What do the ‘no deal’ notices tell us about Brexit and health?


Sarah McCloskey and Professor Tamara Hervey, University of Sheffield
The clock ticks towards
Brexit Day and time to devise an agreement dwindles. The odds on reaching one
are said to be at 50:50.
This means increased incentives for both the UK and the EU to set out exactly
what the implications of the UK leaving the EU without a legally binding
Withdrawal Agreement (‘no deal Brexit’) would be. The EU
began doing this in January
2018
, through a series of ‘Brexit preparedness notices’. The UK issued its
equivalents in August.
Here we focus on the UK
notices, with reference to their EU counterparts, considering their
implications for the health sector.
Overall, the UK’s
notices attempt to pursue two conflicting functions. This leads to a pervading
sense of contradiction. On the one hand, they aim to assure and provide
certainty. Simultaneously, however, they set out to paint a sufficiently bleak
picture to seek to deter
negotiators from such an outcome
.
Indeed, contrary to the
idea propagated by some ministers that defaulting
to WTO rules would be favourable
, each notice begins with a statement that
the statements merely represent a responsible government prudently preparing
for all eventualities in the context of otherwise promising negotiations.
The Secretary of State
for Health and Social Care has taken this one step further by advising
that
the work already done gives a clear basis for the health sector “to
plan so that patients can continue to receive high-quality care unhindered.”
Said planned actions
outlined within the respective notices include:
       Stockpiling
a six-week supply of medicines to allow for delays as a result of e.g. border
controls.
       Setting
up new national systems – e.g. a national
portal
to which regulatory information about human medicines and devices
can be submitted directly.
Regulatory alignment –
the solution in the EU (Withdrawal) Act 2018 – does not remove the need for
contingency planning. For example, despite the UK’s plan to retain regulations
on blood
and blood product standards
, to import into the UK, it will be necessary to
show compliance with UK standards, which are to be a continuation of EU
standards. But the systems by which such compliance is shown involve
cooperation and mutual recognition, not unilateral behaviour.  Similarly, the UK government’s intentions to
align with the 2019
Clinical Trials Regulation
‘wherever possible’ when it comes into force
post-Brexit Day won’t prevent the UK’s exclusion from the new
EU clinical trials database
. (Indeed, the EU has advised that efforts have
already begun to remove the UK from several existing databases once it exits
the EU.) Every example where there are elements of reciprocity in EU-UK
relations is similar. UK patients will be excluded from the EHIC scheme. The
system of sharing information about medical professionals won’t apply any more,
so the UK won’t be notified of concerns about EU-27 doctors working in the UK.
On a no-deal Brexit,
the UK will be immediately excluded from EU decision-making processes. The UK
will no longer be represented at committees
which decide on safety of certain medical devices (including cardiac pacemakers
and breast implants). It has already
been excluded
from some EMA processes, on the basis that the person
chairing the EMA committee has to be present for the whole period of
decision-making, and that’s not the case for the MHRA.
One of the EU’s
strengths is in its collective decision-making powers, used to devise common
regulations. Of course, no regulatory system is perfect, but on leaving the EU,
the UK loses many of the trade-improving, burden-easing, and practice-refining
benefits that come with economies of scale.
And, for the health
sector, there are no clear counter-advantages. The EU regulations are a product
of the member states’ views; the UK’s voice has been heard and expert research
has been considered to create them. Thus, as highlighted by the UK’s notices,
there is no clear motivation to do anything other than copy and paste them.
But, as
the EU has stated unambiguously
, the UK’s fundamental change in status to a
third country means that this will by no means equate to continuity.
Photo credit: Royal
College of Nursing



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