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On the contrary we have multiple posts presenting doomsday scenarios based on the relocation of two advisory/regulatory bodies. The impact for both has been deliberately over hyped. I have merely pointed this out. I appreciate that sticking to underlying facts is an unpopular basis for "discussion" especially when it doesn't suit a remoan agenda.
Talking of straw men, what was the purpose of your link and why did you not caveat it by noting that the drug was widely available. Don't worry, no need to answer...
TP - thanks for the clarification
Countries that MRA's with Europe don't automatically accept the EC decision and grant license. It just means that whats good enough for the EMA is also an acceptable pathway for that country.e.g. if a Pharma company goes to the EMA for scientific advice, agrees a development plan for their new medicine and meet all EMA guidelines, then that is the minimum threshold to apply for a medicinal license in Europe. The EMA then reviews that and gives an opinion.
So, in the example of Canada, that strategy will broadly be acceptable to Health Canada (national authority). However, they still review the whole package and grant their own license. They will ask the applicant different questions and the product can either be refused approval or approved with a different set of conditions to the EC.
Sounds pretty good to me. Best of both worlds.
It wasn't [b]my link[/b]. It was a link supplied by Tallpaul, that had a brief description of one of the things the EMA is for. Learning lots from the sources posted in this thread today.
was made available to EU and to EEA-EFTA states at the same time according to the Roche 2010 announcement and ismore widely available too.
but May has ruled out ECJ jurisdiction, which is an EEA condition and doesnt it also include free mvement?
or is the Norway option now back on the cards?
Well TP talked about the EMA being the licensing body which it isn't, it's an advisory body, so I chose to check what he was saying myself.
I didn't. I said this:
- 12,000 centrally licensed medicines (i.e. blanket licensed in all EU via the EMA) will no longer be licensed in the UK.
The licenses come via the EMA. There are no centrally approved medicines in the EU that have not been reviewed by the EMA. The Licensing authority is the EC. However, you may like to note that even the MHRA in the link I provided don't bother to make that distinction. They and many others in the Pharma industry refer to EMA as the licensing agency, nobody within the industry would bother to correct it. Unless you actually deal with the EMA and the authorisation procedures, I honestly doubt you'd know or care that EC approval is the formal licensing after EMA (CHMP) opinion. For you to attempt to use it to undermine my point is quite laughable.
indeed the EC - thanks for clarifying
Sounds pretty good to me. Best of both worlds.
so a drug company has to go to 2 licensing bodies b4 it can sell an emotive cancer drug, wonder which market will be the priority?
thats why eg Australia has 6mth delay on avaerage, iirc
edit 6-12mths later
Sounds pretty good to me. Best of both worlds.
I don't see an upside from an industry perspective nor from the viewpoint of a national authority.
National authorities require the funding, resource and expertise to make the correct assessment of new medicinal products. Remember that the EMA reserves it's centralised procedure for special cases. I have first hand experience of just how stretched MHRA resources are right now.
In addition, there is the impact to overall development costs from having to engage multiple agencies to get products to the market. The EMA granting assessment via the centralised procedure is very attractive and highly prized. It offers significant cost and time saving, which ultimately reduces the cost of the product to end user. In the case of the UK, this means the NHS.
12,000 centrally licensed medicines (i.e. blanket licensed in all EU via the EMA) will no longer be licensed in the UK.
Unless all such licenced medicines are grandfathered on exit, which is entirely within our gift.
Everyday is a school day… thank you Tallpaul.
the grown ups know that.
If only some were in charge.....
Unless all such licenced medicines are grandfathered on exit, which is entirely within our gift.
how would that take into account new evidence coming to light? licenses are constantly under review, would we be constantly changing our rules to copy the EUs ?
Unless all such licenced medicines are grandfathered on exit, which is entirely within our gift.
That's a big leap for the MHRA to take without a deal to back it up.
