From dress size to drugs – data regulation is coming

May 17, 2018
Posted in: Blog

Much has been made of the new GDPR rules which come into effect this month concerning personally identifiable information (PII). In fact, many industries are facing stricter regulation and scrutiny of the provenance of the data they hold on all sorts of transactions, throughout their operations. How do you keep track of data where interoperability between siloes inside your own large enterprise is challenge enough, let alone throughout the entire supply chain?

 

Where are the drugs?

If you thought that tracing drugs was the sole concern of agencies like the FBI or, in the UK, the NCA, think again.

Thanks to FDA legislation first enacted by the US Congress in 2013, all parties involved in the manufacturing and supply of pharmaceuticals will soon have to comply with new regulations. This will mean that they have to be able to prove the journey and destination of a whole plethora of drugs lawfully prescribed in the US. And if you thought this will only extend to US companies, you’d be much mistaken. Any company whose activities involve the provision of drugs on this list to US citizens must comply; whether in production, transportation or export.

 

What is the DSCSA?

Title II of The Drug Quality and Security Act (DQSA) – the Drug Supply Chain Security Act (or DSCSA for short) – will be introduced in phases. Already, manufacturers must be compliant, and by 2020, when the introductory phases are complete, hospitals and pharmacies will have to comply. At that point, all qualifying drug classes will need to be traceable all the way from manufacture through to the end consumer.

Unsurprisingly, this will present a huge challenge across the pharmaceutical supply chain. In order to protect such sensitive and competitive data, traditional infrastructure has promoted a silo-ed mentality where information is buried under swathes of security layers. The result is complex and time-consuming processes for collaboration within individual teams – processes that become potentially unmanageable across the many players in supply chains.

 

Increasingly regulated industries

It isn’t just big pharma that is being shaken up by heavier regulation. Banking, insurance, construction and many others are coming under increased pressure with extraordinary levels of fines, high profile lawsuits and, in some extreme cases, jail time for individual directors whose companies fall below the required standard.


Unsurprisingly, this will present a huge challenge across the pharmaceutical supply chain


And yet, week after week, we see breaches of enormous amounts of sensitive data, where protocols have been skipped or systems left vulnerable through human error or speculative sharing. So how, in such an environment, do you gain total trust in the data you’re collecting across a supply chain with multiple partners whilst minimising flows of data?

 

Step forward blockchain

Distributed ledger technology can offer a very comprehensive solution for companies in heavily regulated industries who have the primary responsibility for protecting the provenance, security and availability of the data that must be shared between parties. The very nature of enterprise (private) blockchain is geared-up for multiple external parties to determine trusted, shared access to a single set of data, with no fear of compromising the integrity of that data set.

Gospel adds to this security “baked in” at the data layer, meaning everyone can only see what they need to in order to achieve the task at hand and even read access is audited. At any point in time that history can be traced and examined, satisfying the regulators.

 

The added benefits of data compliance with Gospel

The good news for all concerned is that in resolving the compliance problem with DLT, it’s not just empty spending to conform. Serialising drugs and having reliable traceability throughout the entire supply chain can vastly reduce the costs associated with product recalls, inventory management and even settling disagreements. Trials with some of Gospel’s customers in manufacturing industries have reduced the identification process for potential failure points from weeks to minutes with all the savings both financially and reputationally that brings.

So, perhaps the onset of data regulation could actually be the catalyst for a smoother, more effective supply chain process.

 

If you’d like to find out more about how you can quickly set up a non-disruptive pilot to apply Gospel’s acclaimed enterprise blockchain platform within your current supply chain processes, email [email protected] or use our contact form.

For a 90 second overview of the Gospel platform click here.