It isn’t. In reality, the MHRA is making no progress. They’ve said they’ll regulate e-cigarettes at a later date, which might be anytime between 2014 and 2016, depending on the EU decision.
The exact wording in the PR is:
“The UK Government will press for EU law to create a Europe-wide legal position on NCPs as medicines through the revision of the Tobacco Products Directive. The European Commission has said it expects the new legislation to be adopted in 2014 and come into effect in the UK in 2016. From that point, all NCPs will require a medicine licence.”
So, at this time (which may alter)
1. Allow the EU procedure to complete. If e-cigs are prohibited (i.e., a de facto ban requiring a pharmaceutical license for refill liquids), the MHRA will do nothing since EU legislation has already supplied the required regulatory framework.
2. The FDA is also looking into a regulatory solution. It may be possible that the EU ban will go into effect, in which case the MHRA would follow suit with a similar or identical regulation to enforce it.
3. Alternatively, if the EU ban goes into effect, the MHRA will also need a pharmaceutical license for the hardware, thus eliminating both
If the EU ban fails
What we don’t know is what will happen if the EU process fails. Things are already a mess since many individuals are upset that the pharmaceutical business may buy a ban to protect its profits at the expense of millions of EU citizens’ lives. Let’s hazard a guess:
1. The MHRA will implement a nicotine-containing liquid prohibition or complete hardware and refill ban, regardless of the outcome of this vote.
2. The MHRA will give up because the procedure failed in the EU, and it will undoubtedly fail in the UK under British law.
Licensing or ban?
Pharmaceutical licensing is a ban because it is, in my opinion. There are at least 5,000 different pharmaceuticals on the market now, the majority of which are refill versions.
All goods will have to be removed from the market as soon as licensing is implemented (within 21 days is the usual timetable).
A license can only be used on one item or product combination: a single hardware model, a single liquid type/flavour, or a single device with one liquid type.
There is no way to get a single license for several items. It takes at least three years and £2 million in investment to obtain a license for each individual product (as it has taken Intellicig time and money to acquire their license thus far, with no result yet)
Outcome
If the EU or MHRA achieve a ban via either the pharmaceutical licensing or tobacco product classification processes, legal e-cigarette sales will be halted in the UK, resulting in a large black market.
In the next five years, perhaps one or two goods will be accessible: beginner-style minis with prefilled sealed cartomisers (disposable vapes) from a pharmacy for around £30 – £40 per single unit (to speculate; recall that the closest competitor has had to invest about £2m thus far).
In contrast, because the EU has a legal framework for tobacco products, about 95% of items will go away, with a 99 percent decrease in time (since web sales, vape flavours, and any new goods will be illegal).
Who is behind this?
The pharmaceutical business controls and runs the regulatory process to safeguard its earnings. They make as much as the tobacco industry from smoking: £2 billion or more in the United Kingdom each year.
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A tobacco harm reduction product that attracts at least 50% of smokers (at least) and leads to the same number of people stopping smoking (e-cig use has no known disease vectors) will eventually cost them more than £1 billion each year in the United Kingdom.
This is what occurred in Sweden, and they are desperate to avoid a similar situation from happening elsewhere: a 50% reduction in smoking followed by illness; pharma’s worst nightmare.
Smoking is one of their most essential income streams, and it is guarded very strongly at the government level (primarily, the large drug market for treating sick smokers like chemotherapy and COPD medication; then there’s the boost to a variety of other pharmaceutical sales, including diabetes treatments and over-the-counter medicines.
Conclusion
Pharma has decided that the EU process requires some pressure, as things appear to be going backwards in Brussels, and this is how it comes about.
They will continue to dominate health regulation and keep the cash flowing as long as things go according to plan. Interlopers who can halve disease rates are not wanted in the status quo.
