Final vote on the TPD; what now for ecigs?



Guest Post from Rebecca Taylor MEP.

After several weeks of complicated discussions with colleagues, I was disappointed to hear yesterday that the Conference of Presidents (the leaders of the Parliament’s political groups) has not yet given the go-ahead to allow split or separate votes in next week’s final vote on the Tobacco Products Directive.

The current argument is about whether the split or separate votes should come before the single vote on the trilogue agreement or afterwards. If they come afterwards, they can only be voted in the unlikely event of the trilogue deal being rejected – so obviously they must come beforehand. I am of course working with colleagues to try to push for this. If there is the possibility to vote to remove certain parts of article 18 or reject the entire article, I will do that as will a number of ALDE colleagues.

So it is possible that on Wednesday MEPs may only have a single vote

(Yes/No/Abstain) on the entire TPD, with no opportunity to single out and remove specific parts of the text.

However, as I have already made clear numerous times, I will not vote against the Directive as a whole. Unlike some who have supported the case for sensible regulation of e-cigarettes, I also support the tobacco control measures in the directive (my voting record speaks for itself). I believe that tobacco control measures and e-cigarettes are two sides of the same coin; the tobacco control measures can discourage people from starting to smoke and sensible regulation of e-cigarettes can provide a way for smokers to quit their tobacco habit. I know that some e-cig users disagree with me about the tobacco control measures or consider them to be unimportant; there we can agree to disagree.

However, I believe that one of the key reasons that myself, Frédérique Ries and Chris Davies were able to get enough MEPs to vote in favour of the ALDE plenary amendment on e-cigarettes in the first place, is because none of us could be identified as MEPs who backed the tobacco industry line on the TPD.

This was against a backdrop of some opponents of e-cigarettes deliberately trying to blur smoking and vaping (and in fact some still are, which annoys me greatly).

So where does this leave e-cigarettes now?  Well, we must recognise that an awful lot of progress has been made compared to the initial Commission proposal, which would have seen across the board medicines regulation.

But the fact remains that there are parts of the agreed Article 18, which are far from satisfactory, and this is why the Liberal group negotiator

Frédérique Ries refused to sign up to the final deal. The problematic points include:

•   Continued option for Member States to regulate e-cigs as medicines “by function or presentation”

•    The arbitrary threshold of 20mg/ml of nicotine to be allowed in e-liquids;

•    The possibility for the European Commission to propose ban on a specific device in all Member States, if three or more countries remove it from their own markets.

This means that there is still work to do if the TPD is approved next week.

Implementation will be key and it is vital to ensure national governments take as flexible an approach to e-cigs as possible.

It is therefore necessary to keep up strong lobbying of national governments, so that ministers go for consumer product regulation of devices, which is set as a precedent by this Directive on a European level.

After reading clarifications of the technicalities involved in this

Directive provided by the Health Commissioner Tonio Borg (in response to questions from Chris Davies), I am optimistic that it would difficult for a

Member State to regulate a product under pharmaceutical rules, except where companies chose to opt for medicines regulation themselves. The wording of the article obliges governments to prove that an e-cig meets the definition of a medicinal product as set out in Directive 2001/83 EC – namely a substance must have properties for treating or preventing disease in human beings. Numerous courts across the EU have already rejected the application of this definition to e-cigs.

On the banning of devices across the EU, not only do three Member States have to prove that the devices have pose a ‘significant risk to human health’ (quite a high bar), but the Commission can only use this power through a procedure called ‘delegated acts’, which allows the Parliament to veto such a decision if enough MEPs disagree with it (and MEPs regularly reject delegated acts).

And finally, regarding the 20mg/ml threshold, this has been significantly raised from the original 4mg/ml suggested by the Commission, and the 2mg/ml put forward by national governments and, as we are told by a number of scientific experts that this will satisfy the majority of vapers, around 70% of whom use 20mg/ml or less. However, I accept that vapers who use a higher nicotine threshold may suffer unnecessarily because of this.

I understand and share consumers’ frustration and disappointment that the final text on e-cigarettes has enough caveats and loopholes to cause great concern. It is a massive improvement on the original proposal, but still not good enough.