Malleus Homeopathicum

Are Homeopathic Medicines Safe? Part 3

2012-11-15T13:05:00.000-08:00

Something different this time and an example of the MHRA acting.

Homeopathic hCG
This is a long and complex story. By and large it is a story of unscrupulous manufacturers and internet entrepreneurs sensing a quick buck to be made. It is a story of a weight-loss protocol that has considerable risks.

The HCG Diet
In essence, a British endocrinologist A.T.W. Simeons believed that he had discovered that the combination of a Very Low Calorie Diet (VLCD) combined with injections of human chorionic gonadotrophin (hCG) resulted in selective weight loss of fat without the loss of lean tissue. The diet has enjoyed periods of popularity in the US but there is no compelling evidence that hCG has any effect on weight-loss.

hCG is a hormone. It is licensed as a prescription only medicine (POM) for use in the treatment of female infertility but not for weight-loss. Certainly, the HCG Diet would be very difficult to do in the UK.

It is worth noting that many proponents of the HCG Diet allege that there is a conspiracy to suppress the evidence that the diet works in the way described. It is possible that this conspiracy theory makes the HCG Diet more attractive to some. The proponents of the diet also make some extraordinary claims.

Very Low Calorie Diets
The definition of a VLCD varies. You may also see them described as "crash diets" or even "starvation diets".

The adverse effects of a VLCD are generally minor although death can occur. Some of these deaths have been linked to drinking too much water causing electrolyte imbalance and heart failure.

Typically, homeopathic hCG products are supplied with a diet plan of 500 calories a day and that plan is not nutritionally balanced. The plans sometimes suggest consuming vast amounts of water, the use of laxatives . The fact that VLCDs are not recommended for those with a BMI of less that 30 is generally not mentioned. That they are only recommended where the risks associated with obesity outweigh the risks associated with rapid weight lost is not mentioned. Nor the need to see a medical professional before contemplating such a diet.

The Double Deception
The hCG diet involves injections of hCG. The homeopathic version generally involves the use of oral drops that contain absolutely no hCG whatsoever. They are combinations of dilutions of hCG at various strengths - none of which contain measurable amounts of hCG.

Considering that hCG has no effect on weight-loss, it could be argued that when vendors claim that their homeopathic hCG products have the same effect as injected hCG they are telling the truth. However, the claims made for the products are identical to those made for "real" hCG. The sort of claims that are made are -

Quickly reduce difficult body fat areas around the stomach and hips.
Re-sculpts the body loosing inches as well as reducing weight.
Resets the body to a normal metabolic functioning.
No unsightly loose skin left in areas where reduction has taken place.
A feeling of well being during the treatment with no hunger.

Weight-loss of up to 7 lbs a week is sometimes claimed. More troubling are the frequent claims that weight-loss is permanent.

I've not seen a justification of the homeopathic products having the same purported action as hCG. It seems inconsistent with any model of homeopathic use that I am familiar with. Most homeopaths would stress the importance of individualised treatment - the claims made for the products suggest that someone has discovered the genus epidemicus of obesity!

However, the idea that homeopathic hCG is somehow to the hormone is not unique. It has cropped up before with secretin - some homeopaths had picked on the concept that secretin could be used to treat autism (which there is no evidence for).

Surely Just a US Thing?
Although the US is the heartland of homeopathic hCG, it has shown up in the UK. In fact, at one point Helios Homeopathy manufactured the product and sold it. The price of these products varies but they often cost considerably more than any other homeopathic medicine despite the fact that the cost of manufacture is going to be roughly the same. Although most vendors seemed to sell just the product and provide a link to the book that Simeons wrote, some offered more (and some still do but with a replacement product). But what they offer is certainly not medical supervision.

Most of the products for sale in the UK were illegally imported into the UK by individuals and small business. It is difficult to tell whether any of them acted as a wholesaler, supplying other UK vendors.

Despite much research, it has not be possible to determine who first suggested the use of homeopathic hCG but there are some obvious suspects.

Regulators Act
This statement on the MHRA website only tells part of the story.

It has been brought to the MHRA's attention that there are a number of websites promoting and/or selling a product containing a homeopathic dilution of hCG (human chorionic gonadotrophin) as an aid to help promote weight loss. Homeopathic hCG is not authorised or registered for use in the UK and it is an unlicensed medicine. The promotion and/or sale of unlicensed medicines is not permitted.

The quality and safety of unlicensed medicines have not been assessed by the MHRA and it is recommended that consumers do not purchase unlicensed homeopathic medicines, including homeopathic hCG in the UK.

Homeopathic hCG has almost completely disappeared from the UK market. The only websites selling it are actually US websites masquerading as UK-based. Action was taken against vendors - not just by the MHRA but also Trading Standards. The statement is also very clear on the status of unregistered homeopathic medicines.

Unfortunately, due to the nature of how the MHRA et al work, they do not always reveal that they have acted, nor the extent of their actions. It is known that are least one vendor was forced to write to all their customers warning of the dangers of the diet and also to refund all their money.

This ASA adjudication makes for very interesting reading as well.

Of course, the fact that regulators have acted is obviously part of a grand conspiracy. It was not just regulators that acted. eBay removed all listings as did Amazon. Paypal suspended accounts associated with vendors of the public.

The Triple Deception
Because of the action of regulators, some companies have moved away from using hCG in their homeopathic hCG products. What is used instead varies. Some companies are using combinations of amino acids, some are using radionics and some are using gem essences and they will often still use hCG in the product title and description. The same claims are made.

Unsurprisingly, homeopathic leptin is also making an appearance in the US although I have not seen

No Different?
Arguably, the sale of homeopathic hCG is no different from the sale of many of the other magic slimming pills out there such as the Acai berry capsules. But there is a significant difference in that homeopathic medicines are regulated and so are the homeopathic manufacturers, whereas a product such as Acai berry extract is not treated as a medicine. Very different regulations and different regulators.

Supporters of homeopathy often seem to have a blind spot when it comes to the activities of manufacturers. They can and sometimes do behave as badly as Big Pharma. They are businesses, not charitable foundations. Yet you will rarely, if ever, see a homeopath criticise them. Given this, it's not surprising that I've failed to come across any homeopath criticising homeopathic hCG. You'd think that homeopathy being linked to a scam would not play very well.

What the homeopathic pharmacies did not tell you

2012-08-08T15:52:00.003-07:00

I wrote about the implications of legislation and regulation for the homeopathic pharmacies a while ago. Considerably more information has come to light.

Homeopaths offer to rebrand products as 'confectionery'
This blogpost on the Guardian website is very interesting. A voluntary reclassification of homeopathic medicines as food productions is not a new idea and one I touch on here. The idea has been kicking about for well over a year in some circles.

The most interesting part of this is that the Freedom of Information Act disclosure reveals that the Medicines and Healthcare products Regulatory Agency (MHRA) did instruct the homeopathic pharmacies to amend their websites as a result of this guidance document which was issued in February 2011. Note that the guidance document is a result of consultation and it reflects the MHRA's understanding of the law regarding medicines advertising.

From an MHRA letter to Helios dated 07 March 2011

We request that you review you website and any other materials against the attached guidelines and make any changes necessary to ensure compliance.

Please acknowledge receipt of this letter and provide a response with details of any steps being taken to amend your website to comply with the attached guidance for our review by 21 March 2011. Please let me know if your require and furthe information.

A virtually identical letter was presumably sent to other "industry stakeholders". The implication is that the homeopathic pharmacies were well aware of the legal situation regarding advertising prior to February 2011. Compliance was requested in March 2011.

Supply
Yes, just advertising. What the MHRA guidance fails to make very explicitly clear in terms that even Pollyanna would understand is that it is not just a question of advertising unregistered homeopathic medicines being illegal, the supply is also illegal.

Complaints to the MHRA about Helios and Ainsworths were raised in August 2011. These complaints related primarily to remedy kits. As a result, on the 5th September 2011 the MHRA instructed both Helios and Ainsworths that that remedy kits containing unregistered homeopathic medicines must be removed from the market. They also stated that both were in breach of the Medicines Regulations - in particular the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994.

Hang on...
Referring back to the letter that was sent out by various homeopathic organisations, including Ainsworths and Helios back in May 2012, there seems to be a disconnect.

It is clear that both Ainsworths and Helios had been made very aware of Medicines Regulations and that the promotion and supply of unregistered homeopathic medicines is illegal. Yet there is this whole notion of the consolidation of the Medicines Act suddenly making it illegal.

And as Karin Mont says, the homeopathic trade associations and the homeopathic pharmacies had been working together to "secure patients' ongoing access to quality homeopathy".

The newsletter from H:MC21 I discuss here raises all sorts of questions. It is possible that H:M21 are not regarded as a key stakeholder in UK homeopathy - which would be odd. The newsletter is dated 22 June 2012. I'll quote the key paragraph again -

Our concern is that the simplification and consolidation has revealed that the normal practice as regards the supply of homeopathic medicines has at some point become a contravention of the law.

So many questions... And there will never be answers.

A difference perspective
It's also worth reading Zeno's Blog for a different take on the FOIA disclosure.

Are Homeopathic Medicines Safe? Part 2

2012-07-26T06:26:00.000-07:00

My last post was about an illegally imported product that was marketed in a totally irresponsible fashion. This is more about a significant section of homeopaths who do crazy things.

Example 2: Homeopathic Medicines for Malaria
Oh, this is an old story. It's been kicking around several years now but it is an ongoing situation. There were reports on BBC Newsnight back in 2006 and also in 2011. There are also plenty of blog posts by skeptics on the matter. The 2006 report contains the words -

Dr Behrens has treated patients who fell for the homeopaths claims "We've certainly had patients admitted to our unit with the malignant form of malaria who have been taking homeopathic remedies and without a doubt the reason that they were taking them and not effective drugs was the reason they had malaria."

and more worrying -

Helios in Covent Garden, London told Newsnight's researcher she only needed their homeopathic compounds to protect her, saying "Yes you don't need to take anything else."
Helios told us they still defend their advice. "Many people have researched anti-malarial drugs," they said, "and are concerned about the side effects. We give advice on traditional homeopathic remedies."

The latter statement is particularly important.

What was being supplied?
It isn't clear. In the 2006 report, there is mention of products containing quinine. In the 2011 report, the products are clearly China 30c and Malaria 30c. If you can be bothered to search the internet, there are plenty of websites that have information regarding the treatment of malaria but what was being touted by homeopaths in these reports was prevention of malaria.

China 30c is prepared from Cinchona bark which is the source of quinine. It is part of the story of homeopathy and arguably at the heart of the delusion but it is not a story I will tell here.

Malaria 30c is somewhat different. It is a nosode - a remedy prepared from human/animal tissue or excretions from a subject suffering from the disease. It is linked to a branch of homeopathy called isopathy.

Neither of these products are registered. Lay homeopaths should not possess them.

Controversy
There are experiment vaccines for malaria which show some promise, but standard prevention or prophylaxis with anti-malaria drugs. It is true that they can have side effects but the risk of side effects must be balanced with the risk of malaria infection. Some homeopaths suggest that homeopathic medicines can be used as homeoprophylaxis.

Homeoprophylaxis is a controversial subject and homeopaths are divided on whether it works - sometimes bitterly. The use of homeoprophylaxis for serious otherwise preventable diseases is even more controversial. Dr Peter Fisher, homeopathic doctor to the Queen and director of the alt-med out-patient clinic known as the Royal London Hospital for Integrated Medicine is very clear on this -

I have to say I think the homeopathic community is in many ways its worst enemy, particularly in this country –we have people who make silly claims, frankly, who are not qualified and say things they really shouldn’t say, for instance, about preventing malaria. That is potentially very dangerous and gets us a bad press.

Of course, the taking of homeopathic medicines to prevent malaria is ineffective but the idea of using homeopathic medicines to immunise against malaria is bonkers even by homeopathic standards. It is even more controversial than prophylaxis. I know that it does go on but...

Real Harm
There is absolutely no doubt that direct harm has been caused by the advice of homeopaths (and clients taking the advice). The numbers may be small, but malaria can be fatal. Whilst I am sure that there are those who have used malaria homeoprophylaxis and never contracted malaria, this is not proof of efficacy. But this type of anecdotal evidence is exactly that used by Ainsworths in the leaflet mentioned in the 2011 report. The ASA adjudication on the leaflet is worth reading.

