This is the current situation:
- The MHRA attempted to regulate and license ecigarettes as a pharmaceutical after requests from the pharmaceutical industry to do so. This regulatory move was sympathetically viewed by the socialist government in power at the time, who agreed with more regulation in principle.
- During the consultation process which the MHRA were required to complete, the government changed, and a conservative/liberal alliance came to power, who were less sympathetic to increased regulation and the costs / impact that accompany it. The MHRA regulatory attempt stalled at ministerial level as a result.
- At the same time, the RPC, a watchdog empowered to oversee new proposals for regulation, was given more teeth in a bid to ensure it would be able to stop creeping regulation and thus movement toward nationalisation and socialism of industry, together with the increased central costs but no financial benefits.
- The RPC has now been given powers to stop all new regulatory attempts that fail to meet certain criteria. In brief, the new system works like this:
1. Traffic light system
The sponsors of all new regulatory moves are required to produce an IA, Impact Assessment, laying out the reasons for the proposed new regulations, their benefits, and the costs to industry / government / community. The IAs are rated by the RPC according to a traffic light system: green, amber, red.
Green indicates an approved IA that will move forward to the introduction of regulations.
Amber indicates an IA that will need work before approval.
Red indicates an IA that fails on numerous points, for example: the basic need for regulation in the first place is not proven as few if any strong arguments are made for regulation; the costs do not add up.
2. One-In, One-Out requirement
All new regulatory proposals introduced require a one-in one-out balance. As a balance to introduced regulations, which always have some form of negative impact, some other regulations somewhere must be removed, or some other form of compensation offered.
RPC IA list
The RPC have published a list on their website of all the recent regulatory approaches made to them for approval, from September 2010 onward. The E-Cigarette IA is not listed, so it is assumed this took place before the new RPC systems came into play.
Looking at the new RPC system, it would appear that the MHRA E-Cigarette regulations would fail with a Red classification, since:
(a) There is no evidence whatsoever that any regulations are needed.
(b) No one except the pharmaceutical industry has asked for regulation. Their motives are entirely based on protecting their revenues and there is no other benefit.
(c) The cost to industry, the community, and government would be severe, since 99% of products would be removed from the market, hundreds of jobs would be lost, public health would be severely compromised, and all tax revenue would be lost as the industry would move abroad.
(d) The biggest black market ever seen would be created.
(e) None of the figures quoted in the MHRA IA were remotely accurate.
(f) No One-In, One-Out proposals have been made.
(g) All medical experts who have published, have backed the encumbrance-free introduction of e-cigarettes as a risk-free immediate priority for public health. All agree that e-cigarettes are likely to be 99% safer than tobacco cigarettes as there are no harmful ingredients, all of them being currently licensed for human consumption in any case.
March 2011
This leaves us at:
1. Neither the industry nor the community has had any communication from the MHRA or the RPC on this matter, which is not acceptable.
2. Nobody knows what stage the regulatory proposals are at, or indeed if they have been dismissed. If this is the case, we need confirmation.
3. The government is avoiding communication on this matter and the documentation appears to be hidden from the public. There is no record of the RPC's current IA review status nor is there any information regarding the future of the regulatory proposals.
We do not find this situation acceptable and we want to know who is responsible and what is being done about it.
ECF will be contacting various parties to enquire further.
______________________
RPC website:
Regulatory Policy Committee
RPC PDFs:
Independent-watchdog-challenges-Whitehall-to-make-a-stronger-case-for-new-regulations-FIN2
http://www.e-cigarette-forum.com/forum/pdf/rpc1.pdf
RPC-Report-Challenging-Regulation-Feb-2011-FINAL
http://www.e-cigarette-forum.com/forum/pdf/rpc2.pdf
- The MHRA attempted to regulate and license ecigarettes as a pharmaceutical after requests from the pharmaceutical industry to do so. This regulatory move was sympathetically viewed by the socialist government in power at the time, who agreed with more regulation in principle.
- During the consultation process which the MHRA were required to complete, the government changed, and a conservative/liberal alliance came to power, who were less sympathetic to increased regulation and the costs / impact that accompany it. The MHRA regulatory attempt stalled at ministerial level as a result.
- At the same time, the RPC, a watchdog empowered to oversee new proposals for regulation, was given more teeth in a bid to ensure it would be able to stop creeping regulation and thus movement toward nationalisation and socialism of industry, together with the increased central costs but no financial benefits.
- The RPC has now been given powers to stop all new regulatory attempts that fail to meet certain criteria. In brief, the new system works like this:
1. Traffic light system
The sponsors of all new regulatory moves are required to produce an IA, Impact Assessment, laying out the reasons for the proposed new regulations, their benefits, and the costs to industry / government / community. The IAs are rated by the RPC according to a traffic light system: green, amber, red.
Green indicates an approved IA that will move forward to the introduction of regulations.
Amber indicates an IA that will need work before approval.
Red indicates an IA that fails on numerous points, for example: the basic need for regulation in the first place is not proven as few if any strong arguments are made for regulation; the costs do not add up.
2. One-In, One-Out requirement
All new regulatory proposals introduced require a one-in one-out balance. As a balance to introduced regulations, which always have some form of negative impact, some other regulations somewhere must be removed, or some other form of compensation offered.
RPC IA list
The RPC have published a list on their website of all the recent regulatory approaches made to them for approval, from September 2010 onward. The E-Cigarette IA is not listed, so it is assumed this took place before the new RPC systems came into play.
Looking at the new RPC system, it would appear that the MHRA E-Cigarette regulations would fail with a Red classification, since:
(a) There is no evidence whatsoever that any regulations are needed.
(b) No one except the pharmaceutical industry has asked for regulation. Their motives are entirely based on protecting their revenues and there is no other benefit.
(c) The cost to industry, the community, and government would be severe, since 99% of products would be removed from the market, hundreds of jobs would be lost, public health would be severely compromised, and all tax revenue would be lost as the industry would move abroad.
(d) The biggest black market ever seen would be created.
(e) None of the figures quoted in the MHRA IA were remotely accurate.
(f) No One-In, One-Out proposals have been made.
(g) All medical experts who have published, have backed the encumbrance-free introduction of e-cigarettes as a risk-free immediate priority for public health. All agree that e-cigarettes are likely to be 99% safer than tobacco cigarettes as there are no harmful ingredients, all of them being currently licensed for human consumption in any case.
March 2011
This leaves us at:
1. Neither the industry nor the community has had any communication from the MHRA or the RPC on this matter, which is not acceptable.
2. Nobody knows what stage the regulatory proposals are at, or indeed if they have been dismissed. If this is the case, we need confirmation.
3. The government is avoiding communication on this matter and the documentation appears to be hidden from the public. There is no record of the RPC's current IA review status nor is there any information regarding the future of the regulatory proposals.
We do not find this situation acceptable and we want to know who is responsible and what is being done about it.
ECF will be contacting various parties to enquire further.
______________________
RPC website:
Regulatory Policy Committee
RPC PDFs:
Independent-watchdog-challenges-Whitehall-to-make-a-stronger-case-for-new-regulations-FIN2
http://www.e-cigarette-forum.com/forum/pdf/rpc1.pdf
RPC-Report-Challenging-Regulation-Feb-2011-FINAL
http://www.e-cigarette-forum.com/forum/pdf/rpc2.pdf
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