To whom it may concern
For the avoidance of repetition, we shall try to condense our response to answer all the questions and provide our evidence as succinctly as possible. My name is Katherine Devlin, and I am the President of ECITA (EU) Ltd, the Electronic Cigarette Industry Trade Association. Naturally, this industry, its products and Tobacco Harm Reduction are my specific fields of interest and expertise. Therefore, our submission will be deliberately focussed on these areas. Having said that, where appropriate, it will be possible to comment more widely, based on available evidence.
ECITA is directly involved in assisting the electronic cigarette industry – predominantly, our membership, but with a wide range of advice and assistance offered more broadly – with achieving legal compliance with the regulations which currently apply to electronic cigarette products. Trading Standards described ECITA’s Industry Standard of Excellence as “a Code any industry would be proud to have.” These are consumer products, not medicines or tobacco products. As such, they are subject to a variety of EU legislative instruments, all of which have been adopted by the UK.
Our business operation is based in South Wales, but we work with partners across the UK – both in the industry, and in co-operation with Trading Standards Officers and the National Measurement Office – and our members are located across England and Wales, as well as on the continental mainland of Europe. Our organisation, and all the SME’s which make up our membership, as well as the rest of the industry, are providing employment, paying taxes to the UK government, and achieving significant growth despite the recession – particularly in areas of low employment, such as South Wales, the North East of England, and elsewhere. Reclassification as a medicinal product would put ALL of us out of business, and assist both the tobacco industry, by making more appealing products less available, and serve to maintain the pharmaceutical industry’s monopoly on non-tobacco nicotine products. This is anti-competitive, disproportionate, and illegal. (There have already been 4 cases fought and won concerning this in Europe.[i])
The EU’s competence, along with that of each Member State, is crucially important, and we have grave concerns that there is an astonishing lack of knowledge about electronic cigarette products and the scientific evidence base concerning them. This is evident at the Commission, with the ill-conceived proposal to include electronic cigarettes in the revisions to the Tobacco Products Directive, despite the Commission’s own acknowledgement that these are not tobacco products. Worse still, the European Commission is proposing to include electronic cigarettes in the revised TPD, but as medicinal products unless diluted to the point of utter uselessness. Under Article 288 of the TFEU, this proposal would lead to a regulation “binding in its entirety and … directly applicable in all Member States”. It is probably fair that the Tobacco Products Directive should be such an instrument, but the inclusion of electronic cigarettes in it demonstrates the risks inherent in the EU having such legally-binding competences.
There is a worrying tendency to ignore scientific evidence, and not to robustly assess it. This seems to be a disturbingly wide-spread trend, which has significant implications for every area of society, and must be addressed by policy-makers; it is simply not good enough to skim read conclusions from a study, or assess the methodology of a research protocol from the associated press release. We have no desire to ‘cherry-pick’ the evidence, but ask that all the scientific research studies relating to electronic cigarettes, tobacco harm reduction, etc., be allowed to stand on their own merits, but this is only possible if policy-makers will pay them the proper attention and take the time to properly assess them. We have collated all the studies we could find (‘good’ and ‘bad’, in terms of scientific rigour) on our website at www.ecita.org.uk[ii].
The UK national interest is currently enjoying health advantages in having the robust and stringent EU legislation on consumer products (e.g. the General Products Safety Directive, and attendant regulatory statutes) ensuring that the standards of electronic cigarette products are necessarily high. The fact that these standards are codified centrally by the EU for all Member States is actually enormously beneficial, particularly with regard to the centralised reporting systems (i.e. RAPEX) which allow for sub-standard products to be swiftly removed from the market. This system is effective, and very beneficial in protecting the UK’s ‘vapers’ as well as those in the other Member States, and ensuring they can have access to properly legally compliant products which are safe for use as intended. (The same cannot, of course, be said for tobacco products, or some medicinal cessation products.[iii])
The UK national interest would, however, be severely disadvantaged if the EU were to reclassify electronic cigarettes out of this robust system, and into the inappropriate (and disproportionate) medicinal classification, as they appear to be trying to do. Ultimately, the EU’s approach is legally flawed (Article 34 protecting the Internal Market, proportionality requirements, etc.) and is likely to fail on challenge, but nevertheless, I believe it is crucially important for the UK – with its potentially influential role – to remain in the EU, so as to be able to provide that all important influence to ensure that the citizens of all Member States are empowered to achieve the best possible public health outcomes. That said, the UK must be careful not to make counter-productive decisions on this issue for itself anyway.
