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Post by Chrissie on Jun 9, 2010 8:39:19 GMT
Similar Kate, but not exactly the same :
Meeting Report
ECF attended the June 4th MHRA e-cigarette consultation meeting at their head office in Vauxhall, London.
The MHRA is the pharmaceutical regulatory arm of the Department of Health, and controls the licensing of medicines and some healthcare products. Present were about thirty-five people, approximately twenty-five trade and community representatives and ten MHRA staff. The stated objective of the meeting was a consultation exercise in which the MHRA would engage with stakeholders to determine the current situation in order to decide whether or not to impose a new regulatory control framework for e-cigarettes in the UK.
The meeting was a part of the consultation process in which the MHRA would determine further courses of action.
Trade representatives pre-meeting discussion
Prior to the meeting, the trade reps met and discussed the day's agenda. Although some had met previously, mainly those from the same locality, most had never met or perhaps even communicated beforehand.
There was clear and unanimous agreement that ecigarettes were a consumer product and not a medicine of any kind. None of those present marketed ecigarettes as a quit-smoking or health product, but as an alternative nicotine product that could be described as an Electronic Nicotine Product or ENP, or an Electronic Nicotine Device or END. It was agreed that ecigarettes were no more a medicine than coffee, alcohol or tobacco cigarettes - none of which are licensed medicines.
A pro tem Chair was elected to chair the pre-meeting and act as a spokesperson/contact point if/when required by the MHRA. Tony Price, CEO of the E-Cigarette Forum, was chosen for this task since he was seen as independent, and not connected to any of the suppliers present, and had experience chairing committees in other arenas.
Katherine Devlin was chosen as the trade technical/legislation spokesperson, who would present the trade opinion at the subsequent meeting.
Jim Palasota of Njoy USA / UK would present the view of international suppliers who operated in more than one country.
The meeting
In the following report, text marked thus: [# text here #] is our analysis and not necessarily that which was stated, or stated in full as given here, within the meeting
The event lasted for two hours and was chaired by the MHRA. It was a professionally presented affair, handled very competently by the Chair, Dr June Raine, Director of Vigilance and Risk Management. The MHRA technical spokesperson was Jeremy Mean. MHRA at all times adopted a non-confrontational approach and invited a rational presentation of the ecigarette industry's concerns.
MHRA asked that the trade not record the meeting, their minutes would be provided at a later date. MHRA requested responses on the meeting from the industry at the latest by June 9th. Since the minutes were initially promised for the 16th this created an unworkable situation and therefore either the minutes will need to be submitted much earlier, or the trade responses will need to be accepted much later, otherwise the trade is placed in an impossible position.
From the outset MHRA maintained their position that ecigarettes appeared to be a medical device. Three options were presented for a legislatory framework (from document MLX364), the first two of which involved licensing as a medicine and which were therefore unacceptable to the trade, and the third being a 'Do Nothing' option. The wording of the options as presented in the meeting were significantly different from the options as written in MLX364, being foreshortened. This led to the removal of the heavily biased and inflammatory language which had been included in Option 3 of the original MLX364.
It was explained that the MHRA stated preference for option 1 (recommending withdrawal from market within 21 days)* in MLX364 was a facet of the way that the MHRA would usually operate and included by default. However, it was acknowledged that this is an unusual case and that other alternatives would be considered on the basis of the consultation process.
* Withdrawal meaning subsequent to when the consultation process terminates, probably September
It was also stated that government did not allow a 'green paper' approach in which new and innovative products could be assessed independently of other existing products. All new products would need to fit somehow into existing legislation.
In addition, MHRA attempted to take control over and ownership of Harm Reduction mechanisms, and their stated position was that all/any Harm Reduction came under medical licensing controls.
