Electronic Cigarettes and the MHRA Numbers Game - ECCAUK Blog

[KulrMeStoopid]

http://www.eccauk.org/index.php/latest/electronic-cigarettes-and-the-mhra-numbers-game.html

At the beginning of August, we wrote to Linda McAvan in an attempt to help educate her with regards to the EU TPD and the impact that the proposed MHRA regulation would have on the UK market. She is yet to reply.


The main thrust of our letter was to explain our interpretation of the MHRA 'clarification' on the Licensing Procedure for NCPs (document ref con297583) when read in conjunction with the MHRA Impact Assessment (document ref con286852).


We explained our interpretation of the documents:


...The cost of MA [marketing authorisation] is calculated on a per product basis. The definition of a product is such that any differences in (say) nicotine levels or excipient type would designate the product as distinct …. A vendor offering a 'small' range of products is likely to have a line of 200 'different' liquid items and many have significantly more...


To make life simple, we presented McAvan with an example using only 100 product 'variations' (roughly equivalent to a vendor with 8 flavours, 3 PG/VG combinations and 4 nicotine options):


...The MHRA figures published on 12th June indicate that this would cost such a vendor between £25.2 Million and £39 Million with a further recurring annual cost between £6.5 Million and £24.9 Million on licensing alone...


Huge numbers for a small vendor.


In the real world, the numbers quickly go from huge to ridiculous. ECigWizard have been told by the MHRA they will need to obtain 900 MA at a cost upwards of £1.8 billion. In other words, at least £2 million for each MA.


Another UK vendor sells 152 flavours of liquid and offers the following options


3 flavour strengths
4 different PG/VG ratios
8 different nicotine strengths
3 throat hit versions
To you and I, this represents the choice that makes vaping a viable alternative to smoking. However, in the eyes of the MHRA, it represents


152x3x4x8x3 = 43,776 'unique' products each requiring MA.


Calculating directly from the lowest figures in the MHRA impact assessment, it means an initial cost of £11 billion and a recurring annual fee of £2.8 billion.


Ridiculous numbers.


However, using the MHRA advice provided to ECigWizard (£2 million per MA) that would mean a cost of £87 billion


Farcical.


McAvan either has not read, does not understand, or is deliberately misrepresenting, the MHRA proposals.

 

[Mark]

Linda McKaven continue to suggest that these are just scare stories and it would be light touch etc. Her interview shown on VTTV last night continued along that line. Adding the insulting remark to the effect that of course ecig companies are all about profit and are avoiding the extra costs involved in ensuring their products are safe because that eats into their profits. Government isn't there to protect them. It's there to protect us. To Joe Public this sounds like common sense. We know the feckin truth

 

[VaperCaper]

I am stil dumbstruck after watching the interview she gave that was on VTTV last night.

How can anyone that clueless about the effects of the regulation she is rapporteur for be a rapporteur?

She claims that e-cigs under the proposed regs would still be available everywhere in the UK and they'd be cheaper (as there is no VAT on meds) while they might stll be available everywhere there would be an extremely narrow range of products to choose from as nearly every e-cig company around now would be put out of business. Anyone that did get a MA would increase the prices due to lack of competition and from the need to recoup the costs of the MA itself.

The single worst claim was "there aren't any UK manufacturers anyway - it's all imported from China" - still speechless.

All of the other tobacco control measures in the TPD combined might decrease smoking prevalence by maybe 1% - e-cigs would decimate smoking prevalence inside of a decade.

 

[steffijade]

Yep... their true motivations are apparent to those of us who realise what an impact these bullshit regulations will have for our current vendors.

Trouble is, the health 'professionals' and anti smoking lobby are by and large blinded to the implications by their single minded crusade to eradicate smoking and anything that even resembles smoking. They choose to class current smokers (and vapers) as being expendable, acceptable collateral damage in that crusade.

The largely right wing media pumps out mostly ill informed articles that often seem to be biased against vaping (perhaps the controlling interests in those media outlets are also heavily invested in tobacco?)

The government is full of corrupt, greedy politicians who are quite willing to sell out the public to protect their tax revenue streams, or even more deplorably, to line their own pockets by lobbying/legislating for greedy corporations that they then go on to receive sinecures from when they leave parliament.

It's a perfect storm of corruption, hypocrisy, greed, blind acquiescence by an uninformed general public and tunnel vision by health 'nazis' and poor feckers like us are caught slap bang in the middle of this tidal wave of bullshit.

I grow more cynical as every day goes by and apparently, with good reason.

 

[Tim]

Yep... their true motivations are apparent to those of us who realise what an impact these bullshit regulations will have for our current vendors.

Trouble is, the health 'professionals' and anti smoking lobby are by and large blinded to the implications by their single minded crusade to eradicate smoking and anything that even resembles smoking. They choose to class current smokers (and vapers) as being expendable, acceptable collateral damage in that crusade.

The largely right wing media pumps out mostly ill informed articles that often seem to be biased against vaping (perhaps the controlling interests in those media outlets are also heavily invested in tobacco?)

The government is full of corrupt, greedy politicians who are quite willing to sell out the public to protect their tax revenue streams, or even more deplorably, to line their own pockets by lobbying/legislating for greedy corporations that they then go on to receive sinecures from when they leave parliament.

It's a perfect storm of corruption, hypocrisy, greed, blind acquiescence by an uninformed general public and tunnel vision by health 'nazis' and poor feckers like us are caught slap bang in the middle of this tidal wave of bullshit.

I grow more cynical as every day goes by and apparently, with good reason.

Stop sitting on the fence and say what you mean why don't you...

Seriously though I agree entirely, and can't help but think that there are two forces driving this neither of them an elected body, and neither of them particularly ethical, but rather driven by profits, bonus' and share holders divvy.

my OPINION (which I am entitled to and have earned the right to hold and voice) is quite simply that the fag industry is concerned about losses but bigger than that the large Pharma companies stand to lose a fortune on not very effective cures which require will power. Moving onwards and outwards I speculate that there is a possibility these companies may fund certain R&D projects close to hearts of individuals and organisations involved in issuing papers on the effectiveness, and safety of Ecigs enmasse.. I would suggest that this might lead to a conflict of interest similar to those already seen and documented in the press.

Now call me old fashioned but IF my opinion, and speculation are correct isn't this corruption at the highest level?, and shouldn't there be an investigation into this open and without censure into this?

just a thought.