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Re: Re: The whole Legal point

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Dear ,

Thanks for that.

A couple of points. Do you know where the reference to 'authorised

health care professional' can be found in the proposed legislation?

Regarding safety, I think we have to give people credit to make their

own minds up about who they see. Regulation does not, in itself,

guarantee safety as we know from conventional medical practice. We must

always check people out. It is a myth that regulation makes practice safer.

I was also impressed by Craig's post. An important point of course was

that there is not the aggressive hostility there towards alternative

medicine that there is in the UK. The risk for us is what regulation

leads to in the future. OT's are happy being subservient to medics -

will the same happen for herbalists and acupuncturists? We live in a

world and a society which happily medicalises every process from birth

to death. We need to be very careful that the form of regulation we are

looking for preserve our traditions and our autonomy.

Regards

laurastannard wrote:

>

>

> Hi Licia

>

> The short answer is no.

> Voluntary regulation is what we have now (those of us in prof bodies).

> That gives us zero status - basically no matter how many

> qualifications I have, in legal terms I am nothing more than a member

> of the public. No point stamping feet and saying but but but.....

>

> Basically European legislation, as says, means you have to be

> authorised healthcare professional to be able to give herbs that do

> not have a licence.

> Some herbal products will have licences and will be available is shops

> etc.

> Of course we have FUNCTIONAL authority - we know what we are doing,

> we're trained, we're insured etc, but what we don't have is FORMAL

> authority. There is a difference and the difference is what determines

> who can do things in law and who can't. In law you have to have formal

> authority - sorry if capitals appear to be shouting but I have no

> other way of emphasising the point like underlining. I'm not shouting.

>

> In answer to 's questions about safety - the safety issues are

> not just to do with the herbs themselves but also those giving them.

> Basically you don't know me from Adam (or Eve) - in fact you don't

> really even know if I am male or female because I could be

> masquarading as some person called that sometimes posts things

> on the internet. I could in fact be Myra Hindley, the Yorkshire Ripper

> or some other person who ...

> I'm exaggerating here to try to make a point.

> The point being that none of us can actually say 100% that every

> single herbalist now or in the future might not act inappropriately

> towards someone in a vulnerable position. - regulation won't stop it

> happening but it does mean that if something like that happens said

> person can be dealt with.

>

> I've just seen a patient this afternoon who is an occupational

> therapist, regulated by HPC and a member of the OT's prof body. Apart

> from being outraged at what could happen, she just said - regulation

> is no big deal. You herbalists need legal status. I'm a member of x

> body and regulated by HPC. HPC costs me about £60 a year and I don't

> even notice I'm part of it.

>

> So that will be the reality for most of us. Apart from an extra £60 a

> year and sending some forms to x rather than y, we won't notice. Other

> than, we won't have do what herbalists have had to do every so often

> for hundreds of years. Fight for a right to practice.

>

> When I qualified in 1994. I was a herbalist for just a few weeks when

> I had to fight for my profession. I understand there was also a

> campaign to protect herbal medicine in the 1980s and in the 60s, and

> during the blitz a law was passed to ban herbalists. It's been going

> on since god knows when.

>

> ly I'm sick of this, and I'm sick of having to ask my patients to

> support me and write to their MPs, and I daresay all our forefathers

> were also sick of it.

>

> We have an opportunity here to do something major. We owe it to all

> the future generations of herbalists, all those training at the

> moment, people like you who probably have student loans to repay, to

> our patients, and to those who have tried before and not succeeded to

> take this opportunity.

>

> I read Craig's post and I thought WOW. What I'd give for that.

> I'd love to stop being just a member of the public.

>

> best wishes

>

>

>

> >

> > Dear

> > I'm still trying to understand it all.

> > Would Voluntary Self Regulation no make herbalits 'authorised

> healthcare professionals'? and therefore no need for SR and be in the

> big pharma's pocket.

> >

> > licia

> >

>

>

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Dear Craig,

Thank you. Are there any restrictions on what alternative practitioners

can and cannot do in South Africa? In some parts of Scandinavia, for

example, acupuncturists cannot treat children.

It sounds as if practitioners there are very much on the same level playing

field with more respect for each other. Maybe its the class system in the UK but

many medics are at the least dismissive of alternative medicine and in some

cases openly vitriolic.

Regards

Dr Craig wrote:

>

>

>

>

> Hi

>

> " An important point of course was that there is not the aggressive

> hostility

> there towards alternative medicine that there is in the UK. "

>

> I believe that statutory regulation has played a big role in this.

> Homeopathy etc. were banned here in the 70's by the Nationalist government

> of the time and even when I was a student in the early 90's doctor's and

> dentists were prevented by Rule 9(2) of the Medical and Dental Council

> from

> associating with people like phytotherapists and homeopaths. On the whole,

> there is now a lot more openness and tolerance and interest and many, many

> good working relationships between medical professionals of all kinds,

> and I

> believe that having formally recognised and protected alt med professions

> (and excellent University-based training) has really contributed to this

> state of affairs. Don't get me wrong, it is no Utopia here, but, as you

> point out there is very little hostility.

>

> Best wishes

>

> Craig

>

> rom: ukherbal-list

> <mailto:ukherbal-list%40yahoogroups.com>

> [mailto:ukherbal-list

> <mailto:ukherbal-list%40yahoogroups.com>] On

> Behalf Of Gascoigne

> Sent: 26 October 2009 20:27

> To: ukherbal-list <mailto:ukherbal-list%40yahoogroups.com>

> Subject: Re: Re: The whole Legal point

>

> Dear ,

>

> Thanks for that.

>

> A couple of points. Do you know where the reference to 'authorised

> health care professional' can be found in the proposed legislation?

>

> Regarding safety, I think we have to give people credit to make their

> own minds up about who they see. Regulation does not, in itself,

> guarantee safety as we know from conventional medical practice. We must

> always check people out. It is a myth that regulation makes practice

> safer.

>

> I was also impressed by Craig's post. An important point of course was

> that there is not the aggressive hostility there towards alternative

> medicine that there is in the UK. The risk for us is what regulation

> leads to in the future. OT's are happy being subservient to medics -

> will the same happen for herbalists and acupuncturists? We live in a

> world and a society which happily medicalises every process from birth

> to death. We need to be very careful that the form of regulation we are

> looking for preserve our traditions and our autonomy.

>

> Regards

>

>

>

>

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Share on other sites

Hi

" An important point of course was that there is not the aggressive hostility

there towards alternative medicine that there is in the UK. "

I believe that statutory regulation has played a big role in this.

Homeopathy etc. were banned here in the 70's by the Nationalist government

of the time and even when I was a student in the early 90's doctor's and

dentists were prevented by Rule 9(2) of the Medical and Dental Council from

associating with people like phytotherapists and homeopaths. On the whole,

there is now a lot more openness and tolerance and interest and many, many

good working relationships between medical professionals of all kinds, and I

believe that having formally recognised and protected alt med professions

(and excellent University-based training) has really contributed to this

state of affairs. Don't get me wrong, it is no Utopia here, but, as you

point out there is very little hostility.

Best wishes

Craig

rom: ukherbal-list [mailto:ukherbal-list ] On

Behalf Of Gascoigne

Sent: 26 October 2009 20:27

To: ukherbal-list

Subject: Re: Re: The whole Legal point

Dear ,

Thanks for that.

A couple of points. Do you know where the reference to 'authorised

health care professional' can be found in the proposed legislation?

Regarding safety, I think we have to give people credit to make their

own minds up about who they see. Regulation does not, in itself,

guarantee safety as we know from conventional medical practice. We must

always check people out. It is a myth that regulation makes practice safer.

I was also impressed by Craig's post. An important point of course was

that there is not the aggressive hostility there towards alternative

medicine that there is in the UK. The risk for us is what regulation

leads to in the future. OT's are happy being subservient to medics -

will the same happen for herbalists and acupuncturists? We live in a

world and a society which happily medicalises every process from birth

to death. We need to be very careful that the form of regulation we are

looking for preserve our traditions and our autonomy.

Regards

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Share on other sites

OT's are not subservient to medics - IMO that sort of thinking has changed.

Although medics refer patients to them, such health professionals are now

largely seen as specialists in their own field.

Helen

Re: Re: The whole Legal point

Dear ,

Thanks for that.

A couple of points. Do you know where the reference to 'authorised

health care professional' can be found in the proposed legislation?

Regarding safety, I think we have to give people credit to make their

own minds up about who they see. Regulation does not, in itself,

guarantee safety as we know from conventional medical practice. We must

always check people out. It is a myth that regulation makes practice safer.

I was also impressed by Craig's post. An important point of course was

that there is not the aggressive hostility there towards alternative

medicine that there is in the UK. The risk for us is what regulation

leads to in the future. OT's are happy being subservient to medics -

will the same happen for herbalists and acupuncturists? We live in a

world and a society which happily medicalises every process from birth

to death. We need to be very careful that the form of regulation we are

looking for preserve our traditions and our autonomy.

