The work of UK health and regulatory authorities has mainly been targeted on COVID-19 work over recent months but there has been an increasing focus on End of Transition work in recent week’s and given that the Brexit transition period ends at 11pm on 31st December 2020 (GMT). As part of this work, UK MHRA has started to issue multiple separate pieces of guidance for the UK Life Science industry that covers many areas including clinical trials, medical devices, marketing authorisations, pharmacovigilance and manufacture and supply. These are to apply from the start of 2021 and 31 separate pieces of guidance were issued on 1 September with more to follow soon.
The guidance recognises that Northern Ireland will continue to apply EU rules in respect of medicines and device law and will be subject to the EU acquis under the Northern Ireland Protocol. Great Britain will be subject to UK law and guidance seeks to explain how this will fit together in terms of ability to market and supply and comply with a jigsaw of obligations going forward.
One emerging major question that arises in relation to the new guidance is how this might fit with powers that could be exercised under the new United Kingdom Internal Markets Bill, if enacted and published this week. The Bill contains powers that could seek to override differences in regulatory requirements across the UK from 2021. Finally, it is also noted that the ongoing aim of a UK-EU FTA and guidance that may emerge from committees tasked with applying the Northern Ireland Protocol could also impact on how the UK Life Science industry should operate after the end of this year.
There are clearly many moving parts still and scope for significant shifts in the regulatory landscape in coming weeks.