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Analysis of Regulatory Policy Committee Opinion of June 2010

14, Mar, 2011

When this opinion was first published last year, I produced an analysis of it. Since this predated the beginning of ECITA and our blog, I shall reproduce it here now, despite its being somewhat ‘dated’. 

Regulatory Policy Committee

9 June 2010

OPINION
Consultation on regulation of nicotine containing products

Introduction
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.

MHRA are seeking to change how medicinal products are classified. The use of the word ‘hence’ here seems to imply that the normal mechanism for deciding whether products should be regulated by MHRA as medicines, or by another regulator as general consumer products, relies solely upon whether or not claims or implications of health benefits are being made for a product.

In reality, this is unworkable, since there are many products making health claims which are not (nor ever will be) regulated as medicines by the MHRA, e.g. Red Bull, life-jackets, running shoes, seat belts, Yakult, hard hats, Lucozade, etc., etc.

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 UK1.

3. The RPC has looked at the quality of evidence and analysis provided in the consultation letter2 and accompanying impact assessment (IA) and, following a meeting with MHRA and DH, would like to make the following comments.

Summary Opinion

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.

It is entirely possible that the RPC is ill-informed enough to believe that this is merely an oversight on the part of the MHRA, and that (now that they have been prompted) the MHRA will go away and find the evidence which suggests that “there is a significant risk to public health from currently unlicensed NCPs” which would justify the MHRA’s behaviour. We know that this evidence does not exist, and if any proof of this were needed, it seems obvious that if such evidence were to be found anywhere in the world, the FDA in the States would have found it by now, and taken it to the Appeal Court as part of its legal case (which returns to Court 23rd September 2010). In the absence of any such evidence, the FDA will be returning to Court with no new evidence at all, and is highly likely to obtain a very similar verdict to that given in January by Judge Richard Leon.

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.

This paragraph appears to represent a resounding rap across the knuckles of the MHRA, but more importantly, the RPC appears to emphasise the fact that the MHRA should have undertaken much more thorough research and evidence gathering before entering into the consultation process. This is likely to become significant if legal action is pursued subsequently for punitive damages to the many small to medium enterprises which make up the UK ecig industry. The wording ‘mandatory licensing requirement’ smacks of disapproval in this context, too. Finally, to suggest that ‘the data and assumptions used… do not appear to be robust’ may well qualify as the understatement of the century, but at least the RPC return to this later on.

Detailed Opinion

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 advice, MHRA has concluded that nicotine may potentially fall within medicines legislation because it affects human metabolism.

MHRA has refused to disclose any details concerning this purported ‘legal advice’, claiming confidentiality privileges, despite numerous Freedom of Information requests. We simply do not believe that a legal mechanism has been found which exempts tobacco cigarettes while leaving ecigs affected. The MHRA acknowledges this challenge in MLX364 and the RPC Opinion seems to have a similar leaning. At the stakeholder meeting on 4th June, the MHRA were repeatedly pressed to quantify the precise level at which nicotine is determined to have an “appreciable effect on human metabolism”. To date, they have been unable to provide this information. Also, consider how many non-medicinal products/substances appreciably affect human metabolism, but are not being dragged kicking and screaming into requiring a Marketing Authorisation: the air we breathe, all foods and drinks, pollution, caffeine, chocolate, glucose, vigorous exercise – all these things affect metabolism significantly, and yet none are regulated as medicines. It seems unlikely that reliance upon an effect upon human metabolism can provide a legally sound basis for requiring all nicotine containing products – except tobacco products, potatoes, aubergines, tomatoes and many other vegetables which naturally contain nicotine – to be regulated as medicines, or arbitrarily removed from sale.

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.

I think it is significant that the RPC points out that the consultation proposals actually represent the MHRA’s considering “changing its practice” on determining how products should be classified for regulation. The MHRA is clearly aware that it cannot ever expect to have regulatory control over tobacco cigarettes, hence its desire to exempt them from this consultation, and yet their preferred option appears to leave little wriggle room for such an exemption!

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.

I believe there is a case to be made here: if tobacco products are excluded “as they have a separate regulatory regime and have no medicinal function” then so are ecigs. Our separate regulatory regime is the General Product Safety Regulations, CHIP and any and all other regulations monitored and policed by Trading Standards (having nothing whatsoever to do with the MHRA unless health claims are made or implied), and there is no medicinal function in switching from obtaining nicotine from tobacco cigarettes to maintaining one’s nicotine addiction by using an ecig. Job done, thank you very much RPC!

