SecuringPharma: German Pharmacies Infiltrated by Fake Medicines

Phil Taylor wrote and posted a story August 12th in SecuringPharma about a scandal that involves dozens of pharmacies in the northern portion of Germany that are being investigated about the distribution of illegal medicines, including counterfeits.

Mr. Taylor reports that “the case suggests that far from being mainly a risk associated with purchase of medicines over the Internet, in some parts of Germany counterfeit and otherwise illegal drugs may be on pharmacy shelves and getting into the hands of patients.”

Also included in the posted story:

· Prosecutors have brought charges against one pharmacist from the Braunschweig region who is accused of handling €1.68m-worth and are investigating several others, according to a report by German business magazine Markt.

· The affairs of other pharmacies in Hamburg, Celle, Verden and Kiel are also being probed, according to the report, which notes that the counterfeit goods being traded included not only lifestyle medicines such as impotency drugs and bodybuilding products, but also painkillers, antibiotics and cancer treatments.

· Among the practices alleged to have been carried out by the pharmacists is mixing of illegally-acquired medicines with legitimate, genuine product.

· Last year, Germany suffered other high-profile cases in which counterfeit versions of GlaxoSmithKline's Combivir (lamivudine and zidovudine) and Boehringer Ingelheim's Viramune (nevirapine) - both used to treat HIV infection. The fakes were discovered in the legal supply chain, Combivir in Bremen and Viramune on the island of Sylt in northern Germany.

The suspected introduction and mixing of counterfeit medications into the trusted supply that consumers rely upon to be safe, make this a very troubling story.

When one of the most trusted health care professionals, pharmacists, poison their own supply chain with fraudulent, counterfeit medications, the only protection is in the members of the supply chain routinely verifying the safety and clinical efficacy of the product through authentication technologies.

Secure Pharma Chain encourages everyone within the pharmaceutical supply chain to deploy a variety of technologies, specifically authentication solutions to protect their inventories from fraudulent, adulterated and counterfeit medications. Authentication solutions go beyond pedigree or track and trace solutions and verifies to the end user what is inside the box within their inventories.

Knowing where the box has been is important but knowing what is inside the box is critical.

To read the SecuringPharma post, visit: http://www.securingpharma.com/40/articles/548.php.

To learn more about authentication solutions, visit: http://www.xstreamsystems.net/.

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.