EGM & SR

[Guest guest]

I write to you as a member of NIMH who is very concerned about this

EGM, the manner it has been arranged, and the motion to vote to

pursue Statutory Regulation (SR). There is no urgency to go ahead and

vote for this now considering the three month long public

consultation has not even started and I wonder why Council is trying

to push through with this so quickly. I believe our herbal traditions

and our livelihood are under threat. I am aware that not everyone

has been politically active nor kept up with what is happening but

even if this is the case I urge you to read this. I know that the

complexity of the situation makes it hard to understand.

Council has issued members with a 13 page document of inaccurate and

misleading statements presumably to ensure as far as possible that

members vote to give Council a mandate to pursue SR. We were informed

of the EGM and motions at the last possible moment it could be

legally done; i.e. three weeks before the EGM leaving insufficient

time to counter their statements and with no easy access to all the

membership.

I would say the majority of members do not understand the possible

implications of SR; in truth no one does at this time because we are

not in possession of all the facts. Many members are completely lost

as to the whole process. No proper members' consultation has been

held, the full facts have not been given, many questions have been

asked but have not been answered, information has been withheld, the

pros and cons of regulation have not been presented or discussed in a

balanced manner. How can members make an informed choice at this

time?

SOME QUESTIONS THAT NEED TO BE ANSWERED BEFORE WE AGREE TO

STATUTORY REGULATION (SR)

What form will Statutory Regulation take when and if it happens?

Despite Councils' detailed explanations and reassurances as to what

will happen and the benefits of SR, it needs to be pointed out that

in actuality what Council has presented as facts are most definitely

not. The Steering Group (SG) report on which they base their `facts'

is nothing more than a proposal to present to the Dept of Health

(DH). They have no idea what will happen in the future in respect to

SR; whether it will take place, or the form it will take if it does.

It is now commonly rumoured amongst `those in the know' that SR will

now not happen. This comes from DoH and Woodfield of the

MHRA - the government has changed its policy and is not likely to

regulate herbalist (or other CAM practitioners). Yet Council has not

made an official statement on this, and has not told the membership

but holds an EGM asking for a mandate from members to pursue SR

without informing members of the situation. Given that it would seem

that the government is now unlikely to regulate us, or at the very

least is not happy with the idea, I think we can suppose that the

government is not happy with the SG proposal in its current form and

therefore if regulation does occur it will not be in the form the SG

has proposed and in the form that Council has presented! Given the

uncertainty of regulation why is Council pursuing this now and

without first verifying the situation and telling members?

Therefore, how can we possibly vote to go ahead with SR now when we

do not know what we are agreeing to and effectively giving EHPTA,

Council & the DoH etc a carte blanche to do as they want? Will we be

taken into an increasingly tighter corner that we have difficulty

getting out of and some sort of `regulatory' set-up we never dreamed

of? We need to know what form regulation will take, if it will take

place, (and until the public consultation has taken place we won't

know) before we vote for it.

I would therefore strongly recommend that members vote against this

motion for SR until they know what they are voting for.

Will the 1968 Medicines Act be changed should regulation of

herbalists not happen? It might a strange question to insist on an

answer to in a motion concerning voting for regulation. However, if

we vote for SR in this motion we are in affect also voting and

demonstrating our agreement for changes to take place in the 1968

Medicines Act under which we practice. Should these changes to the

1968 Medicines Act take place and regulation does not happen we will

in affect be banned from practicing! As it would appear that

regulation is unlikely to happen why are we being asked to vote now

for SR before this is clarified?! Even if regulation does take place

we still need to know what changes to the Medicines Act will take

place.

Following a letter put out by Philip on these very concerns

McIntyre countered this saying no changes would happen `to

the scope' of the Medicines Act but close questioning as to what he

actually meant has not got an answer; the same questions posed to

Woodfield of the Medicines and Healthcare products Regulatory

Agency (MHRA) have also not been answered. Presumably, if they are

not prepared to say that no changes will take place to the Medicines

Act if SR does not happen, must mean that some sort of change is

being considered if so what? It is our livelihoods that could be at

stake here, we need to know exactly what is going to happen in

respect to the Medicines Act should regulation not happen (or happen)

before we agree to anything and this is a perfectly reasonable

request.

I therefore strongly recommend that members vote against the motion

for SR until we are assured that the Medicines Act will remain

unchanged if SR does not happen and the form it will take if it does.

Will herbalists be able to continue making their own medicines? We

have been assured time and again that herbalists will be allowed to

continue to make their own medicines. However, we have also been told

that we will need to adhere to Good Manufacturing Practice (GMP)

which is currently under discussion. Council has been asked what this

might entail but we have not been told. Will the required GMP

procedures be something that a herbalist will realistically be able

to do and will it be affordable? Pharmacognosy has been mentioned.

What will be required of us in order to verify our plants and

medicines; a microscope and a gas chromatography machine costing

thousands? Or will we be required to send a sample to a laboratory?

Will we need to do training, if so what, how long, and what cost? In

theory we might be able to make or own medicines but in practice will

we be able to do so?

We need this information before we give any mandate to Council to

pursue SR.

What is going to happen to Schedule III list of herbs in the event of

regulation going ahead or even regulation not happening? There has

been talk of having an expanded Schedule III list alongside

regulation, which comes under the Medicines Act. Schedule III herbs

will be restricted to regulated practitioners only. Council has been

asked for information on this but no information has been given.

Schedule III herbs will not be available to those herbalists who do

not join the register. Nor will Schedule III herbs be available to

the general public. If there is the intention to have an expanded

Schedule III list we need to know the details of what is being

considered and the herbs that would go on it before we vote for this

motion as we might not agree and it might later be imposed on us. An

expanded Schedule III list might severely restrict the general

public's ability to access herbs; and would also severely restrict

ourselves as herbalists should changes be made to the Medicines Act

and we are then not regulated; leaving only doctors & pharmacists

access to the list.

As such we need to know what is going to happen in this respect

before we make a choice and vote to give Council a mandate on SR.

European Directive (THMPD)

Whilst on the subject of medicines I would like to clarify something

to the members. In Council's document it states that " Medicines

legislation in the European Union is dealt with under the First

pillar of the European Union… (which) …uses directives which are

signed up to by all MS's (Member States) and must under a time frame

be transposed into national law of each MS and in accordance with

each MS's legislative system. There are therefore no opt-out or

different speed possibilities from this directive in the UK. "

Daunting stuff! Fortunately it is not true.

An EU Directive cannot be imposed on a MS even though the objective

may be binding. It only aims to harmonise legislation. But if a

tradition is going to be wiped out by a directive the MS cannot be

expected to implement the directive. We therefore are able to opt out

of this directive and instead of pursuing it, we should have been

opposed a long time ago!

I, personally, am opposed to regulation for many reasons; maybe you

are not. However, whatever your views, I strongly recommend that

members vote against this motion to pursue SR until they are in

possession of all the facts and know what they are voting for. Nor do

I consider it a good time to extend the period between AGM's.

Yours,

Verge

If you cannot go to the EGM then please vote via proxy through

another member; I would be happy to take your vote in so feel free to

email me if you would like this. Email:

herbal.traditions@...