EU draft directive to be presented on wed 19th Dec

grindle

drkpower wrote: »

Do you mean the price it will cost to authorise each as a medicinal product? If so, it is worth bearing in mind that the scientific data in respect of each different strength would be relatively limited. And the scientific data per each flavour should be very very limited.

For instance, where a pharma authorises a regular drug at a particular strength, the later authorisation of a slightly diffferent strength drug with the same active ingredient is usually relatively straightforward (as regards the scientific dossier that must be submitted).

From ECCA (Electronic Cigarette Consumer Association UK):

Since most vendors sell at least four hardware products and twenty liquid refill products, it is a simple fact that whatever way you look at it, 99.9% of the products currently on the market would need to be withdrawn.

All would have needed to close down for three or four years until licensing could be obtained for one product, as it requires clinical trials, research of existing documentation, writing up the results, some legal work, submitting the documentation, and waiting for a decision. We currently think the theoretical minimum possible cost per product is about £500,000, although we have no examples of any product with such a low cost to license. It is not known what the cheapest-ever product cost to obtain a license for, though some have obviously cost millions.

The best guide we have at present is the average £750,000 per product that the health supplements industry had to find for licensing natural plant products, some having been used safely for 50 years, when recently forced to do so by new EU legislation. Only skeleton documentation and testing would have been required for this exercise, compared to licensing a new pharmaceutical. An entirely reasonable point of view is that the prime purpose of this food supplement legislation was to remove some of the pharma industry's competitors - which it has been spectacularly successful in achieving.

Q1 2012 update: the first company to apply for a medical license for their e-cigarette in the UK has borrowed £2m to do so, to add to previous spend. We now therefore know that a single product will cost about £2.25m and 3 years+ to bring to market successfully.

drkpower

grindle wrote: »

From ECCA (Electronic Cigarette Consumer Association UK):

cheers for that. No doubt it is seriously expensive. But as far as i know, the development costs for the initial product will not need to be repeated. For instance, the clinical trials for a 24mg juice will be effectively identical (or can be done at the same time and with the same trial population) to the trials for a 18mg, a 12mg juice and so on. So that at least means that it is not €2m per individual product.

Now, im not saying thats cheap - far from it - but given the potential profitability of these products over time, surely some of the bigger e-cig companies can afford to do these clinical trials, without the prices of prouctt sky-rocketing. And once one juice is authorised, competitiors can later short-circuit the authorisation process (because a 'bio-similar' has already been authorised).

I would certainly prefer that these prodcuts are regulated under general product directives but i am stil hopeful that the directive will not spell the end of affordable e-cigs as we know them.

csi vegas

grindle wrote: »

Like dumping a shot of vodka into a gallon of water and hoping you'll get pissed.

Oh Jeezus...what is to become of me?

ATTENTION ALL POSTERS: Enable your PM function now. Seriously.
We are about to become an underground movement (and I don't mean pants) :eek:

grindle

drkpower wrote: »

cheers for that. No doubt it is seriously expensive. But as far as i know, the development costs for the initial product will not need to be repeated. For instance, the clinical trials for a 24mg juice will be effectively identical (or can be done at the same time and with the same trial population) to the trials for a 18mg, a 12mg juice and so on. So that at least means that it is not €2m per individual product.

Now, im not saying thats cheap - far from it - but given the potential profitability of these products over time, surely some of the bigger e-cig companies can afford to do these clinical trials, without the prices of prouctt sky-rocketing. And once one juice is authorised, competitiors can later short-circuit the authorisation process (because a 'bio-similar' has already been authorised).

I would certainly prefer that these prodcuts are regulated under general product directives but i am stil hopeful that the directive will not spell the end of affordable e-cigs as we know them.