See Note 1
Trade representatives repeatedly stated that since ecigarettes were not a medicine, and had no known negatives, there being no recorded case of any harm resulting from their use, and there being no research or other data that suggested they might in any way be harmful, and since they were a consumer leisure product of the same class as caffeine/coffee or alcohol, and since they were not sold as medicines or devices having any medicinal function*, and since they were not sold for the purpose of or designed for or used to treat any disease, they were clearly a GSP product (a General Sales Product under Customs & Excise classification) and therefore under the remit of the DTI**, and not in any way under the remit of the MHRA, especially since they were already effectively regulated by LACORS / Trading Standards authorities.
While Mrs Devlin was explaining the current GSP classification, Dr Raine interjected that Mrs Devlin appeared to have misunderstood the MHRA's GSL medicinal classification; it was therefore clear that MHRA did not know of the GSP classification (General Sales [ie consumer] Product) - and therefore clearly outside the MHRA's remit.
* If a supplier sells ecigarettes as a quit-smoking device then that would define it as a medicinal device, probably an NRT (see below). No suppliers present did so.
** Recent changes in government mean that the DTI is now reformed as the BIS, the Department for Business Innovation and Skills. The DTI website now redirects to the BIS site.
MHRA continued to assert that in their view ecigarettes were a medicine of some kind, probably an NRT (nicotine replacement therapy), and should probably be licensed as such.
MHRA clearly demonstrated little knowledge of the product and could not answer any questions on specifics regarding the constituents or their effects, or even the requirements for the technical specifications of an NRT* such as a minimum blood nicotine level for classification as such.
* Nicotine replacement therapy, a quit-smoking aid.
It was then revealed that there was in fact no requirement for an NRT to have any nicotine nor indeed any effect. MHRA stated clearly, openly, and repeatedly that it is not necessary for an NRT to supply any nicotine whatsoever (since it is not specified or measured), and that an NRT, even nicotine patches, could be - and indeed currently are - licensed by MHRA even if they do not supply any nicotine to the user, since this is neither measured nor is there any minimum or maximum standard for such devices and thus there is no requirement for them to function in this way.
When repeatedly asked for a specification for the nicotine efficacy of NRTs such as nicotine patches, MHRA repeatedly affirmed that there was no such specification. NRTs were classified as such because they were marketed as such, there was no requirement for them to supply any measurable amount of nicotine. An NRT will be licensed even if it supplies no nicotine as this is not measured.
See Note 2
MHRA's Jeremy Mean, when asked to give a specific response to the question of what exactly nicotine can be used to medically 'treat', replied: "Well, nicotine treats tobacco addiction" - presumably inferring that (a) nicotine-supplying devices were therefore devices "to treat tobacco addiction", and (b) that nicotine is used to treat tobacco addiction - both points on which there might be some disagreement.
The implications of a ban
It was explained to MHRA that they seemed to have little knowledge of the product, no idea of the scale of the issue, and even less appreciation of the fact that licensing as a pharmaceutical would inevitably drive product supply underground and create a massive black market.
This is because MHRA licensing costs are in the region of £350,000 - as has been confirmed by one UK ecigarette supplier who has chosen to take this route. The product license has a price in the region of £30,000; together with the fact that getting to the stage where a license application can even be made can cost more than £300,000 according to a supplier who has elected to comply with MHRA requirements for commercial reasons*. There are very few suppliers who could afford this process, and even less who would want to. The result would be the termination of the industry as it stands, with the loss of more than 500 jobs, high expense for the social services as a result, and the movement of supply to black market sources.
* Compliance would then open the door for the specific ecigarette involved to be prescribed as a medicine for Harm Management**. This has attractions for those who can operate on a scale large enough to justify the costs.
** Harm Management [see Note1] is the correct term for a Harm Reduction strategy that involves licensed pharmaceuticals, as against Harm Reduction products which may be consumer products and not licensed in any way. Harm Reduction by definition includes non-licensable products.
It was further explained that they did not seem to appreciate the twin issues of a potentially very large consumer base combined with a universal appreciation that there are no known negatives to using ecigarettes, plus strong public and media support for those forced to return to smoking tobacco and therefore a one in three chance of early death. These factors would allow ecigarette use to grow even if 'banned', since supply would not be an issue.