It's not just the licensing but the life-cycle management and safety monitoring. How will this information, gathered within the EU be shared with a third country? If no sharing deal in place, how does the MHRA hit the ground running in less than 18 months for this additional workload?
how would that take into account new evidence coming to light? licenses are constantly under review, would we be constantly changing our rules to copy the EUs ?
That would be dependent upon where we end up i.e. co-operating or going it alone, just wanted to make the point that the idea that the likelihood of loads of drugs becoming unlicensed on exit is exceedingly small as it is something we will be in control of, wherever we end up.
£40Bn.
Good to know my taxes are being spent wisely.
That's the cost of no continuing influence within Europe.
how does the MHRA hit the ground running in less than 18 months for this additional workload?
They need some of David Davis' #creativesolutions . For example, like the NI/ROI border, there is obviously a technological 'virtual' way to do it. Or pixie magic, or something.
A giant rubber stamp operated by fairies. That's it.
Or a big rubber stamp.
And an inkpad of red white and blue that plays rule britannia when you open the lid.
Thank goodness; we haven't a chuffing clue what's on the other side, what costs will be incurred, or how it'll work but at least we'll be 'in control' of it. Well done us.
I appreciate the UK is still a 'big 5' market in Europe. However, this all fails to consider that some companies may simply withdraw their products from the UK rather than have to put in place a UK specific supply-chain...
I'll be honest, this seems highly unlikely in the overwhelming majority of cases. But, it's a risk.
Even if the MHRA get busy with their stamp, there could certainly be short-term supply issues. Not all Pharma companies are multi-national behemoths with vast spending power, some are small, niche and operate on incredibly tight margins.
at least we'll be 'in control' of it.
"We"?
Withdrawal of drugs is a very real risk. However more likely is that new drugs will be registered later as the uk is a smaller market, so potentially ground breaking life saving drugs will not get here until later in their life cycle.
If that doesn't worry you then it really really should
Any reports on the licensing arrangements for whatever medication is keeping Theresa May's corpse animated?
[url= http://www.politics.co.uk/comment-analysis/2017/11/21/carbon-trading-the-brexit-cliff-edge-starts-on-new-year-s-da ]yay...it all starts sooner than you thought[/url]
They need some of David Davis' #creativesolutions . For example, like the NI/ROI border, there is obviously a technological 'virtual' way to do it. Or pixie magic, or something.A giant rubber stamp operated by fairies. That's it.
Unicorns.
Armed with death rays.
Just a little nugget from the Twodogs link:
"The government had planned to issue about 61 million permits in 2018, at a price of €7.15 (£6.38) each. That adds up to a £389 million grant, one which would have been given to hundreds of companies, but now cannot.
The NHS, whose combined heat and power plants are regulated by the ETS, is now set to lose out. It got its permits for free. That will end on New Year’s Day.
The government response has been characteristically inept. A draft statute has been written shifting the UK deadline for surrendering permits to March 22nd. This does not help, as the change in European legislation refers to the EU-wide deadline, rather than the domestic deadlines of individual member states.
Instead, the government should have announced its desire to stay in the ETS, until a UK body can be set up and linked to it. Switzerland has such a link, which is overseen by the Permanent Court of Arbitration. In Norway, participation is overseen by the European Court of Justice. Or the government could have announced that a UK ETS, to be created by the withdrawal bill, will accept EU ETS permits. Either option would take away the EU's legitimate fears of a UK sell-out.
On New Year’s Day, Brexit will start in earnest, in this small policy area. The UK government will grant 61 million permits to hundreds of companies and claim they are valid. The European Commission will say they are not. Confusion will reign. Unless the government reveals how it wants to regulate carbon dioxide emissions after Brexit, almost £400 million will fall over the cliff edge."
Well, maybe not so little......
David Davies has a plan for the Irish border!
TP - thanks to to links too. I have learned a lot about this today - even if we disagree on emphasis. But I think this nails it
I'll be honest, this seems highly unlikely in the overwhelming majority of cases. But, it's a risk.
