Blockchain – a digital ledger that records data in a secure, chronological way – has attracted increased attention for its use in pharmaceutical logistics, drug development protection, and as a cryptocurrency payment tool.
But at TraceLink’s FutureLink conference in Munich last week, Epista Life Science consultant Pasi Kemppainen told delegates he was not convinced Blockchain is the “perfect fit” for pharma’s digital supply chain.
While the technology is indisputably secure and offers unlimited network scaling, he said: “I’d be cautious myself. It is a fantastic technology, and very stimulating from a possibility point of view.
But would you test a new technology [to solve] problems we have with [serialisation] technologies that are already available? I would wait a couple of years before we go for that.”
Industry doesn’t appear convinced either. A live poll at the event revealed approximately 50% of attendees were ‘undecided’ about the digital ledger’s compatibility with the digital supply chain.
A primary concern for Kemppainen is Blockchain’s ‘public’ nature, whereby the technology enables access to all participating parties.
However as pharmaceutical regulation requires a legal entity be accountable – such as the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) – the ledger would need be set up and operated privately, he explained.
Blockchain is also incompatible with the recently implemented EU general data protection regulation (GDPR), which enables ‘data subjects’ the right to revoke the use of personal data at any time.
“What you put into the Blockchain, you can’t take out,” said Kemppainen. To comply with GDPR, “you would need to be able to remove data…[and] if you enable that, it’s not a Blockchain anymore,” he added.
The consultant also flagged Blockchain’s transaction performance as a potential hindrance across the digital supply chain: “Bitcoin [a cryptocurrency based on Blockchain technology] is facing a huge lack of performance, it can take hours to finalise a block. It just doesn’t work.”