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Activities

The cost of healthcare is rising yearly due to high demands on health prevention and diagnosis, unmet patient needs, an increase of an older population, costs of new drug development, an increase in chronic diseases and other factors.

The pharmaceutical and healthcare industries are complex. These industries need the cooperation of multiple stakeholders to comply with highly regulated environments that ultimately seek to ensure patients’ safety. All aspects of the production of new medicines including, among other things, clinical trials, manufacturing and distribution, have strict regulatory and ethical guidelines to which both industries must adhere to.

The complexity and the lack of transparency, coordination and trust are big challenges in this context. This is where blockchain could provide solutions by reducing the costs of healthcare, drug development processes, and time of delivery of the drugs to patients with unmet needs. The PharmaLedger consortium will drive early adoption of disruptive blockchain-based digitisation technology, with key industry participants joining forces to build a comprehensive solution for improving the quality of healthcare. The pharmaceutical industry has come together in the PharmaLedger consortium in order to explore blockchain technology’s application to these real-world challenges. Specifically, supply chain, health data exchange in the marketplace and clinical trials.

Supply Chain

Counterfeiting of drugs are on the rise in Europe and worldwide, putting the health of millions of patients at risk. These drugs are dangerous as they are not produced under safe manufacturing conditions that are supervised by regulatory authorities.European statistics show a strong increase of drug counterfeit seizures at European customs.

The global counterfeit drug market is estimated at EUR 160 billion. To help combat the scourge of counterfeit drugs, the European directive 2011/62/EU (with reference to the medicinal products for human use and prevention of entry into the legal supply chain of falsified medicinal products, patient safety) specifies a combination of three actions: a) Verify the authenticity of the medicinal products; b) Identify individual packs or batches, and c) Check whether the outer packaging has been tampered with. As there is no easy solution to the counterfeit drugs problem, the pharmaceutical manufacturers, wholesalers, dispensers, government regulators and patients must recognise the important role they are to play to ensure a safe and secure drug supply chain. Blockchain is one of the most promising and potentially efficient tracking, verification and authentication technologies. The end-to-end blockchain-based authentication solution to be implemented in PharmaLedger integrates all stakeholders of the supply chain.

Health Data

Access to health data is critical to a well-functioning health 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.

Further, patients frequently have very little knowledge about how their data are used with even less ability to control data-use. Economic rewards typically go to data brokers, who anonymise patient data and resell it but do not pass any of the rewards or incentives back to the patients themselves. In this direction, patients may hesitate to share their data for research purposes in clinical trials despite the positive impact that such a sharing can have. Inappropriate disclosure of their data and/or of their identities could have a direct impact on their health, and/or indirect financial or social implications as regards their employers, involved insurance companies, and so on. Blockchain capabilities hold significant potential to reduce this friction and enable secure, permissioned, auditable and patient mediated exchange of health data. PharmaLedger will create the capabilities and infrastructure that enables health data exchange. The necessary capabilities include:

Identity: the ability to verify and authenticate the owner of health data
Permission: the ability to record the granting/revoking of a right to use data
Interoperability: the ability to connect data from different sources into a cohesive whole
Incentive: the ability to incentive/reward actions that enable data exchange

Clinical trials

Clinical Trials are fundamental to the advancement of medical science. Trials are the most widely accepted way to demonstrate the safety and effectiveness of new treatments. However, clinical trials are difficult to administer, costly and time consuming.

Significant opportunity exists to transform clinical trial processes to accelerate time to market, increase patient centricity, and reduce the development and validation costs for new drugs. Many clinical trial processes are dependent on intercompany workflows (with CROs, clinical sites, labs, etc.), which require a high degree of security, transparency and robust tracking and audit trails. Blockchain could be a natural fit – including tracking biospecimens used in a clinical trial, ensuring the integrity and immutability of data and documents from clinical trials, and improving patient consent collection and management. Collectively, these efforts will reduce the friction in conducting clinical trials and increase trust in their outcomes.

Workpackage

WP1

Requirements & Business Use Cases

Lead: UPM | Co-Lead:MSD

To update and analyse the status quo of the overall picture, refining the DRAs and determine three highest priority Use Cases (UC) based on industry requirements to be deployed over these applications.
To identify, analyse and prioritise the technical and non-technical needs from stakeholders for the DRAs and Blockchain Architecture.
To refine the use-case methodology proposed in Section 1.3 and plan use case deployment
To design process, system, data and organisational model for the DRAs and four high priority use cases

WP2

Reference Domain Applications Use Cases Implementation, Validation and Piloting

Lead: PDM | Co-Lead ABBV

To demonstrate that the PharmaLedger framework can be used to support multiple applications (each representing a
relevant Use Case for the industry) with disparate requirements.
To write the Technical Specifications for each of the applications to be selected in WP1, for implementation and
validation (at least one per DRA).
To implement and validate each application derived from the Use Cases selected.
To support the selection for implementation of Use Cases in WP1, by providing analysis of Expected Implementation
Costs (i.e. effort), using mapping of common functionalities among Use Cases.
Design and implement UI for each application.
To perform extensive testing of the integrated components according to the Integration Plan to be developed.
To customize, localize and deploy the integrated PharmaLedger system across the pilot sites and provide technical
support to the pilot sites.
To provide continuous technical support to the pilot sites.
To validate the pilots and improve the implementation based on the feedback received from the pilot users.

