Supply chain
Disputes
Product liability
Cybersecurity
and data
Regulation
33% of respondents are dealing with cybersecurity as a top priority.
Supply chain
This is a major area of concern. The ongoing COVID-19 pandemic has severely disrupted supply. Now, the war in Ukraine is adding further complexity. Respondents expect this to be a key challenge - from product development to legal disputes - for some time to come.
“Healthcare and life sciences is affected
by shortages, supply chain disruption,
government interference into the
company process, and IP, patent and
trademark rights. All of that is in the
mix in this new world.”
Watch Bryn Reynolds discuss tax considerations in the supply chain
Annabelle Bruyndonckx: supply chain issues provide opportunity for innovation.
Disputes
Disputes are growing. That’s the view of many respondents, who note that multiple crises are fuelling the level of legal intervention between healthcare and life sciences companies, their competitors, supply chain firms and governments. Forthcoming regulation will exacerbate the issues.
“IP is critical to our company. We invested
heavily to create technology innovations.
We see a lot of piracy and infringements
for our trademarks and patents.”
Product liability
A growing area of focus. An expectation of product liability being opened up to intangible products, in tandem with the development of AI regulations, requires healthcare and life sciences companies to mitigate liability for novel products.
“I think the biggest challenge is
uncertainty around the EU Product
Liability Directive. Along with AI, it’s
probably the biggest question across
the board.”
David Kidman: the importance of stress testing your product liability program.
Cybersecurity and data
This came through as the sector’s highest priority. This reflects the growth of online attacks against businesses in every sector. Firms must constantly review incident management plans and digital security. This is especially sensitive for healthcare and life sciences companies which are handling healthcare and personal data.
“Everything is about data, from patients for
clinical trials to interacting with healthcare
professionals or authorities. How we
manage it is key.”
Robert Allen: cybersecurity plans should not be deprioritised.
Regulation
Growing in complexity. Respondents observed that they must account for country-specific patent and IP regulation, besides laws applying to pharmaceuticals and other aspects of healthcare.
“We must be mindful of working in a regulated
space. We cannot just ignore change, we need to
be on top of it locally and globally to
understand developments in the market.”
of respondents are prioritising new health product regulation.