The Tobacco Products Directive (TPD) regulates the manufacture, sale and marketing of most safer nicotine products (as well as combustible tobacco products) across the EU.
The TPD is the most comprehensive regulatory framework for safer nicotine products worldwide and is also the only regional framework. This gives the TPD global as well as regional significance because (1) regulators worldwide look to it as a legislative model; and (2) the EU is a powerful player in WHO FCTC and COP (Conference of the Parties),which has global affect. The tobacco control field does not operate in silos and so there is considerable overlap and inter connectivity between tobacco control activity and actors, at global, regional and national levels.
Which tobacco harm reduction products does the TPD regulate? Not snus: the TPD prohibits the sale of snus throughout the EU, except for in Sweden, which gained an exemption when joining the EU. The World Health Organisation published European data in 2018 which indicated that Sweden had the lowest rate of tobacco-related mortality and the lowest incidence of male lung cancer. So, the safest harm reduction product is actually banned by the TPD. White nicotine pouches are not covered by the TPD, because they do not contain tobacco and are not e-cigarettes. Heated tobacco products are regulated under the TPD, they fall into the "novel tobacco products" category and, like e-cigarettes, have to undergo a notification procedure before being placed on the market.
The current TPD is the second TPD and so is often referred to as TPD2. TPD2 entered into force in May 2014 and became applicable in EU Member States in May 2016. TPD2 states that:
"No later than five years from 20 May 2016, and whenever necessary thereafter, the Commission shall submit to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions a report on the application of this Directive". From Article 28 of the current Tobacco Products Directive.
The application report process is now well underway and the report should be ready in May 2021. This report is important as it is likely to lead to decisions on whether and how TPD2 should be revised.
Frustratingly, it is difficult to find information on how the TPD application report is being produced and so here we present what we know. We will update this article as information becomes available.
If you spot any errors or have any additional information do please write to us via our Contact form or tweet to @europethra
TPD Milestones 2020 - 21
TPD Application Report – the legal basis (Article 28)
TPD2’s article 28 mandates the scope and timing for the TPD application report (also often referred to as “TPD review” or “TPD evaluation”).
- DG SANTE is preparing the report on behalf of the European Commission, to be ready in May 2021
- If the Commission deems it necessary to adapt the TPD then the European Commission should indicate which elements should be reviewed. If the conclusions of the report do not indicate that the described developments require amending then the EU Commission has no obligation to propose amendments.
- Article 28 states: “When drafting the report, the Commission shall be assisted by scientific and technical experts in order to have all the necessary information at its disposal.”
The areas to be focussed on include, among other things:
“market developments concerning electronic cigarettes and refill containers considering, amongst others, information collected in accordance with Article 20, including on the initiation of consumption such products by young people and non-smokers and the impact of such products on cessation efforts as well as measures taken by Member States regarding flavours;”
as well as:
“market developments concerning novel tobacco products”
- Member states are to have a key role:
“The Member States shall assist the Commission and provide all available information for carrying out the assessment and preparing the report.”
(See Tobacco Products Directive )
Our comment: Consumers reading this will appreciate that the report is examining some highly controversial topics in vaping: youth initiation, influence on smoking cessation and flavours. Two member states, Denmark and the Netherlands, are currently legislating to restrict e-liquid flavourings and flavour bans are already in place in several other member states.
Who are the scientific and technical experts who are assisting the Commission, with this evaluation - which is likely to affect consumer lives worldwide? What are the data sources for the report? What questions are being asked? What is the role of member states? Where are consumers in all this? What follows is the little we know.
INPUT TO THE TPD2 APPLICATION REPORT
Report on the Application of the Directive 2014/40/EU
Indicative Description of Data Sources for Article 28 of Directive 2014/40/EU - Tobacco Products Directive
INFORMATION WEBINAR ON TOBACCO POLICY (given to member states)
1. Product perception study aimed at assessing consumer perceptions of tobacco and novel tobacco products
The “Consumer preference and perception of specific categories of tobacco and related products” study is being conducted by Open Evidence, with London School of Economics, BDI Research and the Catalan Institute of Oncology. See Open Evidence’s press release, here and ”Article 28 report update”, from here.
