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[Closed] EU Referendum - are you in or out?

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Has anyone quantified what the Brexit farce has cost to date

I am sure it will be easily balanced out by all the savings made.
If it doesnt it will be the fault of traitorous enemies of the people and the evil EU.


 
Posted : 21/11/2017 10:22 am
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It's OK, I'm just humming God Save The Queen until the bad news goes away.

https://www.reddit.com/r/ChapoTrapHouse/comments/793kk5/boris_johnson_covers_his_ears_and_hums_god_save/


 
Posted : 21/11/2017 10:24 am
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so captain, what will need replacing when the EBA moves? Just how big is the hit to the UK economy when it does?

Why would we pay the relocation bills? That would be absurd.

Plus note that one of the biggest concerns is that staff do not want to relocate away from London.


 
Posted : 21/11/2017 10:26 am
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I know of £700m that's been spent on a government project that's needed specifically because of Brexit. And it's pretty small time compared to everything else too.


 
Posted : 21/11/2017 10:27 am
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Plus note that one of the biggest concerns is that staff do not want to relocate away from London.

Well they will be unemployed and deported then.


 
Posted : 21/11/2017 10:33 am
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No really

Some perspective please

Expanding existing agencies, recruiting new staff, training etc takes time, time that doesn't exist.

You are aware what the EBA does?


 
Posted : 21/11/2017 10:34 am
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THM, I was thinking more specifically of the EMA. You agree we will need to construct and pay full running costs of an equivalent body?


 
Posted : 21/11/2017 10:40 am
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Plus note that one of the biggest concerns is that staff do not want to relocate away from London.

Tough. the jobs are going. The staff have a choice. Move with the jobs or lose their job.


 
Posted : 21/11/2017 10:49 am
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£40Bn.

Good to know my taxes are being spent wisely.


 
Posted : 21/11/2017 10:51 am
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THM, I was thinking more specifically of the EMA. You agree we will need to construct and pay full running costs of an equivalent body?

Don't drugs licenced for use in the UK and NHS go through MHRA then NICE even if they already approval from EMA?

Some of the differences between the US and the EU in the actual use of drugs arise because each EU member state has its own system for determining which therapeutics will be approved by that member state. For example, in the United Kingdom (UK), a new therapeutic can apply for a license through the Medicines and Healthcare products Regulatory Agency (MHRA), or go through the EMA. If the agent is approved by the EMA, it then must be approved by the MHRA in order to be marketed in the UK. In addition, the National Institute for Health and Care Excellence (NICE) must then evaluate the agent for both efficacy and cost concerns in order to determine whether the agent that has been approved for sale by the MHRA will actually be purchased by the National Health Service


 
Posted : 21/11/2017 10:51 am
 mrmo
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THM i am not talking about EBA, i am talking about Eurotom, please pay attention! How long do you think it takes to recruit and train inspectors for nuclear facilities?

If banking screws up so be it, lose nuclear,bang goes medical treatments, energy etc.


 
Posted : 21/11/2017 10:58 am
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Why would we pay the relocation bills? That would be absurd.

"“What spectacular financial incompetence,” said Ray Finch, a Ukip MEP on the parliament’s budget committee. “Just imagine the stupidity of signing a 25-year lease without an escape clause — it beggars belief.”

An EBA briefing to MEPs noted that the banking agency had negotiated a break clause “well ahead of the UK referendum on EU membership [which] significantly reduces the potential costs”.

“If this clause had not been included in the lease then EBA would have been liable for a cost of £16 million [about €18 million] for the six years to December 2026,” an EBA briefing document read."

"Unlike the smaller European Banking Authority (EBA), with 189 staff, which is also leaving London after Brexit, the medicines agency neglected to negotiate a “break clause”, meaning taxpayers are locked into a rent contract for its offices until June 30, 2039.

The cost of breaking the lease is more than €347 million and takes the total relocation cost for the EMA to almost €600 million."

[url= https://www.thetimes.co.uk/article/relocation-cost-for-european-medicines-agency-hits-600m-after-lease-bungle-brexit-ema-rj80txg5x ]Source[/url]

Because there wasn't a fing break clause!


