Hi Clarisse! Nice to meet you. Can you tell us a bit about how the PharmaLedger project got started?
The initial idea came out of a small group of professionals working in the pharmaceutical industry who believed in the potential of blockchain to address many systemic issues of the healthcare supply chain. After applying to an IMI call for proposals and winning, in January 2020 we kicked off the project with 29 partner organisations.
How can blockchain help to improve the supply chain?
In the healthcare and pharmaceutical-related industries, ensuring the availability, safety and integrity of products is paramount. Product falsification, diversion and supply disruptions affect even the most developed health systems and organisations, which creates a challenge for businesses and governments as well as the people that rely on these products.
In any given medical supply chain, the high number of handoffs and the complexity of operations between an enormous set of participants makes security and visibility of the product challenging. Think about all the manufacturers, logistics operators, warehouses, distributors and dispensers involved in any local, regional and global supply of healthcare products. Finding a solution that is feasible, inclusive and can add value for all parties has never existed up until now – blockchain offers a secure and tamper-proof solution.
What was one key result to come out of the PharmaLedger project?
As part of PharmaLedger we developed 8 prototypes that successfully demonstrated the suitability and feasibility of this technology to address many serious systemic issues in the supply chain, clinical trials and health data domains. That said, the most significant result of the project was probably the creation of the PharmaLedger Association (PLA). For us, this proved that many visionary organisations had an appetite to sponsor the creation of a trusted and shared infrastructure using blockchain technology.
Under the PLA we were able to finalise the qualification of our electronic product information app, ePI by PharmaLedger. A user scans their medical product with our app and immediately receives accurate product information that is updated in real-time in any language that they choose. They can trust the information that they receive because it is in encoded in blockchain. In the future, we hope to expand this offering by also integrating a function that will indicate whether the product is counterfeit or not.
Does the person using the app need to know how to use blockchain?
Not at all. The app is as intuitive as any simple app on the market. All you need is a device with a camera and internet connection. The blockchain is silently running in the background. You can use it the same way that most of us use the internet, without necessarily knowing how the infrastructure behind it works.
What is the Innovation xLab?
It’s the research and development heart of the association. We welcome stakeholders from healthcare-related industries to bring challenges and brainstorm ideas, develop prototypes and demonstrators, and evaluate technical feasibility, risks, and benefits. Not all problems will be solved by blockchain but all ecosystemic problems have the potential to be resolved and the xLab can help the industry validate assumptions in a low-risk environment.
What happens to the tech developed by the Innovation xLab?
We generally advocate for projects to use an open-source core platform to develop their blockchain product which is governed, maintained and exploited by PLA as the nonprofit, neutral, standard-setting party. The public and private sector can then make use of this shared and trusted infrastructure by connecting their systems to it or building additional services on top of it. Our vision is that our platform, which we call the Product Trust Platform, once scaled to a certain maturity, will be capable of hosting multiple solutions like ePI, falsified medicine detection, traceability of clinical and commercial products among others.
What projects are you working on now?
ePI by PharmaLedger, our first graduated product, has reached a stage where we're actively seeking to expand its adoption and prepare for global scaling via our member organisations.
The scaling process requires significant effort but serves as the cornerstone for our broader supply chain traceability platform, which is also a current priority. With a traceability solution, suppliers have less compliance costs, buyers have greater visibility, and patients and doctors have higher confidence in product integrity and a more personalised experience with their healthcare. It’s a win-win-win.
What is the value of the public-private framework?
Public-private partnerships and joint investments have numerous benefits, but for PharmaLedger, it's not just beneficial, it's the right thing to do. The healthcare sector is gigantic and encompasses many distinct stakeholders from the public and private sectors. PharmaLedger is the venue where companies, public health departments, technology experts and patient groups can come together under a pre-competitive umbrella to innovate for a better healthcare industry and experience for everyone on a neutral ground.
When tackling industry-wide problems like supply chain visibility and the detection of falsified medicines, all stakeholders need to be on board to create and implement industry-wide solutions. A public-private framework like the Digital Trust Ecosystem we are building is essential in making sustainable improvements on the challenges of today.
What do you think are the key milestones over the next few years?
As a nonprofit, innovation-driven start-up we face all the challenges of the market in a hyped technological context, within a heavily regulated environment with high standards. Most start-ups take many years to arrive at the level of compliance and readiness that we sustain at PharmaLedger. This is in itself a continuous challenge as we are a very small team. The first key milestone therefore is sustaining the organisation beyond the turbulence of the first five years of operations.
The official adoption of ePI by PharmaLedger at scale, after validation by the regulatory authorities, is a critical one. The successful enhancement of our Product Trust Platform is another key milestone, and I would like to see more happening in the decentralised clinical trials and health data space.
PharmaLedger is supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.