Insulin

[fourplusonemore]

Okay, genuine question. Insulin is not made in the U.K. and can’t be by March. Lets say we leave with a no deal Brexit, how do we stop the diabetics dying? Since medical licensing have to hold licences in the country they’re being used in and the EMA would no longer be applicable without a regulatory agreement which we wouldn’t have in a no deal scenario, how does this work?

How do people think up all this rubbish? Read the story of Chicken Licken?

confusedbeetle

Oh, I don't think anyone's "thinking up all this rubbish".

In an interview with The Pharmaceutical Journal, Medicines and Healthcare products Regulatory Agency chair Sir Michael Rawlins has warned that insulin supply could be disrupted in the face of a ‘no-deal’ Brexit because the UK imports “every drop of it”.

www.pharmaceutical-journal.com/news-and-analysis/news/millions-of-patients-could-be-affected-by-no-deal-brexit-medicines-shortages-says-mhra-chief/20205240.article?firstPass=false

HTH

Not just insulin. Its a nightmare and not sure if anyone has the answers. EMA (European level) licenses would no longer apply and all medicines used in Uk would need MHRA licenses. Any medicine not manufactured (and packaged and signed off for quality etc etc) would need an import licence from Home Office and associated fees paid in order to enter UK. Possibly also storage and distribution issues to consider. An impossibly huge logistical nightmare.

To answer your question about diabetics though - consider a low carb high fat diet - seems to be lots of good evidence coming through to show that this diet can reverse diabetes

The ignorance on this thread is astounding. I doubt diet is going to help as Type 1 diabetic....

Confusedbeetle (apt name) this is being reported by reputable news sources.

There's no evidence to suggest that Octopus. You can't reverse Type 1 diabetes. Diets low in carbs and high in protein can stabilise blood sugars but that's it. Type 2 may be reversible but not insulin dependent.

Octopus - isn't that just type 2 that is dietary effected?

I'm no expert but I thought that type 2 make insufficient insulin, but still some, so changes to diet can make better use of it. Where as type 1(who are insulin dependent from childhood) made no insulin so will always need to take some, though can reduce the amount with careful diet?

You're right Bubblegum. Type 1 is so far incurable. Without insulin the sufferers will die.

Sorry should have specified - lchf can reverse type 2 but can also assist with regulation of type 1.
Really no need to call me ignorant

Regulation alongside insulin. Without insulin these people will die.

I'm Type 1 and follow LCHF - yes, it is helpful, and does mean that blood sugars are more stable and therefore I need less insulin to survive, so that much is accurate. Type 1, as said by PP, isn't reversible (the pancreas has packed up completely and doesn't produce any insulin), but it is manageable, and low-carb helps that. Incidentally, it isn't always diagnosed in childhood - many cases are, but you can develop it at any age - I was diagnosed at 37.

I think the panic about no insulin after Brexit and diabetics dying in the street is just that - panic. You seriously think that's going to happen...?

I don't think it's going to happen. Theresa May is a type one diabetic and it affects enough of the population to warrant a massive problem for the government. I was posting hoping that someone far smarter than I am could explain the route through this and if it is going to be as big of an issue as it could be.

Power cuts are a threat, just as much as supply chain issues. (Obviously the supply chain depends on mains electricity, among other things.) Anyone remember David Clapson, who died when he could no longer afford to refrigerate his insulin? It goes to show how price rises and supply disruption will exacerbate existing problems of poverty and social exclusion - not that Brexit-created problems will be limited to those already marginalised.

www.theguardian.com/commentisfree/2014/sep/09/david-clapson-benefit-sanctions-death-government-policies

@fourplus I imagine our PM has adequate personal supplies and security in place. This does not help those who are not part of the political elite. Whether the population dropping like flies will cause the government to fall, I have no idea. They seem to be getting away with it so far. Currently they seems to think that it's all good (for them) as long as they and a complicit media can manage to shift all the blame onto the EU.

Medicines that don’t have a UK marketing authorisation (i.e. a PL number for UK-only medicines or EU number for centrally authorised) must currently be imported by suppliers with a MHRA licence (not the Home Office) that permits importation. Every consignment (and permissible quantities are small) must be notified to the MHRA, who decide whether to object or not.

If insulin products have UK licenses (PL numbers) there should be no legal barrier to importation, even if they are made in the EU.

It seems to me that the most likely scenario will be that the MHRA waves through large shipments of the centrally authorised medicines (which were licensed in the UK before Brexit) so there is no legal impact in the short term. The problems will arise when the shipments are stuck in 20 mile tailbacks, with possible loss of refrigeration, and then quite soon afterwards when some of the EU manufacturers stop making English language labelled packs of the centrally authorised product because it is no longer economically viable to do so.

And no, dietary adjustments won’t help most people with type 1. Eating less will mean fewer units are required, but it’s not much of a solution.

Thank you so much @WiseUpJanetWeiss. I understand it a bit more!

You’re welcome. I should add that the NHS is dealing with multiple shortages of essential medicines already for unrelated reasons. Those problems are unlikely to go away in the next 8 months, and I have no idea how the country will manage if the JIT supply chain is disrupted further.

WiseUpJanet do you happen to know if there are likely to be any problems with supplies of Prednisolone, Azathioprine or Levothyroxine?

Oh and asthma inhalers.

No I don’t know any specifics at all. Procurement/supply is not really my field.

I would guess that medicines licensed in the UK and manufactured in the UK or a non EEA country should be relatively OK (notwithstanding problems sourcing the starting materials and other general issues that may come to pass e.g border delays, staff shortages, fuel crises, power cuts etc.). You can check this detail on the leaflet in the pack and on the SmPC available from the manufacturer’s website or at www.medicines.org.uk/emc/
One or other usually states both the MA holder and the manufacturer.

There is no way this risk isn’t being taken extremely seriously by the NHS, the MHRA and the DH, but I doubt they have magic wands.

Why do power cuts keep coming up, oh, and water supply issues. It is complete nonsense. With regards to drug supply the EMA already "mutually recognises" standards with third party countries (ie: outside the EU) regulations with regards to drug manufacture and testing. There is no reason to believe they will suddenly not accept our competence, or that we will no longer accept theirs. We, the UK and the EU, currently, accept drug compliance from USA, Canada, Australia, New Zealand, Switzerland etc etc

Mutual recognition is not the same as centralised authorisation. At all.

This makes me worry for my dad
Type 2
Very well controlled diet (eats very little)
But even with all his insulin (3/4x a day injections) plus tablets his blood sugars are still high. Sometimes to the point it wont read on the meters! His average for over night 16+
We now have to check hos keytones.
Waiting on emergency appt from the consultant

Amber
My son is on azathioprine (liquid version)
Im hoping it Should be ok as from what I can tell it's manufactured in the UK (from what the label says)

I have type 1, it is an autoimmune condition, not curable. I'm on 2 types of insulin, a 'basal' or background insulin and a 'bolus' rapid insulin that I inject when I eat. Both are produced in Denmark. My blood testing meter and testing strips are manufactured in Germany. I'm very concerned as basically I will die without insulin and the means to check my blood.
Anyone who thinks being worried equates to being hysterical can do one. Try living with this condition and the threat of having your life life saving medication disrupted, and then comment.