How should the EU regulate e-cigarettes?

Background: revision of the tobacco directive

The European Parliament is currently examining the proposed revision of the EU tobacco products directive. The tobacco directive regulates many aspects of how tobacco products can be marketed and sold including ingredients, packaging, labelling, health warnings, pricing, advertising and promotion. 

The aim of the legislation is to make tobacco products unattractive and inform users as much as possible of the health dangers of tobacco, in recognition that these products are so bad for health that they kill hundreds of thousands of Europeans every year. 

In public health terms, tobacco control policies are highly successful and have resulted in falling levels of smoking across Europe and the world:

http://www.ash.org.uk/files/documents/ASH_743.pdf

http://www.bvsde.paho.org/bvsacd/cd51/tobacco-past/cap4.pdf


http://old.ensp.org/files/effectivefinal2.pdf

http://tobaccocontrol.bmj.com/


For more information on the proposal, please see: http://ec.europa.eu/health/tobacco/products/revision/index_en.htm

As a member of the ENVI (environment, public health and food safety) committee 
 with a strong interest in public health, I am following discussions on the directive closely, although I do not have any official role (my Belgian Liberal colleague Frédérique Ries is the MEP responsible in the Liberal group). 

However, I am following the proposal for the Liberal group in the Legal Affairs committee, which will naturally examine the legal soundness and clarity of the proposal rather than the public health aspects. 


Electronic cigarettes

During the last few years, we have seen the arrival of electronic cigarettes (e-cigarettes) on the market in various European countries. For those who do not know, e-cigarettes are devices that resemble a cigarette or a pen and enable the user to inhale nicotine containing vapour. Some e-cigarette users call their habit "vaping". 

Supporters of e-cigarettes say that provide a less harmful alternative to tobacco for smokers unable to quit. E-cigarettes contain only nicotine, the addictive component of tobacco, and do not contain the many other components of tobacco including those which are carcinogenic (cancer causing). 

Public health organisations such as Action on Smoking and Health (ASH), the UK anti-smoking charity agree that e-cigarettes can be a harm reduction tool for smokers who want to quit but have not managed to do so. 

The UK National Institute for Health and Clinical Excellence (NICE) will also look at e-cigarettes in its next review of smoking cessation guidelines. 

The regulation question
 
As e-cigarettes are new products, they are currently only very loosely regulated under general consumer products legislation, which does not take into account their rather specific nature. The European Commission (EU civil service) therefore included proposals to better regulate e-cigarettes in the revision of the tobacco directive. 

What is currently proposed in the tobacco directive would require e-cigarettes containing a nicotine concentration of more than than 4mg per ml to fall under the pharmaceutical legislation that covers nicotine replacement therapy (NRT) products such as nicotine patches and chewing gum. This would mean e-cigarette companies having to submit marketing authorisation applications to the European Medicines Agency.

E-cigarettes contain on average a nicotine concentration of around 18mg/ml, with some products going up to 20mg/ml. That means most e-cigarettes would under the current proposed regulatory regime fall under the scope of EU pharmaceutical legislation. 

One solution could be that e-cigarettes producers lower the nicotine levels in their products  so they are 4mg/ml or less. However, e-cigarette companies and consumers say that this level of nicotine is too low to satisfy the nicotine cravings of ex-smokers who have switched to e-cigarettes and could lead to them returning to tobacco. 

Considerations for the regulation of e-cigarettes

It seems to me that maintaining the status quo is not an option, but I am not yet convinced 
that requiring e-cigarettes to get a pharmaceutical marketing authorisation is the way to go
either. 

I believe it is necessary to develop a regulatory regime specifically designed for e-cigarettes that will achieve the delicate balance of keeping the products available for existing users who are ex-smokers, while not making the products attractive to new users who do not smoke, especially young people. Very difficult!

I am not sure how best this can be done, but I would suggest that the following needs to be taken into consideration:

• While it is clear that e-cigarettes are far less harmful than tobacco, nicotine does have some negative health effects, but the long term health impacts of using e-cigarettes are currently unknown;

• Expanding on the previous point, it may be appropriate to require e-cigarettes to come with a general health warning such as "may damage your health" until evidence is available to make a more precise warning;

• There are currently no standards in relation to the quality and safety of e-cigarettes, something which needs to be rectified for reasons of consumer protection;

• The aim of regulation should be to keep e-cigarettes available as a harm reduction tool for adult smokers, while taking every precaution to ensure their use does not "renormalise" smoking and that they are not marketed in a way that broadens their appeal to non-smokers, especially young people. In order to guarantee this, it may be necessary to subject e-cigarettes to marketing restrictions such as minimum age of purchase requirements, forbidding free samples or below cost pricing, a ban on characterising flavours (e.g. chocolate) and advertising restrictions such as prohibiting billboards near schools, daytime TV adverts and adverts in magazines, websites aimed at or read by young people. 

• Following on from the previous point, e-cigarettes used in public places where smoking is forbidden or in front of children would also contribute to "renormalisation", so steps should be taken to avoid this, for example restricting the use of e-cigarettes in public places. 