That initial development cost would decimate the companies that exist right now unless they intend to vend only the goods that a pharmaceutical company makes. Pharmaceutical drugs are sold in pharmacies, not through online vendors with no business in medical licences .
None of the Irish vendors would manage to get their juices passed unless they (and a mysterious multi-multi-millionaire benefactor) formed one giant company to produce different strengths of nicotine base blends - then they could sell their flavours as concentrates, to be thrown in separately later.
That's just about the only workable way of doing it without being bought out by either a tobacco or pharmaceutical company (who only want to buy companies with their own devices as well), and not many consumers would bother picking it up if they have to do more work.

The resilience of your hope given the fairly straight-forward lies being told by governments, health authorities and anti-whatever lobbying groups is astounding.
When have you come across a cheap pharma product? 2ml of Zovirax is €10.39!!! Diazepam costs less than a penny to produce yet sells for hundreds of times the cost by the time your prescription is paid.
Of course they'll charge through the nose.

drkpower

grindle wrote: »

That initial development cost would decimate the companies that exist right now unless they intend to vend only the goods that a pharmaceutical company makes. Pharmaceutical drugs are sold in pharmacies, not through online vendors with no business in medical licences .

Not all pharmaceutical products need be sold in a pharmacy, and it is not yet clear whether juices could - or could not be - sold by mail order. There is a general prohibition on the sale of medicinal products by mail order but the (present) wording of the draft directive might leave some room for juices to be sold in that manner. Anyway thats not really a core point.

grindle wrote: »

None of the Irish vendors would manage to get their juices passed unless they (and a mysterious multi-multi-millionaire benefactor) formed one giant company to produce different strengths of nicotine base blends - then they could sell their flavours as concentrates, to be thrown in separately later.
That's just about the only workable way of doing it without being bought out by either a tobacco or pharmaceutical company (who only want to buy companies with their own devices as well), and not many consumers would bother picking it up if they have to do more work.

Im not sure what the potential turnover is for the typical e-cigs & juice manufacturer/retailer. There is no doubt that the situation that exists now (perhaps over a dozen or more irish companies) will not continue. But it may be feasible for a limited number of e-cig companies to still maintain a prescence. If it costs, lets say €2m to authorise a product (and assuming that the authorisation of 24,18, and 12mg juices can effectively done with the same outlay), one would expect that a one-time only outlay of €2m is not such that would drive an e-cig compay out of the market if their turnovers are reasonable). And after some have gone through the authorisation process, it will allow smaller operators to authorise their 'bio-similar' products at a much lower outlay.

grindle wrote: »

The resilience of your hope given the fairly straight-forward lies being told by governments, health authorities and anti-whatever lobbying groups is astounding.
When have you come across a cheap pharma product? 2ml of Zovirax is €10.39!!! Diazepam costs less than a penny to produce yet sells for hundreds of times the cost by the time your prescription is paid.
Of course they'll charge through the nose.

One of the main reasons for high cost pharmaceuticals is the patent system. I cant imagine a patent being given for a compound that has already been produced by multiple manufacturers. Believe it or not, there are relatively cheap medicinal prodcuts out there; diazepam is a good example - if it were not a prescription product (which e-juices will not be), it would cost pennies. You can get 24 paracetamol for about 20p up north (why you cant here in ROI is beyond me).

Listen, I am not attempting to defend the current directive - at all. But nor do i automatically think that the directive means that the pharma companies will monopolise the market. Clearly some e-cig compaies are already going down the authorisation road which at least suggests that it may be feasible.

was.deevey

IF it goes the route of Pharmacies - the only ingredient in juice that really would need to be sold OTC is the Nicotine/PG/VG base which could be sold in separate packs designed to be added to 10mg base liquid.

However, ecigs in all forms should be classed as a legal over 18's adult product to be comsumed in a responsible way by the purchaser. Exactly same way as Fags and Alcohol - 2 things we KNOW can kill you and yet its left up to ourselves to self regulate our intake, regardless of the fact that both can be bought in toxic volumes in any street corner shop..