 
Posted : 21/11/2017 10:58 am
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IIRC, the EMA is an advisory body for the EU and indirectly the pharma industry. Do we need our own version? I don't know, others will be better placed.

I would imagine that the MHRA will end up working with the EMA in the way that Swissmedic does or the same bodies in Norway etc,

I doubt the world is going to end. Do you think that the EMA is going to want to take on al the work that the MHRA does? NO exactly. Unlike inflexible remoaners (see above^) they are grown ups and will continue to work together. LIke financial services, there is shared knowledge and expertise that leads to similar regulation. That does not disappear.

As for relocation costs, relocation is their choice - does that sound familar?


 
Posted : 21/11/2017 10:58 am
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Indeed, decisions over drug availability are handled in the nation states... sovereignty and all that… we just pool a lot of the testing work to avoid 30 national agencies having to do (and pay for) the work separately. Will we still make use of the work the EMA do, without paying for it? Cake and eat it again? Probably at least partly the plan.


 
Posted : 21/11/2017 11:00 am
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The absence of EMA approval means that much more work within the approval process will have to be carried out by the MHRA for new pharmaceuticals and medical devices.

NICE is something completely different. That's looking at cost-effectiveness in terms of NHS use, and will continue post-Brexit in much the same fashion. Obviously the extra 350 million a week for the NHS will offer scope for improved access to high-cost treatments.*

If we withdraw from the EMA, then the workload on the MHRA has to increase substantially.

*I read this on a bus.


 
Posted : 21/11/2017 11:03 am
 kilo
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If we withdraw from the EMA, then the workload on the MHRA has to increase substantially.

Does it if MHRA just ask suppliers "is this drug EMA approved?", presuming suppliers will still seek EMA approval.


 
Posted : 21/11/2017 11:12 am
 mrmo
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Does it if MHRA just ask suppliers "is this drug EMA approved?", presuming suppliers will still seek EMA approval.

Very simple question, A drug lets call it thalidomide, gets approved by the EMA, down the line it is discovered that there are complications. Who is liable for its release into the UK?


 
Posted : 21/11/2017 11:16 am
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Well that's assuming we are willing to let the EU make all these decisions for us, without providing any input. It's not exactly what most people would think of when they hear the phrase "take back control".

We could do the same thing with safety and environmental standards, labour laws, etc etc. Just adopt EU rules as they are made. Would save a lot of time and money!


 
Posted : 21/11/2017 11:17 am
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Does it if MHRA just ask suppliers "is this drug EMA approved?", presuming suppliers will still seek EMA approval.

Yes, but they no longer have access to those who carried out the detailed work done by the EMA as part of the verification. If there are subsequent problems with the drug, a tickbox like that would not be enough. The UK regulator has to create and consider its own paper trail of evidence before it can allow access to our market.

It's undoubtedly a massive problem for the EMA and pharmaceutical industry too.But I suppose they have to plan for the worst-case eventuality of that the UK decides to chuck out the baby with the bathwater in regulatory terms.


 
Posted : 21/11/2017 11:21 am
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How do the Swiss and the Norgwegians deal with this?


 
Posted : 21/11/2017 11:22 am
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oldnpastit - Member
£40Bn.

Good to know my taxes are being spent wisely.


Tip of iceberg, it's telling that tory boy doesn't want to divulge a figure despite having done extensive research. It's going to blow your mind. It will make bribing the dup look like pocket money. Awaits no answer... The answer is to name a figure (hint)


 
Posted : 21/11/2017 11:23 am
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IIRC, the EMA is an advisory body for the EU and indirectly the pharma industry. Do we need our own version? I don't know, others will be better placed.

I would imagine that the MHRA will end up working with the EMA in the way that Swissmedic does or the same bodies in Norway etc,

I doubt the world is going to end. Do you think that the EMA is going to want to take on al the work that the MHRA does? NO exactly. Unlike inflexible remoaners (see above^) they are grown ups and will continue to work together. LIke financial services, there is shared knowledge and expertise that leads to similar regulation. That does not disappear.