Regards

laurastannard wrote:

>

>

> Hi Licia

>

> The short answer is no.

> Voluntary regulation is what we have now (those of us in prof bodies).

> That gives us zero status - basically no matter how many

> qualifications I have, in legal terms I am nothing more than a member

> of the public. No point stamping feet and saying but but but.....

>

> Basically European legislation, as says, means you have to be

> authorised healthcare professional to be able to give herbs that do

> not have a licence.

> Some herbal products will have licences and will be available is shops

> etc.

> Of course we have FUNCTIONAL authority - we know what we are doing,

> we're trained, we're insured etc, but what we don't have is FORMAL

> authority. There is a difference and the difference is what determines

> who can do things in law and who can't. In law you have to have formal

> authority - sorry if capitals appear to be shouting but I have no

> other way of emphasising the point like underlining. I'm not shouting.

>

> In answer to 's questions about safety - the safety issues are

> not just to do with the herbs themselves but also those giving them.

> Basically you don't know me from Adam (or Eve) - in fact you don't

> really even know if I am male or female because I could be

> masquarading as some person called that sometimes posts things

> on the internet. I could in fact be Myra Hindley, the Yorkshire Ripper

> or some other person who ...

> I'm exaggerating here to try to make a point.

> The point being that none of us can actually say 100% that every

> single herbalist now or in the future might not act inappropriately

> towards someone in a vulnerable position. - regulation won't stop it

> happening but it does mean that if something like that happens said

> person can be dealt with.

>

> I've just seen a patient this afternoon who is an occupational

> therapist, regulated by HPC and a member of the OT's prof body. Apart

> from being outraged at what could happen, she just said - regulation

> is no big deal. You herbalists need legal status. I'm a member of x

> body and regulated by HPC. HPC costs me about £60 a year and I don't

> even notice I'm part of it.

>

> So that will be the reality for most of us. Apart from an extra £60 a

> year and sending some forms to x rather than y, we won't notice. Other

> than, we won't have do what herbalists have had to do every so often

> for hundreds of years. Fight for a right to practice.

>

> When I qualified in 1994. I was a herbalist for just a few weeks when

> I had to fight for my profession. I understand there was also a

> campaign to protect herbal medicine in the 1980s and in the 60s, and

> during the blitz a law was passed to ban herbalists. It's been going

> on since god knows when.

>

> ly I'm sick of this, and I'm sick of having to ask my patients to

> support me and write to their MPs, and I daresay all our forefathers

> were also sick of it.

>

> We have an opportunity here to do something major. We owe it to all

> the future generations of herbalists, all those training at the

> moment, people like you who probably have student loans to repay, to

> our patients, and to those who have tried before and not succeeded to

> take this opportunity.

>

> I read Craig's post and I thought WOW. What I'd give for that.

> I'd love to stop being just a member of the public.

>

> best wishes

>

>

>

> >

> > Dear

> > I'm still trying to understand it all.

> > Would Voluntary Self Regulation no make herbalits 'authorised

> healthcare professionals'? and therefore no need for SR and be in the

> big pharma's pocket.

> >

> > licia

> >

>

>

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In Australia, regulation led to the loss of Ephedra, Lobelia, Tussilago,

Convallaria and apparently some others.

Best regards,

Tim.

From: Gascoigne

Sent: Monday, October 26, 2009 7:01 PM

To: ukherbal-list

Subject: Re: Re: The whole Legal point

Dear Craig,

Thank you. Are there any restrictions on what alternative practitioners

can and cannot do in South Africa? In some parts of Scandinavia, for

example, acupuncturists cannot treat children.

It sounds as if practitioners there are very much on the same level playing

field with more respect for each other. Maybe its the class system in the UK but

many medics are at the least dismissive of alternative medicine and in some

cases openly vitriolic.

Regards

Dr Craig wrote:

>

>

>

>

> Hi

>

> " An important point of course was that there is not the aggressive

> hostility

> there towards alternative medicine that there is in the UK. "

>

> I believe that statutory regulation has played a big role in this.

> Homeopathy etc. were banned here in the 70's by the Nationalist government

> of the time and even when I was a student in the early 90's doctor's and

> dentists were prevented by Rule 9(2) of the Medical and Dental Council

> from

> associating with people like phytotherapists and homeopaths. On the whole,

> there is now a lot more openness and tolerance and interest and many, many

> good working relationships between medical professionals of all kinds,

> and I

> believe that having formally recognised and protected alt med professions

> (and excellent University-based training) has really contributed to this

> state of affairs. Don't get me wrong, it is no Utopia here, but, as you

> point out there is very little hostility.

>

> Best wishes

>

> Craig

>

> rom: ukherbal-list

> <mailto:ukherbal-list%40yahoogroups.com>

> [mailto:ukherbal-list

> <mailto:ukherbal-list%40yahoogroups.com>] On

> Behalf Of Gascoigne

> Sent: 26 October 2009 20:27

> To: ukherbal-list <mailto:ukherbal-list%40yahoogroups.com>

> Subject: Re: Re: The whole Legal point

>

> Dear ,

>

> Thanks for that.

>

> A couple of points. Do you know where the reference to 'authorised

> health care professional' can be found in the proposed legislation?

>

> Regarding safety, I think we have to give people credit to make their

> own minds up about who they see. Regulation does not, in itself,

> guarantee safety as we know from conventional medical practice. We must

> always check people out. It is a myth that regulation makes practice

> safer.

>

> I was also impressed by Craig's post. An important point of course was

> that there is not the aggressive hostility there towards alternative

> medicine that there is in the UK. The risk for us is what regulation

> leads to in the future. OT's are happy being subservient to medics -

> will the same happen for herbalists and acupuncturists? We live in a

> world and a society which happily medicalises every process from birth

> to death. We need to be very careful that the form of regulation we are

> looking for preserve our traditions and our autonomy.

>

> Regards

>

>

>

>

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Share on other sites

Dear Helen,

All therapies such as physiotherapists and OT's are subservient to

medics because they have to have patients referred to them. They cannot

see a patient who wants to self-refer. So, when a doctor, for example,

asks a physio to treat a patient's knee, if that patient then complains

of a hip problem, the patient has to go back to the doctor for another

referral. That is my definition of subservient. There is a hierarchy

here and I would assume that herbalists want equal status with doctors -

to be able to diagnose and treat without the need for the patient to see

a doctor first.

Regards

Helen Duxbury wrote:

>

>

> OT's are not subservient to medics - IMO that sort of thinking has

> changed. Although medics refer patients to them, such health

> professionals are now largely seen as specialists in their own field.

>

> Helen

> Re: Re: The whole Legal point

>

> Dear ,

>

> Thanks for that.

>

> A couple of points. Do you know where the reference to 'authorised

> health care professional' can be found in the proposed legislation?

>

> Regarding safety, I think we have to give people credit to make their

> own minds up about who they see. Regulation does not, in itself,

> guarantee safety as we know from conventional medical practice. We must

> always check people out. It is a myth that regulation makes practice

> safer.

>

> I was also impressed by Craig's post. An important point of course was

> that there is not the aggressive hostility there towards alternative

> medicine that there is in the UK. The risk for us is what regulation

> leads to in the future. OT's are happy being subservient to medics -

> will the same happen for herbalists and acupuncturists? We live in a

> world and a society which happily medicalises every process from birth

> to death. We need to be very careful that the form of regulation we are

> looking for preserve our traditions and our autonomy.

>

> Regards

>

>

>

> laurastannard wrote:

> >

> >

> > Hi Licia

> >

> > The short answer is no.

> > Voluntary regulation is what we have now (those of us in prof bodies).

> > That gives us zero status - basically no matter how many

> > qualifications I have, in legal terms I am nothing more than a member

> > of the public. No point stamping feet and saying but but but.....

> >

> > Basically European legislation, as says, means you have to be

> > authorised healthcare professional to be able to give herbs that do

> > not have a licence.

> > Some herbal products will have licences and will be available is shops

> > etc.

> > Of course we have FUNCTIONAL authority - we know what we are doing,

> > we're trained, we're insured etc, but what we don't have is FORMAL

> > authority. There is a difference and the difference is what determines

> > who can do things in law and who can't. In law you have to have formal

> > authority - sorry if capitals appear to be shouting but I have no

> > other way of emphasising the point like underlining. I'm not shouting.

> >

> > In answer to 's questions about safety - the safety issues are

> > not just to do with the herbs themselves but also those giving them.

> > Basically you don't know me from Adam (or Eve) - in fact you don't

> > really even know if I am male or female because I could be

> > masquarading as some person called that sometimes posts things

> > on the internet. I could in fact be Myra Hindley, the Yorkshire Ripper

> > or some other person who ...

> > I'm exaggerating here to try to make a point.

> > The point being that none of us can actually say 100% that every

> > single herbalist now or in the future might not act inappropriately

> > towards someone in a vulnerable position. - regulation won't stop it

> > happening but it does mean that if something like that happens said

> > person can be dealt with.

