Re: Re: Regulation

February 17, 2011

Hi Lorraine

were you at conference the year the MHRA representative gave a

presentation? I don't remember the year.

I asked him directly to assure me that our right to make our own

medicines would be maintained, and he assured us that it would be

They have continued to take this stance. (It was the one point i

thought I most important to clarify, as it is, as you say, fundamental

to our practice to have access to good medicines.

To the best of my knowledge they have never wavered from this position.

The following year gave an excellent workshop on making

medicines, and reading this list and elsewhere, there are obviously a

growing(!) numbers of herbalists brewing, macerating and steeping

away.....

splendid!

re a path for genuine herbalists - grandfathering is the term I think,

best wishes

Sally Owen MNIMH

> We must fight to the death to retain our right to make up and

> dispense medicines to our patients after consultations in the same

> time honoured safe way we have always done. It has been voiced in

> some circles that a GMP only situation would arise. Meaning that by

> default our right to make and dispense expired.

>

> I'm for legislation but not for any loss of of our rights. The full

> function of a Herbalist should be legally protected and

> strengthened. Also a path should be opened for other genuine

> professional Herbalists while leaving those 'pseudo' and unsuitable

> behind.

>

> Lorraine Hodgkinson

>

> Lorraine Hodgkinson MNIMH MRCHM

> HERBS AND HELPERS

> 6, Butts Fold, Cockermouth,

> Cumbria, CA13 9HY. UK.

> Tel: +44 (0) 1900 826392

> Mobile: 07761 489838 (O2)

> www.herbalmedicineuk.com

>

>> Hi Zoe and all,

>>

>> feeling negative about it in some respects as the following from

>> the DoH makes me wonder how long it will be before they intefere

>> and change the section 12(1) act and what next, a u-turn on who can

>> supply us? There seems to be a hint at production and making of

>> medicines. See below the bit PERMIT AND REGULATE. If they are

>> saying on one hand that medicines can still be made by individual

>> herbalists a right that we want protected, how are THEY going to

>> quality control what we make??? Alarm bells are ringing big time.

>> Lets face it, DoH and others probably want a state controlled

>> operation whereby you can only get your herbs from one of 2

>> suppliers that have GMP and likely we will be stopped from making

>> our own.

>>

>> Just posted the merest bit of DoH, but encourage all of you to look

>> more deeply. Also, what is going to be the cost to the herbalist,

>> it will put people out of business because its going to costs

>> thousands like the chiropractors and osteopaths...anyone car to

>> comment????

>>

>> " If practitioner regulation is in place for the purposes of

>> creating an Article 5(1) scheme this also opens the way to reform

>> Section 12 (1) of the Medicines Act 1968. Under Section 12 (1),

>> practitioners may prepare unlicensed herbal medicines on their own

>> premises for use following consultation with individual patients.

>> It is intended to move to the position that only registered

>> practitioners would be able to operate under Section 12 (1) after

>> regulation of practitioners is in place " .

>> be underpinned by a strengthened system for regulating medicinal

>> products.

>>

>> From the official government statement.....

>>

>> This approach will give practitioners and consumers continuing

>> access to herbal medicines. It will do this by allowing us to use a

>> derogation in the European legislation to set up a UK scheme to

>> permit and regulate the supply, via practitioners, of unlicensed

>> manufactured herbal medicines to meet individual patient needs.

>>

>> Best wishes

>>

>> Jacqui

>>

>>>

>>> Well - it's done now.

>>> My instincts lean towards feeling negative but on the plus side I

>>> won't have to clean up the mess made by insane herbal bowel, liver

>>> cleanse, detox products prescribed by " holistic blah blahs " or

>>> undo the orthorexia and malnutrition caused by stoopid diets for

>>> " candida " . Or hilda style parasite cleanse capsules..... etc etc

>>>

>>> We must now stand REALLY STRONG and united to protect our rights

>>> as Medical Professionals and EXPERTS. The people we will be

>>> dealing with are anything but expert and know nothing about what

>>> we do. " What herb's good for Blah blah? "

>>>

>>> For me one of the most important things, especially given the

>>> global climate (of everything) is to maintain our rights to

>>> harvest, grow and make our own medicines.

