Meet the Other Phone. Child-safe in minutes.

Meet the Other Phone.
Child-safe in minutes.

Buy now

Please or to access all these features

Brexit

The approval and licencing of medicines (and other regulatory activities) post Brexit

82 replies

user1471451327 · 17/11/2017 17:47

All you happy Leavers -explain to me why this man's explanation of the disaster that awaits us will not occur.....

threadreaderapp.com/thread/931546699033710592

"The UK has no structures or agency of its own for approving and licensing medicines. It relies almost exclusively on the European Medicines Agency. The MHRA is an ancillary organisation. In precisely 15 months UK access to the EMA ends; abruptly if the "no deal" voices prevail.
Where are the UK's preparations for replacing this vital framework? The answer is: Non-existent. Not even embryonic. Just a statement by Hunt this summer that the UK "will look to continue to work closely” with the EMA, but we're ready "to establish our own system if necessary".
The EU started planning to relocate the EMA (currently in London) the week after Art50 was notified to much tabloid chagrin, the idea that EU agencies should be located in the EU having come as a shock. That's just RELOCATING. We, who actually need to REPLACE it, have done nowt.
Having worked for a similarly sized gov't agency for most my professional life, I estimate that in order to "establish our own system" and have everything in place to take over March 2019, we needed to have started two years ago. And even that would be tight. I'm deadly serious.
The setting up will require complex, technical, primary legislation, which will be hotly contested between strong counter-pulling lobbies and interests (big pharma, NHS, patient groups, ethics cmtees) and require extensive consultation, expert advice and debate.
Only at THAT point, can you start looking for a CEO, a board, expert staff, support, training, a building etc. In all honesty, 15 months isn't even enough time if you were ONLY looking at the recruitment of such technical staff. Especially in such a niche area.
Then there's cost. Even by Eurosceptic estimates the UK pays a fifth of an agency like the EMA. It would need to set up the UK equivalent for a fifth of the cost just to break even. This is fantasy of course. Testing, assessing and licensing a new drug is inelastic, cost-wise.
This exposes the myth of "saving lots of money by leaving the EU". Much of the money we paid was to centralise essential tasks, like the medicines regime, with huge efficiency and time savings. Not dealing with multiple authorities also reduces costs for pharma cos, ergo prices.
This simple example also puts to bed any "they need us more than we need them" nonsense. Yes, we are an important contributor to the EU. Yes we are also an important market. They want us, for sure. But we need them. Structurally. Desperately. Not forever, but certainly now.
The day the UK leaves, everything in the EU27 will function PRECISELY as it does now. Money will be tighter. Some of their sectors will face challenges. But none of their rules or processes change. They face no transition. We do -in a myriad ways- and are totally unprepared.
Because medicines is only one of a 100 such regimes that need replacing which will fall on the same unfathomably stretched civil service to do; the same exhausted people trying to also do the other 99 things, as well as renegotiate 700 treaties, on TOP of their ordinary duties.
So, what happens if there's "no deal", in this, as in a thousand other areas for which the UK has simply made NO preparations? This isn't fluff. It's life and death. Sick people will end up waiting for years for available treatments, stuck in a bottleneck of unapproved meds.
Does your faith and patriotism have the magical power to make technical legislation and multidisciplinary agencies just spring into being? Is it unpatriotic to raise the #Brexit alarm or quite the reverse? Am I a remoaner for thinking about this? Or are you a fool for not?

END"

So is he right or wrong? Why?

OP posts:
OliviaD68 · 20/11/2017 13:34

@JumpingJellybeanz

8% of GDP.

OliviaD68 · 20/11/2017 13:37

@JumpingJellybeanz

“The EU is so mean.”

Cailleach1 · 20/11/2017 14:29

A propos of "Theres various options, but the obvious first one is, leave it where it is"

Here are the contenders if you're a betting person, or not. How very odd Caroline, Tokyo, Manchester, New York or Caracas ain't on the list. Even London, where it is currently based. Now what do all the contenders have in common. Lemme scratch my loaf! Ah, the EU agency will be based in an EU country, whichever one wins.

