Having been closely involved in this for nearly 4 years now, the behavior of the EU lawmaking process has been utterly shocking.
There is a monumental democratic deficit in the EU, and it's one we hoped we'd addressed as a community by lobbying MEPs and attempting to present the commission with good, robust scientific data.
In the end, we were successful on the first count but the other two seats of power (the commission and the council) colluded to roll back most of the gains from the MEPs vote in the October vote.
So, what had the most influence over this process?
1. The history of the Tobacco industry and the successful spin created by Tobacco Control (and associated public health groups) which associated the e-cig industry with the tobacco industry. By the time we were able to persuade Public Health groups that this was a half (or quarter, even) truth, it was too late - council and commission had their positions set in stone.
2. General ignorance about nicotine: this is a huge issue. The addictiveness and toxicity of pure nicotine has been greatly exaggerated over time, and this had led to it's notoriety becoming completely entrenched in public opinion and, by extension, political opinion.
3. Ignorance of scientific data on e-cigarettes specifically. Children, gateways, safety; all the usual talking points for which there are no evidence have been given a starring role as a function of the (almost univerasally misapplied) Precautionary Principal.
4. National governments - hard to know exactly what their motivations are, or where the influence comes from. In most cases, probably from tobacco control, but there is certainly a concern about tax revenues which was expressed openly by Italy. In any case, national governments were strongly opposed to ecigs. All lobbying efforts towards the UK government, for example, were met with almost universal dismissal.
5. Lobbying. Although there was a paucity of lobbying from the pharma sector in the early part of the process, it stepped up at the point at which med regs were removed from article 18 (the October vote). They probably thought they had this one in the bag to begin with, but it's also worth bearing in mind that their lobbying resources are thinly spread currently because of the new rulings on clinical trials. Also, the tobacco industry was lobbying very strongly on other areas of the TPD, and their support for our position (broadly speaking) did not play favourably to us. One could almost suspect that this was done in the full knowledge that their support would be the strongest move they could make against us.
In the end, scientists' were misrepresented. The commission and the "Rapporteur" (the MEP in charge of the process, Linda McAvan) chose their own sources and disregarded dissenting voices, smearing them as either 'unknowns' or as paid stooges. They were, of course, neither of these.
I suppose the saddest part of all of this is that the vote itself was a total mess. Watching it online there was obvious confusion as to whether or not voting against article 18 would undermine the whole tpd which, if it were delayed now, would go to the next parliament. The fact is, very few MEPs cared sufficiently about e-cigs to risk the TPD being derailed. The real tragedy of this is that the commission's own estimate is that the TPD as a whole is likely to result in a 2% reduction in smoking prevalence (I.e. 2% of 28% of the adult european population) over 5 years. Year on year, this could not be measured to statistical significance. Compare this with an 8% decline in cigarette sales volume in France over the past year!
And all of this doesn't even touch on the fact that the travesty of the 20 year ban on Snus never even surfaced as a serious point of debate. Tobacco harm reduction is clearly not on the agenda of the European parliament.