Blockchain erupted into public discourse as the distributed ledger technology that acts as the foundation of the digital currency Bitcoin. Fundamentally, a blockchain is a growing, real-time list of electronic records, with each block unit containing a timestamp, information about the previous block in the chain and data. The blockchain architecture is therefore resistant to the modification of data or its provenance. Fintech quickly recognized the potential of blockchain, with multiple use cases now implemented in areas such as financial transactions and service/product life cycles. For the life sciences industry, blockchain has the potential to enhance cross-industry partnerships, integrity and trust built on consensus, interoperability, tracing, and tracking of tangible and intangible entities in many service and product pipelines.
A recent report published by PreScouter reviewed three broad areas of blockchain deployment in the healthcare, biopharmaceutical, and medical technology sectors as well as the challenges these sectors need to overcome for wider adoption. The report also enumerates developing use cases of blockchain, from proof-of-concept to real-world large-scale deployments, and identifies first movers/early adopters of blockchain, including key collaborations, across the pharma, biotech and healthcare industries.
Challenges to wider blockchain adoption in the life sciences
Within the life sciences sector, blockchain use cases are complex to implement, and the rapidly changing landscape of blockchain technology also presents a challenge for companies seeking to adopt.“Blockchain has great potential to improve upon various activities within the life sciences sector, although it still has a number of challenges when it comes to adoption,” says Dr. Charles Wright, co-author and PreScouter Technical Director for the healthcare and life sciences industry. The consensus opinion is that changing the mindset of private, public and political leadership for adopting blockchain technology and the requisite change in management is the single greatest hurdle facing blockchain deployment, adds Dr. Wright.
As the technology matures, experts believe that mainstream adoption will be rapid. It is predicted that the value added by blockchains will grow to $176 billion by 2025 including non-financial uses in the life sciences, according to Gartner. Even with blockchain adoption gaining traction, PreScouter identifies 10 key challenges to wider adoption of the technology (seen in figure below).
Figure: Main Challenges to Adoption of Blockchain in Healthcare. Source: PreScouter.
The three life science fields impacted by blockchain:
The PreScouter report identifies drug development and supply chain management, clinical trials management and patient-centric usage as three areas with the most potential for blockchain adoption and impact.
Drug development and supply chain management
In the areas of drug manufacturing and supply chain management, blockchain can be very effective for ensuring integrity. Provenance and tracking of compounds are two key areas that are under the purview of authorities such as the FDA, with oversight through the Drug Supply Chain Security Act. Blockchain can provide immutable batch records of active pharmaceutical ingredients (APIs) in the manufacturing process and easy reporting systems for adverse events and drug batch recall.
Current processes that permit drug provenance and supply chain tracking are fragmented due to data silos and can lead to human errors as well as fraud. One example of blockchain implementation by a public-private collaboration is that between the FDA and IBM. The collaboration is using blockchain to identify, track, and trace prescription medicines and vaccines distributed throughout the country. Another example is the MediLedger Project that brings together a consortium of drug manufacturers and distributors to track/trace drug batches and improve drug supply chain management using internet-of-things (IoT) principles.
Clinical trials management
The PreScouter report also highlights that blockchain technology is impacting the complex processes integrated into the design, implementation and management of clinical trials. Clinical trials have many stakeholders, including patients/study subjects, study sponsors, drug/medical device providers, clinical investigators, healthcare professionals like physicians and nurses and various government regulatory bodies.
Sensitive data, including patients’ health records and a clinical trial’s outcomes, must remain private and secure. The trial protocol itself must be immutable and transparent. However, the entire process has to be conducted transparently for all stakeholders with protocols strictly adhered to. Moreover, secure communication between stakeholders from different professions and multiple clinical trial sites can be inefficient and can easily compromise protected health information.
Clinical trials therefore are perfect for blockchain technology, which allows for immutability, scalability and traceability of records with varied data access permissive levels. A blockchain could help manage patient consent, maintain trial protocols, track patient samples as well as ensure secure communications between trial sites. An initiative by Boehringer Ingelheim (BI) and IBM in Canada, where BI will manage its clinical trials on blockchain technology provided by IBM, was recently inked in 2019.
The company Triall, with its technology partner Sphereon, is developing applications for improving auditability and operational efficiency in clinical trials. The consortium’s Verial application, a clinical document management solution, is being used in a Phase II clinical trial and is touted as the world’s first clinical trial in production on a blockchain.
Finally, PreScouter highlights the potential impact of blockchain technology on activities that surround a patient, which can be termed patient-centric blockchain usage. These use cases are varied and include implementation of “smart contracts” for patient consent and ownership management of health data, patient record management across siloed healthcare data landscapes, prescription medicine management, patient claims and billings management, data security for medical/wearable technology as well as deployment in personalized medicine.
Blockchain implementation has achieved the most traction in patient-centric usage as seen by the number of early collaborations that are underway. A leader in blockchain implementation in Europe is Guardtime, which collaborates with Estonian Health authorities and the National Health Service in the UK for tracking and managing patient consent to use of their health data. Another application is the Prescrypt project, spearheaded by Deloitte in the Netherlands, which blockchains a patient’s drug prescriptions for secure communication, usage tracking and analysis by healthcare professionals.
The blockchain implementation in the life sciences is gaining traction and the authors of the report identify that the key challenge to blockchain adoption is non-technical and non-regulatory. It is rather changing the mindset of private, public and political leadership for adopting blockchain technology. However, they provide a positive outlook for the implementation of blockchain in the healthcare space in the near future. Dr. Rakesh Joshi, a co-author of the report, believes that, “as the technology matures and early use cases emerge to help mitigate risks, more mainstream adoption is to be expected within the next 5 years, which will enable blockchain technology to bear its fruits in the life sciences ecosystem.”
Rakesh, one of PreScouter’s advanced degree researchers, is a life sciences professional with a passion for data-driven analytics and discovery. He earned his PhD is Biochemistry from Purdue University. Currently, he is enrolled in the Schulich School of Business at York University diving deeper into machine learning/artificial intelligence and technology-driven strategic planning & management.