Jan 232024

Beyond Technology: Embracing Blockchain for a Paradigm Shift in Life Sciences

Eva von Mühlenen
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Blockchain is not only the preserve of the fintech industry, but may have multiple uses for life sciences companies, including providing a consent structure for clinical trials to give enhanced patients more control over their own data. Sidley’s Eva von Mühlenen and Daniel Fritz, executive director of the PharmaLedger Association, explain.

The use of blockchain is best known in fintech, where it has long been employed to set up a democratized structure whereby the status of an account can be verified without the need of a bank.

However, blockchain is in essence simply a decentralized storage system. Data that are stored in the secure and anonymous platform of a blockchain are unchangeable, and part of a transparent and immutable infrastructure that can enhance data control for regulators and corporate players. For this reason, blockchain technology is accelerating digital transformation across multiple industries, including the life sciences sector.

Blockchain can be applied to solving many issues which the pharma industry faces, including the handling of extremely sensitive personal data as part of clinical trials. For example, decentralized clinical trials could make use of smart contracts that would employ blockchain-based solutions to allow each patient to decide whether their data could be used for a particular purpose. This would have the potential to provide a completely new type of democratized, dynamic consent structure for clinical trials, one which could give patients more control over their own data.

Pharmaceutical companies stand to gain significantly from the adoption of smart contracts and blockchain solutions in clinical trials. These advanced technologies have the potential not only to streamline trial processes for efficiency but also to bolster data integrity and regulatory compliance. Additionally, they offer potential reductions in the time and costs typically associated with conventional trial methodologies, making them valuable assets in modern drug development.

We are starting to see other interesting applications of blockchain emerge in the life sciences industry. For example, one app — which was backed by EU funding and has already gone live — employs blockchain to provide the latest approved electronic product information. The app enables users to access the most up-to-date product information by simply scanning the barcode on a medical product box with a mobile phone.

This approach ensures that patients, healthcare providers, and other stakeholders can access the latest information directly from the manufacturer, bypassing the need for traditional paper leaflets, which are costly to produce and cannot be updated once distributed​​​. In this instance, Blockchain technology is pivotal in for maintaining a tamper-evident record of product information.

Blockchain also ensures the integrity and security of data, providing a trusted source of information. Additional pharma sector use cases for blockchain that currently are being explored include electronic patient information storage and counterfeit medicine prevention. In relation to the latter, blockchain could allow for the tracking of all medicine via a barcode registered in a blockchain. This could then be incorporated into supply chain requirements, allowing the location of medicine to be followed in near real time to allow proactive management of drug shortages. This could also permit the tracking of the availability of active pharmaceutical ingredients for medicines in supply chains. In this instance, blockchain could provide enhanced supply chain management to help to address product issues, by, for example, enabling recall notifications to all product owners.

Ultimately, blockchain represents more than a new tech system for the life sciences industry; it entails a mindset shift toward a more collaborative approach to patient care and data management.

This post is as of the posting date stated above. Sidley Austin LLP assumes no duty to update this post or post about any subsequent developments having a bearing on this post.

Eva von Mühlenen

Geneva

evonmuehlenen@sidley.com

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