Issue link: https://www.e-digitaleditions.com/i/1244583
8 May 2020 Tablets & Capsules compliance with DSCSA requirements related to the interoperable, electronic tracing of products at the package level. In summary, the project team has drawn the following conclusions: • Industry stakeholders currently use the EPCIS solu- tion (level 4 system) to meet the DSCSA man- dates. Through this project, we have shown that blockchain has the capability to be the technology underlying an interoperable system for the phar- maceutical supply chain, as mandated by DSCSA. When using a single blockchain solution, transac- tion throughput, speed, and reasonable cost can be achieved to meet stakeholder needs. • Data privacy requirements of the pharmaceutical industry can be met using "zero knowledge proof" technology, in which all transactions posted to the blockchain are fully obfuscated, ensuring that no confidential information or business intelligence is shared. The design allows for nodes in the block- chain system to be hosted by multiple unique par- ties while maintaining strict transactional privacy and still ensuring immutability of the transactions. • A blockchain system can be capable of validating the authenticity of product identifiers (verification) as well as facilitating the provenance of saleable units back to the originating manufacturer. • The authenticity of the drug product transaction information can be confirmed with each transac- tion allowing for expedited suspect investigations and recalls. • The group believes that, should a blockchain eco- system be created as a possible solution to the DSCSA interoperable solution requirement, it should have an open system architecture with an appropriate governance to oversee the function of the system and ensure compliance with indus- try-agreed business rules and standards of operation. • Governance should come from the industry itself. • The trust established by a blockchain system can be leveraged for a myriad of additional business appli- cations to the pharmaceutical industry, allowing for compounding benefits for the industry once such a platform is established. • As we see from every step of implementation of DSCSA, this is a complex solution that will require a stabilization period. The implementation date and the FDA enforcement date could be separate and planned in advance. • The long-term success of a truly interoperable blockchain-based solution will require strong par- ticipation and adoption from all industry stakehold- ers (manufacturers, wholesalers, dispensers, service providers, and others). • There are clear challenges with making disparate track and trace systems interoperable. The project group is concerned that no standards currently exist to make the multiple systems interoperable. With- ing partner. Custody of a serialized unit can be trans- ferred, and the transfer function is governed by the smart contract deployed on the blockchain. Smart contracts can be designed to enforce business rules, which are agreed upon across the industry or across trading part- ners. The current custodian initiates the transfer, and the recipient of the transfer needs to accept it in order to complete the transaction. At a high level, the overall MediLedger network archi- tecture consists of two types of nodes, or network inter- faces. Peer-to-peer interfaces allow trading partners to communicate directly with each other, while blockchain interfaces allow each peer-to-peer interface to commu- nicate with the blockchain, as shown in Figure 1. The blockchain interfaces form a blockchain network that is responsible for maintaining the blockchain data. With such a network, we can create the capability of storing records of transactions on the blockchain while allowing the exchange of electronic data, just as compa- nies are currently expected to do using EPCIS messages. The blockchain provides an immutable record of the change of ownership as well as the ability to check busi- ness rules to ensure that each unit of medicine is com- ing from its rightful custodian and being delivered to its rightful recipient. The power of the network is the ability to query partic- ipants about the history of products and receive responses with full provenance in a parallel fashion, rather than requiring people to answer in series. This is critical to patient safety, as it means near real-time alignment on serial number status and location, whereas alignment may take days or weeks with other types of solutions. Conclusions The MediLedger FDA Pilot Project has shown that it is feasible to use a blockchain-based solution for Figure 1 MediLedger network architecture Private data never leaves your firewall Peer-to-peer network Blockchain network Proof for every update published on blockchain Blockchain interface P2P interface MediLedger nodes