>>>

>>> I went to an interesting talk by Dr Rosie s the other night.

>>> Apart from being a massive PR machine for her Health Creation

>>> program(Clever Rosie, Transition networks are a good PR target) it

>>> had some interesting stats on the growth of medical expenditure

>>> from the beginning of the NHS to 2020 by which time the

>>> expenditure on drugs will exceed our GNP.

>>>

>>> Zoe

>>>

>>> Medical Herbalist

>>> MNIMH CPP Dip. Phyt.

>>> Buteyko Breathing Practitoner

>>>

>>> " Wild Drugs " 'A Foragers Guide to Healing Plants' Gaia 2010

>>>

>>> Bath

>>> 01761 439920

>>>

>>

>

February 17, 2011

Hello Sally,

When I say making our own medicines I mean everything as we do

now including the right to combine tinctures for individual prescriptions etc. I

don't want to go into details here but I have heard it voiced that once we are

under SR and have the ability to commission third party external prescription

services (whom I presume would have to be licensed) then by comparison members

running their own dispensary would be deemed unsafe and unacceptable to the rest

of Europe. This would open up the possibility of either licensed external

dispensers only or requiring each Herbalist to conform to GMP license.

We must fight to retain the current Herbalist culture we have.

Lorraine

Lorraine Hodgkinson MNIMH MRCHM

HERBS AND HELPERS

6, Butts Fold, Cockermouth,

Cumbria, CA13 9HY. UK.

Tel: +44 (0) 1900 826392

Mobile: 07761 489838 (O2)

www.herbalmedicineuk.com

> Hi Lorraine

>

> were you at conference the year the MHRA representative gave a

> presentation? I don't remember the year.

> I asked him directly to assure me that our right to make our own

> medicines would be maintained, and he assured us that it would be

> They have continued to take this stance. (It was the one point i

> thought I most important to clarify, as it is, as you say, fundamental

> to our practice to have access to good medicines.

> To the best of my knowledge they have never wavered from this position.

>

> The following year gave an excellent workshop on making

> medicines, and reading this list and elsewhere, there are obviously a

> growing(!) numbers of herbalists brewing, macerating and steeping

> away.....

>

> splendid!

>

> re a path for genuine herbalists - grandfathering is the term I think,

>

> best wishes

>

> Sally Owen MNIMH

>

> > We must fight to the death to retain our right to make up and

> > dispense medicines to our patients after consultations in the same

> > time honoured safe way we have always done. It has been voiced in

> > some circles that a GMP only situation would arise. Meaning that by

> > default our right to make and dispense expired.

> >

> > I'm for legislation but not for any loss of of our rights. The full

> > function of a Herbalist should be legally protected and

> > strengthened. Also a path should be opened for other genuine

> > professional Herbalists while leaving those 'pseudo' and unsuitable

> > behind.

> >

> > Lorraine Hodgkinson

> >

> > Lorraine Hodgkinson MNIMH MRCHM

> > HERBS AND HELPERS

> > 6, Butts Fold, Cockermouth,

> > Cumbria, CA13 9HY. UK.

> > Tel: +44 (0) 1900 826392

> > Mobile: 07761 489838 (O2)

> > www.herbalmedicineuk.com

> >

> >> Hi Zoe and all,

> >>

> >> feeling negative about it in some respects as the following from

> >> the DoH makes me wonder how long it will be before they intefere

> >> and change the section 12(1) act and what next, a u-turn on who can

> >> supply us? There seems to be a hint at production and making of

> >> medicines. See below the bit PERMIT AND REGULATE. If they are

> >> saying on one hand that medicines can still be made by individual

> >> herbalists a right that we want protected, how are THEY going to

> >> quality control what we make??? Alarm bells are ringing big time.

