EU UK regulation -- Discussion thread
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Rolygate, Thanks for your post on licensing issues - very informative and helpful. It has given me a much broader understanding of the many particulars involved in this entire issue, both politically and legally.
@Tom
Just what I've been told, as yet. I've asked for confirmation.
@D103
OK.
We don't know how things will turn out in the UK, it all depends on what the government agency concerned decide to do, and perhaps on what they are told to do. Best case is they walk away, worst case is they ban (licence) ecigs. That will cause a massive change in supply here and put up prices, but in the end it will be business as usual because 'unlicensed medicines' aren't illegal to use or to import, just to sell from a UK base.
As in any commercial operation, businesses will then be competing on who can provide the best prices and service, but from an offshore base.
It would be a lot less painful if the government agency concerned backed out gracefully, but the problem is that such agencies are institutionally incapable of foreseeing the consequences of their actions.
Just what I've been told, as yet. I've asked for confirmation.
@D103
OK.
We don't know how things will turn out in the UK, it all depends on what the government agency concerned decide to do, and perhaps on what they are told to do. Best case is they walk away, worst case is they ban (licence) ecigs. That will cause a massive change in supply here and put up prices, but in the end it will be business as usual because 'unlicensed medicines' aren't illegal to use or to import, just to sell from a UK base.
As in any commercial operation, businesses will then be competing on who can provide the best prices and service, but from an offshore base.
It would be a lot less painful if the government agency concerned backed out gracefully, but the problem is that such agencies are institutionally incapable of foreseeing the consequences of their actions.
As elsewhere posted by Kate:
This is a report from an independent government policy committee.
This is a report from an independent government policy committee.
http://regulatorypolicycommittee.in...ng-Products-final-opinion-for-publication.pdf
Tom that made my day. 
Found a tiny reply to the consultation
http://www.rpsgb.org.uk/pdfs/consdoc1887.pdf
Very informed reply,not.
Found a tiny reply to the consultation
http://www.rpsgb.org.uk/pdfs/consdoc1887.pdf
Very informed reply,not.
Thanks for that, Tom
The RPC is advising that the MHRA's Impact Assessment is faulty. They advise that a new IA is needed.
This probably makes no substantial difference and MHRA will doubtless continue as before. They will author a new IA but ensure that the new version is more acceptable, by carefully adjusting the assessment to show minimal negatives.
They will carefully omit to mention that 99% of the trade will continue from offshore and therefore the entire exercise is completely pointless and will only serve to destroy several businesses, put many people out of work, take a large amount of tax revenue out of the system, and cost other departments of government such as social services and legal services a lot of money.
I especially liked their estimate that 50% of importers would license their products. I'm not sure how 3 or 4 out of 25 equals 50% but then again their maths does work in a different way to the norm. The cost to the country will be measured in millions but I doubt that will figure in the IA anywhere.
The RPC is advising that the MHRA's Impact Assessment is faulty. They advise that a new IA is needed.
This probably makes no substantial difference and MHRA will doubtless continue as before. They will author a new IA but ensure that the new version is more acceptable, by carefully adjusting the assessment to show minimal negatives.
They will carefully omit to mention that 99% of the trade will continue from offshore and therefore the entire exercise is completely pointless and will only serve to destroy several businesses, put many people out of work, take a large amount of tax revenue out of the system, and cost other departments of government such as social services and legal services a lot of money.
I especially liked their estimate that 50% of importers would license their products. I'm not sure how 3 or 4 out of 25 equals 50% but then again their maths does work in a different way to the norm. The cost to the country will be measured in millions but I doubt that will figure in the IA anywhere.
On reflection there are several things that can be deduced from reading between the lines of the RPC report.
Firstly, this looks like a CYA job: somebody, somewhere has finally realised that there will be some fallout from this as it's a hot potato on a large scale. That means it's CYA time and those who might catch some blame need to make sure they aren't included when the stuff hits the fan.
The statement that "MHRA's figures do not seem robust" is continually repeated in one form or another, meaning that RPC is saying that the numbers don't add up. This is fairly obvious although the criticism of MHRA's research will probably not stop the process, just ensure that their next documentation is better presented.
