When pharma meets blockchain and sustainability. The case of PharmaLedger.eu consortium - CVA Sustainability Series
CVA Sustainabiltiy Series
A personal blog post from CVA Sustainability WG Member Carmen Cucul
When pharma meets blockchain and sustainability
The case of PharmaLedger.eu consortium
Author: Carmen C. Cucul
Back in 2020, I decided it’s time to consider a sabbatical. At that time, COVID had just hit and I was getting close to a decade working in the pharmaceutical industry. I finally took a break in 2021.
During my sabbatical year, I spent more than 1.000 hours studying blockchain and the digital asset market. I learnt about the good, the bad and the ugly. I understood why self-sovereignty is needed (more than ever during this decade compared to the past several ones), how the unbanked can still get a share of the wealth creation, but also how the lack of regulation (or just bad coding!) allows some of the unworthy to extract value from the worthy.
It wasn’t long until I promised myself I’d keep up with the blockchain space no matter what, once I return to work. So here I am, three months into my good old full-time job (THANK YOU, dear employer, for supporting me in this unconventional journey!), while also volunteering for the Crypto Valley Association (CVA). As its name unambiguously indicates, CVA is a blockchain-focused, membership-based organisation in Zug, Switzerland (aka Crypto Valley). An important part of CVA’s activity is to encourage further knowledge creation, dissemination and application in fields of common interest for the blockchain and cryptoassets communities. One of them is sustainability, and this is where this article comes in.
As a member of CVA’s sustainability workgroup, I volunteered to write a series of articles every now and then… but what should they be about? Well, I know a bit about healthcare, I’m passionate about blockchain and the workgroup’s area of interest is sustainability. How many things come at the intersection of these three domains?” One stood out in mind: a public-private consortium of healthcare (check!), organisations working together (check!), capabilities and use cases based on blockchain (check!) technology and philosophy.
Ladies and gentlemen, let me introduce you to PharmaLedger: “Sponsored by the Innovative Medicines Initiative (IMI) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) under the Horizon 2020 programme, PharmaLedger is a 36-month project that brings together 12 global pharmaceutical companies and 17 public and private entities; including technical, legal, regulatory, academia, research organisations and patient representative organisations”, the website informs us. Their three main areas for blockchain exploration are: supply chain, clinical trials, and health data management. You can find a full description of the project on their website.
Before I move forward with the article, I need to make a disclaimer: since I don’t represent my employer in my CVA volunteer activity, I’m solely responsible for whatever you read today. I accept e-rotten tomatoes, but I’d prefer constructive feedback and insightful comments 😉.
Another disclaimer (well, more a comment than a disclaimer) is related to sustainability. You might wonder: why is a consortium of healthcare organisations trying to do something together such a big story for this topic? Well, let’s start with my own, crude definition of the term. Sustainability to me means: “whatever happens today will still be there tomorrow”. So, if today a clinical trial experiment is running on a blockchain, I’d like to see that growing steadily into the future. Single party experiments rarely achieve sustainability. They are prone to budget cuts, changes of strategy, changes of leadership, siloed execution etc etc. In contrast, experiments run by networks of organizations might have a better chance of survival in the long run. Information is shared faster, member B can take over the experiment if member A cannot, leadership commitments are stronger when there are external parties impacted etc. etc.
With all of this in mind, let’s get back to our beautiful case study: PharmaLedger. I was fortunate enough to get two experts from the consortium return my request for an interview: Daniel Fritz, PharmaLedger Industry Project Leader, Novartis and Marco Cuomo, Manager Applied Technology Innovation, Novartis (although I believe he’d preferred to be called just a “blockchain evangelist”).
In the hour long interview I learnt from Daniel and Marco more than a few things: how the PharmaLedger consortium started, what technical solution they adopted for such a large and heterogeneous group of organisations, which blockchain-based use cases have evolved the most in the years since the launch, why they think some use cases and capabilities developed faster than the others, how people within the healthcare organisation define the value addition of blockchain, where they struggled most, and how far the pharmaceutical industry is from a mainstream adoption of blockchain.
Context
PharmaLedger officially launched in 2020 under the umbrella of the Innovative Medicine Initiative (IMI). However, the groundwork started few years before as programmes of this complexity (3 years, 22 million EUR budget, 29 partners) don’t happen overnight. So Daniel likes to think of this project as being five years old, instead of two. The was a need to find better ways for pharmaceutical industry to advance on sensitive topics such as (patient) data protection, counterfeit medicines, opaque transactions etc.
Technical solution
To my relief, I learnt that the aim of the programme was NOT to create a blockchain in and of itself. It was rather to build APIs, standards and frameworks for any blockchain architecture the partners would choose for their use cases. For example, some use cases were built on ConsenSys’ Quorum, which is an open source Ethereum layer protocol for businesses. Others used Hyperledger Fabric’s open-source modules to integrate with their own platforms.
What’s critical is that the API layer (called open Data Sharing Unit - DSU) is used by all use cases to channel end-user information (who retain the keys of their data). The DSU then creates an anchor on the blockchain of choice, which changes if DSU data is being tampered or altered in any form. No user data is being transferred on the blockchain, just this anchor which serves as a guardian against tampering as it’s publicly visible. Marco spent a good chunk of time explaining this all to me, as I’m not a technical expert in this field. I hope I did justice to explaining it lightly, Marco 😉.
