The obligations under Articles 3 and 4 do not apply to procedures under WIPO-led multilateral agreements on the acquisition or maintenance of intellectual property rights. The third recommendation is to change the language of the TRIPS agreement so that Member States are required to transpose the compulsory licensing provisions into their national legislation. In accordance with Article 31 of the TRIPS Agreement (6), the rights of patent holders may be circumvented in certain situations. In particular, member governments have the power to license a party that is willing to commercialize a patented invention without the patent holder`s consent. In the absence of a “national emergency,” the proposed licensee is required to make reasonable efforts to apply for a voluntary licence (6). If the patent holder refuses to issue a licence, the government may grant a non-exclusive licence. Accordingly, the granting of a compulsory licence, subject to other provisions of the TRIPS agreement, allows generic drug manufacturers to produce patented drugs and sell at a fraction of the price that patent holders would have, since it is sufficient to recover the costs of manufacturing the drug and not the costs of research and development. Critics of the compulsory licensing provisions refer to paragraph f of the same article, which states that compulsory licences must be used “primarily for the procurement of the Member State that has authorized such use” (6). These critics argue that this clause makes it extremely difficult for developing country governments to issue compulsory licenses to combat public health crises, as it would require the production of medicines in developing countries where there is little infrastructure to support this highly developed industry (7). 3The June deadline passed without consensus and the deadline was extended until March 2005. The March deadline also passed without agreement, but on 6 December 2005, the WTO finally reached a consensus on amending the TRIPS agreement. This amendment is in line with the principles agreed on August 30, 2003. Member States have until 1 December 2007 to ratify the amendment so that it can be formally incorporated into the ON TRIPS agreement.
Critics of this recommendation can argue that the obligation of these provisions infringes on the sovereignty of a nation; However, this must be considered as a whole within the framework of the TRIPS agreement.