EU UK regulation -- Discussion thread

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rolygate

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MHRA are entirely autonomous. Their decisions only have to withstand challenge in court. They might not go ahead if their legal advisors tell them there is a very good chance they would be defeated in court, although there isn't even much of a downside in that for them (the taxpayer pays after all).

They will certainly go ahead if their legal advisers tell them there is a only one in three chance of being defeated in court.

Even if they lose, there are probably zero negatives for them: costs are paid by the taxpayer, and there is no disgrace in losing in court if they can describe themselves as defending the health of UK citizens from evil imports.

An expensive loss (ie long drawn out) might be another matter, if legal costs come out of their budget somehow. However they might still be able to go to the Dept of Health and get a budget addition for legal costs for that year.

There are few if any ways MHRA can lose. The biggest way they can lose is if they succeed in banning ecigs (ie licensing them). That is a guaranteed loss for them, in around say four years, when government has to fold under the pressure. But government departments have a history of being unable to foresee the fact they will be defeated by public pressure combined with product availability from external sources. I fully expect they will be blind to this, or will try to ignore or downplay the size and cost of the defeat they would eventually suffer.

In other words: there is no downside for them, as they see it, in any course of action. Possibly the worst option for them is to walk away since they might be seen to lose face. Personally I'd call that a wise course of action, and a sign of skilled judgement, and certainly not a defeat - in fact I'd applaud it. A massive saving of taxpayers money and a huge boost for consumers' rights; but let's face it, that's the least likely course of action right now.
 

freakindahouse

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@ Rolygate:
Sorry, Roly, but I have to jump in here and correct you on the NRT-for-children issue. Here's what actually happened: Nicorette gum was handed out in a school in West Bromwich last July (2009), without the knowledge of the parents. One pupil, aged 14, was given a large quantity by his friend, and took the equivalent of 180 cigarettes' worth of Nicorette gum. He became very ill, collapsed in the playground, and was hospitalised overnight on a heart monitor. It was reported that, had he not already been a smoker, it is quite likely that he would have died. As a mum of four myself, I just thank my lucky stars that I made the decision before my first was even conceived that I would not be sending my kids to school! (I home-educate them.) Nothing would induce me to do so - I'm simply not brave enough. (If anyone's interested, the links to the two reports about this particular incident are here: Boy, 14, overdoses on nicotine gum given out at school - mirror.co.uk and here: Boy, 14, overdoses on nicotine gum - UPI.com

What you say about distribution to children raises another interesting and important point. This was something which we had hoped to bring up at the meeting, but the opportunity did not present itself. However, it is worth noting that at the moment, existing licensed NRT products - often containing considerably higher doses of nicotine than electronic cigarettes do - are widely available in the shops and yet none are marked with toxic/hazard warnings, they are not in child-proof containers, and as we have seen above, they are readily available to children, even to the point of their being directly given to children in school. This, IMHO, makes an absolute mockery of any suggestions by the MHRA that electronic cigarettes pose any kind of risk. We are yet to hear of any incidence of someone coming to harm through using an electronic cigarette, anywhere in the world, and yet there are several documented occasions where people have suffered harm as a direct result of using existing licensed NRT products, one of the worst examples being the one above, though there are many others. And, of course, as Pillbox quite rightly points out, the MHRA have missed the point entirely by not attacking tobacco products directly. Unfortunately, the MHRA have no powers whatsoever to do anything at all about tobacco products, since these are protected by iron-clad layers of law to ensure that they are virtually untouchable, but to suggest that it is in the interests of Public Health to place regulatory hindrance in the way of demonstrably safer alternatives, such as electronic cigarettes, is to turn the whole process into a farce.

The question of new legislation is a bit of a moot point, since the publication and adoption of the Hampton Report. This is a long, and ultimately pretty boring document (although very well researched and presented), but in the briefest possible terms, Hampton concluded that the fewer regulatory agencies, and the fewest possible regulations would provide the most efficient framework, and it is hard to disagree. Unfortunately, when one of the more powerful regulatory agencies is entirely peopled by wombats, efficiency is not likely to be forthcoming!

