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We have been asked to provide our views regarding paragraph 6 of the Doha Health Declaration on compulsory license in the pharmaceutical sector in WTO member countries with insufficient or no manufacturing capacities.
Background information
One of the key documents presently under consideration by the TRIPS Council and the WTO Bodies is the "Declaration on the TRIPS Agreement and Public Health" of November 14, 2001 (hereinafter the "Doha Health Declaration") (WT/MIN(01)/DEC/W/2 - (01-5770)).
Paragraph 6 of the Doha Health Declaration relates to compulsory license in the pharmaceutical sector in WTO member countries with insufficient or no manufacturing capacities.
The concept is to permit WTO members with insufficient or no manufacturing capacities to grant compulsory licenses for the importation rather than local manufacture of relevant pharmaceutical products. On the other hand supplying members should be permitted to grant compulsory export licenses. It is hoped that in this way the countries in need for pharmaceutical products gain access to cheaper generic products produced abroad.
The economic relevance of the issue is disputed.
a) Importing Countries
Only in countries where there is patent protection may there be a need for a compulsory manufacturing or import license.
However, 49 of the least developed countries have been granted a respite for the protection of pharmaceutical products and the implementation and application of Sections 5 and 7 of Part II of the TRIPS Agreement until January 1, 2006 (Section 66.2 of the TRIPS Agreement).
This respite will be extended now for 10 further years until January 1, 2016. For 13 years to come the least developed countries will, therefore, not be bound to grant patent protection for pharmaceutical products and will not depend on compulsory licenses in the health sector.
b) Supplying (exporting) Countries
The idea is that upon request of importing countries with adequate manufacturing capacities should grant compulsory export licenses for export of pharmaceutical products to importing countries in need.
As the solution envisaged in paragraph 6 of the Doha Health Declaration is intended as a longer-term measure and affects basic principles of the TRIPS concept, it merits careful examination.
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