- The study will also examine initiation and cessation potential as well as “attractiveness”. (see here)
- The agency responsible is the Consumers, Health, Agriculture and Food Executive Agency (Chafea)
- The report was due in Quarter 1, 2020
2. Scientific Opinion commissioned by SCHEER (Scientific Committees on Health, Environmental and Emerging Risks)
DG SANTE asked SCHEER to provide scientific input for the report mentioned in Article 28 (link to request).
A core working group was formed – referred to here. We cannot find any information on who the Working Group members are.
The reasons for the report:
“The SCHEER identified a need for an additional expertise in the following areas: addiction to tobacco and e-cigarettes; relation between (abandoning) smoking and use of e-cigarettes; exposure scenarios for e-cigarettes; modelling of exposure scenarios for e-cigarettes and parametrization of these models; analytical expertise specific for (e-)cigarettes; risk assessment and risk management advice in relation to e-cigarettes.” (from these SCHEER minutes)
Opportunity for engagement?
Various references have been made to the Scientific Opinion being opened for consultation but what form this will take is unclear, as the published references to it are inconsistent:
"Deadline for the final Opinion is September/October 2020. A preliminary opinion is planned to be ready for a public consultation in May 2020." (from these SCHEER Working Group on e-cigarettes minutes, April 2019)
“Deadline for the Opinion (SCHEER Committee’s scientific opinion on e-cigarettes and its effects on cessation and initiation) that will be opened for comments is planned in autumn. However, delays may occur in view of the COVID-19 crisis limitations.” (from these SCHEER Working group on e-cigarettes minutes, May 2020)
“The preliminary Opinion is planned to be adopted in September before publication and minimum consultation due to legislative constraints. However, delays may occur in view of the COVID-19 crisis limitations.” (from these SCHEER Working Group on e-cigarettes minutes, July 2020)
UPDATE 9 SEPTEMBER
"The preliminary Opinion is planned to be adopted by written procedure in September before publication and four weeks consultation planned to run during October." (from these SCHEER Working Group on e-cigarette minutes, 1st September 2020)
Our comment: there is much that is unclear about this hugely important Scientific Opinion on e-cigarettes, especially with regards to who is involved in writing this report and what the opportunities for engagement will be. It is ominous that the consultation, initially referred to as “a public consultation” was most recently described as “minimum consultation”.
3. Application study. A support study to the report on the application of the Directive
DG SANTE (Directorate General for Health and Food Safety) contracted external consultants, ICF, to carry out the support study
“The purpose of the study is to examine the practical application of Directive 2014/40/EU (hereinafter TPD) and its specific provisions, which strengthened existing rules on how tobacco products are manufactured, produced and presented in the EU, and introduced new rules for certain tobacco-related products. The study will assess the level of implementation of the TPD by exploring both achievements and hindering factors.” From Denmark’s Member State’s Questionnaire, posted here.
Stakeholder consultation meetings were undertaken in December 2019 (see here). We can’t find any information on which stakeholders were involved in these meetings but as far as we are aware, no consumer groups were invited to participate.
Work for the Support Study also includes three questionnaires /surveys, sent to Member States, to industry and to Civil Society & Health Experts.
- The Questionnaire to Member States was sent out in March 2020. Member States have a legal obligation to contribute to the report (referred to here) .
- ETHRA wrote to the European Commission and to the consultants, ICF, to protest at consumers not having been consulted and at the Member State questionnaire’s failure to examine the potential consequences of bad regulation for safer nicotine products, our letter is here.
- Questionnaires / surveys were sent out in April to industry, NGO’s and to some consumer groups, including ETHRA.
ETHRA participated in the Civil Society & Health Experts survey (online) and in a follow up phone interview and later published a summary of our views, see our article here.
- An example of the Member States Questionnaire can be seen here (Denmark)
- An example of the CSO and Health Experts Survey can be seen here
Our comment: It is not clear why some consumer groups and not others were invited to participate in the stakeholder surveys. This selectiveness and lack of transparency will prevent the Study from being representative of consumer views in the EU region.
4. JATC: joint Action on Tobacco Control [ website ]
This project supports the implementation of the TPD throughout the Member States.