One other point worth mentioning is that whatever regulation is eventually put in place for e-cigarettes, there will be a transition period of several years before it comes into force. This would mean that the e-cigarette industry would have a number of years to comply with the legislation, so there would be no danger of the products disappearing overnight and existing e-cigarette users being left high and dry.

This is indeed a complex issue, with many different viewpoints. I am open to comments and suggestions. 

International Women's Day

This week is International Women's Day and activities are going on all over the UK and the world. 

International Women's Day seeks to celebrate the achievements of women and promote the role of women in business and society. Despite progress women are still more likely to earn less than their male colleagues, be victims of violence including domestic and sexual violence and less likely to be on the boards of companies, in high public office or elected to parliaments. Gender equality is an ongoing battle. 

I went to a great IWD event yesterday in the House of Lords organised by the International Longevity Centre UK . ILC-UK is a think-tank that undertakes research and develops policy in the areas of ageing, longevity and demographic change. For reasons of transparency, I should say that I used to work for ILC-UK : )

The event launched a book of short essays on the topic "Has the Sisterhood forgotten older women?". The essays were written by a wide range of men and women including academics, journalists, parliamentarians, business and charity leaders. 

Several of the contributors to the book spoke at the event and among other points they mentioned the invisibility of older women in the media, pensioner poverty among women, the challenges of dementia, the positive role of grandmothers in development and discrimination of older gay women in care homes by their straight peers. 

For more information on the book or to download an electronic copy, please go to: http://www.ilcuk.org.uk/index.php/publications/publication_details/has_the_sisterhood_forgotten_older_women

I am currently at Liberal Democrat party conference in Brighton and our conference rally tonight is dedicated to International Women's Day and I'll be heading there shortly!

When omission is a lie: The Sun and EU healthcare

We all hear or read EU horror stories in the media. Many are distorted versions of the truth, some are pure fabrication. MEPs spend considerable time refuting incorrect stories, as so many exist. My South East colleague, Catherine Bearder, has even set up a "Euromyths" page on her website  for this purpose.

Catherine alerted me to such a misleading (to say the least) article recently in the Sun "newspaper" on EU citizens obtaining medical care paid for by the NHS "http://www.thesun.co.uk/sol/homepage/news/4809970/Polish-doctors-are-billing-Britain-1M-for-more-than-500-pregnant-mums-who-snubbed-NHS-and-flew-home-to-give-birth.html".

The article was about EU citizens resident in the UK choosing to return to their country of origin for medical treatment, paid for by the NHS. This is possible under EU rules on the coordination of social security systems and patient mobility.  It requires, however, that individuals wishing to use this procedure must:

- be eligible for NHS treatment;

- get prior approval from their local NHS;

- pay costs upfront and claim them back later, claiming back only what would have been available on the NHS (so travel costs or private rooms would not be covered).

More information on this procedure can be found at: http://www.nhs.uk/NHSEngland/Healthcareabroad/plannedtreatment/Pages/TheE112.aspx

The article gave the impression that somehow this was at the expense of "UK taxpayers" while of course ignoring the fact that the EU citizens concerned are UK taxpayers themselves.

The article omitted to mention that there is two-way traffic in this EU free movement of patients as British citizens living abroad and EU citizens living outside the UK can use the same procedure to obtain NHS treatment, the cost of which is then reimbursed by the healthcare system of their country of residence. For example, British and Irish citizens resident in Ireland, who come to the UK for NHS treatment, get the cost of their treatment paid for by the Irish healthcare system.

The Sun also ignored the fact that British citizens use this procedure to obtain treatment in other EU countries. There have even been court cases that have confirmed the right of British citizens to obtain, for example, a hip replacement in another EU country if they would suffer undue delay in obtaining one via their local NHS.  The Sun made a freedom of information request to the Department of Health, but apparently forgot to ask or chose not to publish how many Brits use this procedure and how much money the NHS receives from other countries through it. 

I spoke privately to a Department of Health official who expressed the opinion that the UK might actually be a net beneficiary from this procedure. In addition, the official agreed with me that given that many of the EU citizens resident in the UK seek treatment in countries with cheaper healthcare, such as Poland, it may even save the NHS money!

The Sun found a Conservative MP who said this was "a power that should be taken back from Europe". Given the appalling lack of knowledge of the EU of the average Conservative MP, one supposes that the chap concerned probably doesn't realise that Brits also use this procedure when NHS waiting lists are too long and that the NHS receives money from other healthcare systems through it. I could imagine the same MP being outraged if a British pensioner in Spain wanting medical treatment "at home" was refused reimbursement of NHS treatment by the Spanish healthcare system!

Of course, the facts I mention above significantly weaken the anti-EU bent of the article and don't fit the editorial bias of the Sun, so I understand why they chose to omit them. Such blatantly selective journalism is yet another example of the "clear evidence of misreporting on European issues" mentioned by Lord Leveson in his report (page 687).

Another myth busted!