Issue link: https://www.e-digitaleditions.com/i/1244583
Tablets & Capsules May 2020 7 • Showed how the MediLedger solution could be interoperable with other technology solutions such as the GS1 Standard Electronic Product Code Information Services (EPCIS). • Created a value proposition for the MediLedger solution. System description The overall vision of our work was to create a system that could confidentially track the change of ownership of prescription medicines without requiring trading part- ners to reveal data to each other or requiring a central- ized system to hold the information. Our belief is that a neutral industry platform would enable information exchange and proactive validation of rules that would immediately highlight any suspect products or transac- tions. We believe there is a significant need for such a platform in the US and that it would bring the critical benefits that other countries are experiencing with gov- ernment- or consortium-run systems without the draw- backs of those approaches. The solution uses three core technologies: 1. Private client messaging that allows trading part- ners to exchange confidential messages leveraging EPCIS technology and standards. 2. Blockchain as a shared, immutable ledger to reg- ister the proof of the authenticity of transactions and execute smart contracts. The blockchain will enforce business rules, such as the rule that only one company can have legal ownership of a serial- ized unit at a given time (no double transfer). 3. Zero-Knowledge Succinct Non-Interactive Argu- ment of Knowledge proofs (zk-SNARKs) to fur- ther enhance privacy by ensuring that no business data is revealed. zk-SNARK is a mathematical proof concept where possession of information can be proven without revealing that information. The key design pattern of the solution focuses on the handling of a serialized unit. Each unit is managed as a non-fungible token with the custody assigned to a trad- tributors, pharmaceutical dispensers, logistics compa- nies, professional organizations, and standards bodies [2]—was accepted into the FDA's pilot program with the goal of evaluating blockchain as the solution to the 2023 DSCSA requirements related to the interoperable, electronic, confidential tracing of products at the sale- able-unit and homogeneous-case packaging levels. All aspects of the pharmaceutical supply chain were represented in the project working group and our inten- tion was to deliver a report on how a blockchain-based solution could address industry-wide interoperability, regardless of participant size, function, or business inter- est. We wanted to ensure not only that all parties could comply with the law, but also that potential additional FDA regulations for the increased security of prescription medicines could be achieved. Methodology The original MediLedger Project working group was established in 2017 to bring together representatives from leading pharmaceutical manufacturers, wholesale distributors, supply chain management experts, and var- ious companies to develop industry requirements for an interoperable system to meet the 2023 DSCSA require- ments. The group created a technical, working proto- type that met both the industry requirements and the DSCSA requirements. In the current FDA pilot project, we have added to that work to identify additional components of the future solution with a broader group of stakeholders represented on the project team. As a result of both of these efforts, the group has: • Modeled events in a serialization data exchange environment for prescription drug products using a blockchain-distributed ledger system. • Developed and proposed a business and financial model that allows for the participation of the differ- ent industry stakeholders. • Identified potential issues with system performance and capabilities. • Defined the potential IT architecture of an elec- tronic interoperable system. • Shared blockchain knowledge, separating reality from hype. • Demonstrated how blockchain may be better suited than other technologies to respond to DSCSA requirements and how it can provide other strategic advantages. • Identified industry standards in use for the solution, and standards that would benefit the industry. • Outlined how the system could facilitate solving system and process errors and identify nefarious behavior. • Defined human factors that could present imple- mentation challenges. • Identified a process for onboarding and managing authorized trading partners. • Described possible governance of the system. The overall vision of our work was to create a system that could confidentially track the change of ownership of prescription medicines without requiring trading partners to reveal data to each other or requiring a centralized system to hold the information.