Welcome to the Spring 2020 edition of Inside Life Sciences.
It is near impossible to ignore the impact COVID-19 has had globally, and the present and future implications it poses to Life Sciences are manifold. However, amongst the many remarkable events that we've seen over recent weeks and months (i.e. the accelerated development and trialling of vaccines and the agility and flexibility of the regulatory authorities), the role of digital technology has been at the forefront. The development of digital technology in healthcare and the proliferation of digital and therapeutic applications, particularly over the last five years, has been dramatic. Apps that can monitor and even assist in the prevention and early detection of life threatening conditions such as heart attacks and strokes are changing the face of modern healthcare.
The COVID-19 crisis has seen digital technology move front and centre, with track and tracing systems – which are currently being developed and deployed – being one of the most notable. Though there have been some delays to implementation, it involves individuals downloading an app that allows them to be contacted if they have been in contact with a person who has tested positive for COVID-19, and will likely be a significant tool for assisting in controlling infection rates.
There are of course questions surrounding how the app will be implemented and initial difficulties have been reported. It is heavily dependent on the testing system, and there are very significant sociological and legal issues that it raises, including how people will behave when they are contacted and the potential data protection, equality and discrimination issues that may arise. Nonetheless, the track and trace system is potentially a very important tool in this crisis and is further indication of the inexorable rise of digital healthcare.
Generally, the regulatory and commercial picture is a fast developing one. In this edition, we look at some of the steps the regulators have taken and provide guidance for those businesses entering into PPE manufacture projects.
Whilst the world has been in lockdown, the Courts have continued to operate as fully as they are able to, with hearings and trials taking place remotely. This edition also reports on some interesting patent cases, as well as important cases relating to drug pricing and 'pay for delay' agreements.
Lastly, the patent article reports that the UK has decided to no longer seek a role in the Unified Patent Court regime. With the German Constitutional Court also having decided that the German Parliament's ratification was unlawful, the UPC project is currently stalled, though the German Government is now consulting on a new draft ratification bill.
The industry will also be keeping a watchful eye on Brexit developments as we get closer to the deadline at the end of June for the UK and EU to agree any extension to the transition period. Given the UK Government's stance that it will not agree to any extension, the latter half of the year looks to be a challenging one.
I hope you find the articles in this edition interesting. Please do get in touch with me or your usual Mishcon contact if you would like to discuss any of the issues raised further.