The UK will struggle to have its voice heard at all if we are not a party to the debate, and we have a crucially important role to play, in insisting on robust scientific analysis relating to policy decisions. (To be fair, this is an area which requires some considerable improvement even in the UK, but we are a long way ahead of some of our European colleagues, who will need the UK’s common sense approaches in the future.)
It is fair to say that the UK has been instrumental in driving the growth of the electronic cigarette industry in Europe. Many of our colleagues on the continent are also experiencing significant growth, but the UK has been a leader in manufacturing (we were the first Member State to have entirely EU-sourced ingredients being manufactured into eliquid for electronic cigarettes) and marketing UK-manufactured products to the world. The UK was also the first to develop an internationally-recognised and highly-respected Trade Association with a focus firmly on improving the standards and legal compliance for this industry. These are both businesses that I am personally involved with: my brother owns and operates Decadent Vapours Ltd (of which I am a Director), which was the first company in Europe to produce eliquid manufactured with every ingredient being sourced from within the EU; and ECITA (EU) Ltd is the Electronic Cigarette Industry Trade Association, of which I am President.
Now, I am delighted to see that there are many other well-organised and effective Trade Associations acting for the best interests of public health at a population level, as well as representing the businesses within the industry across other Member States. Also, there is an increasing number of manufacturers sourcing ingredients from within the EU for eliquid. This increases the range of choices available to consumers, thus increasing the likelihood that more smokers will be able to successfully make the ‘switch’. Naturally, however, it is inappropriate to talk in terms of ‘efficacy’ as a ‘quitting tool’, since those are medicinal concepts and this is a consumer-driven behavioural change which has already proven to be more effective than the medical approaches. (The electronic cigarette industry is now estimated to be worth approximately €500m, and has already overtaken the NRT market share, in the space of a few short years.[iv])
It is perhaps worth pointing out that the impact on the pharmaceutical industry, and the tobacco industry, of this ‘shift’ to the electronic cigarette industry is little more than a ‘fly in the ointment’. Both the pharmaceutical and tobacco industries are now ‘buying in’ to electronic cigarettes, but it is important to remember that the electronic cigarette industry was created and developed entirely separately from both these big players. Furthermore, it is the substantial growth of small to medium enterprises, with their significant contribution to the economic health of the nation, which makes this fledgling industry so desperately important – not just for the health of UK citizens, but also for our economic growth, so desperately needed during these austere times.
It is important to recognise the distinction between ‘patients’ and ‘citizens’ (or ‘consumers’, in a non-medicinal context). The reclassification of electronic cigarettes as medicinal products would be a tragedy of significant proportions, if the focus is truly about improving public health outcomes. As Professor John Britton said recently:
“If all the smokers in Britain stopped smoking cigarettes and started smoking e-cigarettes we would save 5 million deaths in people who are alive today. It’s a massive potential public health prize.”
Unfortunately, if electronic cigarettes are reclassified as medicinal products, they will have to fundamentally change, in terms of form factor, flexibility of performance, the range of models, flavours, and strengths available, not to mention the impact this would have on price. At the moment, smokers are not switching to using electronic cigarettes to replace their NRT habit; they are using electronic cigarettes to replace some or all of their tobacco cigarettes.
