The pharmaceutical value chain and the extended healthcare ecosystem have many areas that suffer from complexity, a lack of transparency, coordination and trust.

Examples include:

• counterfeit medicines market estimated at EUR 160 billion with a huge impact on patient health;
• lack of access to medicines, especially in developing countries, impacting patient health;
• data accessibility leading to lost opportunities for improved research and new innovative medicines;
• patient privacy considerations (patient consent) hindering clinical trial recruitment and execution;
• lack of visibility and shared ’source of truth’ leading to friction and costs in development and distribution;
• increasing risk of cyber threats, especially with central data storage and sharing.

By addressing these challenges through a public-private consortium, the evaluation, design, and accelerated adoption of blockchain-enabled healthcare solutions across the industry can be fostered. This will facilitate the delivery of true innovation benefiting both patients and the industry.

The overall objective of the agile project generated by this topic is to establish a common blockchain ecosystem for pharmaceutical development, manufacturing, and distribution that provides an incentive and serves as the basis for all participants to engage, adopt, and benefit from.

The project will initially establish an effective governance organisation and approach to enable continuous improvement and open competition among service providers, while ensuring that critical factors such as data integrity, privacy, regulatory compliance and efficiency are built into a ‘Healthcare Foundation’ which serves as an integration layer between underlying blockchain technologies and the business application layer (see architecture diagram).

The project aims to drive the agile delivery of use cases prioritised by clearly defined business value, benefits (return on investment, ROI) and feasibility. Use cases fall into the domains of supply chain, focusing on supply chain integrity and efficiency; clinical development, focusing on clinical trials and submission; and health data, which among others should enable blockchain-based machine learning data marketplaces. A likely focus for prioritised delivery is enabling end-to-end product tracking with blockchain technology to address the issue of counterfeit medicines, taking into account existing initiatives such as the proposed European Medicines Verification System. The project will also evaluate the use of medical devices across multiple use cases in order to ensure the integrity of device, data and services to enable the benefits of the internet of things (IoT). The initial technology deliverable is an architectural framework enabling such factors as digital identity management, efficient consensus mechanism, off-chain storage, global scalability, security, and high performance. Other use cases can be added based on a value analysis during the project lifetime and proposals from the selected applicant consortium. The scope includes a reference implementation of the solution but does not include specific industry partner implementations.

The project generated by this topic will generally position the industry as a leader in innovation and serve to improve the overall trust and reputation of participants. Full realisation of the envisioned benefits will require a transformation of many core processes in organisations over several years beyond the life of the project. The project will establish a strong foundation to enable these benefits in accelerated manner. Envisioned long term benefits include:

• Patients will have earlier access to both the medicines they need and information on drug provenance; this will improve overall transparency, and with it trust in and the reputation of the industry. The supply chain will be more secure through anti-counterfeiting measures, building on the solutions designed to fulfil the Falsified Medicines Directive (FMD). The project will evaluate and define additional potential patient-centric services.
• Permissioned and secure healthcare data sharing will be enabled between patients, healthcare providers, researchers and other stakeholders. Patients will have full control of their health data and be able to join clinical, sensor and behavioural data into a self-sovereign 360 degree health record. Patients will be able to donate data or grant access to their data for a defined / limited time or purpose to research and real world registries in a trusted and anonymous manner. If seeking information on clinical trials, patients will have recommendations made to them based on their health profiles.
• Healthcare providers will use limited resources more efficiently by streamlining clinical trials and eliminating expenses for counterfeit and substandard medicines. Automation of processes and reliability of data will enable significant improvements to the current status quo.
• The pharmaceutical industry will benefit from widely accepted standards and demonstrated actions to ensure the integrity of drug development and distribution to the patient. Accelerated adoption of digital technology will additionally result in efficiencies across the industry with improved transparency, visibility and availability of drugs to the market. It can also better position the industry for new innovative therapies relying on the patient’s own cells (chain of identity).
• The applicant consortium will benefit from investments in research programmes and early adoption of innovative solutions.
• Applicants should indicate how their proposal will impact the competitiveness and industrial leadership of Europe by, for example engaging suitable SMEs.