PharmaLedger

PharmaLedger

Summary

The most famous application of blockchain technology is the bitcoin currency, yet it could also revolutionise the way other sectors work. The goal of the PharmaLedger project is to deliver a blockchain-based platform for the healthcare sector, using the supply chain, clinical trials, and health data as case studies.

In blockchain technology, data is decentralised, meaning it is stored across multiple servers. It is also immutable; this means data records (or ‘blocks’) cannot be changed or tampered with. Each new ‘block’ of data is connected to the previous one, creating the ‘blockchain’. The blocks are connected by cryptography, making the system secure.

PharmaLedger aims to use these technologies to make blockchain in healthcare a reality thanks to a platform that is supported and trusted by different stakeholders and complies with existing and emerging laws and regulations. For this reason, the project brings together technical, legal, and regulatory experts as well as pharmaceutical companies and patient organisations.

Ultimately, the project hopes that bringing the blockchain into healthcare in this way will help to accelerate the delivery of innovation that benefits patients as well as the wider health ecosystem.

Achievements & News

Blockchain could help put people at ease about sharing their data

Throughout the pandemic, COVID19 contract tracing apps have popped up all over the world. In a recent article, ROMSOFT, a partner in the Pharmaledger project that creates custom R&D software, used the project’s personal health data use case as a good example of how privacy concerns related to systems like tracing apps might be overcome, alongside artificial intelligence and machine learning.###

PharmaLedger proposes a protocol called Open DSU, or open data sharing unit. This is a unit of data that is located off the chain, encrypted and only then directly anchored in the blockchains. This means that patients are in control of their confidential data via a digital wallet on their smartphones. Instead of managing your money, you manage the keys to your private data.

‘With a platform like PharmaLedger, any consumer app that will be built on top of it will follow the governance rules of the PharmaLedger platform, including the way data privacy is enforced,’ the article reads. ‘Enabling this type of ownership and providing information that is relevant, correct and easy to understand is essential in managing fear and increasing trust in data sharing.’

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PharmaLedger selects use cases to advance adoption of blockchain in healthcare

The goal of IMI’s PharmaLedger project is to deliver an open source, blockchain-based platform for the healthcare sector, using the supply chain, clinical trials, and health data as case studies. Now, it has selected use cases in these areas to validate the blockchain platform architecture.###

In the supply chain area, one of PharmaLedger’s selected use cases will help to boost trust in medicines. A patient could simply scan a data matrix (QR) code on a packet of medicine to obtain (via a mobile app or website) a blockchain-anchored ‘eLeaflet’ on the medicine inside. The blockchain technology would guarantee the reliability of the information, and the solution could also be used to implement an anti-counterfeit feature where the user would be able to check product authenticity. Looking to the future, the eLeaflet could also be used to provide updates on the medicine, manage recalls, and offer advice on the safe (environmentally friendly) disposal of the drug.

In the health data field, PharmaLedger has selected a use case that will make it easier to match up patients with clinical trials (all while preserving patient privacy). In the clinical trials field, a use case on medical devices will integrate device data (‘Internet of Things’) with advanced analytics. This will support remote data capture during clinical trials, cutting down on the number of times patients would need to visit the clinic for tests.

In the health data and clinical trials fields, the project will also work on a use case that will strengthen patients’ ownership of their data, giving them greater control over who can access their health data and when, with a view to enabling a health data marketplace.

PharmaLedger plans to open up the platform for external parties to connect their own use case solutions. The platform will work in a similar way to an app store which requires a minimum standard of compliance but which is open and flexible to the needs of different use cases.

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Participants

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EFPIA companies
  • Abbvie Inc, North Chicago, Illinois, United States
  • Astrazeneca AB, Södertälje, Sweden
  • Bayer Aktiengesellschaft, Leverkusen, Germany
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • F. Hoffmann-La Roche AG, Basel, Switzerland
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Janssen Pharmaceutica Nv, Beerse, Belgium
  • Merck Sharp & Dohme Corp, Whitehouse Station, New Jersey, United States
  • Novartis Pharma AG, Basel, Switzerland
  • Novo Nordisk A/S, Bagsvaerd, Denmark
  • Pfizer Limited, Sandwich, Kent , United Kingdom
  • UCB Biopharma, Brussels, Belgium
Universities, research organisations, public bodies, non-profit groups
  • Dimokritio Panepistimio Thrakis, Komotini, Greece
  • Ethniko Kentro Erevnas Kai Technologikis Anaptyxis, Thermi Thessaloniki, Greece
  • Forum Des Patients Europeens, 1040, Belgium
  • Hospital Do Espirito Santo De Evora Epe, Evora, Portugal
  • Katholieke Universiteit Leuven, Leuven, Belgium
  • National Research And Development Institute For Cryogenics And Isotopic Technologies Icsi Rm Valcea, Ramnicu Valcea, Romania
  • Ospedale Pediatrico Bambino Gesu, Rome, Italy
  • Universidad Politecnica De Madrid, Madrid, Spain
  • Universitaetsklinikum Wuerzburg - Klinikum Der Bayerischen Julius-Maximilians-Universitat, Wuerzburg, Germany
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
  • Arteevo Technologies LTD, Tel Aviv, Israel
  • Ekon Modeling Sofware Systems LTD*Ekon, Modi'in-Maccabim-Re'ut, Israel
  • Imprensa Nacional - Casa Da Moeda, S. A., Lisboa, Portugal
  • Onorach LTD, Dundee, United Kingdom
  • Pdm E Fc Projecto Desenvolvimento Manutencao Formacao E Consultadorialda, Lisboa, Portugal
  • Romsoft SRL, Iasi, Romania
  • Technovative Solutions LTD, Manchester, United Kingdom
Patient organisations
  • European Forum For Good Clinical Practice, Brussels, Belgium

Participants
NameIHI funding in €
Arteevo Technologies LTD906 250
Dimokritio Panepistimio Thrakis216 250
Ekon Modeling Sofware Systems LTD*Ekon456 250
Ethniko Kentro Erevnas Kai Technologikis Anaptyxis282 500
European Forum For Good Clinical Practice103 750
Forum Des Patients Europeens143 750
Hospital Do Espirito Santo De Evora Epe351 250
Imprensa Nacional - Casa Da Moeda, S. A.365 625
Katholieke Universiteit Leuven338 500
National Research And Development Institute For Cryogenics And Isotopic Technologies Icsi Rm Valcea370 000
Onorach LTD511 569
Ospedale Pediatrico Bambino Gesu347 500
Pdm E Fc Projecto Desenvolvimento Manutencao Formacao E Consultadorialda648 125
Romsoft SRL1 157 500
Technovative Solutions LTD910 625
Universidad Politecnica De Madrid873 750
Universitaetsklinikum Wuerzburg - Klinikum Der Bayerischen Julius-Maximilians-Universitat307 500
Total Cost8 290 694