Inaction?
Along with the reports, complaints were also made to the pharmacy regulator. Interestingly, no action was taken. To be fair to the General Pharmaceutical Council (GPhC), there is an argument that as long as remedial action has been taken, then it would be pointless to pursue further official action. There is a counter-argument that statutory regulators tend to take a position of benign indifference to homeopathy and would appear to fail to consider how it interacts with professional and ethical standards, let alone the law.

The point about statutory regulation of a profession is that compliance with the law is mandatory. A regulator of a profession that fails to ensure compliance is a regulator only in name.

Unfortunately, that "remedial action" does not include the removal of malaria nosodes from sale. And yes, they are unregistered homeopathic medicines that can not be supplied except in the pharmacy and to doctors. They might use the word "Plasmodium" but any reasonably educated person would understand that to mean malaria.

Quagmire
It is known that there are lay homeopaths who still suggest the use of homeoprophylaxis for malaria and other serious diseases. There is a question of whether cutting off the supply of certain unregistered homeopathic medicines would prevent this.

Possibly not but I think it would be worth trying.

Are Homeopathic Medicines Safe? Part 1

2012-07-07T14:45:00.000-07:00

One of the arguments that that is being used by UK homeopathy regarding unregistered homeopathic medicines is that they are safe. I don't believe that this is necessarily the case and even if it is, the use of homeopathic medicines, unregistered or otherwise can be extremely unsafe and certainly the advice given by some homeopaths can be unsafe.

The Need for Some Regulation

Putting aside EU Directives and the EU manufacturers' insistence that homeopathic medicines are in some way medicine, there is a very strong reason for regulation of some kind for homeopathic medicines: safety. But of course homeopathic remedies are safe! Are they?

US regulation of homeopathic medicines is different to UK/EU regulation. It is questionable as to whether Zicam would have even been permitted in the UK/EU. And of course, Zicam was marketed as homeopathic when it certainly wasn't. It has been suggested that this was merely a ploy to avoid safety testing.

Zicam was not safe. It caused permanent loss of sense of smell in hundreds of users.

It is unlikely that any existing UK manufacturer would stoop to such tactics but a total hands-off approach to regulation would make it easier for an unscrupulous organisation to do so.

It's worth pointing out that current regulation forbids the importation of unregistered homeopathic medicines except as a personal import. UK consumers would have been able to Zicam from the US but no UK vendor would have been able to import it and sell it.

But illegally imported US products turn up in the UK all the time.

Competition

My guess is that illegally imported US homeopathic medicines don't make up a large proportion the UK market, otherwise the UK manufacturers would be up in arms. US products come with therapeutic indications. UK products are allowed therapeutic indications if registered in the correct way but even that is subject to restriction. US products are subject to very few restrictions and those restrictions are rarely enforced by the Food and Drug Administration (FDA).

It's also the case that many vendors do illegally advertise both registered and unregistered UK homeopathic medicines with therapeutic indications. The homeopathic pharmacies have been known to do this but because of their higher profile and greater scrutiny, it is much more difficulty for them to get away with it.

Example 1: Wartrol

The Advertising Standards Authority (ASA) published an adjudication against Comfort-Click Ltd regarding Wartrol. Wartrol is not registered in UK. Importation is illegal, placing on the market is illegal and advertising of any sort is illegal. Yet...

Wartrol Genital Warts Relief is a discreet, fast-working homeopathic spray that can be applied within seconds and used on the go. You can completely clear your infection within just 2-4 weeks without any pain or scarring. The natural ingredients in Wartrol FDA approved for their abilities to effectively eliminate the infection and prevent future outbreaks from occurring. This homeopathic spray can eliminate the infection within just weeks Clears the outbreak completely with no pain, scars or side effects Contains natural ingredients approved for treating genital warts by the FDA Easy to apply, fast-working and discreet - nobody needs to know you're using it Only takes a few seconds to use either orally or topically 2-6 times per day Suitable for use and equally effective for both male and female genital warts

Human papillomavirus is a serious business.

The marketing is wrong. The product contains no FDA approved products.

This marketing is dangerously irresponsible. This is not just a case of discouraging essential medical treatment. This is about people infected with HPV believing that their infection is completely cleared and spreading HPV and potentially causing avoidable cervical cancer.

More Examples?

Yes, there will be but this example is such a shocker...

No Victory for UK Homeopathy

2012-07-03T05:19:00.000-07:00

Various representatives of homeopathic groups met with ministers from the Department of Health (DH) on 27/06//2012. This is touched on by the Quackometer blog. The Homeopathy Action Trust (HAT) have also said something. I'm aware that there are emails floating from other homeopathic organisations but they aren't in the public domain as yet.

Unfortunately, we don't know what was actually said in this meeting. The main difficulty is that homeopaths often get things wrong. There are vague mentions of status quo and business as usual. Reassurances from Ministers that the Medicines and Healthcare products Regulatory Agency (MHRA) is not going to shut down their supply routes (really?) This is being touted as some sort of victory.

We shall see.

But one thing is very clear. Their futile attempts to have the law changed have failed. The supply of unregistered homeopathic medicines still remains illegal. The end result of all their frenetic activity is zero. It's the same result as if they done nothing.

And UK homeopathy still looks naive and ignorant. There is an argument that the campaign against the "threat" to UK homeopathy has been a PR disaster.

They think it's game over. It's not. Far from it.

Relationship between DH and MHRA
I need to be very clear about the DH's relationship with the MHRA. The MHRA is an executive agency of the DH. It is described as being an "arm's length" organisation. Whilst the MHRA is responsible to Ministers and Ministers can provide direction, the MHRA has considerable independence. The MHRA is totally self-funding - it actually generates a small surplus. It costs the tax payer nothing.

Policy Change?
Ministerial direction to the MHRA not to uphold the various laws relating to unregistered homeopathic medicines is possible but such a policy decision carries with it considerable risks. Firstly, it would place the UK clearly in breach of EU Directive 2001/83/EC as amended by 2004/27/EC. Article 13 states -

1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with Articles 14, 15 and 16, except where such medicinal products are covered by a registration or authorisation granted in accordance with national legislation on or before 31 December 1993. In case of registrations, Article 28 and Article 29(1) to (3) shall apply.

This means that Member States shall ensure that unregistered homeopathic medicines are not placed on the market. That includes the UK and the UK has failed.

Secondly, it would look like Ministers had capitulated to a bunch of fringe lunatics who cared nothing for the law anyway. It looks like special treatment and could set an ugly precedent.

Thirdly, and most importantly, turning a blind eye to illegality? Enough of a bad smell emanates from the DH as it is. If the story gets into the mainstream...

Never the Case
The status quo is not what UK homeopathy thinks it is.

Certainly, in the past few years, it has not been the case that access to unregistered homeopathic medicines has been totally ignored by the MHRA. The MHRA do sometimes respond to complaints but they are slow and don't always say what they've done.

The criteria they use to determine whether or not to act on a complaint are not clear. I may well ask them. But my guess is that if a complaint makes a strong public health/safety argument as well as a clear legal argument, they are more likely to act.

A Letter to Ministers
I'm concerned enough that I have written to Ministers seeking clear answers to whether the DH now has a policy of not upholding the law. If that is their choice, Ministers need to make public statements to this effect. And very clear statements at that. No dressing up with blurb about "patient choice" because choice between homeopathic medicines is an illusory choice.

Consequences
Because UK homeopaths have failed to effect a change in the law, much of what goes on in the world of UK lay homeopath is still illegal. The UK homeopathic pharmacies still act illegally. Non-enforcement of the law, assuming that is DH/MHRA policy, does not change that.

The issue of the UK homeopathic pharmacies and how the General Pharmaceutical Council (GPhC) will react to the issue of illegality and a determination to keep on breaking the law is still not resolved. There are also issues with the homeopathic pharmacies having placed unregistered homeopathic medicines into the retail supply chain. This is much more serious than supplying directly to homeopaths and their clients.

The most serious consequence is that UK homeopathy has made itself appear even more ridiculous.

Homeopathic Pharmacies intend to break the law

2012-06-28T15:26:00.000-07:00

The Epoch Times published an article about the threat to homeopathy.

The Society of Homeopaths (SoH) have effectively declared their intent to ignore legislation. Unsurprising, but this was supposed to be kept quiet. Another PR failure for UK homeopathy but it gets worse...

John Morgan of Helios Homeopathy says...

The main stakeholders within the homeopathy profession have worked together for over 18 months regarding the Act’s revision, and had consultations with the MHRA, but “the efforts and suggestions that we made have fallen on deaf ears”, says John Morgan, managing director of Helios Homeopathic Pharmacy.

and

Morgan says, “It is not economically viable to license something that sells 50 to 100 units per year and the licensing process for 30 or 40 remedies takes years.”

Well, the reasons for their suggestions not being implemented will be clear to readers of this blog. As for the speed of the registration (not licensing, I wish they'd get that right), they have had since 1994 to register homeopathic medicines. And it likely that if more homeopathic medicines had been registered over time, the Medicinces and Healthcare products Regulatory Agency (MHRA) would have allocated more resources. Certainly, the increased fee income would have made this possible.

It is worth pointing out that John Morgan is a member of the SoH.

The Mysterious Shocking Text

Pharmacists say that they have a very strong ethical case in terms of patient safety, patient support, expertise, and training to justify continuing practising as they do, and if a case were brought against them they would defend it.

Which pharmacists? Think this through. I really hope the reporting is incorrect because the idea of a registered pharmacist placing themselves somehow over the law is astonishing.

The General Pharmaceutical Council (GPhC) regulate pharmacists, pharmacy technicians and pharmacies. Their professional Code states -

6. Be honest and trustworthyPatients and the public put their trust in pharmacy professionals. You must behave in a way that justifies this trust and maintains the reputation of your profession.
You must:
6.1 Act with honesty and integrity to maintain public trust and confidence in your profession6.2 Not abuse your professional position or exploit the vulnerability or lack of knowledge of others...6.4 Be accurate and impartial when you teach and when you provide or publish information. Do not mislead or make claims that you have no evidence for or cannot justify6.5 Meet accepted standards of personal and professional conduct
6.6 Comply with legal and professional requirements and accepted guidance on professional practice

And the GPhC has various sanctions although in the case of criminal wrong-doing they are likely to refer the case onwards, but they will still act themselves.

This is not a voluntary code. Compliance is mandatory.

The implications do not bear thinking about.

An Open Letter

2012-06-28T03:19:00.001-07:00

I have thought long and hard about how determine the extent of the homeopathic trade associations knowledge of the legislation and regulations regarding homeopathic medicines. I think this is very important for members of the trade associations as well as supporters of homeopathy more generally.

My guess is that none of the trade associations would respond to a letter. I did consider using complaint procedures to get an answer but I doubt that would get much of a response either. So, instead, I am using this blogpost as an open letter, placing my questions in the public domain. I don't for a minute believe that it will generate any response. No, not even legal threats. But the questions do have to asked.

An Open Letter to the Society of Homeopaths and the Alliance of Registered Homeopaths

To: the Directors of the SoH and ARH

I am aware of the campaign to try to amend the consolidated Medicines Act 2012 and I am aware of some of the misleading communications that have circulated. Particularly misleading is the idea that the consolidation results into a change to the regulation of homeopathic medicines. This is not the case.

I have a series of very simple questions that I would like answered. I believe that many of your members and supporters would like to know the answers too.

Are you aware of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 as amended by the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005? In particular, Schedule 6?
If so, at what point in time did you become aware?
If not, has your organisation ever sought the opinion of a medicines regulation expert?
Do your Codes of Ethics and Practice apply to the Directors of your respective organisations? Specifically the items that place a duty on Members to be aware of all legislation that relates to homeopathy and a duty to comply with such legislation?

Nurses and Midwives and Homeopathy Part 1

2012-06-26T01:57:00.001-07:00

To say the that the situation is complicated would be an understatement. It isn't possible to consider all nurses and midwives who use homeopathy as a single group. There are a number of distinct groups.

Ex-nurses/midwives who have become full-on, full time homeopaths. They are no longer nurses/midwives but continue to say they are. This is bad.
Nurses/midwives who practice full-on homeopathy on a part-time basis whilst remaining a nurse/midwife on a part-time basis.
Nurses/midwives who work as such, and are employed to work as such and "integrate" homeopathy into their work.
Nurses/midwives who are essentially independent nurse/midwife practitioners and "integrate" homeopathy into their work.

It is the first two groups that I am interested in in this post, yet some of the detail I will cover here applies to the other groups as well. And some of it also applies more generally to CAM usuage by nurses/midwives.