As for relocation costs, relocation is their choice - does that sound familar?

well there are better placed than me on here to comment on big pharma, but MHRA was scaled back hugely after we set up EMA (and EMA was driven by british pharma industry & science/medicine)

and its more than advisory body, it certfies drugs for use within the EU, this is done by comittee and reviews by experts, they host 1000s of scientists for these reviews and its a big reasn US, japanese etc drug comapnies have moved to London ovber the years. And its been a big boost to UK research & pharma having so many experts here.

Current plan is to replicate EU studies and apply same certfication, which sounds bonkers, expensive & impractical.
EU is one of the worlds biggest drug markets so certfication here is usually 1st or 2nd priority for any drug comapny.
out of EU we are obviously no longer priority

Theres also issue of the big drug side a effect databse, Im assuming UK would stil be part of that. (but as brexies just love pissing off the EU eg todays latest attempts to damage UKs chance of deal by [url= https://www.thetimes.co.uk/article/may-told-to-exploit-merkel-crisis-german-instability-to-reduce-brexit-divorce-bill-tg090h99k ]Mogg, IDS[/url], [url= http://www.telegraph.co.uk/news/2017/11/20/dont-listen-terrified-europeans-singapore-model-brexit-opportunity/ ]Patteson[/url] [url= https://news.sky.com/story/brexit-key-leave-ministers-appear-to-back-16340bn-eu-divorce-bill-11136452 ]Johnson[/url])

But the other big thing was something that Britain had been a big player in the new EU Drug Trials databse, sadly looks like we'll be out of that.

and lots is fair enough, Milan & Amsterdam both good candidates(ironically Barcelona wouldve once been the better choice in Spain thanks to its reseach institutesif not for that catalan business, Im guessing itd have gone spanish)

as for forced relocation
it wouldve been possiblefor them to stay, except final arbiter is ECJ and that was one of May's 'red lines' and much of the pharma/drug stuff comes down to law


 
Posted : 21/11/2017 11:24 am
 kilo
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Mrmo, I've no idea, I suspect the supplier is ultimately liaible but I have no idea of the process EMA put in over MHRA's processes hence my earlier question. Don't read this as me being in favour of this brexit mess!


 
Posted : 21/11/2017 11:26 am
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How do the Swiss and the Norgwegians deal with this?

Norway has its own regulatory authority which controls market access. As a member of the EEA its drug licensing is harmonised with the EU, however. Once we know that we are going to be in the EEA, with all that entails, I suppose we could come to a similar arrangement.

Switzerland remains part of the single market, with all that entails. Haven't looked up their pharmaceutical regulation system, but I'd imagine that their position allows them to piggyback on EMA approvals.

Good job there's no chance that the UK could leave the EU with anything less than these arrangements.


 
Posted : 21/11/2017 11:27 am
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Seems that EMA doesn't actually do a great deal at the moment other than replicate the work of the various member states own agencies. The idea was for it to replace these but at the moment appears to work in conjunction with member states rather than replace.

http://www.pharmaceutical-journal.com/news-and-analysis/mhra/emea-rivalry-or-partnership/10004834.article

Interesting views from various parties prior to the relocation decision

Edit. Kimbers shorter version sums up the above

http://www.pharmaceutical-journal.com/news-and-analysis/relocation-of-the-ema-implications-for-medicines-regulation/20203731.article


 
Posted : 21/11/2017 11:30 am
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How do the Swiss and the Norgwegians deal with this?

They pay for the pooled resource, but also have their own… just like everyone else… will we?


 
Posted : 21/11/2017 11:30 am
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As has been mentioned above, the problem is the jurisdiction of the ECJ. If we remain part of the pooled resource after Brexit, we have to accept that the final arbiter is the ECJ. Which is a red line for the Maybot.

If our courts are the final arbiters of these regulatory issues, then our systems cannot just piggyback on those in the rest of the EU, but need the robustness to support every decision on the basis it may attract challenge in our courts.