Use cases
As mentioned before, the consortium prioritized three domains to build their eight use cases:
- Health data (personalised medicine solutions, clinical trial recruitment)
- Clinical trials (medical device Internet of Things- IoT-, e-consent forms)
- Supply chain (clinical supply & finished goods traceability, eLeaflets for product information (ePIs), Anti-counterfeiting solutions
The most advanced use case, as of February 2022, was the electronic Product Information (ePI) use case regarding eLeaflets. In case you haven’t taken medicines in a long while (which I hope is the case), PIs are those papers you find in any medicine packages, which you need to unfold, put your glasses on to be able to read and forget not to throw away right afterwards.
The electronic version of medical paper leaflets is the same Marie, but with a different hat … a much nicer and easier to wear hat. Usually, you would access the electronic leaflet by scanning a QR code which you’d find on the package or the product itself. You’d be led to an online page where you’d find the information in a “zoomable” version and most importantly: you’d be sure that what you read is 100% updated. A paper version could become outdated by the time you buy the medicine, because it can take several weeks or months for it to move through the long supply chain.
Why was blockchain a superior solution … and why did this use case get ahead of others? My guess is: it’s a combination of need, applicability, risk, focus and expandability (not sure this word exists in English though).
- Need: since information in the ePIs change so quickly (sometimes weekly), pharmaceutical companies need a fast solution to send the updated version to patients and healthcare professionals, otherwise they are in compliance breach and they might put patients’ lives at risk.
- Applicability: the problem I just mentioned above is one that ALL pharmaceutical companies and ALL medicinal products can potentially encounter. This is not to say that there are no other ePI initiatives going on, it’s just to say: anybody can benefit from such a use case.
- Risk: Product leaflets contain publicly available information and don’t require any patient/sensitive data to be collected. From this perspective, the use case has lower risks for implementation
- Focus: projects don’t move by virtue of their existence. I’m sure Daniel, Marco and their teams spent a lot of time communicating to stakeholders, convincing leadership to get green lights, aligning with other stakeholders, tracking progress, mitigating risks, removing roadblocks, keeping the motivation going, communicating again – you see where this is going.
- Expandability: once the eLeaflets are live, the infrastructure they built can (and will) be re-used for additional applications and services: tracking the product across supply chain, providing proof of origin / anti-counterfeiting measures, etc.
A blockchain solution for ePIs was deemed by the team to be easier to scale (it uses open-source technology), it’s cheaper (or equally expensive to other technical solutions) and most importantly: it’s better positioned to become an industry standard than a single entity driven platform.
PS: if you’re curious about the other use cases: e-consent seems to be gaining momentum, while clinical trial and finished good traceability are also very promising, said Daniel and Marco. There is still work to be done on IoT devices and personalised medicine use cases. “They are difficult to implement as some are already built on different platforms, therefore data migration is hard”, said Marco. “Others need more clearance for handling/encrypting sensitive medical / patient-level data”, thought my good self.
Value proposition
“We use the blockchain to transfer trust, not data”, said Daniel in our conversation. While Daniel and Marco don’t need more convincing, others in the pharmaceutical industry still do. The usual suspects are: blockchain consumes too much energy, it’s not developed enough, it’s risky for business-level applications, it takes too long, can we trust an open-source technology etc.?
And yes, some of these are true: proof of work (PoW) blockchains could consume too much energy if their consensus mechanism is too complex. For example: Bitcoin has a mathematical quiz that becomes more and more complex as more validators try to enter the network, which requires computational power. But PoW blockchains are in minority as most of them already operate on energy-minimizing models like proof of stake (PoS).
Many business applications, especially in pharmaceutical industry, are still in their infancy. Daniel thinks the ePI use case is an eight to ten year undertaking until it can reach the status of “industry standard”.
Yet, he confirmed that blockchain use cases he has seen in PharmaLedger are not more expensive versus other technical solutions out there (!). And he sees the network effect starting to benefit others (for examples the ones that now use the open-source module of ePI his project team created). “We just need a killer app to showcase the capabilities of blockchain”, said Daniel.
What’s more important however is that decisionmakers in the pharmaceutical industry understand the ethos of blockchain: decentralisation is the new norm, no central governance is required, one can trust the network trustlessly (another English invention of mine I guess).
Sustainability
To conclude this longer-than-expected article, let’s see how PharmaLedger is planning to address what I called “whatever happens today will still be there tomorrow” (sustainability topic, that is).
The plan is for the consortium to transfer all assets and capabilities created in the three-year program (ending this year) to the PharmLedger foundation. The foundation will be responsible for post-project governance and will be run as a not-for-profit separate legal entity.
While time was too short in the interview (and times were too early) to ask for more details, I‘m sure we can have a follow-up article on this later on. After all, as we all three agreed, the pharmaceutical industry is still in “learning mode” when it comes to blockchain adoption. The journey ahead is long, and change will come individual by individual. Stay tuned!