The Open-SCS Working Group Addresses Packaging Serialization Standard to Accelerate Compliance for Healthcare Counterfeiting Regulations
Addressing compliance to healthcare counterfeiting regulations, the Steering Committee of the Open Serialization Communication Standard Working Group (Open-SCS) announces the accelerated development of an industrial interoperability standard and associated requirements templates for release by the end of 2015.
Since the 2012 Patent Cliff, generic products now make up 80% of the global healthcare market and are a primary counterfeiting target where:
- Counterfeit drugs flood the market and generate ~$75B USD Revenue annually
- The ‘counterfeit industry’ is estimated to grow by 20% annually
- In some countries, counterfeit drugs constitute as much as 70% of total drug supply
McKinsey & Company states, “Global standards could enable substantial patient safety benefits and enable total healthcare cost reduction of $40-100 Billion USD.”
Senior logistics executives polled at the Ninth Annual UPS Healthcare Forum in June 2014 reported an extremely low success rate in addressing the challenge of serialization regulatory compliance. Only 12 percent reported satisfied with their companies’ performance in this area. The scoped Open-SCS work products focus on healthcare packaging serialization interoperability across the plant’s equipment and systems and between the supply chain systems. The Steering Committee members include 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.
The immediate value for all healthcare providers is obtaining the $100,000+ integration specifications for less than $15K per year. The real ongoing high value grows dramatically through lower lifecycle costs from standards-based change management and global multi-plant/line scalability.
In September 2014, Open-SCS founding members first gathered in Frankfurt, Germany as the Open Architecture for Track & Trace Group to specifically address the lack of solution standardization for compliance to healthcare packaging serialization regulations. More than 80 healthcare manufacturers, solution providers, T&T suppliers, and consulting companies contributed to this roundtable. There was a real urgency to develop the standard inter-plant serialization solutions to improve the deployment efficiency and high cost of compliance with the aggressive regulations.
Open-SCS (www. opcfoundation.org/open-scs) operates as an OPC Foundation chartered working group evolving relationships with GS1, Rx-360, ISA and ISPE to accelerate work product releases in months and not years. 2015 work products are intentionally scoped as a “plug-and-deploy” set of user and functional requirements for data exchanges between the equipment level, operations management level and the serialization supply chain platforms. This scope directly addresses regulations requirements currently not covered by supply chain standards organizations.
“Current interoperability standards such as OPC-UA, ISA-95/88/B2MML, EPC-IS, PackML, and others do cover most of the requirements but in no standard implementation form across the available parts. A single standard interoperability implementation will sufficiently cover the entire requirement for healthcare serialization compliance”, says Charlie Gifford, Executive Director of the Open-SCS Group.
Serialization legislation from many countries dealing with the global healthcare counterfeiting crisis require immediate serialization and aggregation of products from the manufacturer to the patient. This requires that production floor and warehouse equipment and systems are able to exchange information with the manufacturers’ supply chains and the patients’ support systems. The Open-SCS scope serves as the blueprint on how these data exchanges meet the following goals:
- Define and simplify the base roles for each actor in the data flow to supply chain.
- Define the communication protocols used for each connection point.
- Enable greater flexibility of the serialization architecture available to the industry.
- Substantially reduce integration cost and delays of products from different vendors.
With all healthcare providers and vendors working together, the Open-SCS is on the right track with their new standard and implementation specifications by the end of 2015.
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