Track and Trace: Summary of the MediLedger DSCSA Pilot Project Report to the FDA

Muffie Fulton, Chronicled

In February of 2019, the FDA requested proposals for pilot projects to demonstrate an electronic interoperable system for the confidential track and trace of pharmaceuticals throughout the supply chain as outlined in the DSCSA¹. The FDA requested reports from these pilot projects in late 2019 or early 2020 that could inform the agency and industry stakeholders about possible ways forward to enable compliance with the regulation. 

The MediLedger Pilot Project—a consortium of 25 leading pharmaceutical manufacturers, wholesale distributors, pharmaceutical dispensers, logistics companies, professional organizations, and standards bodies²—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 saleable-unit and homogeneous-case packaging levels. 

All aspects of the pharmaceutical supply chain were represented in the project working group and our intention was to deliver a report on how a blockchain-based solution could address industry-wide interoperability, regardless of participant size, function, or business interest. 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 various companies to develop industry requirements for an interoperable system to meet the 2023 DSCSA requirements. 

The group created a technical, working prototype 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 different industry stakeholders. 
• Identified potential issues with system performance and capabilities. 
• Defined the potential IT architecture of an electronic 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 implementation challenges. 
• Identified a process for onboarding and managing authorized trading partners. • Described possible governance of the system. 
• 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 partners 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 transactions. 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 government- or consortium-run systems without the drawbacks of those approaches.

The solution uses three core technologies: 

1. Private client messaging that allows trading partners to exchange confidential messages leveraging EPCIS technology and standards. 
2. Blockchain as a shared, immutable ledger to register 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 serialized unit at a given time (no double transfer). 
3. Zero-Knowledge Succinct Non-Interactive Argument of Knowledge proofs (zk-SNARKs) to further 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 trading partner. Custody of a serialized unit can be transferred, 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 partners. 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 architecture consists of two types of nodes, or network interfaces. Peer-to-peer interfaces allow trading partners to communicate directly with each other, while blockchain interfaces allow each peer-to-peer interface to communicate 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 companies 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 business rules to ensure that each unit of medicine is coming from its rightful custodian and being delivered to its rightful recipient. 

The power of the network is the ability to query participants 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 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 solution (level 4 system) to meet the DSCSA mandates. Through this project, we have shown that blockchain has the capability to be the technology underlying an interoperable system for the pharmaceutical supply chain, as mandated by DSCSA. When using a single blockchain solution, transaction 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 parties 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 participation and adoption from all industry stakeholders (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. Without appropriate standards, it is unlikely that disparate systems can be made successfully interoperable. 
• In the absence of a central point of data sharing as other countries have chosen to implement, the US supply chain will suffer as companies struggle with keeping data accurately and completely shared across a wide variety of partners, systems and technical formats. This means that in the event of a significant public-health crisis, stakeholders and agents will struggle to locate and quarantine suspect products in a timely manner, continuing to put patients’ lives at stake. 
• We believe we have demonstrated that a well-designed, industry-leading, neutral platform (or well-managed interconnected platforms) using the advancements of technology like blockchain can avoid these significant risks. 

Next steps 

The project group identified a number of factors that would increase the chances of success in implementing the 2023 DSCSA requirements. First, at least four sets of standards still need to be developed: messaging (EPCIS updates), system interoperability, APIs, and authorized trading partner identification. The group is also very clear that implementation and usage throughout the industry will be simplest if the industry uses a single neutral track-and-trace platform that ensures confidentiality and trust throughout each step of the supply chain. 

In general, a number of industry problems result from inefficiencies between trading partners, failures in cross-company communication, and the current reliance on antiquated technology to exchange information. Protocols that use blockchain can be established from which groups of companies will benefit by participating together, enabling enforcement of cross-industry business rules. The vision is that these protocols are not, in principle, controversial agreements; on the contrary, they simply put in place the pipes that allow for improved capability and reduced friction, so companies can do business with their trading partners in any way they best see fit. Compliance with DSCSA is just one use case. 

The following are recurring patterns where the MediLedger network with blockchain components can add value in the context of a multi-enterprise business network. 

Data synchronization

A blockchain can be used as an industry utility for accuracy and completeness of data files. The Synaptic Health Alliance’s provider directory data-sharing initiative is an example of this design pattern. Proof of Authority (PoA) consensus creates strong guarantees around master data synchronization. 

Asset exchanges

The network can be used as a two-sided market for the exchange of digital assets that have value for buyers and sellers/curators. Product identifiers serve both as digital intellectual property and as an endpoint in an operational messaging so that they can actually be transferred under the mergers and acquisitionsscenario without interrupting the system’s operational performance when a seller sells a molecule to a buyer. 

Multi-party business process automation 

A foundational use of the network is as a shared source of truth between transacting parties in a business process for the purpose of automation, operational intelligence, and model innovation. A decentralized business process for sending and responding to drug verification requests means that hundreds of companies can participate in a mostly closed-loop process that upgrades trust and security in the supply chain in an automated and efficient format. 

Business rule enforcement. With zk-SNARKs plus smart contracts, we can use the blockchain as a neutral regulator, inspector, or enforcer of industry-wide regulatory and business rules. For example, we can create a rule such as, “only manufacturer A is allowed to commission or send SGTINs containing manufacturer A’s company prefix” or “an SGTIN can only move forward in the supply chain if it originated from a licensed manufacturer and if all prior transfers between trading partners on the network followed the rules and were valid.” Used in this way, blockchain plays the role of an army of clipboard-carrying inspectors, checking and approving every transaction to ensure that the letter of the regulation is followed. Even more exciting is that zk-SNARK applies 128-bit encryption to the payload of every transaction, which proves to be a very strong data privacy solution. 

You can access the full MediLedger DSCSA Pilot Project report by visiting www.mediledger.com/ fda-pilot-project. 

References 

1. www.federalregister.gov/documents/2019/02/08/ 2019-01561/pilot-project-program-under-the-drug-supply- chain-security-act-program-announcement 

2. MediLedger Pilot Project participants include: AmerisourceBergen, Amgen, Cardinal Health, Center for Supply Chain Studies, Dermira, Eli Lilly, Endo, FedEx, FFF Enterprises, Chronicled, Genentech, Gilead, GS1, Glaxo Smith-Kline, Hikma, Inmar, Maxor, McKesson, Novartis (Sandoz), Novo Nordisk, Pfizer, Sanofi, Vax-serve, Walgreens, and Walmart.