> >

> > I've just seen a patient this afternoon who is an occupational

> > therapist, regulated by HPC and a member of the OT's prof body. Apart

> > from being outraged at what could happen, she just said - regulation

> > is no big deal. You herbalists need legal status. I'm a member of x

> > body and regulated by HPC. HPC costs me about £60 a year and I don't

> > even notice I'm part of it.

> >

> > So that will be the reality for most of us. Apart from an extra £60 a

> > year and sending some forms to x rather than y, we won't notice. Other

> > than, we won't have do what herbalists have had to do every so often

> > for hundreds of years. Fight for a right to practice.

> >

> > When I qualified in 1994. I was a herbalist for just a few weeks when

> > I had to fight for my profession. I understand there was also a

> > campaign to protect herbal medicine in the 1980s and in the 60s, and

> > during the blitz a law was passed to ban herbalists. It's been going

> > on since god knows when.

> >

> > ly I'm sick of this, and I'm sick of having to ask my patients to

> > support me and write to their MPs, and I daresay all our forefathers

> > were also sick of it.

> >

> > We have an opportunity here to do something major. We owe it to all

> > the future generations of herbalists, all those training at the

> > moment, people like you who probably have student loans to repay, to

> > our patients, and to those who have tried before and not succeeded to

> > take this opportunity.

> >

> > I read Craig's post and I thought WOW. What I'd give for that.

> > I'd love to stop being just a member of the public.

> >

> > best wishes

> >

> >

> >

> > >

> > > Dear

> > > I'm still trying to understand it all.

> > > Would Voluntary Self Regulation no make herbalits 'authorised

> > healthcare professionals'? and therefore no need for SR and be in the

> > big pharma's pocket.

> > >

> > > licia

> > >

> >

> >

>

>

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Hi

Yes, there are. Our Act prescribes exactly what a person registered in

terms of the Act in a particular profession may do.

However, a practitioner registered with our council may:

" For purposes of this Act -

(a) a practitioner may-

(i) diagnose, and treat or prevent, physical and mental disease,

illness or deficiencies in humans;

(ii) prescribe or dispense medicine; or

(iii) provide or prescribe treatment for such disease, illness or

deficiencies in humans; "

So this is an extremely empowering piece of legislation, particularly so for

homeopaths (due to their history here) but is good for the other professions

too, although there are occasionally some strange exceptions (see below for

phytotherapy).

Best wishes

Craig

Phytotherapy

29. Subject to the provisions of the Medicines and Related Substances

Control Act, 1965, a practitioner

registered as a phytotherapist may -

(a) for the purpose of his or her practice possess or have under his or her

control -

(i) vitamins;

(ii) substances that are obtained solely from plants or parts of plants,

that are not

prepared in accordance with homoeopathic pharmacological principles and that

are not scheduled substances;

(iii) the following scheduled substances that are obtained solely from

plants or parts of

plants, and that are not prepared in accordance with homoeopathic

pharmacological principles:

(aa) Alkaloids and glycosides;

(bb) all poisonous alkaloids and glycosides not specifically named in

Schedule

1, 2, 3, 4, 5, 6 or 7 of the Medicines and Related Substances Control Act,

1965, containing not more than one part per thousand of such alkaloids or

glycosides, excluding the following alkaloids and glycosides in the

maximum strength as indicated below:

- Aconite tincture (B.P.);

- Belladonna tincture (B.P. 1980);

- Cocaine: substances containing not more than one part per thousand

of cocaine, calculated as cocaine alkaloid;

- Gelsemium tincture (B.P.C. 1973);

- Ipecacuanha tincture (B.P. 1980);

- Sabadilla alkaloids (B.P.C. 1934);

- Veratrum tincture (B.P.C. 1934);

- Cantharidin;

- Digitalis leaf (B.P. 1980);

- Hyoscine: substances containing not more than one part per

thousand thereof;

- Nux vomica;

- Opium tincture (Ph.Cx., 11th edition): substances containing not

more than one part per thousand thereof;

- Papaverine: substances containing not more than one part per

thousand thereof;

- Pilocarpine;

- Pygeum africanum (lipido-sterolic complex extract thereof);

- Radix valerianae and its extracts;

- Rauvolfia serpentina (dry root), (Ph.Cx., 11th edition);

- Strophanthus (B.P.);

- Tubocurarine: substances containing not more than one part per

thousand thereof; and

- Vincamine;

(B) prescribe for a patient or supply to a patient -

(i) vitamins, excluding any substance containing an injectable form of

vitamin A or

vitamin B12;

(ii) substances that are obtained solely from plants or parts of plants,

that are not

prepared in accordance with homeopathic pharmacological principles and that

are

not scheduled substances;

(iii) substances referred to in paragraph (a)(iii) in a dose not exceeding

one thousandth

part of an allopathic dose, excluding the following substances which may be

prescribed and supplied in a dose not exceeding the dose indicated below:

(aa) Belladonna tincture (B.P. 1980): substances containing not more than

0,1

millilitre thereof per daily dose;

(bb) Cantharidin: substances containing not more than 60 micrograms thereof

per daily dose;

(cc) Radix valerianae and its extracts: substances containing not more than

500

milligrams thereof per daily dose; and

(dd) Rauvolfia serpentina (dry root): substances containing not more than

1,5

milligrams thereof per daily dose; and

© prepare the following:

(i) Substances, preparations and mixtures of substances that are not

scheduled

substances, that are obtained solely from plants or parts of plants, and

that are

recorded in a herbal Materia Medica or herbal Pharmacopeia; and

(ii) substances referred to in paragraph (B)(iii), excluding -

(aa) a basic substance;

(bb) a vitamin;

(cc) a preparation for injection;

(dd) a hormone (natural or synthetic); and

(ee) an enzyme.

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I am not thinking anything. I am just stating what happened in Australia when

regulation was imposed there.

Best regards,

Tim.

From: laurastannard

Sent: Tuesday, October 27, 2009 9:37 AM

To: ukherbal-list

Subject: Re: The whole Legal point

Dear Tim

Do you really think that come 30th April 2011 with no statutorily regulated

herbalists on the horizon, the UK govt or its designated regulators are going to

allow members of the public to continue to dish out Schedule 3 poisons?

That will be the start.

Come 30th April 2011 the MRHA will be required to enforce a law that gives the

public access to only those herbs deemed medicinal that have a licence. If they

don't the European Parliament will sue the British govt.

Now which do you think the govt is going to do? Stand up and fight for the

rights of a bunch of people it doesn't even recognise in its own country,

risking losing huge amounts of public money in a court case they can't win and

would have no interest in anyway, or just impose the law?

Fining herbalists for using unlicenced herbs might not bring in the revenue of

e.g speed cameras, but in this ecomonic climate with this national debt, every

little helps.

Schedule 3s will be an easy target for unregulated herbalists. And then......

Best wishes

> In Australia, regulation led to the loss of Ephedra, Lobelia, Tussilago,

Convallaria and apparently some others.

>

> Best regards,

> Tim.

>

>

>

>

>

>

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Dear ,

Yes, it is true - doctors including myself - are regulated by the GMC.

It is irrelevant whether people agree with it or not - it is a fact.

There are enough examples of doctors causing problems to suggest that

regulation and its benefits are not as straightforward as we would

think. Not least as Western medical treatments are the commonest cause

of death.

The question for herbalists is whether regulation gives us what we want

in order to practice in the way we want. For me, the post-regulation

environment is not clear - will herbalists be able to use all the herbs

they want, who will decide whether they can, will there be restrictions

placed on what we can and cannot treat? As someone who practices Chinese

herbal medicine, there are several herbs which are not available now. It

is unclear whether this will change after regulation.

Regards,

laurastannard wrote:

>

>

> Dear

>

> " It is a myth that regulation makes practice safer. "

>

> I didn't actually say that (but I could ask you to provide evidence to

> back up this statement - we're supposed to be in an evidence based

> culture after all).

>

> What I said was regulation deals with people who take advantage of

> vulnerable people.

>

> I don't really want to get into a discussion on that however. I said I

> was dropping out of this discussion and I will - I have many things to

> do and patients to see. I just wanted to answer Licia as she didn't

> seem to understand she is nothing more than a member of the public.

>

> It's just that one thing has been bugging me since last night. I can't

> quite tie in what you say about herbalists and regulation, when in

> reality you seem to go along with it and buy into regulation without

> question in your other profession.

> Unless I'm much mistaken aren't you regulated by the GMC? Would you

> practise medicine without being regulated?

>

> I remember, must be 20 - 30 years ago when Esther Rantzen had the

> programme on TV. There were a number of so-called 'doctors' working

> with patients but they had never set foot in a medical school in their

> lives. Complete frauds. Basically she exposed them and so no-one can

> call themselves a doctor if they are not actually qualified as a doctor.

>

> So, if it's OK to regulate doctors which I guess you agree with and go

> along with, why question regulating herbalists? We all deal in health,

> and we are in positions of power which can make anyone vulnerable - my

> patients accept what I say and do what I ask them even if wrapping

> clingfilm round their broken ribs might seem a bit bizarre. They might

> not accept that from my next door neighbour who is a genuine member of

> the public and not a trained herbalist.

