Calling all UK homeopaths! Important developments are occurring in your profession, and we believe the current campaign directed at UK Members of Parliament (MPs) won’t give you all the information you need. Download and read our new feature right away!
What’s going on?
A high-profile campaign by representatives of homeopathy in the UK claims that long-cherished prescribing rights are on the verge of being lost, with the result that patients will find it far more difficult to get the specific homeopathic remedies they need.
The concerns stem from a spot of legal spring-cleaning being performed by the UK’s medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA). Having decided, quite rightly, that UK medicines legislation is fragmented, overly complex and difficult to follow, the MHRA is in the process of consolidating all the relevant laws into one piece of legislation.
A consultation took place earlier this year, and homeopaths, their professional organisations and homeopathic pharmacies all contributed concerns and suggestions. According to the letter-writing campaign, these concerns were not acted upon by the MHRA – and the consolidated legislation will cause enormous difficulties for UK homeopaths and their patients.
The truth in brief
When we looked into it, we found that the legal situation appears to be somewhat at odds with the information provided in the campaign. In short, we don’t think that the MHRA’s legal consolidation will change anything, because professional homeopaths in the UK have never had the legal right to prescribe anything – and that includes the unlicensed homeopathic remedies that constitute the major part of the Materia Medica.
You need to know this information!
UK homeopaths – if you are going to make an informed decision about this issue, and perhaps your professional future, you owe it to yourself to read our feature. Homeopathy exists in a legal grey area, and we don’t feel that the current campaign provides all the facts you need.
It’s not just the UK...
Confusion about homeopathy is the norm throughout Europe. According to Steve Gordon, General Secretary of the European Central Council of Homeopaths, “The situation elsewhere in the EU is, at least, heterogeneous. In fact, it’s a complete mess. The EU Directives have attempted to harmonise the situation across Europe...but the unharmonised way the new regulations are being interpreted and implemented in many countries is making it more difficult and expensive for the manufacturing companies to make their products. It’s a bit of a nightmare for everyone.”
Call to action
- Read the feature
- Contact your professional organisation and the homeopathic pharmacies and share our interpretation of the legal situation with them. A new and more effective lobbying strategy may be required and the best place to start is a point of total transparency!
List of homeopathic pharmacies
Professional organisations:
Alliance of Registered Homeopaths
British Homeopathic Association
Homeopathic Medical Association
Other organisations that may be involved in the campaign:
Comments
your voice counts
27 June 2012 at 10:05 pm
Homeopathy does not exist in a grey area. The law is clear enough for those can read it.
Firstly, the definition of a medicine can be found in Section 130 of the Medicines Act 1968 as enacted. The key phrase is -
"(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 ;"
I can not see how this doesn't encompass homeopathic medicines. Weasel words aside, if they aren't used for the purposes of treating disease why are they used on ill people?
Secondly, Section 10 of the Medicines Act 1968 is pretty clear, but for a really clear indication of illegality see the Medicines (Homoeopathic Medicinal Products for Human Use) Amendment Regulations 2005.
Anyone call themselves a "homeopath" - it's not a protected title. There's absolutely no need for qualifications whatsoever. "Professional" is far too strong a word.
At the time of enactment of the Medicines Act 1968 in 1971, the number of UK lay homeopaths was tiny, a mere handful. Medical homeopaths were in the majority but medical homeopathy had suffered a decline in the post-war period.
29 June 2012 at 5:48 pm
Dear Malleus Homeopathicum, we’re not sure you have read our article in its entirety. If so, it’s a little surprising that you refer just to the definition of a medicine in the 1968 Medicines Act. The European (base) Directive 2001/83/EC and its even more problematic 2004 amendment (2004/27/EC) contain the updated definition of a medicine, as well as specific articles that relate specifically to registration of homeopathic medicines. The relevance of the 2001 Directive is clearly seen by the repeated references to the “2001 Directive” (i.e. 2001/83/EC) in the Medicines for Human Use (National Rules for Homeopathic Products) Regulations 2006 (SI No 1952).
27 June 2012 at 11:23 pm
Thank you for that analysis; I quite agree with most of it.
I'm also astounded that so many homeopaths have such little grasp of the situation, so little interest or skill in watching legislation; it's as if we've been out-manoeuvred in a long chess game, without noticing.
Two things stand out: firstly that the MHRA & ministers continue to claim "no regulatory change", in a narrow focus on section 10, when there clearly is relevant change (and it is not in section 10), and secondly the (stop-gap) regime of licensing PLRs, where it is claimed that homeopaths are at fault for not licensing more.
