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?
Until recently, the pragmatist principle of ‘letting sleeping dogs lie’ ensured that, without any red tape, certain regulations governing pharmaceutical practice clearly intended for mainstream drugs only were quietly ignored in the case of homeopathic remedies BY THE REGULATOR. This quiet policy has ensured the ready access to homeopathic medicines by the public, safely and for decades.
The safety record of homeopathic medicine speaks for itself: no deaths and no litigation in this country, either within the NHS or in private practice. But sleeping dogs are no longer left alone in the current era – ever-tighter regulation affects all parts of life.
With low-level changes to current regulations (requiring no legislation), the previous status quo can easily be continued – maximising patient choice even where direct access to homeopathic medicines via a specialist pharmacy is not possible (in-person supply from a pharmacist is a key issue in the regulations). The vast majority of the UK’s 5-6 million homeopathy users have no direct access to a specialist homeopathic pharmacy but all users of homeopathic products should be entitled to continued choice and therefore the necessary and well-established modern supply paths such as internet orders.
Ensuring this is easily achieved, without red tape: some of the relevant sections of current regulations need a change of wording to ensure that freedom of choice for UK consumers can be secured.Comment Tags: Consumer Choice, homeopathy, Safety
I work as a homeopath and I am worried that this legislation will restrict the freedom of access to homeopathy & homeopathic remedies for the public. To remove choice from the public in this way when there is no evidence that homeopathic remedies are dangerous (in fact they are both safe & effective) would be a very short sighted move. An introduction of a clause making homeopathic remedies exempt would safeguard this important freedom of choice and ensure that an effective and safe treatment; that works well alongside conventional medicine would provide the . possibility of ‘integrated’ medicine to become the norm for all practitioners and patients. Homeopathic remedies should not be required to ‘re-authorise’ their products as they have been previously covered by existing legislation and there has been no alteration to their method of manufacture or their action, as is the case with the other medicines covered by this legislation. Last year Government debated on Homeopathy and it is still included under the umbrella of the NHS, as such it is vital that legislation should protect the remedies this treatment uses not remove or restrict them in anyway. Advice on labels to consult a qualified homeopath prior to taking the remedy could become a statutory requirement. Consultation between Government & Homeopaths (via their lead body representatives) could result in dissemination of information available to those of the public who choose to use this treatment via affordable courses (free via vouchers for those in receipt of benefits) ensuring that informed usage would negate the need for labelling with indications.Comment Tags: effective, homeopathy, medicine, safe
Aside from some minor legitimate concern for the standardization of homepathy laboratories, there is every reason to not legislate homeopathy. I have yet to hear of any labs sellling bogus remedies. Other than this relatively non-issue, leave homeopathy alone. Big pharma, big money competes by trying to kill the competition. They need to market fear and attack others because they know full well that what they sell is poison to people, animals and the environment. Thus they can do nothing but buy the media and the politicians using lies and more lies to push their nefarious agenda. It is the truth they subvert because they cannot stand up to the reality of their harmComment Tags: big pharma, homeopathy, Legislation
Homeopathy is a non-toxic system of western medical science originated in Germany. A basic principle of solvent chemistry states that a substance will be a solvent to another substance when it has a similar type of molecular bond. Immunology applies the Principle of Similars to activate antibody responses with small doses of a similar substance that will evoke the allergic symptoms.
In 1790, Hahnemann became the first person in the history to test the effect of drug (Cinchona) on healthy human being. First Double-Blind Randomised Placebo Controlled Trial (DBRPCT) was conducted by a homeopath Johann Jacob Reuter. Blood Pressure measuring instrument Sphygmo-graph was invented by a UK homeopath Robert Ellis Dudgeon.
As far as people demand quality multi-dimensional homeopathy health care, governments are obliged to provide. Till 2010, there have been 220 human studies published in 95 peer-reviewed international medical journals including 17 meta-analysis, 2 systematic reviews and 2 Cochrane Reviews in support of homeopathy.Comment Tags: #regulation, government, homeopathy
It is unacceptable that homeopathic treatments are still available in some circumstances on the NHS. They have largely been proven to be completely ineffective and in today’s evidence based medicine NHS, funds should be freed up to pay for treatments that have been scientifically proven to be effective.
