According to the OPC Foundation, since the 2012 patent cliff, generic products now make up 80% of the global healthcare market and are the primary counterfeiting target where:
• Counterfeit drugs flood the market and generate ~$75B USD revenue annually
• The “counterfeit industry” is estimated to grow more than 20% annually
• In many countries, counterfeit drugs constitute 70% of total drug supply
• Large increase in thefts and reimbursement frauds
• Authorities and industry push for real-time data to analyze/control supply chain
With that in mind, OPC Foundation will hold an Open-SCS Webinar Sept. 3, 2015 at 10 a.m. Eastern U.S. time. Click here to register.
Charlie Gifford, Executive Director of the Open-SCS, discusses how the Open Serialization Communication Standard Working Group’s (Open-SCS) was specifically formed to address the lack of compliance standardization for healthcare packaging serialization regulations.
The Open-SCS is focused on accelerating compliance to global healthcare counterfeiting regulations. The industry urgency is explained for immediate development of standard inter-plant serialization solutions to accelerate deployment and lower the high cost of available compliance systems.
Aggressive serialization regulations from many countries are now directly addressing the global healthcare counterfeiting crisis by requiring serialization of products and packaging aggregation from the manufacturer to the patient. The webinar explains the requirement for healthcare packaging and warehouse equipment and associated systems to exchange real-time data with the manufacturers’ supply chains and the patients’ support systems.
Senior logistics executives polled at the Ninth Annual UPS Healthcare Forum in June 2014 reported an extremely low rate of success in addressing the challenge of regulatory compliance. Only 12% reported they were satisfied with their companies’ performance in this area.
OPC Foundation says McKinsey & Company states, “Global standards could enable substantial patient safety benefits and enable total healthcare cost reduction of $40-100 Billion USD.”
A work product overview is provided of the rapid development of the Open Packaging Serialization Global Name Registry and associated plant-to-supply chain interoperability requirements specifications packaging serialization for release by early 2016. These work products are intentionally scoped as a “ready-to-deploy” set of user and functional requirements for data exchanges between the equipment (L2), operations management (L3) and the supply chain serialization platforms (L4) to support patient safety.The Open-SCS scope directly mapped into regulations requirements currently not covered by partner supply chain standards organizations.
The Open-SCS was formed by founding members Abbott, Teva Pharmaceutical Industries Ltd., Famar Health Care Services, Mylan Pharmaceutical, NNEPharmaplan, SAP AG, OptelVision Inc., Systech International, Werum IT Solutions GmbH, and Antares Vision Srl.
Open-SCS operates as an OPC Foundation partner as a chartered working group evolving relationships with GS1, Rx-360, ISA and ISPE to accelerate work product releases in months and not years. With all healthcare providers and vendors working together, the Open-SCS provides the right track with their new standard and implementation specifications by the end of 2015.
Since 1996, the OPC Foundation has facilitated the development and adoption of the OPC information exchange standards. As both advocate and custodian of these specifications, the Foundation’s mission is to help industry vendors, end users, and software developers maintain interoperability in their manufacturing and automation assets. The OPC Foundation is dedicated to providing the best specifications, technology, process and certification to achieve multivendor, multiplatform, secure, reliable interoperability in industrial automation and related domains.
