March 24th, 2015

Latvia consults on protecting the cigarette trade by crushing e-cigarettes with hyper-regulation

Latvia within European Union

Latvia: aiding bootleggers and big tobacco

 

More pernicious creeping back to medicines regulation within the EU.  Just as a parliamentary review in one country that applies it, Canada, recommends going the other way, Latvia consults on making it mandatory. This post has my response to Latvia’s consultation, which closes 24 March.  The relevant implementing law mostly follows the anti-scientific requirements of the Tobacco Products Directive, but throws in a near total ban on vaping in public places for good measure.  However, it also goes further than the TPD by making medicine regulation mandatory for e-cigarettes, an option the Commission has indicated it believes is open under the TPD – but cannot be compatible with free movement of goods in the EU internal market or a harmonising measure. The egregious text on medical regulation is here: 

(1) In Latvia, it shall be prohibited to place on the market:

1) nasal tobacco and chewing tobacco

2) tobacco products for oral use;

3) electronic smoking devices and refill containers of electronic smoking devices other than electronic smoking devices and refill containers of electronic smoking devices that have been deemed to be medical devices in accordance with the regulatory enactments governing the area of health care;

Here is my response below and in PDF form:

Implementing the Tobacco Products Directive in Latvia: e-cigarettes

Clive Bates
Counterfactual
London, United Kingdom
24th March 2015

Dear Ms Alise Krūmiņa

I am writing to provide a brief contribution the Government of Latvia’s consultation on Latvia’s proposed implementation of the Tobacco Products Directive. I regret I am constrained to respond in English, but I hope the information and arguments presented are of value.

Summary: classifying e-cigarettes as medicines under a Latvian implementation of the EU Tobacco Products Directive will be: damaging to the health of Latvian citizens; protect the cigarette trade and increase smoking; create an unnecessary illegal market while damaging legitimate small businesses; and violate European Union law. There is no credible evidence to support the policy as proposed on either public health or legal grounds. There is however, a strong and growing evidence base to justify encouraging e-cigarette use among smokers as a ‘harm reduction’ strategy to reduce disease and premature death.  The best approach is to adopt a ‘light touch’ regulatory regime for e-cigarettes using the flexibilities provided by the European Union Tobacco Products Directive.

  1. The classification of e-cigarettes as medicines and so requiring manufacturers or importers to obtain a medicines marketing authorisation to place each e-cigarette or liquid variant on the market is extremely burdensome.  It has repeatedly been found to be unlawful in the courts of European member states. This will continue for one obvious reason: e-cigarettes do not conform to the definition of a medicine either in law or in common sense. They are recreational nicotine products acting as rivals to cigarettes, and are not primarily for the “treatment or prevention of disease”, even if that is the welcome effect.  Please see the attached discussion of the legal status of e-cigarettes under the EU Medicines Directive [1].
  2. Medicine regulation is disproportionately burdensome, restrictive and costly and will provide no net health benefits.   It is an impediment to free movement of goods under the EU Treaties. It is not required by the Tobacco Products Directive and may not be permitted by it. To require highly burdensome regulation of e-cigarettes while allowing widespread availability of cigarettes with only the lightest regulation is discriminatory and counter to principles of the European Union treaties. I enclose a summary report on the impact of medicines regulation [2].
  3. The practical effect of designating e-cigarettes as medicines will be to increase harm. The designation of e-cigarettes as medicines will create ade facto ban on almost all products and destroy almost all firms in the Latvian market.  Its main effect will be fourfold:
    1. To protect the cigarette trade from competition and so increase smoking while sheltering the profitability of major tobacco companies;
    2. To shape the e-cigarette market to be a narrow niche that only large tobacco companies will have the financial resources to meet the high costs and cash flow strains of a lengthy and mostly pointless authorisation procedure;
    3. To develop a black market in vapour products to meet the demand for such products in Latvia, which will not disappear simply because most products were removed from the legal supply chain;
    4. To make a legal challenge more likely. Such a challenge would almost certainly succeed and lead to a costly defeat for Latvia’s government.
  4. The most damaging aspect of the proposal is the lost opportunity to reduce cancer, cardiovascular and respiratory disease by allowing and encouraging smokers to switch to much less risky products than cigarettes. I attach a briefing on the positive role that e-cigarettes and vapour products can play in public health. This document summarises the most important findings in the evidence base – and these should give the government some confidence that e-cigarettes will greatly benefit health in Latvia [3].
  5. So far, neither the European Commission nor the Government of Latvia has provided any compelling evidence that regulating e-cigarettes as medicines is justified for public health reasons. So far, neither the European Commission nor Government of Latvia has shown that regulating e-cigarettes as medicines would not be disproportionate and discriminatory and therefore in violation of the European Union treaties. There is no credible impact assessment or evidence base to support the policy.
  6. The Tobacco Products Directive has numerous flaws and is likely to be challenged successfully in the Court of Justice of the European Union [4]. However, it does provide a range of flexibilities and rules designed to implement the aim of developing the internal market. Latvia should adopt the rules and flexibilities of the Tobacco Products Directive. The Government should aim to establish a lawfully robust, light-touch regulatory regime for e-cigarettes with a view to maximising the public health benefit from smokers switching to e-cigarettes while mitigating any residual risks.
  7. I have no competing interests. I was formerly head of the UK’s main tobacco control organisation, Action on Smoking and Health (1997-2003), and a UK senior civil servant (2003-2012). I have been a long-standing advocate of harm reduction strategies in public health and tobacco control and believe these will ultimately bring an end to the epidemic of disease causes by smoking. These views do not necessarily reflect the positions of former employers.