In the end RPC do not have the power to stop mistakes at an early stage, just comment on the process, and they are voicing their misgivings - a wise move since if things go pear-shaped they are covered. But MHRA look to be on a railway track and there seems no way to get off now.
On the other hand, this is certainly an extremely positive sign, as the only thing that can possibly stop MHRA's descent into fiasco is pressure from other government agencies - who will bear the brunt of the error, of course. At least, we are now seeing that not everyone in government is blind.
.
Firstly, this looks like a CYA job: somebody, somewhere has finally realised that there will be some fallout from this as it's a hot potato on a large scale. That means it's CYA time and those who might catch some blame need to make sure they aren't included when the stuff hits the fan.
The statement that "MHRA's figures do not seem robust" is continually repeated in one form or another, meaning that RPC is saying that the numbers don't add up. This is fairly obvious although the criticism of MHRA's research will probably not stop the process, just ensure that their next documentation is better presented.
In the end RPC do not have the power to stop mistakes at an early stage, just comment on the process, and they are voicing their misgivings - a wise move since if things go pear-shaped they are covered. But MHRA look to be on a railway track and there seems no way to get off now.
On the other hand, this is certainly an extremely positive sign, as the only thing that can possibly stop MHRA's descent into fiasco is pressure from other government agencies - who will bear the brunt of the error, of course. At least, we are now seeing that not everyone in government is blind.
.
The fundamental problem for the MHRA remains the same for a new IA as it was for the first one, and it's two-fold: firstly, they don't have the first clue about electronic cigarettes, or (frighteningly!) nicotine, as was made abundantly clear at the meeting; secondly, they can carry out impact assessments until they are blue in the face, but unless they are going to force a child to drink eliquid to the point of death or serious harm, they are not going to be able to find any evidence to suggest that electronic cigarettes are dangerous. Such evidence is not available to them (or to the FDA) because such evidence does not exist, despite the fact that ecigs have been in the global marketplace for in excess of 6 years, and are currently regularly used by millions of people around the world.
Good luck, MHRA, if you try to come back with another IA. It cannot be done any better than it was the first time - and we're all aware how shoddy that was! - because it cannot be done in your (paymasters')favour AT ALL!
BTW, I think we may have missed a trick in this thread. That post with the link to another response? From the Royal Pharmaceutical Society? Wow! That is sooooooo embarrassing for the MHRA! I don't know if you guys are aware of it, but there exists a Memorandum of Understanding between the MHRA and the Royal Pharmaceutical Society of Great Britain, which makes for rather interesting reading. Check it out (if you can be bothered!): http://www.rpsgb.org.uk/pdfs/rpsgbmhramou0803.pdf
Now, when we consider that the MHRA has just had its knuckles rapped to the point of disintegration by their own regulators, its more than a little suspicious that the last paragraph of Big Pharma's response to the waste-paper that is MLX364 states:
"Based on the very limited data available concerning the quality, safety and efficacy of unlicensed NCPs on the market, the Society supports policy option 1: 'All NCPs should be classified as medicinal products and all unlicensed NCPs be removed from the market within 21 days'.
We hope these comments are useful.
Thank you for contacting the Society."
(Bear in mind whose products our infinitely superior electronic cigarettes threaten.)
In the aforementioned Memorandum of Understanding, under the heading 'Scope and Purpose', at para 2.2 it says:
"It [this memorandum] outlines the basis of co-operation and collaboration between the two organisations. This includes practical arrangements designed to ensure that the relationship is effective and that together we meet our aims and objectives, particularly when there are overlapping interests and responsibilities." (my emphasis)
Correct me if I'm wrong, but there are some conspiracy theorists out there who might suggest that this borders on being documented evidence of extraordinary competitive corruption. (I'm not one of them, you understand. I merely point out that such may exist!
)
Food for thought, MHRA. You might want to off-load this particular hot potato and walk away with your heads bowed in shame (with your sore knuckles dragging along the ground) while you still can. If an attempt is made to return with a redrafted IA, it can only end in disaster - and public humiliation of the worst kind!
Just my opinion, for what it's worth.
Cheers - let's all celebrate a great victory for vapers!