As the PJ article suggests, ultimately, if a pharmaceutical company has to focus its efforts on crossing regulatory hurdles in two different markets, the default position will be to get into the larger EU market first. Which opens the possibility that patients in this country will have to wait longer for new pharmaceuticals to pass regulation here.


 
Posted : 21/11/2017 11:38 am
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On the divorce settlement. May and co are prepared to offer more - raising their offer from derisory to to little too late.

Johnson and Gove have said this offer must be conditional on what sort of trade deal we get. A condition specifically ruled out by Barnier some months ago.

Shambles


 
Posted : 21/11/2017 11:43 am
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craigxxl - Member
Seems that EMA doesn't actually do a great deal at the moment other than replicate the work of the various member states own agencies.

Really ? 2007 article doesn't say that

I can't view the 2nd one, I'll get my UCL login...

My ex boss disagrees
https://www.theguardian.com/science/2017/mar/09/uk-children-with-cancer-could-miss-out-on-drug-trials-after-brexit-doctors-warn

https://www.vwv.co.uk/news-and-events/blog/pharma-life-sciences-law/calls-for-mhra-to-work-with-ema-after-brexit-or-face-drug-uptake-delays


 
Posted : 21/11/2017 12:13 pm
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[url= https://www.theguardian.com/politics/blog/live/2017/nov/21/former-brexit-minister-urges-may-to-abandon-talks-with-eu-and-prepare-for-no-deal-politics-live ]Further dispatches from the outer fringes of Brexit La-La land that presently constitutes the Tory party[/url]

There's no way someone as weak as May can get paying 40 billion to the EU past these fruit loops.

They'd rather see the economy go off a cliff. They have a weird sort of anti-pragmaticism going on. We'll not pay the EU 40 Billion, which is comparative peanuts, but in not doing so, we'll bankrupt the entire economy.


 
Posted : 21/11/2017 12:16 pm
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40 billion is too little too late anyway


 
Posted : 21/11/2017 12:17 pm
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In further 'no shit Sherlock' news....

[i]Open Britain, which is campaigning for a soft Brexit, has put out this statement from the Labour MP Chuka Umunna condemning what Owen Paterson said about wanting the UK to become a low-tax, deregulated economy like Singapore. Umunna said:

The mask has slipped again as Brextremists like Owen Paterson reveal the real agenda behind their obsession with wrenching the UK out of the single market and the customs union.

Their hard Brexit vision is set out for everyone to see. Cut taxes for big corporations while cutting protections for workers, lowering our food safety standards and opening up our NHS to privatisation.[/i]

Anyone with any knowledge of the past statements by any of the leading Brexiteers knows that this is exactly what they're fantasy destination is. And with each day that passes, they get closer to achieving it


 
Posted : 21/11/2017 12:21 pm
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I see the eropean convention onhuman rights / charter onfundamental rights is also being discussed again.

No one mentioning the elephant in the room on this. The ECHR is incorporated in the scotland act that set up holyrood. this cannot be chnged without the consent of holyrood so if may and co really want to get rid of this a it looks like they are going have to face the issue it will still apply in Scotland ( and Wales IIRC)


 
Posted : 21/11/2017 12:26 pm
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Anyone with any knowledge of the past statements by any of the leading Brexiteers knows that this is exactly what they're fantasy destination is. And with each day that passes, they get closer to achieving it

No wonder THM, Jamby, and the rest of the rabid Tories are so struck with the idea


 
Posted : 21/11/2017 12:27 pm
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craigxxl - Member
Seems that EMA doesn't actually do a great deal at the moment other than replicate the work of the various member states own agencies. The idea was for it to replace these but at the moment appears to work in conjunction with member states rather than replace.

I can assure you, the EMA does a great deal. The fact it couldn't replace member states own regulatory agencies is not a failing of the EMA or the EC.

If we hit the wall of a 'no deal' Brexit on the 19th March 2019, the UK and remaining EU states will feel the impact.

- At least 750 UK company sponsored clinical studies will be running in mainland Europe without a valid clinical trial authorisation.

