The House of Lords External Affairs sub-committee has published a report On Brexit: trade in goods. The report examines the impact of Brexit on trade in goods between the UK and the EU. It is based on an inquiry conducted by the External Affairs Sub-Committee of the European Union Committee and builds on the previous report Brexit: the options for trade, published on 13 December 2016.
This latest report highlights that discussions have already begun with regards to moving the EMA to one of the EU-27. Professional services firm Deloitte LLP noted “this will be a disadvantage for the UK life sciences industry, both in terms of status as host nation but also there is likely to be a reduction of research and other work contracted to the MHRA by the EMA”. Dr Virginia Acha, Executive Director of Research, Medical and Innovation of the ABPI stated that the UK Government would have to determine how the UK could “align with the standards that have been arranged after so many years of careful thought”. Dr Acha also stated that the ABPI “would like the role the MHRA plays ”—as an important voice in the EMA and in international groups on harmonisation—“in the future to be no smaller than in the past”. She hoped that “the British voice” would “continue to weigh importantly in the scientific developments on standards”, and she looked to the Government “to ensure that … we are directly represented at the ICH [International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use] and other relevant bodies”. The UK is currently represented at ICH only as a member of the EU, and the Government will need to establish itself as an independent member.
Deloitte stated that the UK had three options for the future of its medicines regulatory framework “It could either continue to align with the EMA (particularly given the “potential disadvantages of losing mutual recognition with the EU”), align with another regulatory framework (such as the US Food and Drug Administration (FDA), or create a new/enhanced UK regulatory body”. Aligning with another regulatory body such as the FDA is likely to be “time-consuming” and “costly” while the “size and complexity” of the task of creating a new regulatory body and supporting a new regulatory framework meant that this was “unlikely to be feasible in the time available”. The UK’s continuing participation in the EMA following Brexit would have been possible if the UK had chosen to remain part of the EEA however the Government’s decision to rule out membership of the Single Market means that the UK may be unable to maintain its membership of this body. The report urges Government to “bring forward proposals for future collaboration with the EMA”.
The full report can be found here.