Remove Red Tape

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.

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?

152 comments on “Medicines: Homeopathic Medicine”

1. C. McLeod on March 23, 2012 at 1:06 pm said:

   Surely, applying the logic(?) of homeopathy, the less regulation that exists, the stronger will be its effects! So scrapping all regulation should have the effect of banning homeopathic remedies completely! ;-)
2. Maria Malan on March 23, 2012 at 12:47 pm said:

   Homoepathic medicine is safe if the rules of Homoeopathic prescribing are followed. In my opinion Homoepathic medicine should also be regarded as safe if used in combination with allopathic medicines and treatment if carefully chosen and prescribed by a registered Homoeopath. Maria Malan, Homoeopath, Johannesburg, South AfricaComment Tags: Homeopathy is safe.
3. Stephanie Field on March 23, 2012 at 12:37 pm said:

   There has, to my knowledge, never beed any problems with the current definition of hoeopathic remedies, nor their marketing to the public. The current legislation has wserved well and does not need to be altered to this much more complicated and restrictive format. If it works, why change it.Comment Tags: If it works, why change it.
4. Richard Paterson on March 19, 2012 at 10:42 pm said:

   All these regulations should be scrapped and homeopathic products regulated in the same way as other medical products, with no further special treatment. Homeopathic products should no longer be permitted to be described as medicines until they pass all the normal tests required for such labeling.
5. Bea Masters on March 19, 2012 at 12:43 pm said:

   Despite the evidenced based arguments, the fact remains that homeopathy remains safe and useful especially for sub-clinical signs and symptoms where western medicine doesn’t have a great deal to offer. I use Arnica on my children for bruises and sprains and one of my children, aged 5 saw a homeopath for bedwetting with successful results, whereas the GP had had told me to come back in 2 years time. I’m sure my positive experience is reflected by other homeopathy users who would definitely not want to see homeopathy further restricted.Comment Tags: popularity
   • Alan Henness on March 19, 2012 at 1:16 pm said:

     Bea Masters said:

     “Despite the evidenced based arguments”

     What would you use instead of ‘evidence-based arguments’?

     “the fact remains that homeopathy remains safe and useful especially for sub-clinical signs and symptoms”

     Is that a fact? How do you know it’s useful for these conditions?

     “I use Arnica on my children for bruises and sprains”

     It is likely that you used a cream that was not a homeopathic product, but actually contained a reasonable amount of arnica – can you confirm this? However, there is no good evidence that even in non-homeopathic doses it is any good for bruises.
6. Joe Blogs on March 16, 2012 at 9:27 pm said:

   there is very little evidence that homeopathy works(Text Deleted) Homeopathy is based on the premise that a compound that at a reasonable dose would produce the symptoms and signs of the ailment when given at very low levels is therapeutic. This is not logical. Eg fever can be caused by infection by bacterial, viruses, and other microorganisms but can also be caused by inflammation unrelated to infection. Clearly the infective causes need treatment with the appropriate antimicrobials if significant but the non-infective causes need to be managed differently
   • Dr Andrew Sikorski on March 17, 2012 at 12:29 am said:

     Incorrect- the homeopathic principle arose from observations on the use of significant material doses and when dilution was used to reduce side-effects there was a scientific observation of the beneficial effect being increased. Digoxin can cause arrythmias as well as being used to treat them; ritalin is an amphetamine (speed) which is used to treat hyperactive children; sleeping tablets can cause hyper-arousal especially in the elderly; consumption of painkillers is a known cause of persistent headaches. These examples demonstrate the homeopathic principle at work in humans.
7. Howard Anderson on March 16, 2012 at 8:42 pm said:

   In the same manner as goods deemed fit for purpose or not under the Sale of Goods Act and similar legislation, Homeopathic Medicines should be classed as unfit for purpose and banned from sale altogether until such time that reliable, repeatable evidence of their efficacy is made available.
   • Benjamin Edom on March 28, 2012 at 10:08 am said:

     A recent Swiss Government report on homeopathic medicine found the treatments were effective and cost-effective in treating illness, and should be reimbursed by the country’s national health insurance program.

     The Swiss Health Technology Assessment, considered one of the most comprehensive reports undertaken by any government to date on homeopathy, includes a review of evidence from randomised double-blind and placebo controlled clinical trials.

     The most pertinent point, in my opinion, is that the SHTA was firmly evidence based and scrupulously impartial whereas the majority of other official reports and perspectives are heavily influenced by mainstream medial opinion, commercial agendas and conflicts of interests so that the design of trials is designed for them to fail.

