It represented the first implementation of the TRIPS flexibilities declared in the August 30, 2003, General Council decision.
[1] The drugs that fight these diseases are expensive to create and manufacture and thus are usually unaffordable for those who need them the most.
[1] Some questions have been raised concerning the Act's efficacy, or lack thereof, at increasing the availability of pharmaceuticals in poor nations.
[citation needed] It has been suggested that this is because restrictions incorporated into the Act make it too difficult for generic drug companies to get permission to produce a generic and to export it to countries in need.
[3] Additionally, exporting pharmaceuticals under the Act to countries that are not part of the World Trade Organization's TRIPS agreement is made more difficult by further restrictions.