Another new Brexit thread

[casserole of nonsense]

Fair questions. I guess we might add to those with do drugs and medicines that currently meet fda standards via EU regulations need to be reevaluated and approved once they are no longer under the EU umbrella and if so what are the costs and timescales of those processes?

The EMA, not the FDA, is responsible for regulating the approval and monitoring of drugs for use in humans in EU. Not all FDA-approved products are EMA-approved, and vice versa. UK is still a member of the EMA post-Brexit, but that transition agreement currently runs only until end of 2020. EMA has already moved its HQ from London to Amsterdam, it's in the charter that it has to be based in the EU.

Nothing is decided about what happens 1st January 2021 as yet, it's still under negotiation. I hope that UK can remain a full contributor to the EMA, but I understand that drug companies in the UK are also preparing to submit regulatory packages to the MHRA in UK for local approval. This would be a shame, as EMA pools data from all member countries and this is very valuable information.

I couldn't guess at the costs to the UK industry, but it is taking up a large slice of corporate regulatory and safety resource preparing for the MHRA scenario. Re. timescales, drug companies want an unbroken transition (as do patients!) so are mostly already prepared for MHRA submission.

I wouldn't imagine the MHRA would have many, if any, problems with existing EMA status for any drug, having been a significant contributor to EMA processes in the past. It's pretty important that the MHRA continues to be very closely aligned with the EMA, if not a full member.

 

[west didsblue]

The EMA, not the FDA, is responsible for regulating the approval and monitoring of drugs for use in humans in EU. Not all FDA-approved products are EMA-approved, and vice versa. UK is still a member of the EMA post-Brexit, but that transition agreement currently runs only until end of 2020. EMA has already moved its HQ from London to Amsterdam, it's in the charter that it has to be based in the EU.

Nothing is decided about what happens 1st January 2021 as yet, it's still under negotiation. I hope that UK can remain a full contributor to the EMA, but I understand that drug companies in the UK are also preparing to submit regulatory packages to the MHRA in UK for local approval. This would be a shame, as EMA pools data from all member countries and this is very valuable information.

I couldn't guess at the costs to the UK industry, but it is taking up a large slice of corporate regulatory and safety resource preparing for the MHRA scenario. Re. timescales, drug companies want an unbroken transition (as do patients!) so are mostly already prepared for MHRA submission.

I wouldn't imagine the MHRA would have many, if any, problems with existing EMA status for any drug, having been a significant contributor to EMA processes in the past. It's pretty important that the MHRA continues to be very closely aligned with the EMA, if not a full member.

So that’s EASA, ECA, EMA and CE Marking discussed on here so far that will be superseded in the UK by CAA SRG, UK REACH, MHRA and UKCA Marking at great expense and no perceptible benefit. Just another 30 agencies to go.

This taking back control doesn’t come cheap but it’s what we want.

 

[Mazzarelli's Swiss Cheese]

So that’s EASA, ECA, EMA and CE Marking discussed on here so far that will be superseded in the UK by CAA SRG, UK REACH, MHRA and UKCA Marking at great expense and no perceptible benefit. Just another 30 agencies to go.

This taking back control doesn’t come cheap but it’s what we want.

Was he trying to suggest it may not be a complete disaster? How very dare he - well retrieved mr didsbury, bravo!

 

[Vic]

There is a new version of Project Fear being brought forward - but rather than orchestrated by the government it is undertaken by desperate reality deniers on internet forums

So now we have someone getting hold of a comment about some considerations that are being given to how to replace (at some point) the environmental payments and then try an make capital out of that - just childishness and ignorance.

Close to (your) home - the SG have just spent (lost) £ many millions on a programme of CAP reform and they have spent further money implementing capability and systems to manage the identification of land parcels as part of a revised approach to the accuracy of land management and payments to farmers. And, because it is the current work that it recognises the UK leaving the EU, replacement of CAP and the Single Application process (SAF).

There are all sorts of considerations being played into the thinking of Scotland's ARE (and they are working closely with DEFRA) with regards to rural land management, reducing greenhouse gas emissions, preventing, controlling and eradicating animal disease, forestry management etc. Yes - such considerations will inform future policy decisions - but there will be no significant change for many years to come (at least 4 - probably more like 6)

So who doesn't think that it is a good idea for the government departments (across the UK) to work with the various communities involved in rural and farming to plan the replacement of CAP - and not just some form of a UK 'son of CAP'

And some on here use some crumb from the internet and think that they can use it to be clever

They say that a little knowledge is dangerous - it can also be embarrassing

Ok. Second bite at this.

I think you mean the Scottish government has spent millions on refining the CAP scheme with better mapping and other stuff and it's "lost" only because of Brexit and the UK government decision to do something different to a "son of CAP".

You might not want to do how we got from maintaining farming subsidies during the referendum campaign to the "here and now" but when the vast majority of Scottish farmland is classed by the EU as "less favoured" so attracted extra help.

You can see what "The Scottish Farmer" thinks from this:
https://www.thescottishfarmer.co.uk/opinion/17443216.leave-campaigns-farming-promises-forgotten/
but it will be the Blue Slurry Lagoon Tory heartlands in England where the real damage will be for the Tories as they realise the priority is cheap imports (cheap, that is, until our domestic farm industry is wrecked and the importers can then put up their prices).

Of course, you may have had something entirely different in mind.

 

[west didsblue]

Was he trying to suggest it may not be a complete disaster? How very dare he - well retrieved mr didsbury, bravo!

No, and that wasn’t my point.

 

[casserole of nonsense]

Was he trying to suggest it may not be a complete disaster? How very dare he - well retrieved mr didsbury, bravo!

It's a pain in the arse, but it shouldn't be a disaster. We are where we are with Brexit, so I'd like to think patients will be put to the fore and the agencies will accept working closely. It's too important not to do so. I have a (diminishing) faith in common sense prevailing.

 

[BobKowalski]

Was he trying to suggest it may not be a complete disaster? How very dare he - well retrieved mr didsbury, bravo!

No, he is saying it will be expensive and a duplication of effort. The same will be true of chemicals. All Brexit does is add layers of administrative burdens on companies be it through extra regulatory compliance and/or customs procedures.

The money we don't send to the EU is spent replicating the services the EU did on our behalf while losing seamless access to the European Single Market and adding costs and inefficiencies to UK industry.

We are also paying the EU £39 billion and creating internal trade barriers.

Yay.

 

[west didsblue]

It's a pain in the arse, but it shouldn't be a disaster. We are where we are with Brexit, so I'd like to think patients will be put to the fore and the agencies will accept working closely. It's too important not to do so. I have a (diminishing) faith in common sense prevailing.

I’m sure most changes due to Brexit will not be a disaster, but as you say they will be a pain in the arse, expensive and not give us anything we haven’t already got for less expenditure and bureaucracy.

 

[casserole of nonsense]

I’m sure most changes due to Brexit will not be a disaster, but as you say they will be a pain in the arse, expensive and not give us anything we haven’t already got for less expenditure and bureaucracy.

"Expensive and painful bureaucracy" is an accurate summary.

It has to be done to protect patients, without yet knowing if it is even necessary. And it's not the government that is doing, or funding, the vast majority of the work.

 

[west didsblue]

"Expensive and painful bureaucracy" is an accurate summary.

It has to be done to protect patients, without yet knowing if it is even necessary. And it's not the government that is doing, or funding, the vast majority of the work.

Are you saying it is being funded and resourced from existing budgets and people that could be better used on patient care?