They also seemed unaware that this has happened before both in the UK and USA with a popular consumer product*, and the result was defeat for government and an inevitable U-turn forced on the department concerned by government colleagues.
* The alcohol ban in the USA known as Prohibition, and the CB Radio ban in the UK which also resulted in defeat for government, in the 1970s.
See Note 3
Low-cost licensing options
MHRA posited that perhaps there might be two routes to a more economic way to license ecigarettes.
1. It was stated and repeated by MHRA that wide scale clinical research trials are not now needed, if previous research could be utilised. Instead, current research data could be quoted, and small-scale trials involving no more than 20 people could be conducted. The combined results would normally be acceptable to the MHRA, if favourable, for licensing purposes.
2. It was suggested that there might possibly be some way to combine applications so that costs could be reduced further.
The industry response was that in the case of Option 1, costs of trials were so high that this option would still come in at around £100,000 gross and therefore be untenable for most suppliers. It was known that even the smallest trial involving one researcher was currently costed at around £50,000. Given that a trial would probably involve more than one researcher, and that the license cost approaches £30,000, even a figure of £100k looked optimistic.
In the case of Option 2, facts and figures would in any case need to be hard confirmed and stated in writing before any action be be taken that relied on this option.
[# It is thought that, in practice, costs would not be able to be reduced significantly, given that there were so many imponderables with this option:
(a) Would MHRA commit to a written undertaking in any case?
(b) Precisely what form would aggregation take in any case - combining the many different products offered by any given supplier? Combining the products of more than one supplier?
This option looked the least attractive of all since it would create a precedent and is therefore most unlikely to be honoured in full over any period of time, no matter what oral assurances MHRA might give while avoiding a written commitment. The very fact that MHRA are unlikely to offer any such deal in writing is a measure of how reliable the offer is. #]
However since e-cigarettes are not a medicine and are not marketed as NRTs, they fall outside of MHRA's remit in any case.
MHRA desire for e-cigarettes to be seen as an NRT
MHRA asked three times, at different points in the meeting, if trade reprentatives present currently sold any other form of nicotine product such as nicotine gel or nicotine gum. Each time it was firmly stated that none did, as they only sold a consumer leisure product and not medicines of any type.
MHRA stated that some suppliers marketed their products as smoking cessation devices. The trade countered by stating that if some rogue traders did so, they should be controlled and licensed as suppliers of pharmaceuticals, but that did not mean that the majority of the trade engaged in unethical marketing practices or sold medicines. Any product can be sold as a medicine by any trader - such as caffeine or alcohol for example - but that did not mean that the other 99% of the trade were selling medicines. It simply meant that such traders had voluntarily placed themselves in the medical supply area and should be licensed as such.
In addition, LACORS / Trading Standards has entirely sufficient powers of regulation and appears to be using those powers effectively. If this is not the case, examples would need to be given.
MHRA clearly does not have a monopoly on regulation of nicotine-containing products.
MHRA lack of knowledge
It was further stated by MHRA that ecigarettes are currently unregulated. This is clearly wrong and was strongly countered by the trade, since they are firmly regulated by LACORS through their local regulators, the Trading Standards authorities. All sales of ecigarettes via UK-based high street and Internet sales outlets are regulated by their local Trading Standards authority. Not just high street outlets but also UK Internet-only businesses were regularly visited, inspected, and materials-tested by Trading Standards. All suppliers present and tested had passed.
[# Therefore it appears that MHRA either is not aware of this or chooses to ignore this fact. It may be the case that MHRA is trying to take control of a general consumer product and take it away from BIS control as a general sales product, and from LACORS / Trading Standards, and both LACORS and BIS must therefore now be asked if they are aware of this strategy and whether or not they approve. #]
MHRA market research
MHRA stated that market research had been carried out, to research various aspects of consumer use and consumer opinion.