Ex-Nurses and Midwives
Use of homeopathy amongst nurses and midwives is mysterious and strange. Yet there are some common themes. Of course, there is the magical cure of the dog/child/self by homeopathy that convinces them that homeopathy works but another theme that comes out is that working in the NHS does not provide sufficient patient focus. Which is why some leave the NHS and leave nursing/midwifery behind. Or they wait until (early) retirement to indulge their hobby.

Now, here's the rub. The titles of Nurse and Midwife and all those letters that nurses and midwives put after their names are conditional on them being registered with the Nursing and Midwifery Council (NMC). The use of qualifications and titles after registration has lapsed may be a criminal offence. It is acceptable to speak of experience in nursing/midwifery or a background in such, but once registration has lapsed, you are no longer a nurse/midwife.

Oh dear. There certainly a number of ex-nurses/midwives who practice homeopathy yet cling onto those titles and letters. I choose to think they are ignorant of the law.

Maintaining Registration
This really about the question of whether is possible to maintain a career as a nurse and a homeopathy practitioner. The number of opportunities to practice both simultaneously are very limited. There are some positions in the NHS and in private healthcare in what is called "integrated medicine".

Once you qualify as a nurse or midwife, that's not the end of the story. In order to maintain registration it is necessary to complete a number of hours of practice as well as Continuous Professional Development (CPD). And hours as a homeopathy practitioner do not count as practice hours. Dual registration increases the number of hours and CPD required.

Part time posts for nurses and midwives do exist in the NHS. Working as an agency nurse or midwife is possible, but the work can be unpredictable although at the moment I'm told the market is OK. Volunteering is a possibility for nurses - although I can't see that being a possibility for midwives - but it must be in a role where registration is a pre-requisite.

Prescribing Rights
Of course, registered homeopathic medicines are not a problem but unregistered ones are. The big question is whether nurses and midwives can prescribe unregistered homeopathic medicines. It's a question of additional qualifications.

The default position is the nurses and midwives can not prescribe.

Community Practitioner Nurse Prescribers are only entitled to prescribe from the Nurse Prescribers' Formulary for Community Practitioners. It is a shame that I can't find an online copy of. A midwife can also be a Community Practitioner Nurse.

Nurses and midwives with supplementary prescribing qualifications can prescribe unlicensed medicines as part of a treatment plan that has been formulated by doctor. In theory, if the doctor has included unregistered homeopathic medicines in the treatment plan, well, yes, they can prescribe but that's not really how homeopathy practitioners work...

Independent prescribers act on their own initiative have no limitations on what they can prescribe.

However, the vast majority nurse/midwife prescribers work in the NHS. It is not just a question of gaining the qualification and being able to prescribe anything. Competency to prescribe in their area of specialism is important. For example, one area that nurse prescribers are often found is palliative care. Such a nurse specialist would not be describing medicines for common childhood ailments.

Split Personality
Putting aside those ex-nurses/midwives whose registration may have lapsed, which is a different issue, the claim to be a nurse/midwife and a homeopathic practitioner is highly problematic. A nurse/midwife can not prescribe unregistered homeopathic medicines and a lay homeopath can not but the sanctions faced are different.

Is there a separation of roles? That's a very interesting question and at the heart of the matter. If there is, homeopathic practitioners should not emphasise in advertising that they are midwifes/nurses. If there isn't, they should be held to the profession standards of nursing and midwifery, with all the discipline that entails.

Well, there is this advice from the NMC on CAM. It makes reference to The Code: Standards of conduct, performance and ethics for nurses and midwives.

You must always act lawfully, whether those laws relate to your professional practice or personal life.

That will include complying with the legislation on unregistered homeopathic medicines.

Use the best available evidence
• You must deliver care based on the best available evidence or best practice.
• You must ensure any advice you give is evidence based if you are suggesting healthcare products or services• You must ensure that the use of complementary or alternative therapies is safe and in the best interests of those in your care

Plenty of problems there. Returning to the advice document.

It is the nurse or midwifes responsibility to judge whether the qualification awarded in a complementary therapy has brought them to a level of competence to use that skill for the people in their care. Where a nurse or midwife is working independently, self-evaluation of competence and accountability is particularly vital.

Self-evaluation? That's going to be a tough one for a lot who believe in homeopathy.

Nurses and midwives considering advertising services offering complementary therapies should be aware that the NMC considers overt reference to registration with the NMC unnecessary in any advertisement.

Interesting. It suggests that the NMC see some separation between the role.

My opinion?
I think the issue of the supply of unregistered homeopathic medicines makes it untenable to be a full-on homeopathic practitioner and a nurse/midwife. Individuals will have to choose between homeopathy and nursing/midwifery. The risk is being disciplined because of breaches of the law.

The use of nursing/midwifery registration to promote homeopathic services is a very bad idea.

Is it a big problem?
From the perspective of the nursing and midwifery professions - the numbers of homeopathic practitioners is tiny compared to the overall numbers. Yet from the perspective of lay homeopath, my guess is that nurses and midwives may make up as much as 5% of lay homeopaths.

How deep a grave do they want to dig?

2012-06-23T14:22:00.000-07:00

I have to hand it to the Homeopathy Action Trust (HAT). I mean, the opponents of UK homeopathy have to do nothing and HAT serves UK lay homeopathy dead on a plate for the vultures to argue over. They do seem to have plenty of help from Homeopathy: Medicine for the 21st Century.

Same Old Wrongness
There is the strange belief that trying to affect UK law can somehow over-ride EU directives. It can't and trying to would set UK homeopathy against a powerful EU lobby that doesn't really care about them. But...

The response from members has been impressive with many writing to their MPs and providing feedback to us.

As expected, many members have received standard replies stating that no changes are being made to the law, including Section 10.These responses are correct in so much as the MHRA's consolidation process is a routine exercise designed to simplify the law without changing it.

However, these standard MP responses are misleading because they infer that because the law is not being changed, access to unlicensed homeopathic medicines will continue.

The law is not being changed. Access to unregistered homeopathic medicines has always been restricted since 1971 if not before. The wrong question is being asked of MPs, because if the right question was being asked, they would tell you the same thing that I do.

And I wish they'd stop talking about "unlicensed" homeopathic medicines. Homeopathic medicines are not licensed, they are registered. It is true that unregistered homeopathic medicines are de facto unlicensed medicines but registered homeopathic medicines do not enjoy the same status as licensed medicines.

This is not the case.

Sorry, it is because the restriction on access to unregistered homepathic medicines/unlicensed medicines has existed since 1971.

The Medicines Act 1968 aims to ensure that medicinal products are produced and supplied in a way which ensures both product quality and patient safety. The MHRA's recent consultation and ‘consolidation' aimed to make this vast, confusing, out-dated law simpler, clearer and up to date.

However, this process has highlighted ways in which the Act is inappropriate when applied to modern use of homeopathic medicines because, the Act was written with conventional drugs in mind i.e. the regulations it created were designed to protect the public from potentially dangerous substances, and it was written long before the phone, internet and mail order became major supply routes.

Once this review of the Medicines Act has been concluded, if Section 10 remains unchanged, it will clearly state that it is unlawful to supply unlicensed homeopathic medicines (i.e. most remedies) by phone, mail order or via the internet.

It's not a review, it's a consolidation and it has been clear for a while that supply of unregistered homeopathic medicines is unlawful. And how recent an innovation is mail order? 1744 is one date I've seen quoted. And the Victorian era was certainly one of the golden ages of mail order quackery. The Quack Doctor is a very distracting website.

Oh, the horror!
The HAT webpage links to further information from H:MC21 or rather, an email newsletter. I do think that H:M21's attempts at lobbying will prove fruitless.

Some key points from the newsletter.

Earl Howe’s letter

Some people have received a letter from their MPs forwarding a standard response from Earl Howe. The key points which we think need to made in reply are:

Homeopathic organisations took part in the MHRA’s process of public consultation, but the issues they raised do not appear to have been addressed.
Our concern is that the simplification and consolidation has revealed that the normal practice as regards the supply of homeopathic medicines has at some point become a contravention of the law.
At the same time the simplification and consolidation has revealed that the law prevents homeopaths from practising correctly by restricting access to remedies their patients may need.
As a result some changes in the regulatory framework are required if it is to be “fit for purpose”.

Homeopathic organisations have consistently failed to grasp that the real issues. The "issues" they have raised so far are so wrong headed that they can not be "addressed". The regulatory framework is fit for purpose. It works perfectly well in other EU countries. That UK homeopathy has consistently chosen to ignore the framework does not invalidate it - far from it. But the show stopper is -

Our concern is that the simplification and consolidation has revealed that the normal practice as regards the supply of homeopathic medicines has at some point become a contravention of the law.

It has been since 1971. The problem is by acknowledging that it is in "contravention of the law", any lay homeopath reading the email should stop what they are doing. Hardly professional to knowingly break in the law and violate their Code of Ethics and Practic, is it?. The situation for anyone in a homeopathic pharmacy is worse.

H:MC21's website is difficult to deal with. They have come with a critique of the House of Commons Library Note, which I discuss here. Their critique can be found on this page. I particularly enjoy this.

It is suggested that homeopaths and patients are being misled because they are being made
aware of a previously unrecognised legal issue.

They have been misled. It is a previously recognised legal issue. I've been aware of it for sometime, so have the MHRA and I find it difficult to believe that homeopathic organisations have not been aware. Indeed they were involved in consultations in 2010(?) and 2005 (if not more) that would have certainly touched on the issue. There is a lot of talk of a right to access to unregistered homeopathic medicines that has never existed.

Elsewhere they say -

The BHA/HAT statement quoted is clear and accurate, and it is seriously pejorative to suggest that it is misleading.

I would disagree.

The “other commentators” have no standing other than as vehement opponents of homeopathy and other CAM therapies, but this is not made clear.

The standing of "other commentators" is irrelevant because what is at question is a matter of law that can only really be interpreted in one way. Conversely, as homeopathy has no recognition is UK law, homeopaths and their apologists are essentially functioning as members of the public, not some expert group. Their inability to grasp the real issues, the use of shrill invective and the belief in conspiracies reduces any standing that they might have.

And on it goes, repeating the H:MC21 line about Sense About Science.

Rachel Roberts on the Interwebs!
The HAT webpage links to this interview with Rachel Roberts. Please, don't listen to it. You will have wasted an hour of your life and also had to endure an incredibly noisy trailer for Abraham Lincoln: Vampire Hunter

This doesn't really add very much. Represents the position that there is a change to the law. There isn't. Repeats the mistake that each individual potency of a homeopathic medicine need to registered. The MHRA don't think so.

But there is an assertion that the Medicines and Healthcare product Regulatory Agency (MHRA) have been been OK with the sale of unregistered homeopathic since the 1990s. Really? The MHRA was created in 2003. Its predecessor was the Medicines Control Agency (MCA). I suspect the inspections referred to are GMP inspections. Not inspections of compliance with the Medicines Act 1969 et al.

No mention of EU Directives. No mention of the duty of EU member states to prevent unregistered homeopathy medicines from coming onto the market. Fails to grasp that legislation.

And all the key stakeholders in UK homeopathy have been working together been the scenes for nearly a year now. Oh dear. This would suggest that if one stakeholder understands the implications of current legislation, they all do.

So full of errors. So ignorant of the real issues.

No Hope
There really is not hope for UK lay homeopaths. They've had it.

Wrong Again!

2012-06-19T04:52:00.000-07:00

Watching UK lay homeopaths try to get their heads round UK legislation and regulations would be funny if their livelihoods weren't at stake. In reality, it's just very sad watching their leadership and interest groups farting about whilst their carefully constructed denial of reality disintegrates and takes down individual practitioners.

Homeopathy: Medicine for the 21st Century Strikes Again!
Oh joy. Not only is there are exhortation to supporters to write to their MP, there are some documents for supporters to send to their MP as well. I can't get the website to give link to the documents. But...

Briefing Notes about the proposed Human Medicines Regulations 2012
This document is full of errors.

The Regulations can be easily changed to take into account the safety of homeopathic medicines, and proposals have already been put forward to the MHRA.

No, they can not be easily changed. As I have discussed before, it requires either a change to EU legislation or a UK opt out.

The 1968 Act makes no mention at all of homeopathy. Because of this, and because the vast majority of homeopathic medicines are inherently safe, the sale and prescription of homeopathic medicines continued after this Act much as it had before.

Irrelevant. And how many lay homeopaths were there in 1968? Tens at most. The Act applies because of the definition of what a medicine is; essentially a substance used to treat or prevent disease. Restrictions applied back in 1971 when the act was implemented.

