Following the end of the transition period, the UK life sciences industry will face significant challenges. The objective of removing barriers to trade in the EU, together with the life sciences industry being one of the most regulated in the world, has created an intricate network of EU regulation, and this is heavily embedded within the UK life sciences industry. As just one illustration, the European Medicines Agency only is authorised to approve biotech medicines within the EU, and so the UK's Medicines and Healthcare products Regulatory Agency has not had to develop this capability until now.
As businesses located within the EU, UK life sciences companies enjoyed multiple benefits that facilitated trade within the EU. For example, drugs manufactured in the UK could be quality approved in the UK and sold throughout the EU. Post Brexit, the EU will not recognise the quality assurance (or QP release) by a UK business unless a reciprocal recognition measure is agreed. Similar issues will impact upon the UK's involvement with the EU pharmacovigilance system, also coordinated by the EMA. After the end of the transition period, UK based companies will need to alter their current pharmacovigilance reporting system from using one qualified person (as is usually the case) to having two separate qualified people, one resident in the UK and the other in the EU.
The UK's vibrant drug development and clinical trial market could also be less attractive to those non-EU companies that previously relied upon the UK's position within the EU. For example, the ability of UK based development companies and contract research businesses to act as the legal representative of a foreign life sciences business without any presence in the EU may be affected.
UK based research organisations are also likely to lose the benefit of the significant R&D funding available through the EU. As yet, it is not clear how this funding shortfall will be addressed.
However, the UK's life sciences industry is one of the most important in the EU, and UK based Universities and R&D institutions are amongst the most respected in the World. There is therefore a real incentive for the UK Government and EU to reach a sensible modus vivendi. Whilst much has been done to prepare for the new UK regulatory framework, a lot of work is still required, in a relatively short time. Due to the current uncertainty as to what regulations and processes will apply post Brexit, contingencies should be put in place in order to preserve the position.