APPENDIX TO THE ANNEX TO THE TRIPS AGREEMENT
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:
(i)the Member in question has established that
it has no manufacturing capacity in the pharmaceutical sector;
or
(ii)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.
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