Publication
04 Dec 2023 ·
International
Legal teams have a critical role to play from the start of life sciences innovation projects
3 min read
The healthcare revolution is forging ahead with advanced technology that is addressing everything from cancer to the common cold. The spectrum of disruption is diverse, ranging from stem cell engineering to AI innovation, but they have one challenge in common- the need to navigate existing regulations and laws.
Whether there are ethical or evidential barriers, technical or financial hurdles, a legal lens should be applied at the inception of every innovation process, a leading professor told a life sciences Forum.
Wouter Boon, Associate Professor of Innovation and Translation Studies at Utrecht University, told delegates from the pharma industry, medtech and the life sciences legal community: “Take into account legal issues, from the very start of an innovation process. Technology can only work if legal constraints are considered.”
Professor Boon, whose research focuses on the dynamics and governance of emerging technologies, was speaking at CMS’s Global Life Sciences & Healthcare Forum 2023, Blurring Boundaries – Exploring the convergence of life sciences and law.
He highlighted that radical innovations had the ability to reshape society and the future of healthcare, but they were often slowed down from reaching potential, and patients, by regulatory regimes.
“Rules and regulations are present everywhere but particularly in health and life sciences,” he added. “It is a highly regulated sector for good reasons, but it means that radical innovation sometimes has a tough job.
“For instance, there is a Catch 22 surrounding eHealth where there is a need for safety and efficacy data, but you can only generate that data if you can prescribe it and it is used sufficiently broadly. Similar Catch 22 situations exist across the field of emerging technologies in healthcare and life sciences.
“There are many more innovations in the pharmaceutical industry that are coming towards us, such as AI and 3D printing of biomaterials, but they need to break through existing regulatory regimes that might be resistant to new ideas.
“The Ubers of this world that change things without taking regulations into account in a ‘Do First – Ask Permission Later’ approach can achieve their goals in other sectors but that won’t work in life sciences because you need medical validation.”
The Forum was organised to promote debate and collaboration around how legal teams can work with start-ups and established companies to help realise their innovations.
“There was a lot to consider in the contribution from Professor Boon and the other speakers, but it was clear that we, as lawyers, have a critical role to play from an early stage,” said Gertie Lintjens, Of Counsel, Co-Head of Life Sciences and Healthcare CMS Netherlands, who co-organised the Forum.
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