Much more has to be done to advertise the differences between homeopathic and herbal medicine. Most members of the public still believe them to be the same thing.Comment Tags: homeopathy
I think that all medicines or products claiming medical benefits, homeopathic or otherwise, should in general (apart from small packs of some essentials) only be sold in pharmacies where people can get balanced advise from trained healthcare staffComment Tags: homeopathy
Some effective regulations for homeopathic remedies, and control over the claims that can be made for them, must be implemented. Otherwise the implication is that anyone can market as a medicine any substance that has no effect, using whatever fanciful claims they wish.
After all, what could be more ridiculous than claiming that a homeopathic remedy called Luna is a medicine that can have an effect. It is made by leaving some sugar in moonlight for a while, then massively diluting it. Other “remedies” sold by homeopathic pharmacies are made from the light of saturn, antimatter, and a range of different colours.
The risks to people who believe this nonsense and so avoid effective health advice and treatment are very real. Of the many known cases of unnecessary suffering and deaths, a couple of examples that have been reported in the press:
In 2009 a couple were convicted in Australia for the manslaughter of their 9-month old daughter, after rejecting effective treatment for her eczema and instead using homeopathy. As a result, she was vulnerable to an infection starting in her eye which caused her much pain, and she died a few days later. Homeopathy is claimed to very effective for eczema. Her father, a homeopath, stated after his conviction that it was better for his daughter to have died than for her life to have been saved by conventional treatment.
In 1993 a couple were convicted in a UK court for the manslaughter of their 9-year old daughter, after rejecting medical advice for urgent treatment of her diabetes and instead using a homeopathic remedy recommended by a prominent homeopath. The homeopath was not prosecuted for his role in this unnecessary death of a young child, and was allowed to continue making money by selling ineffective treatments, and by running a “college” to teach others to do the same.
Homeopaths irresponsibly frighten people into such extreme and dangerous rejection of medical treatment, with exaggerated scare-stories about drug side-effects. Drugs can indeed have side-effects – but these are mostly mild and are generally vastly outweighed by the positive and sometimes life-saving benefits of the treatment. As always in life the benefits need to be balanced against the risks. Or do homeopaths suggest that we all teleport around the country to avoid the risk of having a car accident?
The more extreme fundamentalist homeopaths preach that conventional medical treatments actually harm people. Some even deny the great advances being made in healthcare and the obvious improvements in people’s healthy lifespan over the past couple of centuries. If they had their way and replaced medical treatments with homeopathy, they would unleash a nightmare of suffering and early death.
Operations would have to be carried out without anaesthetic, or stopped altogether. Diabetics would die young. Women would have to give birth without pain relief. Effective treatments for cancers and cardiovascular disease would be abandoned. Asylums would have to be rebuilt for people with serious mental-health problems, withdrawn from their drugs. Victims of accidents would be left to die. Travelling and living abroad would be dangerous, with no vaccinations or treatments for tropical diseases. Polio and other devastating diseases would again spread unchecked.
Homeopaths have repeatedly shown how they are unable to regulate themselves, or to behave responsibly and professionally. Of course, most people have too much common sense and experience of real healthcare to be taken in by their absurd claims, and understand how important effective medical treatment is to our modern lifestyles and expectations.
However, to enable the gullible and vulnerable to make an informed choice, clear information and warning of the risks (based on the scientific evidence) must be mandatory with any homeopathic remedies – in whatever way they are sold or supplied. This must use unambiguous wording to underline that the remedies have no active ingredients and have been shown to have no effect, and to warn of the potentially very serious consequences of using them in place of effective treatment.Comment Tags: homeopathy, risks, scientific evidence, side-effects
It’s not at all clear how this rambling diatribe from William LaChenal relates to the question posed by this web-site – how regulation can be simplified. From his earlier posting, it seems he’s opposed to any suggestion that the current regulations be replaced by a simple requirement to provide clear and accurate information based on scientific evidence, so that the public can make an informed choice.
If two unnecessary deaths of children are not considered too many, more examples of harm caused by using homeopathy in place of effective treatment can readily be found with a quick Google search. Many more are no doubt known to doctors who have to deal with the after-effects, but haven’t been made public.
Like his previous misinformation about the Science and Technology Committee inquiry and other issues, his denial of the harm homeopaths cause by misleading people about their health would only fool someone who didn’t bother to check the real facts.
Unfortunately homeopaths choose to hide and deny the whole issue – rather than taking responsibility for their actions and being open about the scale of the problem. The homeopathic industry seems to have absolutely no mechanism for reporting serious issues relating to their customers, which would allow the full picture to be collated and lessons to be learnt. That’s what professionals would do.
