PharmaLedger: Blockchain-Enabled Healthcare

PharmaLedger is proposing a safer and more efficient healthcare ecosystem with blockchain technology.

PharmaLedger aims to create an innovative blockchain-based platform to be validated through a set of use cases in three reference implementations: supply chain, clinical trials and health data. These early implementations throughout each referenced domain helps bring value and trust to unlock the potential of the digital healthcare ecosystem, especially to patients. By building a privacy-enabled, efficient foundation using blockchain technology, a stronger and trustworthy healthcare ecosystem emerges. 

Maria Teresa Arredondo and Maria Eugenia (Xenia) Beltran are PharmaLedger’s lead Coordinators and Project Managers from Universidad Politécnica de Madrid, which co-leads the PharmaLedger project with Novartis. They oversee the project’s activities and report the project’s compliance to the European Union. They add that PharmeLedger goes beyond blockchain implementation to further unlock new potential of a consortium approach in healthcare.

This can be done by supporting a new mindset shift with this technology, which also creates new business and value-based healthcare models. With this change, new laws, regulations and governance must emerge to enable trust, just as the workflows, processes, roles and responsibilities change as well. Maria Teresa and Xenia say, “It’s more than implementing new technologies and tools. PharmaLedger aims to create an impact on the broader healthcare infrastructure. The reference implementations go beyond the buzz and help move this vision forward.”

PharmaLedger – Blockchain Enabled Healthcare

About the PharmaLeger Project

This three-year private-public project’s consortium joins over 29 partners (12 global pharmaceutical companies and 17 public and private entities) and aims to bring blockchain solutions to the healthcare value chain. The project focuses on use cases in three areas: supply chain, clinical trials and health data. 

Xenia underlines that the project aims to generate deeper experiences and expertise in linking new technologies such as blockchain with existing ones to manage confidential patient information (health data) and implement relevant business (supply chain) and clinical trial applications in this highly regulated environment. Establishing the groundwork and customisation of blockchain technology through effective governance and proper education, this collaborative platform builds trust and transparency into a more efficient ecosystem. 

The partner consortium includes pharmaceutical companies, hospitals, universities, tech companies, research organisations and patient representative organisations.

PharmaLedger Main Objectives

  • Transparency through traceability and data exchange
  • Patient empowerment through improved data control and ownership in the healthcare data marketplace. 
  • Added security and access rights management
  • Clinical trial efficiency through trusted data recording and digitisation
  • Historicity and inviolability of data 
  • Propose an integrated health data marketplace and collaborative platform
  • Enable agile and secure delivery of innovative applications
  • Ensure privacy and confidentiality of PharmaLedger data and transactions
  • Allow security of information and greater access across use cases
  • Provide a legal and ethical framework to ensure regulatory compliance
  • Define and formalise effective governance for a sustainable PharmaLedger framework

The PharmaLedger consortium aims to use the benefits of blockchain technology by creating a scalable open source platform through reference use cases in supply chain, clinical trials and health data. PharmaLeger also integrates regulations and standards to apply this technology in an ethical and legal manner.

Photo of PharmaLedger consortium members Kick off meeting from January 2020

Supply Chain – Business-Value

Pharmaceutical manufacturers, distributors, dispensers, and governments involved in the medical supply chain aim at supporting patient safety and reliable product traceability, all while complying with European regulations. There is also a key objective to help aid the fight against counterfeiting and reduce fraud. PharmaLedger wishes to strengthen these measures and ensure transparency with blockchain technology data exchange throughout the supply chain. 

Pharmaledger works on building a foundation for using blockchain technology and serialisation throughout the medicine supply chain, from start to finish. This includes the drug manufacturers, distributors, repackagers, and wholesalers that are involved before a given product reaches end-patients. Traceability and transparency throughout the drug supply chain will ensure greater trust in medicine. 

The downstream traceability of finished products, thanks to the tamper-proof blockchain data collected throughout the supply chain, would help gather relevant product data to strengthen the option of product authentication by the end users and patients. Quick identification of suspected or expired products adds a new single source of truth to the entire process, and opens the doors for further transparency in future iterations of the solution. This could include notice on recalls and other communication important to patient awareness and safety.

In fact, PharmaLedger intends to be a point of information access to patients, regulators and law enforcement. With data gathered voluntarily and collaboratively, PharmaLedger supports the fight against counterfeit medicine, which every year puts the life of millions of people at risk globally.

Colm Caroll (IMI) speaking during the PharmaLedger consortium member’s Kick Off meeting held January 2020

Health Data – Patient-Value

Health data are critical to generate value and evidence to the healthcare system, yet there are many roadblocks in gaining access and storing data in the current system, and in doing so, enabling privacy. 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 data usage.

Xenia notes that PharmaLedger is working on creating a fair, ethical and privacy-compliant data platform and marketplace for supporting the use of personal health data. Using blockchain technology, this trusted platform strengthens not only patient data ownership and aims to provide full control over who can access health data, but also to trace data points throughout the patient journey to enable better healthcare outcomes. 
By having stronger ownership over health data, patients can use their health data as digital assets in the monitored and controlled healthcare marketplace. Also, by allowing traceability and provenance, blockchain provides the grounds to capture data, on which other technologies such as AI can build on new ways to support diagnostic and/or therapies for value-based health care.

Representatives from Bayer and JNJ presenting during the PharmaLedger consortium Kick Off meeting in January 2020

Clinical Trials – Clinical-Value

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 creates historicity and inviolability of data to enable transparency, auditability, traceability and fine-grain access control on all aspects of clinical trials processes conducted by various stakeholders, including patients and regulators.

Clinical trials are often time-consuming and costly, yet they’re crucial for finding new and effective treatments. With many players involved in the entire process, a high degree of security and transparency is required in the entire process. Blockchain technology can provide greater efficiency by tracking data used in clinical trials while ensuring the collected data is authentic and access permission based. 

By also digitising patient consent processes and integrating advanced analytics into medical devices, data traceability and remote auditability decreases the need of patient site visits and increases flexibility in participating in clinical trials. This reduces burdens in the current clinical trial structure, creates a more trustworthy and efficient outcome, and also supports a further degree of automation through smart contracts.

A Better Future in Healthcare

Blockchain technology is paving the way for providing more efficient, safe and transparent healthcare. Each of the three reference implementation areas stated above allow PharmaLeger to integrate blockchain into the healthcare ecosystem with the joint effort of all involved in the partner consortium, and thus further engages the community at large.

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