There is no suggestion in MLX364 or by the MHRA elsewhere that they are looking to introduce new legislation. It is important that we all understand this. What they are suggesting is that electronic cigarettes, and indeed all nicotine containing products (except, of course, the armour-plated tobacco cigarette!) be brought within the existing new legislation which was recently passed to allow existing NRT products to be made more widely available, including an extended indication for use in pregnancy, and indeed in children (with disastrous consequences, as illustrated above). This is where the MHRA has attempted - hitherto successfully - to take ownership of Harm Reduction, which falls squarely outside their remit. (In their hands, I fear it is reduced from Harm Reduction to Harm Mismanagement!)

Again, Roly, I'm afraid I have to disagree with you: the existing regulatory frameworks actually do currently provide sufficient safeguards for just about any product that could ever be invented - assuming they are applied correctly. There is no need for a new regulatory body, since the existing ones - specifically MHRA for medicines and Trading Standards for General Sales Products - are more than sufficient to cope with the task... unless extreme wombattery gets in the way, which unfortunately it does. That said, I do believe that the Royal College of Physician's call for an independent Nicotine Regulatory Authority, to regulate all nicotine containing products (including tobacco products) would be an excellent idea. They have called for this twice, and yet we still do not have it, so it is unlikely to be forthcoming. In the absence of this, we must work with what we've got, and providing products are classified correctly (which they are at the moment), there should be no problem. It is the MHRA's attempt to reclassify a product which has caused the current challenging situation.

I am working directly with MEPs, and with agencies beyond Europe, to try to ensure that this issue is handled correctly, but I cannot sit back and allow my own country to fall by the wayside. Therefore, together with the industry team (which is successfully growing by the day, I'm very pleased to report!), we have been and will continue to 'fight the good fight' on home soil, too. We have already seen some success with this kind of campaigning, in the removal of LACORS' inaccurate press release, but clearly there is much more to be done. Be assured, my vaping friends, we will not rest until this issue is resolved properly.

For the record, I fear we are simply too young an industry to be able to take on lengthy and expensive legal battles, but we have an armoury of other weapons available to us, and believe me, we will stop at nothing. (We are not ruling out legal action, but this will have to be taken under advisement.)

@ Mr Longbeard:

You might be surprised, but there is a growing body of evidence supporting the safety of electronic cigarettes and their use. However, as Roly quite rightly points out, the onus is on the regulators to prove that they are dangerous before they can remove them from sale. The EC Directives are very clear on this point. They haven't got a leg to stand on - and I fear they time-share a brain cell!

@ Foxy9212:

I know exactly what you mean about 'preaching to the converted', which is why I don't often post on fora. Please be assured that the message is being taken to the right people, and we're not just blowing smoke (or indeed vapour!) in here. The campaign is operating at increasingly high levels, and we'll be keeping the momentum moving onwards and upwards...

@ Petbe:

You're far too cute and cuddly to be regarded as 'daft', but thanks for the vote of confidence!

@ Rolygate:

As far as ecigarette control's being 'unattractive' to the MHRA goes, I should imagine they will wince more than slightly when the FDA's case comes crashing down in September, as it inevitably will. I should have thought they would want to off-load this particular hot potato as fast as possible, since they had no idea of the can of worms they would be opening when they instigated this farcical process. As for them walking away, I believe this is where our efforts should be concentrated in the short-term: offering the MHRA a means by which they can go with their 'Option 3: Do nothing', without having egg on their faces. To this end, we are beavering away behind the scenes to establish our industry alliance cohesively, and creating a regulatory framework which will be very attractive to Trading Standards. This will allow the MHRA to demonstrate that they have fully considered all the issues surrounding electronic cigarettes and have discovered - through their highly effective consultation process - that electronic cigarettes are not medicines. As part of their remit to protect the Public Health, they have taken this a step further and ensured that there are sufficient safeguards in place for electronic cigarettes to be regulated properly by Trading Standards. Job done - and MLX364 is consigned to the waste-bin, where it belonged from the beginning.

@ Mr Longbeard:

We are all over the due diligence like a rash, believe me, and our industry standards will be shiny and gleaming, to the point where Trading Standards Officers will salivate at the prospect! (They're already pretty excited in certain areas.)

@ Moog:

Hello darling! Long time no see. Hope you are well? Thank you, too, for the vote of confidence. xxx

@ Moonible:

The MHRA is a government agency which will ultimately report back the findings from their consultation to the Department of Health. Actual MPs, including Andrew Lansley - who is already interceding on our behalf, to a degree (although he needs further education on the subject!) - will be expected to sign off on it.

