Medicines: Homeopathic Medicine

These regulations affect companies who wish to market homeopathic medicines. There are currently three schemes in the regulations that apply to homeopathic medicines. Product Licences of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented (in 1971). Homeopathic products covered by PLRs may have indications. The Simplified Registration Scheme was introduced in 1992. Products registered under this scheme have been shown to meet safety and quality requirements but are not permitted to be labelled with indications.

A National Rules Scheme allowing homeopathic products to be indicated for the relief or treatment of minor, self-limiting conditions was introduced in September 2006. PLR holders are encouraged to re-authorise their products under the National Rules Scheme, which provides a more secure regulatory position.

We want to hear your views on what more we can do to deliver a simpler, less bureaucratic and more effective system, increase choice and opportunity, and maintain necessary safeguards and legal protections. You can find the regulations that relate to Homeopathic Medicines to the left below.

Please note that some regulations in the medicines section also apply to homeopathic medicines.

Medicines for Human Use (National Rules for Homoeopathic Products) Regulations 2006, SI 2006/1952

Amends the Medicines for Human Use (Marketing Authorisations) Regulations 1994, to introduce a new scheme for homoeopathic products. A definition of a “national homoeopathic product” is given and specific rules for marketing authorisation applications for such products are introduced.

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EU regulation

Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1994, SI 1994/899

Amends the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994. Measures include criteria for determining whether a product is sufficiently dilute to guarantee its safety.

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EU regulation

Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005, SI 2005/2753

Amends the regulations which implement the EU legislation relating to registration of homoeopathic medicinal products for human use that may be placed on the market in the United Kingdom. It implements the provisions relating to the grant, suspension and revocation of certificates of registration and the obligations of certificate of registration holders.

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EU regulation

Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994, SI 1994/105

Implements provisions on medicinal products and homeopathic medicinal products. In particular they bring into operation for homeopathic medicinal products for human use a simplified registration procedure.

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EU regulation

Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996, SI 1996/482

Amends to set out the fees payable.

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EU regulation

Medicines (Labelling and Leaflets) Amendment Regulations 1994, SI 1994/104

These regulations impact upon medicines consolidation and patient information exempting homeopathic medicines from certain labelling regulations applied to other types of medicines, providing definitions of certificates of registration and homeopathic medicines and defining the requirements for leaflets provided with homeopathic medicines.

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 UK regulation

Tell us what you think should happen to these regulations and why, being specific where possible:

152 comments on “Medicines: Homeopathic Medicine

  1. William LaChenal on said:

    I write as a user of homeopathy who has personally benefited from homeopathy (in respect of difficult & “incurable” conditions), and who has cured others of long-standing difficult & “incurable” conditions by using homeopathy.

    Some generalities & some specifics.

    First one must ask, why is legislation, regulation required?

    If it is simply to ensure the supremacy of the profit-based pharmaceutical model of herd-treatment, there is no point in further discussion, except to say that such an approach would be profoundly wrong, and expensive.

    If it is to indulge the prejudices, however justified, of opponents of homeopathy, that again would be wrong & counter to the benefit of many patients, taxpayers, voters.

    If it is to ensure public safety from harm caused directly by homeopathic remedies, I know of no evidence (or anecdote) where a genuine homeopathic remedy has directly harmed anyone (though I am sure it is possible to mis-use homeopathy).
    It’s always a clever trick to take peoples’ freedoms away, to offer them some temporary safety. Don’t do it, it’s wrong.

    There is a fantasy in the minds of various prominent skeptical opponents of homeopathy (some of whom have been busily inventing novel ethical rules to suit their own case) that it may do indirect harm by encouraging non-compliance with their favoured conventional modalities. This view has little merit.

    Broadly speaking, I do not see the manufacture or sale of homeopathic remedies as being in need of anything but light regulation ensuring quality – that a remedy is properly homeopathically prepared as stated, in sufficiently clean conditions, with no adulterations.
    After that, I would prefer it to be up to the user how they take care of their own health, not prescriptive government.

    I see any recommendation for re-registration as completely unnecessary & expensive (both for the “industry” & for regulators), as well as being a minefield for possible refusals of accepted remedies.

    It would be illiberal to impose a regime which might result in any de facto ban on homeopathy, however much its self-interested & influential rivals might wish for that outcome. It would also be harmful to health of many users of homeopathy.