> >> Lets face it, DoH and others probably want a state controlled

> >> operation whereby you can only get your herbs from one of 2

> >> suppliers that have GMP and likely we will be stopped from making

> >> our own.

> >>

> >> Just posted the merest bit of DoH, but encourage all of you to look

> >> more deeply. Also, what is going to be the cost to the herbalist,

> >> it will put people out of business because its going to costs

> >> thousands like the chiropractors and osteopaths...anyone car to

> >> comment????

> >>

> >> " If practitioner regulation is in place for the purposes of

> >> creating an Article 5(1) scheme this also opens the way to reform

> >> Section 12 (1) of the Medicines Act 1968. Under Section 12 (1),

> >> practitioners may prepare unlicensed herbal medicines on their own

> >> premises for use following consultation with individual patients.

> >> It is intended to move to the position that only registered

> >> practitioners would be able to operate under Section 12 (1) after

> >> regulation of practitioners is in place " .

> >> be underpinned by a strengthened system for regulating medicinal

> >> products.

> >>

> >> From the official government statement.....

> >>

> >> This approach will give practitioners and consumers continuing

> >> access to herbal medicines. It will do this by allowing us to use a

> >> derogation in the European legislation to set up a UK scheme to

> >> permit and regulate the supply, via practitioners, of unlicensed

> >> manufactured herbal medicines to meet individual patient needs.

> >>

> >> Best wishes

> >>

> >> Jacqui

> >>

> >>>

> >>> Well - it's done now.

> >>> My instincts lean towards feeling negative but on the plus side I

> >>> won't have to clean up the mess made by insane herbal bowel, liver

> >>> cleanse, detox products prescribed by " holistic blah blahs " or

> >>> undo the orthorexia and malnutrition caused by stoopid diets for

> >>> " candida " . Or hilda style parasite cleanse capsules..... etc etc

> >>>

> >>> We must now stand REALLY STRONG and united to protect our rights

> >>> as Medical Professionals and EXPERTS. The people we will be

> >>> dealing with are anything but expert and know nothing about what

> >>> we do. " What herb's good for Blah blah? "

> >>>

> >>> For me one of the most important things, especially given the

> >>> global climate (of everything) is to maintain our rights to

> >>> harvest, grow and make our own medicines.

> >>>

> >>> I went to an interesting talk by Dr Rosie s the other night.

> >>> Apart from being a massive PR machine for her Health Creation

> >>> program(Clever Rosie, Transition networks are a good PR target) it

> >>> had some interesting stats on the growth of medical expenditure

> >>> from the beginning of the NHS to 2020 by which time the

> >>> expenditure on drugs will exceed our GNP.

> >>>

> >>> Zoe

> >>>

> >>> Medical Herbalist

> >>> MNIMH CPP Dip. Phyt.

> >>> Buteyko Breathing Practitoner

> >>>

> >>> " Wild Drugs " 'A Foragers Guide to Healing Plants' Gaia 2010

> >>>

> >>> Bath

> >>> 01761 439920

> >>>

> >>

> >

February 18, 2011

Hello Philip,

Just to make a few points:

The House of Lords report in 2000 did find that there was enough evidence for

Herbal Medicine and Acupuncture. For Homeopathy it did not.

In my opinion a lot of the scare mongering over loss of herbs has been put out

by those currently relying on external dispensary services. On 1st May this

procedure would not be legal as it would mean third parties supplying 'finished'

unlicensed herbal remedy without a THR or MA.

However as you say under section 12.1 we would have the full right as we always

have to dispense for our patients and continue making up our own medicines. The

problem is if you practise TCM is that all the many classic Chinese formulas in

tablet form would go! Some 300-500 items! As no TCM product has a THR or MA. How

can you make a tablet in your practice? I believe Ayurvedic practitioners would

be similarly affected.

The crazy thing is that attempts to get TCM products through the THMPD process

failed from a stability point of view. So there was no where to go!

