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Media And Political Bulletin – 10 December 2018

Media and Political Bulletin

10 December 2018

Media Summary

Health sector warned of 6-month medicine shortages in no-deal

Financial Times, Laura Hughes, 7 December 2018

The Financial Times reports that the UK Government has warned drug companies and the health service sector to prepare for up to six months of ‘significantly reduced access’ to UK borders in the event of a ‘no-deal’ Brexit.

In a letter to the sector on Friday, Matt Hancock also warned that the current guidance encouraging providers to stockpile six weeks of medicines may not be enough to cover the ramifications of a disorderly exit.

He said that their assessments had been ‘revised’ to factor in the possibility that the EU could impose import checks on goods from the UK.

Please follow links to read Hancock’s letters: ‘Government’s preparations for a March 2019 no-deal scenario: an update’ ; ‘Medicines supply: no-deal Brexit preparation plans update’

ABPI response to medicine supply contingency plans for no deal Brexit

ABPI, Press Release, 7, December 2018

The ABPI responded last week to the UK Government’s additional information on contingency planning for medicines supply in the event of a ‘no-deal’ Brexit.

The ABPI highlighted the need to provide more detail so that companies can make plans. Mike Thompson, Chief Executive of the ABPI said that ‘pharmaceutical companies continue to do everything in their power to make sure that patients get access to medicines whatever the Brexit scenario. This includes duplicating processes, changing supply routes and stockpiling medicines in line with the Government’s guidance. However, we have been clear that there are things which are out of our control. Today’s update on potential border delays for six months in a no deal scenario is stark. Stockpiling more medicines is not the solution to this problem.’

The NPA also published a response, stating that the ‘NPA has been invited to comment on the proposals set out by the DHSC.  We are currently in the process of preparing our detailed response…Government has asked manufacturers and wholesalers to ensure they have a minimum six weeks’ additional supply in the UK as buffer stock in case the UK leaves the EU next March with no-deal and without a transitional agreement.  By itself, this is an insufficient contingency to deal with the potential disruption that might occur.’

Brexit: pharmacists to get emergency powers to ration drugs

Pharmacy Business, Kiran Paul, 8 December 2018

Pharmacy Business reports that the Government is set to invoke a ‘serious shortage protocol,’ giving pharmacists emergency powers to alter prescriptions without consulting GPs, in the event of a ‘no-deal’ Brexit. It reports that the Department of Health and Social Care is conducting an urgent consultation on the measure.

Pharmacy Business also reports on Matt Hancock’s letter to the health and care sector last week. Where he said that additional actions may be needed to supplement the medicine stockpiling due to the changed border assumptions.

See this also reported in the IndependentReutersChemist and DruggistEvening StandardSky News, and the BBC

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 7 December 2018

Ben Bradshaw, MP: To ask the Secretary of State for Health and Social Care, whether contingency planning and expenditure by the Medicines and Healthcare products Regulatory Agency (MHRA) on any systems or processes, including software is being incurred on systems or processes which will be redundant in the event that an agreement is reached that includes continued full co-operation, based on regulatory alignment, with the European Medicines Agency after the UK leaves the EU.

Answered by Jackie Doyle-Price: The Medicines and Healthcare products Regulatory Agency (MHRA) has undertaken contingency planning in the event the United Kingdom leaves the European Union with no deal. MHRA currently interacts with 40 systems and processes. The total estimated cost to replace them is expected to be £9.3 million on completion.

Ben Bradshaw, MP: To ask the Secretary of State for Health and Social Care, what other aspects of medicines regulation including regulation related to patient safety is postponed due to contingency planning for the UK leaving the EU without a deal; and if he will make a statement.

Answered by Jackie Doyle-Price: The Government is committed to making sure that patients continue to access safe and innovative medicines and devices, and regulation related to medicines and patient safety have therefore not been postponed because of contingency planning.

For example, we have continued with the implementation of the Falsified Medicines Directive, which is designed to help identify and remove falsified medicines from the supply chain, ahead of coming into force in February 2019, and continued to make the necessary preparations to implement the new Clinical Trials Regulation and Medical Devices Regulation, both due to be implemented before the end of 2020.

Ben Bradshaw, MP: To ask the Secretary of State for Health and Social Care, how much funding for contingency planning for the UK leaving the EU without a deal will be made available to the Medicines and Healthcare products Regulatory Agency for the development of new processes or systems including software.

Answered by Jackie Doyle-Price: The Department continues to work with partners across Government, industry and its arm’s-length bodies (ALBs), including the Medicines and Healthcare products Regulatory Agency (MHRA), to ensure that required systems and processes, including software, will be available on Exit Day. Support is being provided including European Union exit funding for contingency preparations where it is necessary and the Department is engaging with its ALBs including MHRA to ensure their needs are met.

The Autumn Budget 2018 confirmed an additional £500 million of cross-Government EU exit funding for 2019/20, meaning the Government will have invested over £4 billion in preparing for EU exit since 2016.