Sure regulate the packaging of Ecigs, Regulate where and how they sold and how they advertise (credit card verification online - no TV coverage, no magazines etc... ) but FFS don't start banning the sales of it.

tommy2bad

drkpower wrote: »

Not all pharmaceutical products need be sold in a pharmacy, and it is not yet clear whether juices could - or could not be - sold by mail order. There is a general prohibition on the sale of medicinal products by mail order but the (present) wording of the draft directive might leave some room for juices to be sold in that manner. Anyway thats not really a core point.




Im not sure what the potential turnover is for the typical e-cigs & juice manufacturer/retailer. There is no doubt that the situation that exists now (perhaps over a dozen or more irish companies) will not continue. But it may be feasible for a limited number of e-cig companies to still maintain a prescence. If it costs, lets say €2m to authorise a product (and assuming that the authorisation of 24,18, and 12mg juices can effectively done with the same outlay), one would expect that a one-time only outlay of €2m is not such that would drive an e-cig compay out of the market if their turnovers are reasonable). And after some have gone through the authorisation process, it will allow smaller operators to authorise their 'bio-similar' products at a much lower outlay.
No, it will be 2 milion per product with an ongoing cost of monitoring the product in use. A licence for 24mg will not transfer to 18 mg or to 24mg in a different flavor.


One of the main reasons for high cost pharmaceuticals is the patent system. I cant imagine a patent being given for a compound that has already been produced by multiple manufacturers. Believe it or not, there are relatively cheap medicinal prodcuts out there; diazepam is a good example - if it were not a prescription product (which e-juices will not be), it would cost pennies. You can get 24 paracetamol for about 20p up north (why you cant here in ROI is beyond me).

Listen, I am not attempting to defend the current directive - at all. But nor do i automatically think that the directive means that the pharma companies will monopolise the market. Clearly some e-cig compaies are already going down the authorisation road which at least suggests that it may be feasible.

No current ecig companies are going down the authorization route, the only one to try has had to be bought out by a tobacco company. Pharma isn't interested in producing ecigs, they want them neutered to avoid the competition.

Theirs some rumors of the regulation that the MHRA will propose in this show, it's a must watch as what is rumored is workable depending on how it actually turns out. If this is adopted by the UK before the EU directive comes in then it may ripple into some compromise that the EU could accept.
http://blip.tv/vapourtrailstv/vttalk-27-02-you-call-your-voice-6541472

P.I.T.A

Liam Elwards assistant Laura Real phoned me a few minutes ago, and she sent me this reply. They have been the only Irish Mep's to have replied to me from the 12.

Please find attached the response Mr Aylward has received from the Commissioner for Health in relation to the concerns raised. As discussed the European Parliament Committee on Environment and Public Health have been appointed as the lead committee on this file and while Mr Aylward is not a member of this Committee he will bring your concerns to the attention of his party colleague with responsibility for this file in the main Committee and also the Committees which will be giving legislative opinions. The Environment Committee will be preparing a report on the Commission's proposal in the coming months which will then be presented to the Committee for debate and amendment. There is a tentative date of November 2013 set for the vote of the full European Parliament.

Answer given by Mr Borg
on behalf of the Commission
(28.2.2013)

1. The sales of electronic cigarettes have increased substantially in recent years and the products are often placed on the market without appropriate control. Member States take different approaches how to regulate electronic cigarettes. This leads to fragmentation of the market and justifies action at the EU level.

The Commission proposal seeks to encourage research, innovation and development of safer products which have undergone a prior risk/benefit balance and which are more adapted for smoking cessation.

2. According to the Commission proposal, electronic cigarettes above the suggested nicotine threshold would still be allowed on the market, provided they have been authorised as medicinal products. Therefore, the risk of illicit trade of such products is considered limited.


She recommended we find out who will head the Parliament Committee on Environment and Public Health and and focus our efforts their way as they will have a big say in what is presented overall for the big vote.

was.deevey

The Commission proposal seeks to encourage research, innovation and development of safer products which have undergone a prior risk/benefit balance and which are more adapted for smoking cessation.

