Concerning adherence to healthcare counterfeiting regulations, the Open Serialization Communication Standard Working Group (Open-SCS) working group is aiming to create an industrial interoperability standard and associated requirements templates for release by the end of 2015.
Since the 2012 Patent Cliff, generic products now constitute 80% of the global healthcare market and are vulnerable to counterfeiting, whereas the counterfeit industry is projected to grow at 20% annually and generate $75 billion each year.
According to McKinsey and Company, “Global standards could enable substantial patient safety benefits and enable total healthcare cost reduction of $40-100 Billion USD.”
At the Ninth Annual UPS Healthcare Forum in June 2014, only 12% of senior logistics executives said they were satisfied with their company's performance in addressing the challenge of serialization regulatory compliance.
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 an urgency to develop the standard inter-plant serialization solutions to improve the deployment efficiency and high cost of compliance to the aggressive regulations.
The steering committee now includes the following: 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.
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 goals like defining and simplifying the base roles for each actor in the data flow to supply chain, defining the communication protocols used for each connection point, enabling greater flexibility of the serialization architecture available to the industry and substantially reducing integration cost and delays of products from different vendors.