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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:
Mistigri · 26/08/2018 21:36

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

Trade works two ways. Lorries delivering from the EU may be able to get into the UK, but they also need to be able to get back home again. And customs checks on the EU side could significantly reduce effective capacity at the ports and cause serious delays in both directions. This is what I would be concerned about in the initial days after a "no deal" brexit - it's all very well saying that you'll just let in everything without checking, but if movement at the ports seizes up then that will disrupt the flow of goods.

lljkk · 26/08/2018 21:39

good points!!

Cailleach1 · 07/09/2018 17:20

It is not really taking back control, is it? UK won't be setting standards. No dossier to assess for UK standards, no assessors needed. What will the MHRA scientific staff do? Maybe be let go? It will downgrade the MHRA.

The worst case scenario of 6% EMA staff retention was if it went to somewhere like Slovakia. No offence Slovakia. Now it is going to the Netherlands. Cooler than cool, and pharma EU HQ's will be following.

Cailleach1 · 07/09/2018 17:21

That is if the MHRA just rubber stamp products approved by the EMA.

1tisILeClerc · 07/09/2018 17:40

While in theory hard leavers want total control of everything, to achieve this in their lifetime may be impossible so at least for a while a 'fudge' needs to be applied. Whether at this level of control it would ever be worth replicating the EMA or having the MHRA make 'spot checks' I suppose could be open to negotiation.

DGRossetti · 07/09/2018 18:37

Seems appropriate

www.independent.co.uk/news/uk/politics/no-deal-brexit-medicine-stockpile-taxpayers-nhs-matt-hancock-a8525051.html

Taxpayers will have to foot the bill for stockpiling NHS medicines to prepare for crashing out of the EU without a deal, the health secretary has said.

Matt Hancock revealed he was “talking to the pharmaceutical industry about what extra costs the government should cover” for the task of building up supplies.

He also said he was planning to “switch supply from land to air” for short-life medicines – although that would appear to depend on a scrambled aviation agreement with the EU.

(contd)

jasjas1973 · 07/09/2018 20:41

So, he is envisaging significant delays via land routes.

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