Smokers are individuals, with individual needs and preferences which are many, varied and constantly variable: one smoker may smoke 3 tobacco cigarettes in quick succession first thing in the morning one day, then hardly smoke at all until the evening; on a different day, this same smoker may not smoke at all until lunch time, and then have occasional cigarettes throughout the afternoon. Each cigarette smoked by this one smoker may be smoked differently at different times – sometimes smoking every possible puff, other times, allowing the cigarette to burn away for much of the time without puffing. It remains a stubbornly tenacious fact that approximately 20% of UK smokers are unable or unwilling to ‘quit’, and the medicalised interventions are simply not working to reduce that number.[v]
This is the habit which millions of EU smokers are replacing with ‘vaping’. And it has nothing whatsoever to do with ‘medicine’ or ‘treatment’. It is crucially important that the ‘massive potential public health prize’ Professor Britton spoke of is not thrown away due to dogmatic ideology (the ‘quit or die’ mentality, espoused by the WHO, and widely disseminated with the almost global adoption of the distinctly unpleasant connotations arising from ‘denormalising’ smokers).
There are already reputational benefits for the UK as being seen to ‘lead the way’, with the Behavioural Insight Team’s acute analysis of the issue, published in September 2011[vi], and the Royal College of Physician’s frequent calls for an overhaul of the approach to nicotine in all its forms (dating back to 2007)[vii]. Indeed, quite recently, Professor Ron Borland, Nigel Gray Distinguished Fellow in Cancer Prevention at Cancer Council Victoria, based in Australia, said:
“The death and disability toll from cigarette smoking is far too high not to be doing all that we can. The rise of a consumer movement, as I understand almost entirely consisting of ex-smokers, supporting the use of e-cigarettes is the first social-level evidence that there might now be substitutes for cigarettes that will be readily taken up by smokers. These and other strategies should be actively considered. The UK should be congratulated in their apparent leadership in this regard (if the current draft NICE proposal is adopted). More countries should follow.
If tobacco control is important enough to have the FCTC, it is important enough to be taking bold steps to eliminate. We must be doing more.”[viii]
Whilst we recognise that this might appear to be an issue of minuscule importance in the grand scheme of public health issues, for individuals such as myself, and the million other vapers in the UK, and the many millions across the EU, it is very significant and literally a matter of life or death. I speak from bitter personal experience having lost my husband to tobacco-related cancer at the age of just 31.
The “extent to which the EU’s role in public health supports member state actions effectively and efficiently” is not an area I have studied extensively, but my view is that the EU needs to calm down a bit, and perhaps step away from making centralised rules, but rather seek out best practices from across the Member States and then put these forward for harmonised adoption. Once again, the UK should be a leading voice in such activities, since we have some demonstrably excellent practices, particularly compared to some of our fellow Member States. We cannot influence the EU if we are not part of it, and I believe we have a duty to our fellow citizens on the mainland to offer them the benefit of our considerable expertise and best practices in a range of areas.
There is also the fact that the UK can benefit from the best practices of other Member States in areas where we are not doing so well by ourselves. Certainly, the European Union has many, many flaws and failings. It is almost inevitable that such a huge project would make a great many mistakes – as is true of any political body, or any other large gathering of flawed humans (‘to err is human’, after all). But surely the UK has a duty, along with all the other Member States, to continue to fight for the best that can be achieved, particularly with regard to public health outcomes for the millions of EU citizens.
In terms of public health, it is crucially important to remember that the ‘delivery of health and social care’ is not just about health care service providers; the single market is an enormously beneficial tool for ensuring that health-improving lifestyle choices can be promoted. If policy makers care about public health, surely this should not be in a blinkered, localised manner, but should spread to our neighbours on the continent too? We benefit from having the free movement of workers, since we can welcome skilled workers from outside the UK, and our own citizens can choose to work elsewhere in the EU. This sort of choice is beneficial in the broader sense of ‘well-being’ promotion, in the sense that EU citizens have some freedom in choosing where they want to live and work.
