What regulatory challenges are facing the life sciences sector?

30 Apr 2021

Charleen O’Keeffe, William Fry. Image: Luke Maxwell/Siliconrepublic.com

William Fry’s Charleen O’Keeffe discusses some of the regulatory trends and challenges she sees coming down the line.

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The last year has seen a massive acceleration when it comes to digital transformation and the life sciences industry is not immune.

From game-changing technologies within the healthcare sector to the increased demand for telemedicine, there are plenty of ways digitisation is improving the industry as a whole.

Charleen O’Keeffe, a partner in William Fry’s life sciences group, spoke to Siliconrepublic.com about some of these trends in more detail. She said along with digitisation, there is also a move towards non-pharmacological intervention, the use of devices to screen for diseases and changes to the medicines themselves.

“We are seeing a shift away from the one-size-fits-all approach to personalised, individualised medicines. We’re seeing development of advanced therapy medicinal products, particularly gene and cell therapies.”

While the advancements herald positive moves for the sector, O’Keeffe warned about regulations and policies that are likely to affect the world of life sciences.

“The industry’s future is likely to be shaped in some form by the European Commission’s recently published pharmaceutical strategy,” she said.

“One of the key drivers of the strategy is to ensure access for affordable medicines for all patients and also to address unmet medical needs, particularly in the areas of antimicrobial resistance and rare diseases.”

O’Keeffe also said that life sciences companies are facing the full implementation of clinical trials regulation as well as compliance with GDPR against the backdrop of “an increased appetite from European regulators to enforce the GDPR”.

She added that, as with many other industries, the life sciences sector must contend with changing consumer behaviour, accelerated technologies and cyberattacks.

Medtech challenges

More specifically to the medtech sector, O’Keeffe highlighted the imminent Medical Device Regulation (MDR), which is due to become fully applicable from next month, and the In-vitro Diagnostic Medical Devices Regulation (IVDR), which will come into effect in 2022.

There’s two big changes under the MDR. Firstly it brings all economic operators in the supply chain within its scope and it broadens the range of devices under its remit,” she said.

“From our clients’ perspective, one of the key challenges is that it has mandated a full review of their intra-group agreements and also their upstream and downstream third-party agreements. They’ve also had to do a full review of their product portfolio to ensure compliance with the MDR.”

On a broader scale, the increased number of medical devices that will require mandatory conformity assessment along with the low rate of approval of notified bodies may result in “bottleneck and a shortage of supply of products onto the market”.

Jenny Darmody is the editor of Silicon Republic