lordbarby
Postman
- Joined
- Jul 13, 2012
- Messages
- 126
My MP has sent me a letter from Anna Soubry, Parliamentary Under Secretary of State for Public Health, setting out the the Government's position on this matter.
Make of it what you will, I think its the usual stuff.
Yours sincerely,
~I
Further to my previous correspondence to you in respect of your concerns relating to
the European Tobacco Directive, please find enclosed a copy of a substantive
response that I have received today from Anna Soubry MP, the Parliamentary Under-
Secretary of State for Public Health at the Department of Health.
I trust that this response is of interest to you and clarifies the Government's position
on this matter.
Once again, thank you for having taken the time to contact me and if I can ever be of
any further assistance to you then please do not hesitate to contact me again.
CHRIS HEATON-HARRIS MP
MEMBER OF PARLIAMENT FOR DAVENTRY
, ~ De';artme~t \C of Health
From Anna Soubry MP
Parliamentary Under Secretary of State for Public Health
P000000747771
Richmond House
79 Whitehall
L.ondon
SW1A 2NS
Tel: 020 7210 4850 Chris Heaton-Harris MP
House of Commons
Westminster
London S\" lA OA~;\
1 4 JAN 2013
~~G' a... v: C~-'"-,~s I ~ -~._- _.
Thank you for your letter 0[20 December to Jeremy Hunt on behalf of your
constituent 1 F I 3 J b • r I L'"B I }, about
the draft European Union Tobacco Products Directive. I am replying as the
Minister responsible for tobacco policy.
It may be helpful if I set out the position in relation to electronic cigarettes.
There are a number of products that are widely and easily available on the
market, such as nicotine-containing electronic cigarettes, that claim to contain
nicotine but are not licensed medicines. Currently, any nicotine-containing
product (NCP) that claims or implies that it can assist in giving up smoking is
considered by the Medicines and Healthcare products Regulatory Agency
(MIIRA) to be a medicinal product. This approach has allowed NCPs, such as
electronic cigarettes, that do not make such claims to be used and sold without
the safeguards built into the regulation of medicinal products, Therefore the ~
safety and efficacy of the products as they are used has not been subject to the
type of rigorous testing expected for medicines regulation.
The MHRA is responsible for the regulation of medicines and medical devices,
and deciding where products fit can be very difficult. Alcoholic drinks and
coffee, for example, are regulated as foodstuffs. However, there are products
containing caffeine that are regulated as medicinal products due to the medicinal
purpose of the product and some foods fall within the definition of a medicinal
product because they modify physiological processes for a medical reason.
Until relatively recently, there were few or no nicotine products available and so
how they were regulated was not a concern. The increasing availability of these
products and potential impact on public health means that we need to consider
how they are regulated. Products that contain nicotine and that appreciably
affect metabolism in normal usage fall within medicines legislation in terms of
pharmacological action. In light of this, the MHRA undertook a public
consultation exercise to seek views on the regulation ofNCPs.
In March 2011, the MHRA published the outcome of the public consultation,
which is available at www.mhra.gov.uk (enter 'Public consultation (MLX 364):
The regulation of nicotine containing products' in the search bar and follow the
links). The consultation highlighted the need for further information about levels
of nicotine that have a significant pharmacological effect and the need for further
information on the impact of regulation on public health and business. The
MHRA is coordinating further scientific and market research with a view to a
final decision on the application of medicines regulation later this year.
The Government wants to ensure that an effective regulatory framework exists to
protect consumers from any electronic cigarette products that fail to meet
acceptable standards for quality, safety and efficacy. Reducing the public health
impact of smoking remains a priority. The Government does not want to reduce
the availability of products that help to reduce smoking but does want to ensure
that smokers have access to products that are acceptably safe and that support
smokers in reducing the number of cigarettes they smoke or to quit.
With the ongoing work of the MHRA in mind, the Government will be
reviewing the proposals in the draft Tobacco Products Directive carefully. The
proposals will be discussed by the member states and the European Parliament
and will be subject to change during this process. The legislation is unlikely to
be adopted before 2014 or to come into effect before 2015/2016.
