US pharma industry leaders support blockchain tech to aid track and trace systems

A working group of 24 industry leading pharmaceutical manufacturers, distributors, retail chains, logistics partners and solution providers in the US, has released a report detailing how and why blockchain technologies are necessary for the adoption of track and trace in the country. 

The document comes after the US Food and Drug Administration‘s (FDA’s) announced a pilot proposal programme to identify solutions for meeting the 2023 conditions of the Drug Supply Chain and Security Act (DSCSA). In June 2019, the MediLedger Project was accepted by the FDA as one of their approved proposals. The group’s purpose was to evaluate blockchain technology, like the MediLedger Network, in the track and trace of prescription medicines in the US.

Their report concludes that blockchain can meet the 2023 DSCSA requirements for an interoperable, confidential change-of-ownership system in the US pharmaceutical supply chain. 

According to the group, the report found that a well-designed, industry-led, decentralised blockchain platform would be compatible with the 2023 DSCSA. Mack MacKenzie, Vice President of Digital Market Access and Revenue Management solutions at Pfizer said: “I am very encouraged by this demonstration of broad industry commitment to an interoperable system that achieves DSCSA compliance. It is exciting to imagine how we can build on this success to jointly deliver transformative digital services that add more value for patients.”

The proposed solution is a combination of:

• business rules and standards that govern how data is shared
• a blockchain-based network capable of enforcing those standards.

The core function of the network is to validate the authenticity of drug identifiers and the provenance of saleable units throughout the supply chain. This can be completed without any proprietary data being shared openly on the blockchain or ever leaving a company’s control. Instead, proprietary data can be exchanged directly with certain trading partners. What is posted on the blockchain are cryptographic proofs, also known as zero knowledge proofs, of these exchanges to ensure they are valid and follow business rules and data standards. This enables all trading partners to operate on the same up-to-date data as well as certifying that interactions throughout the supply chain are based on trust.

Matt Sample, Vice President of Manufacturing Operations at AmerisourceBergen said: “There’s a lot of unknowns on what the 2023 interoperable system will be and what technologies will enable that system. However, what we were able to demonstrate during the FDA MediLedger pilot was the power of a connected network of authorised trading partners, including those without direct business relationships. The use of blockchain enabled a shared ‘phone book’ of authorised trading partners, locations and connection points that enabled that network. Whether blockchain is or is not part of the 2023 landscape, we hope this pilot at least demonstrated the viability of blockchain in the pharma industry and the industry can learn from the use cases evaluated.”

David Vershure, Vice President Channel and Contract Management at Genentech said: “We are excited to see our industry working together to build a truly resilient system that is crucial for the future of patient safety. The current point-to-point systems infrastructure lacks the ability to keep data in-sync across the healthcare supply chain, which ultimately increases the risk of counterfeit, diverted or otherwise illegitimate products.”