SR Not Needed under Medicines Act - is this true?

[Guest guest]

Fiction: Unless SR is implemented by 2011, section 12(1) of the Medicines Act

1968 will be superseded by the Traditional Herbal Medicinal Products Directive

(THMPD) and European medicines legislation, effectively banning the practise of

herbal medicine in the UK.

Fact: Section 12(1) of the Medicines Act 1968 remains available to herbalists in

the UK beyond 2011, whether SR is implemented or not.

In an email (dated 6 November 2009), Woodfield of the MHRA clearly

stated that beyond 2011 `the s12(1) exemption [will remain] available where

herbal practitioners are carrying out activity in accordance with the terms of

that exemption.'

What exactly are the terms of the section 12(1) exemption? The exemption appears

in statute in the following form:

'12. Exemptions in respect of herbal remedies

(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates

relating to Medicinal Products] of this Act do not apply to the sale, supply,

manufacture or assembly of any herbal remedy in the course of a business where—

(a) the remedy is manufactured or assembled on premises of which the person

carrying on the business is the occupier and which he is able to close so as to

exclude the public, and

( the person carrying on the business sells or supplies the remedy for

administration to a particular person after being requested by or on behalf of

that person and in that person's presence to use his own judgment as to the

treatment required.'

In 2011, only section 12(2) of the Medicines Act 1968 will be replaced by the

THMPD. Mr Woodfield picks up the story… `[H]istorically, OTC unlicensed herbal

remedies supplied under the s12(2) exemption in the Medicines Act 1968 were

regarded as non industrially produced – and hence not required to comply with

European medicines legislation. However, with the advent of the European

Directive on traditional herbal medicinal products [the THMPD] which provides a

suitable regulatory home for OTC manufactured traditional herbal medicines, MHRA

is switching its interpretation position to regard typical manufactured herbal

medicines as being industrially produced. Whether a product is supplied for

retail or for supply via practitioners does not affect whether it is viewed as

industrially produced.'

Fiction: Unless SR is implemented by 2011, section 12(1) herbalists would not

have access to unlicensed herbal medicines. Only registered/licensed herbal

medicines or homemade remedies would be available to their patients.

Fact: Section 12(1) herbalists can continue to access unlicensed herbal

medicines from their UK suppliers whether SR is implemented or not.

Woodfield has confirmed the following to be accurate, `If a supplier is

supplying ingredients for a herbal practitioner to prepare, e.g. blending into

s12(1) remedies, this doesn't require the supplier to have THR/MA [a

registration or licence] for the product. t is well known that many

herbalists will buy in stocks e.g. of bulk tinctures and use them as [start-up]

materials/ingredients to blend as individualised remedies. So in that situation,

unless there are other factors, the MHRA wouldn't need to challenge the supplier

as to why they hadn't got THRs etc.'

Mr Woodfield goes on to say, `In preparing their remedies to meet the needs of

individual patient identified in consultation under s12(1) some practitioners

will no doubt blend ingredients. Whether an item (e.g. a tincture) is itself a

product or whether it is supplied as an ingredient for someone to use in making

up a product is of course case specific. Overall, we expect the current position

to be that some herbal practitioners rely mainly on s12(1) in their practice

whereas others make more use of unlicensed herbal medicines manufactured by a

3rd party.'

Fiction: Unless SR is implemented by 2011, section 12(1) herbalists would be

unable to access a wide range of `manufactured' herbal medicines.

Fact: In 2011, `manufactured' herbal medicines will come within the scope of the

Traditional Herbal Medicinal Products Directive (THMPD) and will continue to be

available to herbalists regardless whether SR is implemented or not.

Woodfield states that, `These products [`manufactured' herbal medicines]

would require either a marketing authorisation [MA] or traditional herbal

registration [THR], unless it is possible to construct a UK scheme under the

derogation in Article 5.1 of Directive 2001/83/EC [European medicines

legislation].'

The only way for herbalists to bypass the THMPD (which Mr Woodfield says

`represents a major advance… in terms of safety, quality standards, and

systematic consumer information.') and access unlicensed `manufactured' herbal

medicines commissioned from a 3rd party would be via the above mentioned

derogation (which is a type of escape clause or exemption). To do so, herbalists

would have to be recognised as `authorised health-care professionals'. This

status, the DH has indicated, is most probably not attainable unless herbalists

submit to SR. However, Mr Woodfield also reveals, `If there were to be a version

of this arrangement for herbal practitioners [i.e. a UK scheme under Article 5.1

of Directive 2001/83/EC] this would require further specific consultation…'

A Note on Rights and Privileges

A number of herbalists believe that SR will preserve their `right to practise

traditional western herbal medicine'. This is a misconception. SR is a

government-granted `privilege' to practise. Privileges are benefits that

governments create and delegate; their terms can be altered or even revoked at

any time. Rights are unalienable and cannot be taken away. By submitting to SR

herbalists would not be asserting their rights, instead they would be taking a

government conferred benefit.