Mainstream product? Probably not, no, since it is only appealing to a specific group really. However, that doesn't mean it has to be reclassified as a medicine. IMHO, these are consumer products for smokers - a bit of fun, and a demonstrably safer way to enjoy nicotine, which even the MHRA acknowledge, is recognised as being a safe (and, of course, legal) drug for recreational use.

Sorry for the lengthy post, but I shall be unlikely to have time to post again for a while, as I crack on with the campaign, so thought I'd better make this one count! :vapor:
 
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Nick O'Teen

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@ Rolygate:
Sorry, Roly, but I have to jump in here and correct you on the NRT-for-children issue. Here's what actually happened: Nicorette gum was handed out in a school in West Bromwich last July (2009), without the knowledge of the parents. One pupil, aged 14, was given a large quantity by his friend, and took the equivalent of 180 cigarettes' worth of Nicorette gum. He became very ill, collapsed in the playground, and was hospitalised overnight on a heart monitor. It was reported that, had he not already been a smoker, it is quite likely that he would have died.

Interesting - it says in the article "there is nothing stopping youngsters from the age of 12 buying [nicotine gum] over the counter.". And as you say, there are no hazchem labels or childproof packaging on these products.

I'd like to think Trading Standards would be down on Nicorette, ordering them to package and label their toxic product appropriately (but I ain't going to hold my breath!)
 

rothenbj

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I'd just like to post in to let you know that there are some, perhaps many, that are keeping track of what's happening in the UK from the US. I certainly have since I recognize that this isn't a local battle, but a global one.

There is a common thread through what is happening here and in the EU, as well as over the globe. It's not just about E-cigs either. When the anti-smoking war moved beyond smoking to become the anti-tobacco war, the gloves were taken off. When smoking and nicotine became synonymous you knew the battle plan.

Can they actually implement and succeed at prohibition? Perhaps attempt to implement, most likely not succeed. I don't believe that the MHRA or the FDA will listen to whatever is said. The only hope is the courts will stop them but the opposition has an awful lot of money, ours.
 

Nick O'Teen

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Can they actually implement and succeed at prohibition?

In a word, no. Not in the EU. They can jerk manufacturers and sellers around here in the UK, but Germany and Italy have already gone through similar processes, and although they went with an "Option 2" requirement to comply with medical regulation, it's my understanding that they both gave their ecig industries 10 years to comply.

With a timescale like that, I'd be happy to work with them. With 21 days notice to quit, they can go boil their heads - that is just proof of their bad faith and vexatious intent. If the UK doesn't want the employment and taxes I can offer, other countries are less picky.

Since they can't make nicotine a controlled drug (that would unavoidably impact on over-the-counter NRT products, and the big-Pharma bully boys would never stand for that!) it is my understanding that they can't stop the import of what would be defined as "unlicensed medicines" from other EU states. Imports of unlicensed medicines for personal use are perfectly legal if they don't contain controlled drugs.

Even if the whole EU took the MHRA stance (which it doesn't,) prohibition never works. It didn't work in the USA in the 20s and 30s , it certainly isn't going to work in a web-wired 21st century where mail order is only ever a click away.
 

rolygate

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There is another way MHRA could walk away without loss of face: they could report that they would like to regulate e-cigarettes, but that in practice it is impossible since due to internet sales, which cannot be stopped, the industry would simply go offshore. Therefore, MHRA is not at fault, it requires other Departments or new legislation to solve the issue.

This is a realistic appraisal and one that would bring them praise from most parties, sympathy from the anti-smokists, and condemnation from no one.

As Nick O'Teen states, nicotine is not a controlled drug, therefore imports cannot be stopped; consumers cannot be prosecuted; and the only action that could be taken would be to prosecute UK-based sellers. They would all move their operations offshore.



.
 
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MrLongbeard

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@ Mr Longbeard:

We are all over the due diligence like a rash, believe me, and our industry standards will be shiny and gleaming, to the point where Trading Standards Officers will salivate at the prospect! (They're already pretty excited in certain areas.)

:headbang:
Cool glad to hear it.
If you are ever in need of another UK independant lab let me know.
 

rolygate

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Members: please do not publish private email correspondence here. If you do so, from this point onward, it will be deleted.

If you wish to publish your own emails you can do so. You cannot publish emails from others without their written consent.

Please ensure that you do not publish any email addresses except those of people who have consented to this.

