COMPILATION OF WTO LEGAL DOCUMENTS RELEVANT TO
CANADA’S ACCESS TO MEDICINES REGIME AND BILL C-398
WORLD TRADE ORGANIZATION
Doha, 9 - 14 November 2001
DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH
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:
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.
Each Member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted.
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.
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.
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.
WT/L/540 and Corr. 1
WORLD TRADE ORGANIZATION
IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON
THE TRIPS AGREEMENT AND PUBLIC HEALTH
to paragraphs 1, 3 and 4 of Article IX of the Marrakesh Agreement
Establishing the World Trade Organization ("the WTO Agreement");
the functions of the Ministerial Conference in the interval between meetings
pursuant to paragraph 2 of Article IV of the WTO Agreement;
(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;
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;
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;
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
*Secretariat note for information purposes only and without prejudice to Members' legal rights
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.
active ingredients necessary for its manufacture and diagnostic kits needed for its use would be included1;
b) "eligible importing Member" means any least-developed country Member, and any
other Member that has made a notification2 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 Members3 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.
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 notification2 to the Council for TRIPS,
specifies the names and expected quantities of the product(s) needed5;
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 licence in accordance with Article 31 of the TRIPS Agreement and the provisions of this Decision6;
b) the compulsory licence issued by the exporting Member under this Decision shall contain
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, the Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland, the United Kingdom and the United States.
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
6 This subparagraph is without prejudice to Article 66.1 of the TRIPS Agreement.
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;
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
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;
c) the exporting Member shall notify8 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.
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.
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.
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
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 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;
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 TRIPS.
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.
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.
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 (WT/MIN(01)/DEC/1).
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.
WORLD TRADE ORGANIZATION
13 November 2003
GENERAL COUNCIL CHAIRPERSON’S STATEMENT
Excerpt from the minutes of the General council meeting 30 August 2003 (paragraph n°29)
29. “The General Council has been presented with a draft Decision contained in
document IP/C/W/405 to implement paragraph 6 of the Doha Declaration on the TRIPS
Agreement and Public Health. This Decision is part of the wider national and
international action to address problems as recognized in paragraph 1 of the Declaration.
Before adopting this Decision, I would like to place on the record this Statement which
represents several key shared understandings of Members regarding the Decision to be
taken and the way in which it will be interpreted and implemented. I would like to
emphasize that this Statement is limited in its implications to paragraph 6 of the Doha
Declaration on the TRIPS Agreement and Public Health.
, Members recognize that the system that will be established by the Decision
should be used in good faith to protect public health and, without prejudice to paragraph
6 of the Decision, not be an instrument to pursue industrial or commercial policy
, Members recognize that the purpose of the Decision would be defeated if
products supplied under this Decision are diverted from the markets for which they are
intended. Therefore, all reasonable measures should be taken to prevent such diversion in
accordance with the relevant paragraphs of the Decision. In this regard, the provisions of
paragraph 2(b)(ii) apply not only to formulated pharmaceuticals produced and supplied
under the system but also to active ingredients produced and supplied under the system
and to finished products produced using such active ingredients. It is the understanding of
Members that in general special packaging and/or special colouring or shaping should not
have a significant impact on the price of pharmaceuticals.
“In the past, companies have developed procedures to prevent diversion of products that
are, for example, provided through donor programmes. “Best practices” guidelines that
draw upon the experiences of companies are attached to this statement for illustrative
purposes. Members and producers are encouraged to draw from and use these practices,
and to share information on their experiences in preventing diversion.
, it is important that Members seek to resolve any issues arising from the use and
implementation of the Decision expeditiously and amicably:
“To promote transparency and avoid controversy, notifications under paragraph 2(a)(ii) of the Decision would include information on how the Member in question had established, in accordance with the Annex, that it has insufficient or no manufacturing capacities in the pharmaceutical sector.
“In accordance with the normal practice of the TRIPS Council, notifications made under the system shall be brought to the attention of its next meeting.
“Any Member may bring any matter related to the interpretation or implementation of the Decision, including issues related to diversion, to the TRIPS Council for expeditious review, with a view to taking appropriate action.
“If any Member has concerns that the terms of the Decision have not been fully complied with, the Member may also utilize the good offices of the Director-General or Chair of the TRIPS Council, with a view to finding a mutually acceptable solution.
, all information gathered on the implementation of the Decision shall be brought
to the attention of the TRIPS Council in its annual review as set out in paragraph 8 of the
“In addition, as stated in footnote 3 to paragraph 1(b) of the Decision, the following
Members have agreed to opt out of using the system as importers: 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.
“Until their accession to the European Union, the Czech Republic, Cyprus, Estonia,
Hungary, Latvia, Lithuania, Malta, Poland, the Slovak Republic and Slovenia agree that
they would only use the system as importers in situations of national emergency or other
circumstances of extreme urgency. These countries further agree that upon their
accession to the European Union, they will opt out of using the system as importers.
“As we have heard today, and as the Secretariat has been informed in certain
communications, some other Members have agreed that they would only use the system
as importers in situations of national emergency or other circumstances of extreme
urgency. These are the following: Hong Kong, China; Israel; Korea; Kuwait; Macao
China; Mexico; Qatar; Singapore; the Separate Customs Territory of Taiwan, Penghu,
Kinmen and Matsu; Turkey and the United Arab Emirates”.
Attachment : “Best practices” guidelines
Companies have often used special labelling, colouring, shaping, sizing, etc. to differentiate products supplied through donor or discounted pricing programmes from products supplied to other markets. Examples of such measures include the following:
Bristol Myers Squibb used different markings/imprints on capsules supplied to sub Saharan Africa.
Novartis has used different trademark names, one (Riamet®) for an anti-malarial drug provided to developed countries, the other (Coartem®) for the same products supplied to developing countries. Novartis further differentiated the products through distinctive packaging.
GlaxoSmithKline (GSK) used different outer packaging for its HIV/AIDS medications Combivir, Epivir and Trizivir supplied to developing countries. GSK further differentiated the products by embossing the tablets with a different number than tablets supplied to developed countries, and plans to further differentiate the products by using different colours.
Merck differentiated its HIV/AIDS antiretroviral medicine CRIXIVAN through special packaging and labelling, i.e., gold-ink printing on the capsule, dark green bottle cap and a bottle label with a light-green background.
Pfizer used different colouring and shaping for Diflucan pills supplied to South Africa.
Producers have further minimized diversion by entering into contractual arrangements with importers/distributors to ensure delivery of products to the intended markets. To help ensure use of the most effective anti-diversion measures, Members may share their experiences and practices in preventing diversion either informally or through the TRIPS Council. It would be beneficial for Members and industry to work together to further refine anti-diversion practices and enhance the sharing of information related to identifying, remedying or preventing specific occurrences of diversion.
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