Activities

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.

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

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.