Yes I champion the right of dispensaries to be fully kept and we must never let

this right be compromised or lost. It is inherent in our herbal culture in this

land.

Lorraine

Lorraine Hodgkinson MNIMH MRCHM

HERBS AND HELPERS

6, Butts Fold, Cockermouth,

Cumbria, CA13 9HY. UK.

Tel: +44 (0) 1900 826392

Mobile: 07761 489838 (O2)

www.herbalmedicineuk.com

> Thanks for that Philip and

>

> >

> > Afraid of Statutory Regulation not going ahead? Reassurance for you

> >

> > Having read many fearful predictions concerning losses of herbal medicines

if statutory regulation does not take place, we find the need to write something

reassuring for herbalists, their patients, and the public alike.

> >

> > As a starting point, it needs to be recognised that the government is unable

to regulate herbal practitioners, for three reasons:

> >

> > 1) There exists no risk-assessment tool for herbal practice

> >

> > 2) There is no evidence-base for herbal practice

> >

> > - these two requirements before a profession can be regulated are set out in

the Report of the Working Group on Extending Professional Regulation, which was

published last year just prior to the public consultation on the Steering

Group's Report.

> >

> > 3) The argument put forward by the pro-SR campaign, that the Traditional

Herbal Medicinal Products Directive will severely affect access to medicines,

and therefore herbalists must be regulated, is one that cannot be taken into

account by the government.

> >

> > In the EU document `Communication from the Commission to the Council and the

European Parliament', dated Sept 2008, it is stated " ....it should be emphasised

that Community legislation on medicinal products, in particular Directive

2001/83/EC laying down the procedures for placing products on the market,

follows a product-specific approach and does not attempt to provide a framework

for the regulation of traditions of medical practice " . This statement goes out

of its way to state that the THMPD solely concerns the marketing of products,

and not the regulation of practitioners: therefore the government is simply not

allowed to link the two together, and bring in statutory regulation for

herbalists as an integral part of the implementation of the Directive.

> >

> > The other point that needs making is this: whilst the current public

campaign is saying that if there is SR all unlicensed herbal products will be

saved, this should be seen in the light of what the MHRA (Medicines and

Healthcare products Regulatory Agency), which is the body in charge of all of

this, itself has to say on the matter:

> >

> > `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 MHRA further says:

`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 consultationâ€¦'

> >

> > The expressions `unless it is possible to construct a UK scheme' and `if

there were to be a version of this arrangement for herbal practitioners.

.....this would require further specific consultation' are not the language of

something that is already in place. So if you think that it is just a question

of having SR, and then a derogation under Article 5.1 can come into force, you

are mistaken. The fact is that whilst the Directive provides the possibility for

a derogation, there is no guarantee that this would be enacted in the UK. This

is what the MHRA is making clear. If you are beginning to have doubts about the

claims being made by the pro-SR campaigners, why not ask them " If there is SR,

can you give me an absolute guarantee that we will have continued access to all

our unlicensed herbal products? " If their answer is " yes " , then you might like

to quote the above references to them, and ask for an explanation.

> >

> > A number of fearful scenarios have been put forward suggesting that vast

numbers of medicines will be lost after the implementation of the THMPD in April

2011, if SR does not go ahead. Therefore we would like to provide some

reassurance for herbalists and the general public alike:

> >

> > Some of the specific fears expressed for post-2011 concern: loss of

dispensary services, creams, syrups, and capsules. The simple solution without

SR, is that herbalists will have to do more pharmacy themselves, and work from

what are designated `start-up materials', rather than use finished products

requiring product licences. Doing some more pharmacy themselves would perhaps

also be good for herbalists' own development. By buying in their own materials

and stocks, herbalists will be able to continue providing everything to their

patients: for example they can buy in a base cream and add their own therapeutic

ingredients to make Marigold cream etc; they can buy in Licorice and Thyme

syrups separately (or even make their own), and mix them together to make

Licorice and Thyme syrup; to avoid the alcohol content of tinctures for any

patients, they can do their own capsuling from powdered herbs, or give herbal

teas; they can stock their own tinctures and other start-up materials rather

than use a prescription service, which is what most herbalists do anyway; they

can also make their own tinctures (not really very difficult). None of this is

exactly rocket science surely, is it?

