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PharmaLedger

Periodic Reporting for period 1 - PharmaLedger (PharmaLedger)

Reporting period: 2020-01-01 to 2021-06-30

PharmaLedger is a 3 year Public Private Partnership (PPP) Project, that started in January 2020 and which will run until December 2023. The PharmaLedger project is funded through the Innovative Medicines Initiative (IMI) 2 Joint Undertaking (listed under grant agreement No.85399) which receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
PharmaLedger is backed by a consortium of 29 public and private entities, including global pharmaceutical companies, technical partners, universities, research organizations, hospitals and patients` organisations. These 29 partners collaborate under one common goal, which is to create an agile and secure blockchain-enabled platform that supports, on the top of it, a set of decentralized and thrustless healthcare solutions by nature. These applications are designed to: a) share data in a way that, data and processes are compliant not only with current standards of the healthcare sector, but also with the current legal and ethical framework (data and processes are privacy-enabled by design), and b) allow security, trust and provenance of data and information, by linking data and processes together through the PharmaLedger platform services, which provides the capabilities and infrastructure that allows secure, permissioned, auditable, and patient-mediated exchange of data environment, for exchanging data in the healthcare ecosystem and serving as a single source of truth for the pharma ecosystem.
PharmaLedger provides a 4 layer architecture (see fig. 1); the three layers at the bottom ensure the data self-sovereignty through the OpenDSU approach, while the top and fourth layer enables and integrates the solutions and applications being developed for the use cases.

Figure 1: PharmaLedger Architecture
OpenDSUs stands for Open Data Sharing Units that is a technology that works as a container for Data and the code being built in the blockchain. The DSU is cryptographically secured, anchored in the Blockchain, and in control of the user, defining a standard manner of how to store data and code outside the Blockchain (off-chain). The OpenDSUs are supported by digital wallets, which allow users to interact with the blockchain.
The course of action within PharmaLedger project is organized in agile development cycles, staring with a foundational phase that provides the building blocks to generate the bases of a solid healthcare ecosystem using blockchain technology driven by the end users and stakeholders oriented requirements. The agile development is transversal to the seven (7) workpackages that rule the operative, technical and managerial activities of the project, and at high level can be divided in two high level development cycles:
• The first integration cycle (1st integration cycle) which provides the first level of integration for the PharmaLedger reference architecture, including the development (innovative DSUs approach) and initial deployment as well as validation of the architecture blocks, enabling the preliminary demonstrative integrations for all the use cases; supporting the integration of the requirements at high level (not yet with full integration of data, but linked to a front end supporting a proof of concept approach)
• The second integration cycle (2nd integration cycle), which is the final integration phase that delivers the final technical and service components; and will provide the developed applications of the selected use cases, that will demonstrate, validate and test the PharmaLedger architecture.
PharmaLedger demonstrates its value through eight Use Cases through applications are clustered in three domains of reference: Supply Chain, Health Data and Clinical trials:
• In the Supply chain domain we are developing four (4) solutions supporting the use cases in the areas of Clinical supply traceability, finished goods traceability, electronic leaflet (eLeaflet or electronic Product information ePI) and Anti-counterfeiting.
• In the Health Data domain we have two (2) applications which support the Clinical Trial Recruitment and Personalized Medicine use cases.
• In the area of Clinical trials we are delivering two applications: the eConsent and the IoT devices monitoring health .
When putting together the use cases in PharmaLedger, we can see that they are linked and can be shown as part of an upstream or downstream path of the healthcare value chain; depending on the stakeholder perspective.

Figure 2: PharmaLedger Use Cases in healthcare value chain

During the first period of the project (M1 to M18), the efforts focused on the following activities:
• Securing the project kick-off and roll-out, consolidating a shared vision for common understanding among partners on the operational details of the project;
• Designing the PharmaLedger Platform Architecture and services, providing the initial infrastructure developments (focus on OpenDSU).
• Assessing and designing the PharmaLedger Governance, providing the preliminary recommendations for Platform Governance and Operating Model.
• Engaging the External Expert Advisory Board to participate in the project, as well as engaging selected regulatory and standardization bodies (e.g. European Medicine Agency, FDA, GS1, HL7, etc.)
• Strong design and actioning of the Dissemination and Communication activities, driven by a continuous set of activities to spread the concept, technologies and activities being developed on the PharmaLedger project; using the different PharmaLedger channels: website, social media, conferences, partnerships, webinars, etc.
• Designing the initial scenarios and options for the Pharma Ledger governance.
PharmaLedger creates value through Responsible Research and Innovation (RRI) processes involving patients organisations, healthcare providers and other societal actors (researchers, policy makers, business and supply chain intermediaries, standardization organisations, etc.) through its whole research and innovation process, aligning the results and its outcomes with the values, needs and expectations of the healthcare sector and society.
PharmaLedger results are based on the developments over the blockchain enabled, interoperable and secure Data Sharing Units (DSUs) architecture, developed for sharing data and processes transparently and trustworthy, while collaborating in real time. We expect to create impact by increasing digital trust among Pharmaceutical supply chain and healthcare stakeholders, support medicine drug traceability and data privacy, as well as build a new culture of collaboration of sharing data in healthcare domain, under enhanced security; compliance with data-protection rules; and interoperability schemas. Thus, value is created for all stakeholders through an interoperable platform, that manage digitized as well as accessible immutable and traceable data, and combines the benefits of Blockchain such as integrity, traceability, and non-repudiation while preserving confidentiality and data privacy for the data owners.
In addition, we, at PharmaLedger want to remain technology neutral; so in the future we can also create value by being able to quickly integrate with any other new coming blockchain technology.
PharmaLedger Architecture
PharmaLedger Use Cases in healthcare value chain
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