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.

The MHRA, together with the FDA, has been unable to find evidence “that there are serious risks to public safety and health to warrant regulatory intervention” because such evidence does not exist. On the contrary, the existing regulatory framework is a very comfortable ‘fit’ for ecigs, with regulation by Trading Standards.

“MHRA has informed the RPC that there is potentially a legal obligation to licence these products.” What can this mean? Can they believe that Competition Law requires that we have to license our products because NRT has to be licensed? No, that can’t be the case, since we make no health claims, treat no disease and are not medicinal products, whereas NRT claims to be a medicine (albeit a largely ineffective one!). I cannot see how there could be a “legal obligation to licence” these products which would be capable of excluding tobacco products and caffeine products. (It is rather interesting to see that this is what the MHRA believes, however ill-informed it may be!)

“Limited evidence of potential harm” is loose and woolly, and simply doesn’t stack up, particularly when one considers the truly robust scientific evidence which has been brought forward to negate the FDA’s initial report. The so-called toxins which were found were at levels similar to, or below those found in existing licensed NRT products. Even the dreaded di-ethylene glycol – a long-term approved additive in tobacco cigarettes – was found in only one out of 16 cartridges and at a level which would not cause harm. The UK government’s ongoing reliance upon debunked junk science (for which read ‘propaganda’) from the FDA is baffling in the extreme! However, I do not believe that we can successfully challenge this consultation (or its reliance upon junk science) until after the MHRA deigns to release its decision. Then, heaven help them!

Options

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.

Hear, hear!

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 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.

It will be enormously difficult for the MHRA to ‘clearly explain’ and present accurate information in a rehashed IA since they appear to be entirely clueless as to the extent of the UK ecig industry, or the numerous types of product ranges available. Despite the fact that the MHRA appears to have realised that they have insufficient knowledge about this, they do not seem to be attempting to find out any information which they could effectively use to create a realistic IA. Therefore, I believe it is unlikely that one will be forthcoming. I think that the fundamental problem faced by the MHRA concerning the IA is that it will not be possible for them to produce an IA which demonstrates the point the MHRA is trying to prove: that ecigs can be simply removed from sale with no negative impact and lots of positives. This is a fallacy, so creates an insurmountable challenge for the MHRA.

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.

We know that existing licensed NRT products fail at best 93% of smokers attempting to quit using these methods. Plucking figures from the air about the numbers who may or may not quit if ecigs were licensed as medicines, or removed from sale, indicates the MHRA’s entrance into the realms of fantasy, and is a total waste of time.

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.

The MHRA can’t have it both ways: they have not accurately reflected the costs of obtaining a licence, and yet assume that 50% will follow this course. This is highly unlikely, since it is exponentially cheaper simply to operate in a black market, which would be the logical conclusion of most businesses in this sector. Due to the high prevalence of internet sales in this industry, simply moving off-shore will guarantee that these products continue to be sold, resulting in any and all regulatory safeguards being lost.

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.

The RPC neatly side-steps the cross-industry competition issues (as does the MHRA’s consultation letter) by avoiding any acknowledgement of the competition issues between our industry, and the pharmaceutical and tobacco industries. It is entirely unrealistic to expect that any products would actually be removed from the market: prohibition didn’t work in the 1920s with alcohol in the US, and it won’t work with ecigs today. Our industry and customer base is just too big to be halted now.

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.

Since other Member States have made relatively sensible decisions regarding ecigs, e.g. Germany has offered 10 years to licence, Malta and Italy appear to have no problem with ecigs remaining on sale, it is hard to see how the MHRA can rely on the European Commission for support. It would be literally impossible to enforce or police restrictions on sales of ecigs across Europe and/or the rest of the world, and therefore it becomes even more important that the correct regulatory framework (under Trading Standards) be applied. The alternative is a completely unregulated – and ‘unregulatable’ – black market.

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.

Is it optimism, hope, or fantasy to suggest that there will be a ‘next version of the IA’? As indicated above, no matter how hard the MHRA tries, it cannot produce an IA which shows what they are trying to show. (They can claim the sky is green until they’re blue in the face, but we all know the truth….)

Michael J S Gibbons OBE
Chair

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 organisations, and not a full consultation document. RPC Reference: RPC10-MHRA-0374

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