This page has been validated.
  • boxes, arresting nine people and seizing 41 boxes, but greater action and coordination will be needed in this region.

The United States continues to urge trading partners to undertake more effective criminal and border enforcement against the manufacture, import, export, transit, and distribution of pirated and counterfeited goods. USTR engages with its trading partners through bilateral consultations, trade agreements, and international organizations to help ensure that penalties, such as significant monetary fines and meaningful sentences of imprisonment, are available and applied so as to have a deterrent effect on counterfeiting and piracy. In addition, trading partners should ensure that both counterfeit goods, as well as the materials and implements used for their production, are seized and destroyed, and thereby removed from the channels of commerce. Permitting counterfeit and pirated goods and enabling materials to reenter the channels of commerce after an enforcement action wastes resources and compromises the global enforcement effort. Trading partners should also provide enforcement officials with the authority to seize suspect goods and destroy counterfeit and pirated goods during import or export, or in transit movement, ex officio, without the need for a formal complaint from a rights holder. The U.S. Government coordinates with, and supports, trading partners through technical assistance and sharing of best practices on criminal and border enforcement, including with respect to the destruction of seized goods. (See Annex 2).

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 a contributing dimension of the larger problem of the proliferation of substandard, unsafe medicines. The United States notes its particular concern with the proliferation of counterfeit pharmaceuticals that are manufactured, sold, and distributed in trading partners such as Brazil, China, India, Indonesia, Lebanon, Peru, and Russia. China and India are the sources of most of the counterfeit pharmaceuticals shipped to the United States. While it is impossible to determine an exact figure, studies have suggested that up to 20 percent of drugs sold in the Indian market are counterfeit and could represent a serious threat to patient health and safety. The U.S. Government, through the United States Agency for International Development (USAID) and other Federal agencies, supports programs in sub-Saharan Africa, Asia, and elsewhere that assist trading partners in protecting the public against counterfeit and also substandard medicines (medicines that do not conform to established quality standards) introduced into their markets. (See discussion immediately below).

In many cases, the bulk active pharmaceutical ingredients (API) that are used to manufacture pharmaceuticals bear counterfeit trademarks. Because such API are unlawfully produced or marketed, their manufacturers are unlikely to subject themselves to regulatory oversight or comply with good manufacturing practices. Hence, these products may contain substandard and potentially hazardous materials, and may threaten the health of American consumers. For

14