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.

Dramatic Rise in Drug Seizures by EU Customs

SecuringPharma.com posted a story by Phil Taylor on July 24th, outlining and giving background on an astounding increase in drug seizures by EU Customs Officials.

Some interesting tidbits include:

• Seizures of pharmaceutical products at the European Union’s borders rose 57 per cent last year, while the total number of items detained more than doubled to around 8m items.


• That increase came against a backdrop of a 13 per cent hike across all product categories to nearly 50,000 seizures overall, with the number of detained articles swelling to 180m from 80m in 2007.The report notes that seizures of medicines were among the most controversial developments in 2008.


• There were cases in which generic medicines destined for a developing nation being seized in transit at EU borders, even though they did not infringe intellectual property rights in their destination markets (such as Latin America and Africa).


• Around 70 per cent of all seizures were carried out at the request of an intellectual property rights holder, with the remainder ex officio actions by customs officials where there was a suspicion of infringement.

To read the story visit SecuringPharma.com at the following link: http://www.securingpharma.com/40/articles/184.php

US Drug makers Express Concern with USA Trading Partner Countries

The US Trade Representative (USTR) released its 2009 Special 301 Report on Friday May 1, 2009. According to the report, US drug makers have expressed concern over the policies of a number of USA’s trading partners - including Canada, France, Germany, Italy, Japan, New Zealand and Taiwan in regards to global intellectual property protection.

“In this time of economic uncertainty, we need to redouble our efforts to work with all of our trading partners – even our closest allies and neighbors such as Canada – to enhance protection and enforcement of intellectual property rights in the context of a rules-based trading system,” said the USTR, Ambassador Ron Kirk.

The USTR Priority Watch List for 2009 names countries requiring particular scrutiny - Algeria, Argentina, Canada, Chile, France, Germany, India, Indonesia, Israel, Italy, Japan, New Zealand, Pakistan, Taiwan, Thailand and Venezuela. Canada was added to list for the first time this year, due to “increasing concern about the continuing need for copyright reform, as well as continuing concern about weak border enforcement.”

Brazil, China, India, Indonesia and Russia are listed as areas where the manufacture of counterfeit drugs is rampant.

Indonesia joins the list for its counterfeit manufacturing, its counterfeit drug trade and the introduction last year’s law on the operation of foreign pharmaceutical companies that raises “significant market access concerns;”

China is also listed due to its regulatory lapse in the enforcement of active pharmaceutical ingredients (API) – since often these ingredients are not declared as a bulk chemical intended for use in pharmaceuticals by API makers to avoid regulatory oversight.

To read a recap on the USTR Report visit Pharma Times.

It is understandable that China’s lack of regulatory control for APIs would be of particular concern to the US since China provides 40% of the APIs for drugs. The impact of this danger was felt dramatically last year when an adulterated substance added by a Chinese supplier resulted in the heparin recall and almost 100 deaths in the United States.