The dangers of taking a benefit are illustrated in the DH consultation document.

On page 11 of the `Impact Assessment' report, under the heading `Risks', is the

following statement: `There is some evidence that some herbal medicines … are

supplied for use on vulnerable patient groups, such as children and people who

have serious illness.' Does the DH really believe that herbalists should not be

treating children and the seriously ill? Remember, it is alleged that the poor

practice of herbalists is putting patients and the public at risk. DH

bureaucrats view herbalists as a danger to the public. If herbalists submit to

SR, then they are tacitly agreeing to these terms. Under such circumstances it

would be perfectly reasonable and necessary for the government to ban herbalists

from treating vulnerable patient groups.

To summarise, with or without SR

Section 12(1) of the Medicines Act 1968 remains available to herbalists in

the UK.

Herbalists can continue to access unlicensed herbal medicines from their UK

suppliers under the terms of section 12(1).

`Manufactured' herbal medicines will continue to be available to herbalists

by way of the THMPD.

Any herbalists submitting to SR in the hope of making use of Article 5.1 of

Directive 2001/83/EC – in order to access unlicensed `manufactured' herbal

medicines commissioned from a 3rd party – should bear in mind that this

derogation does not currently exist in UK statute for herbalists and will

require further consultation before being enacted, if at all.

Source:

http://theherbarium.wordpress.com/2009/11/10/statutory-regulation-facts-fictions\

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[Guest guest]

From Poster Rees:

" Here in South Africa, a few Medical Herbalists decided it would be a groovy

idea to get a statutory register going for their elitist grouping. At first it

sounded quite advantageous, having a piece of paper on the wall from government

to make the public believe that they were more `worthy' and `professional' than

the rest.

At the end of the day, once they were under government's control and the

Department of Health's rule, the screws were slowly turned and their scopes of

practice were severely restricted and their benefits curtailed.

Others who were not Phytotherapists (Medical Herbalists) who decided to

differentiate themselves from the `elitists' put it on record throughout the

process that they were not to be included in the statutory apparatus, as they

never gave over their right to be controlled by the State.

At the end of the day, herbalists and phytotherapists are separated by law. Now

we have only 30 phyotherapists on a government register and thousands of

herbalists practising freely without constraint, seeing as many patients as

before.

What difference has statutory recognition and registration had on

phytotherapists? Arguably, none!

What effect has this had on people prescribing herbal medicines? Arguably none!

At the end of they day, threats of herbs being taken out of the hands of

practitioners is nothing more than hot air. Please don't get fooled by the

carrot in front of you (fancy registration papers on the wall) and the big stick

tapping you back (the threat of having your tools of the oldest trade on Earth

taken away).

Those calling loudest for statutory recognition are usually power hungry

individuals and organisations who merely want to control your market. They will

simply place themselves at the front of your queue and further their political,

financial interests to the fullest. "

Source:

http://theherbarium.wordpress.com/2009/11/10/statutory-regulation-facts-fictions\

/#more-687

[Guest guest]

Hello Neil, As a practitioner of Western and Chinese tradition and a supplier of Chinese Medicines, since 1st May I have not been able to import more tablets. Doing so puts me at risk of prosecution. Tablets on the whole cannot be made by the average practitioner in their practice and cannot be a start up or raw ingredient!?!?? In the light of your posts can you tell me then how I can legally use tablets? I have existing stocks that are fast running out, some replaced by existing capsules however they all contain medicinal herbs not nutrients. I'd be pleased to hear your response. LorraineLorraine Hodgkinson MRCHMHERBS AND HELPERS6, Butts Fold, Cockermouth,Cumbria, CA13 9HY. UK.Tel: +44 (0) 1900 826392Mobile: 07761 489838 (O2)www.herbalmedicineuk.comOn 20 Feb 2012, at 21:33, "Neil" wrote:

From Poster Rees:

"Here in South Africa, a few Medical Herbalists decided it would be a groovy idea to get a statutory register going for their elitist grouping. At first it sounded quite advantageous, having a piece of paper on the wall from government to make the public believe that they were more `worthy' and `professional' than the rest.

At the end of the day, once they were under government's control and the Department of Health's rule, the screws were slowly turned and their scopes of practice were severely restricted and their benefits curtailed.

Others who were not Phytotherapists (Medical Herbalists) who decided to differentiate themselves from the `elitists' put it on record throughout the process that they were not to be included in the statutory apparatus, as they never gave over their right to be controlled by the State.

