
(b) "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 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 and that some other Members (3) 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.
2. 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) (4) has made a notification (2) to the
Council for TRIPS, that:
(i) specifies the names and expected quantities of the product(s) needed
(5);
(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 (6);
(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 (7) 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 (8) the Council for TRIPS of the grant
of the licence, 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 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. 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.
4. 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.
5. 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.
6. 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;
(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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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).
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.
Notes:
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. back to text
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 Dec
Mauro Guarinieri
EATG
Rome
"Mauro Guarinieri" <m.guarinieri@agora.it>
Access Essential Drugs Monitor #32 at http://www.who.int/medicines/mon/mon32.shtml
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