Shaun McVicar, Global Head of Pharmaceuticals, and Solicitor Marine Giral, , of law firm Herbert Smith Freehills, delve into the much-talked about technology, which looks set to be a game-changer in the handling and exchange of data.
Originally devised for the digital currency Bitcoin, the blockchain revolution has expanded to other industries. Coupled with innovative technologies such as Internet of Things (IoT) devices and smart contracts, blockchain is likely to disrupt and has the potential to benefit every stage of the pharmaceutical lifecycle.
Blockchain in drug discovery and development
Blockchain has the potential to considerably reduce drug development costs, alleviate inefficiencies and improve clinical research quality. The development of interoperable and secured blockchain platforms to collect and exchange healthcare data such as the one developed by IBM Watson Health and the FDA increases the number and quality of participants potentially available to be recruited for clinical trials.
Existing electronic health records are currently scattered amongst different healthcare providers using different (and generally non-interoperable) systems. For example, in Boston alone, 26 different systems are used for maintaining electronic medical records. Blockchain could record the generation of any data by a prescription, imaging scan, diagnosis test or monitoring device in a systematic way on a distributed database. Patients could then more efficiently access their medical/genomics data and reliably share that data with health providers or researchers, with no need to rely on a third party. Trial recruiters could then reach out directly to patients if their data qualifies them for a particular study. As blockchain ledgers are both mirrored and decentralised, there is not one single point of failure, which protects data integrity.
Blockchain can also be used to streamline patient consent collection and minimise documentation error or fraud. Participants could be assigned private keys linked to their digital signature. Blockchain could then record each step of the patient consent in a standardised, time-stamped and immutable way. It can also facilitate more efficient research collaborations. Data recorded on decentralised ledgers can be accessed and verified in real-time by all relevant parties, instead of sitting with one entity responsible for sharing it with other interested parties.
Computer protocols (so-called "smart contracts") built on the blockchain can automate the validation of certain steps once pre-determined requirements have been met, leading to greater efficiencies. For instance, they could automatically allow patient inclusion once (but only if) consent is obtained, or prompt data analysis as soon as (but not before) the database is frozen. They can also be linked, for example, to clinical trial protocol revisions or updates, necessarily generating patient consent renewals. With the development of data driven artificial intelligence, increasingly complex decision could be automated, and implemented without delay.
Blockchain transactions are immutable, which makes it virtually impossible to alter or selectively report clinical trial results and could ensure greater transparency and trust in reported outcomes.
Blockchain and intellectual property
Companies could use blockchain to record exactly when digital content was created or when a step in the drug discovery and development process occurred, for example by recording and distributing electronic laboratory notebooks. Time-stamped records could alleviate concerns associated with sharing research data prior to publication or patent filing and could also be used by companies in priority disputes.
Companies that need to share trade secret and other trusted information with collaborators can do so using private and permissioned blockchain platforms, which offer fine-grained access control over transaction details. The combined features of encryption, decentralisation and immutability protect data integrity and ensure that confidential information cannot be shared outside the network of authentified and authorised users without the consensus of the entire network. Blockchain can therefore enhance non-disclosure agreements. In the event of a breach, the time-stamped record will help establish that a business held a particular concept or information at a s...
(All Rights Reserved)