>

> best wishes

>

>

>

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on a point of accuracy. The Minister for Health in Ireland signed a Statutory

Instrument (SI), no. 627 in 2002 allowing herbalists to prescribe Hypericum and

Gingko biloba both of which are not allowed in general over the counter sale but

are prescription only by medical doctors and/or ourselves.

ri Kingston

Herbalists in Ireland

Re: The whole Legal point

So, , you are regulated by GMC and are a doctor, so for you SR for

herbalists is pretty irrelevant.

You already count as an authorised healthcare professional whereas I and other

non-doctor colleagues are just members of the public.

As a doctor you can prescribe off-licence anyway.

So come 2011 there will be no problem for you. Not that I am suggesting for

one minute that any sort of self-interest might be behind what you're saying and

heaven forbid that you might think that.

For unregulated herbalists the story will be different. Some people might hope

for changes to the EU law but the commission has said that isn't going to

happen, and if any kind review takes place down the line it will be years after

2011 - by which time.....

Now unless I am very much mistaken, an anti-regulation lobby in Ireland

succeeded in preventing the regulation of herbalists there, and herbs such as

Hypericum disappeared off the shelves of the dispensaries of unregulated

herbalists and healthfood shops alike.

But doctors can still prescribe it in Ireland should they wish to. It's a POM.

So doctors working against SR in Ireland would appear to have done pretty well

out of that, as would any kind of pharma lobby.

With herbalists and the public as losers. And several years on despite

protests SJW remains a POM.

Now I certainly wouldn't want to see that sort of thing happen here.

best wishes

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As far as patenting a single herb standardised extract I would think that it

would be almost impossible as there has to be a significant inventive step. This

would mean that the extract would have to be manufactured in a new way and be

significantly different from other standardised extracts of the herb.

If the inventive step is too great then the product would not be viewed as

" traditional " by the EMEA or MHRA and so would have to go down the full licence

route.

However there is nothing to stop a pharmaceutical company getting a herbal

license for a standardised extract and marketting to GPs as the costs involved

in getting a herbal licence are minuscule compared to conventional licenses.

However many pharmaceutical companies would probably not bother as the size of

the potential market is extremely small in their terms. Most would be looking to

make a margin of at least £4-5 million per product per month and as the total EU

herbal market is €300 per year (according to Mintel) then the numbers do not add

up.

This is not to say that many smaller companies are now entering the standardised

extract sector but whether they have the same marketting budgets as the big

players is doubtful.

Hope this helps.

Whitton

Sent using BlackBerry® from Orange

Re: The whole Legal point

I was talking to a GP about SR today and he wasn't aware of the EU directive (or

the consultation). He thought pharmaceuticals might see the lack of OTC herbal

remedies from 2011 as an opportunity to market herbal products direct to GPs.

Perhaps this is obvious, but it was a shock to me.

Would standardised extracts eg of a single herb be patentable, as an SE isn't

the whole herb? what if there were more than one herb?

Dead cheap for a pharmaceutical company to get licences for SJW and other herbs

where evidence already exists with that volume of sales ahead. Easy to set up

RCTs too with NHS patients and plenty of money suddenly for research into

lesser-known herbs.

Could we soon have a scenario like Germany, where GPs would be prescribing some

standardized extracts routinely, in favour of orthodox medicine with side

effects?

Please, someone - ? - reassure me that this scenario won't be possible

legally/technically!

Without SR, we have no place in the system. No official voice. No corner to

fight, as we have no corner but are simply a really very small number (relative

to other professions) of disparate individuals. Fewer and fewer rights, more

than likely. And invisible.

Katharine Locke

>

>

> Thanks for that clarification ri.

> It looks to me like you have a positive list of 2 herbs.

>

> Personally, I think the only real safeguard is to be designated an 'authorised

healthcare professional', which is of course what is by virtue of his

being a doctor. For herbalists that requires us to have something written on the

statute books.

> mentioned the 1941 act a little while ago.

>

> So, no more debate from me - I'm taking a leaf out of others books and getting

on with acting to preserve my right to practice, which I consider to be under a

very real threat that will only get bigger if we don't do something.

> And I actually feel very positive about it - in case any of my messages come

across as someone who is acting out of fear.

>

> best wishes

>

>

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On the bleak side I think the whole process is going to take us down the road of

seeing herbal remedies becoming part of the pharmaceutical industry and will

lead to a loss of the traditional practice of herbal medicine.  I think

statutory regulation is the only chance we have to stop this happening. 

 

Personally I can hardly think of anything worse than the loss of our tradition -

not just for ourselves but for all of humanity.   I think it is absolutely

essential that we all act now.

 

Flower

 

Subject: Re: The whole Legal point

To: ukherbal-list

Date: Thursday, October 29, 2009, 4:31 PM

 

I was talking to a GP about SR today and he wasn't aware of the EU directive (or

the consultation) . He thought pharmaceuticals might see the lack of OTC herbal

remedies from 2011 as an opportunity to market herbal products direct to GPs.

Perhaps this is obvious, but it was a shock to me.

Would standardised extracts eg of a single herb be patentable, as an SE isn't

the whole herb? what if there were more than one herb?

Dead cheap for a pharmaceutical company to get licences for SJW and other herbs

where evidence already exists with that volume of sales ahead. Easy to set up

RCTs too with NHS patients and plenty of money suddenly for research into

lesser-known herbs.

Could we soon have a scenario like Germany, where GPs would be prescribing some

standardized extracts routinely, in favour of orthodox medicine with side

effects?

Please, someone - ? - reassure me that this scenario won't be possible

legally/technically !

Without SR, we have no place in the system. No official voice. No corner to

fight, as we have no corner but are simply a really very small number (relative

to other professions) of disparate individuals. Fewer and fewer rights, more

than likely. And invisible.

Katharine Locke

>

>

> Thanks for that clarification ri.

> It looks to me like you have a positive list of 2 herbs.

>

> Personally, I think the only real safeguard is to be designated an 'authorised

healthcare professional' , which is of course what is by virtue of his

being a doctor. For herbalists that requires us to have something written on the

statute books.

> mentioned the 1941 act a little while ago.

>

> So, no more debate from me - I'm taking a leaf out of others books and getting

on with acting to preserve my right to practice, which I consider to be under a

very real threat that will only get bigger if we don't do something.

> And I actually feel very positive about it - in case any of my messages come

across as someone who is acting out of fear.

>

> best wishes

>

>

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Don't give up yet !

Surely traditions need to be living and evolving and must not end up as

quaint re-enactment tableaux.

I think the whole process is one of the pharmaceutical industry having

to go down the road of natural medicine - in the end - but it may take a

long time yet.

Arsenic and lead have definitely frowned on for years now and

thalidomide is certainly not very profitable. The poor agrochemical

companies (mainly same ownership as pharma) are seeing their pesticide

and herbicide catalogues decimated by governmental legislation (in

Europe anyway) and have even been turning to natural controls and

(shock horror ) researching " natural synergistic molecules " in their

desperation.

Whatever will they think of next?

Organic farming and environmental awareness, once ridiculed by the

clever dicks and dinosaurs of 20th century technological tradition, are

now mainstream, as more and more people realise that it is the only

chance for survival.

Things often have a way of working out.

>

>

> On the bleak side I think the whole process is going to take us down

> the road of seeing herbal remedies becoming part of the pharmaceutical

> industry and will lead to a loss of the traditional practice of herbal

> medicine. I think statutory regulation is the only chance we have to

> stop this happening.

>

> Personally I can hardly think of anything worse than the loss of our

> tradition - not just for ourselves but for all of humanity. I think

> it is absolutely essential that we all act now.

>

> Flower

>

>

>

>

>

> Subject: Re: The whole Legal point

> To: ukherbal-list

> Date: Thursday, October 29, 2009, 4:31 PM

>

>

>

> I was talking to a GP about SR today and he wasn't aware of the EU

> directive (or the consultation) . He thought pharmaceuticals might see

> the lack of OTC herbal remedies from 2011 as an opportunity to market

> herbal products direct to GPs. Perhaps this is obvious, but it was a

> shock to me.

>

> Would standardised extracts eg of a single herb be patentable, as an

> SE isn't the whole herb? what if there were more than one herb?

>

> Dead cheap for a pharmaceutical company to get licences for SJW and

> other herbs where evidence already exists with that volume of sales

> ahead. Easy to set up RCTs too with NHS patients and plenty of money

> suddenly for research into lesser-known herbs.

>

> Could we soon have a scenario like Germany, where GPs would be

> prescribing some standardized extracts routinely, in favour of

> orthodox medicine with side effects?

>

> Please, someone - ? - reassure me that this scenario won't be

> possible legally/technically !

>

> Without SR, we have no place in the system. No official voice. No

> corner to fight, as we have no corner but are simply a really very

> small number (relative to other professions) of disparate individuals.

> Fewer and fewer rights, more than likely. And invisible.

>

> Katharine Locke

>

>

> >

> >

> > Thanks for that clarification ri.