I hope this reply is helpful.
ANNASOUBRY
Make of it what you will, I think its the usual stuff.
Yours sincerely,
~I
Further to my previous correspondence to you in respect of your concerns relating to
the European Tobacco Directive, please find enclosed a copy of a substantive
response that I have received today from Anna Soubry MP, the Parliamentary Under-
Secretary of State for Public Health at the Department of Health.
I trust that this response is of interest to you and clarifies the Government's position
on this matter.
Once again, thank you for having taken the time to contact me and if I can ever be of
any further assistance to you then please do not hesitate to contact me again.
CHRIS HEATON-HARRIS MP
MEMBER OF PARLIAMENT FOR DAVENTRY
, ~ De';artme~t \C of Health
From Anna Soubry MP
Parliamentary Under Secretary of State for Public Health
P000000747771
Richmond House
79 Whitehall
L.ondon
SW1A 2NS
Tel: 020 7210 4850 Chris Heaton-Harris MP
House of Commons
Westminster
London S\" lA OA~;\
1 4 JAN 2013
~~G' a... v: C~-'"-,~s I ~ -~._- _.
Thank you for your letter 0[20 December to Jeremy Hunt on behalf of your
constituent 1 F I 3 J b • r I L'"B I }, about
the draft European Union Tobacco Products Directive. I am replying as the
Minister responsible for tobacco policy.
It may be helpful if I set out the position in relation to electronic cigarettes.
There are a number of products that are widely and easily available on the
market, such as nicotine-containing electronic cigarettes, that claim to contain
nicotine but are not licensed medicines. Currently, any nicotine-containing
product (NCP) that claims or implies that it can assist in giving up smoking is
considered by the Medicines and Healthcare products Regulatory Agency
(MIIRA) to be a medicinal product. This approach has allowed NCPs, such as
electronic cigarettes, that do not make such claims to be used and sold without
the safeguards built into the regulation of medicinal products, Therefore the ~
safety and efficacy of the products as they are used has not been subject to the
type of rigorous testing expected for medicines regulation.
The MHRA is responsible for the regulation of medicines and medical devices,
and deciding where products fit can be very difficult. Alcoholic drinks and
coffee, for example, are regulated as foodstuffs. However, there are products
containing caffeine that are regulated as medicinal products due to the medicinal
purpose of the product and some foods fall within the definition of a medicinal
product because they modify physiological processes for a medical reason.
Until relatively recently, there were few or no nicotine products available and so
how they were regulated was not a concern. The increasing availability of these
products and potential impact on public health means that we need to consider
how they are regulated. Products that contain nicotine and that appreciably
affect metabolism in normal usage fall within medicines legislation in terms of
pharmacological action. In light of this, the MHRA undertook a public
consultation exercise to seek views on the regulation ofNCPs.
In March 2011, the MHRA published the outcome of the public consultation,
which is available at www.mhra.gov.uk (enter 'Public consultation (MLX 364):
The regulation of nicotine containing products' in the search bar and follow the
links). The consultation highlighted the need for further information about levels
of nicotine that have a significant pharmacological effect and the need for further
information on the impact of regulation on public health and business. The
MHRA is coordinating further scientific and market research with a view to a
final decision on the application of medicines regulation later this year.
The Government wants to ensure that an effective regulatory framework exists to
protect consumers from any electronic cigarette products that fail to meet
acceptable standards for quality, safety and efficacy. Reducing the public health
impact of smoking remains a priority. The Government does not want to reduce
the availability of products that help to reduce smoking but does want to ensure
that smokers have access to products that are acceptably safe and that support
smokers in reducing the number of cigarettes they smoke or to quit.
With the ongoing work of the MHRA in mind, the Government will be
reviewing the proposals in the draft Tobacco Products Directive carefully. The
proposals will be discussed by the member states and the European Parliament
and will be subject to change during this process. The legislation is unlikely to
be adopted before 2014 or to come into effect before 2015/2016.
I hope this reply is helpful.
ANNASOUBRY