Posted on May 3, 2013 by admin

Another very interesting week in Politicoville

While the ENVI Committee has arranged its workshop for 7th May with a distinctly biased panel of experts , neatly lined up to make a case for the reclassification of electronic cigarettes as medicinal products, effectively banning them and removing them from the millions of EU citizens who are already vaping instead of smoking (not to mention the many more millions who would not have the option to even try them), the JURI Committee the Legal Affairs team has published its Draft Opinion. And guess what?

There is no legal basis for reclassifying electronic cigarettes as medicinal products, and no legal or moral justification for restricting access to products demonstrably far less harmful than smoking tobacco.

The workshop agenda reads like a who s who (WHO?) of zealous ANTZ whose single minded aim is the utter destruction of the tobacco industry, to be achieved by denormalising (and dehumanising) smokers. Heaven forbid that smokers should be offered products that are a demonstrably attractive, appealing and far, far less dangerous alternative. No, say the ANTZ. They will still look like they re smoking, and they ll be enjoying themselves, and that doesn t fit with our plans at all!

Following an intro by the ENVI Rapporteur, Linda McAvan MEP, and a position statement from the European Commission, the line up includes

Roberto Bertollini, Chief Scientist and WHO Representative to the European Union allocated 15 minutes to speak.


Dr Roberto Bertollini holds a degree in medicine and a postgraduate degree in paediatrics, as well as a master s degree in public health from the Johns Hopkins University, United States of America. In addition to his position as WHO Representative to the European Union, Dr Bertollini is Chief Scientist with the specific task of supporting the Regional Director s Office with the scientific evidence that underpins WHO health policies and strategies.

From 2007 to 2010, he was coordinator of evidence and policy for the environment and health at WHO headquarters, from 2000 to 2007 he was a technical director at WHO/Europe, and from 1993 to 2000, he was the founding director of the WHO European Centre for Environment and Health in Rome, Italy.

His main professional interests concern the environmental influences on health, with special reference to the effects of emerging threats such as climate change as well as the use of epidemiology for public health policy development and the evaluation of public health programmes and practices.

I am sure that Dr Bertollini is a dedicated professional, with the very best of intentions, but since his job is to deliver the WHO s position, his contribution to this workshop is unlikely to be helpful concerning electronic cigarettes. (The WHO s position was set out in no uncertain terms here.)

This will be followed by 40 minutes from various medicines regulators. Yes, that s right medicines regulators for 40 minutes. I wonder if anyone can guess what their perspective on this issue is likely to be?

Well, the first of these is Jeremy Mean from the MHRA. (I don t think he likes me very much.) In February 2010, the MHRA s position was that electronic cigarettes are dangerous (wrong) unregulated (untrue) products which ought to be removed from the market immediately (within 21 days), or be given one year to get a marketing authorisation (impossible), or left alone (but this last option was worded in such a way as to be a non option ).

(The MHRA Public Consultation MLX364 can be found here.)

The Regulatory Policy Committee gave MLX364 a resounding thumbs down in June 2010.

The MHRA s report of the outcome of this public consultation included the following detail on work it would be carrying out

The programme of research will include a work stream on investigation of the levels of nicotine which have a significant pharmacological effect, the actual use of existing nicotine products in the marketplace, their effect on smoking cessation and modelling of the potential impact of bringing these products into medicines regulation on public health outcomes. We envisage the programme of research will take about 18 months to complete and that a final decision on the regulation of nicotine containing products will be made in Spring 2013.

Well Spring has sprung, the grass is riz, I wonder where the evidence is? Perhaps we shall find out on Tuesday .

The other medicines regulators are from Germany where two court cases have been fought and lost by Health Ministries in two of the Bundesl nder, and Finland, whose National Institute for Health and Welfare had this to say in February last year

According to the reliable research available, electronic cigarettes contain the same components that endanger health as conventional cigarettes, some that even cause cancer, says the Director General of THL, Pekka Puska. The long term effects on the functioning of the respiratory organs are not well known. Research has also shown that the quality of the liquids used in electronic cigarettes varies greatly, and that the product descriptions do not always match the real contents.

FIOH urges workplaces to treat the smoking of electronic cigarettes in the same way as that of real cigarettes. A non smoking workplace is the most advisable solution, says Harri Vainio, Director General of FIOH.

(How they have the audacity to describe what fed into this position as reliable research is beyond me!)

So it is unlikely at best that any of these presenters will have anything useful to contribute to this workshop, which is supposed to be providing information for MEPs so that they can make informed decisions in the legislative process.

Part 3 of the bill of fare for this workshop is entitled Scientific information clinical and research findings , and who is topping the list? Oh dear, oh dear the European Respiratory Society. Many of you will remember the outrageous behaviour of Professor Christina Gratziou in dramatically misrepresenting her research findings to the press, leading to dangerously misleading headlines in the papers such as Electronic cigarettes could damage your lungs as they cause less oxygen to be absorbed by the blood not even remotely borne out by the (as yet unpublished) study referred to. (For more on this, see our blog post here.)

This has severely damaged the European Respiratory Society s credibility, particularly with regard to electronic cigarettes! Mercifully, it is not Professor Gratziou who will be presenting, but Professor Francesco Blasi.

Does Professor Blasi take a more enlightened, public health focussed approach? Judge for yourselves

at present, we have no certain figures to say if e cigs are good or bad for your health , although they can have an incidence on young people , giving rise to a new lifestyle and vicious circle of emulation and addiction.