What we need is balanced, rational analysis if the risks and how to mitigate them, rather than the wild exaggeration that tends to accompany these stories (not suggesting you tbc!). Definitely a learning day for me, not least in understanding how the EBA and EMA compare and differ - again HoL briefing papers are always interesting!
The EU Emissions Trading System gives countries wriggle-room in meeting environmental targets. Instead of having to reduce their emissions at home, which is much more expensive, they are able to do so abroad. In 2014, a quarter of the UK target was met by reducing emissions in Poland, Romania, and other European countries. This system works well for a wealthy country like Britain. [b]Leaving it is expected to cost us £70-140 million per week.[/b]
That cost can't be close to correct, can it?
THM, your selected quoting of Tallpaul forgets the increased cost for the drugs that will be kept available. A big concern for those drugs developed for rare conditions, where the cost is not spread widely. Increasing the cost of drugs is just as important as the risk of them not being available at all. Affordability is key for getting drugs for rare conditions to the people that need them. A single pan-Europe licence for those kinds of drugs is essential.
True. Same in financial services and it cuts both ways, hence I am more positive that compromise solutions will be found. It's matters of degree.
But don't forget I am a remainer, just not a remoaner 😉
I'm surprised that you are still obsessed with "remoaners" when it is the hard line Eursosceptics in and around the Conservative party, and those that seek to placate them to either hold on to, or gain, power, that stand in the way of the [b] compromise solutions[/b] you still seem, amazingly, to feel are the most likely outcome. I wish I was as "positive" as you.
But don't forget I am a remainer, just not a remoaner
THM your faith (naivete?) in the brexiters is touching
just 8 months ago David Davis was saying that the EMA & EBA werent necessarily going to leave the UK, that was just a 'risk' then too
https://www.ft.com/content/b9215c96-3faa-11e7-82b6-896b95f30f58
never underestimate the ability of the brexies to balls things up
THM your faith (naivete?) in the brexiters is touching
Took the words out of my mouth.
For validation you only have to look at the wailing & gnashing that goes on the second ANY compromise is mooted....
I rather think he's a bit of a fantasist, if he does genuinely believes the "adults" will get the final say.....
Just so it’s clear, drugs not being on the pharmacy shelves is the absolute worst case. Best case is a huge cost to both national agencies and pharma industry to implement new processes to replace perfectly good ones with a yet to be defined knock on effect for the general public (but most likely increased cost and less choice) and no net benefit.
This, for me, is Brexit in microcosm.
For those that may have missed it on [url= http://singletrackworld.com/forum/topic/animals-are-no-longer-sentient-in-britain ]the animals thread[/url], back in July [url= https://hansard.parliament.uk/Commons/2017-07-20/debates/3087E6DC-8EB6-4DFD-9B0E-AFE3C1968BB0/BrexitEnvironmentalAndAnimalWelfareStandards ]the Hansard records[/url] the following exchange:
Henry Smith (Crawley) (Con):Can my right hon. Friend confirm that article 13 of the Lisbon treaty, which categorises animals as sentient beings, will be part of the repeal Bill?
Michael Gove:
[b]Absolutely.[/b] Before we entered the European Union, we recognised in our own legislation that animals were sentient beings. I am an animal; we are all animals, and therefore I care—[Interruption.] I am predominantly herbivorous, I should add. It is an absolutely vital commitment that we have to ensure that all creation is maintained, enhanced and protected.
Then a couple of days ago, as discussed in that thread, Michael Gove along with the rest of the Tory party voted unanimously that article 13 of the Lisbon treaty should [i]NOT[/i] be part of the repeal Bill.
I don't want to revisit that debate in this thread - I just want to make the point that actions like this are why some people are finding it difficult to put their faith in the Brexiteers.
