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First amendment to WTO rules since the organization was established

15 February 2017

On January 23, 2017, two-thirds of WTO members approved the first amendment to TRIPS rules to ease access to medicines.

This amendment relates to the “paragraph 6 system” of the Doha Declaration, according to which WTO member countries with insufficient or no manufacturing capacities in the pharmaceutical sector could face these difficulties by using compulsory licenses.

However, Article 31 (f) of the TRIPS Agreement stipulates that products manufactured under compulsory licenses should be primarily for domestic supply.

In order to resolve this inconsistency, WTO Members agreed in 2003 to waive the limitation in Article 31 (f) of the TRIPS Agreement to supply primarily the domestic market when generic medicines are produced under License required.

This is now done through Article 31bis of the TRIPS Agreement, which allows the compulsory licensing of patent-protected generic drugs specifically for export to countries with no or limited pharmaceutical production capacity.

“This is an extremely important amendment. It gives legal certainty that generic medicines can be exported at reasonable prices to satisfy the needs of countries with no pharmaceutical production capacity, or those with limited capacity. By doing so, it helps the most vulnerable access the drugs that meet their needs, helping to deal with diseases such as HIV/AIDS, tuberculosis or malaria, as well as other epidemics. I am delighted that WTO members have now followed through on their commitment and brought this important measure into force,” said WTO Director-General Roberto Azevêdo.

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