- 12,000 centrally licensed medicines (i.e. blanket licensed in all EU via the EMA) will no longer be licensed in the UK.

- 37 million UK prescriptions [i]per month[/i] that are manufactured in the EU will no longer be freely importable.


 
Posted : 21/11/2017 12:27 pm
 DrJ
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All things considered, it's a blessing that the NHS can't, in any case, afford all those drugs. Yay, Jeremy Hunt!!


 
Posted : 21/11/2017 12:44 pm
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Thanks for the links Craig - some refreshing perspective and rationality

- 12,000 centrally licensed medicines (i.e. blanket licensed in all EU via the EMA) will no longer be licensed in the UK.

Are you suggesting that the EMA is a licensing body?


 
Posted : 21/11/2017 12:47 pm
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mad thing is brexies just love pissing off the EU

eg todays latest attempts to damage UKs chance of deal by [url= https://www.thetimes.co.uk/article/may-told-to-exploit-merkel-crisis-german-instability-to-reduce-brexit-divorce-bill-tg090h99k ]Mogg, IDS[/url], [url= http://www.telegraph.co.uk/news/2017/11/20/dont-listen-terrified-europeans-singapore-model-brexit-opportunity/ ]Patteson[/url] [url= https://news.sky.com/story/brexit-key-leave-ministers-appear-to-back-16340bn-eu-divorce-bill-11136452 ]Johnson[/url])
to them no deal is somehow the preferred option!!

[url= https://english.cbg-meb.nl/latest/news/2017/07/11/the-dutch-bid-for-the-european-medicines-agency ]would be bad all round for UK & EU, dutch Medicenes Review Board already ramping up to take over MHRA role as lead trial regulator, investing millions, but that will take time,[/url]

As I said b4, great for the dutch, sad day for uk science & medicine


 
Posted : 21/11/2017 12:48 pm
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I see increasing attention is being made to Legatum, the tories go to hard brexit think tank, the one run by an New Zealand billionaire who made his money during the "chaos" in Russia.

I mean who'd have thought that someone with these credentials would now be circling the UK? Along with AggregateIQ/Cambridge Analyitca...

No matter how dirty Brexit is with all this outside influence I don't expect brexiters to change.

Q: "Why did you vote to leave the EU?" Because I didn't want to be in the EU any more.
Q: "What did you hope to gain by leaving the EU?" I hoped to gain not being in the EU any more.
Q: "What defines whether Brexit succeeds?" Whether, at the end of the process, we've left the EU.

With this kind of logic, they really don't understand who they've jumped into bed with.


 
Posted : 21/11/2017 12:52 pm
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Davis falls off stage after no deal brexit speech - it's like they want the meme's and derisive laughter.

[img] [/img]


 
Posted : 21/11/2017 12:56 pm
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On the divorce settlement. May and co are prepared to offer more - raising their offer from derisory to to little too late.

this is all BS anyway - if there is a bill then it should be known what that bill is - there shouldn't need to be any negotiation.

When I last visited a resturant the bill showed a breakdown of evwerything I owed, they didn't just request a number and I suggested a lower one.

It's incompetance on both sides, but worse from the EU as their language keeps trying to suggest there is some precision about the number they want, whereas it is plainly obvious they have as little clue as us.

We should tell them to come up with a breakdown of what they think we owe, by a certain date, or they get nothing and we exit with no deal and become a low corporation tax environment.

They should also realise that all the rubbish they keep coming out with just strengthens the resolve of the majority to leave.


 
Posted : 21/11/2017 12:58 pm
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Are you suggesting that the EMA is a licensing body?

Well, the EC is for the products authorised via a centralised procedure (which is what I'm referring to). One license which covers all EU. EC grants licenses based on the opinion of the CHMP, which is the part of the EMA responsible for human medicinal products.


 
Posted : 21/11/2017 1:02 pm
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It isn't a negotiation Turnerguy - thats the point. The EU have a minimum amount they believe the UK owes. We either pay it or we don't


 
Posted : 21/11/2017 1:03 pm
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Turner Guy - the process involves extensive negotiation at nearly every line. Which is what is being worked on. A good example is pension liabilities. Here, as elsewhere, the EU are trying every trick in the book including the use of dodgy discount factors.