It's a shame when the practicalities of all these issues is discussed in more detail on STW than appears in Parliament or the press in many cases.
I don't view this as remoaning just pointing out the obvious.
I am not moaning about Brexit but I have no desire to roll my sleeves up and try and sort the post brexit world out. I have no obligation as far as I can see to assist the folks who voted for this when/if things turn shite. I am simply not getting involved, people need to be aware of their actions and the consequences.
Same point was made in the above thread oldmanmtb. We literally spent longer talking about in the thread than parliament did.
That's the major issue that they are facing: they have an absolute metric crapton of EU legislation to convert to an imperial shitload of UK legislation and no time to debate and scrutinise the changes properly.
Such discussions do go on, in far more detail, in committee rooms. You can even watch them on TV.
I just want to make the point that actions like this are why some people are finding it difficult to put their faith in the Brexiteers.
+1!
But I'm assuming those committee rooms don't house all the 608 MPs that voted on those amendments? So most of them are just voting as instructed by their respective party instead of actually considering the debate.
TBC, my "Faith" is not with the Brexshiteers - I still hold them in contempt - it is more in the way the things ultimately get addressed. I still believe that the outcome will be a messy compromise that will leave us worse than the status quo but not disastrously so. In the field that is of direct relevance to me, all the players know what to do, they are well prepared and can deal with each outcome - hence my dismissal of Barnier's comments on passporting. That does not mean that things will be good, just that they are manageable.
I am concerned about the fate of Merkel, because she is ultimately a compromiser. So that raises the risk is she goes. But from what I see directly in my sector, I remain confident that the real action is going on behind the scenes. That is where the key decisions and progress will be made. As before, the rest is noise and posturing.
But more than anything I have contempt for blatant lies - be it from Brexshiteers before or remoaners now. Both are as bad as each other and make the likelihood of a less harmful outcome lower. That is even more stupid as it's something we can control.
So you are saying that remainers are wrong to be talking about doom?
How would we know? We don't have inside knowledge. We can only look at the shitstorm that is being talked about in the press.
To be honest, it's only you that's saying 'it'll be fine'. Can't blame me for being worried can you?
No it’s not just me. The oft misquoted analysis also suggests the same. It’s has to be misquoted - see the IB regularly - otherwise it’s not sufficient.
Remainers don’t talk doom, remoaners do. It’s part of their agenda to win by default
The press!!!! It’s hard to find any decent analysis.
I think it would be ironic if the increase in numbers of civil servants provided a sort of Keynesian stimulus to grow the economy.. Government investment at last.
Good to see her paymasters getting their money's worth out of her. "Some people are taking their moment in the sun, to try and get the maximum in relation to the negotiations" Yes, you and your cronies.
perditus - MemberJust as well there was a leave majority in NI..
An interview broadcast from a parallel universe.
Then a couple of days ago, as discussed in that thread, Michael Gove along with the rest of the Tory party voted unanimously that article 13 of the Lisbon treaty should NOT be part of the repeal Bill.
It is always sensible to look at the debate rather than the vote so that you understand why the Government may reject an amendment, the crux of the argument is summarised in this passage from Hansard
To tack on to the Bill the hon. Lady’s new clause, which simply refers to article 13, would add nothing, however, and she was fairly honest in her speech about the limited practical impact it would have. Given that it is ultimately fairly superfluous, it risks creating legal confusion. Obviously, if she wants to propose improvements to wider UK legislation—I am sure she will, knowing her tenacity—she is free to do so, but this new clause is unnecessary, and it is liable only to generate legal uncertainty. Having addressed some of her concerns, I hope that she will withdraw the new clause, having powerfully and eloquently made her point.
If you want to read the arguments around the point you can [url= https://hansard.parliament.uk/Commons/2017-11-15/debates/7A700C0E-8BA2-4EEC-B53D-997028C06900/EuropeanUnion(Withdrawal)Bill ]here[/url]
You’ll be right Mefty, but you’ve been reduced to defending Gove.