> > It looks to me like you have a positive list of 2 herbs.

> >

> > Personally, I think the only real safeguard is to be designated an

> 'authorised healthcare professional' , which is of course what

> is by virtue of his being a doctor. For herbalists that requires us to

> have something written on the statute books.

> > mentioned the 1941 act a little while ago.

> >

> > So, no more debate from me - I'm taking a leaf out of others books

> and getting on with acting to preserve my right to practice, which I

> consider to be under a very real threat that will only get bigger if

> we don't do something.

> > And I actually feel very positive about it - in case any of my

> messages come across as someone who is acting out of fear.

> >

> > best wishes

> >

> >

>

>

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Sorry In Germany Gps prescribe standardised extracts so pharmaceutical

companies are already involved, if there was none us, they would hold a

monopoly, for all of Europe, don't you think. The thought has knocked me

sick, but it could be looking something like that.

Im not going to sit down and Im going to stand up and fight our corner, and

if we all fight we've still got till the 16th to really be heard.

Re: The whole Legal point

I was talking to a GP about SR today and he wasn't aware of the EU directive

(or the consultation). He thought pharmaceuticals might see the lack of OTC

herbal remedies from 2011 as an opportunity to market herbal products direct

to GPs. Perhaps this is obvious, but it was a shock to me.

Would standardised extracts eg of a single herb be patentable, as an SE

isn't the whole herb? what if there were more than one herb?

Dead cheap for a pharmaceutical company to get licences for SJW and other

herbs where evidence already exists with that volume of sales ahead. Easy

to set up RCTs too with NHS patients and plenty of money suddenly for

research into lesser-known herbs.

Could we soon have a scenario like Germany, where GPs would be prescribing

some standardized extracts routinely, in favour of orthodox medicine with

side effects?

Please, someone - ? - reassure me that this scenario won't be possible

legally/technically!

Without SR, we have no place in the system. No official voice. No corner

to fight, as we have no corner but are simply a really very small number

(relative to other professions) of disparate individuals. Fewer and fewer

rights, more than likely. And invisible.

Katharine Locke

>

>

> Thanks for that clarification ri.

> It looks to me like you have a positive list of 2 herbs.

>

> Personally, I think the only real safeguard is to be designated an

> 'authorised healthcare professional', which is of course what is

> by virtue of his being a doctor. For herbalists that requires us to have

> something written on the statute books.

> mentioned the 1941 act a little while ago.

>

> So, no more debate from me - I'm taking a leaf out of others books and

> getting on with acting to preserve my right to practice, which I consider

> to be under a very real threat that will only get bigger if we don't do

> something.

> And I actually feel very positive about it - in case any of my messages

> come across as someone who is acting out of fear.

>

> best wishes

>

>

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Share on other sites

Dear ,

Some GPs already use herbal starting materials, such as tinctures, in

the same way as herbalists do. A small number of GPs might well be

called, or think of themselves as 'herbalists' as well. I wouldn't think

that the market would be sufficiently lucrative to attract the really

big companies, as says, although there are some smaller companies

but actually owned by bigger ones that certainly have been in the retail

(i.e. licensed) market for years. As far as I can gather, the THMD would

be a good vehicle for marketing standardised extracts, as part of the

passage to licence is rather precise product pharmaceutical parameters,

which SEs have by definition. So, you may see more licensed SEs on the

retail shelf - but then you will see less unlicensed (and currently

often unqualified) stuff. SE's are closer to pharmaceutical drugs than

they are to what most UK herbalists think of as 'herbal medicines',

which are holistic whole plant extracts. Even the " active " in European

Pharmacopoeia herbal monograph is the " whole herb " and not a

standardised molecule. So, I would not think this will affect herbalists

work noticeably, but that's just a personal opinion.

>

>

> I was talking to a GP about SR today and he wasn't aware of the EU

> directive (or the consultation). He thought pharmaceuticals might see

> the lack of OTC herbal remedies from 2011 as an opportunity to market

> herbal products direct to GPs. Perhaps this is obvious, but it was a

> shock to me.

>

> Would standardised extracts eg of a single herb be patentable, as an

> SE isn't the whole herb? what if there were more than one herb?

>

> Dead cheap for a pharmaceutical company to get licences for SJW and

> other herbs where evidence already exists with that volume of sales

> ahead. Easy to set up RCTs too with NHS patients and plenty of money

> suddenly for research into lesser-known herbs.

>

> Could we soon have a scenario like Germany, where GPs would be

> prescribing some standardized extracts routinely, in favour of

> orthodox medicine with side effects?

>

> Please, someone - ? - reassure me that this scenario won't be

> possible legally/technically!

>

> Without SR, we have no place in the system. No official voice. No

> corner to fight, as we have no corner but are simply a really very

> small number (relative to other professions) of disparate individuals.

> Fewer and fewer rights, more than likely. And invisible.

>

> Katharine Locke

>

>

> >

> >

> > Thanks for that clarification ri.

> > It looks to me like you have a positive list of 2 herbs.

> >

> > Personally, I think the only real safeguard is to be designated an

> 'authorised healthcare professional', which is of course what

> is by virtue of his being a doctor. For herbalists that requires us to

> have something written on the statute books.

> > mentioned the 1941 act a little while ago.

> >

> > So, no more debate from me - I'm taking a leaf out of others books

> and getting on with acting to preserve my right to practice, which I

> consider to be under a very real threat that will only get bigger if

> we don't do something.

> > And I actually feel very positive about it - in case any of my

> messages come across as someone who is acting out of fear.

> >

> > best wishes

> >

> >

>

>

>

>

>

--

Chenery

Rutland Biodynamics Ltd.

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I have to agree with . My initial point was that Patenting an extraction

technique for a herb is not going to affect others using that herb on its own.

The problem will face as well as other UK manufacturers is that THMPD suits

the continental manufacturers more than those in the UK. On the continent most

herbal products are in the form of standardised extracts and there are a number

of manufacturers who make between 5 and 30 different products. These companies

can easier afford the licence fees as they have a smaller catalogue. In the UK

herbal manufacturers have upwards of 200 products sometimes running into the

thousands of products which means that gaining individual licences for all is

financially impossible (unless they win the lottery).

UK herbal manufacturers have always dealt mainly with herbalists as customers

not GPs or pharmacies. This means that there has been a restricted customer base

which runs on small profit margins and so does not have the financial reserves

for large marketting campaigns etc.

Also when making a standardised extract compliance to GMP is much easier as

large batches of a low number of products is easier to control. The micro

biological control of the finished product is also much easier when your process

uses high temperatures and neat ethanol or acetone.

This means that UK manufacturers have had much higher costs in compliance than

their continental counterparts and so have not had the opportunity help

herbalists in their campaign for legal recognition of their status in the way

they would probably have liked.

Personally I think that registration and legal recognition of herbalists is the

only way forward. Once herbalists are legally recognised as a profession then

further campaigns to expand their scope can be more effectively fought.

Sorry for the rambling

Whitton

Sent using BlackBerry® from Orange

Re: Re: The whole Legal point

Dear ,

Some GPs already use herbal starting materials, such as tinctures, in

the same way as herbalists do. A small number of GPs might well be

called, or think of themselves as 'herbalists' as well. I wouldn't think

that the market would be sufficiently lucrative to attract the really

big companies, as says, although there are some smaller companies

but actually owned by bigger ones that certainly have been in the retail

(i.e. licensed) market for years. As far as I can gather, the THMD would

be a good vehicle for marketing standardised extracts, as part of the

passage to licence is rather precise product pharmaceutical parameters,

which SEs have by definition. So, you may see more licensed SEs on the

retail shelf - but then you will see less unlicensed (and currently

often unqualified) stuff. SE's are closer to pharmaceutical drugs than

they are to what most UK herbalists think of as 'herbal medicines',

which are holistic whole plant extracts. Even the " active " in European

Pharmacopoeia herbal monograph is the " whole herb " and not a

standardised molecule. So, I would not think this will affect herbalists

work noticeably, but that's just a personal opinion.

>

>

> I was talking to a GP about SR today and he wasn't aware of the EU

> directive (or the consultation). He thought pharmaceuticals might see

> the lack of OTC herbal remedies from 2011 as an opportunity to market

> herbal products direct to GPs. Perhaps this is obvious, but it was a

> shock to me.

>

> Would standardised extracts eg of a single herb be patentable, as an

> SE isn't the whole herb? what if there were more than one herb?

>

> Dead cheap for a pharmaceutical company to get licences for SJW and

> other herbs where evidence already exists with that volume of sales

> ahead. Easy to set up RCTs too with NHS patients and plenty of money

> suddenly for research into lesser-known herbs.

>

> Could we soon have a scenario like Germany, where GPs would be

> prescribing some standardized extracts routinely, in favour of

> orthodox medicine with side effects?

>

> Please, someone - ? - reassure me that this scenario won't be

> possible legally/technically!

>

> Without SR, we have no place in the system. No official voice. No

> corner to fight, as we have no corner but are simply a really very

> small number (relative to other professions) of disparate individuals.

