Legislation to prevent homeopaths prescribing tinctures

IMPORTANT - PLEASE ACT!

Dear All

I received this email only yesterday.  Despite holding a dispensing license from the MHRA I have not received any paperwork from them regarding such proposed consultation/legislation: they are trying to push it through on the quiet, it seems... Deadline is 30th March, so we need to spread the news fast and act even faster! I have included all the information I received from Jerome Whitney, together with a proposed letter you can send/email to the MHRA.  Email me if it doesn't come up on your email client.

Regards

Eleana

Re: Legislation to prevent homeopaths prescribing tinctures

Posted by: "Alliance of Registered Homeopaths" asrv25@dsl.pipex.com

Sun Feb 18, 2007 8:21 am (PST)

The Spring issue of Homeopathy in Practice, which will be mailed to all of
you in the next few days, carries an article about this in the 'News from
the Chair' section. The consultation closes on 30th March, so do take this
opportunity to respond.

BW Karin

Original Messages follow:

From: ARH-Homeopathy@yahoogroups.com [mailto:ARH-Homeopathy@yahoogroups.com]
On Behalf Of Sabine Depner
Sent: 18 February 2007 11:35
To: ARH-Homeopathy@yahoogroups.com
Subject: [ARH-Hom] Legislation to prevent homeopaths prescribing tinctures

I just received this from a colleague, I think it concerns all of us.

Has anyone heard of / responded to this consultation yet?

Best regards
Sabine

Legislation to prevent homeopaths prescribing tinctures

Dear Colleagues

Re: The Serious Restriction on the Prescribing of Tinctures by
Homeopaths Posed by Proposed Legislation, and the need to respond
before the consultation period which ends on 30th March.

Currently The Medicines and Healthcare products Regulatory Agency
(MHRA) is engaged in a consultation in regard to "Reform of section
12(1) of the Medicines Act 1968.

What is being proposed, that has dire implications for homeopaths, is
that only statutorily registered herbalists will be able to:
a) Formulate and dispense herbal tinctures at their clinics or

B) Send oral or written instructions to a chemist to make up a herbal
tincture for a patient.

Meanwhile, homeopaths would only be able to prescribe tinctures that
are available over the counter, at Boots, etc.

It is imperative that the members of the homeopathic community
respond to the consultation requesting that Homeopathy be exempted
from the terms of the proposed legislation.

There are two additional documents attached to this email:

1) The need for exemption from the revision to 12(1), including
suggested points to include in your letter.

2) A summary report by the Foundation of Integrated Health of the
presentation by MHRA on 25th January regarding the proposed
legislative revision to 12(1).

It is essential that MHRA receive a response from as many individual
homeopaths and homeopathic institutions as possible if the practice
of homeopathy, as we know it, is not to be restricted and undermined
by over protectionist legislative dictate.

Yours sincerely,

Jerome Whitney

Unlicensed herbal remedies made up to meet the needs of individual patients: Reform of Section 12(1) of the Medicines Act 1968.

A summary report by the Foundation of Integrated Health on the presentation by the MHRA Stakeholder event - 25^{th January 2007}

^{1. Introduction}

^{Section 12(1) of the Medicines Act 1968 is commonly referred to as the "herbalist exemption" and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual patient or client following a one to one consultation.}

^{Following an earlier consultation in 2004, the Medicines and Healthcare products Regulatory Agency (MHRA) has published a series of informal discussion documents exploring possible reforms to this section of the Act, and its associated provisions, with the intention of encouraging dialogue with all interested parties. The expectation is that this will lead to further public consultation on these issues.}

^{The MHRA had been concerned about the continuing evidence of risk to the public from unlicensed herbal medicines supplied under section 12(1) where practitioners were not following good professional standards. The MHRA's current assessment was that the single most important measure to achieve adequate levels of public health protection would be if practitioners using section12(1) were identifiable in law and required to be competent and accountable. The most defensible case can be made for providing that, in future, after a period of transitional protection, only those subject to statutory registration should benefit from the section 12(1) exemption. It was recognised that there were difficult arguments of regulatory impact, beyond herbal practitioners to other groups of complementary healthcare practitioners operating under section 12(1).}

^{The Prince's Foundation for Integrated Health facilitated a stakeholder event on 25 January 2007 to enable representatives from organisations across the complementary healthcare sector, and other interested parties, to hear about the proposals first hand from the MHRA and to provided a forum for questions and debate. This report summaries the issues discussed at the meeting.}

