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.
“First, 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 objectives.
“Second, 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.
“Third, it is important that Members seek to resolve any issues
arising from the use and implementation of the Decision expeditiously
“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
“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
“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.
“Fourth, 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 Decision.
“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
“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”.
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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
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
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