    Promulgation of advice about homeopathy (including advertising) should not be subject to censorship; people can do their own information-gathering & make their own decisions.
    In the interests of general education, perhaps there should be a provision for collecting & publishing relative figures for adverse effects & deaths (and cost/benefit ratios) between homeopathy & the usual pharmaceutical approach.

    Clearly, if one sides with the premiss of the skeptic movement that homeopathic preparations are inactive, there is no need for regulation whatsoever. Indications of effectiveness should be taken on a caveat emptor (or user beware) basis, as always.

    It is important to expose & dismiss the decision of the Parliamentary Scientific & Technical Committee on the lack of evidential base for homeopathy. The committee was highly biased, and the report was accepted by a minority vote, consisting of one opponent of the homeopathic method, steeped in the rival pharmaceutical approach, and packed with two more who were co-opted after the hearing of evidence. These out-voted an honest committee member who opposed the report. All other committee members who had heard the evidence decided to abstain. The relevant Ministry decided to ignore this biased sham. Why the Committee is not considered in contempt of Parliament is beyond me.
    The pseudo-scientific views of the highly vocal skeptical grouping (many of which have been voiced here), seem to be qualified as “if it supports homeopathy, it isn’t evidence”.
    Real phenomena do not necessarily elect to follow such petty rules.
    Their view is therefore faintly ridiculous in the light of thousands upon thousands of successful cures achieved by homeopathic physicians, the personal experience of thousand upon thousand of users, and a body of experimental results which demolish their favoured hypotheses. Their views are biased towards falsehoods which happen to support their rival medical business approach, and should be discounted.

    As regards labelling, a clear & accurate description of contents would be appropriate. For these purposes, a “homeopathic preparation” should mean just that. The process of dilution & succussion is well-defined. The decimal dilutions, though normally adopted, are not a strictly necessary and should not be insisted upon.

    If a preparation contains significant material ingredients, equivalent to herbal or supplemental substances, it may be as well to say so. Some of these do fall within homeopathy in general.

    Similarly, if the entire remedy is diluted beyond Avogadro’s hypothetical limit (but properly succussed along the way), it would do no harm to state that.
    That is to say, if a preparation is solely an “energetic” remedy with the likelihood of none of the base substance remains (according to the hypothesis of Avogadro concerning perfect gases, as extended), there can be no point in regulating it as for material doses.
    This applies whatever the original base substance, whether it be an established materia medica item or not. This is important for the continued expansion of the field, as many new remedies continue to be added in response to modern conditions.

    Note: where the base substance is potentially infectious, it is important that not enough remains to be dangerous. Quality can be ascertained by following correct methods of dilution, and by testing finished batches of diluted remedy for remaining pathogen. It would be wrong to prohibit the use of live pathogens as base substances, since this would change the nature of the remedy.

    Adulteration of a preparation in a way which is likely to cause harm, or deliberate mis-labelling, should meet the strictest penalties.

    Indications for homeopathic remedies generally apply much more to an individual than to a condition. This is in contrast to the habit of pharmaceutical chemists.
    A wording based on accepted homeopathic materia medica (or other sufficient experience), that a remedy is commonly indicated for a particular condition or set of conditions or type of individual should be allowable, in the context of the homeopathic approach.
    This is not the same as proving safety & efficacy by RCT, which can only be claimed where it is so, and which is inappropriate for individualised approaches. (The classical RCT works by discounting the nature of the individual.)

    I would recommend a slight re-wording of the usual advice about consultations, along the lines of:
    “Unlike conventional medicine, adverse affects are practically unknown for homeopathic remedies.
    It is recommended that you consult a homeopathic physician to arrive at the best prescription for your treatment.
    You should tell you GP that you are taking this homeopathic remedy, because doses of conventional medications may become unnecessary & dangerous as you recover your health.”

    Finally, an olive branch to the skeptics who want equivalent treatment for all methods of medicine; I have sympathy for this view.
    There should be a level field between unconventional & pharmaceutical profit-based medicine. Conventional medicine should be held to the same standards of low incidence of adverse effects, and low costs, and it should be made much more clear which of these approaches is likely to be more harmful to individual personal health and the applied wealth of the NHS.Comment Tags: bias, ethics, harm, health freedom, homeopathy works, Parliamentary Scientific & Technical Committee, personal, pseudo-science, public expense, public safety, skeptic, why legislate?

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