> >

> > We hope therefore that we can all accept the new reality, that SR is off,

with calmness, rather than with fear and panic. Many vague and unsubstantiated

fears have been expressed about the future, along the lines of `will we be able

to keep giving our patients St s Wort and Black Cohosh if we are not

regulated?' and `once we get on the steep and slippery slope, all our herbs

become vulnerable'. Our hope is that all herbalists, whether for or against

statutory regulation, can now work together, along with their patients and the

public, to safeguard and protect this country's access to herbal medicines from

any concrete threats, when or if they occur.

> >

> > Philip and Lynda

> >

>

February 18, 2011

Shame we don't have our own mystery benefactor to pay for an expensive lobbying

group to represent the other side of the SR argument in parliament

From: Jacqui

Sent: Friday, February 18, 2011 4:46 PM

To: ukherbal-list

Subject: Re: Regulation

Hi all

The pro-SR people have taken the announcements by the Secretary of State and the

MHRA to mean they have definitely got Statutory Regulation, but it is jumping

the gun to say this, because this is not what the statements themselves actually

say.

To quote from the announcements:

" Subject to Parliamentary approval, such practitioners who wish to supply

unlicensed herbal products will be required by law to register with the HPC " -

is a clear statement that SR can only go ahead if Parliament agrees to the

proposal; this means that if Parliament does not agree, it cannot go ahead.

" A formal consultation exercise will take place on specific legislative

proposals for establishing the register and proposed reforms of medicines

legislation later in 2011 & #8243; - indicates that the whole thing is a proposal,

and that there is to be a consultation on this proposal later this year.

The recent reversal of the proposals for Forestry during the consultation

process shows us that Government proposals are certainly liable to be changed.

What do you all think about this?????

Best wishes

Jacqui

> > >

> > > Afraid of Statutory Regulation not going ahead? Reassurance for you

> > >

> > > Having read many fearful predictions concerning losses of herbal medicines

if statutory regulation does not take place, we find the need to write something

reassuring for herbalists, their patients, and the public alike.

> > >

> > > As a starting point, it needs to be recognised that the government is

unable to regulate herbal practitioners, for three reasons:

> > >

> > > 1) There exists no risk-assessment tool for herbal practice

> > >

> > > 2) There is no evidence-base for herbal practice

> > >

> > > - these two requirements before a profession can be regulated are set out

in the Report of the Working Group on Extending Professional Regulation, which

was published last year just prior to the public consultation on the Steering

Group's Report.

> > >

> > > 3) The argument put forward by the pro-SR campaign, that the Traditional

Herbal Medicinal Products Directive will severely affect access to medicines,

and therefore herbalists must be regulated, is one that cannot be taken into

account by the government.

> > >

> > > In the EU document `Communication from the Commission to the Council and

the European Parliament', dated Sept 2008, it is stated " ....it should be

emphasised that Community legislation on medicinal products, in particular

Directive 2001/83/EC laying down the procedures for placing products on the

market, follows a product-specific approach and does not attempt to provide a

framework for the regulation of traditions of medical practice " . This statement

goes out of its way to state that the THMPD solely concerns the marketing of

products, and not the regulation of practitioners: therefore the government is

simply not allowed to link the two together, and bring in statutory regulation

for herbalists as an integral part of the implementation of the Directive.

> > >

> > > The other point that needs making is this: whilst the current public

campaign is saying that if there is SR all unlicensed herbal products will be

saved, this should be seen in the light of what the MHRA (Medicines and

Healthcare products Regulatory Agency), which is the body in charge of all of

this, itself has to say on the matter:

> > >

> > > `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 MHRA further says:

`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 consultationâ?¦'

> > >

> > > The expressions `unless it is possible to construct a UK scheme' and `if