@Jason
I understand your frustration but you cannot publish private correspondence verbatim. The content must be re-written using your own terms, if you wish to make it public.
 

rolygate

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Just to give a little guidance - here is how to re-write private correspondence.


actual message from ECF Member and Supplier:

----------------------------------------------------
[various email addresses]
[various other private info]

From: Mr A. Topper@ecig.co
To: F. Acelessperson@gov

Hi Felicity,

Please give the attached information to your power-hungry money-grabbing empire-building consumer-choice-crushing boss.

Have a nice day,

Alan
[attached: grovelling-plea.zip]

---------------
version to be posted on ECF:

I sent the attached information to the department head, who I feel is overlooking the consumers' rights on this issue.
grovelling-plea.zip

A. Topper

========
Government Agency's reply:

[various email addresses]
[various other private info]

Dear Mr Topper,

Dr Paine has noted your objections. We will of course completely ignore them, while obfuscating all the issues and publishing what basically amounts to gross distortions of the facts. Government will attempt to avoid any pertinent issues and instead chase the money, while if possible trying to undermine the individual's rights to the point where they are left powerless and easily controlled. With luck we'll come back to you later but don't count on it.

Best regards,

Felicity

----------------
A. Topper's report of the email, to be published on ECF:

Dr Paine's secretary reported that my objections had been received and passed on, but they might not be taken into account. Goverment may report on the issue later.

---------------------------------------------------


Hope that points out how to publish private correspondence. The substance but not the content. Anything contentious, or private information such as email addresses, removed.

Have a nice day now.


.
 

Lithium1330

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Just to give a little guidance - here is how to re-write private correspondence.


actual message from ECF Member and Supplier:

----------------------------------------------------
[various email addresses]
[various other private info]

From: Mr A. Topper@ecig.co
To: F. Acelessperson@gov

Hi Felicity,

Please give the attached information to your power-hungry money-grabbing empire-building consumer-choice-crushing boss.

Have a nice day,

Alan
[attached: grovelling-plea.zip]

---------------
version to be posted on ECF:

I sent the attached information to the department head, who I feel is overlooking the consumers' rights on this issue.
grovelling-plea.zip

A. Topper

========
Government Agency's reply:

[various email addresses]
[various other private info]

Dear Mr Topper,

Dr Paine has noted your objections. We will of course completely ignore them, while obfuscating all the issues and publishing what basically amounts to gross distortions of the facts. Government will attempt to avoid any pertinent issues and instead chase the money, while if possible trying to undermine the individual's rights to the point where they are left powerless and easily controlled. With luck we'll come back to you later but don't count on it.

Best regards,

Felicity

----------------
A. Topper's report of the email, to be published on ECF:

Dr Paine's secretary reported that my objections had been received and passed on, but they might not be taken into account. Goverment may report on the issue later.

---------------------------------------------------


Hope that points out how to publish private correspondence. The substance but not the content. Anything contentious, or private information such as email addresses, removed.

Have a nice day now.


.

What? that makes no sense to me, is there a real law about publishing correspondence without written consent or is this just an ECF rule?

The info posted by pillbox38 looks very important to be ignored or rewritten and even more if it comes from a government agency!
 
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rolygate

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An outline of licensing issues

It is hard to escape the likelihood that ecigarette suppliers would need to obtain two (or more) MAs, not just one. (An MA or marketing authorisation is the pharmaceutical license issued by the MHRA without which a product must be removed from sale.) This is because most suppliers have two product lines, the hardware and the refill liquids.

Where the products are sold as a single unit, with no variation in hardware or liquid constituents, then a single MA would most likely apply - but that is only a fraction of the market of course. It might be available for (a) 2-piece ecig suppliers or (b) those who can create a 'single product' with a 3-piece kit containing a single-recipe eliquid that is then also sold for refills.

If we look at the licensed medical nicotine inhaler, which licensed ecigarettes would probably need to resemble in terms of the finished product for sale, it has one model of hardware and one refill type - since variations would most likely need additional licenses. If different items of hardware are brought to market, or different refills, they would need to be tested and licensed since they are different.

In the case of (a) above, 2-piece ecigarette suppliers, compliance would be easier for them than anyone else. One model could be sold, along with a standard refill of various strengths, as this is a normal feature of medicines. However if there were a substantial difference in the liquid ingredients, the new recipe would need separate licensing as it would have different ingredients. Also, of course, only one model could be sold.

It's hard to work out the proportion of the market that 2 piece-only suppliers have, but in terms of the proportion of suppliers they are approximately 20% or less. However they probably have a much larger proportion of the market than this in turnover, because they principally sell to new consumers, and therefore both sales and prices may be substantially higher than products for the sophisticated consumer.

