At various points over the last few years we have heard the cry of ‘let’s just get Brexit done’. Given that it is over 8 years since the public vote, it would be good to think we are somewhere near closing out the loose ends.
With the implementation of the Windsor Framework, hopefully one of the key areas that was still outstanding has now been closed out, that is the trading status of Northern Ireland. As previously discussed, there are still some contradictions but we do have what the various parties agree is a long term solution.
So, back to the first question, is Brexit done (from a pharma perspective at least)? I think there is certainly clarity in most areas, that will allow companies to confidently plan for the coming years, notwithstanding the current Government’s stated aim to re-set the relationship with the EU, whatever that ultimately means.
There are however some areas within the UK Pharma market that are still tbc, some mean continued uncertainty but others offer opportunities:-
- Future regulation for medical devices – this will be key for UK and EU manufacturers alike. How closely the upcoming UK regulations align with EU MDR will be significant.
- FMD – a replacement system for the scanning system and database seems a long way off but as far as we know is still planned at some point.
- Changes to the ‘lists’ – adding countries to the list(s) may provide significant opportunities to companies.
- Regulatory Burden – this is probably an area that may have slipped under many peoples radar, but a significant consequence of Brexit is a massive increase in the workload on the regulators, both in terms of additional changes that have been required across the industry (such as the UK Only labelling) and in the overall number of applications that they are required to handle. With finite resources and increasing funding constraints, the impact of this could be significant.
The reality is that there will always be evolution and potential revolution within the sector, whether that is a direct result of Brexit or not, but we can probably move away from separating out the Brexit specific changes.