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release: Members OK amendment to make health flexibility permanent
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“It is understood that paragraph 4 of Article 31bis in the proposed
amendment is without prejudice to the overall question of the applicability
of subparagraphs 1(b) and 1(c) of Article XXIII of GATT 1994 to the TRIPS
Agreement and to the different positions of Members on this subject.”
“Pursuant to paragraph 11 of the General Council Decision of 30 August 2003,
the General Council has been presented with a draft Decision containing a
proposed amendment to the TRIPS Agreement to implement paragraph 6 of the
Doha Declaration on the TRIPS Agreement and Public Health. This amendment 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 amendment to be submitted
for acceptance 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.
“First, Members recognize that the system that will be established by the
amendment should be used in good faith to protect public health and, without
prejudice to paragraph 3 of the Article 31bis of the amendment, not be an
instrument to pursue industrial or commercial policy objectives.
“Second, Members recognize that the purpose of the amendment would be
defeated if products supplied under this amendment 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 amendment. In this regard, the provisions of paragraph
2(b)(ii) of the Annex to the TRIPS Agreement in the amendment 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.(1) Members and producers
are encouraged to draw from and use these practices, and to share
information on their experiences in preventing diversion.
“Third, it is important that Members seek to resolve any issues arising from
the use and implementation of the amendment expeditiously and amicably:
“To promote transparency and avoid controversy, notifications under
paragraph 2(a)(ii) of the Annex to the TRIPS Agreement in the amendment
would include information on how the Member in question had established, in
accordance with the Appendix to the Annex to the TRIPS Agreement in the
amendment, 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 amendment, 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 amendment 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.
“Fourth, all information gathered on the implementation of the amendment
shall be brought to the attention of the TRIPS Council in its annual review
as set out in paragraph 7 of the Annex to the TRIPS Agreement in the
amendment.
“In addition, as stated in footnote 3 to paragraph 1(b) of the Annex to the
TRIPS Agreement in the amendment, the following Members have agreed to opt
out of using the system as importers: 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.
“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
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“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.
Note:
1. Reproduced as the Attachment to this
Statement. back to text
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