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The EU TPD – Any room for flexibility in the UK?

10th August 2015

Good news folks! The Government has set up a public consultation to seek views on implementing the revised Tobacco Products Directive (TPD), which if you were hibernating, comes into force next year in May. To be frank I’ve never even noticed any previous public consultations, but as the TPD now includes the controlled regulation of e-cigs, a subject very important to me – I felt that I’d better take a look. The TPD covers all things tobacco, however I’m primarily only really concerned with Article 20 which relates to e-cigs.

The Consultation

 

Worried as I am by the measures Article 20 takes in restricting the choices one can make with regard to vaping products (nicotine strength limited to 20mg, restricting e-liquid bottles to just 10ml, the ban on advertising e-cigs and all the other onerous and in my opinion unnecessary legislation) I was nevertheless pleased to read that “The UK has some flexibility in how it might choose to implement the new rules.”

My enthusiasm however was dampened as soon as I read the next sentence “The purpose of this consultation is to seek further information on the impact of the directive and flexibilities to inform the government’s final decisions on implementation”

So this EU Directive will become law next year and affect over two million UK users of e-cig products and yet this Government now wants to understand or assess the impact for these 2 million ex smokers. I then started reading the Impact Assessment – all 59 pages of it.

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For the uninitiated the definition below is important as this is what an Impact Assessment is defined as: note the use of the words, formal and evidence based. No lazy policy guesswork or blank pages here then?

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The background evidence first of all highlighted one glaring fact. When it was first proposed by the EU Commission to include the consumer product e-cigs within the Tobacco Products Directive, vapers weren’t granted any public consultation or even a parliamentary debate before the dirty deed was agreed.

Despite e-cigs containing no tobacco the decision was never democratically aired. Instead the Government in true democratic style made its decision by simply asking the European Affairs Committee (EAC). Our own MPs – our democratically elected representatives – weren’t even granted an opinion! Makes you wonder what our elected politicians do all day at Westminster? Although wearing ill fitting bras and sucking white powder through straws whilst in the company of dubious women readily springs to mind.

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The impact assessment then describes the problem under consideration for the directive i.e. Tobacco smoking, the rationale for EU wide intervention and the stated policy objectives.

Next up was a section describing how to assess the effects of the directive (especially in relation to e-cigs) what is known as a Counterfactual must be established.

In the case of EU legislation, the agreed counterfactual for Impact Assessment purposes is a state in which the EU has not passed legislation. So in order to justify the proposed policy “benefits” of the Directive, the Impact Assessment should/must be able to distinguish the overall impact between 1) the Directive becoming law as is proposed and 2) Not actually taking place in terms of the economic, social and environmental effects.

In respect of e-cigs this is hugely crucial. Remember the definition of an Impact Assessment and the use of formal evidence based procedures. Since the emergence and popularity of e-cigs (2 million+ UK converts alone) and the resulting drastic fall in smoking prevalence rates and tobacco consumption, one would expect this would lead any policy maker to be extremely wary of any proposed regulatory measures that could in fact either reverse these positive trends or potentially place them at risk.

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The next paragraph got me livid!

6‘In other words Article 20 of the Tobacco Products Directive, which will regulate e-cigs has been made law with our Government admitting that it is unable (or unwilling) to gauge the likely impact of the new regulations’.

So they can’t quantify the tangible benefits of the proposed article in terms of an Impact Assessment.

The Cart before the horse?

 

Surely before any proposed legislation is put before a vote, a logical mandate should be agreed to ensure the measures proposed will have a positive effect? You surely can’t impose legislation, then openly state that we have been unable to produce a definitive Impact assessment counterfactual?? This is why an Impact Assessment must be produced prior to policy. It seeks to place real numbers and facts on proposed policies. Especially as this directive will have a crucial future impact on public health and EU citizens.

For the Government to admit within its own Impact Assessment that it simply hasn’t a clue must surely be inept policy making at the highest level. If an accurate counterfactual wasn’t possible for the reasons cited then the only sensible course of action would have been to delay the regulations in order for the market to reach a stable equilibrium. More importantly we’re not talking about a policy that relates to vacuum cleaners or banana shapes, but a policy that has massive public health implications for smokers. It will determine if a smoker in the future will have the same opportunities as today. Future smokers will no longer be able to use e-cigs to successfully quit smoking. Before ecigs arrived there wasn’t a credible alternative to the tobacco cigarette. The quit or die option became vape and live for millions of smokers.