You’ll feel dirty in the morning. Morally correct, but hollow inside. 😉
I have no qualms in admitting I have quite a lot of time for Michael Gove.
😯
mefty - Member
I have no qualms in admitting I have quite a lot of time for Michael Gove.
and the last 50 pages of the thread now make sense! 😆
Most people would make the time to punch him a lot, I don't think I could spend much time close to him without his views making me feel quite ill. He certainly has't given much confidence in trusting anything he says.
Gove is a devious, dissembling, disingenuous, lying, opportunistic, untrustworthy wordsmith.
Apart from that he's probably ok.
That was rather generous Frank, a description of Gove that avoids the swear filter is increasingly difficult. See also Boris, May, Davies....
It is always sensible to look at the debate
Already covered in great great depth in the other thread which I don't want to repeat here.
In summary the main thrust of Dominic Raab's argument was "we'd love to do that but it would create legal confusion because AWA legislation already defines them as sentient "
The reference to animals as sentient beings is, effectively, a statement of fact in article 13, but even though it is, in effect, declaratory, I can reassure Caroline Lucas that it is already recognised as a matter of domestic law, primarily in the Animal Welfare Act 2006. If an animal is capable of experiencing pain and suffering, it is sentient and therefore afforded protection under that Act.
Except that is blatantly untrue as Caroline Lucas points out:
It is not good enough to claim that animal sentience is already covered by UK law by virtue of the Animal Welfare Act 2006 since the protocol is not even explicitly included or referred to in that Act and the word “sentience” does not appear anywhere in it. The Act applies only to companion animals—domestic pets. It does not apply to farm animals, wildlife or laboratory animals
The text of the act is available here:
https://www.legislation.gov.uk/ukpga/2006/45/contents
mefty - Member
I have no qualms in admitting I have quite a lot of time for Michael Gove.
https://www.theguardian.com/politics/2016/may/21/vote-leave-prejudice-turkey-eu-security-threat
From his King James Bible ego trip, to his legacy in UK prisons to the delightful way he stabbed Johnson in the back...
I can see why you'd admire someone so honest & principled!
I have no qualms in admitting I have quite a lot of time for Michael Gove.
A bare faced liar - he & Bojo are peas in a pod.
What is remotely likeable about someone so odious?
Stephen Collins perfectly nailed the yawning chasm between Gove's perception of his own talents and the reality.....
[img] 
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Yesterday it was medicine, today it really is rocket science...
http://www.bbc.com/news/business-42065836
In summary the main thrust of Dominic Raab's argument was "we'd love to do that but it would create legal confusion because AWA legislation already defines them as sentient "
No, you missed out the fact that Gove is going to promulgate further measures in the new year which will also address these matters. Letwin's speech, who is a back bencher now, gives a preview of these. It is quite clear that there is a strong measure of agreement on what should be achieved, but disagreement on how it should be done and hence the amendment was voted down.
No, you missed out the fact that Gove is going to promulgate further measures in the new year which will also address these matters.
[img]
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No, you missed out the fact that Gove is going to wait until the new year to see if everyone's forgotten about it by then.
FTFY.
zokes - Still not a customer
Yesterday it was medicine, today it really is rocket science...
its ok , blue passports, just think of the blue passports
Re: animal sentience and its implications.
The worry for me in all this is that the suggested changes to legislation will bring us very close to the US view on this. The EU are further forward, ethically anyway, than the US are.
So to me, this just reads like another attempt to pre-bake the US-UK trade agreements cake.
Brexit
£3bn to be set aside over next two years to prepare UK for every possible outcome as it leaves EU
Coming over from the budget thread, by prepare we know that is only thinking and planning not actually doing stuff??
None of this was in the brochure was it?
How many lorry parks in Kent and customs officials does £3Bn get you? HMRC will probably sub-con the work out to G4S and in March 2019 there'll be a big no-show like the Olympics because they failed to get past immigration?