Ok - So first off I DONT WANT TO QUIT VAPING!

It relaxes me when im stressed, it stimultates me when im feeling worn out - Factual benefits of Nicotine.

Secondly - this is no longer about electronic cigarette Devices is it? It should be simply about the Juice itself seeing as:

• Juice Containing no nicotine will still be allowed - Unregulated
• Mods / Ecigs with no Nicotine will still be allowed - Unregulated

Now if the EU are REALLY concerned about health issues, surely the studies should be about the unregulated devices and the inhalation of the non-nicotine juice itself that will be coming on the market. These devices and juice are identical to the proposed regulated ones without one single ingredient - Nicotine in a dose large enough to make you not want a fag.

P_1

Just wondering if we're taking the right tactic here folks.

I wonder if we present the reasons why people enjoy taking nicotine would it be a better tactic to take?

tommy2bad

Answer given by Mr Borg
on behalf of the Commission
(28.2.2013)

1. The sales of electronic cigarettes have increased substantially in recent years and the products are often placed on the market without appropriate control. Member States take different approaches how to regulate electronic cigarettes. This leads to fragmentation of the market and justifies action at the EU level.
Fair enough, it's the nature of the controls we are concerned with.
The Commission proposal seeks to encourage research, innovation and development of safer products which have undergone a prior risk/benefit balance and which are more adapted for smoking cessation.
Funny you say that when you specifically rulled out low risk products during the public hearing.
2. According to the Commission proposal, electronic cigarettes above the suggested nicotine threshold would still be allowed on the market, provided they have been authorised as medicinal products. Therefore, the risk of illicit trade of such products is considered limited.
But they are not medicinal products and wont be outside of the EU (unless you know something we don't) so illicit trade is extremely probably.

Borg is a nicotine prohibitionist, unless it a medicine he wants it removed form public availability. Apart from cigarettes of course but thats a historical issue and cant be helped.

Keep the letters going and keep on protesting this nonsense, we might end up using the limited illicit trade but at least we will have tried.

tommy2bad

was.deevey wrote: »

Ok - So first off I DONT WANT TO QUIT VAPING!

It relaxes me when im stressed, it stimultates me when im feeling worn out - Factual benefits of Nicotine.

Secondly - this is no longer about electronic cigarette Devices is it? It should be simply about the Juice itself seeing as:

• Juice Containing no nicotine will still be allowed - Unregulated
• Mods / Ecigs with no Nicotine will still be allowed - Unregulated

Now if the EU are REALLY concerned about health issues, surely the studies should be about the unregulated devices and the inhalation of the non-nicotine juice itself that will be coming on the market. These devices and juice are identical to the proposed regulated ones without one single ingredient - Nicotine in a dose large enough to make you not want a fag.

Actually part of the problem is that most MEP and such don't know enough to be aware of anything more than cig alikes.

richardw001

Have to say the more I read on this the more questions I have :-)

Alcohol, Caffeine, and Nicotine are all bundled together in most jurisdictions
They are addictive substances - however because of historical reasons they aren't under drug regulation.
So allowing 4mg Nicotine eLiquid and putting higher levels under an medicinal umbrella where does that leave things ? - in a confused limbo.

In my opinion all nicotine based e-liquids (> than 4mg or < than) should be lumped in with cigarettes in terms of availability unless shown otherwise.
Its a nicotine based consumer product - widely available and therefore they should have the same availability - and have manufacturing standards as other products that put the same level of nicotine in someones body.
They could have the same level of taxes as cigarettes (with all the revenue specifically going into eliquid research) as cigarettes.

Perhaps a strong defense would be to be lumped in with tobacco cigarettes because to be quite honest - I fail to see how someone is going to win a harm reduction debate - there is no study that shows this either way and one would take decades show something relatively conclusive.