^{2. The MHRA discussion documents}

^{Eight informal discussion documents on reforms of section 12(1) of the Medicines Act 1968 have been published by the MHRA and are available from their website. Each discussion document includes a number of questions for consideration.}

^{http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025657&ssTargetNodeId=387}

^{The work on the reform of section 12(1) is taking place alongside the related Department of Health work programme to develop proposals for the statutory regulation of the herbal medicine profession.}

^{A powerpoint presentation from the MHRA, and giving an overview of the proposals, is available on the Foundation's website at www.fih.org.uk.}

^{3. Issues raised}

^{Discussion on issues raised by the MHRA proposals and presentation centred on three main areas: who would be affected by the proposals, the supply of herbal medicines, and arrangements for the consultation process and timetable. Representatives from the MHRA stressed they were at the event to listen to the concerns of those present and that nothing was "set in stone".}

^{3.1 Who will be affected by the proposals?}

^{The proposals as written will restrict the use of section 12(1) to practitioners subject to statutory regulation only. It was envisaged that herbal medicine, traditional Chinese medicine and ayurveda, currently working towards statutory regulation, and led by the Department of Health working group on Acupuncture and Herbal Medicines, would therefore be able to continue to operate under section 12(1). It was stressed that the work on the revision of the Medicines Act 1968, and the regulation of the herbal profession would need to proceed in tandem.}

^{There was evidence that some practitioners in a number of other complementary healthcare professions used section 12(1). Among possible current s12(1) users were some naturopaths and homeopaths and, to a lesser extent, aromatherapists and nutritional therapists (discussion paper two). These professions are all working to establish robust systems of voluntary self-regulation and practitioners were keen to point out that this involves working to codes of ethics, conduct and practice as required of the statutorily regulated professions, and to have professional indemnity insurance. However, the difficulty in defining in law those who are engaged in voluntary self-regulation was acknowledged as, without the same obligation on the practitioner to comply with professional practice, it is not easily captured in legislation. Those present were encouraged to submit suggestions to the MHRA on how this might be achieved. Comment was also made that statutory regulation should not be seen as the panacea since the regulation of professions such as nurses, doctors and others did not prevent the activities of rogue practitioners.}

^{The perceived difficulty that the proposals presented for aromatherapists were discussed in detail. Guidance given by the MHRA is that aromatherapists do not generally operate under Section 12(1), as they do not consider essential oils to be medicinal. A problem exists only where practitioners make medicinal claims in advertising, for example in printed leaflets and on websites. The Aromatherapy Council, the voluntary regulatory body for Aromatherapy, had recently been launched.}

^{The regulatory impact on homeopaths in relation to proposed changes to the Act was also discussed. The Council of Organisations Registering Homeopaths (CORH) had been established to take forward arrangements for voluntary self-regulation and was in the process of establishing a single register for the profession. However, as this was on a voluntary basis, homeopaths would fall outside the proposed revisions to section 12(1). This would create difficulties for homeopathic practitioners in relation to the use of tinctures which are important for homeopathic purposes. As the proposals currently stand, homeopaths would not be able to commission unlicensed herbal remedies, for example a mixture of tinctures, from a third party. They would be able to refer to an herbal practitioner to prescribe. Alternatively, registration of the combination would be required so that it was available over the counter to members of the public. An increasingly wide range of herbal medicines made to assured standards would become available via the herbal medicines registration scheme. The MHRA indicated they wished to receive information from the homeopathic profession about the overlap of practice with the herbal profession.}

^{Concern was expressed that other statutory regulated practitioners of allopathic medicine were currently able to prescribe herbal medicine without having undertaken the necessary training, or having the necessary experience. This posed its own risks to the public. It was noted that this issue would need to be considered as part of the new arrangements for a statutory register of herbal practitioners and those present from the Acupuncture and Herbal Medicines Working Party were asked to take this back to the group.}

^{3.2 The supply of herbal medicines}

^{Proposals included the development of an herbal formulary (discussion paper three) by the profession to identify the herbal ingredients that have an acceptable and safe place in the practice of herbal medicine. It was noted that a range of books and directories of herbal ingredients already exist, which would prove to be a useful resource in the development of a formulary.}

^{In response to an enquiry about commissioning herbal medicines from abroad, the MHRA highlighted the possibility of extending the current pre-notification of imports scheme that operates for allopathic medicine, to herbal medicine. Steps to prevent the importation of unlicensed herbal medicines were the responsibility of the MHRA enforcement team. Discussion paper six includes proposals on the licensing requirements that would apply to manufacturers, importers and wholesale dealers. It was acknowledged that this was a big area of challenge to ensure product quality. The need to be aware of conservation issues in relation to the import of herbal remedies was also noted. The possibility that section 12(1) could be extended to other non-herbal ingredients was discussed and the professions were invited to put forward proposals and suggestions.}

