No-deal Brexit Plans Include 6 Weeks' Medicine Stockpile

Peter Russell

August 23, 2018

Patients would continue to have access to medicines, medical products and high-quality care in the unlikely event of a 'no-deal' Brexit, Matt Hancock, the Secretary of State for Health and Social care, has said.

He was speaking as the Government published the first tranche of technical guidance on how the UK would cope in the event that it leaves the European Union without an agreement in place.

In a speech in London earlier, Dominic Raab, the Brexit secretary, said a deal remained "the most likely outcome" but the country had to be "ready to consider the alternative". He sought to make light of concerns that crashing out of the EU in March next year would have grave consequences by joking that "contrary to one of the wilder claims, you will still be able to enjoy a BLT after Brexit".

Leave negotiations were "progressing well", the Department of Health and Social Care (DHSC) said, but it was the duty of a responsible government to "prepare for all eventualities".

It urged clinicians to reassure patients there would be enough medicines to go round in the event that a UK-EU deal could not be negotiated.

However, the British Medical Association (BMA) said it was clear that Brexit meant an impending catastrophe for patients, the health workforce, services, and the nation's health.

We round up today's technical announcements in the field of health and some of the reaction to the Government's plans.

Batch-Testing medicines

In the event of no deal being in place, the UK would accept batch testing of medicines carried out in the EU.

"At the moment they only need to go through one set of checks, either here in the UK or in the EU in order that they are deemed safe to be used by patients, and that's by virtue of our participation in the European regulatory network," said Mr Raab. "Now, in a no-deal scenario, the UK won't be a participant in the European regulatory network that supports this process. 

"But, we don't want delays or disruption to supplies from the EU so we propose accepting the testing and safety approvals of existing medicines if they've been carried out by a member state regulator."

However, Mr Raab was unable to give assurances that the situation would work in reverse. "Given that we start from a position of common rules, we would also hope and I think expect, in good faith between close partners, that the EU would recognise medicines from this country with our regulatory approval," he said. "But in a no-deal scenario we can't guarantee it."
 

Supply of Medicines

The DHSC said plans were in place to ensure that the UK had an additional 6 weeks' supply of medicines in case imports from the EU were disrupted. It said this measure would be reviewed in the light of future developments.

In cases where prescription-only and pharmacy-only medicines from the EU/EEA could not be stockpiled because of a short shelf-life, and were usually delivered by ferry, road and rail, suppliers were being asked to ensure they had plans in place to air freight those products to avoid border delays.

There were no plans to enlist the RAF to deliver medicines, Mr Raab insisted.

In a letter to all NHS organisations, GPs, community pharmacies and other service providers, Mr Hancock wrote: "Hospitals, GPs and community pharmacies throughout the UK do not need to take any steps to stockpile additional medicines, beyond their business as usual stock levels. There is also no need for clinicians to write longer NHS prescriptions. Local stockpiling is not necessary and any incidences involving the over ordering of medicines will be investigated and followed up with the relevant Chief or Responsible Pharmacist directly."

"Clinicians should advise patients that the Government has plans in place to ensure a continued supply of medicines to patients from the moment we leave the EU. Patients will not need to and should not seek to store additional medicines at home."

Blood and Blood Products

In the case of a no-deal, the EU Blood Directives would no longer apply to the UK. That would mean that arrangements for sharing blood, blood components and information with EU partners would be based on the UK's status as a third country.

The DHSC said it was engaging with blood establishments, the Medicines and Healthcare products Regulatory Agency (MHRA) and devolved UK governments to ensure that there was "day one operability for blood safety and quality".

It said it was also working to ensure it could evolve to meet changing safety and quality standards in the EU.

However, the UK was largely self-sufficient in the supply of blood and blood components, the DHSC said.

Quality and Safety of Organs, Tissues and Cells

In the event of no agreement being reached, the UK would still meet the current EU safety and quality standards for organs, the DHSC said.

Only a small number of organs are shared with EU countries. There were 22 organs from deceased donors arriving in the UK from the EU in 2017/18, while 19 organs left the UK for an EU destination in the same year.

Organisations that currently exchange organs would need to make written arrangements to ensure organs can still move between the UK and EU countries unless an agreement was reached.

Hospitals, stem cell laboratories, tissue banks, and fertility clinics would continue to work to the same quality and safety standards as they did before exit but some would need new written agreements with relevant EU establishments, the DHSC said. However, UK licensed establishments that import or export tissues or cells from EEA establishments would need to make written agreements with those bodies to continue importing or exporting products after the UK leaves.

Tobacco and E-cigarettes

In the event of a no-deal, the UK would create new domestic systems to allow producers to notify tobacco products and e-cigarettes in accordance with existing rules.

New picture warnings for cigarettes and other tobacco products would have to be created as the copyright for the existing picture library is owned by the European Commission. The new picture warning labels would be in place from exit day, the DHSC said.

Further technical guidance notices would be published in September, the Government said.

Reaction to Today's Announcements

Commenting on the technical notices, Dr Chaand Nagpaul, the BMA's council chair, said: "Many of the no-deal outcomes outlined in this paper would result in the UK becoming both less influential within the health sector and a less significant market."

He added: "Despite concerns being raised before the vote, no one could have imagined the extent of the complications that Brexit would bring to both the UK and the rest of Europe. However, in light of what we know now, it is imperative that the public has a say in any proposed Brexit deal."

Aisling Burnand, CEO of the Association of Medical Research Charities (AMRC), said: "Delays at border controls are clearly anticipated in the event of a no-deal Brexit. The Secretary of State has written to reassure the public that plans are in place, so patients do not need [to] take action themselves. However, patients, and the medical research charities who support them, will need more clarity that they will still be able to continue to get vital medication in the event of a no-deal Brexit."

Mike Thompson, chief executive of The Association of the British Pharmaceutical Industry, said: "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.

"We need to be clear that a no-deal scenario is not in the interest of patients.  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."

Dr Sam Barrell, chief operating officer at biomedical research centre, the Francis Crick Institute, said: "A no-deal Brexit would undoubtedly be bad for science; the only real question is how bad. We should not underestimate the value of the UK's strong international position in science, and the potential impact of failing to reach a deal.

"Although it's nice to hear the Secretary of State's reassurances that we can still enjoy a sandwich after Brexit, it's less clear if the UK will still be able to enjoy our status as a world-leading scientific power."

John Hardy, professor of neuroscience at University College London, commented: "Through our integration with our European partners, scientific cooperation and drug industry regulation cooperation has benefited all Europeans but has especially benefited the UK.  

"Brexit is an uncontrolled experiment and everyone who understands the level of cooperation forecasts the outcome will be worse than the present excellent arrangement."
 

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