To implement full Traceability, the physical supply chain flow of goods needs a parallel flow of serialization information. For every movement or change of ownership, a new status with specific characteristics is updated. All this information requires:
- Storage and maintenance in a secure database;
- Shared infrastructure among partners, regulatory organizations, and patients;
- Use of a globally accepted standard;
- A secure and open platform.
Recently blockchain technology emerged as one of the best options to fulfill these traceability requirements.
The major question we are looking to answer is:
Can Blockchain Technology be used to implement a serialization information flow?
On one hand Blockchain technology fulfills basic requirements for global traceability:
- Immutable Storage (impossible to manipulate data);
- Distributed Technology (accessible everywhere and scalable);
- Open technology (easily adapted and implemented all around the world).
However, it has some limitations such as:
- Storage – Blockchain should store only transactions with a small amount of data and not blocks with too many characteristics;
- Speed – Initial use cases of blockchain can process only a few transactions per second;
- Cost – The costs of each transaction are dependent on the nodes that make the network and the rules agreed between them;
- Security – By hacking more than 50% of the nodes, pirates can create a new truth (highly improbable).
In this article, we aim to create the required awareness explaining our view of traceability of life science products. This will provide you with the background to make the option to participate (or not) in some blockchain initiative. Finally, we share our opinion on how to be ready for full traceability in a life sciences supply chain ecosystem.
Traceability starts during manufacturing by assigning a unique Serial Number to each stock unit. This unique identifier remains with the product throughout the supply chain until its consumption.
Technical packaging solutions such as RFID, micro-tagging or even nanoscale encryption together with packaging techniques like tamper-evident labeling provide increased security, but they are still subject to falsification and manipulation. Even the most advanced technologies are subject to falsifications if not implemented consistently throughout the increasingly complex pharma supply-chain that includes CMOs, LSPs, Wholesalers or Retailers (physical or web-based) and multiple ways of dispensing to the patients.
All these supply-chain partners form different networks:
- Manufacturing Network
- Transportation Network
- Dispensing Network
Integrating these networks guarantees the traceability of the products and helps to implement anti-counterfeiting measures. The current approach uses cloud serialization services to interconnect all these partners into a serialization network and report to the required regulatory agencies.
The blockchain is an alternative background technology that allows the secure recording of the serial numbers and consequent status updates required for a full traceability solution. Each one of the partners of the supply-chain is one of the Distributed Nodes which shares a Distributed Ledger with agreed formats and smart-contracts to implement the rules defined by the Blockchain Consortium.
From the multiple existing Blockchain Initiatives (see Infographic below), we’ve selected the ones where top Marketing Authorization Holders (MAH) of the pharma and biotech markets have already joined:
During 2017, the MediLedger Project developed during 2017 a blockchain-based system for tracking the legal change of ownership for prescription medicines.
The MediLedger Project’s work will continue in 2018 with the following goals:
- Identify a framework for Pharma industry governance for blockchain-based track and trace solution;
- Continue the evaluation of a possible blockchain ecosystem;
- Determine Service Provider Integration.
- SAP Blockchain Co-Innovation Initiative
This SAP initiative divides the work in several workstreams focusing on target SAP products and Industry use cases:
- The first PoC of integration with Advanced Track and Trace for Pharmaceuticals (ATTP) implemented unit verification on an iOS App using Hyperledger and SAP Block Chain Service (Blockchain as a Service – BaaS)
- Currently, SAP is working with 15 big pharma companies to develop a second PoC, focusing on scalability and multi-distributor collaboration. This new PoC uses Multichain instead of Hyperledger to test the use of permissioned based networks.
After investing so much in other technologies should Pharma invest also in Blockchain?
The adherence to Blockchain Traceability related initiatives includes many of the Big Pharma companies already. As we can see from the infographic above, at least McKesson and AmerisourceBergen have joined both initiatives. As an integration technology, Blockchain technology is a useful tool. Different players in the pharma supply chain can use blockchain to support the implementation in the near future of an end-to-end traceability platform. Blockchain can provide the required security and flexibility to satisfy the most up-to-date anticounterfeiting measures and regulations.
Join a Blockchain initiative now or wait?
Whether to join a Blockchain initiative depends on the readiness of your organization to be able to take advantage of the integration capabilities provided by Blockchain. In 2018 all the major Pharma companies should be prepared with L1 to at least L3 or L4 levels of Serialization implemented in their own organization. Blockchain integration needs to be coordinated with the current Level 5 – Network implementation strategy.
In conclusion, we think that Blockchain shouldn’t be considered the answer to all problems, but must be part of the traceability integration strategy:
- Look at the current blockchain initiatives and results being presented;
- Participate in some of them to develop the internal know-how;
- Start by participating in the initiative that makes more sense considering current participating partners and serialization platform being used.
If you are looking for the right blockchain initiative to participate, contact us and we can help you define the best approach for your company.