WORLD TRADE
ORGANIZATIONIP/C/W/396/Corr.1
10 February 2003
(03-0854)
Council for Trade-Related Aspects
of Intellectual Property RightsOriginal:  English
MORATORIUM TO ADDRESS NEEDS OF DEVELOPING AND LEAST-DEVELOPED
MEMBERS WITH NO OR INSUFFICIENT MANUFACTURING CAPACITIES
IN THE PHARMACEUTICAL SECTOR
Communication from the United States
Corrigendum
In the attachment to document IP/C/W/396, the last eight words of paragraph 5 and the whole
of paragraph 6 were omitted.  For the convenience of delegations, a complete copy of this attachmentincorporating the missing passages is attached to this document.
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ATTACHMENT
MORATORIUM TO ADDRESS NEEDS OF DEVELOPING AND LEAST-DEVELOPED
MEMBERS WITH NO OR INSUFFICIENT MANUFACTURING CAPACITIES
IN THE PHARMACEUTICAL SECTOR
1. The United States will not seek to enforce Article 31(f) of the TRIPS Agreement through the
WTO dispute settlement procedur e against a WTO Member where:
- a Member issues a compulsory licence to permit a party or parties in its territory to
produce and export a patented pharmaceutical product or HIV/AIDS test kit to anyeconomy, other than those classified by the World Bank as "High Income
Economies";  and
- the importing economy or region is facing a grave public health crisis associated with
HIV/AIDS, malaria or tuberculosis or other infectious epidemics of comparable scale
and gravity, including those that may arise in the future, has no or insufficientproduction capacities in the pharmaceutical sector, and has so notified the TRIPS
Council.
- Least-developed countries will be considered to have no or insufficient production
capacities in the pharmaceutical sector.  Any other eligible importing economy will
be considered to have no or insufficient manufacturing capacities if it hasdemonstrated that it has no or insufficient technical manufacturing capacities in the
pharmaceutical sector.
2. Where a patent exists, each economy importing a pharmaceutical product or HIV/AIDS test
kit must also issue a compulsory licence, consistent with Article 31, to import and sell the product.
3. Each WTO Member exporting needed products will issue a TRIPS-compliant compulsory
licence under this solution and require the recipient of a compulsory licence to export the entirety of
the pharmaceuticals or HIV/AIDS test kits produced to the economy for which they were intended.  In
order to prevent diversion of such products into markets for which they are not intended, licensed
manufacturers of needed products must provide the means by which the products can be identified
through packaging, labeling, and product characteristics (shape or colour).
4. In order to ensure transparency and competition among supplies, the exporting Member must
inform the TRIPS Council and post, on an official government website accessible to the public,
information regarding the grant of the licence, in cluding 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
economy(ies) for which it has been granted, the economy(ies) to which the product is to be supplied
and the duration of the licence.
5. An economy seeking to import pharmaceuticals or HIV/AIDS test kits shall first provide an
opportunity to the right holder to supply the needed products.  We encourage producers to rapidly
respond to the request of poor economies lacking the capacity to produce products to address the
scourge of HIV/AIDS, malaria or tuberculosis or other infectious epidemics of comparable scale and
gravity, including those that may arise in the future.IP/C/W/396/Corr.1
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6. In order to ensure that the medicines reach the people for whom they are intended, we expect
all economies to take reasonable measures proportionate with their administrative capacities to ensure
that pharmaceuticals are not diverted into markets for which they are not intended or re-exported from
markets for which they are intended.
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