Long awaited MHRA announcement

[santa668]

I'm not sure when this Impact Assessment by MHRA came out but it is interesting. It's quite long so I've summarised some interesting points in case tl:dr...

"We are only interested in e-cigarettes that contain nicotine, and we have adopted the term Electronic Nicotine Delivery Systems (ENDS) to describe these particular products."

Here's the key fact for cynics:

"The UK market for unlicensed NCPs is expected to be worth around £100m in 2014. By comparison, the existing licensed NRT market was worth £110m in 2012"

But they are happy to say (in a begrudging, convoluted manner):

"28. While contaminants in ENDS have been identified, and the long term health effects of inhaling ENDS vapour are unknown, so far there is an
absence of evidence that shows that these problems create significant harm to health.
29. There is also uncertainty about the long term effects of nicotine consumption, although it is worth noting that any risk is likely to be very small
compared with smoking."

They discuss 4 options, from "Do nothing" to "Medicinalise everything" (favoured result...)

And here are the estimated costs to manufacturers/vendors (of Options 3/4 - medicinalisation):

"51. To abstract from this uncertainty and provide an illustration of potential costs, we have estimated the direct costs that would be borne by a single UK firm wishing to import an ENDS product from a non-EU source. Such an importer would have to acquire and maintain a Marketing Authorisation (MA), a Manufacturer’s/Importer’s Authorisation (MIA), and as part of the MA, satisfy requirements for on-going monitoring of product safety and effectiveness once the product is on the market (pharmacovigilance). Distributing ENDS in the UK would also require a Wholesale Dealer Licence."

 
                                                             One-off | Annual Recurring | Present Value | Annualised

Marketing Authorisation costs
Lower estimate                                        £215,000     £1,000         £222,000     £26,000
Upper estimate                                        £350,000     £1,000         £357,000     £41,000

Manufacturer's Import Authorisation costs
Lower estimate                                        £23,000       £39,000       £322,000     £37,000
Upper estimate                                        £23,000       £190,000     £1,467,000  £170,000

Wholesale Dealer Licence costs
Lower estimate                                        £4,000         £9,000         £70,000       £8,000
Upper estimate                                        £7,000         £43,000       £331,000     £38,000

Pharmacovigilance costs
Estimate                                                 £10,000       £16,000        £150,000     £17,000

TOTAL
Lower estimate                                        £252,000     £65,000        £747,000     £87,000
Upper estimate                                        £390,000     £249,000      £2,288,000  £266,000

[I'm not sure what Present Value refers to here? Anyone else?]

Conclusion:

"Putting the costs into context 
58. From a UK societal perspective, our estimated costs of compliance lack meaning unless they can be put into the context of the possible benefits
the policy might bring. The lack of direct evidence of the safety and efficacy of licensed versus non-licensed NCPs (discussed in previous sections of this IA) means that we can not estimate these benefits directly. However, we can calculate the number of additional successful smoking quit attempts a year that the proposed policy intervention would need to generate in order for the benefits to justify the costs. On the costs side, we have used our estimated annualised cost range of £87,000 to £266,000. On the benefits side, we have used the estimated value of the health benefits gained from a successful quit attempt. We reported this figure as £74,000 in paragraph 35.

59. The calculation reveals that very few additional successful quit attempts would be needed in order to justify the costs borne by a single UK
MA holder. Given the uncertainty of our estimates, we think that the precise result (between 1 and 3 additional successful quit attempts a year) is much less important than the orders of magnitude of our estimates. These suggest that the policy would only need to be marginally successful (generate very few additional successful quit attempts) for it to be justified.

60. However the reverse might also be true. The policy might only need to be marginally unsuccessful for it to be considered a costly failure. If the
design and implementation of the policy has the effect of reducing access to NCPs (particularly ENDS) then it is possible that the number of successful quit attempts could decline. If there were no substantial countervailing health gains from improvements in safety, the policy’s overall impact could be highly negative."


