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.
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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. Read More… (opens in a new window)
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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. Read More… (opens in a new window)
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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. Read More… (opens in a new window)
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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. Read More… (opens in a new window)
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Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 1996, SI 1996/482 Amends to set out the fees payable. Read More… (opens in a new window)
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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. Read More… (opens in a new window)
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Tell us what you think should happen to these regulations and why, being specific where possible:
- Should we scrap them altogether?
- Could their purpose be achieved in a non-regulatory way (eg through a voluntary code?) How?
- Could they be reformed, simplified or merged? How?
- Can we reduce their bureaucracy through better implementation? How?
- Can we make their enforcement less burdensome? How?
- Should they be left as they are?
This legislation is useless as it legalises medical fraud.
Medicine is defined as “The science or practice of the diagnosis, treatment, and prevention of disease (in technical use often taken to exclude surgery).
A drug or other preparation used for the treatment or prevention of disease.”
and a Remedy is defined as “A medicine or treatment for a disease or injury.”
Homeopathic pills are neither medicines nor remedies and must not be sold as such.
There is no evidence that homeopathy is able to treat any condition. The UK House Science and Technology Committee analysed evidence from homeopaths and stated unequivocally that there was no support for homeopathic remedies and that homeopathy should be removed from the NHS.
All cochrane systematic reviews state that research into homeopathy has been weak. This has often been of homeopath’s choosing. All good quality research on homeopathy is negative.
Even some poor quality research, with a vastly greater opportunity for false positives, has demonstrated no effect for homeopathy, further demonstrating it’s uselessness.
One of the biggest companies selling homeopathy has been caught on record stating that their is nothing in homeopathy.
For homeopathy to not be fraudulent the evidence would have to support it’s use for a condition, it does not. Only one homeopathic product is allowed to legally be advertised as being used for one self limiting condition in the UK. even this lacks evidence to support it’s use. All other products have been deemed useless, and assessed as unable to treat any condition by the MHRA, therefore they should not be sold as medicines as remedies. To do so is deceitful.
Also to avoid being fraudulent or making false claims then homeopathic products should not list an ingredient which is not included in the product at all as the main ingredient.
Many homeopathic remedies list an ingredient which at best has a one in 100,000,000,000,000,000,000,000,000,000,000 of even a single molecule being present in the remedy. At any rate this is false advertising. Claiming a substance is present in an advertisement when it is not detectably present. This should not be allowed.
The legislation as it currently stands does not ensure homeopathic remedies are tested for safety and efficacy before brought to market. Many homeopathic remedies may be contaminated with heavy metals and actual pharmacological products, however this has not been effectively regulated. Where research has been done the use of homeopathy instead of effective medicines has lead to the worsening of prognosis for that condition, therefore research into the safety of homeopathy must be conducted before being allowed to go to market. Choosing a useless medicine is not safe. Choosing a contaminated medicine is not safe. Choosing a medicine whose ingredients are not clearly stated is unsafe.
If homeopathy wishes to advertise itself as a medicine then it should pass all 5 phases actual medicines pass. At the very least before being brought to market a homeopathic product must pass a large, good quality randomised control trial to demonstrate efficacy for use against a certain condition. If it does not then any claims that the product can be used in any way, whether complimentary, alternatively, integratedly, holistically, psychologically or medically are false and dishonest, therefore is a consumer scam – Unless the labels and all related advertising clearly state that there is no evidence that the product is effective for any condition.
Regulation ensuring homeopathy is not falsely advertised is too loose, only recent have Boots and Holland & Barratts been told to remove their point of sale false claims that homeopathy can treat conditions.
Homeopathic practitioners are also ineffectively regulated, often giving harmful and dangerous advice such as telling parents not to vaccinate and recommending – illegal due to being useless, and known to be a scam – homeopathic products in the place of vaccines and/or lifesaving drugs.
As it stands the regulation on homeopathy does not offer patient or consumer protection.Comment Tags: ASA, fraud, homeopathy, MHRA, scam
No-one of integrity would trust self-interested anecdotes in preference to objective scientific evidence.
This is a general principle in modern society. We wouldn’t want someone convicted in a court on the basis of hearsay evidence from a notoriously unreliable witness, despite strong evidence that they were not involved (such as from DNA tests, CCTV coverage, and a solid alibi).
If stories were collected from homeopaths, these would need to be investigated thoroughly – claims from homeopaths tend to evaporate rapidly once they are checked.
To get the full picture, evidence would also be needed from real doctors and vets about the health problems they have to deal with after effective treatment has been neglected in favour of homeopathy. That would show the real costs of allowing lactose and sucrose to be marketed as medicines.
We need to move forward from 19th century beliefs by freeing the MHRA from regulations that treat sugars as medicines, according to what’s not in them. The MHRA should instead be given a simple responsibility and accountability for making sure that clear and accurate labelling is used, based on the scientific evidence. There can’t be any objection to clear and accurate information for the public – unless there is something to hide.Comment Tags: anecdotes, MHRA, scientific evidence, sugars