- Consumers, the most important stakeholders and the group most directly affected by the TPD, were overlooked in the review process.
- Failure to regulate vaping and other safer nicotine products appropriately is a win for the incumbent combustible tobacco trade and could trigger more smoking.
*** UPDATE: since sending our letter earlier today we have had an assurance that we will be included in forthcoming stakeholder consultations ***
Photo by Jason Blackeye on Unsplash
The Tobacco Products Directive (TPD) is the European directive which places limits on the sale and merchandising of tobacco and tobacco related products in the EU. Many of us consumers remember the drama around the last TPD, when we mobilised ourselves and successfully prevented the most damaging proposals from being adopted.
That feels like such a short time ago but five years have already passed since TPD came into force, and the evaluation report is due in May 2021 (see Article 28 in the TPD). The TPD may be reviewed or adapted, depending on the proposals in the report.
One of the aims of the TPD is to “ensure a high level of health protection” for EU citizens. Although the most damaging proposals for TPD2 were defeated, much of what was left is concerned with cumbersome regulations and arbitrary restrictions, resulting in less effective products and, ultimately, in more smoking.
The TPD evaluation includes a questionnaire for Member States to respond to. Thanks to one of our Partners we have seen the Questionnaire and have written to the consultants who sent it out on behalf of DG SANTE.
In our letter we object that consumers were not included in the list of stakeholders to be consulted.
Locking out the general public from the review process contravenes the EU’s General principles of consultation in EU law making and review, which state:
“To achieve better results, the Commission is opening up policy and law-making and listening more to the people it affects. Better regulation relies on evidence and a transparent process, which involves citizens and stakeholders (for example, businesses, public administrations and researchers) throughout.”
We also complain that the Questionnaire does not examine whether any of the provisions of the TPD have led to the unintended consequence of favouring combusted tobacco, by making safer nicotine products less appealing or less accessible. We outline some of the areas where we feel the TPD has let us down.
READ OUR LETTER HERE: ETHRA letter to ICF regarding the Member States Questionnaire
ETHRA is pleased to welcome some promising news from Norway.
The Norwegian government has declared that it will lift its ban on e-cigarettes with nicotine and replace it with an authorisation system as it belatedly moves to implement the EU’s Tobacco Products Directive (TPD). Manufacturers of e-cigarettes and new tobacco products will have to apply for authorisation at least six months before they intend to put their product on the market, as the TPD requires. The government is also planning to allow e-cigarettes and refill containers to be advertised at the point of sale and be presented online neutrally, unlike cigarettes.
The Norwegian Directorate of Health, which will evaluate the applications, will look at “whether the product will contribute to tobacco harm reduction;” whether it appeals to youngsters; whether it will lead to the initiation and re-normalisation of tobacco use; and whether it’s addictive, according to draft rules sent to notify the European Commission at the end of November.
The directorate will then decide whether the e-cigarette or novel tobacco product is defined as a nicotine or smokeless tobacco product, or a tobacco product for smoking, and which regulations should apply to it. This measure goes beyond the scope of the TPD.
“Legalising vaping in Norway is a welcoming development and we congratulate our government for aligning with the EU’s TPD,”, says Trond Meier, of Norsk Dampselskap/Norwegian Union of Vapers, a consumer-led association which advocates for vaping in Norway, “however, there is still much negative publicity around vaping in the media and many details still to become clear so our welcome must be cautious for now. There is still more work for us and our ETHRA partners to do.”.
André Bendigtsen, of Nikan, the tobacco harm reduction consumer group, adds: “We understand that these proposals will be implemented during 2020 and we would suggest that the government includes consumers of reduced risk products in the process at every stage.”, André continues, “these products offer a lifeline to many former smokers and can lead to better outcomes for the public’s health in Norway in the future. Consumers are ready and available to offer our experience and knowledge to regulators in order to maximise the many benefits of safer nicotine use.”.
Norsk Dampselskap was established on 6 November 2011 and has over 4,000 members.
The Committee on the Environment, Public Health and Food Safety (ENVI) is the European Parliament Committee which is responsible for public health. The Committee met on the 18th of February and on their agenda was item 16, an exchange of views with the Commission on e-cigarettes and heated tobacco products. Damian Sweeney, New Nicotine Alliance Ireland trustee, gives his account of proceedings, how much (or little) our MEP’s know about tobacco harm reduction and whether or not THR advocates should be worried.
For those of us in Europe with an interest in tobacco harm reduction, especially those that have actively engaged with our elected representatives on the subject, Tuesday the 18th of February was a date we had marked down in our diaries. Up for discussion during a meeting of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) was an exchange of views with the European Commission on e-cigarettes and heated tobacco. Having had numerous conversations with the office of one of the Committee members I was slightly more optimistic that I normally would have been. But as George W Bush once famously said “Fool me once, shame on ... shame on you. Fool me... You can't get fooled again!”
