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Pharma Manufacturing not contain a self-effectuating, date-certain mandate, which thereby requires the FDA to evaluate and promulgate regulations before final enactment,Ó Meyers says. After markup, the Senate bill calls for unit-level traceability within seven years, with an additional evaluation and final enactment in 2027. The California regulation, in comparison, calls for 50% unit level by 2015 and 100% by 2016. The extended time frames to phase in the federal legislation are included to allow industry leaders and regulators time to analyze the issues associated with each block of implementation process before proceeding to the next. ÒWe need some transition period for the industry to ramp up and decide how to carry out provisions, changes in business practices, and processes,Ó Gallenagh says. Time is needed for education, planning, and technical implementation to ensure that the serialization plan is effective. ÒAnother difference between bills is the whole concept of e-pedigree. That is a technological choke point, and pedigrees can be counterfeited easier than the drugs. They are not needed with serialization,Ó Meyers says. The difficulty is easily underestimated by those who see the ease with which UPS and other international logistics providers expertly track packages throughout their networks in real or near-real time. However, he emphasizes, ÒWeÕre not pushing pedigree information through a pipeline to other users, and our package-tracking systems have taken time and investment to build.Ó The requirement for data to be read and amended at each touch point and accessed by shippers, carriers, or end users creates an enormous database and requires massive standardization, not only of technologies, but of nomenclature. ÒSo far, nobody has an interoperable system that provides a transaction history with a digital signature that does what the California regulation requires.Ó The ideal system may be a cloud-based portal that would provide a single database from which users could store and access information. ÒThat sounds great on paper, but isnÕt necessarily the best approach,Ó Meyers says. It would require massive coordination, significant trust, and a huge budget, among other hurdles (such as privacy concerns). Currently, pharmaceutical manufacturers are developing their individual systems to work with internal applications and are hoping to provide connectivity later for distributors and providers. The closest the industry is coming to standardizing its approaches to serialization is broad agreement to use the GS1 standard for data. GS1 Healthcare U.S. Secure Supply Chain Task Force published a new guideline May 1 to identify and serialize pharmaceutical products using GS1 identification numbers. Called ÒApplying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes to Support Serialization, Pedigree and Track & Trace,Ó the guideline discusses best practices for GS1 deployment. INDUSTRY IS PLEASED ÒWeÕre pleased with overall structure of the bills and the great amount of progress weÕve seen from Congress. WeÕre very encouraged by that and very committed to continuing this momentum to reach a solution this summer,Ó Gallenagh says. Congressional efforts will streamline the regulations Òand make it more difficult for bad actors and products to infiltrate the supply chain. We will build on lessons learned in using new technology to streamline operations to ensure patients get safe products, regardless in which state they reside.Ó The pharma industry supports the federal efforts. HDMA President and CEO John Gray calls the bills Òanother step toward finally eliminating the current patchwork of state requirements. Establishing a federal, uniform traceability solution will offer greater regulatory clarity to the healthcare industry and ensure lifesaving medications are delivered safely to those who need them.Ó The Pharmaceutical Distribution Security Alliance (PDSA) is equally supportive, saying, ÒPDSA strongly supports passage of legislation to protect patient safety and secure the pharmaceutical distribution supply chain through a single, uniform, and national system and urges Congress to enact such a legislative solution as quickly as possible.Ó If this bill makes it to the presidentÕs desk, ÒIt will get there via compromise. No one sector alone will be popping champagne,Ó Meyers says. ÒThere will be shared pain and, hopefully, a shared sense of accomplishment.Ó Ultimately, however, serialization technology could eventually enable consumers to scan serial numbers for their medication into their smartphones and check a database as assurance against counterfeits. OTHER NATIONS Other nations also are advancing their own serialization plans. Globally, serialization efforts began in 2010 with requirements for track-and-trace in Turkey, product codes in Cyprus, traceability in Serbia, and standardized numerical identification in the U.S. Since then, product code requirements have been added by Denmark; batch codes by Canada, France, and Korea; and various traceability requirements by the EU, Spain, and China. Argentina launched an end-to-end serialization system late in 2012. Going forward, Germany is piloting an end-to-end serialization program late in 2013. The EU is calling for compliance by 2014 and Korea by 2015, Cathcart says. China will begin implementing a national track-and-trace strategy in 2015 and began phasing in revisions to its good supply practices June 1. ÒThe EU is expected to implement a staged approach between 2016 and 2018. Brazil and India, which had put their serialization regulations on hold, are dusting them off.Ó The message for pharmaceutical manufacturers is clear. Serialization is coming Ñ either through CaliforniaÕs regulations in 2015 or through a federal bill this autumn with delayed implementation. Either way, now is the time to prepare. July 2013 LifeScienceLeader.com 45