For seven years there has been a sustained campaign of propaganda against homeopathy, and there is a danger that campaigners will try to use weaknesses in the law to maliciously prosecute homeopaths and homeopathic pharmacies (as they have tried to use the Advertising Standards Authority). This threat means that access to homeopathy will be severely restricted.

Weaknesses in the law? Prosecution by the MHRA is possible but unlikely but it could only happen because lay homeopaths and the homeopathic pharmacies do not comply with legislation and regulations.

Homeopathic organisations have raised the problems with the MHRA during the period of public consultation. Because the MHRA has failed to act, it is necessary for the electors to ask the Minister to act on their behalf.

Again, the failure to under EU legislation and its impact on UK legislation. The Minister can not act. It also raises the questions of: 1) how aware of current legislation and regulation the "homeopathic organisations" were and 2) if they are, why they did not comply.

The restriction on access to homeopathic medicines could also result in thousands of homeopaths being unable to practise, increasing the number of unemployed and reducing tax revenues.

Tough but more to the point, why are they in such a position? Because the homeopathic pharmacies have registered so few homeopathic medicines!

Briefing Notes about the propaganda campaign against homeopathy - 1
I hesitate to mention this document because it almost dignifies it. It contains the usual conspiracy theories about Sense About Science. The document is not at all helpful to the cause of UK homeopathy as it reveals the bizarre thought processes of some homeopaths.

The impact? "File under: NUTTER."

FLOW CHART for the Human Medicines Regulations 2012
Oh, a lovely flow chart that gets things wrong again and makes very little sense whatsoever. I've done a lot of flow charts in my professional career and it ain't a flowchart, has no real logic to it and repeats the errors made in many of the texts by homeopaths.

H:MC21 has called for a lobby of Parliament!
Yes, after their massively successful lobbying of Parliament in 2010, they intend to lobby again on 4th July 2012. Somewhat pointless given that the law can't easily be changed.

Missing the Point
I do think that UK homeopathy is totally incapable of dealing with the real issues. It's easy to blame government, the EU, those nasty skeptics and webs of conspiracy that involve Big Pharma and other evil groups.

UK homeopathy, especially the leadership of the trade associations and the homeopathic pharmacies, has only itself to blame. Decades of inaction, pretending that the real world does not exist and then panicking when it is too late to do anything.

House of Commons Library Briefing: Updated

2012-06-18T02:04:00.002-07:00

The letter writing campaigns of the lay homeopaths have had a result but not the result that they were hoping for. There is now a Commons Library Standard Note entitled Homeopathy and the consolidation of UK medicines legislation. This is a document written for information purposes for MPs. It is not a statement of government policy.

What does is say?
Not a great deal. Readers of my blog will be familiar with the issues but...

UK medicines legislation (including for homeopathy) is being consolidated. The law is not being changed. The consolidation will happen through the Human Medical Regulations 2012, which were due to come into force in July 2012. They will be laid under the negative resolution procedure.

Of course. This has always been the case.

Some homeopathic practitioners are concerned that following the consolidation the law will be enforced. This could constrain some homeopathic practices. They are seeking a change in the law. Other commentators believe that homeopathic products should be regulated in the same way as other products that make health claims.

I think that there is a very tricky thing in that for UK homeopathy. It is suggesting that some homeopathic practices are currently illegal and will continue to be illegal. And it is rather different from the message that the homeopaths were sending out - which the business about a "change" to the law. That raises the question, again, of whether the instigators of the writing writing campaign do not understand current legislation or set out to mislead.

The British Homeopathic Association and Homeopathy Action Trust are encouraging users of homeopathic medicinal products to contact their MPs to express their concerns. The information presented by these organisations could be considered misleading as the reader might infer that the consolidation represents a change in the law:

Yes. Plainly misleading.

No Mention
Of course, my scholarship is not mentioned. More seriously, there is a mixing up of claims being made for homeopathic medicines and the issue of the restricted supply of unregistered homeopathic medicines.

The UK has a duty under EU law to ensure that unregistered homeopathic medicines are not placed on the market. It has conspicuously failed.

UK manufacturers can not legally place unregistered homeopathic medicines on the market, yet they do so.

UK lay homeopaths can not legally obtain unregistered homeopathic medicines, except in very restricted cirumstances, yet they do so. They can not supply them either, yet they do so.

UPDATE #1
There's been an update. It doesn't really add very much that readers of this blog don't already know but...

Is it possible to change the law at UK level?

No.

This may mean that EU law would have to be changed to allow unauthorised homeopathic medicines to be available over the telephone or internet.

It does mean that EU law would have to be changed. That is not going to happen.

Why has the law not been enforced in the past?

It has been only in a few cases. It's a question I asked here.

The MHRA is obliged to investigate any complaint concerned with the manufacture and supply of medicines for human use. Each case will be considered on its individual merits, set in the wider context of the MHRA's role in the protection of public health.

Which casts the MHRA in a reactive role. The difficulty I have with this statement is that the MHRA has a duty to ensure that unregistered homeopathic medicines do not come onto the market. Individual merits don't really come into it if there are clear breaches of the law.

However, take a look at this page and note the date. Homeopathic hCG is associated with a dangerous diet that is clearly a threat to public health.

The promotion and/or sale of unlicensed medicines is not permitted.

Hmm. The interesting thing is that Helios Homeopathy certainly were involved in the sale of homeopathic hCG.

The quality and safety of unlicensed medicines have not been assessed by the MHRA and it is recommended that consumers do not purchase unlicensed homeopathic medicines, including homeopathic hCG in the UK.

It's almost impossible to do so now.

If you wish to advertise and/or sell a homeopathic medicine in the UK, the following provides a link to the relevant page on the MHRA website detailing how to apply for a homeopathic marketing authorisation or registration certificate.

Advice seemingly not taken by the homeopathic pharmacies...

Chiropractors and Osteopaths and Homeopathy

2012-06-16T13:07:00.001-07:00

Let's be very clear. Chiropractors or Osteopaths have no prescribing rights of any kind unless they are dual-qualified. There have been suggestions in the past both should be given prescribing rights but this has never happened and it is unlikely that it ever will.

Do they really do Homeopathy?
Yes, some do. I do not want to provide examples because that would be an open invitation for some people to make complaints. Of course, it is easy to find them.

In both professions, there is a fundamental tensions between hard-line traditionalists who seem to view the medical profession as the enemy and more pragmatic modernists who would like to be more integrated into the healthcare landscape. The hard-liners are wont to talk of "allopathy" and the dangers of conventional medicine. There is often a correlation with their stance on vaccination.

Whilst some hard-liners might wish to restrict themselves to just chiropractic/osteopathy, there is also a strand of being able to accept one form of vitalism making it easier to accept others.

Where does it say that Chiropractors/Osteopaths can not prescribe?
Chiropractors? Strangely the General Chiropractic Council (GCC) has nothing to say on the matter. However the British Chiropractic Association (BCA) did poll its members regarding prescribing rights. It is unfortunate that no direct evidence can be found on the internet but this article explains things from a particular viewpoint.

I've scoured the existing legislation and found absolutely no evidence for prescribing rights being to chiropractors.

The General Osteopathic Council (GSoC) are about to implement new Osteopathic Practice Standards. However, compared to the previous Code of Practice there is a considerable amount of material missing, in particular -

LEGAL LIMITATIONS ON WHAT AN OSTEOPATH CAN DO92. The law prohibits you as an osteopath from doing a number of things, including:
• advertising treatments for certain conditions
• performing certain procedures
• prescribing, providing or administering prescription-only medicines
• signing certificates that require the signature of a registered medical practitioner
• treating animals, except on a referral by a registered veterinary surgeon.
93. You may practise as a member of another healthcare profession only if you are recognised by that profession as competent to do so, are registered with an appropriate body and hold adequate professional indemnity insurance.

Pretty clear.

Faculty of Homepathy
The Faculty of Homeopathy (FoH) represent certain regulated health professionals who This is one of those "oh dear" moments. They offer training courses and qualifications to statutorily regulated health professionals who can not make (full) use of them.

Disciplinary
Whether the GCC or GOsC would view the prescribing of homeopathic medicines as a serious matter it itself is moot. The GCC merely admonished a member who believed that they could write prescriptions.

Of course, if they had wished, they could have referred the case to Medicines and Healthcare product Regulatory Agency (MHRA) who have the ability to prosecute. The pharmacist could have been referred to their regulator - which is now the General Pharmaceutical Council (GPhC), who could have disciplined the pharmacist and even referred onwards to the MHRA.

Prescribing Rights

2012-06-14T03:50:00.001-07:00

Lay homeopaths froth about not being able to "prescribe" unregistered homeopathic medicines any more.

But Unregistered Homeopathic Medicines are not Prescription Only Medicines!
This is true. Registered homeopathic medicines can be sold anywhere but as the rest of my blog makes very clear although unregistered homeopathic medicines can be obtained face to face from the pharmacy or branch of the pharmacy that makes them, there is no way for lay homeopaths and the general public to obtain them from these UK pharmacies by any other route except...

Prescription
As I have said before, unregistered homeopathic medicines are treated as unlicensed medicines. There are a number of reasons that unlicensed medicines exist but one is that in the past all pharmacies were compounding pharmacies. Before the rise of Big Pharma, pharmacists compounded their own medicines. That right has never been taken away - although it is subject to greater legislation and regulation these days.

But the point about unlicensed medicines is that they have not been tested. Their safety and quality has not be determined. I find it really strange that it is at all possible for a member of the public to obtain an unlicensed medicine. But the exemptions exist in Section 10 of the Medicines Act 1968. But a couple of the other exemptions matter more. Section 9 states -

9 Exemptions for doctors, dentists, veterinary surgeons and veterinary practitioners.
(1) The restrictions imposed by sections 7 and 8 of this Act do not apply to anything done by a doctor or dentist which—
(a) relates to a medicinal product specially prepared, or specially imported by him or to his order, for administration to a particular patient of his, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that patient or to a person under whose care that patient is, or
(b) relates to a medicinal product specially prepared at the request of another doctor or dentist, or specially imported by him or to his order at the request of another doctor or dentist, for administration to a particular patient of that other doctor or dentist, and consists of manufacturing or assembling, or procuring the manufacture or assembly of, the product, or of selling or supplying, or procuring the sale or supply of, the product to that other doctor or dentist or to that patient or to a person under whose care that patient is.

Which needs to be read in conjunction with Section 10 (1) -

10 Exemptions for pharmacists.
(1)Subject to the next following subsection, the restrictions imposed by sections 7 and 8 of this Act do not apply to anything which is done in a registered pharmacy, a hospital, a care home service or a health centre and is done there by or under the supervision of a pharmacist and consists of—
(a)preparing or dispensing a medicinal product in accordance with a prescription given by a practitioner, or
(b)assembling a medicinal product provided that where the assembling takes place in a registered pharmacy—
(i)it shall be in a registered pharmacy at which the business in medicinal products carried on is restricted to retail sale or to supply in circumstances corresponding to retail sale and the assembling is done with a view to such sale or supply either at that registered pharmacy or at any other such registered pharmacy forming part of the same retail pharmacy business, and
(ii)the medicinal product has not been the subject of an advertisement; and those restrictions do not apply to anything done by or under the supervision of a pharmacist which consists of procuring the preparation or dispensing of a medicinal product in accordance with a prescription given by a practitioner, or of procuring the assembly of a medicinal product.

There is more but I don't think any reader would enjoy reading it.

Prescribing Rights
Who has prescribing rights? More importantly, who can prescribe unlicensed medicines?

Doctors - can effectively prescribe anything.
Dentists - can effectively prescribe anything relevant to dentistry.
Nurses and Midwives - there are restrictions except for qualified independent prescribers who can prescribe unlicensed medicine but there are serious issues. Can also be supplementary prescribers.
Pharmacists - there is training available to become an independent prescriber and prescription of unlicensed medicines is allowed. Can also be supplementary prescribers.
Optometrist - again, they can be independent prescribers but are limited to eye related issues and licensed medicines. Can also be supplementary prescribers.
Physiotherapists - can undergo training to become supplementary prescribers.
Radiographers - can undergo training to become supplementary prescribers.
Chiropodists - can undergo training to become supplementary prescribers.
Podiatrists - can undergo training to become supplementary prescribers.

An independent prescriber can prescribe on their own initiative - within the limits of training and clinical competence. A supplementary prescriber can not - they can only prescribe according to a plan formulated by a Doctor.

Who is not on the list?
There are two important groups who are not on the list that have statutory regulation as health professions - chiropractors and osteopaths.

Further Posts
I want to look at Chiropractors/Osteopaths and Nurses/Midwives in more detail.