Katherine
Good luck, MHRA, if you try to come back with another IA. It cannot be done any better than it was the first time - and we're all aware how shoddy that was! - because it cannot be done in your (paymasters')favour AT ALL!
BTW, I think we may have missed a trick in this thread. That post with the link to another response? From the Royal Pharmaceutical Society? Wow! That is sooooooo embarrassing for the MHRA! I don't know if you guys are aware of it, but there exists a Memorandum of Understanding between the MHRA and the Royal Pharmaceutical Society of Great Britain, which makes for rather interesting reading. Check it out (if you can be bothered!): http://www.rpsgb.org.uk/pdfs/rpsgbmhramou0803.pdf
Now, when we consider that the MHRA has just had its knuckles rapped to the point of disintegration by their own regulators, its more than a little suspicious that the last paragraph of Big Pharma's response to the waste-paper that is MLX364 states:
"Based on the very limited data available concerning the quality, safety and efficacy of unlicensed NCPs on the market, the Society supports policy option 1: 'All NCPs should be classified as medicinal products and all unlicensed NCPs be removed from the market within 21 days'.
We hope these comments are useful.
Thank you for contacting the Society."
(Bear in mind whose products our infinitely superior electronic cigarettes threaten.)
In the aforementioned Memorandum of Understanding, under the heading 'Scope and Purpose', at para 2.2 it says:
"It [this memorandum] outlines the basis of co-operation and collaboration between the two organisations. This includes practical arrangements designed to ensure that the relationship is effective and that together we meet our aims and objectives, particularly when there are overlapping interests and responsibilities." (my emphasis)
Correct me if I'm wrong, but there are some conspiracy theorists out there who might suggest that this borders on being documented evidence of extraordinary competitive corruption. (I'm not one of them, you understand. I merely point out that such may exist!
)Food for thought, MHRA. You might want to off-load this particular hot potato and walk away with your heads bowed in shame (with your sore knuckles dragging along the ground) while you still can. If an attempt is made to return with a redrafted IA, it can only end in disaster - and public humiliation of the worst kind!
Just my opinion, for what it's worth.
Cheers - let's all celebrate a great victory for vapers!
Katherine
I can't see how they can possibly shoehorn another IA into the process at this late stage (after they've finished accepting responses.) Given that the inadequate initial consultation with the industry is a key criticism, they won't get away without repeating the whole consultation process as well (if they have the stomach for it,) - it's basically back to square 1 as I see it 
If they do try to force it through in its current shape, a legal injunction would not be hard to achieve - the RPC's done most of our work for us to discredit the current process, and I'm sure the MHRA's lawyers would advise them of this.
And as Katherine says, they can look for evidence of risk until they're blue in the face - they won't find any, because there isn't any. For all the crazy ways folks find to meet their maker, there's no record of even a hospitalization as a result of ecigs (which can't be said for the licensed NRT products that are packaged with no CHIP-compliant labelling or childproof caps,) let alone a death!
The only positive thing they could say about the MHRA was that at least they accept they've made a complete hash of it :
Yep, back to square 1 I think.
If they do try to force it through in its current shape, a legal injunction would not be hard to achieve - the RPC's done most of our work for us to discredit the current process, and I'm sure the MHRA's lawyers would advise them of this.
And as Katherine says, they can look for evidence of risk until they're blue in the face - they won't find any, because there isn't any. For all the crazy ways folks find to meet their maker, there's no record of even a hospitalization as a result of ecigs (which can't be said for the licensed NRT products that are packaged with no CHIP-compliant labelling or childproof caps,) let alone a death!
The only positive thing they could say about the MHRA was that at least they accept they've made a complete hash of it :
Yep, back to square 1 I think.
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The MHRA Impact Assessment must have read like a half-baked, poorly researched, ill thought through, overly opinionated essay by an arrogant, lazy student. Well done to the RCP for putting them in their place
With luck there should be enough legal basis to contest the MHRA process now. In addition to the previously existing issues, the fact that RPC is highly critical (in government terms) of MHRA's evidence base may mean that they must start the process again, or face the possibility of the trade asking the courts to rule against them.