     Added to this, all the prestigious medial journals in whose hallowed pages researchers’ work gain kudos, refuse to publish any but damning designed-to-fail-reports on homeopathy or any other alternative systems that could, on one hand save the nation billions each year and deprive the present medical industry of the same billions.

     If those who proudly support the “evidence based” model were as objective and impartial as they claim, they would vigorously demand reassessment of all key trials that claim to “prove” the ineffectiveness of homeopathy and insist on properly designed trials as in the Swiss model.

     However, the existing evidence suggests that proponents of “evidence based” medicine are antagonistic to any evidence coming to positive conclusions about any non-mainstream modality; and that is tragically unscientific.Comment Tags: Swiss Government report on homeopathic medicine
8. Evelyn Liddell on March 16, 2012 at 4:20 pm said:

   I think the current situation prevents the public from accessing information on eg homeopathics is detrimental in empowering the patient in their choice of health promotion. Allowing access to traditional use information or allowing indicated uses would assist the patient to become more informed. Gagging such information should not be allowed. Ensuring that the manufacturers are fully licenced pharmaceutical manufacturers ensures standards of quality, gagging detracts from the customer becoming more informed and choosing the most appropriate remedy. Either permit indications or allow ready access to information re traditional use. Do not allow the public to be kept in the dark.Comment Tags: indicated use
   • Alan Henness on March 21, 2012 at 4:03 pm said:

     Evelyn Liddell

     Do you think Big Pharma companies should be allowed to claim what they want for their products? If not, why do you want homeopathic product manufacturers to be able to? Why the double standards?
9. Dr Andrew Sikorski on March 16, 2012 at 3:30 pm said:

   The Dept of Health has just written to all GP’s concerning MoM hip replacements which have been shown to do harm…albeit in a minority of cases. Could it be true the same criteria would be applied to Homeopathy? I remain unsure of the proven harm from Homeopathic treatment within the NHS?

   DoH ref CEM/CMO/2012/07
   Para 6/7

   “We emphasise that decisions on the clinical effectiveness of specific treatments and interventions must take account of a patient’s individual circumstances; that different interventions will provide different levels of benefit depending on the individual; and that the realtive value an individual will receive from a treatment (compared to alternatives or receiving no treatment) is the primary and legitimate consideration.

   For these reasons, we suggest that any decision to restrict access to a particular treatment or intervention must be able to be justified, be based on good evidence and take individual circumstances into account; and that any individual affected must be able to be challenge such decisions through a review process.
10. Dr William R Otto on March 16, 2012 at 1:47 pm said:

    There needs to be a debate about the snake-oil salesmen and women selling homeopathic materials who con people out of much money on the promise of a mysterious ‘cure’ for their affliction. There is not a single molecule of the ‘active’ agent in their preparations, which can by definition have zero clinical effect. They trade on the general lack of knowledge of the public and specifically the placebo effect and all preparations should make this abundantly clear.Comment Tags: medicine labelling, placebo effect
11. Robin on March 16, 2012 at 11:02 am said:

    There is no credible evidence for efficacy. Allowing homeopathic products to be sold as medicines is misleading the public. For a government organisation to collaborate in such misleading behaviour is unacceptable. The regulations need tightening to prevent the British public from being mislead.

    Little extra cost or red tape would be involved, and perhaps many members of the public would not be defrauded by being persuaded to purchase a product currently afforded a credibility it does not deserve.
12. Vincent on March 15, 2012 at 2:03 pm said:

    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
13. Ben Day on March 15, 2012 at 10:10 am said:

    The regulation must be tightened.

    The description of homeopathic products as medicines should be banned. To market homeopathic products as medicines is in violation with advertising standards. For anything to be accepted as a medicinal treatment, it must be subject to rigorous scientific double blind trials performed by independant researchers (i.e. with no vested interest in homeopathy). Homeopathic products have repeatidly been shown to not work any better than a placebo, which is not suprising given they are diluted to the extent that no active substance is left, leaving you with a cup of water or a sugar pill.

    If new cancer/HIV/flu drugs must pass rigorous testing to be accepted as viable treatments, then so should homeopathy.
    • S Judge on March 15, 2012 at 2:14 pm said:

      Hear hear.

      I have no vested interest. However, my thoughts hardened on this when my wife accidentally brought a homoeopathic ‘remedy’ in a chemist (for cholic for our newborn) having assumed it would have some effect (or, specifically, have evidence of some effect) as it was sold by a chemist.