So that s a no then.

Next up is Dr Charlotta Pisinger, Senior research fellow at Research Centre for Prevention and Health, Copenhagen. Surely she will want to promote harm reduction strategies for smokers?

There is no control of the e cigarette and some of them have been found contamination with very harmful / toxic substances. In addition, you have no idea what effect inhaling fumes all day, for perhaps years, has on the lungs. With e cigarette consumed in everyday life, will be smoking again normalized, which affects the social norm. One can assume that it will thus inspire children to start smoking or smoke vapor cigarettes. And it’s really a bad thing, she says.

So that s another no , then.

The final speaker in this section of the workshop is Jean Fran ois Etter, whose presentation is entitled Understanding nicotine addiction .

Many of you will have read Dr Etter s book (as have I), The Electronic Cigarette an Alternative to Tobacco? (If y
ou haven t done so yet, I can highly recommend it.) On the whole, Dr Etter has spoken a great deal of good sense on the subject of electronic cigarettes. Furthermore, he has made a significant and very useful contribution to the scientific evidence base with two published papers (here and here).

However, there is a possibly unavoidable bias in favour of some kind of light touch medicinal regulation for electronic cigarettes. It often feels as if these eminent professionals are incapable of recognising any value to any kind of regulation unless it is medicines regulation despite the well publicised and frequent failings. (See Chantix, Seroxat, MHRA dereliction of duty, Avandia, Device regulation scandal, etc.)

As it stands, Dr Etter is the only one in the current line up from whom there is even the slightest chance of hearing anything positive about electronic cigarettes, but the context is still likely to be with reclassification as a medicinal product. Where is Professor Gerry Stimson, the father of Harm Reduction? Where is Clive Bates, former Director of ASH UK? Where is Dr Konstaninos Farsalinos, who is tirelessly providing the very studies policy makers keep asking for? Where is Professor Peter Hajek? Dr Jacques Le Houezec? Dr Carl Phillips? Paul Bergen? Anyone with something useful to contribute???

None of these renowned experts has been invited to provide the benefit of their considerable knowledge and expertise in this field. Not one.

Finally, a grand total of five minutes yes, five minutes will be given to the German ecig consumer group, IG ED. Five minutes to rebut these professors, scientists, doctors, and experienced political players. Five minutes to describe the vital importance of keeping electronic cigarettes in the hands of the millions of former smokers who have already made the switch. Five minutes to make the case for ensuring that current and future smokers who have not yet made the switch are given that opportunity. Five minutes to beg for their lives and yours, and mine.

Nice to see that there will be a balanced position, isn t it?

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Landmark ruling on e-cigarettes by the european parliament

Discount cigarettes – sonoma, ca

On October 8th in Strasbourg, France, the European Parliament passed a draft law that the World Health Organization and EU health officials described as a landmark ruling. Among stricter regulations towards tobacco products and advertising, it was the first time an elected government institution made sweeping regulations on e cigarettes.

E cigarettes should be regulated, but not be subject to the same rules as medicinal products unless they are presented as having curative or preventive properties. Those for which no such claims are made should contain no more than 30mg/ml of nicotine, should carry health warnings and should not be sold to anyone under 18 years old. Manufacturers and importers would also have to supply the competent authorities with a list of all the ingredients that they contain. Finally, e cigarettes would be subject to the same advertising restrictions as tobacco products. (EP News)

Like any legislative vote, its passing created a range of opinions by MEPs on the success and failure of such a law. On one hand, approval of the new measures was particularly welcomed by European health commissioner Tonio Borg I welcome the positive vote in today s European Parliament EU citizens expect all of us to act on tobacco and to adopt in the near future a new legislation which will put the EU on the frontline on a global stage.

MEP Chris Davies agreed with Borg s view of the draft law E cigs can be a game changer. Hundreds of former smokers have written to tell me that they have helped them give up cigarettes when nothing else worked. They are successful because they are not medicines but products that smokers enjoy using as an alternative to cigarettes.

On the other hand, not every country within the EU sees the revision of the Tobacco Products proposal as a step forward. Anti smoking lawmakers hoped to diminish the availability of e cigarettes by repositioning them as a medicinal device. Co chair of the public health committee and Swedish MEP, Carl Schlyter, is one of those who view the amendment differently. This is a shameful day for the European Parliament as a centre right majority has done the bidding of the tobacco industry and voted for weaker rules, which are totally at odds with citizens interests and public health.

It s always interesting to see the difference in opinion among the array of parties voting on a draft law such as this. No different to any other debate on legislation there are those with very contrasting points of view. However, one thing that everyone can agree on is that whether this draft law was or will be a success or failure, the ultimate ruling by the European Parliament sends a strong message to the FDA who was originally scheduled to make a decision on e cigarette regulation by the end of October. This will most likely be delayed due to the U.S. government shutdown.

The amendment to the EU Tobacco Products proposal does not go into full effect until next year when another vote by MEPs may ratify the law for good.

For related coverage, check out

  • The proposed text for Amendment 170
  • BBC News
  • Reuters
  • New York Times
  • Wall Street Journal
  • Bloomberg Businessweek
  • Malta Today
  • Globe and Mail
  • CTV News
  • Toronto Star
  • National Post
  • The Parliament