First to hold the floor was Andrzej Rys, speaking on behalf of the European Commission’s Directorate-General for Health (SANTE). Mr Rys began by giving a run through of the TPD and how it has been working to date and congratulated the Commission for having foresight to include vitamin E acetate in the list of prohibited compounds, thus sparing the EU from EVALI. However, there was no mention that vitamin E acetate is not used in e-liquid nor that EVALI was caused by illicit THC products, but who has time for pertinent facts when there’s more important things to talk about? Then came the obligatory ‘think of the kids’ moment when he stated that "25% of 15 to 24 year olds have ever tried vaping", undoubtedly fuelled by the evils that are flavours. Adding to this point he said it is within the remit of member states to "ban flavours and indeed one already has, with more to follow in the coming months". The contagion from the USA could very well have given prohibitionists the excuse they were looking for.
Next up was Mairead McGuinness, MEP (Ireland), the first Vice-President of the European Parliament. This contribution was more of the same, repeating the points from the opening presentation, lung injuries in the USA but predictably no mention of illicit THC. One interesting question she did raise was on the statistics for youth use and whether or not it was known if vaping was first initiation or if there was prior use of tobacco products. If only someone in her constituency had given her all that information, after a conversation with her parliamentary assistant months ago, this could have been easily addressed (in case you haven't guessed, I did). There was one positive when she brought up a recent study by the Coombe hospital that found pregnant women who used e-cigarettes delivered babies who had the same birthweight as non-smokers. Not wanting to end on a positive note, she then went on to suggest vaping was an attempt by the tobacco companies to diversify, and that the impact of flavours needs to be assessed, adding “It’s a shame we have to wait for the field work to guide us in our risk assessment”.
It wasn’t until Peter Liese, MEP (Germany) took the floor that a meaningful exchange of views threatened to break out. Rather than follow what went before he asked the Chair if he or the Commission have details of exactly what happened in the USA, and whether or not the EU have rules in place to prevent a similar occurrence happening here. Following up with another excellent contribution he made reference to the potential health benefits, specifically reduced cancer risks, of heavy smokers switching to vaping and suggested switching should be encouraged for this group.
Normal proceedings were quickly established as Chair, Cesar Luena Lopez, MEP (Spain), spoke to once again cite statistics on youth ever vaping and to warn that “these products are harmful and do induce people to smoke”, as per the WHO. He ended by saying new regulations are needed to include non-nicotine containing products and a tax regime that will consider "all aspects of fighting tobacco use."
The next three contributions came from Veronique Trillet-Lenoir, MEP (France), speaking on behalf of Frédérique Ries, MEP (Belgium), who asked about known data regarding USA lung injuries, youth vaping and flavours, the efficacy of flavoured vaping in adult smoking cessation attempts and if the Commission will take this aspect into consideration when regulating. Aurelia Beigneux, MEP (France) added that vaping being included in indoor smoking bans was a move in the right direction. In stark contrast to her colleagues that wanted data based decisions, Michèle Rivasi, MEP (France), took a much more hard-line stance. She insisted that the EU should implement more draconian regulations but rather than wait for a revision of the TPD, flavours should be banned now as they "lure" young people in. There was a clear agenda at play in Ms Rivasi’s contribution, one that didn’t include adult rights to safer nicotine products.
As if to balance out the previous statements, Pietro Fiocchi, MEP (Italy), got straight to the point in a very short and concise use of his speaking time. He simply asked to see a real, scientific study on vapour products that shows whether or not they can be used successfully as cessation products and if there are any inherent risks to never smokers that use the products, specifically youths.
In a session that had provided some of the most irresponsible, ill-informed and ridiculous statements from our elected representatives there was still time for one more, and that came from Christel Schaldemose, MEP (Denmark). Bemoaning the difficulty of making decisions due to a lack of long term data, for products that have been on the market for roughly 10 years, she proposed that the Commission adopt the precautionary principle and start banning e-cigarettes, and that if in the future there is proof of no negative health effects they can be allowed back on the market. Adding that a number of cancer societies in the EU were recommending a stronger approach to regulation, she asked if this would be taken into consideration. In essence, keep smoking for the time being and we’ll get back to you some time...maybe.
Finally, it was back to Andrzej Rys, speaking on behalf of the Commission, to answer some of the questions and provide information on what was coming in the future. I think we all know flavours will, without a doubt, feature heavily in the next iteration of the TPD, and he once again stated that two or three member states were planning a flavour ban in the coming months, in response to the USA hysteria we’re all too familiar with. However, he did aver that vitamin E acetate and cannabis products were the cause of the USA lung injuries but swiftly moved on from that, no doubt not wanting to get too accurate with the information. Thankfully it was pointed out that banning and waiting is not within the remit of the Commission, and that the final decisions about what to do should be based on the evidence. Unfortunately, two of the institutions being consulted to provide that evidence are the FDA and WHO FCTC.
What I took away from this meeting, besides a sense of bewilderment and a migraine, was that despite the huge amount of work put in by advocates, a large number of our elected representatives remain painfully ignorant to the most basic principles of tobacco harm reduction. I prefer to see that as a challenge and one I’m more than happy to accept. It’s time for us all to get louder.
ENVI, the green monster, blog post by NNA Ireland’s Tom Gleeson [link]
ENVI agenda for Tuesday 18th February [Link]
ENVI Committee exchange of views on e-cigarettes and heated tobacco (18/02/20) courtesy of David Newell