Closer but still no Cigar

2012-06-10T15:47:00.001-07:00

Homeopaths still haven't quite got the grasp of current legislation. Louise Maclean, mentioned in a previous post, has written something else on her Homeopathy Heals Me website.

It is worth pointing out that Ms Maclean is a member of the Homeopathic Medical Association. What she has written has implications that I will go into later.

I'm not going to reproduce the whole of the text, it serves no purpose.

Not Understanding the Basics
This is interesting.

As many have pointed out, no change to 10(4)(a) of the Medicines Act 1968 is the problem. The law has always said that unlicensed homeopathic medicines must be purchased face to face at a homeopathic pharmacy but this has not been enforced.

No, that's not what the law says at all. The Medicines Act 1968 as enacted makes no mention of homeopathic medicines whatsoever. It has said that unlicensed medicines, baring exemptions, need to be obtained face to face from a pharmacy. Enforced? Compliance with legislation and regulation is not a voluntary thing for pharmacies or pharmacies.

The problem started when the EU Human Medicinal Products Directive 2001/83/EC was amended by EU Directive 2004/27/EC in Article 1, Clause 2
2. Medicinal product:(a) "Any substance or combination of substances presented as having propertiesfor treating or preventing disease in human beings."
This meant homeopathy became redefined as a 'medicinal product' and hence fell under the legislation of the EU Human Medicinal Products Directive, when previously it had been regulated under The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994. In the MHRA Consolidation and Review of UK Medicines Legislation, there are frequent calls for the Medicines Act 2012 to be brought into line with EU law.

Not so. ~~Although the original Act does not contain such a clear definition of a medicinal product, it contains the following -~~

~~(3) The activities referred to in subsection (2) of this section are—~~
~~(a) the practice of medicine (other than veterinary medicine) ;~~
~~(b) the practice of veterinary medicine ;~~
~~(c) the practice of pharmacy;~~
~~(d) chemistry other than pharmaceutical chemistry;~~
~~(e) the pharmaceutical industry.~~

~~Given that pharmacists ran homeopathic pharmacies, it suggests that homeopathic medicines were covered.~~

Here I admit to forgetting something - Section 130.

(1) Subject to the following provisions of this section, in this Act " medicinal product" means any substance or article (not being an instrument, apparatus or appliance) which is manufactured, sold, supplied, imported or exported for use wholly or mainly in either or both of the following ways, that is to say—
(a) use by being administered to one or more human beings or animals for a medicinal purpose ;
(b) use, in circumstances to which this paragraph applies, as an ingredient in the preparation of a
substance or article which is to be administered to one or more human beings or animals for a medicinal
purpose.

(2) In this Act " a medicinal purpose " means any one or more of the following purposes, that is to say—
(a)treating or preventing disease ;
(b)diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;
(c)contraception;
(d)inducing anaesthesia;
(e)otherwise preventing or interfering with the normal operation of a physiological function, whether
permanently or temporarily, and whether by way of terminating, reducing or postponing, or increasing
or accelerating, the operation of that function or in any other way.

Treating or preventing disease? Yes.
CONSULTATION LETTER MLX 312 from the Medicines and Healthcare product Regulatory Agency (MHRA) contains some very interesting information.

9. When the UK joined the European Community in 1973 European legislation came into force here and the review of those products covered by PLRs became mandatory. By the time of the Review it was recognised that providing proof of efficacy for homeopathic products would pose a difficulty if conventional clinical trials were required. Consequently homeopathic medicines were exempted from the Review and the PLRs remained in force.

10. At the time of the review, the requirement for proof of efficacy in clinical trials also meant that no new homeopathic products had been introduced onto the market since 1971. To resolve this situation, protracted negotiations in Europe led, in 1992, to the publication of Directives on human and veterinary homeopathic medicinal products that set out a ‘simplified’ regulatory procedure for homeopathic products that meet the following eligibility criteria:

The criteria aren't interesting in themselves. But that 1971 to 1992 period is interesting given that both Helios Homeopathy and Ainsworths were founded then.

It's pretty clear that Ms Maclean is wrong in her assertion. Homeopathic medicines have been considered medicines ~~because they were produced by pharmacies and pharmacists who insisted they were medicines.~~ because they are purported to be able to treat or prevent disease.

Ms Maclean continues

So if we want homeopathic medicines to be exempted, we would have to ask the EU to change this, not the UK Government but we must hope they will have some influence.

True. But current EU Directives suit the big European manufacturers very well thank you and they are a more powerful lobby group than UK homeopaths.

The Very Wrong
It gets worse.

Only a doctor homeopath or vet will be able to prescribe homeopathic medicines and these must be licensed ones. Even a doctor homeopath will have to go to the homeopathic pharmacy to buy unlicensed homeopathic medicines face to face, as unlicensed medicines will not be allowed to go through the post. But not even a doctor homeopath will be legally allowed to prescribe unlicensed homeopathic medicines, only the pharmacist. The lay homeopathic prescriber won't be allowed to prescribe any homeopathic medicines, as they will have no prescriber rights.

Registered homeopathic medicines can be sold over the counter by anyone. Pharmacists, unless they have the necessary qualifications can not prescribe. And those that are qualified are supplementary prescribers. As for the post stuff, yes, unlicensed medicines can go through the post in response to a prescription but courier is much better.

The lay homeopath can not prescribe, has never been able to prescribe and will never be able to prescribe. I really don't get why the writers of all these texts do not grasp this.

No person will be able to prescribe, supply or sell an unlicensed medicine except a registered pharmacist, who will be allowed to prepare them. Hence in order to buy them people will have to go to a homeopathic pharmacy.

You might think that if you don't charge for the homeopathic medicine, only for the consultation, surely that will be legal? But here it clearly says 'a person may not sell or supply'.....a medicinal product that is not subject to general sale (i.e. unlicensed).

As I've pointed out, no, clients can buy homeopathic medicines from EU countries where they are registered. Of course, lay homeopaths can not.

An MHRA official has disclosed that "for the purpose of Section 10 of the 1968 Medicines Act, there is no distinction made between homeopathic medicines and other medicinal products" and that "prescriptions may only be issued by appropriately authorised healthcare professionals such as UK registered doctors, dentists or supplementary prescribers".

The MHRA consultation process is over and an official at the MHRA has disclosed that final enforcement of these laws will come into effect on 17 January 2013.

Of course. But the current implications of this are conveniently forgotten.

Economics for Dummies

So what would be the cost to the UK homeopathic pharmacies of licensing 3500 homeopathic medicines?! Obviously it could bankrupt them.

I wrote about this here.

Super Muddled
Ms Maclean says further -

In clause 195 of Medicines Act 2012 'high dilutions' in the 1x, 3x and 6x potencies appear to be EXEMPT, though it takes very careful reading to ascertain this. Homeopathic practitioners may all have to go back to prescribing like Clarke and Burnett! The remedies allowed are listed in Schedule 21, though homeopathic practitioners may not be able to prescribe them, having no prescriber rights. The language is exceptionally hard to follow and you have to keep relating back to other clauses.

No. That's a misreading. The Prescription Only Medicines (Human Use) Order 1997 should be read first.

Compliance?
I would ask the question of Ms Maclean as to whether she understand the implications of current legislation and regulation? And whether she will comply by them?

The Suicide Notes

2012-06-07T05:16:00.001-07:00

On reflection, yes, I do think that UK homeopathy may well have decided to commit suicide. Why? I'll spell it out in simple language.

The Letter Writing Campaign Texts
I'm not going to reproduce them again. You can find them here and here. The most important thing they say is that access to unregistered homeopathic medicines will become largely illegal. That's wrong in that's the current state of the law, but...

These texts have been widely distributed. Certainly to members of the Society of Homeopaths and the Alliance of Registered Homeopaths and to customers of Ainsworths and Helios Homeopathy.

I view these texts as suicide notes.

A Huge Gamble
My guess is that the instigators of the letter writing campaign believed that they could have an effect on the consolidation of the Medicines Act. It is a gamble that never stood a chance. The campaign was too late and aimed at the wrong target.

The result of that gamble is almost certainly the death of UK lay homeopathy.

Doomsday
What the homeopathic trade associations and their supporters have effectively done is create a deadline for compliance by lay homeopaths. Not just with the law but also their Code of Ethics and Practice. That deadline is the day that the consolidated Medicines Act is passed into law.

It is also the day that they will have to start disciplining members for non-compliance. Whilst they can choose not to, it would jeopardise any attempt to gain accreditation from the Council for Healthcare Regulatory Excellence (CHRE) as a voluntary register. It might be a price they are happy to pay.

Ainsworths and Helios have also created the same deadline for themselves. But that is the day when they must remove unregistered homeopathic medicines from the market. No choice really. The stark admission that supply will be illegal should stop them. The potential sanctions they face from both the General Pharmaceutical Council (GPhC) and the Medicines and Healthcare products Regulatory Agency (MHRA) include pharmacists being struck off and criminal prosecution.

The Genie
Putting the campaign issues into the public domain means that there is no way back. What has been said can not be unsaid. The bridges have been burnt. The genie will not go back in the bottle.

Worse from the Trade Associations etc

2012-06-02T04:10:00.002-07:00

The Homeopathy Action Trust (HAT) have also issued the same statement as the Society of Homeopaths (SoH). I expect to see this appearing in a number of other places over time. But you can always depend on the Alliance of Registered Homeopaths (ARH) to come up with their own spin on things.

Fight for Homeopathy - Now!
I do not know how official this blogpost by Steve Scrutton is. It would be worrying for the ARH if it were. Scrutton is highly antagonistic towards medicine - but that is not of interest here.

When ARH members were discussing the 'consolidation' of the Medicines Act recently, one of our members wrote in with a heart-felt plea - to reject this particular attack, one of a series over recent years, and not to allow matters to rest.

So ARH members have been discussing the consolidation of the Medicines Act? I suspect that it was an ill-informed discussion.

What follows is an extraordinary piece of polemic that totally fails to understand a key feature of the regulation of homeopathy in many countries. Homeopathy is considered to be part of medicine in many countries and only the medically qualified can practice it. UK lay homeopathy will often make statements regarding the prevalence of homeopathy in other European as a justification. They often point to the funding of treatment by the State and insurance companies as validation and yet there is the "health freedom" message that is pretty much guaranteed to upset medics who provide homeopathy.

We cannot just allow our opponents, and the vested interests they support, to attack us without responding vigorously.

Here's the rub. The legislation that Scrutton baulks as is the result of lobbying by the European homeopathy "establishment". The consolidation of the Medicines Act is not an attack on homeopathy. Talk of freedoms being taken away simply does not wash.

Failure
Equating the regulation of homeopathic medicines with "health freedom" is a game that can only be lost. There is a perfectly workable system for the registration of homeopathic remedies already. That it is not used is the problem. It works reasonably well in other EU countries.

Arguing for an additional exemption for homeopathic medicines in the UK is ludicrous in the face of that.

More Misinformation from the Society of Homeopaths

2012-06-01T08:42:00.000-07:00

I did say that I had accomplished my mission but the Society of Homeopaths (SoH) have distributed a document that beggars belief.

I'm not going to reproduce the whole of it. Even if it does disappear from the SoH website, someone else will doubtless has preserved it for posterity.

The response has been impressive with many writing to their MPs and providing feedback to us. As expected, many have received standard replies stating that no changes are being made to the law, including Section 10.

These responses are correct in so much as the MHRA’s consolidation process is a routine exercise designed to simplify the law without changing it. However, these standard MP responses are misleading because they infer that because the law is not being changed, access to unlicensed homeopathic medicines will continue.

Come again?

This is not the case

Sorry?

Once this review of the Medicines Act has been concluded, if Section 10 remains unchanged, it will clearly state that it is unlawful to supply unlicensed homeopathic medicines (i.e. most remedies) by phone, mail order or via the internet.

So that's the issue? I believe that existing legislation and regulations already state that the supply of unregistered homeopathic medicines is unlawful. I believe that guidance issued by the Medicines and Healthcare products Regulatory Agency (MHRA) over several years confirms my belief. And -

For over 18 months, the homeopathy profession has engaged with the MHRA concerning key issues of access to medicines and the potential negative impact on homeopaths as well. As a profession and as individual practitioners we have responded to the Medicines Act public consultation and the MHRA Red Tape Challenge suggesting practical and workable solutions.

I would question the definition of "engaged". I would be surprised in the MHRA did not appraise the homeopathy profession of the implications of current legislation. I'm aware that interpretations of the legislation have existed in the public domain for several years at least.

