Far from being just another fading trend, blockchain technology has forever changed the way we look at trust in digital systems. The applications of blockchain are endless – and one area that’s taken the spotlight in the last year more than ever is the Pharma industry. Read on to find out the progress we’ve made with PharmaLedger, an EU-funded blockchain project where RomSoft is a technical partner.
Building a trust-based ecosystem
Despite all the challenges that 2020 brought, work on the EU-sponsored project PharmaLedger continued as planned. At the end of the year 2020, the PharmaLedger consortium delivered a valuable amount of information regarding the current state of the project and the conclusions the various PharmaLedger workgroups arrived at with respect to the project’s use cases definition.
You can watch the first open PharmaLedger webinar here. Our team at RomSoft has been working together with the consortium partners in defining the use cases and how these will be implemented by using blockchain technologies.
It is a common understanding across all partners in the PharmaLedger consortium that the main objective of the project is to build a trust-based ecosystem for all the actors involved, whether they are manufacturers, health authorities, clinical sites, distributors, or patients. And that this can be achieved via blockchain technologies.
With this thought in mind, we are trying to summarize one by one the first use cases that are lined up for implementation in the following months, and for which we are expected to have functional MVPs by June 2021.
Use-cases lined-up for implementation
Alongside Novartis, RomSoft is coordinating the technical side of the PharmaLedger blockchain, but also participates in the development of domain reference applications (DRA) for the pharmaceutical industry (supply chain, clinical studies, and health data). Each DRA is layered into multiple sub-cases that will be analyzed and implemented throughout the project duration.
There are eight main use cases defined that are lined up for implementation in the upcoming months:
- Clinical supply
- Finished goods traceability
- IoT medical devices in trials
- Clinical trials recruitment
- Personalized medicine
The eLeaflet Use-Case
Starting with this first use case, the electronic product information (a.k.a. ePI or eLeaflet), we must say that this is not a new idea. It’s been around for at least a decade. There are plenty of challenges for a paradigm shift like this, transferring from paper to completely electronic. Yes, we are talking about the paper leaflet which goes inside the package of the pharmaceutical product.
While the leaflets themselves are very valuable, as they provide essential information like ingredients, most common adverse effects, how to report these effects when they appear, administration indications, and so on, these documents can become pretty big, with lots of text printed in small font, and their readability and search-ability are not very good.
Also, these documents are closely regulated and updated over the product life cycle. If the information on a product is updated, for example with new cautions on side effects, the paper leaflets already on the market are impossible to update after distribution.
Not in the least, paper leaflets are costly to produce and have a high environmental impact.
So why the resistance to putting them online?
One of the biggest problems in this particular case – the healthcare industry – is the issue of trust. We need to have a method in which patients can access the content and be sure that it is the correct, up to date, authentic content. And these key issues can be addressed by blockchain technology.
Can blockchain help fulfill the promise of ePI?
Increasingly, health authorities are opening up to the idea of e-leaflets. The European Medicines Agency has issued guidance to the industry with 10 principles for e-leaflets (among the Common standard definition, Accessibility to users with diverse abilities, or Data protection, to name just a few).
So the framework exists. But there’s no digital solution yet.
With PharmaLedger, the potential solution is considered not only from the backend point of view but from an end-to-end approach with benefits for all ecosystem players. Here are some key points to consider:
- At the patient end of the value chain, there needs to be only one application, for example one mobile phone app that needs to work for all manufacturers. That’s where PharmaLedger comes in, as it brings all major players at the same table
- The next question is how the application delivers the eLeaflet to the patient. And the most agreed solution is to make benefit of the 2D data matrix on the drug package. This code can incorporate a lot of information (the GTIN, the serial number, the batch code, the expiration date, and so on). By scanning this code from a phone application, the patient can have instant access to the latest information
- Last but not least, is how we know which eLeaflet to display. The application will run a piece of code in the background called a “resolver” that will decode the 2D matrix and will display the eLeaflet. But is it enough to display a PDF version or do we need a more user-friendly approach?
After accomplishing the task of putting the eLeaflet online, many other sub-cases and challenges open up, which leads us to the next question.
Why put it on the blockchain?
Of course, the ePI use-case could be built with other technologies, but there are many benefits for building it on the blockchain:
- Even if you just have the PDF versions, by putting them on the blockchain, you benefit of this trusted environment
- Every actor in the ecosystem, starting with the manufacturer and ending up with the patient, will trust to have access to the correct version of the eLeaflet, every time a 2d matrix on a medicine package is scanned. The term “correct” will be answering more questions at once: is it genuine? Is it approved? Is it the latest? Is it specific? It’s like putting a puzzle back together
- But why stop at just scanned PDFs? Another major advantage is that blockchain allows layering in additional use cases and value, towards this blockchain enabled value chain: the anti-counterfeit check, the batch recall, adverse events reporting, electronic health records, finished goods traceability, and clinical decision support system
For example, when you press the button for Product Information, the resolver could return not the eLeaflet, but a message that the batch is subjected to anti-counterfeit problems, or that the serial number is unknown to the manufacturer, or that the batch is subject to a recall, with further indications for the actions the patient needs to take.
That being said…
It will be a lengthy process that could take years, but it is happening. Blockchain has had a lot of hype and people are just learning what it could do, but in PharmaLedger, we’re actually doing it.
In the following days we’ll be back with details on the other use cases, so stay close.
P.S. If you’re interested in joining our research team and work on blockchain technologies you can check out this role:
P.P.S. Another thing to look forward to is the 2nd PharmaLedger Open Webinar, on which you can find valuable info here.