Odd that those who complain about the cost are at the same time advocating that we simply pay what the EU are demanding despite their dodgy numbers. It's a bloody good job that out side is going through this sensibly and in detail not rolling over wth the KY in hand.


 
Posted : 21/11/2017 1:09 pm
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Mr conspiracy theory TurnerGuy of controlled demolition WTC7 claims the EU is conspiring againt Britain.

The EU has done exactly what you've requested TurnerGuy, but your own government chooses not to inform you of those details or indeed any other dtails pertaining to Brexit (those hundreds of impact report). Your own government wants you to remain ingnorant. There is no EU conspiracy - the conspiracy if there is one is between the lobby groups and finaciers, and British politicians.


 
Posted : 21/11/2017 1:09 pm
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No matter how dirty Brexit is with all this outside influence I don't expect brexiters to change.

Q: "Why did you vote to leave the EU?" Because I didn't want to be in the EU any more.
Q: "What did you hope to gain by leaving the EU?" I hoped to gain not being in the EU any more.
Q: "What defines whether Brexit succeeds?" Whether, at the end of the process, we've left the EU.

Nail on the head.....


 
Posted : 21/11/2017 1:15 pm
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When I last visited a resturant the bill showed a breakdown of evwerything I owed, they didn't just request a number and I suggested a lower one.

It's a divorce, it's not clear-cut as everything is intertwined with everything else - we're arguing over who gets the fine bone china...

<sigh> It's all a shambles and not in the UKs best interests at all.


 
Posted : 21/11/2017 1:32 pm
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The news that at a former colony has pinched our seat on the UN ICJ must put a bit of a dent in May's vision of a post-EU Global Britain.


 
Posted : 21/11/2017 1:41 pm
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for TG, this explains how the EU wants to calculate the bill vs how the UK wants to calculate it

https://www.ft.com/content/61e4faea-cac5-11e7-aa33-c63fdc9b8c6c


By March 2019, when the UK is scheduled to leave, the EU estimates there will be €582bn outstanding EU commitments along with €83bn of long-term liabilities such as pensions — leading to a total of €665bn.

The demand is for Britain to honour its share — estimated to be 13 per cent, or €86.4bn gross — and offer assurances over a further €11.5bn of additional contingent liabilities, such as EU loans to Ukraine. Britain has so far offered to make transition payments — worth about €20bn net — for 2019 and 2020, since during those years it wishes to retain most membership rights.


 
Posted : 21/11/2017 1:47 pm
 DrJ
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Odd that those who complain about the cost are at the same time advocating that we simply pay what the EU are demanding despite their dodgy numbers.

Who is doing that? I haven't seen anybody advocating that we don't negotiate; just people pointing out that we have dealt ourselves a weak poker hand.


 
Posted : 21/11/2017 2:01 pm
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Mr conspiracy theory TurnerGuy of controlled demolition WTC7 claims the EU is conspiring againt Britain.

Except that all I said was the video was 'compelling' - at no point did I say I believed any of it.


 
Posted : 21/11/2017 2:14 pm
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The EU has done exactly what you've requested TurnerGuy

I am afraid I do not believe that 🙂


 
Posted : 21/11/2017 2:19 pm
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TurnerGuy - Member
The EU has done exactly what you've requested TurnerGuy
I am afraid I do not believe that

facts just bounce off you like nerf bullets dont they?

http://researchbriefings.parliament.uk/ResearchBriefing/Summary/CBP-8039


 
Posted : 21/11/2017 2:31 pm
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Good to see the rigour of the process to select the stand out location - drawing up lots!!

I foolishly looked at what the Telegraph had to say about this; they're sneering at the process used to select the new locations too instead of mentioning anything actually important such as the loss of jobs, direct and indirect income, influence, attraction of related businesses, the contradiction of what DD said about it ages ago...


