211. The representative of the United States said that his delegation strongly supported the Paragraph 6 System as established under the 2003 waiver Decision and the 2005 Protocol Amending the TRIPS Agreement in order to allow medicines to be exported under a compulsory license under the terms set out in that decision and the accompanying Chairman's Statement. His delegation had been the first Member to notify its acceptance of the amendment. Members who had already notified their acceptance were developed, developing, and least developed countries and that though some were pharmaceutical producers, most were not. He encouraged other Members to notify their acceptance of the amendment so that the amendment could enter into force.
212. Although the Paragraph 6 System represented an important failsafe, it was only one tool for addressing the larger issue of access to medicines. In discussions with stakeholders in recent years, his delegation had consistently heard that the issue of access to safe and effective medicines was being addressed by a variety of other means. His Government had also been actively working to address the factors that had been shown to reduce access to safe and effective medicines, including tools to deploy trade policy to promote trade in, and reduce obstacles to access, innovative and generic medicines. It had also been supporting the innovation and intellectual property protection that was vital to developing new medicines and achieving other medical breakthroughs.
213. Those tools included (i) enhancing legal certainty for manufacturers of generic medicines; (ii) eliminating tariffs on medicines and medical devices, thereby decreasing costs for hospitals, clinics, aid organizations and consumers, among others; (iii) reducing customs obstacles to medicines by minimizing import barriers, such as discriminatory, burdensome, and unpredictable customs procedures, that impeded access to innovative and generic medicines; (iv) curbing trade in counterfeit medicines by making customs and criminal enforcement measures available to prevent medicines bearing counterfeit trademarks from entering national markets, and thus supporting efforts of countries to address the serious risks to patients posed by such counterfeits; (v) reducing internal barriers to distribution of medicines by guaranteeing importing, exporting, and distribution rights with respect to medicines and minimizing internal barriers that could stand in the way of efficiently distributing medicines to those in need; and (vi) minimizing unnecessary regulatory barriers by promoting transparent and nondiscriminatory regulatory structures to facilitate the availability of safe and efficacious medicines to the public, while also improving coherence of future rules across the region. He recalled that his delegation had elaborated those systemic issues in the Council's annual review carried out in 2010 (IP/C/M/57, paragraphs 198 to 201). The list of other tools demonstrated that one policy alone could not solve the challenges relating to access to medicines. Rather, a variety of tools, including the Paragraph 6 System, were needed to promote access to medicines.
214. Regarding the proposal of some Members to hold a workshop which would include non governmental actors, he said that his delegation did not support the idea of having the Council organize such a seminar. Members were free to bring into the Council's review of the Paragraph 6 System perspectives they had gleaned from stakeholders, such as companies or civil society. What Members got out of the review was very much a function of what they put into it. His delegation had hoped that Members would provide information on their experiences as input for the Council's discussions of the System's functioning at the current meeting, but it was disappointed by the details of experiences that had been provided. It could be that the Paragraph 6 System had not been necessary, and for this reason many Members had not implemented it, or that capital-based experts from health ministries could simply not attend the Council's meeting because of other competing demands. He reiterated his delegation's interest in hearing other Members' experiences and views on how best to gather additional information.
