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Partners in Action
Anti-Counterfeiting Enhances Patient Safety
by Kimberly Thomas, EMD Serono, Inc.Understanding the importance of patient safety, counterfeiting, diversion, adulteration, misbranding and illegal importation have all become a high priority for both the pharmaceutical industry and government agencies recently. As companies and agencies make their best efforts to mitigate this activity, there are many challenges.
The pharmaceutical industry endeavors to find innovative solutions to strengthen and increase patient safety and provide continued support to various government agencies.To achieve this industrywide goal, EMD Serono has taken a number of proactive steps. EMD Serono created a cross-functional team, including corporate security, Intellectual Property Rights (IPR)/trademark, product security, quality assurance, government affairs and legal, and held a workshop in July 2008 for the U.S. launch of global anti-counterfeiting initiatives. The objectives were designed to foster increased levels of communication both internally and externally. In conjunction, EMD Serono developed and implemented a trace initiative for U.S. law enforcement agencies and has also been successfully passing electronic pedigrees with both serialized and non-serialized products.
In addition to taking steps forward in developing a trace initiative, EMD Serono has also focused its efforts on a number of different activities, such as partnering with the FDA for trace initiatives. EMD Serono has also implemented training and outreach programs to U.S. Customs and Border Protection (CBP) and U.S. Immigration and Customs Enforcement (ICE) on identification of EMD Serono’s products and ports of entry in an effort to ensure legitimacy of products imported into the United States. This program established a relationship with both CBP and ICE by introducing EMD Serono’s initiatives in enhancing patient safety. EMD Serono continues to work with trade associations, such as BIO, HDMA and PhRMA, to ensure harmonized approaches from industry are taken to enhance patient safety.
The pharmaceutical industry and government will continue collaborate on their mutual goals of protecting innovation and patient safety by working behind the scenes to deliver safe and effective products through the normal channels of distribution.
The opinions expressed by the author in this article is solely the view of the author, and does not necessarily reflect the views of the U.S. Government, the Department of Homeland Security (DHS) or any person or entity for any policy, position, program, service or product. No compensation has been paid for this article.
