Similarly, changes to national legislation will be required in potential exporting countries. Compulsory licences are granted for reasons provided by national legislation. The supply of export markets is not a recognized reason in most national legislation.16 In addition, in the implementation of Article 31.f of the TRIPS agreement, WTO members granted 17 compulsory licences for the “predominant” supply of the internal market. When a company receives a request for delivery from a foreign country under paragraph 6, it cannot obtain a compulsory licence exclusively for export, unless national legislation has been amended accordingly. It is questionable to what extent governments will be prepared to initiate the complex process of amending patent law, particularly on the basis of an interim waiver. This decision does not prevent developed countries from exporting generic drugs under the system, but it is not known how their governments would react if they were asked to amend their legislation and grant compulsory licences for the supply under paragraph 6. Indeed, most observers expect that large generic drug manufacturers in developing countries (such as India, China, Brazil, Thailand and South Africa) will support this production and export.18 Another advantage inherent in TRIPS is the “flexibility” offered to all members to interpret different articles of the agreement (Vandoren, 2001). Article 27.3, for example, allows members to exclude certain inventions and objects from patentability, and allows the protection of others – such as plant varieties – through compatible sui generis systems. The Doha Declaration reiterated that developing countries have the right to issue compulsory licences or to authorize parallel importation of medicines under Article 31 to deal with “national emergencies or other extreme emergencies” – and that public health crises such as HIV/AIDS, malaria and other epidemics can be declared as such (WTO, 2001). TRIPS is an agreement under the W.T.O., concluded in 1994 by its members in Marrakech, Morocco.
It sets minimum standards for the protection of intellectual property rights and the procedure and remedies for their implementation by all W.T.O. members in their national intellectual property rights laws. This agreement came into force on January 1, 1995. Prior to the TRIPS-Trips agreement, intellectual property laws varied from one Member State to another, formulating local laws that met the needs of each society. The Presidency`s statement adds that the special conditions (as defined in point 2b) of the decision12 apply not only to the drugs formulated, but also to the active substances manufactured and delivered under the system as well as to the finished products made with such active substances. The statement also adds (although there is no evidence) that “members understand that, in general, special packaging and/or specific colourings or shapes should not have a significant effect on drug prices.” In addition, the declaration establishes a monitoring system, including the verification, as the member concerned found, of insufficient or non-existent production capacity in the pharmaceutical sector13. The decision takes the form of a provisional waiver allowing countries that manufacture patented products under compulsory licences to export products to approved importing countries, provided that a compulsory licence has also been issued in the country of import and various other conditions are met, as explained above. The derogation would take time until the amendment of the TRIPS agreement14 The Doha Declaration specifies the right of members to adopt an international principle of tariff depletion (in which parallel imports can be accepted).5 It states that “the effects of the provisions of the TRIPS agreement … To release each member, to create his own unchallenged exhaustion regime” (paragraph 5d).