Objective: Reduce tobacco smoking or restrict the effective e-cigs?

 

The overriding stated objective of the TPD is fundamentally to reduce tobacco smoking…..or so it’s claimed…The e-cig is proven a less harmful product than tobacco smoking. In the real world, plenty of evidence already exists. Evidence that uses former tobacco smokers and quantifiable statistical evidence. The facts are clear – ecigs = less people smoking. The success of e-cigs I think, should bemeasured by the millions of ex-smokers using them throughout the EU.

Compare this with the stated TPD policy gains in terms of reduced smokers and one starts to wonder have they all been sniffing that white powder?

7That’s right, The TPD as a whole, is projected to achieve 200,000 fewer UK smokers in 5 years. But hold on! The very same Impact Assessment admits that the current regulatory status of e-cigs as a consumer product, not a tobacco product or a medical product, without any regulatory political intervention has already so far generated in excess of 700,000 ex UK smokers!

8UK smoking prevalence rates are now at their lowest. More smokers are successfully using e-cigs to give up smoking than any other known product, yet this EU Directive is wholly expected to reverse these historic trends!

The dire conclusion of the Impact Assessment should have politicians questioning it and more importantly putting the brakes on? Unless… The measures being taken to regulate e-cigs within Article 20 have actually always been intended to stop/decrease this Public Health success? Just a thought…

When 2+ 2 = 5

 

I’m no mathematician, but it doesn’t take a genius to work out… If e-cigs have generated at least 700,000 UK ex smokers over the past 5 years and the new Directive is only expected to generate 200,000 fewer UK smokers over the next 5 years. The policy is flawed. Not just flawed, but designed to limit the success and health gains generated by smokers switching to e-cigs. The proof is in black and white – clearly stated in their own Impact Assessment.

So the growing UK/EU e-cig industry will now have to face regulations that for the next 10 years will determine how easily tobacco smokers can choose a safer alternative.

• We already know that no adequate Impact Assessment was undertaken prior to the regulations being proposed.

• We also know that the e-cig has been the single most effective and popular option/solution for smokers looking to stop smoking.

• We also now know that over the past 5 years in excess of 2 million UK smokers now regularly use e-cigs with a third having totally stopped smoking tobacco.

• We know that the projected deduction of smokers is expected to be less than a third of what has been historically accomplished and already proven with e-cigs over the past 5 years.

Even the inclusion of e-cigs within the TPD is suspicious in that e-cigs are clearly not tobacco products. They contain no tobacco and produce no combustion and therefore fall outside of the Smoke Free legislation tobacco cigarettes belong to. The whole basis of their inclusion within the TPD appears to be the misguided (or deliberate ruse)?

‘The more I read the Impact Assessment the clearer it became. The whole mess that is Article 20 of the TPD stems from one very simple and I suspect manipulated fallacy’.

Regulating e-cigs was inferred as regulating the Tobacco industry. By linking e-cigs as solely belonging to the tobacco industry meant e-cigs could be demonised in the same way as the Tobacco Industry. The fact that e-cigs have the potential to totally eradicate harm from smoking was never embraced. Or if it was, this vital public health benefit was very quickly trodden on and still is. Subsequently, the Impact Assessments produced are focus more on the economic and financial for existing stakeholders (Tobacco industry, Government etc.). It fails to focus on the health and well being of the EU citizens it’s meant to serve.

Article 20 of the TPD was deemed necessary to control the big tobacco Industry, yet in reality it appears to have been constructed to control the success that e-cigs have already demonstrated.

How the Tobacco companies bought into the e-cig market

 

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The fact is, the tobacco industry are not not the e-cig industry. More importantly they now only represent around 40% of the ecig market in the UK. Yet within the political/public health arena, e-cigs have been routinely linked the tobacco industry. We’ll never know if this was simply political ineptitude or a deliberate means to stifle an emerging disruptive industry by knowingly associating e-cigs as wholly belonging to bad tobacco? After all most politicians rely on advice and I remember vividly that whilst the EU deliberations were taking place, the majority of politicians thought that all e-cigs looked like cigarettes and were in fact big tobacco owned.