When details of this research were given, it was revealed that the trade technical / legislation advisor, Katherine Devlin, had been a participant in one of the MHRA focus groups whose opinions were sought.
Mrs Devlin was able to point out that the entire methodology of the research was flawed since the consumers had been told that ecigarettes were unregulated. Therefore, when they had expressed a preference to purchase products that were regulated, instead of reinforcing the MHRA's position in fact it utterly destroyed the validity of the research. Since consumers had been falsely told the products were unregulated, when traders present were able to show they were well-regulated and could give details of Trading Standards authorities' inspections and testing, it immediately showed that due to MHRA ignorance of many aspects of ecigarettes, their market research had been worthless (or that the process had been based on a deliberate lie in order to affect the outcome, which presumably is less likely).
Later, MHRA did state that they were aware that Trading Standards inspected and tested materials; but claimed that Trading Standards representatives had in fact come to them to "help them improve the regulations".
See Note 4 - the 'LACORS affair' [edit, Monday June 7th]
[# We think that if in fact this is true, the correct protocol between government departments would be that MHRA approached BIS with their concerns and asked permission to proceed. At no time was the responsibility for ecigarette sales regulation by BIS and Trading Standards acknowledged, in fact this point was consistently ignored. At no time was there any mention of a directive from BIS or LACORS authorising MHRA to proceed, and in fact the MHRA's consistent position was that no such notification would be needed. Perhaps the possibility that large amounts of medical license fees might theoretically end up in MHRA's coffers could be a factor. #]
Taxation
It was firmly offered by the trade that some form of alternative or additional taxation might be considered. It was recognised that as more smokers convert to e-cigarettes, at some stage there will be a shortfall in tax revenue, which should be addressed.
However if ecigarettes are classified as medicines then this option would not be available since extra taxation is not levied on medicines. Nicotine inhalers are not taxed extra and there would be many obstacles to doing so.
Meeting closes
The meeting ended with a strong case for maintaining the status quo, plus additional industry self-regulation, having been presented by the trade. MHRA had recorded the views presented on the day, and will return with a decision on further regulation possibly in September.
______________________________________________
Analysis
The single most promising result of the day was that ecigarette representatives agreed to form a UK trade body to continue to improve on self-regulation. It was agreed that if they could not work together to fund lobbying, legal advice, and self-imposed sane and sustainable controls such as a unified strategy for correct practice in packaging, marketing and materials testing, then the outlook was grim at best since they might be forced to accept the worst form of government control.
This in itself is something of a victory since it has compelled the trade to work together in the face of an outside threat.
It is hard to be optimistic about the outcome if the MHRA continue to maintain their position that they should oversee ecigarettes in the UK. They are clearly the wrong department to be regulating the ecigarette since it is not a medicine and is currently well-regulated by another department.
If LACORS / Trading Standards is demonstrating a lack of competence then in what form exactly does MHRA think their lack of competence is being demonstrated?
All trade and community efforts therefore need to be concentrated on reinforcing the fact that products are currently regulated by LACORS through their local representatives, the Trading Standards authorities, and that the status quo should not be altered in any way, except to provide a national framework for regulation by the self-imposition of standards by a trade body. Extensive detail was provided by members of how the TSA currently regulate suppliers and it was seen that such regulation was both fair and entirely sufficient for the products; but that an additional level of trade guidelines would help to cement the position of the current regulatory framework at a national level.
It is also now imperative that the level of public awareness of e-cigarettes (currently exceptionally low) should be raised by multiple means.
What now
It may be that MHRA's best course of action would be to document that detailed research has revealed that:
* E-cigarettes are currently regulated in an efficient and successful manner by another department
* That ecigarettes are not a medicine by any current definition of the term
* That MHRA are not therefore the correct body to be determining the legislative framework for ecigarettes in the UK
Proceeding contrary to this will:
- force ecigarette supply into the black market due to the pointless and prohibitively high costs of medical licensing;
- will remove a large amount of tax revenue from the domestic system;
- will destroy many hundreds of jobs;
- will impose extensive costs on the social support services;
- will eventually create a massive backlash from other government departments when the extent of MHRA mismanagement becomes apparent;
- will inevitably end in a painful defeat for government due to a large consumer base with wide support from the public and the media and of course free supply via the internet.
