Dr Kevin Robinson (KSR) caught up with Najib Rehman (NR), Data Strategy Lead at FarmaTrust, for an in-depth discussion about the use of blockchain technology in the pharmaceutical and healthcare industry
The company recently won a US patent for its Hataali platform — a unique vein-to-vein software solution for the personalised medicine sector — which has been granted the exclusive use of blockchain in advanced medicinal therapy product tracking.
KSR: What’s the knowledge barrier for blockchain in the pharma sector like regarding getting partners to understand its use?
NR: The short answer is a lack of knowledge and the willingness to adopt newer technologies. By nature, the industry is (necessarily) conservative and often likes to stick with processes that are familiar. However, mindsets are now changing quite rapidly!
One area of considerable interest is the use of blockchain to address supply chain logistics. The post-COVID industry understands the importance of data integrity, the ability to track data from provenance to consummation, and its ability to span the lifecycle of a drug or therapy. Not only is this critical from a regulatory perspective, but it’s also a great potential benefit to the patient as well in that they will also have visibility on therapies and products.
KSR: What issues in the pharma sector does blockchain technology address?
NR: The most immediate and pressing are those in supply, logistics and manufacturing. Blockchain-based solutions are much more secure and allow you to more effectively plan — as data is available always in real-time.
And, perhaps most importantly, it also helps to eliminate the issue of bad actors in the supply logistics ecosystem. For example, the “grey market” is worth more than over $200 billion globally; this includes both genuine drugs that get “diverted” out of legitimate supply chains and also the substandard products or fake and falsified drug that enter it. And, this is not simply just about missing revenues and drugs: a very real consequential impact of this is lost patient lives.
One further application that we’re particularly excited about is helping to simplify the relationship between payors, hospitals and developers of treatments. For instance, by reducing the paperwork and administrative burden between hospitals, the payor (insurer in the US/NHS in the UK, for example) and the developer of the therapy.
I believe blockchain technology is going to completely change the way we interact with healthcare, medicines and the broader life science/biotech space.
KSR: How does it intersect with other trends, such as increasing digitalisation and personalised medicine?
NR: We are currently in the midst of a crossover period in which society is transferring from being largely paper-driven into a new digital world. The challenge is to make all parts of society embrace digitalisation and adapt to new processes; healthcare and pharma have historically been slow movers.
However, the hope is that nascent life science areas, such as advanced therapy medicinal products (ATMPs), will show a greater level of “digital nativeness.” It will be disappointing if, in a few years from now, these new and emergent biotechs have to implement digital transformation strategies. It means that we failed to fully elucidate the benefits at the key moment – now.
The ability to securely track a sample from the patient to the manufacturing facility where the therapy is made — and back again to the individual patient — is huge leap forward in an area in which paper-based administration still leads. It also provides assurance from a patient point of view; they can know at all times where and when the samples are taken.
I am therefore optimistic about seeing the increased adoption of blockchain-based technology, especially in the cell/gene therapy space as we see increasing numbers of new therapies — because blockchain answers so many of the scaling issues we currently see.
KSR: Where does a blockchain solution fit into the supply chain and what kind of partners benefit?
NR: Well, I think I have alluded to how blockchains can fix supply chain issues. The great benefit is its inherent immutability, but we can also apply layers of checks and real-time monitoring — everything from the location, temperature, storage conditions and ownership of a product at any given moment.
Any stakeholder associated with the lifespan of a drug stands to benefit from its adoption. The pharmacies, the payors and service providers, the patients and even the regulators will benefit from the automation it provides. From the regulator’s point of view, blockchain provides clarity and even the ability for digital QP (Qualified Person) release.
We already have a worldwide shortage of QPs, so I can envision blockchain and AI being applied to automate the release of ATMPs.
KSR: What does a blockchain-enabled pharma industry look like 5–10 years from now?
NR: Ten years from now, I think it will be an industry standard; we won’t even think about it. One optimistic hope is that we’ll see a significant reduction in the grey market, which would potentially mean a million lives saved per year from falsified, fake and substandard drugs in low/middle income countries.
But, having a blockchain-enabled delivery system will also enhance the operational efficiency of logistics and provide an opportunity for specialist third-party carriers and niche delivery and shipping technologies — this means everything from drones to autonomous vehicles that are managed and controlled by blockchain and AI.
Regulators will mandate full end-to-end transparency and this adoption will also be revolutionary for patients. Records will be linked with doctors and innovators in ways that were previously unimaginable in a globally centralised structure.
Collating real world evidence (RWE) will also be as easy as organising data for the financial markets is today. Aggregating data across the entirety of a therapy sector with a multitude of stakeholders — including competitors — will be vastly simpler. These are big aims, yet they are all very achievable and close with a blockchain future.
KSR: Any other topics or ideas you think would be of interest to pharma/healthcare industry in the near future?
NR: There are many different technologies that are being developed more broadly under the banner of cryptography. There are things such as verifiable credentials, which will become prevalent in the near future. Everybody will have credential authentication in the manufacturing supply logistics operations. The concept of verifiable credentials is an exciting area regarding how individuals, organisations and things will be connected using blockchains.
What is a blockchain?
On a technical level it’s a shared digital ledger of transactions across disparate (business) stakeholders that eliminates the need for control by any single entity — meaning that it’s free from any centralised oversight. The ledger works by grouping information into chronologically ordered bits of information (or blocks) that are linked and secured using the latest cryptography technology.
The second important point is that because the database is distributed across a network of multiple computers, it has much stronger security as there is no single point of failure.
Finally, these platforms also safeguard data against losses by being frequently verified and distributed, and any individual changes will be tracked in the blockchain itself. This means that the entire digital record is visible to everyone who is authorised, including all and any changes during its lifespan (including who made the changes). It’s essentially a digital photographic memory of everything that ever happened.