Leaving aside peoples experiences etc. (which are that they are better for health than smoking) - unless the EU commission are prepared to ban all cigarette sales other than silk cut ultra or herbal cigarettes then they are being inconsistent in terms of nicotine based consumer products in this category of allowable addictive substances.

grindle

Silk Cuts contain the same amount of nicotine as normal cigarettes, they just haveholes poked into the filter-sides which results in less nic being inhaled.

Not sure why you think a harm reduction debate couldn't be won. there's no smoke. Instantly less harm, no debate necessary.
And a study (Clearstream) has been done which shows second-hand vapour is as safe as having a lasagne.

tommy2bad

Perhaps a strong defense would be to be lumped in with tobacco cigarettes because to be quite honest - I fail to see how someone is going to win a harm reduction debate - there is no study that shows this either way and one would take decades show something relatively conclusive.

Hundreds of studies show harm reduction works, ironically it's one of the arguments used by the same people ,the EU health committee, to seek the legalization of marijuana. One rule for this another for that. This is driven by ideology and lobby group influence. The trouble with tieing ourselves to tobacco is we them receive the same tax and duty, bans on use in public places and packaging requirements. See what happened with snus! The latter would be misinformation as ecigs don't have the same health risks as cigarettes.
Remember that this is about regulating the market not health, the ideology of Borg and Rielly is influencing the form of regulation but it doesn't have to be their way if we can get enough support for our point of view. Up till now MEP have had no idea of the existence of ecigs other than in passing and our letters have brought this onto their radar. Any regulation thats agreed on can be shown as a victory by the commission, it doesn't have to be regulation that they first proposed. Spinning the outcome positively is what they will do anyway.

Send off another volley of letters and emails, they are discussing this again on march 19. One good thing is this time ECITA representatives, together with one of their counterparts in Europe, have been invited to attend another public meeting, specifically to discuss ecigs, on 19th March.
Ectta

P.I.T.A

grindle wrote: »

And a study (Clearstream) has been done which shows second-hand vapour is as safe as having a lasagne.

Come to dinner and taste my wife's Lasagne and you'll edit your post :eek:

grindle

P.I.T.A wrote: »

Come to dinner and taste my wife's Lasagne and you'll edit your post :eek:

Well... With your username and all... I think she might be trying to kill you.

P.I.T.A

grindle wrote: »

Well... With your username and all... I think she might be trying to kill you.

Nah she's mad about me Grind's, well who could blame her

richardw001

tommy2bad wrote: »

Hundreds of studies show harm reduction works, ironically it's one of the arguments used by the same people ,the EU health committee, to seek the legalization of marijuana. One rule for this another for that. This is driven by ideology and lobby group influence. The trouble with tieing ourselves to tobacco is we them receive the same tax and duty, bans on use in public places and packaging requirements. See what happened with snus! The latter would be misinformation as ecigs don't have the same health risks as cigarettes.
Remember that this is about regulating the market not health, the ideology of Borg and Rielly is influencing the form of regulation but it doesn't have to be their way if we can get enough support for our point of view. Up till now MEP have had no idea of the existence of ecigs other than in passing and our letters have brought this onto their radar. Any regulation thats agreed on can be shown as a victory by the commission, it doesn't have to be regulation that they first proposed. Spinning the outcome positively is what they will do anyway.

Send off another volley of letters and emails, they are discussing this again on march 19. One good thing is this time ECITA representatives, together with one of their counterparts in Europe, have been invited to attend another public meeting, specifically to discuss ecigs, on 19th March.
Ectta

I wouldn't mind paying extra or having to go outside to a "vaping shed" to be able to use in peace what I believe is a safer alternative - that is when you look at the other options on the table (effectively an outright ban)
snus is a case where there is statistical proof that its less harmful - however that and lots of money haven't made its sale legal. Correct me if i'm wrong but from what I can see the use of nicotine e liquid - has no long term impact studies etc. - so can we really say its safe or safer than smoking ? I believe it is however I haven't seen any conclusive scientific proof that it is.
And I can't see that proof being there for many years.
Contrast this against snus which has been proven to be safer - and yet this hasn't stopped it being banned.
Smokers have rights - they are entitled to buy and enjoy a consumer product with nicotine in it - if all else fails can Vapers not demand the same rights as smokers ?
The harm reduction and health arguments make me nervous because they haven't helped to legalise the sale of snus - which has a lot more scientific evidence and a harmonised industry than e-liquid behind it.

