Quaker United Nations Office (Geneva) (QUNO), Occasional Paper No. 14, April 2004

Download here

In the Doha Declaration WTO Members committed themselves to implementing and interpreting the TRIPS Agreement to allow full use of its flexibilities, and to promote access to medicines for all. In the Doha Declaration there was an express acknowledgment of the right of Members to grant compulsory licenses on grounds determined by them. 

The provisions relating to patents and regulatory approvals with respect to medicines in recently concluded FTAs such as the CAFTA and U.S. – Morocco FTA are intended to restrict the flexibilities inherent in the TRIPS Agreement, Doha Declaration and Decision on Implementation of Paragraph 6. They are designed to prevent registration and marketing approval of generic versions of medicines that are not under patent by establishing data exclusivity rules far beyond anything contemplated by Article 39.3 of the TRIPS Agreement. They appear designed to negate the effective use of compulsory licensing by blocking the marketing of third party medicines during the term of patents. This is contrary to the letter and spirit of Paragraph 4 of the Doha Declaration, “that the [TRIPS] Agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all.” 

The provisions of the CAFTA and U.S. – Morocco FTA relating to patents and pharmaceutical regulation are not accessible to laypersons. They are confusing to specialists in the field of intellectual property law and medicines regulation. Public international lawyers are needed to work out the complex hierarchical relationships among the conflicting provisions. From a practical standpoint, the overall effect of these provisions will be to establish potentially impenetrable obstacles to the supply of low priced medicines. Individuals operating in the real world of medicines regulation, procurement and distribution cannot be expected to sort out these incredibly complicated rules. This point cannot be stressed too strongly. This is not a happy occasion for lawyers to spend countless hours traveling to meetings to discuss the role of non-derogation clauses in international agreements, or the relationship between the WTO Agreement, GATT Article XXIV, TRIPS Article 4(d) and free trade agreements. Theses rules affect the lives and health of people – children, women and men.