King College London Fight the Fakes Series invited PharmaLedgers’s Industry Lead Daniel Fritz (Novartis) to discuss how PharmaLedger and blockchain can help put a stand against counterfeit medicine.
King’s College London created the student-led Fight the Fake campaign to bring awareness to the impact of falsified, counterfeit and substandard anti-infective medicine. It shares the stories of those that have been impacted by counterfeit medicine and of those that are working hard to put a stop to it. In their recent seminar series, PharmaLedger’s Industry Lead Daniel Fritz (Novartis) was invited to talk about the PharmaLedger project and our two use cases that are related to the fight against counterfeit healthcare products: the ePI (electronic Product Information) and the Anti-Counterfeiting use cases. You can watch the full video of Daniel’s presentation below.
The PharmaLedger Project
At Novartis, Daniel is the supply chain architect, where he often also looks at emerging digital technologies. Through this, he was introduced to blockchain a number of years ago and realised that this technology requires a joint collaborative effort in order to be implemented. This was the start of the idea to build a consortium of public and private partners in the healthcare industry.
PharmaLedger emerged as a part of the umbrella organisation and private-public funding of the Innovative Medicines Initiative (IMI). It is under the Horizon 2020 Framework Programme (H2020) from the European Union and European Federation Pharmaceutical Industries and Alliance (EFPIA), the trade association in Europe. PharmaLedger has 29 consortium partners made up of pharmaceutical manufacturers, universities, hospitals, patient organisations and a government agency.
With its consortium members, PharmaLegder shares the risk, funding and resources to accomplish the goal of proving the value of a blockchain platform through eight use cases. The three-year project that started in January 2020 is open-sourced. The idea is to provide adoption packages and lower the barrier for implementing blockchain technology in healthcare. You can find out more about our eight use cases under our Resources & Publications page.
Even after the project ends, there is a plan to address the governance and sustainability of the project results. PharmaLedger wants to put together a governance organisation that would oversee the future operation and scale-up of the blockchain solution. You can follow the roadmap below to see how the project is progressing so far.
Blockchain – The Five A’s
Daniel introduced blockchain technology using the Five A’s.
Blockchain can provide end-to-end traceability in supply chains, from raw materials to the end-patient. “All the supply chain actors could use a single source of truth, which is what we are calling here a blockchain trust fabric…it’s a thin backbone that connects these different data silos which may be within an organisation, or it connects different organisations themselves,” Daniel stated.
All the stakeholders involved in the blockchain ecosystem have access to the same reference and can share data confidently. This can create new capabilities or simplify processes. Eliminating third parties (middlemen), automation, protecting privacy and having something that scales are all part of PharmaLedger’s vision of using blockchain in the healthcare ecosystem.
PharmaLedger’s electronic Product Information (ePI) Use Case
Starting with the ePI use case, Daniel introduced the problems concerning paper leaflets found in medical products. Since the information on these leaflets changes frequently, digitising them (eLeaflets) with the help of blockchain would provide the most up-to-date product information to patients. It would be easier to navigate these eLeaflets via a mobile app, and less paper would be wasted leading to a positive environmental impact.
The ePI would work with a 2D data matrix code that is on a medicine package. This code is embedded with various information (seen in the image below). Europe and other markets are now requiring this information and serialized packages. PharmaLedger hopes to take this 2D matrix one step further by embedding various information to ensure compliance, help streamline processes and create new capabilities in supply chains. Leveraging the data matrix is the point of entry for ePI and Anti-Counterfeiting use cases.
Through an app available via a smartphone, you can scan the matrix or other barcodes to access the digitalised product information. A resolver is used to find out who the manufacturer is, and the manufacturer then provides the latest product information. Additional capabilities could be added in the future, such as a recall notification or that a certain medicine has expired.
PharmaLedger’s Anti-Counterfeiting Use Case
Daniel then introduced the Anti-Counterfeiting use case, which consists of multi-factor product authentication (MFPA). This empowers patients to perform different checks on medical products and increases the confidence in a given medicine’s authenticity. The second part of this use case is Anti-Counterfeiting Data Collaboration (ACDC), where big data and analytics are leveraged to gain insights into the problem and combat fake medicine in an innovative way.
Building upon the ePI use case, after a patient scans a product code, seven multi-factor product authentication (MFPA) checks can be performed, which you can view below from the presentation slide.
One benefit of this digital system would be that you would use the same app that other various manufacturers are using. Currently, there are four different authentication feature providers that are integrating their checks into the PharmaLedger app. Lastly, the anti-counterfeit data collaboration (ACDC) uses the collected data anonymously to run evaluations through data analytics to determine if there is an issue, such as the theft of a given medicine.
PharmaLedger Application Demo
Daniel then ran a demo on his phone where he scanned a matrix code to show how the PharmaLedger application would look like. After scanning a code, a demo product was verified and the app showed access to the product leaflet. He then scanned another code to show an example that the serial number of the product code indicates that the product was stolen. The last scanned code showed that the serial number failed. These three product scan examples show how the ePI use case and multi-factor authentication would work.
To conclude the presentation, Daniel showed the ACDC results of various medicine product scans in real-time around the world. The information can be filtered through with different features, such as the batch or expiry date. These scans can give insights into where counterfeit products are located, and this can help with reporting issues to law enforcement and regulatory authorities if needed.
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