UK regulation - reports and updates
A thread for reports and updates on the possible UK regulation of e-cigarettes.
Discussion is at:
UK regulation -- Discussion thread
Last edited by rolygate; 06-06-2010 at 09:02 AM.
June 4th MHRA meeting
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 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.
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, and the same applies to adjacent notes marked with an asterisk, so: *.
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 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 - 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 any case there is a valid argument that if an ecigarette is sold as a quit-smoking aid, along with a statement such as, "Quit smoking and change over to using an ecigarette", then the invitation is clearly that the smoker would change from one product to another (perhaps a cheaper product or one seen as a better proposition), and that the meaning of the words 'quit smoking' is that they would do so (and are clearly invited to do so) by changing to a different product - which is not the same as giving up nicotine dependency since this is neither stated nor implied; and therefore the use of the term 'quit smoking' is justified and not an invitation to cease nicotine dependency which the use of the term 'smoking' might well be judged to mean.
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. #]
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. NRTs containing nicotine are not subject to extra tax and there would be many obstacles to imposing such taxes. #]
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.
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.
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.
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.
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).
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.
Since 'unlicensed medicines' are not controlled drugs, it is neither illegal to import them or illegal to use them. Crucially, it is not illegal to supply them by post, from overseas. Unless there were changes to existing legislation, this means it is impossible to prevent supply and use. If such changes were tabled then it would be clearly seen that the move was a direct reponse to the building ecigarette fiasco; and no doubt there would be opposition to such changes by other groups.
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. Korean manufacturers are now coming online. 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.
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
Last edited by rolygate; 06-16-2010 at 07:51 AM.
RPC Report on MHRA NCP consultation
Regulatory Policy Committee
66-74 Victoria Street
London SW1E 6SE
+44 (0)20 7215 5721
9 June 2010
Consultation on regulation of nicotine containing products
1. The Medicines and Healthcare products Regulatory Agency (MHRA), an executive agency of the Department of Health (DH), is consulting on introducing new regulations on nicotine containing products (NCPs) (excluding tobacco). At present any nicotine containing product that claims or implies that it can help with the cessation of smoking is considered a medicinal product by presentation and is regulated by MHRA (“regulation by claims”). These products are widely referred to as Nicotine Replacement Therapy (NRT). However, there are a number of NCPs, such as electronic cigarettes, which do not currently make such claims and hence are not regulated by MHRA.
2. MHRA believes that the regulation of all NCPs will “protect public health from products that have not been assessed for safety, quality and efficacy”. Any requirement for NCPs to be brought within medicine licensing would apply throughout the UK 1 .
3. The RPC has looked at the quality of evidence and analysis provided in the consultation letter 2 and accompanying impact assessment (IA) and, following a meeting with MHRA and DH, would like to make the following comments.
4. The RPC is of the opinion that the IA and consultation letter do not provide sufficient evidence to suggest that there is a significant risk to public health from currently unlicensed NCPs which would justify the future regulation of these products. MHRA should have made clearer what evidence is available to suggest there are safety and public health concerns about these products and considered a wider range of policy options before consulting on the introduction of a mandatory licensing requirement for all NCPs. In addition, the data and assumptions used in the IA for estimating the costs and benefits of the new regulations do not appear to be robust.
Policy background and rationale
5. Following a recent review of its current policy on the application of the definition of a medicinal product in the context of nicotine and, after obtaining legal
1 To the extent that this RPC opinion refers to a devolved matter it relates only to England. 2 There is a consultation letter sent to all interested organisation, and not a full consultation document. RPC Reference: RPC10-MHRA-0374 advice, MHRA has concluded that nicotine may potentially fall within medicines legislation because it affects human metabolism. MHRA is therefore proposing to regulate all NCPs (“regulation by function”), which means that all currently unlicensed products containing nicotine (excluding tobacco products) will either need to be removed from the market or licensed by a specific date. However, if MHRA considers changing its practice from regulating “based on claim” to a “regulation by function” principle, then it is not clear from the consultation letter how this will affect tobacco products (e.g. cigarettes), which also contain nicotine and hence will be within scope for these new regulations. MHRA has told the RPC that the tobacco products are excluded from this consultation as they have a separate regulatory regime and have no medicinal function.
6. It is not clear from the consultation letter or IA what specific policy problem MHRA is trying to address through the proposed new regulations. MHRA claims that the licensing of all NCPs is needed “in order to ensure there is no risk to public health from these products” (paragraph 18 of consultation letter). However, the evidence provided in the IA and consultation letter is not sufficient to conclude that there are serious risks to public safety and health to warrant regulatory intervention. In fact, the consultation letter itself acknowledges that the risk to the public health from NCPs is “unknown” (paragraph 17 of the consultation letter). MHRA has informed the RPC that there is potentially a legal obligation to licence these products. However, this issue is not clearly discussed and presented in the IA. The RPC also understands there is some limited evidence of potential harm from testing carried out by the US Food and Drug Administration.
