Publication
13 Nov 2023 ·
International
Collaboration between legal teams and life science innovators is the key to unlocking potential
4 min read
The importance of challenging legal frameworks and developing new regulatory strategies was brought into sharp focus at the CMS Life Sciences & Healthcare Sector Group’s Forum 2023 Blurring Boundaries – Exploring the convergence of life sciences and law.
Delegates from across the life sciences sector heard high profile speakers highlight how advances in health technology were outstripping regulatory frameworks, as well as discuss how legal teams can navigate road blocks to progress.
Experts from CMS, which has more than 80 offices worldwide, outlined how their practice was meeting the challenges to accelerate the introduction of new products, devices, processes and services that are powering the future of life sciences.
Ellen Gielen, Partner, Co-Head of Life Sciences & Healthcare CMS Netherlands, commented: “With new business opportunities, it is often necessary to amend existing models. Developments are moving rapidly but the laws cannot always keep up with those developments.”
She highlighted the case of a Dutch supermarket group that wanted to extend its role as a certified drug store by dispensing medicines via an in-store video link direct to a prescribing pharmacist or doctor. The courts blocked the innovation because there was no provision in existing legislation to allow it.
“That was obviously disappointing, but the good thing was that the court saw it’s benefit and said the law should be changed to permit the service. That change is going through now which demonstrates that the law can respond, although it will take time.”
Roland Wiring, Partner CMS Hamburg, observed that new digital capabilities created potential, and problems, across geography and jurisdictions such as doctors in China being able to consult and prescribe with patients in Europe.
“There are a lot of questions around telemedicine treatments and how they are implemented with regard to data privacy questions, payment models and liability. It is our task as lawyers in advising start-ups or on new business models to find solutions, even if we are making new ground.
“For instance, we had a project with a virtual trials company that used AI to predict a medicine’s outcome on patients and it was not clear that it would be classed as a service or medical device. How the legal rules apply, either existing ones or new ones, is a complex area that needs attention.”
Analysts Deloitte cautioned that the shifting regulatory landscape and growing demands from healthcare providers posed significant challenges. Its 2023 Global Life Sciences Outlook framed the need for a legal focus as an integral part of innovation strategy.
Gertie Lintjens, Of Counsel, Co-Head Life Sciences & Healthcare CMS Netherlands, added that life sciences was an ever-broadening landscapes with challenges emerging from new technologies being deployed and new areas, such as nutrition plant-based medicines and service provision, being explored.
“We have pharma companies that are thinking out of the box about the potential of building business by offering integrated healthcare with medical devices, pharmaceuticals and care, which is not familiar territory, so you need to address issues around compliance,” she says.
“There is a lot of innovation, change and challenge in the sector and it is exciting to be working with innovative companies and helping shape the future.”
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