I simply cannot understand why homeopaths are so opposed to any suggestion of simply supplying clear and accurate information with anything sold as a medicine, so that the public are empowered to make their own informed choices.Comment Tags: harm, homeopathy, misinformation, scientific evidence
Some of the comments here show why regulation is needed for homeopathy. Apparently some people want to hark back to pre-Dickensian beliefs about health, ignoring the advances in knowledge and experience of the past 200 years.
As clearly shown by the publicly-available submissions from a range of organisations and individuals to the recent Science and Technology Committee inquiry, the current scientific evidence clearly shows that homeopathic remedies have no effect byond that of a placebo.
The legislation should be simplified to give the MHRA responsibility and powers to ensure that any homeopathic remedy that is sold or supplied by a practitioner should include a data sheet based on the scientific evidence.
This sheet should state that the remedy has no active ingredients; that scientific evidence shows it has no effect beyond that of a placebo; and that taking it in place of effective medical advice and treatment could have serious consequences for a person’s health.
This would make the evidence clear, allowing people to make an informed choice about whether to waste their money and take this risk.Comment Tags: homeopathy, risk, scientific evidence
I don’t understand all the current legislation, however, I have used homeopathic remedies safely and effectively for over 15yrs. Marketing of homeopathic products to the public allows a helpful alternative so people can make informed choices about proactively managing their health. Therefore basic guidelines for use need to be included, however the individual response to remedies can make this of limited use.
Legislation should be directed to safety of manufacture.Comment Tags: homeopathy, informed choice
Why more regulations to protect homeopathic remedies when they have been clinicaly proven for the last 200 plus years to be non toxic and without any side effects? This would be inappropriate, only creating more bureaucracy and increased costsComment Tags: homeopathy
Homeopathic remedies have proven to be safe over the years. Further regulation is unnecessary and would only serve to make such products more expensive reducing public choice and contributing to more beaurocracy.
Traditional manufacture of these products has always proven to be safe and should not have any more red tape as this would be redundant.Comment Tags: homeopathy
There is scientific evidence Homeopathy works which is presented by the Faculty of Homeopathy at: http://www.facultyofhomeopathy.org/research/
Also check out the research pages on the Homeopathic Research Institute www.homeoinst.org
Or, the Society of Homeopaths research pages www.homeopathy-soh.org
Clearly there is a demand by the public for Homeopathy in this country and worldwide. It makes sense that the public should have easy access to Homeopathy as it can and does offer help and support. We should work to provide useful information and let patients make an informed choice. As a Homeopath I work with many GPs and Consultants and most I have found to be supportive of Homeopathy, they all have patients that Homeopathy has worked for, and some even see Homeopaths or use it themselves!
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.Comment Tags: Homeopathic Research Instiute, homeopathy, Society of Homeopaths
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
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
It is not surprising that someone who is implicated in the homeopathic industry would seek to defend and promote that industry. However, this propaganda is typically misleading.
The authors of the Science and Technology Committee report are no doubt well-able to defend themselves. The enduring importance from their inquiry is that when invited to make submissions, the homeopathic industry was unable to provide reliable scientific evidence.
Their submissions ranged from selectively quoting some poor quality studies that support their beliefs, to criticisms of scientific methods (an implicit admission that there is no reliable evidence). They offered no balanced analysis of the full body of scientific evidence available – as this would clearly show that the weak and unreliable studies purporting to show that homeopathic remedies have an effect are vastly outweighed by the strength of evidence that there is no effect beyond placebo.
This is why the report from the inquiry states that “We regret that advocates of homeopathy, including in their submissions to our inquiry, choose to rely on, and promulgate, selective approaches to the treatment of the evidence base as this risks confusing or misleading the public, the media and policy-makers.” Together with the submitted evidence, the report is freely available online for any who are interested.
The suggestion that “the relevant Ministry decided to ignore” the report is more misinformation circulated by the homeopathic industry. In fact the response from the then newly-elected coalition Government states that “We agree with many of the Committee’s conclusions and recommendations”. However, their position is that local NHS and clinicians, rather than Whitehall, should make decisions about treatment for their patients. It will be interesting to see the impact of this as GPs take on more control over commissioning for the NHS.
Again, this response is available online, and can be checked by anyone who doesn’t blindly accept the myths propagated by the homeopathic industry.
The persistent misinformation from that industry, aimed at confusing and misleading the public, shows why some simple and effective legislation and controls on their claims are needed. It is also the reason they resist the suggestion that open, clear, and accurate information should be provided about homeopathic remedies.Comment Tags: government, homeopathy, misinformation