Internet sales will be forced offshore and there will then be no controls whatsoever, in contrast to the current system.
All this when applying unnecessary controls to a consumer product with no known negatives, that is currently regulated efficiently, and where absolutely no need for any change in the current regulatory environment has been demonstrated.
______________________________________________
Notes
Note 1
Comparison of Harm Reduction and Harm Management
The statement by MHRA that all Harm Reduction comes under MHRA remit runs counter to all logic and indeed medical practice since by definition many Harm Reduction products are consumer products, otherwise they could not work as they would not be chosen. Harm Reduction often involves consumer choice.
[There is a view held by a proportion of professionals working in the Harm Reduction field that all Harm Reduction products are consumer products and non-licensable.]
Medical licensing of Harm Reduction mechanisms transforms them into Harm Management, which is a different concept and differently regulated. Harm Reduction is a consumer-driven process which involves a choice of products that are both seen as less harmful and are desirable choices for the consumer - such as decaf coffee and low-alcohol beer. Harm Management on the other hand involves pharmaceuticals and is a licensed treatment regime, and is therefore not applicable to consumer choices such as low-alcohol beer and e-cigarettes.
Therefore the statement that Harm Reduction is an MHRA-controlled mechanism is fundamentally flawed. Harm Management on the other hand certainly is in the MHRA remit. Decaf coffee and e-cigarettes are not Harm Management products.
It is true that currently Harm Reduction and Harm Management are new concepts to the public and therefore knowledge of the terminology and practice are limited; and that 'harm reduction' may be used as a blanket term to cover both systems.
Note 2
NRT licensing specification
It appeared that MHRA technical knowledge of nicotine delivery systems as a whole, and their technical specifications for such devices, and even their requirements for such devices to be proven to work at all, were limited. The basic requirement seems to rest solely on the fact that if a device is marketed as an NRT, then it should be classed as one, and licensing will be available. Apparently it does not need to actually work since there is no measurement of that factor nor indeed any specifications for nicotine delivery nor any requirement for proof that the device functions as a nicotine replacement system.
Therefore, anything could be classed as an NRT and successfully licensed by the MHRA, even a bottle of ketchup, if it was sold as such. Presumably then the converse would be true - if a product was not marketed as an NRT then it would not be licensable by the MHRA.
This supposition was confirmed by the fact that there were many nicotine-containing products that are not sold as NRTs and are not licensed or licensable by the MHRA because they do not claim to be NRTs. NRTs are not measured for either efficacy (minimum levels of supply) or toxicity (over-supply) in any way, as far as nicotine is concerned. Clearly, they do not need to replace nicotine since this is neither measured nor specified in any way (neither the amount of nicotine in the device is specified or measured in any way, nor the effect of the device on blood nicotine levels is specified or measured in any way).
Note 3
The impossibility of maintaining import controls
It is impossible in practice to prevent the supply and sale of products that are in great demand by consumers and are widely supported by the public and the media, and this situation always results in defeat for government.
This is because it is not possible to prevent the supply or even the import of large quantities of products - especially when they are very small in size, since Customs has never succeeded in any such exercise. It proved impossible to stop the import of 'illegal' radio transmitters in the 1970s, which resulted in a defeat for government and forced public access to radio to be legalised, and it has always proved impossible to prevent the import of illegal drugs.
In addition there is now the considerable factor of internet sales. It is not possible to stop internet sales of unlicensed medicines since postal imports of such materials are not controlled when delivered in small consumer quantities, and where the website offering the medicines for sale is offshore. Therefore any ban in the UK would simply shift sales offshore and the supply would in effect be uninterrupted.
