What made you decide to specialise in life sciences law?
I specialise in advising on digital health solutions – that means advising on the regulation of health data, digital health solutions (including AI solutions, software and medical devices), as well as contracting in this space. I genuinely find the digital health space as exciting as it gets! The legal landscape is changing at breakneck speed, and I spend a few minutes every morning scanning for new regulations, new announcements and new guidance. Hot topics for legal developments include the regulation of AI, the European Health Data Space, and local laws on medical confidentiality.
Digital health might sound specialised but you really need to be a ‘Jack of all trades’ (master of all) to meet client needs. On an average project, I may advise on a combination of data protection laws, medical device laws, consumer protection laws and contracting. You need a firm grasp of myriad practice areas and black-letter law but, more importantly, you need to be able to translate that into a holistic, practical narrative for clients on next steps and risk.
I also enjoy the spectrum of clients I get to interact with, from big tech and start-ups, to the traditional pharma and medtech players. Each of these clients have their own unique legal risk appetites, and their own range of pioneering products that they believe will change health outcomes for patients. It’s a real privilege to be involved in getting these products to market.
What do you see as the key regulatory challenges facing the life sciences sector at the moment?
The life sciences industry is as heavily regulated as it gets, and the regulatory landscape only ever seems to increase in complexity. Even now, EU regulators are preparing an avalanche of new laws that are going to have a monumental impact on pharma and medtech in the next few years.
The big one is the EU pharmaceutical law package, which represents the biggest overhaul of pharmaceutical laws in over 20 years. The package touches on everything from regulatory data exclusivity to orphan medicines and paediatric medicines. It’s a controversial set of proposals – there are significant concerns from industry that the net impact of the proposals will be to undermine Europe’s competitiveness and slow the development and delivery of new treatments in Europe. Critics point to the provisions around regulatory data protection as particularly disappointing – the proposals modulate and reduce the regulatory data protection period from eight to six years.
Then we have emerging laws that touch on data and emerging technology, like the EU AI Act and the European Health Data Space. Organisations in the digital health space are facing a regulatory landscape that is shifting under their feet – as the regulatory burden grows, they’ll need to invest heavily in compliance in order to keep a foothold in the European market.
What impact do you think AI is going to have on the healthcare industry?
I’ve been lucky enough to work with some of the real pioneers of AI in healthcare for almost seven years now, and have seen products all the way through from the ideation stage to market. Throughout these projects, I’m constantly in awe of the range of AI applications that our clients are working on, from AI for ophthalmology and diagnostic imaging, to drug discovery and robot-assisted surgery.
The real impact of AI in healthcare hasn’t hit us yet – we’re still on the precipice, but the impact will be huge. These use cases are the tip of the iceberg and it’s only a matter of time before the use of AI technology is routine across the patient journey. We’ll eventually stop talking about ‘AI in healthcare’ and just call it ‘healthcare’!
What do you think are the key skills you need to succeed as a life sciences lawyer?
You need curiosity – this is an area where the ‘right answer’ can change quickly as the technology and the law develops, and the only way to keep on top of this is through independent reading and research.
It also helps to have a few strings to your bow so your advice is practical and holistic. This means having a firm grasp of a few regulatory regimes, whether it’s medical devices, pharmaceuticals, data privacy, consumer laws, or cyber security. A single project can involve several (seemingly totally unrelated) areas of law, and thinking in a silo will not give you the whole answer. A successful life sciences lawyer can spot issues across practice areas.