include requirements that pirated and counterfeit goods – as well as materials and implements used for their production – are seized and destroyed.
The manufacture and distribution of pharmaceutical products bearing counterfeit trademarks is a growing problem that has important consequences for consumer health and safety. Such trademark counterfeiting is one dimension of the larger problem of substandard medicines. The United States notes its particular concern with the proliferation of the manufacture, sale, and distribution of counterfeit pharmaceuticals in countries such as Brazil, China, India, Indonesia, and Russia.
In many cases, bulk active pharmaceutical ingredients (API) that are used to manufacture pharmaceuticals that bear counterfeit trademarks are not made according to good manufacturing practices. Hence, these products may contain sub-standard and potentially hazardous materials. For instance, in China, domestic chemical manufacturers that produce APIs can avoid regulatory oversight by not declaring that the bulk chemical is intended for use in pharmaceutical products. This contributes to China being a major source country for APIs used in counterfeit pharmaceutical products. Although China has taken some welcome steps, such as requiring manufacturers to register with the State Food and Drug Administration, more effective regulatory controls are needed to assist China and its trading partners in their efforts to address this problem.
Internet and Digital Piracy
While the increased availability of broadband Internet connections around the world is generating many benefits, from increased economic activity and new on-line business models to greater access to and exchange of information, this phenomenon has also made the Internet an extremely efficient vehicle for disseminating copyright-infringing products.
Internet piracy is a significant concern with respect to a number of trading partners, including Brazil, Canada, China, India, Italy, Russia, Spain and Ukraine. Unauthorized retransmission of live sports telecasts over the Internet continues to be a growing concern in many countries, particularly China, and "linking sites," many reportedly based in the Netherlands, are exacerbating the problem. In addition, piracy using new technologies is an emerging problem internationally. U.S. copyright industries also report growing problems with piracy using cellular telephones, palm devices, flash drives, and other mobile technologies. In some countries, these devices are being pre-loaded with illegal content before they are sold. In addition to piracy of music and films using these new technologies, piracy of ring tones, games, and scanned books also occurs. The United States will work with our trading partners to combat these growing problems. The United States urges governments to ratify and implement the WIPO Internet Treaties, which provide tools necessary for protecting copyrighted works in the digital environment.
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