If a product is then considered which will have a large and growing consumer base, that will have wide public support due to its obvious benefits and no known negatives, that will gain a sympathetic media profile, that is very small in size, we can clearly see that a ban (as any form of medical licensing would effectively be) can only have a marginal effect on supply. In addition if users are not prosecuted due to the fact that using the product is not illegal, leaving only the importers and sellers to be prosecuted, then if sellers are offshore the chances of preventing sales and use are not just extremely slim but zero. The product has every chance of developing into a massively popular fashion trend if 'banned' in this way. Ultimately, defeat for government after great effort and expense is assured, along with a major public humiliation.
Compared with the radio fiasco, the difference this time will be one of scale: ecigarette usage would be of the order of at least ten times the magnitude. This leads to the inevitable conclusion that defeat for government would be even more certain and more painful.
It also needs to be understood that global supply is at an all-time peak as more and more manufacturers come online and supply gears up for the inevitable rising global consumer demand as smokers convert en masse to e-cigarettes. When global supply is abundant but one region has a vacuum plus strong demand, supply penetrates that region with ease.
There are dozens of large manufacturers and the annual turnover of just one of those in 2008 was $36m (thirty-six million dollars). That firm's turnover will be much higher now.
The largest manufacturers are in the Shenzhen industrial region of China. They are well-supported by government, as the business brings in large amounts of foreign earnings, provides many jobs, is a highly-respectable new business innovation of high quality, has zero negatives of any form whatsoever, and is positioned in one of the fastest-growing markets in the world. It is of course the ideal manufacturing business since manufacture is medium-tech, most labour is unskilled or semi-skilled, and growth is assured.
Note 4
The LACORS Affair
To all this must now be added an extraordinary incident involving LACORS.
Today, Monday June 7th, this affair is becoming a little clearer. A vitriolic attack on ecigarettes was launched on the LACORS website by their Chairman, Coun. Geoffrey Theobald on 2009-03-30. He launched into a tirade against PVs that seemed to feature a discovery by Trading Standards / LACORS of dangerously high-strength nicotine in ecigarettes on sale in several places. The strength was quoted as about 18% nicotine or 180mg [sic], or alternatively 20% strength. Not, you may note, the more likely 1.8% or 18mg. To this was added a rant about selling poisons to children.
These false claims were investigated by Katherine Devlin, an ecigarette technical & legislation expert. It might have been easier to explain away by LACORS if they admitted that an office junior had made some sort of elementary mistake in reading the ingredients label; but KD had obtained a lab report which was thought to be the source of the affair. The lab technician seems to have made an error of a factor of ten in calculating the strength.
In addition to the incompetence of the laboratory staff must be added LACORS failure to check such a serious allegation, and then publishing this damaging and completely untrue report without further investigation. They published a press release as well as publishing the article on their official website. In addition, the leader of the agency then launched an attack on the ecigarette industry that was founded on completely wrong data and quoted several falsehoods, and moreover appeared to have some sort of personal agenda. Further, they then refused to reply to correspondence on the subject and polite requests to remove the inaccurate material. Then, they also left the inaccurate, damaging and defamatory information on their website and refused to remove it until early June - a period of over a month.
Their incompetence - if that is what it is - in several different areas is hard to comprehend, and people are now starting to question whether an FDA-style 'dirty tricks' war has been started by two government agencies acting in concert.
At first, such thoughts seem a little harsh - but the timing of the LACORS errors together with the unwarranted MHRA assault now looks rather too coincidental, and a little too reminiscent of the desperate fight by the FDA to try and win at any cost.
We didn't think it possible for UK government agencies to engage in dirty tricks - but unfortunately we might have to think again. No doubt all is fair in love, war, and regulation.
Note: our analysis may be edited to reflect trade opinions as they are reported
Edits: Monday June 7th - added Note 4
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I do get the gist of most of it but I really struggled to make any valid points at all.
Lol I'd wondered why there would be 2 lots of minutes taken 
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