We believe the UK government is right to insist on a reduction in the budget for the proposed ‘Health for Growth’ campaign. It is all too easy to see examples of wastefulness in a range of health projects and other areas of government – in the UK and EU. In terms of cost-effectiveness, government investment in NRT and Smoking Cessation Services through the NHS has been criticised by the Behavioural Insights Team and others, but what we are seeing with the significant uptake of electronic cigarettes is costing the UK and EU governments nothing; citizens are willingly funding this behavioural change for themselves, independently. This is not a health project requiring government funding, and so would seem to be an ideal ‘fit’ for the ‘Health for Growth’ campaign, as well as providing support for a reduction in the budget.
The UK electronic cigarette industry has significant ‘home-grown’ sales in the UK, but is also heavily reliant upon exports to our European partners in particular, as well as to partners in the rest of the world. It is difficult to see how this would not suffer a negative impact if the UK were to leave the EU, even if some attempt were made to remain part of the single market; inevitably, the UK would be perceived as being ‘cut off’ from continental Europe.
A fundamental misunderstanding has occurred at the EU level about the significant differences between smoking tobacco cigarettes and using an electronic cigarette: a smoker may smoke 20 cigarettes over the course of a day (and many do, hence the problem!) but if that smoker switches to using an electronic cigarette, they are likely to use 2-3ml of eliquid of 2.4% nicotine concentration over the same period. The level proposed as a ‘cut-off’, above which a Marketing Authorisation would be required from an MS Medicines Regulator, is 0.4%. Clearly, this is not a proportionate or effective level to propose.
It seems quite likely that the UK has a marginally better grip on this point, and yet there is still a push to reclassify them as medicinal products, with the MHRA due to report back this spring (2013). The MHRA was unable to make a compelling case for burdensome and unnecessary over-regulation back in 2010, and is no closer to being able to do so now. (The Regulatory Policy Committee recently confirmed that the MHRA has not submitted any further policy proposals for consideration, so this is not a viable option and will be legally challenged if an attempt is made to force it through.)
Fortunately, we are confident that the UK will take a strong leadership position with regard to the classification of electronic cigarette products, once the evidence is properly evaluated, particularly since there are considerable concerns (which I have heard from UK public health experts, such as Clive Bates, former Director of ASH UK, as well as UK policy-makers) that although the UK’s medicines regulators might – and I must stress, might – be able to take a pragmatic ‘light touch’ approach, there is so much disparity across the other Member States that it is likely that harmonisation would be enormously difficult. This is similar to the situation regarding the proposed Directive 2009/39/EC (Foods for particular nutritional uses), which was “precipitated partly by perceived difficulties in achieving market harmonisation and consistent enforcement across the EU.”
Fortunately, there is already a robust and extremely well-harmonised regulatory framework under the GPSD et al which is already in place and being enforced successfully. We would like to see more rigorous enforcement of the existing legislation, in order to continue to drive standards up for our industry, but we believe that this is being hampered by long, drawn-out uncertainty about the classification. The UK needs to take the lead, and help to influence EU policy on this issue (and others).
I believe the EU could and should act as an ‘overview position’ provider to the Member States, and can see little benefit for the UK in the EU taking more specific actions in regard to public health. The UK is notably better-placed than some other Member States to make independent decisions, and yet surely the EU could provide a centralised resource for the collation of best practices from across the Member States, and robust scientific evaluation to the benefit of all the Member States.
The European Commission has exhibited a tendency to become too embroiled in the details. Certainly, their proposed interference with the electronic cigarette industry is decidedly counter-productive for the health of UK citizens (along with the rest of the EU) and I would hope that the UK (and other MS) would be strongly critical of this being allowed to pass into mandatory legislation for Europe-wide adoption. Furthermore, it would be an absolute tragedy if the better parts of the revisions to the Tobacco Products Directive (i.e. those concerning tobacco products, which ought to be the focus of this Directive) were delayed because of the inappropriate and disproportionate inclusion of electronic cigarettes which are neither tobacco products nor medicines. We trust that the UK government will act swiftly and strongly to guide this significant Directive through to completion in the most expeditious manner – which must include the removal of recommendations about electronic cigarettes from the proposals.