In (b) above, we're talking about normal suppliers with a normal product line - and by definition a consumer product line is varied, and often has new items or variations introduced to test the market. This is the opposite perspective from that of a medical supplier, who has one product and needs substantial investment to bring in another.

Normal (3-piece) suppliers would need to create a standardised kit, containing a basic 3-piece model, along with a basic refill type that could come in different strengths. A doctor could prescribe refills of high, medium, low or zero-nicotine strength according to the requirement.

Alternatively if these products went onto the GSL list (the general sales list, ie OTC, over the counter, as in available on supermarket shelves) then the various refill strengths would be on the shelf alongside the hardware.

Of course, no one knows if ecigarettes as a medical device would be OTC or prescription-only - which is yet another interesting question. It is questionable if MHRA would give any undertaking on this; and in any case the only assurances of value are written ones. At present the signs are mixed: it may be that hardware and zero-nic cartridges would be OTC but nicotine-containing cartridges would be prescription-only.

All of this means that other ecigarette models could not be sold as they would need another licence. And the same thing certainly goes for liquid refills since unless the contents are identical, they would probably qualify as a different 'medicine' and therefore need separate licensing. It is hard to see how a 90-10 PG-VG mix with tobacco flavour could be on the same license as a 100% VG liquid with toffee mint flavour, since the ingredients are completely different (the only common ingredient would be nicotine). But these types of differences are standard for most ecigarette or liquid suppliers since that is what consumers want.

By the same token, a 510-based model with a licence could not be replaced by an 801 penstyle, since that is an entirely different piece of hardware.

As each license would in practical terms cost about £100k and up, it means that even suppliers who elect to go into the medical system would most likely be limited to one model of ecig and one type of liquid refill.

There is one get-out here, though: persuading the original manufacturer to pay for the license cost. They have done this for CE and UL marks of course. However there is a massive difference in cost since a CE mark can be obtained for a few hundred pounds. On the other hand, the manufacturer of for example one model of penstyle might help with costs since the hardware can be distributed through several vendors. In addition, if a product has a UK medical license, this might tend to improve marketing opportunities elsewhere. Perhaps a DSE801 with a UK MA might become a useful product to have in other places.

Nevertheless, the early years of medical licensing would be an impossible situation for most UK vendors because of the wide range of products they supply, each of which would require separate licensing due to the wide variations. A 510 is demonstrably not an 801, and PG tobacco liquid is obviously not the same thing as VG toffee.

Perhaps suppliers would need to become agents for other licensed suppliers - only - and just resell licensed products. For example they might be only able to sell Ecopure liquid since it looks as if that will be licensed fairly soon. This would be a sad day for consumers as it would remove all choice. Of course, it would be a sad day for all, as the market would be forced to change drastically in many ways.

It would also be a big blow to Harm Reduction for UK smokers, since it would remove 99% of consumer Harm Reduction choice from the market, if all suppliers complied by shutting down or only selling licensed products. As Harm Reduction is a consumer choice it would be a serious issue and of course would effectively hurt many people. Luckily, there is little chance that the market would allow government to interfere so drastically in an ordinary consumer product with massive market expansion occurring - other arrangements would simply be made, which would put up costs but be affordable in a bull market, and the only feasible choice anyway. Suppliers will simply move their servers and mailing operation elsewhere.

There will soon be a lot of enquiries into hosting and legal issues in Southern Ireland, Germany, Holland and France. The Isle of Man and the Channel Islands are other possible options.

In Germany and Italy the medical licensing authority has reportedly decided that it will be licensing ecigarettes - but the industry has ten years in which to comply. Germany therefore looks a sensible place to host a server and have a business address, even if not a mailing operation. Ten years is a nice long time. By that stage ecigarette users will certainly have reached a critical mass and any form of licensing will be impossible due to public pressure.

[edit]
Update July 27th 2010
The Wikileaks website network has these same problems: governments everywhere trying to shut them down. Apparently several of the servers on their network are hosted in Sweden and Belgium, who have demonstrated more regard for human rights than other countries. Therefore these countries might be investigated as an offshore base until the UK gvernment are defeated by public pressure, if it comes to the crunch. Norway and Switzerland are other alternatives since they are outside the EU and not subject to pressure from grasping governments / agencies within the EU.



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