UK government publishes long-awaited Brexit ‘no-deal’ guidance

by Natalie Morrison
LONDON, 23 Aug (APM) - The UK government on Thursday promised to continue using medicines and vaccines licensed and manufactured in the EU even in the event of a ‘no-deal’ Brexit, and set out assurances that it will attempt to align with incoming EU clinical trials regulation.
The commitments came as part of its long-awaited no-deal guidance, published in the form of 25 technical documents for a range of sectors - including for medicines - outlining how it will proceed if no trade deal is reached before the rapidly approaching Brexit date of 29 March 2019.
The documents state that the UK could continue to use medicines and vaccines licensed and manufactured in the EU in case of a no-deal scenario, and sets out policies for stockpiling medicines and batch testing.
They also establish some ground rules for drugs regulation if no deal is reached, noting that national regulator the MHRA would take on the functions currently undertaken by the EU for medicines on the UK market.
“This would require changes to UK law, via the Human Medicines Regulations 2012 (HMRs). The MHRA is planning a public consultation in early autumn on some of the key proposed legislative changes,” it said.
For clinical trials, it said the older 2004 EU clinical trials regulation will remain in force, “modified using powers under the EU (Withdrawal) Act (EUWA) to make sure they still work in the UK after exit”.
This means the new EU clinical trials regulation (CTR), expected to come into force in the EU after Brexit, will not be incorporated into UK law under the terms of EUWA.
However, the government echoed a recent MHRA statement (APMHE 59219), promising: “we’ll align where possible with the CTR without delay when it does come into force in the EU, subject to usual parliamentary approvals. This alignment will happen after 29 March 2019 so it’s not addressed in this guidance”.
Shortly after the lunchtime release, UK trade bodies published their reactions, largely welcoming clarity on a no-deal situation, but also issuing some warnings.
The Association of the British Pharmaceutical Industry (ABPI) was one of these. It said: “The UK government will take a pragmatic approach to the regulation of medicines by recognising and using medicines and vaccines which have been licensed and manufactured in the EU.
“Companies can now focus on those medicines which have the most complex supply chains.”


On Thursday, the UK’s Department of Health (DoH) also wrote to pharma companies on the no-deal guidance, reiterating previous calls to stockpile medicines to avoid shortages.
In the letter, health secretary Matt Hancock called on companies to increase their stocks by at least six weeks’ worth on top of usual buffer stocks, and to ensure plans are in place to air freight products which cannot be stockpiled.
ABPI warned that stockpiling is just one part of detailed contingency plans which will be required from pharma companies, the government and the NHS.
Meanwhile, head of fellow UK trade body the BioIndustry Association (BIA), Steve Bates, warned that the stockpiling measures are a “massive challenge”, and encouraged members to engage with the DoH as to “how, or whether, they can, or cannot, ensure an additional minimum of six weeks supply in the UK” by 29 March 2019.
“Companies should receive an email from the Department within 24 hours with an ask to engage next week, and respond formally by 10th September,” Bates, who has been working closely with the government on Brexit medicines policy, said in the Thursday statement.
“We have stressed and recognise that endeavouring to deliver on this in less than 200 days will be a massive challenge for industry and the MHRA alike,” he said. “Given that over 150 BIA members are actively involved in clinical development in the UK, we will pay particular attention to the implications of this work with regard to ongoing clinical trials.”
ABPI chief executive Mike Thompson added that the pharma industry is doing everything in its power to minimise disruption of medicines in case of every possible Brexit outcome.
“By agreeing to recognise and use medicines and vaccines licensed and manufactured in the EU, the UK Government has taken an important step to protect patients. We urge the EU Commission to do the same,” he said.
Still, despite having some plans now in place - at least on the UK’s side - Thompson warned that a no-deal scenario is not in patients' interest, and urged both sides to come to an agreement.
“Both sides must rapidly agree the terms of the UK’s withdrawal and a future relationship based on cooperation to protect public health, control infectious diseases and manage medicine safety,” he said.
“A ‘no deal’ Brexit would mean the biggest dis-integration of the complex regulated medicines market in Europe in terms of regulation, cross-border movement of goods, comparative pricing and intellectual property. On behalf of patients, we encourage all participants to be as prepared as possible for a scenario industry really does not want, but we should be under no illusions that this will be easy or smooth.”

Batch release

Generics and biosimilars trade body the British Generics Manufacturers Association (BGMA) also waded in, welcoming the clarity over how the UK would handle regulation if it were to leave without a trade deal.
“We have been discussing what is needed with the government for some time: these notices build on past ministerial commitments and are a tangible expression of the pragmatic approach that we understood they would take,” said its director general Warwick Smith.
In particular, he highlighted the government’s commitment to accept batch testing and release in the EU - a matter that has been high on the list of concerns for pharma and biotech (APMHE 58587).
Still, he said: “Further detail is needed on some issues, such as the approval of biological medicines, and we welcome the government’s commitment to consult industry further on these outstanding issues.
“But what we have today already gives industry much more of the certainty that we need, and we welcome the realistic and pragmatic approach that the government is taking.”



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