Driving patient safety, reliable product traceability, aiding the fight against counterfeiting, reducing fraud and complying with European regulations are key priorities for pharmaceutical manufacturers, distributors, dispensers, and governments. European regulators and the European Federation of Pharmaceutical Industries and Associations (EFPIA) have implemented serialisation of prescription drugs (by the manufacturer) with systematic control at the point of dispense (Pharmacy or Hospital), to solve the aforementioned sectoral priorities, aiming at balancing efficiency (ensuring patient safety) and cost control. Product serialisation at the saleable unit is the foundation upon which PharmaLedger will be built.
Blockchain Enabled Healthcare
PharmaLedger brings together experts from both the pharmaceutical and technology sectors as well as patients and hospitals, making it a true cross-sector, multi-disciplinary public-private partnership. As such, it is well placed to generate practical solutions that will allow blockchain technologies to be integrated into drug development and healthcare in a way that is supported by all stakeholders.
“Clinical research is a complex process involving various actors where trust, data sharing, security, and visibility need to be established from clinical trial participants, physicians, researchers, service providers, sponsors, and regulators. Blockchain stood out as one of the most disruptive technologies that could tackle these issues. The IMI PharmaLedger project provides the opportunity for the industry to engage, share, and work together to address these issues.”
“The approach we take at PharmaLedger is one that enables us to have two dimensions and speeds in addressing challenges in healthcare. The reference implementation of the prioritised use cases will allow us the depth and breadth to research, design and deliver both: use case specific solutions and our open source platform.”
“Changes in technology occur at rapid speeds and often lead to a wide gap between policy and technology. That’s why PharmaLedger has a dedicated team to not only ensure that regulatory demands are met but also push forward policy innovation alongside technological innovation. And there is no better time than now to get innovation right where it is most needed – the healthcare sector.”
“Engagement of healthcare stakeholders is a cornerstone for PharmaLedger. Through the blockchain enabled healthcare approach we will deepen transparent and trusted connections that will facilitate how healthcare stakeholders engage. By doing so, we aim at contributing towards having better healthcare continuum and higher quality process in healthcare value-chain. “
“Blockchain is a team sport. Now we have the right team with the right resources to lead the development of interoperable solutions that can eliminate waste, enhance security and privacy, build trust and ultimately benefit patients and the healthcare ecosystem.”
“Blockchain is a key technology for the future. Coupled with HL7 FHIR standards we aim at supporting the FAIR (Findable, Accessible Interoperable, Reusable) principles in the health sector shaping a major standardization driver for data quality and interoperability to enable empowered patients and the health data economy. PharmaLedger sets the foundations to enable that future.”
The PharmaLedger project will create a scalable blockchain platform validated through reference use cases in supply chain, clinical trials and health data that will serve trendsetters in the industry, thus enabling early adopters.
PharmaLedger will serve as a single source of truth for the healthcare ecosystem and will be designed for efficient decentralised governance, wide adoption by the stakeholders of the ecosystem, compliance with extant and emerging standards and regulation, and end-to-end connectivity and interoperability.
Clinical Trials are fundamental to the advancement of medical science. PharmaLedger aims at accelerating clinical development and the submission process by providing an end-to-end clinical trial solution. This will provide transparency, auditability/traceability and fine-grain access control on all aspects of the clinical trial conduct with various stakeholders, including patients and regulators.
Access to health data is critical to a well-functioning healthcare system. Health data are needed to deliver the right care at the right time, discover new medicines, test their safety and effectiveness in clinical trials, and monitor real world usage. Yet friction exists throughout the health system that makes access to health data a challenge. These impediments lead to the data being stuck in silos or fragmented throughout the value chain.
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Maria Eugenia Beltran
Project Coordinator – UPM
Industry Project Leader – Novartis