The potential of truly digital, data-driven product labeling in life sciences is huge, allowing companies to tailor and update their information more readily, unencumbered by space restrictions or print/production line deadlines. But what will it take for today’s discrete, local pilot projects to evolve into something more permanent and transformational for patients and healthcare professionals?
At Amplexor BE THE EXPERT 2022, I will assess the latest developments, the emerging challenges that need to be resolved, and what’s needed now to maintain and build momentum.
Although digital labeling is widely available today across the globe through regulatory agency, trade association and company websites, this is largely in the form of static, unstructured content presented as published pdfs. While this option offers patients and healthcare professionals the convenience of easy lookup (in the event that packets and patient information leaflets have been mislaid, for instance), as well as the ability to make text larger, the broader benefits are limited. That’s because the content isn’t dynamic – based on the very latest data, reflecting updates as they happen. Or not yet, anyway.
Industry is faced with a perplexing array of implemented and emerging regulations, alongside an increasing variety of pilots and intitiatives, and whilst all will contribute to the evidence base for a more dynamic, data-driven labeling reality, balancing the complexity within an already fragmented labeling regulatory environment remains a challenge. So, the question is, how do we deliver the best labeling experience for each, and every patient based on their needs?
In my presentation at BE THE EXPERT 2022, I’ll take us through some of the latest digital labeling pilots currently underway around the world – from the Benelux region of Europe, which is testing digital labeling at a hospital prescribing level; to Singapore, which has moved past the pilot phase to embrace e-labelling nationally (but without the Regulator acting as the online hub for approved content). I’ll also ask what can be learned from the example of Australia, as a country which defaulted to online labeling for most products a great many years ago.
Each model currently being trialed or rolled out introduces its own benefits, and challenges. Practical considerations include:
- What is patients’ readiness for this fundamental change in how they access information about their medicines and/or medical devices, and what are the technical hurdles?
- How will patients be notified about updates to digital information (e.g. revised safety guidance)?
- Which code should be the standard for unlocking digital information? (QR codes are well supported by popular makes of smartphone, but harnessing the GS1 serialization code would minimize physical label ‘clutter’.)
- What will need to happen at a supply chain level/from a validation perspective, given that the paper label is part of the structural integrity of a product?
Certainly, there is much to be excited about as advances in technology converge with regulator openness to drive the current wave of pilot activity – from which there can be no going back.
The overarching challenge now is how to convert current momentum into something with broader impact and greater global coordination, so that practices are transformed irreversibly, and sustainably – with critical mass.
I look forward to discussing these themes with you at BE THE EXPERT.
Regulatory Industry Thought Lead at Navitas
About the author
Tris Nockles has been leading the Navitas Regulatory Industry Networks for the last two years, with 18+ years of industry exp in Life Sciences, Devices & Consumer Products. She specializes in strategy, process improvement and development initiatives focusing on Regulatory, E2E labeling & RIM. Tris is located in the UK, and is fortunate to live near the coast where she loves to walk on the beach with her partner and her three dogs.