> Fewer and fewer rights, more than likely. And invisible.

>

> Katharine Locke

>

>

> >

> >

> > Thanks for that clarification ri.

> > It looks to me like you have a positive list of 2 herbs.

> >

> > Personally, I think the only real safeguard is to be designated an

> 'authorised healthcare professional', which is of course what

> is by virtue of his being a doctor. For herbalists that requires us to

> have something written on the statute books.

> > mentioned the 1941 act a little while ago.

> >

> > So, no more debate from me - I'm taking a leaf out of others books

> and getting on with acting to preserve my right to practice, which I

> consider to be under a very real threat that will only get bigger if

> we don't do something.

> > And I actually feel very positive about it - in case any of my

> messages come across as someone who is acting out of fear.

> >

> > best wishes

> >

> >

>

>

>

>

>

--

Chenery

Rutland Biodynamics Ltd.

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,

Agreed except (1) there is no need to license starting materials for use

by herbalists to make up medicines on a 1:1 basis and no-one will (2) at

Rutland we have no widespread problem in complying with EP micro limits

on our existing tinctures. We have occasional problems with herbs of

Chinese origin. Have seen big and potential nasty problems with some raw

herb capsules (unless irradiated) nd am amazed these are still on the

market.

More of a problem is suppliers who don't test at all and your assumption

of compliance raises issues of concern re professional recognition in

the market (the customer). Herbalists by and large still do not realise

there are already two playing fields in the UK market - those that

already produce to internationally acceptable standards and those who do

not. The former have approx. double the process costs of the latter

(depending on scale somewhat). The matter is made worse by misleading

GMP claims! If in doubt ask to see the compliance certificate - or just

put into google or similar the (accurate) company's name and the letters

'MHRA' and see if anything comes up.

Chenery

> I have to agree with . My initial point was that Patenting an extraction

technique for a herb is not going to affect others using that herb on its own.

> The problem will face as well as other UK manufacturers is that THMPD

suits the continental manufacturers more than those in the UK. On the continent

most herbal products are in the form of standardised extracts and there are a

number of manufacturers who make between 5 and 30 different products. These

companies can easier afford the licence fees as they have a smaller catalogue.

In the UK herbal manufacturers have upwards of 200 products sometimes running

into the thousands of products which means that gaining individual licences for

all is financially impossible (unless they win the lottery).

> UK herbal manufacturers have always dealt mainly with herbalists as customers

not GPs or pharmacies. This means that there has been a restricted customer base

which runs on small profit margins and so does not have the financial reserves

for large marketting campaigns etc.

> Also when making a standardised extract compliance to GMP is much easier as

large batches of a low number of products is easier to control. The micro

biological control of the finished product is also much easier when your process

uses high temperatures and neat ethanol or acetone.

> This means that UK manufacturers have had much higher costs in compliance than

their continental counterparts and so have not had the opportunity help

herbalists in their campaign for legal recognition of their status in the way

they would probably have liked.

> Personally I think that registration and legal recognition of herbalists is

the only way forward. Once herbalists are legally recognised as a profession

then further campaigns to expand their scope can be more effectively fought.

> Sorry for the rambling

> Whitton

> Sent using BlackBerry from Orange

>

> Re: Re: The whole Legal point

>

> Dear ,

>

> Some GPs already use herbal starting materials, such as tinctures, in

> the same way as herbalists do. A small number of GPs might well be

> called, or think of themselves as 'herbalists' as well. I wouldn't think

> that the market would be sufficiently lucrative to attract the really

> big companies, as says, although there are some smaller companies

> but actually owned by bigger ones that certainly have been in the retail

> (i.e. licensed) market for years. As far as I can gather, the THMD would

> be a good vehicle for marketing standardised extracts, as part of the

> passage to licence is rather precise product pharmaceutical parameters,

> which SEs have by definition. So, you may see more licensed SEs on the

> retail shelf - but then you will see less unlicensed (and currently

> often unqualified) stuff. SE's are closer to pharmaceutical drugs than

> they are to what most UK herbalists think of as 'herbal medicines',

> which are holistic whole plant extracts. Even the " active " in European

> Pharmacopoeia herbal monograph is the " whole herb " and not a

> standardised molecule. So, I would not think this will affect herbalists

> work noticeably, but that's just a personal opinion.

>

>

>

>

>

> >

> >

> > I was talking to a GP about SR today and he wasn't aware of the EU

> > directive (or the consultation). He thought pharmaceuticals might see

> > the lack of OTC herbal remedies from 2011 as an opportunity to market

> > herbal products direct to GPs. Perhaps this is obvious, but it was a

> > shock to me.

> >

> > Would standardised extracts eg of a single herb be patentable, as an

> > SE isn't the whole herb? what if there were more than one herb?

> >

> > Dead cheap for a pharmaceutical company to get licences for SJW and

> > other herbs where evidence already exists with that volume of sales

> > ahead. Easy to set up RCTs too with NHS patients and plenty of money

> > suddenly for research into lesser-known herbs.

> >

> > Could we soon have a scenario like Germany, where GPs would be

> > prescribing some standardized extracts routinely, in favour of

> > orthodox medicine with side effects?

> >

> > Please, someone - ? - reassure me that this scenario won't be

> > possible legally/technically!

> >

> > Without SR, we have no place in the system. No official voice. No

> > corner to fight, as we have no corner but are simply a really very

> > small number (relative to other professions) of disparate individuals.

> > Fewer and fewer rights, more than likely. And invisible.

> >

> > Katharine Locke

> >

> >

> > >

> > >

> > > Thanks for that clarification ri.

> > > It looks to me like you have a positive list of 2 herbs.

> > >

> > > Personally, I think the only real safeguard is to be designated an

> > 'authorised healthcare professional', which is of course what

> > is by virtue of his being a doctor. For herbalists that requires us to

> > have something written on the statute books.

> > > mentioned the 1941 act a little while ago.

> > >

> > > So, no more debate from me - I'm taking a leaf out of others books

> > and getting on with acting to preserve my right to practice, which I

> > consider to be under a very real threat that will only get bigger if

> > we don't do something.

> > > And I actually feel very positive about it - in case any of my

> > messages come across as someone who is acting out of fear.

> > >

> > > best wishes

> > >

> > >

> >

> >

> >

> >

> >

>

--

Chenery

Rutland Biodynamics Ltd.

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Hi

To put it simply the large pharmaceuticals such as GSK, Pfizer ,Eli Lily etc.

would find the market size too small to deploy their resources in as even with

herbal licences the products would be similar to generic pharmaceuticals and so

not deliver the same margins as their patented drugs.

Smaller pharmaceuticals such as lichtwer pharma, Boots, AAH etc have had

standardised extract products in this country for years and have always had the

opportunity to market these to GPs yet the GPs have never taken them up in any

significant way. This may be to do with the way GPs are trained in this country

and also the fact that if they prescribe anything which does not have a license

for the specific condition they can be held responsible for side effects etc.

The fact that the wording on the herbal licence is " traditionally used for " does

not actually imply efficacy. Before everyone starts complaining I know that

herbs are effective and but from a legal standpoint it will be easier for GPs to

prescribe pharmaceutical drugs as the manufacturer takes the legal

responsibility for side effects etc NOT the GP.

The history of prescribing in Germany is very different to this country as is

the training of doctors in herbs which is why I think there would have to be a

much larger change in attitude and training of GPs in this country before they

regularly prescribe herbs even as standardised extracts.

Whitton

Sent using BlackBerry® from Orange

Re: The whole Legal point

Thanks for making me laugh in your reply to , !

Sorry, and , if I'm being dense and I've only read your responses

superficially. But I still can't see anything stopping pharmaceutical companies

from gaining large sales of the current best sellers one day to NHS

professionals. In Germany, SJW SE is prescribed more than orthodox medicines by

GPs for mild-moderate depression.

GPs and some hospital consultants sometimes advise their patients to " try

Vitex " , " try Saw palmetto - there's some evidence and it probably won't harm

you " , etc etc. if there are fewer OTC products available to patients, more

motivation for doctors and pharmaceuticals to deal direct in herb-type products.

If I've missed the point could you reply in simple, non-technical terms if

poss!!

Katharine

>

> I have to agree with . My initial point was that Patenting an extraction

technique for a herb is not going to affect others using that herb on its own.

> The problem will face as well as other UK manufacturers is that THMPD

suits the continental manufacturers more than those in the UK. On the continent

most herbal products are in the form of standardised extracts and there are a

number of manufacturers who make between 5 and 30 different products. These

companies can easier afford the licence fees as they have a smaller catalogue.

In the UK herbal manufacturers have upwards of 200 products sometimes running

into the thousands of products which means that gaining individual licences for

all is financially impossible (unless they win the lottery).

> UK herbal manufacturers have always dealt mainly with herbalists as customers

not GPs or pharmacies. This means that there has been a restricted customer base

which runs on small profit margins and so does not have the financial reserves

for large marketting campaigns etc.

