TPD timeline, what happens next and what we vapers can do…guest post by Martin Callanan MEP.

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As with most trilogue meetings between the Parliament and the Council (in this case represented by the Lithuanians in the rotating chair), the tobacco talks started in the evening and concluded in the early hours. What came out of them was perhaps better for vapers than we first feared, but it is still far too prescriptive and restrictive for me to be able to support it.

The infamous Article 18 is now so long it is practically a directive in itself. In many cases it will allow national governments to maintain the status quo and classify e-cigs as medicinal products, and potentially even ban flavourings.

Refillables will be hardest hit. An EU ‘elf and safety review will take place in 2016. But it probably won’t be needed as the legislation allows the Commission to extend a ban across the EU if just three Member States apply a ban. This dagger hanging over the industry’s head is unacceptable.

Products will also be limited to a nicotine strength of 20 mg/ml. For someone moving off of a serious habit, such a small dose risks just sending people back on to hard cigarettes. We would want to see at least the 30mg limit set out in parliament’s vote in 2013.

Ok, so that’s what we don’t like. Unfortunately this agreement was agreed by representatives of national governments a few days after our meeting. Personally, I was disappointed to see the LibDem MEPs – who had fought alongside us to date – claim that this deal was a good one for e-cigs. It’s not too late to change their minds. And with elections coming you may be able to sway others too. But it will need the vapers of Europe to really step up their pressure on MEPs. The timeline is as follows (although it isalways likely to change):

1) In accordance with the Parliament’s Rule 70.5, the single vote on this compromise agreement will be scheduled in the environment and public health (ENVI) committee on 22 January 2014. A simple majority of MEPs is needed for the committee’s consent on the negotiated text.

2) Following the vote in the ENVI committee, the agreed text must then undergo a further legal-linguistic verification, which can take several weeks before the recast TPD is translated into the 24 official and working languages of the European Union.

3) The compromise text is then expected to go the plenary in Strasbourg inMarch 2014.

4) If the report is adopted in the ENVI committee with fewer than one-tenth of MEPs voting against, the report will go under Rule 138 at plenary. This means that the report shall then be subject to a single vote unless, before the drawing up of the final draft agenda, political groups or individual Members who together constitute one-tenth of the MEPs have requested in writing that the item be open to amendment, in which case the Parliament’s President shall set a deadline for tabling amendments.

So we do have options open to us. As it’s unlikely we will get sufficient votes to reject the whole directive outright in committee, the best course of action, in my view, would be to collect enough signatures (76) to enable amendments to be tabled at plenary, and then to reopen Article 18 with amendments to make it more sensible. Getting these amendments passed would require a Herculean effort from vapers right across Europe. You’ll be fighting against enormous and powerful lobbies from big tobacco to national governments. Conservative MEPs and the ECR Group will be on your side and we will keep working to bring other support behind your campaign. But we can’tdo this alone. This battle is not yet lost.

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9 thoughts on “TPD timeline, what happens next and what we vapers can do…guest post by Martin Callanan MEP.

  1. Firstly,thank you from all vapers for your continuing support.

    In addition to the amount of nicotine to be allowed as detailed in the previous blog here,I would also like to raise the question of the date the directive will come into force.In the plenary report,ecig manufacturers were to be allowed 3 years instead of the 2 years applicable to the majority of the tobacco articles.On their (revised) web page,our MHRA give the impression only 2 years will be allowed for both forms of regulation.

    We do not know how long the authorisation process will take for the non-medicines route – ideally, MEPs should request some clarification from the Commission.It can appear that this route is actually more onerous than the medicines route.

    With regard to the medicines route,the Commission have recently released minutes of their meeting of 3 May 2013 with the AESGP(the self-medication association – containing mainly Big Pharma).The AESGP outlined the medicines authorisation procedure – stating that it takes 2.5 to 4.5 years depending on whether clinical phase III trials are required(I think these are the efficacy trials) and costs between $5-10m.The implication is that the phase III trials take 2 years and cost $5m.They state that some MS regulators require them and some do not and imply that they seek initial authorisation in the more lenient states(I won’t comment on harmonisation).

    It is also relevant that the last new NRT product authorised in the UK – the oral strip – took 4 years from the start of the safety trial to the receipt of the MA.As it was similar enough to other NRT products,no efficacy trial was required so,in theory, this followed the more lenient route.

    I think it is important for all MEPs to know how medicinal authorisation happens in practice – it is relevant for both those seeking the medicinal route but may also give an indication of the time needed to follow the ‘tobacco product’ route.

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