Deal Or No Deal – Government Opens The (First) Box

In the first in a series, we examine the Government's plans for products in the event of a "No Deal" Brexit.

The UK Government has been publishing technical notices, setting out its plans in the event that the UK and the EU fail to reach agreement before March 2019. Following publication of the last batch at the end of September, we take a look at what has been announced so far, from the standpoint of product manufacturers who need to make informed contingency preparations. This is the first in the series; stay tuned for further instalments.

It is evident from the first batch of technical notices that a "no deal" scenario will not be plain sailing for businesses. Additional hurdles for food producers, changes to packaging and changes to processes for sale of medicines all suggest that, despite the Government's commitment to minimise disruption, there could be choppy waters ahead. Businesses will sometimes be required to take action immediately post-Brexit, whilst other changes will be able to be made more incrementally during a transition period.

Medicines and Medical Devices

As human health and safety are at the core of the medicines and medical devices sector, the Government has made clear its concern that regulation of these sectors is seamless post-Brexit.

Yet, even here it seems some change is inevitable. The biggest and most immediate changes are increased administrative burdens for manufacturers wishing to trade in the UK post-Brexit, with requirements to engage in a separate authorisiation process and for a mandatory regulatory presence (responsible person) in the UK. Products currently in the UK market, based on EU-approval, will remain unaffected, at least for the time being.

Areas which remain unchanged

The standard of safety required would be unaffected by a no deal scenario, either because UK legislation will continue to apply (organs, tissues and cells and blood and blood products), or because the Government suggests it will adopt EU safety standards, at least temporarily, post-Brexit (medicines, medical devices and clinical trials).

EU-certified products, including medical devices, blood and blood products and organs, tissues and cells would continue to be accepted, at least in the short term, in the UK. Similarly, EU-based batch testing could continue to be used for products manufactured in the EU and sold in the UK (with UK-based batch testing continuing to be required where products were manufactured in the UK).

Areas of...