whats the news - the UK is ending membership of the EU and EU agencies are relocatin....and the question is?
Good to see the rigour of the process to select the stand out location - drawing up lots!!
Still giggling at Barnier's bluff on equivalence yesterday - hope there were no bankers in the audience unless it was an after dinner speech and he was the comedy turn.
Hint
Ask why the Guardian is writing in the way it does!!!
Nice sneering THM - does it help pay the bills?
Rather obvious what it indicates but you'd rather just curl your lip & look down your nose at the truth.
"What's the news?"
Quite!
THM, doesn't matter how the Guardian is writing the story, the facts don't change. Expanding existing agencies, recruiting new staff, training etc takes time, time that doesn't exist.
Wishful thinking doesn't solve this, just like NI, the Tories and Labour are going to screw the UK.
teamhurtmore - Member
whats the news - the UK is ending membership of the EU and EU agencies are relocatin....and the question is?
How much is this costing the UK economy?
Been asking that one a lot so do keep up at the back there.
How did all your banker mates in Germany feel about the long border queues to get into the UK in future or will you all be meeting in frankfurt?
THM, the question is how much time and money it takes to replace what we are losing with the EMA and EBA moving out.
Captain he knows the question and the magnitude of the answer just the answer is a little embarrassing to admit to.
In fact in summary thm's brexit blame the eu defence is a bit like signing up to a prenuptial from a family full of lawyers and not bothering to check when the wife is home before shagging the au pair.
Has anyone quantified what the Brexit farce has cost to date - from the 23rd June last year to date, cost to the economy, addition tier of government etc.
I think it's the equivalent of not wanting to open your bank statements if you're massively overdrawn. Nobody has a clue, and nobody wants to find out.
At least not until the bailiffs turn up.
Has anyone quantified what the Brexit farce has cost to date - from the 23rd June last year to date, cost to the economy, addition tier of government etc.
Not seen anything overall, only the £400 per annum poorer number floating around. Not sure how you could calculate it. Lost parliamentary time, cost of civil servants, inflation, lost investment, etc.
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.
It's OK, I'm just humming God Save The Queen until the bad news goes away.
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.
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.
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.
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?
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?
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.
£40Bn.
Good to know my taxes are being spent wisely.
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
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.
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!
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?
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.
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.
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.
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?
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!
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.
How do the Swiss and the Norgwegians deal with this?
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)
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
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!
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.
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.
Interesting views from various parties prior to the relocation decision
Edit. Kimbers shorter version sums up the above
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?
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.
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
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
[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.
40 billion is too little too late anyway
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
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)
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
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.
