USTR Lists the Global Hotspots for Counterfeit Drugs

The United States Trade Representative (USTR) recently released their annual Special 301 report on global advances and watch lists for Intellectual Property (IP) enforcement.

The Czech Republic, Hungary, and Poland were removed from the watch list. Czech Republic was removed due to their improved board control and enactment of stricter criminal penalties. Hungary was removed due to their increase of IP enforcement. Poland was eliminated due to significant reduction of pirated goods at border markets.

Saudi Arabia was removed from watch list in Feb. 2010 for its advances in controlling the distribution of counterfeit medicines. Israel is listed as status pending as it works with USTR to resolve their problems with counterfeit medicines.

Currently countries on priority watch list include: Algeria, Argentina, Canada, Chile, China, India, Indonesia, Pakistan, Russia, Thailand, and Venezuela.

• China – although China has made great strides in IP regulation, counterfeiting still remains widespread and China’s IPR enforcement regime remains largely ineffective and non-deterrent. In China, many bulk Active Pharmaceutical Ingredients (API) used in manufacturing medicines avoid regulatory oversight by declaring falsely that they will not be used in manufacturing pharmaceutical products.


• Russia – brand manufacturers continue to report counterfeit problems of their trademarks especially for consumer goods, distilled spirits, agriculture chemicals, biotechnology, and pharmaceuticals.


• Algeria laws ban imported pharmaceuticals in favor of local production. In addition the USTR has concerns of weak protection of patents.


• Argentina has a backlog of pharmaceutical patent applications and USTR cites the need for stronger protection against IPR infringement.


• Canada - displays weak enforcement of IP rights and border protection.


• Chile - has displayed a willingness to work with the U.S. Pharma industry, but still falls short in some areas.


• India – although India has made advances in IP enforcement, the USTR still shares concerns regarding widespread counterfeit medicine and an enforcement regime that remains ineffective at addressing this problem.


• Indonesia shows an overall deterioration of IP protection and enforcement including its inability to address the counterfeiting of pharmaceutical products.


• Pakistan – has made significant advances in patent applications, but needs an effective system to address patent issues.


• Thailand – piracy and counterfeit remain widespread. In the pharmaceutical industry they need to strengthen their IP protection and enforcement.


• Venezuela - does not recognize pharmaceutical patents.

To read the entire report visit: www.ustr.gov.