I'm not sure I quite understand this - the value of the health benefits of one person quitting is £74,000, so they want to put costs of up to £266,000 on the vendor/manufacturer? Surely these costs would otherwise be borne by the NHS or the individual, why should the vendor pay to benefit the consumer?

[santa668]

Actually, what's most interesting about that Impact Assessment is how enthusiastic it is about e-cigs - their main objective appears to be to encourage more smokers to take them up, for GPs to be able to prescribe/recommend them. They clearly state that the health risks are (as far as anyone knows) minimal, and that they are being used to quit smoking. They do identify in point 60 the concern that we all have - that this will kill vaping as we know it - but today's news shows they don't care.

[MarkS]

Jun 12, 2013 17:22:30 GMT matt1988 said:

This made me cross, found it on twitter:

scienceblog.cancerresearchuk.org/2013/06/12/licensing-e-cigarettes-opportunities-and-risks/?utm_source=twitter_cr_uk&utm_medium=cruksocialmedia&utm_campaign=owntwitter_tweet

Good comment Matt

Doubt they will publish mine which was along the lines of  "you lot do rather well out of people becoming
ill and dying of cancer and you see ecigs as a threat to the cosy little positions you've carved out for yourselves by them doing so"

Cynical maybe and I'm sure they have helped many people over the years, but i cannot help but feel there is some truth to it...could be wrong though.

[Banky]

Let's see what happens during the 3 years before the legelistation comes into effect,
I think a lot will happen before this. It won't stop me stocking up with nicotine,
I don't think we won't be able to get our hands on flavour's either it will just be
more expensive to buy. Or for that matter VG and PG.

The only one's who are going to benefit from this, if these proposals are not challenged in a court of law
are the tobacco comp's and the pharma's, and lets not forget the government through tax.

[fiddles]

The real deal here is MONEY>>>>>GOVERMENTS are loosing revenue >>>> Side effects you will live LONGER

anyone who is naïve enough to believe that this has anything to do with health, well there's no hope for you

Goverments want to Screw us for as much money as they can & kill us off as close to retirement age as possible

HOW DARE YOU CHOOSE A HEALTHIER ALTERNATIVE THEY WANT YOU TO CARRY ON WITH STINKIES SO THEY CAN REAP THE REWARDS, NOT YOU !!

[kibbster]

Jun 12, 2013 17:58:11 GMT MarkS said:

Jun 12, 2013 17:22:30 GMT matt1988 said:

This made me cross, found it on twitter:

scienceblog.cancerresearchuk.org/2013/06/12/licensing-e-cigarettes-opportunities-and-risks/?utm_source=twitter_cr_uk&utm_medium=cruksocialmedia&utm_campaign=owntwitter_tweet

Good comment Matt

Doubt they will publish mine which was along the lines of  "you lot do rather well out of people becoming
ill and dying of cancer and you see ecigs as a threat to the cosy little positions you've carved out for yourselves by them doing so"

Cynical maybe and I'm sure they have helped many people over the years, but i cannot help but feel there is some truth to it...could be wrong though.

I've posted a comment about the fact that the body that is supposed to regulate the big pharma (MHRA) is funded by Big pharma.
Tail wagging the dog.

[magicma]

Jun 12, 2013 14:38:00 GMT kurotoshiro said:

Just a quick question that puzzles me. (I don't know if there's a clear answer, but I'd be interested in any opinions.)

Suppose I manufacture an ecig. And suppose there are some regulations that come out of this whole process that classify "nicotine containing products" as medicinal.

Can I just put a sticker on my ecig which says "Only intended for the vapourisation of non-nicotine liquids" and side-step the whole thing???

I havent used tobacco / tobacco flavour in my ecigs for a long time now - just use a fruity juice I like (sometimes topped up with a dash of menthol)- so will I be exempt from 'them' taking my eciggies away???? Hope so. MMa

[Bluefish]

Jun 12, 2013 18:29:57 GMT kibbster said:

Jun 12, 2013 17:58:11 GMT MarkS said:

Good comment Matt

Doubt they will publish mine which was along the lines of  "you lot do rather well out of people becoming
ill and dying of cancer and you see ecigs as a threat to the cosy little positions you've carved out for yourselves by them doing so"

Cynical maybe and I'm sure they have helped many people over the years, but i cannot help but feel there is some truth to it...could be wrong though.

