EU EU Tobacco Directive - COMMENTS NEEDED

[rolygate]

The EU is holding a consultation on tobacco regulations, including smokeless tobacco, and we need to respond. Go here:

http://www.e-cigarette-forum.com/fo...eu-tobacco-directive-public-consultation.html

European residents should fill the online form at EU central.

Please publicize this on other forums and websites.

Ideally we need to organize some suitable text that respondents can use in the comment field.

 

[ckc]

I still need a question answered.If the MHRA decided they're to become part of their Nicotine Containing Products Regs will the EU regs rule over this (and E-Cigs possibly become tobacco) ?

 

[rolygate]

Difficult question to answer - you need a specialist in EU vs UK law.

In theory EU law is superior, and the same situation exists as for federal vs state law in the US. But perhaps it depends on whether these are EU advisories or EU law. I get the feeling that if an EU country wants to restrict something more than the EU statute, then that is OK - but they can't restrict it less. In other words if ecigs become a pharmaceutical in the UK, then if the EU class ecigs as tobacco, it would not be obligatory for the UK to remove the pharmaceutical classification - but that's just a guess.

However, current events seem to contradict that. I'm wondering if the MHRA was being forced to wait until the EU made a decision on this. However, the EU process has now been considerably delayed - their consultation does not end until December now, which means nothing will be done about this till spring 2011 at the earliest.

If this is the case, what MHRA might do is announce a waiting period of 6 or 12 months, for them to 'accumulate more data' or some such. If they do this, it shows they are waiting for the EU decision (ie, are being forced to wait for the EU decision by their masters). In that case the EU decision will be very important to us.

Whatever has caused the MHRA to delay their decision is obviously a serious matter. In my view they had already decided to make ecigs a pharmaceutical when they started the consultation process; that was simply a cosmetic exercise required by regulations. The decision had already been made by that point. As they have not given their 'decision' by now, it shows that they've been told to hold off. Since it appears that they have also not been told to dump the whole idea, it appears they are waiting for something. My guess would be the EU decision. Since that has been delayed by several months it suggests that the MHRA will soon announce a 'waiting period' or similar.

The situation in the US is much clearer, ecigs have to be either a pharmaceutical or a tobacco product, no other option is available. As it appears that the FDA have failed in their bid to make ecigs a pharmaceutical, they will become a tobacco product.

 

[MoonRose]

I wonder if the EU, UK and all other foreign nations are waiting to see what the appeals court here rules. It appears that most other countries have been using the FDA's statements back in 2009 as their reason's for taking action against e-cigs. Is it possible that they are now all awaiting to see if e-cigs are classified as tobacco products or drug delivery devices here in the states before taking action in their own respective countries? Rather like a case of "Monkey see, monkey do."

 

[rolygate]

You could be right of course. The MHRA's decision might depend on the FDA case result. Certainly, when the FDA fails, and if the EU decision supports us, it would make it that much harder for the MHRA to act against us. There are legal issues on which they can be challenged as it stands; with those results against them as well, it might be impossible for them to proceed.

But perhaps it depends on their masters' instructions. As the government has changed, it must be harder to proceed with the last lot's agenda.

 

[MoonRose]

We are coming up on much the same thing here with the mid-term elections in the house-of-representatives and the senate as well as a lot of state and local positions that might be changing as well with these mid-term elections.

 

[freakindahouse]

However, current events seem to contradict that. I'm wondering if the MHRA was being forced to wait until the EU made a decision on this. However, the EU process has now been considerably delayed - their consultation does not end until December now, which means nothing will be done about this till spring 2011 at the earliest.

If this is the case, what MHRA might do is announce a waiting period of 6 or 12 months, for them to 'accumulate more data' or some such. If they do this, it shows they are waiting for the EU decision (ie, are being forced to wait for the EU decision by their masters). In that case the EU decision will be very important to us.

Whatever has caused the MHRA to delay their decision is obviously a serious matter. In my view they had already decided to make ecigs a pharmaceutical when they started the consultation process; that was simply a cosmetic exercise required by regulations. The decision had already been made by that point. As they have not given their 'decision' by now, it shows that they've been told to hold off. Since it appears that they have also not been told to dump the whole idea, it appears they are waiting for something. My guess would be the EU decision. Since that has been delayed by several months it suggests that the MHRA will soon announce a 'waiting period' or similar.

The situation in the US is much clearer, ecigs have to be either a pharmaceutical or a tobacco product, no other option is available. As it appears that the FDA have failed in their bid to make ecigs a pharmaceutical, they will become a tobacco product.

I agree with much of what you say, Roly, but I think it is optimistic (at best!) to suggest that the MHRA will make some public announcement of their intention to delay. I am chasing them regularly for their decision to be published, and the longer it goes on, the more convinced I become that they have simply come up against the fact that this ill-conceived Consultation MLX 364 was signed off by the previous government without much attention, but has now suffered the scrutiny of the new coalition government who have recognised the nonsense it represents.

IMHO, the MHRA might well want to wait for the outcome of the EU Public Consultation, but I can't see how it would make a blind bit of difference to the MHRA's own situation, apart from perhaps getting them off the hook relatively easily, since they could just blame the EU. The fact remains that the legislation is against them, the RPC was against them, the new Government is against them, and now it seems the EU is against them. I think it's fair to say that they are dead in the water now.

I am meeting with my counterpart in Europe next week, and will provide an update then on how we shall be addressing the EU consultation. On reading the document, however, I feel some optimism that this is a far less biassed and 'unfriendly' consultation than that of our own dear MHRA. Let us hope that common sense and solid legal research can win the day again.

 

[Perfectionist]

I agree with much of what you say, Roly, but I think it is optimistic (at best!) to suggest that the MHRA will make some public announcement of their intention to delay. I am chasing them regularly for their decision to be published, and the longer it goes on, the more convinced I become that they have simply come up against the fact that this ill-conceived Consultation MLX 364 was signed off by the previous government without much attention, but has now suffered the scrutiny of the new coalition government who have recognised the nonsense it represents.

IMHO, the MHRA might well want to wait for the outcome of the EU Public Consultation, but I can't see how it would make a blind bit of difference to the MHRA's own situation, apart from perhaps getting them off the hook relatively easily, since they could just blame the EU. The fact remains that the legislation is against them, the RPC was against them, the new Government is against them, and now it seems the EU is against them. I think it's fair to say that they are dead in the water now.

I am meeting with my counterpart in Europe next week, and will provide an update then on how we shall be addressing the EU consultation. On reading the document, however, I feel some optimism that this is a far less biassed and 'unfriendly' consultation than that of our own dear MHRA. Let us hope that common sense and solid legal research can win the day again.

I'm sure all that gaiety sounds very logical and rational in the fantasy world you live in Babe, but as usual, RolyDude is much closer to the truth of what's really going on .....

The EU Directive is being pushed through by the World Health Organisation, who are naturally in bed with the Pharma Industry and (most importantly!) are fully supported by the World Bank .....

There will be a lot of "cooperation" going on between all the different Agencies and indeed, they may well decide to play "good-cop bad-cop" to move things along incrementally ...... on the face of it, you may think the situation in the UK is different to the US, but that's only because you are [moderated out] ...... E-cigs will eventually be treated either as a Medical or Tobacco product, if not a mixture of both thanks to crafty Regulation ......