The final trialogue negotiations on e-cigarettes are now several weeks behind us.
Although the deal reached was far from perfect, we must recognise that remarkable progress has been made.
Just a few months ago it looked like e-cigarettes were well and truly doomed. The original Commission proposal would have effectively imposed pharmaceutical regulation across the whole of the EU on all but the least effective devices, and enjoyed majority support of Parliament’s public health committee (ENVI) and unanimous backing from all 28 national governments.
But a decisive victory was won for e-cig users in October when MEPs in Parliament adopted the Liberal-drafted amendment, which steered e-cigs away from over-burdensome medicinal licensing towards a more appropriate consumer product regulatory framework.
Several national governments then began to privately doubt whether the pharmaceutical regime was the best route for e-cigs, although none said so publicly. This did however lay the groundwork for the deal agreed in December, which whatever you think of it, represents a significant climb down from a position unanimously held by 28 national governments.
The package must now be signed off for a final time by a vote of the European Parliament, which is likely to take place in March.
There have been calls to table an amendment to article 18 ahead of the Parliament’s final vote. This is an infrequently used procedure which, if an amendment were to be adopted, would effectively break the deal reached by the Parliament and national governments on the entire Directive. If the amendment adopted by parliament was not accepted by national governments, the entire Tobacco Directive would then go into second reading.
I fear this could jeopardise the important work that has been done on the rest of the Directive upon which parliament and national governments were able to agree without too many problems. Although this would allow article 18 to be re-visited, it would also give tobacco companies another opportunity to chip away at the tobacco control measures.
In addition, it would provide those who have opposed sensible regulation of e-cigarettes with another opportunity to lump e-cigarette advocates together with the tobacco lobby, which in the worst case scenario could see an even more inappropriate article 18 emerge.
It would be untrue to say that I am happy with Article 18 as agreed in trialogues, but for the reasons stated above, I would not advocate that the Parliament reject the TPD in its entirety.
I do believe there is still a battle left to fight, and so I am currently looking carefully in to a number of options and discussing them with colleagues.
There are essentially three options open:
1) Tabling an amendment which removes article 18 from the Tobacco Products Directive altogether and requires the Commission to come up with a new proposal
This should allow the development of a regulatory framework specifically designed for e-cigs, which could then go through the appropriate consultation procedures. However, if adopted, such an amendment would break the trialogue deal, but it doesn’t have to if national governments can accept moving forward with the rest of the TPD intact.
Potential advantages: the chance to develop a customised regulatory framework for e-cigs that would be workable for manufacturers and vapers and help encourage more switching. With more public health organisations and leading experts moving away from the medicines route, we can be reasonably optimistic that a better outcome can be achieved. This would also not touch the tobacco control measures as long as national governments could agree to move forward with the rest of the TPD.
Potential risks: e-cig opponents get better organised (they thought medicines regulation was in the bag until shortly before the October plenary vote and the hysteria of some anti e-cig messages helped secure amendment 170), and re-opening article 18 results in a worse outcome than the current trialogue deal. This is also linked to uncertainty about the shape of the post June 2014 Commission (Commissioners are appointed by national governments) and Parliament (more Eurosceptics who do not engage with legislation meaningfully?). This is a worst case scenario, which I think is rather unlikely, but not impossible.
2) Tabling amendment which alters the text of article 18 as agreed in trialogues
Potential advantages: we get the right framework for e-cigs sooner rather than later.
Potential risks: As well as being very difficult to convince fellow MEPs to back this option, I am almost certain it would not be accepted by national governments, so it would break the trialogue deal and push the TPD into second reading. This could easily result in e-cigs advocates being held responsible for giving tobacco companies another crack at the whip.
Also worth noting: One of the arguments for removing article 18 and re-doing it, is on procedural grounds, namely that article 18 was inserted into the draft directive at the last minute and not subject to the same consultation as the rest of the proposal and that the final text that emerged in trialogue negotiations has had no input from stakeholders. This is in some ways a stronger argument than simply opposing the content of the trialogue deal on article 18, as the same could be argued about many other proposals, and it could be seen as merely sour grapes. If we were to push a new text that would, due to the nature of the procedures involved, be put forward without any proper consultation or significant time for MEPs to examine it, then we would be doing what we criticised others for doing.
3) We accept the trialogue deal and focus our energies on ensuring the regulatory framework agreed is implemented in the most flexible and workable way possible.
Whatever happens, this needs to be done as with most legislation “the devil is in the details”, so getting things implemented in a workable way is vital.
In the UK, I continue to try and win over more Lib Dem colleagues at Westminster to ensure greater pressure is placed on the UK government not to push regulation towards the MHRA route, as has been advocated by Conservative Health Secretary Jeremy Hunt and Health Minister Jane Ellison. Already, Liberal Democrat MPs such as Norman Lamb (social care minister), Dan Rogerson, John Pugh and Lorely Burt have been fighting the corner for e-cig users.
Potential advantages: we know what we are getting and our engagement cannot make it worse.
Potential risks: losing the opportunity to get something better.
I would repeat my previous call for concerned individuals to contact their local MP to raise this issue (regardless of which way things go), so that a greater number of MPs including Labour and Conservatives, can also be won over.
Until then, as always, I welcome comments from e-cig users, who can rest assured that I and my Liberal Democrat colleagues are still very much on their side.