So let me get this straight. The belief that current legislation is does not "clearly state that is unlawful" to supply/procure unregistered homeopathic medicines somehow justifies non-compliance? I would like to see the SoH argue that against their own Code of Ethics and Practice.

Section 4 - Legal ObligationsCriminal and civil law 32 Registered and student clinical members are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising.
33 Registered and student clinical members must observe and are responsible for keeping up to date with all legislation and regulations relating directly or indirectly relating to the practice of homeopathy

And that would include the members of their Board who are registered members. As a body corporate, there is also the issue of due diligence. The SoH is a company. It has responsibility to its shareholders. It has spectacularly failed on that score. Myself, I pay for expert advice on difficult issues. I am not a lawyer (but I would be a very good one) but I will pay for one if needed.

There is still time to act. There is an urgent need to lobby MPs and Health Ministers to make an amendment to Section 10 (4a) so that it does not apply to homeopathic medicines dispensed at dilutions of 6X or above.

I'm afraid not. It is not the issue. The issue is the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 as amended and EU Directive 92/73/EEC. Amending Section 10 and its counterpart in the consolidated Medicines Act does not get rid of the EU Directive.

I did say that I would not make complaints but this was sent out by Phil Edmonds, Chair of the SoH. I will make a complaint against him to the SoH. I will place the text of the complaint in the public domain.

Further Actions

2012-05-31T05:22:00.002-07:00

The real purpose of this blog is to be a counter balance to the misinformation that is being published on the internet and distributed by UK homeopaths and their supporters.

Open Discussion
The way forward for UK lay homeopathy, the trade associations, the homeopathic pharmacies and their customers is not going to discovered via sticking their collective heads in the sand. Solutions will only be found via frank and open exploration and debate of the issues they face.

I wish that there was open discussion but there is not.

Not a Mandate for Skeptics
Arguably, this blog contains information that could be used by opponents and critics of UK homeopathy to mount a campaign of complaints that could result in severe damage to UK homeopathy. That may be the case but I have deliberately not discussed exactly how to go about making such complaints.

I do not think that such actions would be terribly productive. UK homeopathy has to change and I feel that they should be given an opportunity to do that free from distraction.

But it's not possible to turn the clock back. The knowledge of how to do this does exist and isn't going to go away. And all that complaints do is push regulators into enforcement. The threat of enforcement exists independently of complaints as well.

Mission Accomplished
As far as I am concerned, I've achieved what I've set out to do with this blog. I am unlikely to post much more here.

My focus is now trying to get the information out there to as many interested parties as possible.

Solutions?

2012-05-31T04:57:00.001-07:00

Well, my advice to homeopaths sets out how they and their clients can still obtain unregistered homeopathic remedies over the internet or by phone if they still want to. However, this is very much a stop-gap solution. It does not deal with the fundamental issue of unregistered homeopathic remedies being placed on the UK market.

Remembering that UK regulation of homeopathy is the result of EU Directives - any change to UK regulation requires either - i) a UK opt-out from elements of certain Directives or ii) a change to European law.

MHRA Tolerance and Inaction
The MHRA could just ignore unregistered homeopathic medicines and let the lay homeopaths and the homeopathic pharmacies get on with it. Well, as long as they don't do anything too stupid like place unregistered homeopathic medicines for malaria on the market.

The problem here is the MHRA do have a duty to prevent unregistered homeopathic medicines for reaching the UK market. Although they are not proactive in enforcing compliance with legislation they ultimately do have to respond to complaints. The consolidation of the Medicines Act does make it slightly easier to complain. On the other hand, what I have written in this blog makes it relatively easy for anyone to complain.

It's not really a solution.

Registration of more homeopathic medicines
This is the most obvious solution but cost and time are the issues.

Whilst it is relatively cheap to register a homeopathic medicine, a registration application must be accompanied by various documentation that is time consuming and expensive to produce. Although there is no need to prove efficacy, the document must include -

scientific name or other name given in a pharmacopoeia of the homeopathic stock or stocks, together with a statement of the various routes of administration, pharmaceutical forms and degree of dilution to be registered,
dossier describing how the homeopathic stock or stocks is/are obtained and controlled, and justifying its/their homeopathic nature, on the basis of an adequate bibliography,
manufacturing and control file for each pharmaceutical form and a description of the method of dilution and potentization,
manufacturing authorization for the medicinal product concerned,
copies of any registrations or authorizations obtained for the same medicinal product in other Member States,
one or more specimens or mock-ups of the outer packaging and the immediate packaging of the medicinal products to be registered,
data concerning the stability of the medicinal product.

This might prove difficult for a very small operation. It requires specialist skills and is a lengthy process. Some of the elements here prevent the registration of more esoteric remedies that fail the test of being homeopathic.

For rarely used homeopathic medicines, the costs do not make their registration economically viable.

Although approval of an application by the MHRA is essentially a rubber stamping exercise, it does take time and the MHRA could represent a bottleneck. Large numbers of applications could choke that bottleneck.

This is a long term solution but carries with it increased costs which will be passed onto the consumer but rarely used homeopathic medicines will remain unregistered.

Licensing of manufacturers not remedies
I've seen this proposed in various places. The idea is that if the manufacturer complies with accepted standards, they should be able to place a homeopathic medicine on the market without the need for registration of individual medicines.

It's not an unworkable solution, but it would have to be done at the European level but it would necessitate the creation of a regulatory and inspection framework to ensure that the products being produced were homeopathic. How the fees would be structured is an interesting question.

No Regulation
Frankly, it's completely unworkable. Regulation is desired by the European manufacturers.

Statutory Regulation of Homeopathy
This is often proposed as a solutions to many of the problems faced by UK lay homeopathy. The process towards statutory regulation would not be easy.

There would also need to be changes to the Medicines Act to allow registered lay homeopaths to prescribe unregistered homeopathic medicines. This would take time for drafting the legislation, the necessary consultation process and parliamentary debate etc.

It's unlikely to happen. Some lay homeopaths are vehemently opposed to statutory regulation.

Homeopathic Medicines de-classified as Medicines
I'm not talking a legal re-classification but a voluntary move on the part of the homeopathic pharmacies.

Quite simply, if they stop claiming the products are "homeopathic", they stop being regulated as homeopathic medicines. They would fall under food regulation. In reality, many so called homeopathic medicines are nothing of the sort. They could be called vibronic essences or something equally as daft.

This works because homeopathic medicines contain no active ingredients. It is impossible to distinguish a homeopathic medicine from an inert sugar pill.

This is a very pragmatic solution and could be implemented very quickly. Changes to packaging, labelling, promotional material and websites are all that are required. Yes, there will be a financial cost but this can be passed onto consumers.

However, I think that the homeopathic community will run a mile from such a suggestion. It invalidates so much of their philosophies.

The role of the MHRA

2012-05-31T04:13:00.001-07:00

The Medicines and Healthcare products Regulatory Agency (MHRA) have responsibility for the enforcement of the legislation and regulations that I have mentioned in previous posts. The MHRA is also the body that registers homeopathic medicines.

Mission Statement
From this page -

The MHRA’s mission is to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe.

That doesn't fit very well with the regulation of homeopathic medicines does it? Ensuring that medicines work? Oh dear.

Relevant Legislation
This is not a complete list but it is a good starting point for those wanting to know the legislation that both directly and indirectly impacts homeopathy.

Wanting to? Actually, if you are a lay homeopath and you are a member of a trade association, your professional codes insist that you read the above. To be fair, because legislation is not always presented in an amended form, it is almost impossible to understand when looking at the amending legislation but of course, the consolidated Medicines Act consultation document helps enormously.

Why doesn't the MHRA pro-actively enforce legislation?
I do not know but I do have some theories.

Certain people within MHRA do/do not understand the implications of legislation and regulations regarding homeopathic medicines even if the body corporate does/does not. Those charged with looking after regulation of homeopathy do either not have the knowledge nor the mandate to enforce legislation.

Homeopathic medicines in themselves present almost zero risk to the public. They carry the same risks as anything else that is small and made of sugar. The risks posed by homeopathy do not stem from the products.

The volumes of unregistered homeopathic medicines that make their way onto the market is relatively low compared to other more dangerous unlicensed and fake products. Despite the claims made for the numbers of users of homeopathy and the size of the UK market for homeopathy, it is fairly obvious that both are mostly associated with registered homeopathic medicines.

Homeopathic medicines, despite EU directives to the contrary, are not medicines. I'd not be surprised if some in the MHRA are less than happy with having to deal with homeopathic medicines. If nothing else, it's a distraction. It could be argued that culturally, the pharmacists and regulators as a group have never viewed homeopathic medicines as medicines.

The regulation of homeopathic medicines by the MHRA is supposed to be self-funding. It's not. Fee income is very low. Although the threat of enforcement should increase fee income, there would be a considerable gap in funding. But there is the issue of fees have to raised to cover costs in a climate where complaints to the MHRA regarding homeopathic medicines increase. Proactive regulation of homeopathy would increase fees.

It has been suggested that the Department of Health and the MHRA have been lobbied by the likes of Prince Charles. The MHRA as a regulator should be immune from lobbying (and that includes lobbying from the likes of me).

Enforcement could be a bit of a public relations problem. The MHRA are independent of government and Big Pharma. The consolidation of the Medicines Act is being painted by some as a government/Big Pharma attack on homeopathy. Enforcement would be also seen in that light. Some CAM practitioners have painted themselves as martyrs in response to the ASA acting on complaints regarding their websites.

Consultations and Advice
It is possible that the homeopathic trade associations and homeopathic pharmacies have been given poor advice by the MHRA in the past surrounding the business of placing unregistered homeopathic medicines on the market and the interpretation of "medical professional".

However, it is clear that the homeopathic trade associations and homeopathic pharmacies do respond to the various public consultation documents that the MHRA put out. Some of these consultations contain very clear explanations of legislation. I think this consultation document is somewhat wrong in some areas but...

This guidance has been developed by the Medicines and Healthcare products Regulatory Agency (MHRA) in consultation with the homeopathic medicines sector and advertising regulatory bodies. It is intended for advertisers and suppliers of homeopathic medicinal products.

This guidance interprets the legal requirements for advertising of homeopathic medicines to the public and to homeopathic practitioners and recommends best practice to ensure responsible advertising. It is supplementary to the regulatory framework as set out in the Medicines (Advertising) Regulations 1994 (SI 1994/1932 as amended – the Advertising Regulations), which implement Title VIII of European Directive 2001/83/EC.

Clear evidence that the homeopathic pharmacies were aware of at least most of the issues regarding the supply of unregistered homeopathic medicines.

Practical Advice to Individual Homeopaths

2012-05-30T09:28:00.002-07:00

I do feel genuinely sorry for individual lay homeopaths. Those that go quietly about their business. Of course, I have no sympathy for the foghorns or the lunatic fringe. I have no sympathy for those considered leaders in the community.

Unfortunately, the posturing and inaction of those people is going to hurt the little people. But I do have some practical advice that might help...

Who this applies to
If you are a doctor, dentist or veterinary practitioner, this does not apply to you. If you are a member of a healthcare profession that has statutory regulation, such as a nurse, midwife, osteopath or chiropractor, you could face action from your regulator.

This advice applies to anyone who practices homeopathy who has no medical training. And no, I'm afraid that qualifications from homeopathic schools, colleges and university degrees don't count. Nor do the BHMS and DHMS qualifications. Homeopathy has no legal recognition in the UK. You are just another member of the public.

Risks
You can carry on as you do now. The risks to you are low. You will never face prosecution. If you belong to a trade association, it is extremely unlikely that they will discipline you. What you might find is that your supply of homeopathic medicines may suddenly dry up as the homeopathic pharmacies are forced to comply with the law. And by keeping on in the same way, you dig a deeper hole for them.

The Legal Position
Forgetting advertising and promotion and concentrating purely on unregistered homeopathic medicines -

You can obtain unregistered homeopathic medicinces for yourself or someone under your care face-to-face in a homeopathic pharmacy. But "under your care" is a tricky concept. I think it means nearest and dearest, because you are not recognised as a medical practitioner of any kind.
You can supply a client with a specification for an registered homeopathic medicine that they can present face-to-face in a pharmacy. Do not call it a prescription. You have no prescribing rights.
You can not obtain stocks of unregistered homeopathic medicines even face-to-face. You must not hold stocks of unregistered homeopathic medicines.
You can not obtain unregistered homeopathic medicines by any other route. This includes the internet, telephone or even good old mail order.
You can not hold stocks of unregistered homeopathic medicines except for your own use and the use of your family.
You can not supply unregistered homeopathic medicines. Sale is a real no-no. Do not touch homeopathic childbirth kits because the law gets very messy. Do not attend childbirth.