Proportionality and subsidiarity are particularly key issues. We believe it is essential that, for future proposals, the UK and all the Member States insist on robust academic analysis of the scientific evidence for the development of policy proposals. It is simply not appropriate to disregard some ‘good’ research because it is industry-funded. After all, 90% of all clinical trials are funded by the pharmaceutical industry and there are serious questions about their quality.[ix] Nevertheless, these should not be written off, any more than the research from the tobacco industry, the electronic cigarette industry, the food industry, the alcohol industry, etc., etc. What is absolutely essential is proper academic evaluation of all the evidence on any given proposal, by systematic review undertaken by people properly qualified to undertake such analyses. Without this, we can never have properly evidence-based decision making, despite the fact that the EU and most Member State governments frequently talk about evidence-based decisions.
Greater adherence to the principle of proportionality is equally essential, both at Member State level, but also at EU level. As indicated above, we believe the binding principle of proportionality provides a mechanism for ensuring that “the content and form of EU action must not exceed what is necessary to achieve the objectives of the EU treaties”, but only if this is robustly enforced. There may be benefits overall if the EU views its obligations with regard to proportionality as an obligation to step away from interfering with the details for individual citizens, but rather to focus its attentions on the details of the specific systematic reviews of evidence, including monitoring and analysis of best practices from across the EU, and then presenting these as centralised suggestions for harmonised adoption. The UK could and should have a key role to play in making this happen.
Subsidiarity is likely to be of concern for the UK coalition government, since it is currently focussed on the move to ‘localism’. It remains to be seen how effective this will be in reality, but at least in principle, it seems like a good idea. (How seldom the theory translates into reality, though!) As far as the EU is concerned, subsidiarity can provide effective protection for less democratic or capable Member States, but again, only if this is robustly enforced. This is yet another question which leads me to the conclusion that the UK must remain part of the process, offering the benefit of its experience where appropriate.
Clearly, there are “common safety concerns in public health matters”, particularly with regard to the harms caused by tobacco smoking, and there is a common need for “incentive measures to protect human health”. As indicated above, the EU is in a unique position to be able to engage in systematic reviews of evidence relating to every possible area of policy decision making. However, the EU must stop meddling with the details, and act more to provide advice and suggestions for harmonised adoption, always with the strongest possible evidence-base in support. Furthermore, the systematic reviews of evidence in all areas must be published for scrutiny by the wider academic community, for the widest possible peer review.
The World Health Organisation is more problematic than any individual Member State government, and has greater potential to do harm than the European Parliament and Commission. The Member State governments, together with the European Parliament and Commission have very clear guidelines to follow, and are accountable for their actions. The WHO appears to be acting directly against the best interests of public health with regard to electronic cigarettes, as well as being utterly undemocratic and unaccountable, with concerns having been raised in the BMJ and elsewhere:
‘A joint investigation by the BMJ and the Bureau of Investigative Journalism has uncovered evidence that raises troubling questions about how WHO managed conflicts of interest among the scientists who advised its pandemic planning, and about the transparency of the science underlying its advice to governments. Was it appropriate for WHO to take advice from experts who had declarable financial and research ties with pharmaceutical companies producing antivirals and influenza vaccines? Why was key WHO guidance authored by an influenza expert who had received payment for other work from Roche, manufacturers of oseltamivir, and GlaxoSmithKline, manufacturers of zanamivir? And why does the composition of the emergency committee from which Chan sought guidance remain a secret known only to those within WHO? We are left wondering whether major public health organisations are able to effectively manage the conflicts of interest that are inherent in medical science.’[x]
This is completely unacceptable if elected governments in individual Member States, together with the European Union are going to effectively take on ‘blind trust’ the advice of the WHO. Rather, as signatories to the FCTC, the UK and the EU (together with all other signatories) must challenge the WHO on the robust scrutiny of the scientific evidence. This issue was discussed recently in an Open Letter to delegates to COP-5, by Clive Bates, former Director of ASH UK[xi]:
“I have been prompted to write to you because during COP-5 you will be considering two papers prepared by the Secretariat:
- FCTC/COP/5/12: Control and prevention of smokeless tobacco products
- FCTC/COP/5/13: Electronic nicotine delivery systems, including electronic cigarettes
These papers share a serious weakness: they do not properly consider the role of smokeless tobacco or electronic nicotine delivery systems as credible alternatives to smoking. Therefore their potential positive health value in reducing the burden of disease associated with smoking is ignored or marginalised.”