Of course, you only get the justice you can afford. No money = no justice. But with enough grounds to proceed, suppliers might decide to pool their resources and fight. It would certainly be far cheaper than licensing, in any case.
The LACORS affair might lend some weight to this as it shows a willingness by government agencies to act together in an unfair restriction of trade. MHRA admitted working with LACORS on the regulation issue; the subsequent publication of a farago of false information and accusations by LACORS indicates an attempt to mislead the public and create opposition to ecigarettes.
Add to this the manipulation of the market research results by MHRA due to their giving the focus groups false information, and you have a concerted attempt by both agencies to pervert the public perception of ecigarettes and influence the outcome of the consultation process.
Together with the faulty evidence base and the incorrect and incomplete analysis it means that both the basis for licensing and the consultation process are severely flawed. It would appear that to proceed now would be to risk losing at law.
As Jason Cropper pointed out, the current two-tier system for nicotine containing products has worked perfectly well up to now and shows no sign of needing intervention. There are consumer NCP products that show no need for an MA, and there are NRTs that need licensing. The two types coexist perfectly well. Ecigarettes are a consumer product like low-tar cigarettes, coffee, condoms or alcoholic drinks.
Just because caffeine can be supplied as a licensed medicine does not mean that coffee needs an MA. And if a pharmaceutical licensing agency wanted to license coffee, and knew very little about it and compounded that ignorance by doing no research, then conspired with another agency to manipulate the public's opinion of coffee by publishing lies about it and fixing the market research results, and published documents that clearly showed they didn't have a clue what the implications of their actions were likely to be - then it is unlikely they would survive the inevitable legal challenge and succeed in requiring coffee products to have a marketing authorisation.
They would be better off walking away at an early stage and finding something else to occupy their efforts; perhaps condoms should be licensed as they are a consumer harm reduction product, they probably encourage people to have more sex and that can't be a good thing, there is a provable risk of heart failure leading to death. Which is a lot more than can be shown for ecigarettes since as Katherine pointed out, after being used by millions of people globally for many years, nobody has even suggested that an ecigarette could cause someone to catch a cold, never mind anything more serious.
Dr Laugesen stated that, "It is impossible for ecigarettes to cause lung cancer". But it is not impossible for government agencies to believe that ecigarettes are the root of all evil, apparently - especially if they threaten the revenues of pharmaceutical companies.
Of course, you only get the justice you can afford. No money = no justice. But with enough grounds to proceed, suppliers might decide to pool their resources and fight. It would certainly be far cheaper than licensing, in any case.
The LACORS affair might lend some weight to this as it shows a willingness by government agencies to act together in an unfair restriction of trade. MHRA admitted working with LACORS on the regulation issue; the subsequent publication of a farago of false information and accusations by LACORS indicates an attempt to mislead the public and create opposition to ecigarettes.
Add to this the manipulation of the market research results by MHRA due to their giving the focus groups false information, and you have a concerted attempt by both agencies to pervert the public perception of ecigarettes and influence the outcome of the consultation process.
Together with the faulty evidence base and the incorrect and incomplete analysis it means that both the basis for licensing and the consultation process are severely flawed. It would appear that to proceed now would be to risk losing at law.
As Jason Cropper pointed out, the current two-tier system for nicotine containing products has worked perfectly well up to now and shows no sign of needing intervention. There are consumer NCP products that show no need for an MA, and there are NRTs that need licensing. The two types coexist perfectly well. Ecigarettes are a consumer product like low-tar cigarettes, coffee, condoms or alcoholic drinks.
Just because caffeine can be supplied as a licensed medicine does not mean that coffee needs an MA. And if a pharmaceutical licensing agency wanted to license coffee, and knew very little about it and compounded that ignorance by doing no research, then conspired with another agency to manipulate the public's opinion of coffee by publishing lies about it and fixing the market research results, and published documents that clearly showed they didn't have a clue what the implications of their actions were likely to be - then it is unlikely they would survive the inevitable legal challenge and succeed in requiring coffee products to have a marketing authorisation.
