Patrick Duxbury, Partner and Head of Life Sciences (UK) at Gowling WLG, shared his views on what the key developing trends are for the pharmaceutical industry in 2020.
Over 150 professionals make up the Life Sciences Group at Gowling WLG, having advised clients such as AstraZeneca and worked across a wide range of pharmaceutical areas.
From technological advancements, changes in the litigation landscape and increasing pressure on pricing from policy makers, GCs will have to ensure their teams, both internal and external, are equipped to deal with 2020’s challenges.
The pharmaceuticals industry has recently done very well to consistently develop novel drugs in areas of unmet medical needs, as marked by the increase in the number of approvals last year. Moving into 2020 pharma teams should look to continue that success, while keeping in mind a few key things that will have an impact on the year to come.
1. Keeping up with technology
There is an ever increasing application of technology in the life sciences sector but it’s something that the industry has been a bit slow to grasp - particularly within legal teams. Legal teams need to think about technology in terms of how it’s supplied to their business and the resulting legal implications, as it moves front-and-centre throughout the industry.
This work requires a different set of skills, so having the right team is important, both when it comes to internal teams and external counsel. These skills are ones that the industry hasn’t really thought about before. You need people who understand the cloud, AI and the legal implications these technologies bring.
2. Medical devices regulation
The implementation of regulation of medical devices is one to watch out for. There will be quite a lot of change to the old regime, so the industry is going to need to really understand that to have success in this space long-term.
3. Changing landscape of medicine approvals
One thing the industry should get to grips with in the coming year is the changing landscape of approvals. It’s an area that has been undergoing change, and will continue to do so in 2020. Many medicines these days are approved on a much more accelerated basis - a different basis to the old world of ten years ago.
There’s a very recent example of this in the UK. Biogen announced they’re going to file for approval on an alzheimer's drug that everyone thought was dead. Its phase three is now going to be potentially subject to approval by the FDA. It’s a great example of how the world of authorisations in medicine is changing and these changes seem to be accelerating.
4. Changing landscape of litigation
Disputes between ‘peer pharmaceutical companies’ have been on the up. Litigation used to be focused on generics versus innovators. These days, probably more than 50% of the disputes we see are actually innovators versus innovators. Proactive work to try and either head off the battle or put yourself in the best position for it can help with this litigious shift, but this definitely centres back around having the right people in your team so you can adequately prepare.
5. Pressure on pricing
There’s an increasing pressure on pharmaceuticals and that’s playing out in lots of different ways, from next year’s US election to the Labour Party saying they’d found a state-run generic drug company to overcome some of the pricing issues the NHS faces. If your company is going to be subject to that, or if you think your company will be, then it’s good to get in front of the problem first. Put novel pricing methods forward to help prevent getting into difficult battles and have your legal team front and centre in helping to solve these problems.
The year 2020 will definitely see a number of changes, but nothing that an in-house legal team can’t prepare for. Having the right team is crucial to success in these changing times - whether that be hires that understand technology or external counsel that can help with varied litigious matters. Staying ahead of trends is key so you can help shape the discourse and really understand what external factors will have an impact on your business.