WP3

PharmaLedger Architecture and Reference Implementation

Lead: RMS | Co-Lead: NVS

Research and design the PharmaLedger healthcare framework architecture, including but not limited to the three platform layers of the architecture: Foundation, Blockchain and Interchain.
Identify existing blockchain platforms and analyse them as candidates for the use case specific DRA.
Select the best fitting blockchain technologies as the basis of PharmaLedger Blockchain layer and define the required modifications, if any.
Define an architecture which is blockchain agnostic and supporting multi-blockchain technologies.
Define the Interchain layer requirements for interoperability and the possibility to use IoT-enabled medical devices across current and future business use cases.
Develop standards workshops if required; implied by the modifications and decision use cases.
Research and implement advanced confidentiality/privacy methods.
Develop a working reference implementation of the PharmaLedger Architecture.
Perform continuous integration and deployment of the PharmaLedger reference implementation.

WP4

Governance and Operating Model

Lead: PFE | Co-Lead: AVO

Research and evaluate possible governance and operating models for PharmaLedger platform. Consider all the dimensions of governance, including authority, legal structure, membership and organisation. Consider the various operating models, including potential roles for stakeholders such as application developers, network operators etc.
Design and select optimal governance and operating model that best reflects the objectives of the PharmaLedger initiative.
Evaluate on-chain governance tools that could help streamline voting and enforcement of governance decisions (e.g.,
blockchain-based voting, smart contract enforcement of agreements, etc.), and define the set of on-chain and off-chain governance tools to be implemented in the project.
Implement the target governance and operating model.

WP5

Regulatory, Legal & Data Privacy Framework

Lead: KUL | Co-Lead:NOVO

This WP will provide an ethical and legal framework paying special attention to EU data protection and privacy legislation in order to ensure PharmaLedger compliance. For this purpose, the framework will be provided for each of the Domain Reference Applications: Health Data Marketplace, Acceleration of Clinical Trials and Supply Chain.
The outcome of this WP will be a comprehensive overview of guidelines for compliance on relevant ethical and legal principles, which in the process of being made, will also feed into the users’ requirements regarding the technologies to be developed in WP1 and WP2.
The output of this WP also will serve to define further actions to be taken in order to advance the right ethically and legally compliant use of blockchain in all PharmaLedger approached domains.

WP6

Culture and Adoption

Lead:TVS | Co-Lead:NVS

Develop a methodology for adoption by the small, medium and large organisations in the industry and generate a “playbook”/adoption manual.
The goal is to drive the industry towards wide adoption of a Digital Single Market, with the adoption of blockchain as the common digitisation platform for the entire healthcare ecosystem.
Provide a collaboration platform over blockchain to facilitate adoption and ease of use.
Gain the widest industry endorsement for the PharmaLedger governance scheme.
Plan and initiate interactions with regulatory agencies/health technology assessment bodies to ensure that advice can be obtained on the proposed methods for novel methodologies for drug development.
Plan sustainability, facilitating acceptance and use of the platform beyond the duration of the project.
Plan and perform the strategic dissemination, communication and exploitation of the project’s results.
Create and execute a data management plan (DMP) specifying how research data will be handled and made available during the project and after it is completed.
Plan a strategy for the translation of project outputs into regulatory, clinical and healthcare practice.

WP7

Coordination and Project Management

Coordinator:UPM | Industry Leader: NVS

To coordinate at management level all technical activities of the project.
To provide project structure, coordination, quality standards and assist decision making, internal and external communications, innovation management and encourage greater accountability.
To encourage and facilitate meaningful interaction between all partners and managing conflict resolution.
To facilitate document sharing, exchange of information, real-time on-line discussions and close monitoring of the progress and quality of the team’s activities.
To facilitate communication, decision making and coordinated development of all WPs.
To assure ethical behaviour and data protection, and identify/mitigate potential project’s risks.
To facilitate the data and risk management of the project.

Collaborators

European Blockchain Convention

Visit website here

The European Blockchain Convention is considered to be one of the main Blockchain Conferences in Europe. Throughout the conferences, their mission is to provide relevant and inspiring content in collaboration with the brightest experts in the Blockchain world, while also facilitating an exclusive networking environment where all participants meet to form business relationships.

The EBC is made up of two Editions throughout the year:
The Iberian Edition in Barcelona, and the Nordic Edition in Copenhagen.

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Activities

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