A third is the whole health-censorship issue of what a homeopathic physician may claim to treat, as embodied by the ASA (the organisation that condones, insists upon, the fantasy offer of "up to" 8Mb broadband speeds) on the basis of Singhian pseudo-science.
That little technical tidying-up of who may prescribe (the closed-shop agreement), at the behest of the EU, & behind them, Codex Alimentarius, (and behind them ???? - lets conspire not to recognise the conspiracy) is where the poison lies.
It need not be put into law in the way that is proposed, in my opinion - if not in the opinion of the MHRA. And to claim there is no change is disingenuous.
Perhaps we may secure a formal agreement to excuse highly diluted remedies as inherently safe; any resolution depending on the good will of whoever happens to be incumbent in the position of regulator is clearly unsatisfactory, as is forcing homeopaths into illegality.
Alternatively - and I might begin to sound like a pseudo-skeptic here - I suppose one could open a chain of claim-free specialist sweetshops to stay within the letter of the law (up to & until the THMPD lists lactose as a banned substance, in an echo of the AMA earlier in time).
The other point is the nature of registration of products, as for the treatment of a named disease. It is a narrow view.
Plainly, this is not how homeopathy works; we prescribe according to the nature of the patient, not on the basis of killing a disease.
Hence any licensing scheme depending on indications "for the treatment of" anything but the individual patient is misguided, to say the least.
It is a bias that may well suit opponents of the modality.
This whole style licensing scheme also works against innovation, and specific modes of working like reverse tautopathy - which has had such good results with vaccine-induced autism amongst other things. It is not reasonable to prevent such things unless there is proven danger. (Oooops, am I allowed to say that under the New Censorship? It's true anyway.)
In the UK, all this construction, remember, is on the basis of the 1968 Medicines Act, which was brought into being in the wake of the (pharma) Thalidomide tragedy; the will of Parliament being to minimise the dangers of (pharma) drugs, and balance that harm against possible benefit (benefit in terms of health, not profit, that was to say).
These are poisons to which homeopathy has been in opposition, for its entire existence.
It is just plain injustice that homeopaths should be the ones to suffer from a Napoleonic interpretation of what we free citizens may be allowed to do.
Especially when you consider that Napoleon used homeopathy.
28 June 2012 at 4:55 pm
Maybe this is part of big pharma's plan, just make it as difficult as possible in every way they can. Nothing they do surprises me any more. Their mad, often unverified or downright dodgy science is nothing short of scandalous. Whereas proper science such as homeopathy is constantly dismissed. A shocking state of affairs, it is after all our tax pounds funding this ridiculous situation.
28 June 2012 at 8:07 pm
Usually I applaude the things you do and campaign for, and I have supported you several times with donations. This time, though, you seem to have got it wrong. Wrong in the sense that you seem to be relying on information from a blog by some unknown person. Why would anybody be interested in blogs that are anonymous? The other thing that annoyed me about your fear-mongering article is that you imply that you know more than homeopaths themselves do. You seem to be saying that homeopaths are basically a bunch of ignorants. Sorry, friends, you need to do your homework more thoroughly. Times are always difficult for homeopaths in this country; that's to do with the overpowering influence of the pharmaceutical industry here on the whole health system. And we have not always been great in defending and representing ourselves, but over the last couple of years we have learned a great deal and that will show in this lastest debacle.
Cheers to homeopathy.
29 June 2012 at 5:21 pm
Hi Ursula, thanks for your comment and your support. We thought long and hard before publishing this article, but we feel that we had no choice - thorough research led us to the conclusions we describe in the piece. Changing our conclusions to go along with the current campaign, or not publishing an article at all, would in our view not be doing anyone any favours. Nothing in this tricky situation is going to change unless everyone begins from a position of clarity.
One of the difficulties is that we don’t believe there can be clarity if the EU background to homeopathic legislation is ignored. We feel that confusion has occurred among some sectors of UK homeopathy owing to an inadequate recognition of European law on medicines and homeopathic medicines. This article is our attempt to not only stimulate debate but also hopefully to bring some further clarity. We don’t believe it is "scaremongering" in any way, since it implies that we have invented a situation in order to instil fear. The situation exists; the UK campaign is proof of that; it's the legal reality that matters.
Forgive us for saying so, but you seem to be misreading the relationship between ourselves and Malleus Homeopathicum's blog. The fact of the matter is that his or her reading of the law is very similar to our own - although by no means identical, as we pointed out in the article. We referred homeopaths to it because we think it contains information that they need to consider and evaluate, which isn't available anywhere else. We didn't base our article on the contents of the blog, and the reasoning behind our position was laid out clearly in the article.