For my specific field of knowledge, the relative merits of legislative and non-legislative measures are very clear: the legislative measures in place at the EU level, and well-harmonised and adopted across the Member States concerning consumer products, are currently having a very positive impact on public health in the area of tobacco harm reduction. Non-legislative measures could include a centralised systematic review of all the available evidence on electronic cigarettes and Tobacco Harm Reduction more broadly, with the EU drawing on all the resources available to it from across the Member States, and then providing recommendations on how individual Member States might like to introduce non-legislative measures (to support the central and harmonised consumer legislation) within their own countries. These might include advising health-care providers – from within and without the medical community – to provide accurate, evidentially-sound information to smokers about the range of options available to them.
The vast public health benefits currently being enjoyed would be tragically reduced if legislation is introduced at a national or EU level to reclassify electronic cigarettes as medicinal products.
The UK is capable of making good decisions for and by itself. Clearly, there are some areas where the UK is not strong, or setting a good example, but in many areas of policy making, the UK is a recognised leader. Presumably, as a current Member State of the European Union, the UK has some current obligations to offer its best practices to its EU partners? If not, surely it should have. However, if the EU is getting things wrong – always with a focus on systematic reviews by qualified academics of the entirety of the evidence base – then the UK must, by default, have an obligation to do the right thing for its own citizens. Clearly, this is often a source of conflict between the UK and Europe, but this ought not to be resolved by taking our football and going home.
The EU must be held accountable for its behaviour, and the UK (along with all the other Member State governments) must ensure that this happens. This will always be challenging, but is essential nevertheless. The UK national interest could be very well served by increasing its reputation for best practices, and by engaging more with policy-making processes at the EU level. Ultimately, however, in the policy area of public health, it is too important that citizens are protected; if the EU is getting it wrong, the UK must robustly challenge this, and go its own way if necessary. That said, I do feel it would be a shame to leave our partners on the mainland to suffer the consequences of bad EU public health policy, such as is currently proposed with the inclusion of electronic cigarette products in the revisions to the Tobacco Products Directive – an important instrument which must not be delayed due to the trivial error of having inappropriately included electronic cigarettes.
In the grand scheme of things, this is a ‘trivial error’, but for individuals across the EU, it is literally a matter of life and death. For the whole revisions to the TPD to be derailed because we have no choice but to protect our right to ‘vape’, would be an egregious tragedy.
Future enlargement of the EU would seem to be unwise until the existing Union gets its house in order, hopefully with help from the UK.
There are growing concerns in some quarters about the European Commission ‘interfering’ with the operation of the European Medicine Agency (EMA) regarding ‘Orphacol’, a medicine for treating orphan liver disease. French kidney/liver drug –vs- American pharma product. This was reported by Gilles Pargneaux, MEP:
“This medicine is a product of academic clinical research of a hospital in Paris. A marketing authorization was requested to make it available not only in France but all over Europe.
Despite more than 20 years of use in France, despite the unanimously positive opinion of the European Medicine Agency’s (EMA), despite a qualification of the medicine as having a “notable public health interest,” despite the repeated expression of a favorable opinion from Member States, the marketing authorization was refused by the European Commission.