> Also when making a standardised extract compliance to GMP is much easier as

large batches of a low number of products is easier to control. The micro

biological control of the finished product is also much easier when your process

uses high temperatures and neat ethanol or acetone.

> This means that UK manufacturers have had much higher costs in compliance than

their continental counterparts and so have not had the opportunity help

herbalists in their campaign for legal recognition of their status in the way

they would probably have liked.

> Personally I think that registration and legal recognition of herbalists is

the only way forward. Once herbalists are legally recognised as a profession

then further campaigns to expand their scope can be more effectively fought.

> Sorry for the rambling

> Whitton

> Sent using BlackBerry® from Orange

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I stand corrected and whole heartedly agree with you. The point I was making

about standardised extract manufacture is that the process is going to destroy

micro biologicals and so the need for testing is lower. Therefore lower quality

raw materials can be used which lower costs compared to yours.

Sent using BlackBerry® from Orange

Re: Re: The whole Legal point

>

> Dear ,

>

> Some GPs already use herbal starting materials, such as tinctures, in

> the same way as herbalists do. A small number of GPs might well be

> called, or think of themselves as 'herbalists' as well. I wouldn't think

> that the market would be sufficiently lucrative to attract the really

> big companies, as says, although there are some smaller companies

> but actually owned by bigger ones that certainly have been in the retail

> (i.e. licensed) market for years. As far as I can gather, the THMD would

> be a good vehicle for marketing standardised extracts, as part of the

> passage to licence is rather precise product pharmaceutical parameters,

> which SEs have by definition. So, you may see more licensed SEs on the

> retail shelf - but then you will see less unlicensed (and currently

> often unqualified) stuff. SE's are closer to pharmaceutical drugs than

> they are to what most UK herbalists think of as 'herbal medicines',

> which are holistic whole plant extracts. Even the " active " in European

> Pharmacopoeia herbal monograph is the " whole herb " and not a

> standardised molecule. So, I would not think this will affect herbalists

> work noticeably, but that's just a personal opinion.

>

>

>

>

>

> >

> >

> > I was talking to a GP about SR today and he wasn't aware of the EU

> > directive (or the consultation). He thought pharmaceuticals might see

> > the lack of OTC herbal remedies from 2011 as an opportunity to market

> > herbal products direct to GPs. Perhaps this is obvious, but it was a

> > shock to me.

> >

> > Would standardised extracts eg of a single herb be patentable, as an

> > SE isn't the whole herb? what if there were more than one herb?

> >

> > Dead cheap for a pharmaceutical company to get licences for SJW and

> > other herbs where evidence already exists with that volume of sales

> > ahead. Easy to set up RCTs too with NHS patients and plenty of money

> > suddenly for research into lesser-known herbs.

> >

> > Could we soon have a scenario like Germany, where GPs would be

> > prescribing some standardized extracts routinely, in favour of

> > orthodox medicine with side effects?

> >

> > Please, someone - ? - reassure me that this scenario won't be

> > possible legally/technically!

> >

> > Without SR, we have no place in the system. No official voice. No

> > corner to fight, as we have no corner but are simply a really very

> > small number (relative to other professions) of disparate individuals.

> > Fewer and fewer rights, more than likely. And invisible.

> >

> > Katharine Locke

> >

> >

> > >

> > >

> > > Thanks for that clarification ri.

> > > It looks to me like you have a positive list of 2 herbs.

> > >

> > > Personally, I think the only real safeguard is to be designated an

> > 'authorised healthcare professional', which is of course what

> > is by virtue of his being a doctor. For herbalists that requires us to

> > have something written on the statute books.

> > > mentioned the 1941 act a little while ago.

> > >

> > > So, no more debate from me - I'm taking a leaf out of others books

> > and getting on with acting to preserve my right to practice, which I

> > consider to be under a very real threat that will only get bigger if

> > we don't do something.

> > > And I actually feel very positive about it - in case any of my

> > messages come across as someone who is acting out of fear.

> > >

> > > best wishes

> > >

> > >

> >

> >

> >

> >

> >

>

--

Chenery

Rutland Biodynamics Ltd.

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Share on other sites

www.surfnetusa.com/.../STANDARDIZED%20edited%203.html

an article about herbs and pharmaeucutical companies from the states

lynn

Re: Re: The whole Legal point

>

> Dear ,

>

> Some GPs already use herbal starting materials, such as tinctures, in

> the same way as herbalists do. A small number of GPs might well be

> called, or think of themselves as 'herbalists' as well. I wouldn't think

> that the market would be sufficiently lucrative to attract the really

> big companies, as says, although there are some smaller companies

> but actually owned by bigger ones that certainly have been in the retail

> (i.e. licensed) market for years. As far as I can gather, the THMD would

> be a good vehicle for marketing standardised extracts, as part of the

> passage to licence is rather precise product pharmaceutical parameters,

> which SEs have by definition. So, you may see more licensed SEs on the

> retail shelf - but then you will see less unlicensed (and currently

> often unqualified) stuff. SE's are closer to pharmaceutical drugs than

> they are to what most UK herbalists think of as 'herbal medicines',

> which are holistic whole plant extracts. Even the " active " in European

> Pharmacopoeia herbal monograph is the " whole herb " and not a

> standardised molecule. So, I would not think this will affect herbalists

> work noticeably, but that's just a personal opinion.

>

>

>

>

>

> >

> >

> > I was talking to a GP about SR today and he wasn't aware of the EU

> > directive (or the consultation). He thought pharmaceuticals might see

> > the lack of OTC herbal remedies from 2011 as an opportunity to market

> > herbal products direct to GPs. Perhaps this is obvious, but it was a

> > shock to me.

> >

> > Would standardised extracts eg of a single herb be patentable, as an

> > SE isn't the whole herb? what if there were more than one herb?

> >

> > Dead cheap for a pharmaceutical company to get licences for SJW and

> > other herbs where evidence already exists with that volume of sales

> > ahead. Easy to set up RCTs too with NHS patients and plenty of money

> > suddenly for research into lesser-known herbs.

> >

> > Could we soon have a scenario like Germany, where GPs would be

> > prescribing some standardized extracts routinely, in favour of

> > orthodox medicine with side effects?

> >

> > Please, someone - ? - reassure me that this scenario won't be

> > possible legally/technically!

> >

> > Without SR, we have no place in the system. No official voice. No

> > corner to fight, as we have no corner but are simply a really very

> > small number (relative to other professions) of disparate individuals.

> > Fewer and fewer rights, more than likely. And invisible.

> >

> > Katharine Locke

> >

> >

> > >

> > >

> > > Thanks for that clarification ri.

> > > It looks to me like you have a positive list of 2 herbs.

> > >

> > > Personally, I think the only real safeguard is to be designated an

> > 'authorised healthcare professional', which is of course what

> > is by virtue of his being a doctor. For herbalists that requires us to

> > have something written on the statute books.

> > > mentioned the 1941 act a little while ago.

> > >

> > > So, no more debate from me - I'm taking a leaf out of others books

> > and getting on with acting to preserve my right to practice, which I

> > consider to be under a very real threat that will only get bigger if

> > we don't do something.

> > > And I actually feel very positive about it - in case any of my

> > messages come across as someone who is acting out of fear.

> > >

> > > best wishes

> > >

> > >

> >

> >

> >

> >

> >

>

--

Chenery

Rutland Biodynamics Ltd.

Link to comment
Share on other sites

Below is an extract from this link:

www.consumerhealth.org/articles/display.cfm?ID

The Codex proposals already exist as law in Norway and Germany where the entire

health food industry has literally been taken over by the drug companies. In

these countries, vitamin C above 200 mg is illegal as is vitamin E above 45 IU,

vitamin B1 over 2.4 mg and so on. Shering-Plough, the Norway pharmaceutical

giant, now controls an echinacea tincture which is being sold there as an over

the counter drug at grossly inflated prices. The same is true of ginkgo and many

other herbs, and only one government controlled pharmacy has the right to import

supplements as medicines which they can sell to health food stores, convenience

stores or pharmacies. The Codex proposals have the backing of Canadian Codex

Commission representatives. Further evidence of Canadian involvement is the

position of the Canadian Health Protection Branch (HPB) on what is, or is not, a

food or a drug. For example, garlic, ginger, licorice and peppermint are

considered to be foods when sold as spices. If a grocery store manager makes

claims for their therapeutic effects, they then become drugs via an HPB

mechanism which remains to be defined.

Stop Codex human rights violations by banding together to demand health freedom

and an end to Codex

Re: The whole Legal point

Thank you for explaining it all. I am truly reassured. It's the

liability bit that makes all the difference.

Katharine

> >

> > I have to agree with . My initial point was that Patenting an

extraction technique for a herb is not going to affect others using that herb on

its own.

> > The problem will face as well as other UK manufacturers is that THMPD

suits the continental manufacturers more than those in the UK. On the continent

most herbal products are in the form of standardised extracts and there are a

number of manufacturers who make between 5 and 30 different products. These

companies can easier afford the licence fees as they have a smaller catalogue.

