REPORT: BREXIT BEGINS
28 INSIDER March 2020 http://www.insider.co.uk
outcome of the negotiations on the
future trading relationship between
the UK and the EU and the extent
to which the EU will continue to
recognise the UK’s financial services
regime as equivalent.”
Her colleague Grant Strachan,
a senior associate in commercial
services at Brodies, says: “Whilst
Brexit has undoubtedly created
significant commercial uncertainty
for UK companies, a number
of industry sectors have shown
considerable resilience. Rather
than curbing commercial activity
or moving operations outside the
UK, we’ve seen businesses across
multiple sectors proactively manage
the forecasted Brexit impact. In the
life sciences sector, there are a range
of regulatory compliance issues that
clients have been navigating.
“The approval process for
medicines will be significantly
impacted as UK manufacturers
will not have access to the EU
marketing authorisation framework.
UK manufacturers will also need
to revise their pharmacovigilance
reporting systems to ensure that the
person performing that function
resides and operates in the EU – and
does not have dual responsibility for
pharmacovigilance for the EU and
the UK.
“For medical devices, UK
companies will require an EU-
based authorised representative
prior to accessing the EU market.
There is also the new Clinical Trials
Regulation 536/2014 (CTR) which
provides for a single application for
clinical trials across the EU (through
a single portal) with an associated
EU wide database. The CTR was
adopted on 16 June 2014 but it has
not yet come into effect as the portal
and database remain subject to
audit. It remains to be seen whether
and to what extent the CTR will be
converted into UK law. If the UK
regulatory framework is not aligned
with the CTR this would create
a greater administrative and cost
burden for companies wishing to
conduct multi-centre clinical trials in
the EU and the UK.”
One sector that has been very
vocal about the effects of Brexit
is the Scottish salmon industry.
The Scottish Salmon Producers
Organisation (SSPO) has warned
that the Brexit deal being pursued
by the UK Government is likely to
place “huge unnecessary burdens”
on the industry. Coming from a
member country, Scottish salmon did
not need Export Health Certificates
(EHCs) but once the transition
period is over – due to be the end of
2020 – these exports will needs such
certificates.
The financial impact of this for
Scottish farmed salmon will be
between £1.3m and £8.7m a year
depending on the amount charged
by councils for each EHC and the
number of EHCs required per lorry
load. But the effects wouldn’t stop
there with an expected requirement
of the processing and signing of an
extra 50,000 to 100,000 EHCs every
year, each one of which has to be
signed by either an environmentalhealth officer or a vet. This will
result in extra staff being needed at
the main haulage distribution hub,
the DFDS base at Larkhall in South
Lanarkshire, and delays and hold-
ups in the dispatch of salmon to the
continent.
The seafood industry has also
highlighted major concerns about the
impact of post-Brexit immigration
plans on their industry. The Scottish
Seafood Association and the SSPO
highlight the dependence of the
processing sector on overseas labour
and stress the importance of ensuring
that businesses are able to be fully
staffed to deal with the growth in
seafood volumes from January 2021.
Jimmy Buchan, the SSA chief
executive, says: “These immigration
plans have the potential to severely
restrict the economic boost that
will flow from the UK’s exit from
the Common Fisheries Policy.
At the point of expansion, we
need ministers to allow scope for
recruitment of skilled, semi-skilled
and unskilled labour as they are all
vital to the viability of the sector.”
Construction is another sector
where there have been warnings on
the impacts of Brexit, particularly
in regard to the industry’s reliance5HTXLUHPHQWVWRRIIHUĠH[LEOHZRUNLQJ
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Kate Wyatt, Lindsays (below)Marion McInnes,
BrodiesJimmy Buchan,
Scottish Seafood
AssociationClive Phillips,
BrodiesElaine McIlroy,
Brodies