Practical Advice

Whilst you can not obtain unregistered homeopathic medicines for supply to your clients, your clients do have some options to obtain them.

The best bet for them is to obtain them from Germany via phone or internet - because all almost all homeopathic medicines are registered there. Cultivating a relationship with online vendor in another EU country would be a wise move but be careful about how you promote it.

Cynically, you could just get them to order unregistered homeopathic remedies from UK pharmacies. Leaves you in the clear but the risk of the supply being suddenly cut off still exists.

For some, remedy makers might seem an option. However, the products that these produces can not be described as homeopathic. Supplying them as such opens up a can of worms. Also be aware than the machines are a real rip-off. The cost of the components is a tiny fraction of what is charged.

Further Advice

Don't bother with petitions to Goverment. You need to put pressure on the trade associations and the homeopathic pharmacies to get you out of this mess.

Consider changing from homeopathy to another form of energy medicine that does not involve physical substances.

Ask yourself if you would be comfortable with statutory regulation of homeopathy - bearing in mind you might be left on the outside or subject to a discipline you have never encountered before.

Give up. Do something real, something practical. Re-train.

The Plot Thickens

2012-05-27T16:39:00.002-07:00

I had heard that Karin Mont of the Alliance of Registered Homeopaths (ARH) had sent out an email to ARH members. And it turned up on the internet. I'll not quote the whole thing.

As some of you already know, the main homeopathy registers, and other important stakeholders within the homeopathy profession (such as the pharmacies) have been working together on a number of issues, to secure patients' ongoing access to quality homeopathy. The most recent issue has been the revision and consolidation of the 1968 Medicines Act, which is due to be ratified by the Statutory Instruments Committee any day now.

ARH responded to the recent Medicines and Healthcare Regulatory Agency (MHRA) consultation in depth, and pointed out several potential problems which would occur for both homeopaths and members of the public using homeopathy, if changes were not included.

Unfortunately, we understand that our recommendations have not been acted upon. We are concerned that if Government endorses the revised Medicines Act in its current form, this will have an adverse impact upon our access to the full range of homeopathic medicines.

Details are given below, but we now need you, your patients, your family and friends to take URGENT ACTION, and write to you MPs outlining your concerns. A template letter, which includes the key points, is set out below. We'd also be grateful if you could let us know directly, if you receive any response from your MP. We realise that some MPs may be actively 'anti homeopathy', but this should not deter you. If you write to them as one of their constituents, they are obliged to act on your behalf, even if that means nothing more than Ideclaring that they have a concerned constituent. If they suddenly find they have a number of concerned constituents, they really have to take notice.

This is the first call for mass action from ARH to our members and all their contacts. More will follow. Let's use this as a dress rehearsal to improve our overall performance.

I am sorry but the formatting of the information below will probably corrupt in this email, so please be patient and read through everything carefully, even if it looks a bit confusing! Thanks in advance for your participation.

Together we really can make a difference.

It then goes onto repeat the standard text. "Working together" is a key phrase. It does suggest a sharing of knowledge. Given the John Morgan email you do start to wonder if there is something that is not being shared.

A Bombshell
Louise Mclean is the homeopath behind a number of websites including http://www.homeopathyheals.me.uk Mclean has form in terms of posting very strange stuff on her websites as well as on the internet in general. A post on that website is very strange indeed. And very wrong in lots of ways.

I very much doubt that Mclean would ever directly engage with me. I'm not going to get the answer to the question of whether the post is all her own work or is derived from what is possibly an internal policy document.

I don't want to reproduce the whole post here but rather selected quotes, firstly -

The problem is that there are clauses in the Medicines Act 1968 which are not favourable to homeopathy and the reason for the recent furore, is that these clauses might be enforced in order to comply with EU directives which take precedence over UK law.

But hang on, the Medicines Act 1968 predates UK EU membership!

Around 60 homeopathic medicines, mainly in 30c potency, have actually been registered (licensed) because in order to register them, large batches and lots of paperwork were required for each one. Since 2004, homeopathy has been classified as a 'medicinal product' and the EU and MHRA do not want unlicensed medicinal products.

No. A fundamental misunderstanding. If the MHRA register a homeopathic medicine, potencies from 6X upwards are registered. And the de facto classification of homeopathic medicines as medicines predates 2004 and is the direct result of a long tradition of certain pharmacists insisting that they are medicine. You can't have it both ways.

So due to the fact that the majority of remedies are unlicensed, it would then become illegal to dispense them in any way - make up or prescribe them, as well as order them by phone or on the internet. They would not legally be allowed to go through the postal system. They would only be allowed to be dispensed face to face at a registered homeopathic pharmacy or by a local pharmacy.

Another misrepresentation. It is already illegal to place unregistered homeopathic medicines on the market. And no, a local pharmacy unless it were a branch of a homeopathic pharmacy could not legally obtain unregistered homeopathic medicines. It is slightly more complicated than that but your local pharmacy is not equipped to deal with the complexities.

Homeopathy should NEVER have been regulated along with pharmaceutical medicine and then none of this would have applied.

It isn't. Homeopathic medicines are currently exempt for tests of efficacy, rigourous testing of safety. Registration is a rubber-stamping process. The real implication of this statement is that homeopathic medicines are not medicines. Many would be happy with that but I think many homeopaths would be very upset by the implicit invalidation of the products and their trade.

According to Section 15 of the Medicines Act 1968, the UK Health Ministers will have the final say about changes to the Act. Hence it is vitally important that everyone writes to their MPs to ask them to make an exemption for homeopathic pharmacists to be able to post remedies to individual practitioners and patients, and for homeopathic practitioners to continue to be able to prescribe them.

Continue? Lay homeopaths have never had prescribing rights. And for all the mention of EU Directives, there is a fundamental lack of understanding that UK Health Ministers hands are tied by EU legislation that is a direct result of lobbying by European homeopathic interest and industry groups.

Digging a deeper hole
Frankly, the more that comes out, the worse the "threat to UK homeopathy" becomes. Railing against a "future threat" does not engage with the central problem which is that procurement/supply of unregistered homeopathic medicines is already very limited and has been for a very long time.

There will be no sensible debate or engagement with the UK homeopathic community. Too much is at stake for them.

The Role of the Homeopathic Pharmacies

2012-05-27T03:44:00.001-07:00

The homeopathic pharmacies are very much part of the story of the "future threat" to UK homeopathy. Certainly John Morgan of Helios Homeopathy has been sending emails to various people and Ainsworths have sent an email out too.

My previous post merely hints at the involvment of the homeopathic pharmacies. I think that they are directly implicated in this issue.

Those emails
I want to look very carefully at part of the John Morgan email that goes beyond the standard text -

The vast majority of the 3500 remedies available from homeopathic pharmacies are unlicensed. The 60 or so remedies which are licensed are those retailed in health stores and community pharmacies and include Helios’ licensed remedies. Section 10 (4a) states that a pharmacy can supply an unlicensed remedy to you directly but you have to be physically present in the pharmacy. For the last 44 years and beyond, the specialist pharmacies have provided homeopathic medicines, to all corners of the country, by phone, post, fax and more recently e-mail and internet. This is a safe and convenient service which has continued without complaint or risk to customers for decades and it is important that access to remedies continues.

So, Morgan mentions states that the majority of homeopathic medicines are unlicensed, then that Section 10 of the Medicines Act restricts the supply to pharmacy premises only and then says that for the past 44 years that supply has happened outside of this? There seems to be a fundamental disconnect here if not an outright admission of non-compliance with legislation and regulations.

Has continued without complaint for decades? No, past tense is required. The promotion an supply of unregistered homeopathic has been the subject of complaint (I would guess) resulting in this and this (although technically these webpages are still in breach of regulations).

Without risk to customers? Whilst homeopathic medicines in themselves pose no risk, the advice that goes with them can. But that's another story.

The Ainsworths email would appeal to just contain the text mentioned in a previous post.

Legislation and Regulations
The Medicines Act 1968 Section 10 is important for the exemptions granted to pharmacists in the supply of unlicensed medicines. The Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 as amended by the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005 clearly state the offences associated with the procurement/supply of unregistered homeopathic medicines but there are other regulations to consider.

The Medicines (Advertising) Regulations 1994 are also important. However, it is not necessary to read the document as the MHRA have produced draft guidance. Which states -

iv. Homeopathic products not registered or authorised by the MHRAAdvertising of unlicensed medicines in the UK is prohibited. Therefore homeopathic products which do not hold a current registration or authorisation under one of the above schemes must not be advertised.

and -

These restrictions apply equally to advertising on the internet. Product information, including sales material and any online purchase facility, may only be provided for licensed products.

So online purchase of unregistered homeopathic medicines is not permitted.

Professional Standards
The Pharmacists and Pharmacy Technicians Order 2007 defines the scope of statutory regulation of pharmacists and pharmacy technicians. The regulator is the General Pharamaceutical Council (GPhC).

Reading Standards of conduct, ethics and performance, I came across the following.

6.6 Comply with legal and professional requirements and accepted guidance
on professional practice

and reading Standards for registered pharmacies -

As an owner or a superintendent pharmacist you must...
...
1.7 Ensure that all legal and professional requirements are adhered to

And the GPhC has statutory powers to discipline.

Why are there so few Registered Homeopathic Remedies?
I've no idea. It's possible to speculate but check out this webpage on the MHRA website which says regarding the consultation on the advertising of homeopathy -

The MHRA has worked closely with professional and industry stakeholders to develop specific guidance for advertisers of homeopathic medicines. This is designed to provide clarity about the rules governing the advertising of homeopathic medicines licensed under the three regulatory schemes available. Advertisers of homeopathic medicines are encouraged to review their advertising to ensure that all materials comply with the new guidance. We are also inviting feedback from companies on practical issues raised by implementation.

Industry stakeholders? I would like to know who they were. The reason I mention this is that the need to register homeopathic medicines if they were to be sold over the internet should have been made very clear during the process.

So why didn't this process cause more registrations? I've no idea. But I am going to ask.

But...
I think it perfectly fair to blame the homeopathic pharmacies for most of the current situation. The paucity of registered homeopathic medicines would make life almost impossible to lay homeopaths and their clients if the law were enforced.

But if the law were enforced, other things would happen as well. A revenue stream would dry up. Homeopathic pharmacies and their superintendent pharmacists could face prosecution. Prosecution would lead to disciplinary action from the GPhC.

Implications for Trade Associations

2012-05-25T12:38:00.001-07:00

My last post outlined some of the issues but the implications for the trade associations that represent UK lay homeopaths and their members are extremely problematic.

Background
Although I am more than familiar with the history of the trade associations and some of their more bizarre antics, they aren't of much interest here.

One of the difficulties with the text quoted in my last post is whether the trade associations are aware of the current regulatory position regarding unregistered homeopathic medicines.

Interpretation of Current Legislation
What I find difficult to believe is that the analysis of the consolidated Medicines Act could be done in isolation. I don't think it could have been - the text talks of changes. Logically, a before and after analysis must have been done.

Who performed the analysis? A pharmacist who specialises in regulatory affairs? A lawyer specialising in medicines regulation? My guess is that either would have arrived at the same conclusions as I have. This would imply that whoever wrote the text ignored the the conclusions. Or perhaps it was conducted by someone with little understanding of legislation? Who knows.

The Sticky Bit
I want to return to the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 as amended by the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005. Schedule 6, paragraph 2 to be specific.

2. Any person who, in the course of a business carried on by him, sells, supplies, manufactures or assembles, or procures the sale, supply, manufacture or assembly of, a homoeopathic medicinal product, or who has in his possession a homoeopathic medicinal product, knowing or having reasonable cause to believe that the product was or is intended to be placed on the market contrary to paragraph 1 shall be guilty of an offence.

This is what makes the actions of lay homeopaths legally questionable in obtaining and dispensing/supplying unregistered homeopathy medicines. And the issue of possession is a big problem knowing that the product was or is intended to be placed on the market.

The Society of Homeopaths
Having scoured the SoH's website one thing that I can not find is anything that clearly states the duties of the SoH and its Board of Directors to the membership. Assuming that the SoH as an organisation is aware of the implications of current legislation, does it have a duty to inform members? I do not know but the ethics of not informing them are questionable to say the least.

