Eisai Global Product Security
February 12, 2014
In accordance with our hhcphilosophy, we aim to protect patients from illegally manufactured and/or illegally distributed Eisai products. A proactive approach is taken to prevent and deter illegal activity related to Eisai products.
Product Security is a top priority for Eisai's management, and all possible efforts will be made to address the issue.
To protect patient health, Product Security at Eisai includes all criminal attacks against our products. These crimes include drug counterfeiting*, illegal diversion of products from authorized channels, theft of products, product tampering, intentional adulteration of products or components, and other acts of fraud that may potentially compromise our products and thereby cause harm to Eisai patients. Although criminal attacks against Eisai products are not prevalent, we are determined to take all reasonable measures to prevent, deter, and disrupt these criminal activities. In addition, Eisai investigates any such incidents that may occur and seeks enforcement action through appropriate government authorities whenever possible.
*The term counterfeit medical product describes a product with a false representation of its identity and/or source. This applies to the product, its container or other packaging or labelling information. Counterfeiting can apply to both branded and generic products. Counterfeits may include products with correct ingredients/components, with wrong ingredients/components, without active ingredients, with incorrect amounts of active ingredients, or with fake packaging.
(Source) Third IMPACT General Meeting, 3-5 December 2008, Hammamet, Tunisia
Eisai has established a Product Security Executive Board (PSEB) made up of top company executives to provide strategic leadership and set policies on product security issues. The company has a Global Product Security Director based in the United States to lead these efforts. This is an interdisciplinary effort involving representatives from Quality, Production, Legal, Government Relations, Medical Services, Logistics, and other departments.
Eisai's strategy is to work closely with law enforcement and regulatory agencies around the world and participate with other pharmaceutical companies in a variety of trade associations and international organizations to share information, exchange and learn about best practices, in order to ensure the safety and security of Eisai products. Some examples include:
- Eisai is an active member in the Pharmaceutical Security Institute (PSI), an association of security directors representing pharmaceutical companies from around the world. PSI is dedicated to protecting the public health, sharing information on counterfeit pharmaceuticals, and initiating enforcement actions through appropriate authorities.
- Eisai regularly participates as an industry representative in meetings of the Permanent Forum on International Pharmaceutical Crime (PFIPC). This is an organization of law enforcement and regulatory agencies representing countries from around the world. Among other projects undertaken by PFIPC is the development of training modules to help developing countries gain expertise in counterfeit drug investigations.
- Eisai has participated for several years with Interpol in its Operation Pangea the Internet Week of Action against rogue on-line pharmacies. This coordinated enforcement effort involves the participation of dozens of law enforcement and customs agencies from countries around the world and led to the seizure of millions of dosage units of potentially harmful medicines and the dismantling of thousands of rogue websites. In 2013, Eisai joined an international initiative by Interpol and the global pharmaceutical industry (total 29 companies) in creating the Pharmaceutical Industry Initiative to Combat Crime (PIICC). This Crime Program further builds on the work of Interpol's Medical Product Counterfeiting and Pharmaceutical Crime(MPCPC) unit. This will enhance the law enforcement community's response to pharmaceutical crime through stronger partnerships, coordinated efforts, and the enhancement of enforcement capabilities in developing countries. The program will focus on the prevention of all types of pharmaceutical crime as well as the identification and dismantling of organized crime networks linked to this illegal activity.
Eisai is an active member of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Eisai supports IFPMA's anti-counterfeiting and product security efforts, including its Ten Principles on Counterfeit Medicines. Eisai also supports IFPMA's “Fight the Fakes”campaign, an effort to raise awareness about the dangers of fake medicines and their impact on society.