Annex
TO THE PROTOCOL AMENDING THE TRIPS AGREEMENT
ARTICLE 31BIS
1.The obligations of an exporting Member under
Article 31(f) shall not apply with respect to the grant by it
of a compulsory licence to the extent necessary for the purposes
of production of a pharmaceutical product(s) and its export to
an eligible importing Member(s) in accordance with the terms set
out in paragraph 2 of the Annex to this Agreement.
2.Where a compulsory licence is granted by an
exporting Member under the system set out in this Article and
the Annex to this Agreement, adequate remuneration pursuant to
Article 31(h) shall be paid in that Member taking into account
the economic value to the importing Member of the use that has
been authorized in the exporting Member. Where a compulsory licence
is granted for the same products in the eligible importing Member,
the obligation of that Member under Article 31(h) shall not apply
in respect of those products for which remuneration in accordance
with the first sentence of this paragraph is paid in the exporting
Member.
3.With a view to harnessing economies of scale
for the purposes of enhancing purchasing power for, and facilitating
the local production of, pharmaceutical products: where a developing
or least-developed country WTO Member is a party to a regional
trade agreement within the meaning of Article XXIV of the GATT
1994 and the Decision of 28 November 1979 on Differential and
More Favourable Treatment Reciprocity and Fuller Participation
of Developing Countries (L/4903), at least half of the current
membership of which is made up of countries presently on the United
Nations list of least-eveloped countries, the obligation of that
Member under Article 31(f) shall not apply to the extent necessary
to enable a pharmaceutical product produced or imported under
a compulsory licence in that Member to be exported to the markets
of those other developing or least-developed country parties to
the regional trade agreement that share the health problem in
question. It is understood that this will not prejudice the territorial
nature of the patent rights in question.
4.Members shall not challenge any measures taken
in conformity with the provisions of this Article and the Annex
to this Agreement under subparagraphs 1(b) and 1(c) of Article
XXIII of GATT 1994.
5.This Article and the Annex to this Agreement
are without prejudice to the rights, obligations and flexibilities
that Members have under the provisions of this Agreement other
than paragraphs (f) and (h) of Article 31, including those reaffirmed
by the Declaration on the TRIPS Agreement and Public Health (WT/MIN(01)/DEC/2),
and to their interpretation. They are also without prejudice to
the extent to which pharmaceutical products produced under a compulsory
licence can be exported under the provisions of Article 31(f).
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