The SoH's Code of Ethics and Practice states -

Section 4 - Legal ObligationsCriminal and civil law32 Registered and student clinical members are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising.
33 Registered and student clinical members must observe and are responsible for keeping up to date with all legislation and regulations relating directly or indirectly relating to the practice of homeopathy.

which is problematic given the sheer volume of legislation and regulations that currently impact on homeopathy.

The Alliance of Registered Homeopaths
Again, the ARH's website makes no indication of whether the ARH and its directors have a duty to inform members of the implications of current legislation.

The ARH's Code of Ethics and Practice states -

Legal obligationsCriminal and civil law30 Registrants are required to comply with the criminal and relevant civil law of the country, state or territory where they are practising.
31 Registrants must observe and keep up to date with all legislation and regulations relating directly or indirectly to the practice of homeopathy.

Almost identical wording to the SoH Code.

The Homeopathic Medical Association
The HMA are slightly different. The have an elected council. Their Code of Ethics and Practice states -

2.7. It is the responsibility of Members to be aquainted with and comply with the Laws of the United Kingdom, as they apply to the practice of homeopathy. Overseas Members must abide by the laws of the country in which they practice.

The Faculty of Homeopathy
The FoH do not have a Code of Ethics and Practice per se. They are members of statutory regulated professions with have their own professional standards... yet, baring doctors, dentists and veterinarians, the current legislation has an effect on some members and it begs the question whether the FoH understand current legislation and whether they have a duty to inform those members affected.

Penalties
The penalties that the trade associations impose range from a gentle ticking off to expulsion and being barred from membership of other trade associations.

There is an interesting question regarding suspension. Non compliance with legislation is a serious matter but there is the principle of innocent until proven guilty. But there is also the precautionary principle.

Determining Knowledge of Current Legislation
A straight question should get a straight answer but some of the trade associations have a habit of ignoring or avoiding.

There is another way to reach a determination and it carries with it enormous dangers for the trade associations: formal complaints against Directors/Council Members who are active lay homeopaths. If this were done in tandem with formal complaints to the MHRA, it would be difficult for the trade associations not to act.

I do not think it is necessary to resort to such tactics yet.

But...

Bad Implications
If complaints were made against Directors and assuming that they are taken seriously, there is the potential for Directors to be suspended or removed, effectively crippling a trade association.

Widening the scope of complaints to include some or all ordinary members would choke the trade associations' ability to deal with complaints but widening it to include more notable high profile members might be a useful tactic, especially those involved in training/supervision/education.

The Threat to UK Homeopathy

2012-05-24T03:50:00.002-07:00

UK homepaths are up in arms about what they perceive as a future threat to the supply of homeopathic medicines. There is a text that has appeared in a number of places.

Patient access to homeopathic medicines is under threat

Why?

The Medicines Act is being simplified, which is a good thing because much duplication is being removed. However, as a result there are some key elements which could adversely affect your access to homeopathic medicines if the proposals go into force.
What will happen to my access to homeopathic medicines?
If the current proposals by the MHRA are endorsed by government the following would occur:
You would no longer able to get homeopathic medicines by phone or online
To get any unlicensed homeopathic medicine a face-to-face consultation would be required at a registered pharmacy. Unlicensed medicines number in the thousands and make up the majority of homeopathic prescriptions, while there are only 50 licenced homeopathic medicines. This will also mean you cannot legally buy unlicensed homeopathic medicines online or over the phone as you currently do.
Homeopaths would not be able to dispense or prescribe medicines to you
Homeopathic practitioners would not be able to dispense unlicensed homeopathic medicines to their patients. This arises because homeopaths are not recognised by this law as being supplementary prescribers and it will be illegal for homeopathic pharmacies to supply them with the essential (unlicensed) medicines required for their patients
You would have to get your homeopathic medicines personally at a handful of licenced homeopathic pharmacies in Britain
Hundreds of thousands of people who currently have prescriptions filled for unlicensed homeopathic medicines will be unable to obtain their urgent medicines. The estimated 6 million users of homeopathy in Britain cannot be expected to be supplied medicines face-to-face by less than five licenced premises.

What you can do to stop this from happening!
Write to your MP and tell him or her - especially if your MP sits on the Joint Committee on Statutory Instruments or is involved with Health or Pharmacy.
We are not asking to move mountains. All that needs to be done is a small change to Section 10 of the proposed new Medicines Act to allow greater freedom to dispense remedies to practitioners and could also overcome the face-to-face issue which is unworkable.
On the next page you will find a few helpful bullets and links to assist you in contacting your MP on this issue, if you need any assistance or have concerns, please contact xxxx at yyyyyy@yyyyy.yyy or call nnnn nnnnnn.
It is anticipated that the new Medicines Act will be put before the Joint Committee on Statutory Instruments for approval in late May/early June for implementation in July, so your swift action is critical!

Write to your MP: Medicines Act consolidation 2012
You can identify the name of your MP by using this website: http://findyourmp.parliament.uk/
You can find out who sits on what committees by going to this website:
http://www.parliament.uk/business/committees/committees-a-z/

A few helpful points that could be used in your letter:
It is not necessary or recommended to include all the text suggested here. It is critical that you personalise your letter with your own views and experiences. Overall, try to keep the letter short (a page or less), and emphasise any points that are relevant to the particular MP.
·         I’m deeply concerned a draft proposal set out by the MHRA as part of its consolidation and review of the Medicines Act 1968 could have a significant impact on my ability as a patient to access homeopathic medicines in the UK.
·         In its current form section 10 of the proposal would only allow unlicensed homeopathic medicines to be bought directly from a pharmacist face-to-face, in effect outlawing the purchase of these medicines over the telephone or via online ordering. This would mean I would be deprived of the medicines that I have found to be so beneficial to my health.
·         There are only five homeopathic pharmacies in the UK, so most homeopathic medicines are ordered from these specialist pharmacies either by phone or via the Internet. Therefore the enforcement of section 10 in its current form will have serious consequences for the six million people in the UK who choose to use this form of complementary medicine.
·         If not revised the proposal would also have serious consequences for more than 2,000 homeopathic practitioners, many of whom would find it impossible to treat patients like myself because they can no longer obtain the appropriate homeopathic medicine.
·         I understand that a central plank of government health policy is to increase patient choice. Section 10 will eliminate choice for people like me who want to be treated with homeopathy.
·         I would like to call on your support in getting the Health Minister to revise slightly the proposed language of the revised Medicines Act to ensure that I have continued access to a full range of homeopathic medicines and my right to choose homeopathic treatment is maintained.

I am lead to believe that the main text is something that was agreed between various homeopathic organisations for distribution to their members and more generally.

The problem with the text is that it is misleading and contains various errors and omissions.

General Points

Just Consolidation

What is being proposed is a consolidation of the Medicines Act 1968 and various associated Acts, Regulations and Orders. More information can be found on the MHRA website here.

A consolidation does not mean a change. No new provisions are being introduced (although some contradictory provisions are being lost). There are changes to the language used - it is much clearer than some of the older legislation. It could be argued that the changes in wording cause a change in meaning but in my opinion this is not the case.

No Future Threat - A Current and Historical Threat
Because the consolidation is just that, the perceived future threat must exist now. And it does. In comes in the form of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994 as amended by the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005. Schedule 6 of the amended regulation states -

1. Any person who, in breach of these Regulations, places a homoeopathic medicinal product on the market without holding a certificate of registration in respect of that product, or otherwise than in accordance with the terms of such a certificate, shall be guilty of an offence.

2. Any person who, in the course of a business carried on by him, sells, supplies, manufactures or assembles, or procures the sale, supply, manufacture or assembly of, a homoeopathic medicinal product, or who has in his possession a homoeopathic medicinal product, knowing or having reasonable cause to believe that the product was or is intended to be placed on the market contrary to paragraph 1 shall be guilty of an offence.

and

12. Any person guilty of an offence under any of the preceding paragraphs shall be liable—
(a) on summary conviction, to a fine not exceeding the statutory maximum;
(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.

This is the real issue and it exists in prior legislation as well although not as clearly stated.

What does this mean?
In short, there are a limited number of homeopathic medicines that are registered. These can be sold, bought and supplied to clients freely.

The homeopathic pharmacies often boast that they have thousands of homeopathic medicines available. The majority are not registered. Thus they can not be placed on the market. They can not be advertised. They can not be freely sold by the homeopathic pharmacies nor can they be purchased by lay homeopaths nor can lay homeopaths supply them to their clients.

Exemptions
The Medicines Act 1968 does have some exemptions for pharmacists relating to the supply of unlicensed medicines - which unregistered homeopathic medicines are - to the public. Section 10 contains the exemptions. It is difficult to read yet I see nothing that allows the supply of unregistered homeopathic medicines via telephone or over the internet to the general public. I see nothing that would allow supply to lay homeopaths, full stop, except to clients directly under their care.

The exemptions revolve around what happens in a pharmacy and/or under the supervision of a registered pharmacist.

EU and Industry Driven
UK law relating to homeopathic medicines is ultimately driven by EU Directives - EU Directive 2001/83/EC is the most important. Chapter 2 states -

Article 13
1. Member States shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorized in accordance with Articles 14, 15 and 16, except where the products are covered by a registration or authorization which was granted under national law on or before 31 December 1993 (and whether or not that registration or authorization has been renewed after that date). Each Member State shall take due account of registrations and authorizations previously granted by another Member State.
2. A Member State may refrain from establishing a special, simplified registration procedure for the homeopathic medicinal products referred to in Article 14. A Member State shall inform the Commission accordingly. The Member State concerned shall allow the use in its territory of homeopathic medicinal products registered by other Member States in accordance with Articles 14 and 15.

These directives are the result of heavy lobbying by the homeopathic industry. These directives protect the homeopathic industry from cheap non-EU imports and "fake" homeopathic medicines amongst other impacts.

Indifference
The EU directives place a duty on Member States to ensure that unregistered homeopathic medicines do not reach the market. In the UK, that duty resides with the MHRA. The MHRA rarely enforce regulations and do so in response to complaints from the public rather than pro-actively enforce.

Other EU Member States vary from complete indifference to rigorous enforcement.

Specific Points

Rights, Choice and Freedom
Claims that the proposed changes erode patient rights/choice/freedom are illusory because they never existed.

No way to obtain unregistered homeopathic medicines except by visiting a pharmacy
Not strictly true.

It will still be possible for those that use homeopathic doctors to obtain a prescription and submit the prescription to a homeopathic pharmacy. I would guess that they will accept a faxed or scanned prescription. It may well be the case that some homeopathic doctors will, in some circumstances provide a prescription as the result of a telephone consultation. There are more of them of them than you think.

And because of the bizarre way that regulatory of veterinary homeopathic medicines was introduced, some products that are unregistered for human use are permitted for use of animals (but by owners and veterinarians).

The Medicines Act 1968 allows for importation for personal use. Ordering a homeopathic medicine from another EU country where the product is registered is relatively easy. Ordering from outside of the EU is just as easy.

UK homeopathic pharmacies are only able to supply members of the public, including lay homeopaths, with unregistered homeopathic medicines on a face to face basis for personal use or for someone under their care.

What can they do to stop this from happening?
Nothing. It's already happened.

Petitions, writing to MPs, use of social media will change nothing. It would require either changing EU law (which is unlikely given the vested interests) or securing an opt-out. Then the changes would need to be made to UK law. Parliamentary time would be required.

Remedies such as mass registration of homeopathic medicines would take time and cost money.

6 Million Users, 2000 Practitioners will lose out
Nonsense. The 6 millions users is an estimated figure. Many of them will solely use registered homeopathic remedies that they can buy almost anywhere. I doubt very much that those 2000 practitioners could service 6 million users.

Urgent Medicines
It's a brave lay homeopath who attempts to treat acute conditions without deferring to the medical profession.

Doomsday

The issue with the misrepresentation of the situation is that any open discussion of the issues will reveal the threat is current. Open discussion will reveal that it appears that many in the UK homeopathic community act outside of the law.

Prosecution is not really the issue. Interaction with professional ethics and standards are. Compliance with legislation is part of all professional codes. The ethics of consciously acting outside of the law are tricky to say the least. Non compliance leaves one open to disciplinary action by a professional body. Depending on the body involved, it may have little discretion in mounting disciplinary investigations and failure to do so may carry risks for the body itself.

The financial impact of compliance on the UK homeopathic pharmacies will vary. It depends on how much of their revenue comes unregistered homeopathic medicines.

The impact on lay homeopaths is difficult to quantify. They do have the option to change the way they operate with regards to unregistered homeopathic medicines. Without change, UK lay homeopathy will shrivel away to almost nothing.

Now that the issues are in the open, the process is unstoppable.