Since the MPs’ vote on the Brexit deal on 15 January 2019, the UK continues to face a lot of uncertainty in the coming months and years, with the exit date of 29 March drawing closer, and a ‘no deal’ Brexit looking more and more likely. The life sciences sector, heavily governed by EU Regulations, is likely to be affected, but the extent of this currently remains unknown.

Our New Year update contains updates on a variety of issues, from an industry look at how clinical trials regulation may be affected by Brexit (including in the event of a ‘no deal’), to the proposed unified patent court and a look at AI and data privacy in the context of healthcare. We also look at two cases relevant to the sector, one relating to licence agreements and one relating to consultancy arrangements.

What is clear, however, is that despite the current political issues, the life science industry in 2019 is still buoyant and thriving and there are no signs currently of any change to this.

Artificial intelligence (AI) technologies are providing increasing benefits and potential areas of application in the healthcare sector. This needs to be accompanied by a consideration of legal implications, in particular in relation to data.

In the 18 months since we published our last update on the Unified Patent Court (UPC) little has changed. Previously we reported that only the UK and Germany were yet to ratify the UPC Agreement (UPCA) in order for the UPCA to open for business. Whilst the UK has now ratified the agreement, ratification by Germany is still outstanding and with Brexit fast approaching, there is increasing nervousness amongst its supporters that the multi-billion euro project will never come to fruition.

Currently UK clinical trials are regulated by the EU Clinical Trials Directive, which was transposed into UK law in 2004. In 2014, a new EU Clinical Trial Regulation was agreed that aims to improve clinical trial transparency and simplify the application process for clinical trials across EU member states. This new regulation is expected to be implemented during 2020. If this happens, and the UK secures a deal with the EU, the new regulation would apply under the terms of the implementation period that lasts until 31 December 2020. If the regulation does not come into effect during the implementation period, the UK Government has confirmed its intention to align where possible with the regulation without delay when it comes into force in the EU, subject to the usual parliamentary approvals. In the event of no-deal, the UK Government will re-align with those parts of the regulation that are within its control. The two key elements of the new regulation that the UK would not be able to implement on its own after the withdrawal date are the use of the shared central IT portal and participation in the single assessment model, both of which would require a negotiated agreement between the UK and EU following the implementation period.

The High Court case of Sprint Electric Ltd v Buyer's Dream Ltd is a timely reminder that where an individual provides services through a service company, or is otherwise a contractor, the contractual arrangements can be challenged. Such challenges can extend beyond the question of employment status so as to bring the ownership of IP into question.

The UK life sciences industry continues to grow and, despite Brexit looming, is still receiving a high level of investment and collaboration. Often this leads to deals between UK and US entities. The recent case of Chugai Pharmaceutical v UCB & Celltech demonstrates the importance of clear drafting and the cross-border nature of pharma licences.