They would be better off walking away at an early stage and finding something else to occupy their efforts; perhaps condoms should be licensed as they are a consumer harm reduction product, they probably encourage people to have more sex and that can't be a good thing, there is a provable risk of heart failure leading to death. Which is a lot more than can be shown for ecigarettes since as Katherine pointed out, after being used by millions of people globally for many years, nobody has even suggested that an ecigarette could cause someone to catch a cold, never mind anything more serious.
Dr Laugesen stated that, "It is impossible for ecigarettes to cause lung cancer". But it is not impossible for government agencies to believe that ecigarettes are the root of all evil, apparently - especially if they threaten the revenues of pharmaceutical companies.
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Big Pharma?? Are you aware of the RPS's membership??
pharmacists is who - not pharmaceutical companies.
A tad premature, methinks.
We now have a very powerful card in our hand: the publication of Dr Eissenberg's research trial final report.
This is the third clinical trial that basically states ecigarettes don't do anything. Specifically, the research again proves that ecigarettes either supply no nicotine at all to the user, or such microscopic amounts that they cannot be construed as being a drug delivery device; and that ecigarettes have no effect on the human body and do not affect the user in any way. There is no metabolic effect.
Since there are now three trials with near-identical results, and all three trials can be shown to be valid for numerous reasons, and there are no trials that show different or opposing results, this creates a simple legal fact: ecigarettes don't work and don't do anything.
This is important because there are three main foundations to the MHRA licensing claim: [1] a risk to public health; [2] 'by description'; [3] 'by function'. A product would need to demonstrate a risk to public health, or be marketed as a treatment, or act as a drug delivery device, in order to show a need for regulation.
[1] It would be impossible to provide any evidence for a risk to public health. There are all sorts of statements that could be used to appeal to Sun readers but courts tend to require a higher level of proof. That is unlikely to be forthcoming.
[2] As 99% of suppliers do not market their products as devices to treat a medical condition, but as alternative consumer products, it would be hard to rule that ecigarettes are some form of medicine. The few rogue traders that do this are outside of the mainstream in the same way that internet marketers promote get-rich-quick schemes.
[3] The final piece in the jigsaw is whether ecigs act as a drug delivery device or not. We now have proof they don't.
It is likely that this would remain the case even if trial results were published that reached a different conclusion, since the three trials that state ecigs do nothing and have no medical effect were clearly independent and in some cases might be said to have been funded and/or run by people who were not at all sympathetic to our interests; and a new trial that had different results, if funded or run by persons seeking a different result, could be claimed to be contaminated, in comparison.
Only fully-independent trials reaching a different conclusion, that could also be seen to be equally clean as regards funding or management, could be seen as equally valid (legally). There are results pending from trials by an ecigarette supplier that may have turn out to have conflicting results, but this trial was funded, managed and run by persons who cannot be described in any way as independent, in contrast to the three previous trials.
This is the third clinical trial that basically states ecigarettes don't do anything. Specifically, the research again proves that ecigarettes either supply no nicotine at all to the user, or such microscopic amounts that they cannot be construed as being a drug delivery device; and that ecigarettes have no effect on the human body and do not affect the user in any way. There is no metabolic effect.
Since there are now three trials with near-identical results, and all three trials can be shown to be valid for numerous reasons, and there are no trials that show different or opposing results, this creates a simple legal fact: ecigarettes don't work and don't do anything.
This is important because there are three main foundations to the MHRA licensing claim: [1] a risk to public health; [2] 'by description'; [3] 'by function'. A product would need to demonstrate a risk to public health, or be marketed as a treatment, or act as a drug delivery device, in order to show a need for regulation.
[1] It would be impossible to provide any evidence for a risk to public health. There are all sorts of statements that could be used to appeal to Sun readers but courts tend to require a higher level of proof. That is unlikely to be forthcoming.
[2] As 99% of suppliers do not market their products as devices to treat a medical condition, but as alternative consumer products, it would be hard to rule that ecigarettes are some form of medicine. The few rogue traders that do this are outside of the mainstream in the same way that internet marketers promote get-rich-quick schemes.
[3] The final piece in the jigsaw is whether ecigs act as a drug delivery device or not. We now have proof they don't.