P.I.T.A

richardw001 wrote: »

Smokers have rights - they are entitled to buy and enjoy a consumer product with nicotine in it - if all else fails can Vapers not demand the same rights as smokers ?

My feelings exactly, all we are asking is equal rights the same as smokers, would a court deny us that right? I don't think they could.

grindle

richardw001 wrote: »

Correct me if i'm wrong but from what I can see the use of nicotine e liquid - has no long term impact studies etc. - so can we really say its safe or safer than smoking ? I believe it is however I haven't seen any conclusive scientific proof that it is.
And I can't see that proof being there for many years.

The only thing that needs to be researched is the vapourisation of flavouring. VG, PG and nicotine have been studied to death and are known quantities. Flavourings and what makes them up, not so much.

P.I.T.A wrote: »

Nah she's mad about me Grind's, well who could blame her

Hmmm. New account and an eerie sort of familiarity...
Have we met in a previous life I wonder? How're you keeping, Tiger?

P.I.T.A

grindle wrote: »

The only thing that needs to be researched is the vapourisation of flavouring. VG, PG and nicotine have been studied to death and are known quantities. Flavourings and what makes them up, not so much.


Hmmm. New account and an eerie sort of familiarity...
Have we met in a previous life I wonder? How're you keeping, Tiger?

Wot you mean eerie Grind's :eek:
Learned an expensive lesson "don't leave your laptop hidden under a coat on the back seat of your car and bugger off shopping" And also make sure you don't have a unprotected word doc on the desktop with all your accounts and passwords on it, then you won't have to go around deleting everything or changing passwords
So new laptop and slowly getting back to normal, whatever that is.

BTW I assume you guessed what the P.I.T.A stands for? My Mrs picked it.
Pain In The Arse
Bless her

Vaperus

Hi Kiffy
is all sorted now
Welcome Back

P.I.T.A

Vaperus wrote: »

Hi Kiffy
is all sorted now
Welcome Back

Yeah Mark, bought a new laptop and normal service resuming. Fuming though, I will be getting a 30 year award from the company later in the month and one option is a new laptop to the value of €550 and they wouldn't bring it forward a couple of weeks to save me buying another one, so bought a cheapo notebook for now.

tommy2bad

Smokers have rights - they are entitled to buy and enjoy a consumer product with nicotine in it - if all else fails can Vapers not demand the same rights as smokers ?

As far as the quit or die people are concerned, you have the same rights, the right to smoke cigarettes, what more risk do you want?




Oh and rehi Kiffy, good to read you again.

P_1

Been reading up on this blog written by a former head of ASH UK. I have to say he makes a lot of sense in what he is writing, has anyone else read it?

http://www.clivebates.com

tommy2bad

Read it, I printed it and sent it to Nessa Childers aid or office boy or whatever he is.
The letters are working btw, theirs a meeting with ecig reps now on the cards, so good work everyone.

Lucutus

This here is an interesting development, a rejection of the directive, from a politician, no less.

Hopefully they follow through and make it official.

grindle

Ecigs are already banned in Denmark. Not so forward-thinking.

Weirs that that article doesn't mention that they banned them years ago, what's that about? Was there an about-face very recently?

tommy2bad

grindle wrote: »

Ecigs are already banned in Denmark. Not so forward-thinking.

Weirs that that article doesn't mention that they banned them years ago, what's that about? Was there an about-face very recently?

Think it's more to do with proximity to Sweden and support for snus but on the principal of any port in a storm, hopefully this will be leveraged to get some retraction.