The PharmaLedger Project’s leaders explain why blockchain technologies are needed to meet some of the challenges faced by the healthcare sector and how the project’s innovative platform can help.
The pharmaceutical and healthcare industries are complex. These industries need the co-operation of multiple stakeholders to ensure compliance in highly regulated environments that ultimately seek to ensure patients’ safety and health. This complexity, as well as a lack of transparency, co-ordination, and trust are significant challenges in this context.
At PharmaLedger, we aim to leverage blockchain as a tool to meet these challenges, as this emerging technology facilitates distributed public ledgers holding distributed and immutable data in a secure and encrypted manner, ensuring that transactions cannot be altered. By its nature, blockchain can bring important benefits in healthcare domain. For example, decentralisation makes it possible to implement distributed healthcare applications that do not rely on a centralised authority that validates transactions. This means that the data records (or ‘blocks’) are stored among multiple servers through the stakeholders’ nodes in the blockchain network, allowing stakeholders to have access to the health records without an entity or organisation having the role of a central authority that governs over the global health data. Moreover, immutability means data records cannot be changed or tampered with. These characteristics enable transparency and traceability and thus related valuable benefits such as allowing healthcare stakeholders, and patients in particular, to know how their data is used, by whom, when, and how. Furthermore, for pharmaceutical companies, there is the potential to enhance security, integrity, data provenance, and the functionality of supply chains because, at its core, blockchain technology is transparent, immutable, and auditable.
At PharmaLedger, we are developing a blockchain-based platform that will enable trusted and privacy-enabled digital collaboration through knowledge sharing among the healthcare stakeholders, supporting highly compliant and interoperable data exchange among members of the pharmaceutical and healthcare value chain.
The PharmaLedger platform builds on the key pillars of blockchain (decentralisation, transparency, and immutability). It provides a set of services to ensure regulatory, legal, and data privacy compliance, and will be validated through a set of use cases in three reference implementations: supply chain, clinical trials, and health data. For us, the use of blockchain to build this privacy-enabled and efficient foundation will help a stronger and more trustworthy healthcare ecosystem to emerge.
Moreover, the PharmaLedger consortium drives the early adoption of a disruptive blockchain-based digitisation technology, with key industry participants joining forces to build a comprehensive solution for improving the quality of healthcare. A governance framework is being developed for this blockchain-based pharmaceutical and healthcare ecosystem which shall allow stakeholders to benefit from the adoption of PharmaLedger and reap enhanced efficiency, de-risking, cost reduction, and simplified compliance benefits.
To bring this platform to life, PharmaLedger focuses on validating the platform on a set of use cases from three reference implementations domains: supply chain, clinical trials, and health data. These early implementations throughout each reference domain provide evidence to create value and trust to unlock the potential of the digital healthcare ecosystem, especially to patients.
PharmaLedger is a three-year project which started in January 2020. It receives funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853992. This JU receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. PharmaLedger is driven by a private-public consortium with 29 partners (12 global pharmaceutical companies and 17 public and private entities).
From our perspective, PharmaLedger’s reference implementations will go beyond the typical hype and bring:
- A mindset shift within the health and pharmaceutical ecosystem with new business and value-based healthcare models;
- New ways to support the management of new laws, regulations, and governance under enabled trust;
- Change in workflows, processes, roles, and responsibilities through improved traceability and transparency;
- Reduced costs of manual errors with transparent validation and management via automated smart contracts; and
- Protection for businesses and service provision against fraud or counterfeit via decentralised validation.
PharmaLedger: an innovative blockchain-based architecture
PharmaLedger provides a highly scalable blockchain-centric platform that enables an industry-wide foundation for implementing use cases and operational workflows leveraging blockchain technology in the healthcare and pharmaceutical industry. For this purpose, PharmaLedger is evaluating a hierarchical architecture of the blockchains. This highly innovative architecture shall bring blockchain benefits to the classical Internet. Our approach aims at updating, evolving, and replacing blockchains without losing transaction history and without forcing all participants to have strict deadlines or lose functionality when a switch to a new technology or a new blockchain version is necessary.
Appropriately used, this innovative architecture provides important advantages in terms of the performance and protection of confidential data. The PharmaLedger architecture includes technical means and methods to interoperate or interact with other similar/available healthcare blockchain solutions.