In the UK herbal manufacturers have upwards of 200 products sometimes running

into the thousands of products which means that gaining individual licences for

all is financially impossible (unless they win the lottery).

> > UK herbal manufacturers have always dealt mainly with herbalists as

customers not GPs or pharmacies. This means that there has been a restricted

customer base which runs on small profit margins and so does not have the

financial reserves for large marketting campaigns etc.

> > Also when making a standardised extract compliance to GMP is much easier

as large batches of a low number of products is easier to control. The micro

biological control of the finished product is also much easier when your process

uses high temperatures and neat ethanol or acetone.

> > This means that UK manufacturers have had much higher costs in compliance

than their continental counterparts and so have not had the opportunity help

herbalists in their campaign for legal recognition of their status in the way

they would probably have liked.

> > Personally I think that registration and legal recognition of herbalists

is the only way forward. Once herbalists are legally recognised as a profession

then further campaigns to expand their scope can be more effectively fought.

> > Sorry for the rambling

> > Whitton

> > Sent using BlackBerry® from Orange

>

>

>

>

>

Link to comment
Share on other sites

Hi ,

I agree in principle with your assertion that herbal medicine is too 'small

beer' for pharmaceutical companies to bother with, but what about the sales of

Hypericum outselling Seroxat by some considerable percentage in Germany a decade

ago?

Caroline

> To: ukherbal-list

> From: peterawhitton@...

> Date: Fri, 30 Oct 2009 12:14:21 +0000

> Subject: Re: Re: The whole Legal point

>

> Hi

>

> To put it simply the large pharmaceuticals such as GSK, Pfizer ,Eli Lily etc.

would find the market size too small to deploy their resources in as even with

herbal licences the products would be similar to generic pharmaceuticals and so

not deliver the same margins as their patented drugs.

>

> Smaller pharmaceuticals such as lichtwer pharma, Boots, AAH etc have had

standardised extract products in this country for years and have always had the

opportunity to market these to GPs yet the GPs have never taken them up in any

significant way. This may be to do with the way GPs are trained in this country

and also the fact that if they prescribe anything which does not have a license

for the specific condition they can be held responsible for side effects etc.

>

> The fact that the wording on the herbal licence is " traditionally used for "

does not actually imply efficacy. Before everyone starts complaining I know that

herbs are effective and but from a legal standpoint it will be easier for GPs to

prescribe pharmaceutical drugs as the manufacturer takes the legal

responsibility for side effects etc NOT the GP.

>

> The history of prescribing in Germany is very different to this country as is

the training of doctors in herbs which is why I think there would have to be a

much larger change in attitude and training of GPs in this country before they

regularly prescribe herbs even as standardised extracts.

>

> Whitton

>

> Sent using BlackBerry® from Orange

>

>

>

> Re: The whole Legal point

>

>

>

> Thanks for making me laugh in your reply to , !

>

>

>

> Sorry, and , if I'm being dense and I've only read your responses

superficially. But I still can't see anything stopping pharmaceutical companies

from gaining large sales of the current best sellers one day to NHS

professionals. In Germany, SJW SE is prescribed more than orthodox medicines by

GPs for mild-moderate depression.

>

>

>

> GPs and some hospital consultants sometimes advise their patients to " try

Vitex " , " try Saw palmetto - there's some evidence and it probably won't harm

you " , etc etc. if there are fewer OTC products available to patients, more

motivation for doctors and pharmaceuticals to deal direct in herb-type products.

>

>

>

> If I've missed the point could you reply in simple, non-technical terms if

poss!!

>

>

>

> Katharine

>

>

>

>

>

> >

>

> > I have to agree with . My initial point was that Patenting an extraction

technique for a herb is not going to affect others using that herb on its own.

>

> > The problem will face as well as other UK manufacturers is that THMPD

suits the continental manufacturers more than those in the UK. On the continent

most herbal products are in the form of standardised extracts and there are a

number of manufacturers who make between 5 and 30 different products. These

companies can easier afford the licence fees as they have a smaller catalogue.

In the UK herbal manufacturers have upwards of 200 products sometimes running

into the thousands of products which means that gaining individual licences for

all is financially impossible (unless they win the lottery).

>

> > UK herbal manufacturers have always dealt mainly with herbalists as

customers not GPs or pharmacies. This means that there has been a restricted

customer base which runs on small profit margins and so does not have the

financial reserves for large marketting campaigns etc.

>

> > Also when making a standardised extract compliance to GMP is much easier as

large batches of a low number of products is easier to control. The micro

biological control of the finished product is also much easier when your process

uses high temperatures and neat ethanol or acetone.

>

> > This means that UK manufacturers have had much higher costs in compliance

than their continental counterparts and so have not had the opportunity help

herbalists in their campaign for legal recognition of their status in the way

they would probably have liked.

>

> > Personally I think that registration and legal recognition of herbalists is

the only way forward. Once herbalists are legally recognised as a profession

then further campaigns to expand their scope can be more effectively fought.

>

> > Sorry for the rambling

>

> > Whitton

>

> > Sent using BlackBerry® from Orange

>

>

>

>

>

>

>

>

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Hi Caroline

The simple glib answer would be that the companies providing these products in

Germany are considered herbal companies in Germany not pharmaceutical.

The considered response is more complex. In Germany the use of herbs in orthodox

medicine has been retained whereas in the UK herbs in orthodox medicine have

been replaced by pharmaceuticals. The reasons for this are also extremely

complex but put simply it was probably the formation of the NHS and the removal

of payment for medicine at point of use that was mainly responsible after 1948.

This is because there was a general attitude in the institution at the time that

" science " and " medicine " would be able to cure everything. It became much easier

for central purchasing to be targeted by pharmaceutical companies who pushed

their patented drugs rather than generic or herbal remedies which although

probably just as effective were not as profitable.

With the thalidomide tragedy the government moved to put liability either onto

the practitioner or the manufacturer where a medicines licence was held.

As traditional herbal medicine as recognised by the THMPD does not allow herbal

medicine licence holders to claim efficacy it is extremely unlikely that a GP

would prescribe it over a pharmaceutical drug where liability would rest with

the manufacturer rather than the GP.

It must be remembered that with seroxat the complications that were blamed on

GSK as the manufacturer were associated with young patients who were not covered

by the MHRA license as the product was licensed for patients over 25. However

GSK were held liable as they did not do enough to prevent its use in patients

outside of the licence.

Personally it would be hypericum all the way for me but not a standardised

extract as I prefer to take whole plants (in my opinion all standardised

extracts should be thought of as akin the pharmaceuticals rather than herbs as

by and large there is very little and often dubious evidence that the " active "

ingredient has the activity of the plant).

Sent using BlackBerry® from Orange

Re: The whole Legal point

>

>

>

> Thanks for making me laugh in your reply to , !

>

>

>

> Sorry, and , if I'm being dense and I've only read your responses

superficially. But I still can't see anything stopping pharmaceutical companies

from gaining large sales of the current best sellers one day to NHS

professionals. In Germany, SJW SE is prescribed more than orthodox medicines by

GPs for mild-moderate depression.

>

>

>

> GPs and some hospital consultants sometimes advise their patients to " try

Vitex " , " try Saw palmetto - there's some evidence and it probably won't harm

you " , etc etc. if there are fewer OTC products available to patients, more

motivation for doctors and pharmaceuticals to deal direct in herb-type products.

>

>

>

> If I've missed the point could you reply in simple, non-technical terms if

poss!!

>

>

>

> Katharine

>

>

>

>

>

> >

>

> > I have to agree with . My initial point was that Patenting an extraction

technique for a herb is not going to affect others using that herb on its own.

>

> > The problem will face as well as other UK manufacturers is that THMPD

suits the continental manufacturers more than those in the UK. On the continent

most herbal products are in the form of standardised extracts and there are a

number of manufacturers who make between 5 and 30 different products. These

companies can easier afford the licence fees as they have a smaller catalogue.

In the UK herbal manufacturers have upwards of 200 products sometimes running

into the thousands of products which means that gaining individual licences for

all is financially impossible (unless they win the lottery).

>

> > UK herbal manufacturers have always dealt mainly with herbalists as

customers not GPs or pharmacies. This means that there has been a restricted

customer base which runs on small profit margins and so does not have the

financial reserves for large marketting campaigns etc.

>

> > Also when making a standardised extract compliance to GMP is much easier as

large batches of a low number of products is easier to control. The micro

biological control of the finished product is also much easier when your process

uses high temperatures and neat ethanol or acetone.

>

> > This means that UK manufacturers have had much higher costs in compliance

than their continental counterparts and so have not had the opportunity help

herbalists in their campaign for legal recognition of their status in the way

they would probably have liked.

>

> > Personally I think that registration and legal recognition of herbalists is

the only way forward. Once herbalists are legally recognised as a profession

then further campaigns to expand their scope can be more effectively fought.

>

> > Sorry for the rambling

>

> > Whitton

>

> > Sent using BlackBerry® from Orange

>

>

>

>

>

>

>

>

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