687. The United States respects Members' right to protect public health and, in particular, to promote access to medicines for all, as affirmed in the Doha Declaration on TRIPS and Public Health.
688. The United States is firmly of the view that international obligations such as those in the TRIPS Agreement have sufficient flexibility to allow trading partners to address the serious public health problems that they may face.
689. The United States supports the vital role of the patent system in promoting the development and creation of new and innovative life-saving medicines and urges Members to consider ways to address their public health challenges while also maintaining IP systems that promote innovation.
690. Pricing of medicines is a very important issue that is currently being discussed in the United States.
691. However, we do not believe that it is an appropriate topic for TRIPS Council.
692. It is important to recognize that drug pricing and drug availability are complex issues. There are many factors that play a role in it, with IP rights being just one of those factors.
693. As has been noted during this discussion, the WHO-WIPO-WTO joint study on Promoting Access to Medical Technologies and Innovation (the "Trilateral Study") highlighted many factors that contribute to the availability of medicines. Such factors include regulatory barriers; taxes and tariff policy; procurement mechanisms; increase in the production, sale and use of the substandard/fake/counterfeit medicines; complex supply chains; and the list goes on.
694. We believe that the narrowly-focused mandate of the UN High Level Panel was flawed and therefore cannot lead to outcomes that adequately address this issue.
695. While patents do play a role in the pricing of products covered by patent protection, the primary role of patents is in incentivizing the development of new drug products. Discussions on the pricing of new drug products are moot if there are no new drug products being developed.
696. In our view, a robust patent system does not prevent countries from taking measures to protect public health.
697. An effective patent system not only incentivizes the discovery of new drugs, new uses for existing drugs, and improvements on existing drugs, such as methods that improve drug efficacy, but also importantly enriches the public domain as patents expire.
698. This balance is best shown by the leading role of the United States in pharmaceutical innovation and by the strength of the generic market, with nine out of ten prescriptions being filled in the United States with generic drugs.
699. Without patent protection, especially in the pharmaceutical field, research into new drugs, new uses of existing drugs, and improvements to existing drugs would dramatically decline.
700. In terms of pricing, it is important that patents are not issued for old and obvious ideas and that the patent term is not inappropriately extended, so that generic manufacturers can make medicines available at lower prices.
701. It is necessary to look at the whole picture in order to improve the situation. A narrow focus on patent rights as ostensibly obstructing the availability of reasonably priced medicines would distort a complex and multifaceted picture and would leave out many factors that are fundamental in addressing pricing and access to medicines issues.
702. The experience of the United States shows how patent and pharmaceutical data protection stimulate an environment that promotes innovation, R&D, job creation, and the creation of new life-saving products. In turn, this environment maintains and promotes a strong generic pharmaceutical industry, which accounts for over 90% of all prescriptions filled in the US.
703. Finally, with respect to the proposal to keep this agenda item open, we request that the Council follow the agreed rules of procedure regarding how items are added to the agenda.