It is likely that this would remain the case even if trial results were published that reached a different conclusion, since the three trials that state ecigs do nothing and have no medical effect were clearly independent and in some cases might be said to have been funded and/or run by people who were not at all sympathetic to our interests; and a new trial that had different results, if funded or run by persons seeking a different result, could be claimed to be contaminated, in comparison.
Only fully-independent trials reaching a different conclusion, that could also be seen to be equally clean as regards funding or management, could be seen as equally valid (legally). There are results pending from trials by an ecigarette supplier that may have turn out to have conflicting results, but this trial was funded, managed and run by persons who cannot be described in any way as independent, in contrast to the three previous trials.
I'm sure you've seen these, but just in case...
Frank Davis
It looks like the consultation decision has been made - UK Vapers
Frank Davis
It looks like the consultation decision has been made - UK Vapers
Well, quite simply this will not apply to me as I will openly contravene the ban by vaping my ... off whenever humanly possible. I would hope that every single vaper in the country will do the same.
I have a question for MHRA.
In your deliberations, you talked with a number of stakeholders who are not affected at all, one way or another, by your decision. You also talked with other stakeholders whose only interest in the question is financial. How much weight have you given to the concerns of the only set of steakholders whose health and very lives are affected -- the current and potential electronic cigarettes consumers?
Did you find out how well the products worked for them? Did you learn the effect it had on their health?
Anti-tobacco organizations who don't like the fact that the vapor looks like smoking will have their feelings hurt if they don't get their own way. Phillip Morris Limited stands to lose revenue from smokers who switch or have already switched to electronic cigarettes, as do the pharmaceutical companies.
Former smokers who relapse to inhaling smoke because you banned their less harmful alternative stand to lose a lot more than money. Millions more continuiing smokers will be denied access to what has proven to be a most effective and life-changing tool. These folks will pay for your decision with their very lives.
One last questoion: What does the "H" stand for in the acronym for your organization's name? If it truly stands for "Health", let's hope you lived up to the name.
In your deliberations, you talked with a number of stakeholders who are not affected at all, one way or another, by your decision. You also talked with other stakeholders whose only interest in the question is financial. How much weight have you given to the concerns of the only set of steakholders whose health and very lives are affected -- the current and potential electronic cigarettes consumers?
Did you find out how well the products worked for them? Did you learn the effect it had on their health?
Anti-tobacco organizations who don't like the fact that the vapor looks like smoking will have their feelings hurt if they don't get their own way. Phillip Morris Limited stands to lose revenue from smokers who switch or have already switched to electronic cigarettes, as do the pharmaceutical companies.
Former smokers who relapse to inhaling smoke because you banned their less harmful alternative stand to lose a lot more than money. Millions more continuiing smokers will be denied access to what has proven to be a most effective and life-changing tool. These folks will pay for your decision with their very lives.
One last questoion: What does the "H" stand for in the acronym for your organization's name? If it truly stands for "Health", let's hope you lived up to the name.
I can see your as pd as I about this turn of events. I've never seen you make a spelling error (probably missed some, but whatever).
I signed up for the UK vapers forum after reading this. It is depressing and disgusting. We just don't seem to have a chance against people with a lot of power to do as they please.
If it does happen, then we should all go out and find our local MJ dealer and start using that instead. If it is illegal to do the wrong thing, and illegal to do the right thing, you may as well do the wrong thing and have fun in the process.
I've had it with the BS that is going down over here. Human rights be damned, we are having them rolled back to the stone age. Ban this, ban that, i'm sick of it.
I've already rolled off a five page essay to the PM telling him how disgraceful it is that disabled people are being persecuted here. Telling a person that they are fit for work when they have a terminal illness ffs!
I guess i'll be firing up MS Word again on this issue. Bombard the .......s with snail mails.
I've had it with the BS that is going down over here. Human rights be damned, we are having them rolled back to the stone age. Ban this, ban that, i'm sick of it.
I've already rolled off a five page essay to the PM telling him how disgraceful it is that disabled people are being persecuted here. Telling a person that they are fit for work when they have a terminal illness ffs!
I guess i'll be firing up MS Word again on this issue. Bombard the .......s with snail mails.
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