[1]   Bates C. Are e-cigarettes medicines? Counterfactual, March 2013

[2]   Bates C. Stimson G. Costs and Burdens of Medicine Regulation for E-cigarettes, Nicotine Science and Policy, September 2013.

[3]   Bates C. E-cigarettes, vaping and public health: a summary for policy makers. Counterfactual. February 2015.  This contains links to many peer reviewed sources.

[4]   Bates C. Totally Wicked legal challenge to the Tobacco Products Directive e-cigarette measures. Counterfactual, October 2014.

Note: my thanks to Olga Falenkova, Chair of BENA the Latvian vapour trade association, for drawing my attention to this consultation.

16 comments to Latvia consults on protecting the cigarette trade by crushing e-cigarettes with hyper-regulation

  • […] include a ban on nicotine products. The aforementioned Latvia, for example, might be consulting on ruining the e-cigarette trade by insisting on heavy-handed regulation of the industry to include a near total ban on […]

  • Onguso

    Tight or stringent legislations is not enough to thwart e-cigarette smoking. What is is most important is encouraging people to change their lifestyles by advocating healthy habits

  • Kurtis Sunday

    Clive said:
    I must be missing something. Why does a cigarette company investment in Lithuania cause the government of Latvia to introduce anti ecigarette legislation?

    Just noticed that Latvia/Lithuania, two different countries of course …

  • Kurtis Sunday

    From Reuters – probably an accurate take on this:

    “Special Report: When it comes to e-cigs, Big Tobacco is concerned for your health”

    http://www.reuters.com/article/2015/03/23/us-ecigarettes-regulations-specialreport-idUSKBN0MJ0GN20150323

  • Irish Lass

    Poor Latvia. I hate cynical cigarette manufacturers!

  • Oliver

    I am from nearby country Estonia and I think the topic is serious! I agree that Latvian government is known for its corruption, and actually in Estonia we have branches from Latvian or Lithuanian tobacco product importers and providers! So it is understandable why the most hardest laws come from Latvia. we have the same situation with nicotine in Estonia and Finland. As soon as you try to sell nicotine, then the medicine department starts to ask the documentation for a medical devise. but when yous ell zero liquids , you do not have to provide this proof! But last week on Sunday the Estonian government , made also an stupid law change, and we did fight against it since 2008 and also the public did fight the government. But the ministry of social affairs , placed the e-cigarette under the law of tobacco and banned all advertisments and sales to minors in Estonia! we had no problem regarding the minors, but why to but the e-cigarette in to tobacco law. they made up a new category ” products that are used with similar ways to tobacco products” and e-cigarette did go under this topic. when we told them to wait the EU law and we also told them to take the e-cigarette definition from new directive. then the ministry took the directive definition and added it to the same topic. so now we have e-cigarettes , under the tobacco law! we told the ministry that this is stupid as there are alcoholic beverages and they can be advertised! and there are also beers that have no alcohol and you have no bans on them ! so why do they not call the zero alcohol beer under a topic called” products that are used with similar ways to alcoholic products”.
    we also suggested a long time ago, that it would be so easy to make up a new category called” products for adults” so we could place e-cigarettes, sex toys, non alcoholic beers and etc. under this topic and regulate with it the age problem and also ban the advertisment during day time, but leave it active in evening time! but nothing helped!

  • john

    I used to know a man who spent his teen years in Sweden back in the 70s-80s, when the supply of alcohol in Sweden was pretty restricted and expenxive, he used to tell us how there were car ferries from Sweden to nearby countries that would be packed every weekend with people headed for places where you could fill your carboot with grog (and get really drunk on the trip), and then take it back home.

  • I am Latvian and somehow I am not surprised about this development… Maybe that’s why I live and do business in Ireland right now… ? Our latvian government is still to much corrupted and narrowminded.. Sad but true.

  • Clive Bates

    Yes, there would be something to give a lukewarm cheer about if anyone in public health, European Commission, member states governments took the idea of natural experiments seriously and were prepared to study and learn from them.

    Unfortunately the visionaries who brought us the snus ban, and their successors, are about as likely to learn anything from an e-cigarette ban in Latvia as they learnt from the snus ban and exception in Sweden.

    • But 20 years from now, it will be really useful for someone doing an historical analysis. I sure the thousands of Latvians who die earlier because of it would be glad to know their sacrifice was not in vain.

  • On the bright side, there is something to be said for federalist natural experiments. We would know a lot less about how well snus works (both socially and physically) if all of Europe allowed it. So if you are going to have somewhere be the experimental group for banning ecigs, better Latvia than the UK. (Ok, small consolation, but it is something. I recall a political science prof reminding his graduate students — after an election that went in a rightward direction that they did not like personally — “hey, it is just data”.)

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>

  

  

  

This site uses Akismet to reduce spam. Learn how your comment data is processed.