      Fine, sell this as ‘off water’ – it does no particular harm, but don’t sell it as a medicine. It thus falls under existing legislation – i.e. that regulating drugs (if it is evidenced to have an effect) or that regulating foods (if it is off water).
14. Dr Andrew Sikorski on March 15, 2012 at 9:22 am said:

    The Government of Switzerland, having meticulously assessed all the available evidence, has included Homeopathy into their compulsory national insurance based health care service which action speaks volumes.

    There is scientific evidence Homeopathy works which is presented by the Faculty of Homeopathy at: http://www.facultyofhomeopathy.org/research/

    There has been a concerted effort by prejudiced people to remove Homeopathy provision from the NHS on the basis of cost, lack of evidence of benefit and their not being able to rationalise why homeopathy works at all. Paradoxically their aim would have increased the suffering of patients, especially those who have found scant help, if any, from usual medical interventions and actually increased the care costs to the NHS.

    My overwhelming concern is to do right by my suffering patients according to the expectations of those individuals consulting me and the duties of being a doctor which the General Medical Council and Royal College of General Practice expect of their members.

    For the MHRA to cut red tape in these financially tight times is presumably a Health Department dictat. If the MHRA considers their action to be safe I support them.

    Regulation to ensure patient safety is paramount. Homeopathic prescribing appears to be safe and cheap and popular when practiced by responsible, regulated and appropriately indemnified trained professionals.
15. Emlyn Corrin on March 14, 2012 at 5:37 pm said:

    Homeopathy is not medicine and should not be allowed to be sold as such, let alone provided on the NHS.
16. PL Hayes on March 14, 2012 at 4:37 pm said:

    In my view these regulations are ill-conceived and unethical and /must/ be scrapped. They amount to bizarre exemptions from other regulations¹ for a practice which is potentially medically as well as economically harmful. Official complicity in and sanctioning of homeopathy or any other form of quackery is unjustifiable.

    Comment Tags: consumer protection regulations, ethics, trading standards
17. Paul Morgan on March 14, 2012 at 4:26 pm said:

    If anything, regulation of homeopathic products should be tightened. They should not be allowed to be described as medicines – they contain no active ingredient whatsoever. The promoters and vendors of such products should be compelled to be honest about their lack of active ingredients and lack of proven therapeutic efficacy.
    The public should be educated regarding the lack of benefit for homeopathy and the potential harm than can result from using homeopathy in place of real medicine. So-called homeopathic vaccination and malaria prophylaxis are dangerous scams.Comment Tags: science
18. C A Biddle on March 14, 2012 at 11:32 am said:

    Can we first decide that the correct spelling is ‘homoeopathic’.
    Since current ‘science’ accepts a purely chemical rationale to the above, ie., there is no active concentration in a homoeopathic remedy, how can objections as to its so called dangers be well founded. By their own descriptionof it ,it can fail to do damage. Ergo no legistration is required – save red tape, unnecessary costs. There are many ways of inducing subtle changes to delicate equilibria in the animal body and even more in those human and to date the physicists are coming closer to such understandings than those of us like myself who are or were pure chemists.
    There are more than a few countries world wide who have adopted homoeopathic medicine as main stream. Why are we so arrogant in the west as to assume that western science knows it all. Every day the medical/science books are having to be rewritten. I have used in my practice these remedies which if chosen correctly are just short of miraculous and indeed if chosen in hast can be useless – again testamount to their lack of injury or hurt.Comment Tags: chemical, concentration, science
19. Dr Stuart Pearce on March 14, 2012 at 10:19 am said:

    I think the MHRA on the while does a good job, is very necessary, and needs to be reinforced financially and legislatively rather than impoverished (I am a QP!). However, for homeopathic treatments (whose science I am naturally extremely sceptical about but am prepared to admit might have some effects for reasons (scientific but unrealised) not recognised by their pedlars) should be strictly brought into line with the standard licensing systems which hoepfully would save money there.Comment Tags: Homeopathic medicines
20. Richard Taggart on March 13, 2012 at 1:41 am said:

    The National Rules Scheme should be strenghtened to greater protect the public from dangerous practices such as homepathic immunisation and malaria prophylaxis. Whist he National Rules Scheme does not permit this, there should be greater sanctions against those recommending, distributing and promoting homeopathic remedies for this purposeComment Tags: homeopathy, immunisation, malaria prophylaxis