G. REVIEW UNDER PARAGRAPH 8 OF THE DECISION ON THE IMPLEMENTATION OF PARAGRAPH 6 OF THE DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTHWe welcome the opportunity to participate in the annual review on the implementation of paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health.
The United States strongly supported the General Council’s decision of August 2003 to implement the Doha Declaration on TRIPS and Public Health to allow drugs to be exported under a compulsory license under the terms set out in that decision and the accompanying Chairman’s Statement. The United States also lent strong support to the General Council’s Decision of December 6, 2005 to amend the TRIPS Agreement and make permanent the system and appropriately preserve reference to the Chairman’s Statement. In fact, the United States was the first Member to notify its acceptance of the amendment.
We welcome those Members who have notified their acceptance. Here I note that those Members are developed, developing and least developed country Members. Some are pharmaceutical producers, but most are not. We encourage other Members to notify their acceptance of the amendment so that the amendment can enter into force.
The paragraph 6 system is intended to be one tool to assist in promoting access to medicines and provides an important failsafe in our work to improve access to medicines. This safety valve is, however, only one tool to address the larger issue of access to medicines.
The United States has been actively working to address these factors that have been shown to reduce access to safe and effective medicines, including ways to deploy the tools of trade policy to promote trade in, and reduce obstacles to, access to both innovative and generic medicines, while supporting the innovation and intellectual property protection that is vital to developing new medicines and achieving other medical breakthroughs.
These tools include:
• Enhancing legal certainty for manufacturers of generic medicines;
• Eliminating tariffs on medicines: Eliminate duties on medicines and medical devices, thereby decreasing costs for hospitals, clinics, aid organizations and consumers, among others;
• Reducing customs obstacles to medicines: Minimize import barriers, such as discriminatory, burdensome, and unpredictable customs procedures, that impede access to innovative and generic medicines;
• Curbing trade in counterfeit medicines: Make customs and criminal enforcement measures available to prevent medicines bearing counterfeit trademarks from entering national markets, and thus support efforts of countries to address the serious risks to patients posed by such counterfeits;
• Reducing internal barriers to distribution of medicines: Guarantee importing, exporting, and distribution rights with respect to medicines and minimize internal barriers that can stand in the way of efficiently distributing medicines to those in need;
• Minimizing unnecessary regulatory barriers: Promote 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.
In conclusion, one policy alone cannot solve the challenges relating to access to medicines. Rather, a variety of tools, including paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health, are available to promote access to medicines.
Further elaboration on these systemic issues can be found in paragraphs 1980201 of IP/C/M/57.
Regarding the proposal of some Members to hold a workshop including non-governmental actors, the United States does not support the idea of having the TRIPS Council organize a seminar on the paragraph 6 system.
As we have noted before, if Members wish to bring into the Council’s review of the solution perspectives they have gleaned from stakeholders, such as companies or NGOs, they are free to do so. In this regard, we continue to note that what Members get out of such reviews is very much a function of what they put into them. Indeed, we were hoping that Members could provide information on their experiences as input for the TRIPS Council discussions on the paragraph 6 system at this meeting.
We have listened closely to the experiences that have been shared thus far, but we are frankly disappointed by the details given.
It could be that the Paragraph 6 solution has not been necessary, and for this reason many Members have not implemented the system.
Or it could be that the time and expense to travel to Geneva is too much for someone working in a Ministry of Health, with so many other competing demands.
We share the interest in hearing from other Members about their experiences, and would like to hear Members’ views on how we can best elicit additional information.