7. The IA considers two options in addition to the “do nothing” option. These two options both propose the regulation of all currently unlicensed NCPs, and the only difference between them is the proposed timeline for implementation of licensing requirements. It appears that Option 1, which provides a much shorter transition period (21 days) than Option 2 (implementation by June 2011), is preferred by MHRA on the grounds of being consistent with their current practice. In addition, the “do nothing” option is not developed because MHRA believes that “it is neither in the public health interest nor commercial interest to leave the current regulation of NCP/NRTs untouched” (paragraph 10 of the IA).
8. Subsequent to this the RPC believes that the range of options considered is too limited and the selection of the preferred option is not based on a robust appraisal of alternative options and their costs and benefits.
Costs and benefits
9. The data and assumptions used in the cost and benefit analysis of the IA do not seem to be robust. In the consultation letter MHRA acknowledges that the number of manufacturers of unlicensed NCPs and the number of products on the UK market are unknown. However, the IA estimates of costs and benefits are based on the assumption that there are 24 manufacturers and 50 products available on the UK market currently. However, the origin of these numbers is not provided and this raises concerns about the subsequent quality of cost 2 estimates. MHRA has told the RPC that these estimates were based on the number of importers contacting the agency about licensing requirements. This needs to be clearly explained and presented in the IA.
10. MHRA estimates that there will be 1,312 additional permanent quitters of tobacco product users as a result of licensing of all NCPs. However, the assumptions and analysis behind this estimate do not appear to be supported by strong evidence. For example, the assumption that the proposed new regulations will bring a further 5% reduction in the number of individuals who permanently quit smoking using licensed NCPs per year is not based on a robust evidence and analysis.
11. Also, it is assumed that 50% of producers of currently unlicensed NCPs will obtain licences. It is not clear on what basis this assumption is made, nor is it clear why the cost of the remaining manufacturers and importers (for not being able to sell their products in the UK market) is not included in the cost estimates.
Impact on competition
12. The IA does not provide an appropriate assessment of the impact of the proposed regulations on competition. For example, the IA claims that all businesses will be equally affected by the regulations, while at the same time it assumes that at least 50% of manufacturers will be required to remove their products from the market as a consequence of the regulations.
13. The regulations are likely to create additional barriers for entry for new producers and importers of NCPs, which is not fully discussed in the IA. According to MHRA the European Commission has said that nicotine could fall within the medicines licensing regime. It is however not clear how consistent the proposed new regulations are with European Internal Market rules and how effectively they would be enforced to achieve their aims in this context.
14. The RPC is pleased to note that MHRA acknowledges the deficiencies in the existing analysis and evidence base, and the way the available evidence is presented in the consultation letter and the IA. The RPC hopes that these shortcomings will be addressed in the next version of the IA.
Michael J S Gibbons OBE
download pdf here:
Last edited by rolygate; 06-18-2010 at 11:44 AM.
RPC - First Six Months Report
The RPC has published a Report into its first six months of operation:
Regulatory Policy Committee Blog Archive Publication of first RPC Report “Reviewing Regulation”
The Report notes that while most new regulatory proposals are properly framed, a percentage have issues. In some cases the proposed regulation did not seem advisable.
Whilst the MHRA proposed regulation of ecigarettes would clearly be a prime example of ill-advised regulation, according to the RPC definition, it is still not clear whether the RPC has any influence at Ministerial level to block such badly-planned regulatory moves.
The full report is in a PDF that can be downloaded on the page linked above.
Publication of first RPC Report “Reviewing Regulation”
August 6th, 2010
The RPC today publishes its first report “Reviewing Regulation“, which summarises the results of its independent, real-time scrutiny of new regulatory proposals out to consultation between December 2009 and May 2010, with 107 subjected to detailed review of the quality of evidence and analysis. It has published 22 opinions where it found major issues.
These first findings show that a good proportion of regulatory proposals are well supported by detailed analysis and evidence. However a number of them lack analytical rigour, are poorly presented and appear to be produced as a result of being required to do so, rather than as a means of open and thorough investigation and inquiry.
Commenting on the report, Mr Gibbons RPC chair said: “The RPC’s first six months of operation demonstrate the value of independent challenge – to business, consumers, employees and the general public alike. No-one benefits from poor regulation, particularly in tough economic times, and the RPC’s independent scrutiny of regulatory proposals so far have found that over one in five failed to make the case for intervention. We make six simple recommendations which should help officials make a stronger case. For example, policy-makers should not presume that regulation is the answer to the problem they are trying to solve and, where regulation is necessary and where all other options have been considered, they must produce reliable estimates of costs and benefits. It is not enough to produce apparently thought-free tick box exercises to obtain the necessary approval; policy proposals must be presented with a case that demonstrates how the regulations will achieve what they’re supposed to and fully identify and justify any burdens on the economy and society.”