JATC is a collaborative action between the European Commission and the EU Member States
Runs for 36 months
The objective is to “provide support for the implementation of the Tobacco Products Directive throughout the 28 EU MS” (see here)
30 EU Partners (“scientific and governmental institutions” ) & 13 international Collaborating Partners (including WHO FCTC) (see here)
Organised in 9 work packages under the lead of national organisations (see here)
Work package 7, “E-cigarette Product Evaluation”, deals exclusively with e-cigarettes, see here for the materials
Target date for completion is October 2020
5. Expert Group on Tobacco Policy – Link to group documents
“The purpose of this group will be to assist the Commission in the preparation of policy initiatives for incentive measures in the area of tobacco control, to facilitate cooperation with Member States in this area and to act as a forum through which Member States' experts can be consulted on the preparation of reports, legislative proposals and delegated acts in the framework of Union legislation on tobacco, in particularly those delegated acts provided for under the revised Tobacco Products Directive (Directive 2014/40/EU)” (from the Expert Group’s Transparency Register entry, here)
- Each Member State has a representative in the Group
- There is also an Expert Subgroup for Electronic Cigarettes, which sits below the Expert Group on Tobacco Policy
- The published documents for both groups are a good source of information on the TPD Application Report and the TPD more generally, here are links to some:
MEETING OF THE GROUP OF EXPERTS ON TOBACCO POLICY 21 MARCH 2019, summary record
6. Euromonitor commercial database to provide market data on sales of tobacco and related products - website
Target date for completion March 2021
7. Eurobarometer. Survey on the use and opinion on tobacco and related products across the EU
Postscript – COP9 and Europe’s Beating Cancer Plan
What does the TPD application report have to do with COP9?
There exists a close relationship between the EU and the WHO Framework Convention on Tobacco Control (FCTC). Wikipedia describes the FCTC as a “watershed moment” for the European Union, adding:
"Worldwide tobacco control set a precedent for EU Commission participation and negotiation in multilateral treaties, and further defined the powers and capabilities of the EU as a supranational entity."
WHO Framework Convention on Tobacco Control, Wikipedia, accessed 28 August 2020
The European Union is the only regional economic organisation to become a full signatory member and party to the FCTC. This Commission sponsored research paper from 2010 has some interesting discussion on how the EU mandate for COP is negotiated and the role of the EU within the FCTC. Many of the same actors are involved in FCTC COP and EU and national tobacco control efforts.
COP9 was originally scheduled for November 2020, and so would have taken place before the publication of the TPD application report. It seems therefore a fair guess that DG SANTE might have planned to use decisions made at COP9 to define the revision strategy for TPD2. However, COP9 has been postponed and will now take place after the TPD application report has been issued. Will the TPD application report now be used to influence COP?
Europe’s Beating Cancer plan
Europe’s Beating Cancer plan is a key initiative for the current EU agenda and will include cancer prevention in its terms of reference. The initiative includes a Special Committee on Cancer, which was established in June 2020. In the text for the European Parliament’s decision to establish the Committee, tobacco control – including implementation of current legislation and identification of future measures - is identified as a key focus for the Committee:
‘identifying specific actions, including the strict implementation of current legislation and the identification of future measures in the fields of tobacco control” see 1 (d) here
This implies that the Committee will be looking at the TPD and possible areas for review.
- 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 was invited to participate in the current review of the TPD, by responding to an online stakeholder questionnaire and taking part in a follow up telephone interview. We have written notes summarising the views we put forward in the interview, together with some background evidence.
A failure to regulate safer nicotine products well is a win for smoking. In our notes we outline the key areas where the TPD fails to ensure a high level of health protection: the 20mg/ml nicotine limit, the overstated health warnings, the advertising ban, limits on volume for bottles and tanks, the failure to protect flavours and the ban on the sale of snus. We regret that the TPD evaluation does not examine the unintended consequences of not regulating safer nicotine products well. We call for consumers to be recognised as essential stakeholders in discussions of policy and for all consumers to be given the opportunity to participate in the TPD evaluation.
You can read our notes here.
Interview on Tobacco Products Directive: notes by ETHRA [LINK]
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