Full Coverage

Health sector warned of 6-month medicine shortages in no-deal

Financial Times, Laura Hughes, 7 December 2018

The UK government has warned drug companies and the health service to prepare for up to six months of “significantly reduced access” at UK borders in the event of a no-deal Brexit.

In a letter to the sector on Friday, the UK health secretary Matt Hancock also warned that the current guidance encouraging providers to stockpile six weeks of medicine may not be enough to cover the ramifications of a disorderly exit.

He said their assessments had been “revised” to factor in the possibility that the EU could impose import checks on goods from the UK.

It comes amid fears the industry will be unable to guarantee medicine supplies in Europe if they cannot easily move medicines between Britain and the EU.

Mr Hancock wrote: “These impacts are likely to be felt mostly on the short straits crossings into Dover and Folkestone, where the frequent and closed-loop nature of these mean that both exports and imports would be affected.

“The revised cross-Government planning assumptions show that there will be significantly reduced access across the short straits, for up to six months. This is very much a worst-case scenario.”

On the current request for companies to stockpile six weeks’ worth of medicines, he said: “In areas where we cannot tolerate significant risk to the flow of goods, such as with medicines and medical products, we need to have contingency plans in place for this worst-case planning assumption.

“This means that whilst the six-week stockpiling activities remain a critical part of our contingency plans, this now needs to be supplemented with additional actions.”

The latest no-deal assessment was made by the cross-departmental Border Delivery Group, which a Number 10 spokesman confirmed on Friday would be “talking today to their key stakeholders about the government’s no-deal planning assumptions for the border”.

Paul Carter, leader of Kent county council, called on the government to provide more support in order to avoid a repeat of the “chaos” seen in 2015 when strikes and clashes brought gridlock at Calais and Dover.

In a report to the council on Friday, he said: “We now need far more input and information from national government in how they are going to work with us.”

Chris Grayling, transport secretary, has warned the cabinet that trade on the key Dover-Calais route could be cut by up to 87 per cent in the event of a no-deal exit, as checks and customs controls are introduced in France.

The government is drawing up plans to ration space on ferries carrying vital supplies to Britain.

Officials held two meetings last week to consider how Britain would overcome disruption to the Dover-Calais route.

Because of the shortfall in capacity, Whitehall officials say that Cobra, the government’s emergency committee based in the Cabinet Office, would oversee planning.

The Treasury is said to have argued that market forces should determine which products were allowed on to ships, but other ministers have argued that rationing of space would have to be conducted centrally.

Medicines, vital foodstuffs and chemicals for treating water supplies would be the first priority, but there has been fierce debate about what the other priority goods should include.

ABPI response to medicine supply contingency plans for no deal Brexit

ABPI, Press Release, 7, December 2018

The Government has today published more information on contingency planning for medicines supply in the event of a no deal Brexit. In response, the ABPI has highlighted the need to provide more detail, so that companies can make plans.

Mike Thompson, Chief Executive of the ABPI said:

“Pharmaceutical companies continue to do everything in their power to make sure that patients get access to medicines whatever the Brexit scenario. This includes duplicating processes, changing supply routes and stockpiling medicines in line with the Government’s guidance. However, we have been clear that there are things which are out of our control.

“Today’s update on potential border delays for six months in a no deal scenario is stark. Stockpiling more medicines is not the solution to this problem.

“We welcome the Secretary of State’s intention to prioritise the flow of medicines and vaccines. But with just 16 weeks until the UK leaves the EU, we need the detail.

“The Government should to take immediate action to open up alternative supply routes between the UK and Europe and tell companies so that they can make plans.”

Brexit: pharmacists to get emergency powers to ration drugs

Pharmacy Business, Kiran Paul, 8 December 2018

Government is set to invoke a ‘serious shortage protocol’, giving pharmacists emergency powers to alter prescriptions without consulting GPs, in the event of a no-deal Brexit.

Department of Health and Social Care (DHSC) is conducting an urgent consultation on the measure, revealed several reports.

Royal Pharmaceutical Society welcomed the contingency plan.

“This ‘serious shortage protocol’ will enable community pharmacists to dispense in accordance a protocol rather than contacting the GP. We support pharmacists using their professional judgment to decide on what medicine to dispense. Pharmacists will work with doctors to make sure any communication about changes to medicines is clear,” it said in a statement.

The protocol will allow pharmacists to swap drugs, reduce quantity or change dosage, overruling GP prescriptions.

Speaking to BBC Radio yesterday (7 December), Health Secretary Matt Hancock said he wanted to “make sure [that] if there’s a shortage of individual drugs pharmacists can make clinical and professional judgements.”

In a letter to health and care sector on Brexit contingency plans, he has said that additional actions may be needed to supplement the medicine stockpiling due to the changed border assumptions.

The revised assumptions warns of potential border delays at Dover for up to six months.

Hancock said he will be writing to manufacturing companies and reiterated that health and care providers need not to stockpile additional medicines beyond their business as usual stock levels.

In August, Hancock has asked drug manufacturers to ensure they have a minimum of six weeks additional supply by 29 March 2019, in preparation of a possible no-deal scenario.

Media And Political Bulletin – 10 December 2018

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