Hi, all,
Sorry not to have posted sooner, but got back and haven't had respite from the phone until now!
OK, so until the full press release tomorrow, here is a brief summary of today's meeting:
We were greeted downstairs by Clare Hodges, asking if we were here for the NRT meeting. I, of course, said 'no'. She then turned to the receptionist to ask who she was supposed to be greeting. I confirmed that we were here for the meeting, but it wasn't about NRT. (It REALLY winds me up when they do that! Grrr!)
In the boardroom, there were 7 of them - no June Raine, but Amanda Bryan was there - and 3 of us. Jeremy Mean took charge from their side. They all introduced themselves, and then we did, starting with our legal hotshot, who proclaimed himself to be 'ECITA's retained legal adviser', at which point Jeremy Mean looked like he was facing an imminent cardiac arrest. He blustered a bit, and said, 'I think it's worth pointing out at this stage - in terms of the fact that you have a legal adviser - that we don't have a lawyer present', and seemed thoroughly put out.
Jeremy Mean told us that there is still no decision. I asked him whether or not they were intending to stick to their undertaking to give us a decision in September, pointing out that there were still two days of September after today (ample time, IMHO!), but he said that they were having a few challenges. They have had over 1,200 responses submitted, there are legal issues, the RPC Opinion, issues with the new government, so they are unable to give us a final decision at this stage. He said that it would be weeks rather than days, but they hoped it wouldn't be months.
The
three of us attending for ECITA all felt that what this actually meant was that the MHRA is struggling to persuade the new coalition govt to sign off on the MHRA's untenable position. They certainly seem unable to go ahead and publish the decision they WANT to publish - as detailed in MLX 364, i.e. to license these as medicines and/or remove them from the market - because if they did have ministerial sign off for this, then there would be no reason for them to delay publishing the decision, would there?
We explained a bit about ECITA's aims and goals, what we are doing at the moment and moving forward, and the progress we have already made. We described the work we have been doing in engaging with Trading Standards Officers, and the cooperation we have had from them. Mike Ryan, ECITA's Chairman, pointed out that the delays in finalising MLX 364 have effectively 'muddied the waters', making it harder for ECITA and Trading Standards to effectively police the regulation of our industry. We left them with copies of emails from one Trading Standards Officer, who is the Head of Product Safety for Gloucestershire, and who was involved in drafting the General Product Safety Regulations. He had provided us with a stated position from Trading Standards that these products are not medicines, and are safer remaining within the current regulatory framework, than moving into medicines licensing. (I need to check if I have permission from the rest of the ECITA team to publish these, but if I can, I will.)
Jeremy Mean asked if we were aware of the EU consultation on
tobacco products; we told him we were. (He seemed mildly disappointed that we knew about this.)
He asked if we had anything in particular we wanted to say, and our legal adviser pressed them on their legal advice, since he could not see any way in which they could have had reliable advice to proceed as they have done. They skirted around this, explaining that it is government policy not to publish legal advice, but that they hoped to explain how it 'fits', and the 'trigger' from J&J (i.e. the extension to the indications for use for the inhalator, which started this whole fiasco!), as well as how policy and law fit together.
Our legal adviser skilfully dismembered these arguments, and casually dropped in the fact that we have lobbyists and PR consultants on board, as well as legal, and they clearly recognised that ECITA is a force to be reckoned with: this industry is not simply going to roll over and play dead!
There was some discussion about the fact that NRT products were being regulated as medicines by claim up until the J&J indications extension, and I questioned how they had gone from this position to seeking to remove our products from sale within 21 days. Our legal adviser added, 'without any evidence of harm'.
The MHRA didn't appear to want to discuss this, protesting that we were not looking at dangerous products, and hinting that this was irrelevant. (Another own goal from them there, methinks!)
The longer they prevaricate, and avoid publishing the decision, the more likely it becomes that their untenable position will implode entirely, and MLX364 will take up residence in the bin where it belongs.
It's good news, folks! (And that's not just me: our legal adviser and Mike think so too, so although we haven't won yet, we haven't lost, and our position gets stronger by the day!)
Enjoy!
Katherine