Maybe London could apply for the US FDA to remove itself from Washington DC and relocate in London.

www2.politicalbetting.com/index.php/archives/2017/11/20/betting-on-the-location-of-the-new-hq-of-the-european-medicines-agency/

OliviaD68 · 20/11/2017 14:47

@Cailleach1

Stop being rational.

Carolinesbeanies · 20/11/2017 15:56

I love Russian Oligarch Alexander Lebedevs' Independant. Smile

However, brushing that aside for one moment , if the EU revoke UK passporting then the UK will deny EU financial institutions access to London. EU banks will have to become full subsidiaries and raise a phenomenal amount of capital they dont have. Passporting works both ways and Barnier whilst very happy to be a tv star, needs to think through what he says. Actually he doesnt. We're getting rather familiar with Barniers TV negotiations. He has no authority, and he knows it.

I'm cheering on Dublin by the way. Grin

OliviaD68 · 20/11/2017 16:05

@Carolinesbeanies

Lather on the bullshit again. I do think the Pravda beckons.

And Independent is spelled with an 'e'.

So the EU banks would want to passport into the UK to do what? Domestic £ business ... And compete with the £ clearers. They won't have access to the EU or € business. OK, maybe FX.

Are you out of your mind? Do you have a mind?

Very few - Americans mainly - have been able to break into that business even cap markets which is easier to access.

cathyclown · 20/11/2017 16:08

Ireland has withdrawn its bid for EMA. Hoping to get the EBA instead. Sounds tactical, but who knows.

Word on the street is that EMA will go to Bratislava - a suburb of Vienna!

PattyPenguin · 20/11/2017 16:43

Bratislava knocked out in the first round.

It's between Milan and Amsterdam.

cathyclown · 20/11/2017 16:44

Thanks for the update@PattyPenguin.

It's like the Eurovision now.

PurplePillowCase · 20/11/2017 16:46

...without pompoms...

Cailleach1 · 20/11/2017 17:05

The final two: Milan and Amsterdam fight for EU medicines agency

Cailleach1 · 20/11/2017 17:15

It is Amsterdam

JumpingJellybeanz · 20/11/2017 17:16

This has the feel of that scene in A Christmas Carol where Scrooge witnesses his stuff being divided up and doesn't really have a clue.

Cailleach1 · 20/11/2017 17:17

It was a tie and Amsterdam won the coin toss Grin

Cailleach1 · 20/11/2017 17:20

The EBA are later, I think. Ireland pulled out of the EMA. Maybe to have better chance of EBA. A country can only get one of the agencies. Jeez, it is a rollercoster.

Cailleach1 · 20/11/2017 17:26

But Jumping, it is not the UK's stuff, as such. They just benefitted from a communal agency being based here. It does go to show they were in high standing and had influence when Major was PM.

Cailleach1 · 20/11/2017 17:27

The EBA voting has started already.

JumpingJellybeanz · 20/11/2017 17:40

I know Cailleach1. I was thinking more of the feel of it. The sense off loss and the pointlessness of it all.

Cailleach1 · 20/11/2017 17:44

I know some people who work in the regulatory side of Pharma. MHRA staff and British national experts are held in great esteem. They will be a loss. Everyone is all the poorer.

Cailleach1 · 20/11/2017 17:46

EBA round 1sees Paris, Frankfurt and Dublin go through.

Gosh, it is like the grand national. Should have put a tenner on.

cathyclown · 20/11/2017 17:50

My tenner would be on Frankfurt.

Where are you getting the information from Cailleach? Thanks.

OliviaD68 · 20/11/2017 17:54

Paris?

The approval and licencing of medicines (and other regulatory activities) post Brexit
Swipe left for the next trending thread