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Warning ‘at red’ on no deal Brexit medicines chaos

Report says it's already too late to prepare for a no deal scenario

Brexit

Time has already run out for the UK to prepare for a no deal Brexit, according to a National Audit Office (NAO) report which says that key physical and IT infrastructure won’t be ready in time – with major disruption to medicines supplies highly likely.

The UK pharma, biotech and generics medicines associations and the NHS’ Brexit Health Alliance and others have now called for an urgent meeting with the health secretary Matt Hancock, and say the government needs to act fast to co-ordinate preparations ahead of Brexit day, 29 March 2019.

The coalition of healthcare stakeholders wrote to Hancock yesterday, alarmed by leaks from the government, media interviews with ministers and the NAO report, which all pointed to a severe lack of preparedness for a no deal scenario.

The letter warns:

“We do not believe that the current medicine supply plans will suffice, and we will have widespread shortages if we do not respond urgently.”

It has emerged that the key ports of Dover and Folkestone in England won’t be able to operate a frictionless border with Calais in France, choking off the main supply chain route.

Cabinet Office Minister David Lidington is reported to have told Cabinet that “the normal Dover-Calais route could be at 12% capacity for six months" – severely restricting the flow of goods between the UK and continent, including medicines.

The back-up plan is reportedly to use the ports of London, Tilbury and Liverpool through government-owned and operated logistics – however expert assessments suggest these facilities will neither be prepared in time or have the capacity to compensate for the Channel ports.

Last week Matt Hancock told the Commons health and social care committee that it was vital that “everyone does what they need to do” to ensure medicines get to patients in the event of a no deal Brexit. However the industry and NHS say there is clear evidence the government hasn’t put the necessary preparations in place.

Compounding these concerns, Prime Minister Theresa May yesterday in Parliament refused to guarantee medicines supplies in event of a No Deal Brexit.

The unprecedented letter is signed by eight healthcare leaders, including the ABPI’s chief executive Mike Thompson and the BIA’s Steve Bates.  It continues by saying that only the government has all the data and powers to make arrangements for a no deal scenario.

“We urge you to be more transparent and reveal what cover we have by therapy area and where there are gaps. We all stand ready and prepared to engage with our organisations to find further creative solutions to shortages, but we need the data to engage.

“Time is very tight. We support you in your efforts to raise the warning level in government. Only when we start to work through options will we all know where we are, but on medicines supply, on what we know and can glean from public information, we think we are at ‘red’," it concludes.

The recent National Audit Office report on the UK’s border preparedness compiled an alarming set of facts, suggesting that there simply won’t be enough time to make arrangements:

  • 11 out of 12 critical IT systems at the border that the Border Delivery Group has assessed as being at risk of not delivering on time and to acceptable quality (rated amber or above) by 29 March 2019.
  • That there is a high delivery risk attached to government departments’ border programmes for ‘day one of no deal’ due to their scale, complexity and urgency; this risk is magnified by the degree of interdependence between the programmes.
  • That infrastructure identified by government departments cannot be built before March 2019.
  • That the additional resources required to operate the border may not be ready by March 2019.
  • That businesses do not have enough time to make the changes that will be needed if the UK leaves the EU without a ‘deal’ and
  • That the most complex issues relating to the border in the event of the UK leaving the EU without a ‘deal’ remain to be resolved.

The government has asked the industry to make six week stockpiles of medicines in the UK, and many of the bigger firms have gone above and beyond this in warehousing stock.

However these plans won’t be able to cover all medicines, including those with short shelf lives that are manufactured in the EU.

The lack of adequate planning is causing mounting anger in the industry, although publicly the letter's signatories say there remains ‘good will and commitment to deliver on this [Brexit] for NHS patients across the board.”

Mike Thompson

Mike Thompson

The ABPI’s Mike Thompson told the Commons health and social care committee the industry had spend ‘hundreds of millions’ on planning for a no deal – but still hoped that a last-minute political deal would make this expenditure ultimately unnecessary.

He added: "This is not a situation where if we managed to get 80% of the medicines there that is a good effort and it is okay. Every single patient is reliant on their medicine, so we have to do that for every patient. That is the challenge we are facing."

Time is also running out for this political solution to Brexit which would allow the UK to enter a transition period.

The EU says an agreement must be reached by the beginning of December, or else the UK must leave the EU with no deal.

Negotiations are scheduled to begin again after the budget vote in Westminster later today.

Article by
Andrew McConaghie

1st November 2018

From: Regulatory

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