The European Commission has no scientific expertise whatsoever. It systematically follows the opinions of European Agencies and expert committees of the Member States. In the history of centralized marketing authorization of medicines, it is the first time that a series of scientific opinions are not followed suit by the European Commission.
This unprecedented case must lead to the question: Why? What are the motives of the European Commission and who stands to benefit from these protracted procedures and refusals?
As I have raised at the European Parliament during several committee meetings, everything leads to the conclusion that the aim is to favor an (American) pharmaceutical company that has belatedly requested a marketing authorization for a similar medicine.
When an institution in charge of health and consumer protection overturns a scientific decision, faces the indignation of Member States concerning its tactics and does not meet the demands for transparency from the European Parliament, such suspicions are legitimate.
This case sheds a new light on the arbitrariness that can overtake an institutional machinery when it ignores democratic alerts, in particular coming from the European Parliament. Confident in its rights, its legal and technical know-how, the European Commission has shown its arbitrariness, thinking that an injustice committed to a small pharmaceutical company would go unnoticed.
More than a year before the next European elections and while European citizens are expressing a growing defiance toward Europe, the European Commission shares her fair share of responsibility. On this case, the image of Europe as a whole is tarnished. The European Commission has to acknowledge its error and approve this medicine which is supported by everyone. Most importantly, in order not to have other cases that may raise legitimate or imaginary suspicion, more than ever we have to implement mechanisms that enable the European Parliament to make itself heard and respected. The interest, the credibility and the legitimacy of Europe are at stake.”[xii]
Other concerns have been raised about conflicts of interest, including a Report from the European Parliament[xiii] published in 2012:
“…the European Ombudsman criticised EFSA for the way it assesses potential conflicts of interest and ‘revolving door’ cases; calls on other Agencies to employ efficient procedures to detect and prevent any conflict of interest situations: takes the view that the ‘cooling off’ period of anyone who has served as director of an agency or has discharged major responsibilities within an agency needs to be clarified”
“conflicts of interest are a cause of corruption, fraud, mismanagement of funds and human resources, favouritism and have a negative impact on the impartiality of the decisions and quality of work and undermines Union citizens’ trust in the Union institutions, including the Agencies”.
Closer to home, the UK MHRA is also an agency of considerable and widespread concern. Richard Brook published the following, after resigning from his position as an adviser to one of the MHRA’s ‘expert’ groups[xiv]:
“I resigned. If a regulator will not own up to its mistakes, who knows if data about other drugs has not also been overlooked, with potentially fatal results.
Regulators are supposed to be a stop-check for safety issues. But at the MHRA, many of the people who work there or advise it have ties to drugs firms. Some have shares in the companies, research departments funded by them or receive fees for advice.
The only protection is a musical chairs system where you leave the room if you have an interest in the drug being discussed or its manufacturer, or you can stay but not vote. […]
There is an urgent need for an independent inquiry into the MHRA. The Government must also change its culture of secrecy.”
I am not one to subscribe to populist ‘conspiracy theories’ about corruptive influences of commercial interests. However, it is not a conspiracy ‘theory’ when it is really happening. The UK must get its own house in order by, for example, engaging in particular scrutiny of the operations of the MHRA, and must then assist the EU in combatting its own corruption issues. My own conflicts of interest have been fully declared herein, and I urge you to look to the evidence, rather than to any individual’s claims about any products relative merits – including my own. Please, do not take my word for it; but in disregarding my statements as ‘conflicted’, please ensure that you do take the time to academically analyse the evidence, which is easily accessible. Much of it is linked from this submission, but I would urge you to look wider, to ensure the UK government is able to take the most informed position possible, and then pass on the benefits of this knowledge to the EU.
Thank you for taking the time to consider our submission to your programme, and for engaging in this call for evidence.
ECITA (EU) Ltd
for and on behalf of the members of ECITA, the wider European industry, and all of Europe’s vapers, smokers, and their families and friends, who have supported our organisation
[vi] Cabinet Office, Behavioural Insights Team, Annual Update 2010-11, September 2011