HMRC will probably sub-con the work out to G4S and in March 2019 there'll be a big no-show like the Olympics because they failed to get past immigration?
does that mean the army will have to step in again,
Thatll actually please some brexies will - having soldiers there to keep those scary immigrants out
The £3bn is just in there as a political signal… it isn't lower, as a signal Leaving prep won't be close to neutral cost wise, and isn't higher, as a signal that the government don't see a No Deal as likely or desirable. It doesn't represent the real cost of preparing for whatever replaces EU membership, for obvious reasons.
Brexiteer Border Patrol reporting for duty, sah!
[img] 
[/img]
None of this was in the brochure was it?
page 5
No, you missed out the fact that Gove is going to promulgate further measures in the new year which will also address these matters.
I'd like to believe that mefty, but I was under the impression that parliament might be a bit busy over the next year or two.
Why didn't the debate go like this:
Caroline Lucas: I want to see the Withdrawal Bill recognising the text in Title II, Article 13 of the Lisbon Treaty relating to animal sentience.
Government: Yeah that sounds good babe. We all like animals and that. But our lawyers have advised that directly referencing the Lisbon Treaty would cause a bit of legal head scratching.
So instead how about the Withdrawal Bill just contains a copy of that text, modified for our requirements as follows: [i]"In formulating and implementing the UK's agriculture, fisheries, transport, internal market, research and technological development and space policies, parliament shall, since animals are sentient beings, pay full regard to the welfare requirements of animals, while respecting religious rites, cultural traditions and regional heritage."[/i]. That sound good? It's basically the same thing.
Caroline Lucas: Yeah, that sounds fine actually.
Government: Great. All those in favour... aye... cool. Next item...
I'd like to believe that mefty, but I was under the impression that parliament might be a bit busy over the next year or two.
Well it has been announced that the Government is planning to bring further bills before parliament to implement Brexit including one by Gove's department so your impression is wrong.
There is no place in the law for expressing good intentions, it is to achieve a purpose. The whole furore is pretty dishonest.
I thought the entire purpose of the Withdrawal Bill was to copy-paste EU legislation into domestic legislation to ensure there were no holes on the day we leave?
So isn't this an example of that? I'm not sure why this gets the "We'll do it later" treatment while other stuff gets copied across. All the existing animal welfare directives from the EU are scheduled to be copied so why not this?
There is no place in the law for expressing good intentions, it is to achieve a purpose.
Not really sure what you mean by this. Are you saying you object to having principles like this recorded in legislation?
Kimbers - Army? What Army.
Binners has it ^^^^
Isn't there a whole separate thread on this animal stuff? Why duplicate?
Yeah there is. And I did say I didn't want to duplicate here so I'll shut up.
I will answer your outstanding questions, but try to broaden out it out so it is more generally relevant.
I thought the entire purpose of the Withdrawal Bill was to copy-paste EU legislation into domestic legislation to ensure there were no holes on the day we leave?
It is, but the Article in question has no legal effect, it just informed future policy, so technically it is not EU law. This is outlined in the debate and I may have oversimplified but the gist is right. There is quite alot of debate on technical issues like this where most participants are looking to achieve the same goal but are arguing about how to achieve it. Another example is the Human Rights stuff that was debated yesterday. This is incredibly technical and I am sure some the subtleties have eluded me when reading the very high quality debate, but essentially there is a shared goal. Reading debates like this restores one's faith in the parliamentary process as they are very far removed from the knockabout stuff that is on TV. I was saddened to see David Lammy, who contributed to debate, tweeting the government voted against human rights last night. This is just a cheap shot.
There will be plenty of areas where there will be disagreement on matters of substance but it is important to identify which they are, and Article 13 in my view ain't one of them.
Not really sure what you mean by this. Are you saying you object to having principles like this recorded in legislation?
Yes.