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
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 and
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 utilise 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,
Netherlands, New Zealand, Norway, Portugal, Spain, Sweden, Switzerland,
United Kingdom and United States of America.
Until their accession to the European Union, Czech Republic, Cyprus,
Estonia, Hungary, Latvia, Lithuania, Malta, Poland, 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: Hong Kong China, Israel, Korea,
Kuwait, Macao China, Mexico, Qatar, Singapore, Chinese Taipei, Turkey,
United Arab Emirates.
“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