In addition, this underlying blockchain platform offers common horizontal services to the reference implementations, such as data access and storage, identity management, and we will address privacy management. Extensive support for flexible business processes and a built-in collaboration platform allows all participants in the healthcare value chain ecosystem to seamlessly communicate with trade partners, exchange data, and implement contractual relationships. The collaborative environment has the same level of confidentiality without sharing any special secrets (private keys) that must be managed and can therefore be stolen (and lose cryptographic properties such as forward secrecy). For this purpose, we are working on implementing methods that use multi-party computation (MPC) and which use an execution environment for smart contracts using encrypted choreographies. Our research aims at solving the security scalability issues without adding ordering services or other unnecessary centralisation points.
PharmaLedger the selected reference implementations
PharmaLedger validates and demonstrates the value of blockchain and ledger technologies through the aforementioned set of use cases in three reference implementations: supply chain, clinical trials, and health data. Under this approach, PharmaLedger wants to go beyond mere blockchain implementation; we want to create value and impact on the broader healthcare infrastructure. PharmaLedger’s strategic reference implementations shall empower organisations and patients with effective and scalable emerging innovative blockchain and ledger tools.
With demonstrative use cases in this domain we aim to demonstrate business value for pharmaceutical manufacturers, distributors, dispensers, and governments involved in the medical supply chain with reliable product traceability, while complying with European regulations and encouraging patient safety. There is also a key objective to help aid the fight against counterfeiting and reduce fraud. PharmaLedger wishes to strengthen these measures and ensure transparency with blockchain technology data exchange throughout the supply chain. Improved traceability and transparency thanks to the tamper-proof blockchain data collected throughout the supply chain will support coherent and managed supply chain strategies, procurement, and gather relevant data for the differentiation of genuine supply chain products and counterfeits.
Health data use cases demonstrate the need to support value creation for both patients and the healthcare system; for example, this will help to accelerate clinical trial recruitment and personalised medicine.
With the increasing deployment of eHealth solutions, of critical importance to patients is the ability to grant authorised persons partial or complete access to their personal data. This consent management is key for e-health. Although there are still challenges to support privacy-enabled health data, PharmaLedger aims at enabling a FAIR (Findable, Accessible, Interoperable, and Reusable), ethical and privacy-compliant data platform and marketplace that supports the use of personal health data. Using blockchain technology, the health data reference implementation not only supports patient data ownership but also offers full control over who can access health data, as well as trace data points throughout the patient journey to enable better healthcare outcomes. In this context, PharmaLedger will innovate by:
- Empowering patients: patients currently have no way to divide their consent and no way to control the kind of use made of their data. PharmaLedger will pursue patient mediated data exchange to truly put the patient back in control of their data;
- Improving trust: the ability of the data owner to provide granular consent increases trust;
- Immutability: the protection of eHealth information from tampering; and
- Transparency: auditability of consent given to/by third parties.
Clinical trials use cases are aimed at demonstrating clinical added value as well as new blockchain-enabled business processes in this area, e.g. the acceleration of clinical trial recruitment and providing support for a digitally enabled, trusted consent process for patients in order to reduce the massive burden associated with current paper-based processes. Under these approaches, PharmaLedger aims at accelerating the clinical development and submission process as part of the clinical trials solution.
Clinical trials are often time-consuming and costly, yet they are crucial for finding new and effective treatments. With many players involved in the entire process, a high degree of security and transparency is required in the entire process. Blockchain technology can provide greater efficiency by tracking data used in clinical trials while ensuring the collected data is authentic. This enables transparency, auditability, traceability, and fine-grain access control on all aspects of clinical trials processes conducted by various stakeholders, including patients and regulators.
To facilitate evolutional digitisation and the straightforward integration of data in PharmaLedger’s health data and clinical trials implementations, health providers and patients’ associations support the population of data in the blockchain. The new data will be committed to the blockchain in the form of immutable transactions generated by the ecosystem participants or by smart contracts.
Innovation in blockchain governance
The community built around a blockchain and the ways in which it is involved in the blockchain’s governance are a make-or-break factor of success. PharmaLedger aims to be the industry’s healthcare blockchain that is truly collaborative and decentralised and that will involve the industry and healthcare ecosystems at large in the blockchain.
The PharmaLedger project is considering all the dimensions of governance, including authority, legal structure, membership, and organisation, as well as various operating models, including the potential roles for stakeholders such as application developers, network operators etc. PharmaLedger will provide an on-chain governance tool to streamline the 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.
PharmaLedger is a three-year project which started in January 2020. It receives funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No. 853992. It also 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 driven by a private-public consortium with 29 partners (12 global pharmaceutical companies and 17 public and private entities).
Maria Teresa Arredondo
Maria Eugenia (Xenia) Beltrán
Universidad Politécnica de Madrid (PharmaLedger Co-ordinator)
Novartis Pharma AG
(PharmaLedger Industry Lead)
Please note, this article will also appear in the third edition of our new quarterly publication.