 
Posted : 21/11/2017 2:37 pm
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just popping in to give a shout out to the Leavers for getting the EMA moved out of London. it's much better that the centre of the European pharma industry (a mere 25% of global sales after all) is in another country, and our young smart people will be much happier pulling cabbages than study to work in that industry. good job.


 
Posted : 21/11/2017 2:45 pm
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Don't worrying Matt, Craig has already provided some proper perspective that shows that your concerns are overblown. Thank goodness.


 
Posted : 21/11/2017 2:50 pm
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teamhurtmore - Member
Don't worrying Matt, Craig has already provided some proper perspective that shows that your concerns are overblown. Thank goodness.

did you read the piece thm?

please highlight the bits were it was saying that this was overblown!


 
Posted : 21/11/2017 2:51 pm
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Good links. We'll worth reading. Good comments here from Tallpaul as well.


 
Posted : 21/11/2017 2:53 pm
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Tell you what as this is your centre of excellent ll me where (1) the EMA grants licences (as claimed above) and (2) that it (the EMA) is centre of the pharma industry. Like the EBA, totally overblown stories. Plus ca change


 
Posted : 21/11/2017 2:54 pm
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not sure who said what re the EMA but my partner has decades of experience in pharma and says it attracts significant inward investment and the loss of the ripple effect from it's presence is sad and stupid.

that's good enough for me.


 
Posted : 21/11/2017 2:59 pm
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teamhurtmore - Member
Tell you what as this is your centre of excellent ll me where (1) the EMA grants licences (as claimed above)

Via the centralised procedure, the EMA (CHMP) provides opinion, EC provides license (authorisation). How many sources would you like?

1) From EMA themselves:

http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000109.jsp

2) From the MHRA (bottom of p.2):

This does not mean all medicines in the UK are licensed by the EC but some are. In the no deal scenario, these products will no longer be licensed in the UK at the point of Brexit.


 
Posted : 21/11/2017 3:03 pm
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Indeed is an advisory body not the licence granter itself, despite what you alluded to earlier.

We also know - we can all read from Giv briefing papers that EEA countries are also part of EMA and other countries eg Canada, Switzerland and Australia have mu tail recognition agreements

Do you really think that - given how closely the MHRA and EMA currently work together - that this will suddenly end or that there will be no mutual recognition agreement with the U.K.?


 
Posted : 21/11/2017 3:14 pm
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Do you really think that - given how closely the MHRA and EMA currently work together - that this will suddenly end or that there will be no mutual recognition agreement with the U.K.?

Given what you've seen of the idiots in charge of this, would you be surprised if they ****ed it up to the point that there wasn't?

Assume hardest of hard brexits, anything less that that is an improvement, but not really a win.


 
Posted : 21/11/2017 3:21 pm
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no mutual recognition agreement with the U.K.

Yes. NO deal is possible - see NI. NO deal means no deal on anything


 
Posted : 21/11/2017 3:23 pm
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No deal is better than a bad deal thm.


 
Posted : 21/11/2017 3:24 pm
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Yes. Very much.


 
Posted : 21/11/2017 3:25 pm
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Did you read the links Tallpaul supplied THM?

[b]The role of the European regulator[/b]

Some medicines used in the UK are licensed by the European Medicines Agency (EMEA) (external link) rather than the MHRA. Herceptin, used to treat patients with a certain type of advanced breast cancer, and the flu drug, Tamiflu, are two such examples.

Certain medicines can only be licensed through the EMEA. These include:
“High tech” biotechnology treatments, such as gene therapies
Medicines to treat HIV/AIDS, cancer, diabetes, and neurodegenerative diseases, such as multiple
sclerosis and Alzheimer’s disease
Orphan drugs—medicines that would not normally be commercially viable, because they have been
developed for rare diseases, occurring in fewer than five in 10,000 people

This is to make sure that these important medicines are automatically available in every European Union member state rather than just in individual countries.

Manufacturers who want their medicines to be used across the European Union can also apply to the EMEA for a single licence, rather than having to apply to each country’s regulator separately. This speeds up patient access to these treatments.


 
Posted : 21/11/2017 3:26 pm
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It may be captain but it's in no ones interestes to halt cooperation with either the EBA and the EMA and the grown ups know that.