At the end of the day, herbalists and phytotherapists are separated by law. Now we have only 30 phyotherapists on a government register and thousands of herbalists practising freely without constraint, seeing as many patients as before.

What difference has statutory recognition and registration had on phytotherapists? Arguably, none!

What effect has this had on people prescribing herbal medicines? Arguably none!

At the end of they day, threats of herbs being taken out of the hands of practitioners is nothing more than hot air. Please don't get fooled by the carrot in front of you (fancy registration papers on the wall) and the big stick tapping you back (the threat of having your tools of the oldest trade on Earth taken away).

Those calling loudest for statutory recognition are usually power hungry individuals and organisations who merely want to control your market. They will simply place themselves at the front of your queue and further their political, financial interests to the fullest."

Source:

http://theherbarium.wordpress.com/2009/11/10/statutory-regulation-facts-fictions/#more-687

[Guest guest]

Hi Lorraine

Thank you for raising this. I would like to know how SR would allow you to

import tablets.

Regards

Neil

>

> > From Poster Rees:

> > " Here in South Africa, a few Medical Herbalists decided it would be a groovy

idea to get a statutory register going for their elitist grouping. At first it

sounded quite advantageous, having a piece of paper on the wall from government

to make the public believe that they were more `worthy' and `professional' than

the rest.

> >

> > At the end of the day, once they were under government's control and the

Department of Health's rule, the screws were slowly turned and their scopes of

practice were severely restricted and their benefits curtailed.

> >

> > Others who were not Phytotherapists (Medical Herbalists) who decided to

differentiate themselves from the `elitists' put it on record throughout the

process that they were not to be included in the statutory apparatus, as they

never gave over their right to be controlled by the State.

> >

> > At the end of the day, herbalists and phytotherapists are separated by law.

Now we have only 30 phyotherapists on a government register and thousands of

herbalists practising freely without constraint, seeing as many patients as

before.

> >

> > What difference has statutory recognition and registration had on

phytotherapists? Arguably, none!

> >

> > What effect has this had on people prescribing herbal medicines? Arguably

none!

> >

> > At the end of they day, threats of herbs being taken out of the hands of

practitioners is nothing more than hot air. Please don't get fooled by the

carrot in front of you (fancy registration papers on the wall) and the big stick

tapping you back (the threat of having your tools of the oldest trade on Earth

taken away).

> >

> > Those calling loudest for statutory recognition are usually power hungry

individuals and organisations who merely want to control your market. They will

simply place themselves at the front of your queue and further their political,

financial interests to the fullest. "

> > Source:

> >

http://theherbarium.wordpress.com/2009/11/10/statutory-regulation-facts-fictions\

/#more-687

> >

> >

>

[Guest guest]

It provides a legal niche they can go in.LorraineLorraine Hodgkinson MRCHMHERBS AND HELPERS6, Butts Fold, Cockermouth,Cumbria, CA13 9HY. UK.Tel: +44 (0) 1900 826392Mobile: 07761 489838 (O2)www.herbalmedicineuk.comOn 21 Feb 2012, at 14:19, "Neil" wrote:

Hi Lorraine

Thank you for raising this. I would like to know how SR would allow you to import tablets.

Regards

Neil

>

> > From Poster Rees:

> > "Here in South Africa, a few Medical Herbalists decided it would be a groovy idea to get a statutory register going for their elitist grouping. At first it sounded quite advantageous, having a piece of paper on the wall from government to make the public believe that they were more `worthy' and `professional' than the rest.

> >

> > At the end of the day, once they were under government's control and the Department of Health's rule, the screws were slowly turned and their scopes of practice were severely restricted and their benefits curtailed.

> >

> > Others who were not Phytotherapists (Medical Herbalists) who decided to differentiate themselves from the `elitists' put it on record throughout the process that they were not to be included in the statutory apparatus, as they never gave over their right to be controlled by the State.

> >

> > At the end of the day, herbalists and phytotherapists are separated by law. Now we have only 30 phyotherapists on a government register and thousands of herbalists practising freely without constraint, seeing as many patients as before.

> >

> > What difference has statutory recognition and registration had on phytotherapists? Arguably, none!

> >

> > What effect has this had on people prescribing herbal medicines? Arguably none!

> >

> > At the end of they day, threats of herbs being taken out of the hands of practitioners is nothing more than hot air. Please don't get fooled by the carrot in front of you (fancy registration papers on the wall) and the big stick tapping you back (the threat of having your tools of the oldest trade on Earth taken away).

> >

> > Those calling loudest for statutory recognition are usually power hungry individuals and organisations who merely want to control your market. They will simply place themselves at the front of your queue and further their political, financial interests to the fullest."

> > Source:

> > http://theherbarium.wordpress.com/2009/11/10/statutory-regulation-facts-fictions/#more-687

> >

> >

>