Last week the Department of Health published the result of their nine-week long public consultation regarding the implementation of the revised Tobacco Products Directive, or TPD as it is generally known.
The purpose of the consultation was “to seek views on the options available to Member States under the TPD2.” i.e. on the parts they can decide for themselves.
The consultation process was “not intended or designed to elicit representative samples of public opinion, instead it sought information, comments and views on the draft regulation, impact assessment and equality analysis.”
Shame they didn’t listen to us at the start then, and then most of this would not have transpired.
As one blogger wrote – ‘the consultation exercise was probably as much a cry for help by civil servants as the paper-exercise that these things usually amount to.’
The report provided an overview of all the responses received, 709 in total, plus a summary of the main themes that emerged. It also sets out how the Government intends to proceed in finalising the implemented regulations, and, it’s not all hell and damnation. So what did it say?
Well this is just a run-down of how they will implement the parts they have ‘wriggle’ room with.
First up is the required warning – the government has decided on: ‘This product contains nicotine which is a highly addictive substance.’
Next is the cross border/internet sales issues that had many concerned, with the Government deciding not to ban cross border distance sales, but introduce a registration scheme for sales of tobacco products, e-cigarettes and refills. For businesses selling into the UK they will need to demonstrate an electronic age verification system that can ‘unambiguously’ confirm customers age, so say goodbye to the ‘are you 18? Yes or no’ boxes.
The Government (thankfully) is not completely blind to how businesses operate and as such have decided on a transition period allowing the sell-through of ‘old stock’ until 20 May 2017. However, existing products, with the exception of batteries & parts will still need to be notified from May 2016, with notifications in place for all products by November 2016. The cost of notification will be carried by manufacturers and importers (producers) rather than vendors.
As not all e-cig companies are the same size, there will be “proportionate” fees applied (cue sarcastic ‘whey!’), charged to cover the implementing costs of TPD2. Consequently the same fee will be charged for the notification of a product, regardless of the size of the company making the notification. Some big tobacco companies with limited product ranges will be spending a few thousand pounds on notification fees. Some vaping companies supplying a big range of e-liquid flavours will be spending hundreds of thousands. (Don’t you just love the way the regulators manage to create an income for themselves at our expense?).
Oh, and to keep a little confusion, because the TPD isn’t bonkers enough…
The Government will stick to two definitions when writing about e-cigarettes – ‘electronic cigarette’ and ‘refill container’, despite most of the responses telling them that this IS confusing. In fairness though, this is not an area in which any wriggle room has been offered by the European Commission.
When a notification of a product/e-liquid has been completed, the MHRA will publish all non-confidential information on a designated website in-line with the requirements of TPD2. Manufacturers and importers will have the opportunity to specify information that they consider to be confidential when they submit a notification, but from this there is no certainty that the MHRA will agree as to what is or isn’t confidential.
Businesses will not need to nominate a named person to collect any adverse events information, as the MHRA already have this system in place and is known as the Yellow Card scheme. What they do expect is that businesses will investigate and report such incidents to the Competent Authority (in this case the MHRA), along with the outcome of any action they may have taken.
The Government has decided to give the Secretary of State (SoS) for Health the power to take measures including stopping the supply of an e-cigarette or refill container, or require producers and suppliers to recall a product if he/she considers them a serious risk to public health.
They state, ‘The Government included the provision in regulation 41 (action to protect human health) of the draft regulations to reflect TPD2 Article 20(11) and cover the situation where a product conforms to all the product safety standards in the TPD2, but despite this, the product is found to be a serious risk or potential serious risk to human health, for example due to one of the substances inhaled.’
With e-cigarettes now prescribed as a medicine (well one, anyway), it will be interesting to see if the SoS (oh the irony of those initials) ever uses this, or is influenced to use it by some of the junk science reporting we have become accustomed to.
There were some ‘key overarching comments’ from e-cigarette stakeholders, more concerns really about TPD2 and its impact on the market, the main points being that respondents wanted the DoH to recognise that e-cigarettes are a harm reduction tool, that e-cigarettes are not tobacco products and shouldn’t even be in the TPD, and many quoted the PHE report that stated e-cigarettes are 95% safer than tobacco cigarettes.
How we all wish that report had come out 2 years ago!
As mentioned, this report was about how the Government can use it’s very tiny amount of wriggle room, and they appear to be doing that as much as possible. Could this be a tacit admission that they know the TPD is terrible? The UK often gold plate EU legislation, but with this one, they seem to be bending over backwards not to.
This does in a small way highlight that the Advocate Generals ‘opinion’ that the TPD re e-cigarettes is fine and dandy, is not right. We have to question how she managed to arrive at this conclusion in light of all the good research and more importantly evidence out there regarding e-cigarettes. It seems that those that like the TPD are possibly not thinking the way most of us do.
The other mandated parts of the TPD – the 2ml tanks, the 10ml bottles, the refill technology etc. all remain.