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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:
sundaysurfer · 20/11/2017 18:02

So, Amsterdam for the EMA. I haven’t read the bid but pretty sure that there are offices involved. Also, it’s Amsterdam, so I’d put money on an 80% retention rate ;-)

Please Caroline, do come back and tell us how this is a big problem for the EU and not the U.K. all over again (just like you did at the start of this thread). You will have to explain it very carefully to me, with some actual, you know, facts.

It might cheer me up, since right now I am really sad. Whatever happens now, the EMA is most definitely, permanently gone - and all the associated jobs. Expect announcements about companies leaving U.K. all week now ...

Cailleach1 · 20/11/2017 18:09

all the candidate countries will be providing good office locations. They will be working with the Agency to see what its needs are. Seemingly the EMA's new proposed offices are in Zuidas business district of Amsterdam.

Cailleach1 · 20/11/2017 18:10

Quality of life sounds quite good in the Netherlands. Those dedicated cycle lanes.

Cailleach1 · 20/11/2017 18:11

Down to Paris and Dublin for EBA.

cathyclown · 20/11/2017 18:13

Barnier also said today that Britain's Financial Sector will lose "passporting arrangements" on Brexit. They will not be able to operate in the EU anymore without this.

It won't kill them stone dead, but will be a blow.

Cailleach1 · 20/11/2017 18:24

All in suspense now.

Cailleach1 · 20/11/2017 18:26

Where was the press and commentary when the Bustards said it 'pish, it will all be great for us'? You hardly needed a pulse to see what was going to happen.

PurplePillowCase · 20/11/2017 18:27

Paris, Paris, Paris! After all, who can resist the EBA being pronounced forevermore as ze European Bonking Authority? #EBA

tweet from twitter.com/hughbs displayed on politico (voting has not yet finished)

Cailleach1 · 20/11/2017 18:27

There was a media coup. Wall to wall uncorrected propaganda and ukip fellow travellers.

Cailleach1 · 20/11/2017 18:29

Laughing at the time showing on politico. It is one hour ahead. Fab John Crace about Frank Field going crazy 'cos Europe got all the good things one hour ahead of the UK. Like Christmas.

cathyclown · 20/11/2017 18:32

Tie Dublin/Paris on EBA

Cailleach1 · 20/11/2017 18:32

Paris won.

Cailleach1 · 20/11/2017 18:33

Dublin was robbed. But not bad influence for a tiddler country to come second.

cathyclown · 20/11/2017 18:34

Ireland did well, going down to the wire as they did on this.

lalalonglegs · 20/11/2017 18:52

Aw, I feel a bit sorry for Dublin. Second place doesn't count for much.

TheElementsSong · 20/11/2017 20:47

So can we now start a round of whining about how all this is obviously clear evidence that they're Punishing/Bullying us, and therefore we were right to Leave?

OliviaD68 · 20/11/2017 20:48

@TheElementSong

So mean.

So unfair.

Cailleach1 · 20/11/2017 21:30

It was a tie. Toss of a coin.

PattyPenguin · 20/11/2017 21:43

The tie for the EMA was because Slovakia abstained in the 2nd and 3rd rounds, after Bratislava was knocked out in the 1st.

The tie for the EBA was because one country spoiled its ballot in the final round. Don't know who that was.

Cailleach1 · 22/11/2017 11:08

Manufacturers may have very low margins on some medicines at the moment. If this is wiped out, and it only supplies a small amount of patients, it may not be worthwhile to produce them and some patients may lose their 'drugs'. They may be on them because they have side effects from others and nothing else suits. At least the gov't aren't running Pharma, so there may be some attempt at proper preparation.

I'd imagine that Amsterdam will have some of the best Japanese restaurants in Europe soon.

Iggity · 24/08/2018 18:39

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.

This is not entirely correct. MHRA is a functioning, well respected agency globally. The primary way medicines are licensed in the EU is via the centralised procedure whereby two markets co-lead the assessment of the dossier the pharma company submits for approval. One country leads the assessment (Rapporteur) and the second (Co-Rapporteur) supports it. They evaluate the whole dossier (clinical, nonclinical and cmc i.e. chemistry, manufacturing). MHRA is an incredibly popular country to be the lead country because of their rigorous and well respected approach. They are more than capable of licensing medicines with their own expertise. Sure, EMA adds an element of peers reviewing the dossier and lots of administrative elements but plenty of countries evaluate and approve medicines on a national basis with no need for other markets to support their assessment. Probably what will be difficult for MHRA is no longer having access to EU IT systems so they will need to build their own.

Yaralie · 24/08/2018 19:23

Am I right to be worried that if a no-deal brexit happens a member of my family, who relies on medication currently provided by the NHS to keep him alive, could suddenly find that the essential medication is no longer available? - so he would probably die?? - is that what brexit actually means???

Iggity · 25/08/2018 17:50

Medicines that are currently approved in the UK will remain approved. Centralised licenses will be resubmitted as national licences but will not go through review; just a formality to convert them into UK national licences. There is no reason why any drug currently approved will not be available post Brexit. This assumes that the companies and MHRA manage the transition to national licences in a timely manner. Ensuring there are adequate stocks of medicines in the country is a separate matter.

Yaralie · 25/08/2018 19:14

So I should be worried?

lljkk · 26/08/2018 20:05

If we let everything in from EU then I imagine the insulin (all manuf. outside UK) will get in on time, easily enough.

If we let everything (& everyone) in that easily from EU, under WtO rules then we have to let everything in just as easily from rest of world. Is what I read. If we want to 'control' the border in absence of any trade deal, either everything will get in easily or nothing will get in easily.