‘Reviewing Regulation’ makes six recommendations to contribute to improving the decision-making process with respect to regulation in the UK:
- Don’t presume that regulation is the answer
- Consider all the options – and provide robust analysis of all alternatives,
including the ‘do nothing’ option
- Provide substantive evidence – and make sure it is properly referenced and sourced
- Produce reliable estimates of costs and benefits – assess all risks, costs,
uncertainties and benefits appropriately
- Assess non-monetary impacts thoroughly
- Explain and present results of analysis clearly
Further details on the recommendations are contained in the report.
The issues examined range from the inclusion of aviation in the EU Emissions Trading System to proposed changes to street trading and pedlary. They cover regulations affecting the public sector, the third sector, consumers, and businesses, with annual costs ranging from under a million per year to hundreds of millions.
For each proposal, the RPC has examined the case for government intervention, including whether both the costs and benefits have been properly assessed and whether other non-regulatory options were analysed and considered. Where the RPC had concerns over the robustness of the evidence and analysis presented it commented publicly. It does not however comment on the overall policy objective which is a matter for Ministers.
Last edited by rolygate; 08-09-2010 at 02:41 PM.
A compilation of reports of accusations of incompetence or corruption within the MHRA:
MHRA publishes result of MLX364 - Public Consultation into licensing of electronic cigarettes:
MLXs: Medicines consultation letters : MHRA
MHRA announces 'Do Nothing' as an interim procedure until Spring 2013.
The PDF with the decision contains no substantive decision or discussion regarding a decision, and instead attempts to avoid the issue entirely, merely mentioning in passing that 'more research will be done', and is available from the MHRA site, titled:
Outcome of consultation exercise MLX364 on the regulation of nicotine containing products (NCPs).pdf
We also have it here:
This is a win for the consumer and the industry. In 18 months' time there will be little practical change in the situation - with the exception that an EU decision on the same topic may overrule UK law.
Last edited by rolygate; 03-16-2011 at 06:49 AM.
A recap on the MHRA's MLX364 decision
Now that the dust has settled we can look a little more closely at the implications of the MHRA's announcement of last Thursday.
The first thing to clarify is that the decision is 'none of the above' - it is not Option1, 2, or 3. The MHRA were defeated since their regulatory proposal was rejected by the RPC. However, they cannot let the matter rest there, and since there is probably no rule that says they cannot keep trying even if rejected, they are in effect stating that they are going for an additional route:
Option 4 - avoid any and all IA or RPC problems by making the matter a legal issue and thus immune to blocking by the RPC or anyone else.
The implications of the I.A.'s rejection
Because the Impact Assessment was not perhaps managed as efficiently as it might have been, and was rejected by the RPC (we don't know for sure as the decision process was not entirely transparent, but it would appear to have been given a Red rating), the attack will be repackaged in a different way. Since the RPC have proven troublesome and won't rubber-stamp the IA fantasy tale, and look to be difficult to budge, another route must be found.
The prime thrust of the attack this time will be to attempt to prove that nicotine is a licensable drug, since other arguments (anything health-based or finance-based) were shown to be untenable last time.
The MHRA hopes to circumvent and evade the RPC by legal means since it would appear that a logic and numbers-based argument cannot succeed - as there is no logic to their position and the numbers don't add up. But if, on the other hand, the courts can be persuaded to find that nicotine is a pharmaceutical, then the MHRA succeeds - the RPC will have been outflanked. No I.A. is needed and nothing else needs fixing: job done.
It seems that the only defence against this particular attack will be a legal one, to show that in fact nicotine is a consumer recreational substance like coffee, caffeine-containing drinks, or alcoholic drinks. Some groundwork on this has already been done by the US legal team that defeated the FDA on this very point.
However the main problem for us will be that a legal battle is expensive. We will be facing the might of the pharmaceutical industry, who will use their money and taxpayers' money to fund the attack.
We need to be very clear on one thing: the MHRA have already decided that they will license e-cigarettes as a pharmaceutical, and had decided that before the public consultation. What they have to do is to find a way to push that decision through.
In one year's time (not 18 months) you can expect the MHRA to state they have evidence to show that nicotine is a pharmacological agent, and thus a drug that requires licensing. Many within the pharmaceutical industry will now be put to work to provide evidence for the MHRA to use, and you can be sure this work will be very well funded. They have a year or less to carry this out, and most likely have already started.
Only a legal defence can stop the attack. In this regard the UK situation will then mirror the US one. It does look as if they have chosen their ground well this time, learning from their first failure: a legal battle is expensive, and they hold all the cards. They have pharma money, and they have your money too.
In addition, if the attack should by some chance fail, the MHRA have an excellent excuse for their masters: we did our best but the evidence you provided us with, and/or the legal team, and/or the funding was just not enough - so it's your fault, not ours. Plus: now the courts have told us we have to leave this matter alone.
They failed last time, and managed to look a little foolish, because Goliath should not be defeated by a midget - but this time round they have an excellent get-out-of-jail-free card. Great news for all at the MHRA, because this time they can't really lose, whatever happens.
The unknown quantity in all this is the EU. Nobody knows what they will decide.
Last edited by rolygate; 03-18-2011 at 03:48 PM.