I've posted a comment about the fact that the body that is supposed to regulate the big pharma (MHRA) is funded by Big pharma.
Tail wagging the dog.

Hardly independant is it Kibbster

[Bluefish]

Jun 12, 2013 18:37:29 GMT magicma said:

Jun 12, 2013 14:38:00 GMT kurotoshiro said:

Just a quick question that puzzles me. (I don't know if there's a clear answer, but I'd be interested in any opinions.)

Suppose I manufacture an ecig. And suppose there are some regulations that come out of this whole process that classify "nicotine containing products" as medicinal.

Can I just put a sticker on my ecig which says "Only intended for the vapourisation of non-nicotine liquids" and side-step the whole thing???

I havent used tobacco / tobacco flavour in my ecigs for a long time now - just use a fruity juice I like (sometimes topped up with a dash of menthol)- so will I be exempt from 'them' taking my eciggies away???? Hope so. MMa

Fraid not magicma if it contains nicoteine, but i wouldn't get too worried about it at the moment.

[thingonaswing]

The thing that worries me is the EU muttering about reducing the nicotine content to 4% max, which is what makes the current NRT offerings worse than useless.

[mel]

``Early in 2010, the UK Department of Health suggested consumers should "exercise caution" in the use of e-cigarettes until the findings of ongoing safety studies were published.''

I take it safety studies have been conducted? Or they have, found no safety issues and had to find another argument?




Quote from news.bbc.co.uk/local/stoke/hi/people_and_places/newsid_9145000/9145313.stm

[Karma]

Ecigwizard's response

www.ecigwizard.com/blog/response-to-mhras-statement-today?utm_source=Ecigwizard+Newsletter&utm_campaign=1033b7fbb1-MHRA6_12_2013&utm_medium=email&utm_term=0_d5a6a33ffe-1033b7fbb1-41797381

[andym]

I think this is a bit of an overreaction.Its a well established fact that current NRT is hopelessly ineffective."Vaping" has skyrocketed,not just a bit but DRAMATICALLY.We all as Vapers need to give the Pro Ecig lobbies our FULL and ACTIVE support!!!The stress is on the ACTIVE bit!We cant allow ourselves to sit back and let "Someone" else do it!There has been a lot of what might be called "misinformation" in this report.It seesm to me that they only really looked at the "Lookalikes" rather than ALL of the currently available devices.This is a 2 pronged attack on us to screw more money from us.Lets face it,the Gubbermint has cocked up the Countries Finances and are now GRUBBING around for any stray pennies they can find!One thing that did give me hope was the statement that they would impliment this draconian edict once the EU wide Ruling comes into force.So if the EU one can be blocked/ridiculed or otherwise stopped then we can do the same.we CAN make them rethink,and we NEED to MAKE them rethink,its not like they havent backed down over crap policy decisions in the past!!!

Vapers UNITE and Lobby for a rethink!!!

[Jen]

Jun 12, 2013 19:30:55 GMT Karma said:

Ecigwizard's response

www.ecigwizard.com/blog/response-to-mhras-statement-today?utm_source=Ecigwizard+Newsletter&utm_campaign=1033b7fbb1-MHRA6_12_2013&utm_medium=email&utm_term=0_d5a6a33ffe-1033b7fbb1-41797381

So nice to hear some sense today!!

[greendollar]

' We are only interested in electronic cigarettes that contain nicotine ..... Electronic Nicotine Delivery System (ENDS) '

So vendors can carry on selling the hardware , empty cartomisers , atomisers , batteries and anything else associated with vaping aslong as the product doesn't contain nicotine .
So the legislation they want is really aimed at the crap off the shelf pre-filled rubbish that very few of us use then .