Subsequently, it’s not difficult to comprehend (after all, politicians aren’t always the brightest sparks) that given the wide distrust of big tobacco, any proposed measures to regulate e-cigs would blatantly ignore the important facts and public health objectives. It all begs the question: how were the e-cig industry represented? How did the policy makers obtain all their e-cig market information? Why was it that the voice of the e-cig’s gate crashers – big tobacco – was heard over and above the hundreds of SME’s that had actually created the industry. Even visiting a local MP would have been pointless, as many of us found out during the EU negotiations.

The Consultation Document/Questionnaire

 

So taking all the above into account what is it exactly that the Government is asking for or wanting in terms of this consultation? As a vaper is it worthwhile taking the time to fill out and will it make any real noticeable difference?

Firstly the Government readily admit that their scope for changes to the legal TPD regulations are extremely limited and only in affect relate to a few minor areas. The bottom line is that with 99% of EU Directives there isn’t a revolving door for any UK politician to opt out. For example, If David Cameron wanted to cancel the crazy 10ml max size of liquid refill bottles he now simply couldn’t. So specifics such as maximum nicotine strength and maximum 10ml e-liquid bottle sizes etc. are simply not up for any negotiation or feature within the public consultation. The main focus of the consultation is on certain areas where member states have the ability to choose from a number of specific options. The consultation document is also being used to solicit information from the e-cig industry outside of Big T in order to fill in the gaps pertaining to the Impact Assessment and counterfactual that they to date haven’t been able to complete. For example e-cig advertising will be banned next May and they have zero idea of how much the smaller e-cig companies spend on advertising and the likely affect this will have on their business. They also don’t know for example, if cross border sales within the EU will affect any UK businesses. So the consultation document is an opportunity for affected e-cig companies and concerned consumers to air their concerns and hopefully provide this information.

Article 20 is simply a costly administrative and hugely restrictive nightmare. It enforces:

• Notification scheme for all products including emission testing results.
• Product requirements and testing to an agreed (possibly impossible) standard.
• Point of sale Information requirements
• Advertising restrictions
• Annual reporting requirements
• Monitoring requirements
• Member State powers of potential product banning.

Funnily enough this is almost an exact replica of the administrative demands for a medical product. There will be a huge cost for compliance because of the immense choice and variety within the e-cig industry means that a tobacco company with a single cigalike e-cig battery, 3 e-liquid flavours and 3 nicotine strengths would have just 9 notifications to pay for. Compare this with the current consumer friendly e-cig market place where consumer choice and variety are evident:

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To add insult to injury the actual compliance costs for any e-cig manufacturer/importer is still unknown but ultimately additional costs work their way down to the end consumer which means vaping and the financial benefits to consumers will be reduced.

The technicalities for the EU wide standardised reporting requirements isn’t yet available from the EU Commission. Neither has the technical requirements that determine the standards for leak free refilling (if this is at all possible). From a vapers perspective, I believe that everyone should take the time to engage in this consultation, if nothing more than to inform the Government that to ban advertising for a product that competes against harmful smoking is both illogical and immoral. It doesn’t take too long as there are only a few sectors that relate to Article 20.

So does the UK have any flexibility at all? In short, the only ‘flexibility’ we have, is the choices we make in how we enforce the TPD. For example we have to decide how we test the ‘safety’ of e liquid. How is this ‘safety’ going to be judged and how will it be reported? The only flexibility we have is in deciding the bureaucratic process by which we enforce the TPD’s laws.

The reality is that the independent e-cig industry and vapers have been well and truly shafted by Article 20 of the TPD. We can both do nothing and accept this, or we can make the Government aware that we are not happy. It may not make any substantial difference, but at the end of the day it’s far better to have tried than to have done nothing.

Go here to start your response:

https://consultations.dh.gov.uk/tobacco/tobacco-products-directive

PDF Walkthrough of how to complete the form can be found here courtesy of Vapers In Power.

http://ecigdirectory.co.uk/wp-content/uploads/2015/07/Walkthrough-of-UK-TPD-consultation-form.pdf

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