^{The MHRA had established an independent expert advisory committee, the Herbal Medicines Advisory Committee, to give specialist advice to the Agency in relation to herbal medicines.}

^{It was noted that shop assistants are currently able to give advice to the public on the purchase of over the counter herbal remedies (which include with clear information at point of purchase) and that it was not envisaged that this would change.}

^{3.3 The timetable and process}

^{The exact timetable for the review process and legislative changes is not yet known. The MHRA expressed a desire to see changes in place by 2011 to coincide with changes in European Law and to give time for the work to be taken forward in the context of the statutory regulation of the herbal profession in the UK. Close liaison with the Department of Health on this issue would be necessary. The key next step was seen as the publication of proposals on the statutory regulation of herbal medicine.}

^{4. Consultation deadline and how to comment}

^{The informal discussion documents are open for consultation until 30 March 2007. Each consultation document contains a number of questions for consideration. Comments should be sent to:}

^{Caroline Brennan}

^MHRA

^{Market Towers}

^{Nine Elms Lane}

^London

^{SW8 5NQ}

^{email: caroline.brennan@mhra.gsi.gov.uk}

^{Why Homeopaths Need to Request Exemption}

^{from the MHRA Proposals to Revise the Medicines Act}

^{This document consist of 3 sections:}

^{1) Background}

^{2) Where to respond to the MHRA consultation}

^{3) Suggested points to include in your response}

^{Currently the Medicines and Healthcare products Regulatory Agency (MHRA) is engaged in a consultation process in regard to reform of Section 12(1) of the Medicines Act 1968. The proposed reform has the effect of removing the freedom to prescribe and dispense herbal and mother tinctures as traditionally provided under common law.}

^{What is being proposed is that only statutorily registered herbalists will be able to}

^{a) Formulate and dispense herbal tinctures at their clinics or}

^{B) Send oral or written instructions to a chemist to make up a herbal tincture for a patient.}

^{All others (I.e. non registered herbalists) will only be able to prescribe or dispense licensed herbal tinctures that are currently available in the over the counter market (I.e. Boots, etc). Homeopaths would not be able to prescribe unlicensed herbal tinctures from even a licensed homeopathic chemist.}

^{Unless the MHRA writes an exemption for homeopathy into the legislation that will be submitted to parliament following the consultation:}

^{Homeopaths will no longer be able prescribe Mother Tinctures.}

^{As you well know homeopathy regularly utilizes the complete range of remedies from mother tincture up to extreme levels of potency (serial dilution). Without tinctures the whole traditional practice of homeopathy will be undermined.}

^{The MHRA consultation period ends on 30th March 2007. The MHRA has posted a series of documents on the following web site: http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2025657&ssTargetNodeId=387}

^{There are eight papers at the above site all relating to the proposed revisions. Why is the MHRA taking such a hard stand and making proposals that will have a major effect on a number of Complementary Therapies? Page 3 of document 5 provides a clue: ÒThe MHRA is aware of reports of some practitioners unable to communicate effectively with patients on account of language difficulties. In other cases practitioners have sourced adulterated products from unreliable sources}

^{Make your response known!}

^{Comments on the MHRA discussion papers regarding revision of section 12(1) should be sent to:}

^{Caroline Brennan}

^{MHRA Market Towers}

^{Nine Elms Lane}

^{London SW8 5NQ}

^{email: caroline.brennan@mhra.gsi.gov.uk}

^{Suggested points to include in your request for exemption to MHRA}

^{It is important, in your email or letter requesting exemption for homeopathy from the proposed revision of section 12(1) to include some of the following facts in the text of your response to MHRA:}

^{*The proposed reform undermines the whole traditional practice of homeopathy by using a blanket means to enforce standards.}

^{* The use of herbal tinctures is an integral part of the homeopathic pharmacopoeia and practice.}

^{*Homeopathy is based on individual (extemporaneously) prescribed remedies so that many prescriptions are individually created for a specific set of patient symptoms.}

^{* If homeopathy is to maintain the integrity and effectiveness which has been established during its 200 year tradition, then the continued right to consult, prescribe, formulate, and procure homeopathic remedies and tinctures for our patients from homeopathic chemists is essential.}