But headlines about moving location need to be written and froth created as the truth is so much duller. Note how the roles of both agencies have been exagerated throughout. No need to ask why?


 
Posted : 21/11/2017 3:27 pm
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THM - you come across as quite knowledgeable until you start arguing with people such as TallPaul from the specialist area you're currently opining on. Doing stuff like that tends to give us a glimpse behind the curtain.

Does your 'Chief Economist' have any views on health policy and pharmaceutical regulation?


 
Posted : 21/11/2017 3:30 pm
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Of course he didn't Kelvin. It doesn't fit his narrative so its ignored


 
Posted : 21/11/2017 3:30 pm
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Note how the roles of both agencies have been exagerated throughout. No need to ask why?

Most people don"t fully understand how the agencies work, including, clearly, both of us. Help with the process of gaining understanding, rather than just slapping people down in your condecending fashion THM.


 
Posted : 21/11/2017 3:31 pm
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quite ironic - enough people voted for "more money for the NHS" to decide the vote (says Dominic Cummins), but likelihood, if we leave the EMA as well as it leaving us, is drug costs will rise and time to UK market for new product will lengthen.

or we stay in as a member, or we shadow it somehow, but have no control and have lost the economic benefit of being the host while still bearing our share of the cost.

you couldn't make it up.


 
Posted : 21/11/2017 3:33 pm
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Also, very bored of the [i]"severing ties is in the interest of no one, so stop warning about what occurs in that circumstance"[/i], as if the last few years have taught us nothing.


 
Posted : 21/11/2017 3:35 pm
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So - what would a bad deal look like that would be worse than no deal?


 
Posted : 21/11/2017 3:43 pm
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Well TP talked about the EMA being the licensing body which it isn't, it's an advisory body, so I chose to check what he was saying myself.

Kelvin your link refers to Herceptin which as anyone who wants to stick to facts will know was made available to EU and to EEA-EFTA states at the same time according to the Roche 2010 announcement and ismore widely available too.

Of course mention cancer and you can create an immediate emotive reaction while hiding the facts behind the availability of the drug.

So people can exagerate for effect or stick to the facts. Your choice


 
Posted : 21/11/2017 3:44 pm
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No one has denied that nonEU countries make use of the EMA, nor that we could without being EU members, given the correct deal and arrangements… put away your straw man…


 
Posted : 21/11/2017 3:46 pm
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Just to move away from the EMA & EBA departures, I give you....Aerospace.
http://www.bbc.co.uk/news/business-42065836


 
Posted : 21/11/2017 3:53 pm
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Countries that MRA's with Europe don't automatically accept the EC decision and grant license. It just means that whats good enough for the EMA is also an acceptable pathway for that country.

e.g. if a Pharma company goes to the EMA for scientific advice, agrees a development plan for their new medicine and meet all EMA guidelines, then that is the [i]minimum[/i] threshold to apply for a medicinal license in Europe. The EMA then reviews that and gives an opinion.

So, in the example of Canada, that strategy will broadly be acceptable to Health Canada (national authority). However, they still review the whole package and grant their own license. They will ask the applicant different questions and the product can either be refused approval or approved with a different set of conditions to the EC.


 
Posted : 21/11/2017 3:54 pm
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Also, very bored of the "severing ties is in the interest of no one, so stop warning about what occurs in that circumstance",

Its is moronic since after all whilst it will not be in the UKs or the EU as a whole interest.
It could be in the interests of individual EU countries who could benefit whilst the EU overall loses out. It will almost certainly be in some third party countries interests and also in the interests of some companies and investors.


 
Posted : 21/11/2017 3:55 pm
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Of course mention cancer and you can create an immediate emotive reaction while hiding the facts behind the availability of the drug.

The examples were chosen by the MHRA, presumably more to use examples that people would have heard off, rather than rarer little talked about drugs. I don't see why they would be looking for an emotive reaction for describing which drugs fall outside their own remit (currently).


 
Posted : 21/11/2017 3:56 pm
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