If you think our position is wrong, please point out why and should we concur with your reasoning we’d be more than happy to post a correction. As I alluded to earlier, our main criticism of the UK campaign is that it doesn't take into account the European legislation, something that we at ANH-Intl are all too familiar with! Have a read of the legislation yourself - the links are all provided in our article - and see what you think.
We’d be very happy to continue the debate on points of technicality, as it is the outcome of such debates that is of key issue, rather than the background of the individuals presenting their views.
29 June 2012 at 9:35 pm
I have read the article very careful. I was trying to make the point that definitions of a "medicine" certainly predate the EU directives. The historical context is very important because incorrect interpretations of history form part of the some of the claims made by homeopaths in defence of their untenable position. Sticking your head in the sand for decades is not really a solution to regulatory problems.
30 June 2012 at 12:16 am
These unlicensed homeopathic medicines are not being marketed therefore EU regs dont apply so long as a pharmacy fulfills an unsolicited request from a member of the public. Therefore the GPhC regulates the supply of unlicensed homeopathic medicines from pharmacies. Now if the GPhC dumps homeopathy then Peter who writes Malleus (I cant believe you dont know who he is) may be happy.(If that is possible) You dont mention that the MHRA only pursue complaints that it is 'in the public interest' to pursue. With many MPs following this issue both the MHRA and GPhC will have to be very carefull about enforcment.
Peter is right when he says that the campaign was too late. The MHRA dont like unlicensed medicines being supplied anywhere and they would have advised the minister that a detailed impact assessment would be needed before any change could be made.
You also fail to mention that the health minister can change section 10 according to section 15. Changing this is a tall order but might be possible with a huge coordinated campaign forcing the issue. Meanwhile we have a grey area where no one knows for sure the outcome not even you and Malleus.
01 July 2012 at 8:28 pm
The 2005 regulations wont apply as the pharmacies are supplying these unlicensed medicines as extemperaneous nostrums in the case of supply to the general public. The GPhC do not consider this pharmacy supply route as 'marketed- not when I asked them anyway.' Maybe they have or will change their policy on this? Someone is in for a shock here. It wont be long before we know who is right.
01 July 2012 at 11:30 pm
I have an appointment to meet with THE Health Minister at surgery this month. 12 days time. I have 2 letters sitting in his surgery which he has reviewed. I have 14 minutes so whilst I read the varying views above, could we collectively agree the beginning of what I will continue to hound him about as long as he remains my MP?
I will keep going back, provided I have a clear line of request and detail to back it up which, though hard, can be achieved.
Previously experienced success of getting "Free and Easy access to water" for school children (Healthy Schools policy) which took years and sure beats leaving the state to long term dehydrate them - things are now so much better on that score. So I have experience of persistence, patience and finally getting results (as long as I can find others to work with)! And I have some time so who are the detail experts and strategists who want to back this up? Lets go!
Cambridgemum
02 July 2012 at 2:34 pm
I think "Anonymous" and "Scepticus norvegicus" - if not the same person - both misunderstand the difference being marketing and "placing on the market".
The supply of unregistered homeopathic medicines, whether magistral or officinal, is not restricted on the premises of a registered pharmacy. And of course, there are exemptions for certain registered medical practitioners. Making unregistered homeopathic medicines available to the general public (which non-medically qualified homeopaths are, legally speaking) outside of the physical pharmacy setting is, de facto, placing them on the market.
It is important not to view unregistered homeopathic medicines as a special case. They are unlicensed medicines and the same restrictions apply as for unlicensed medicines that are actually medicines. It is the registration process that gives homeopathic medicines their special status. Although it is extremely unlikely in the case of UK manufacturers, an unregistered homeopathic medicine could potentially contain anything.
The fact that the remedies are held in stock or made to order does not matter. Pharmacies are permitted to hold stocks of unlicensed medicines that they believe will be ordered.
It isn't a question of the MHRA only pursuing complaints that are in the "public interest". Of course, it is understood that the MHRA will prioritise issues that have most impact on public safety but they still have a statutory duty to ensure that the law is upheld without prejudice.
One of the interesting questions to consider is how MHRA regulation of homeopathic medicines is actually funded. Fee income from the registration of homeopathic medicines? That would not cover the costs. By default, regulation of homeopathic medicines is subsidised by Big Pharma (not the tax payer - the MHRA is self-funding and generates a small surplus).
09 July 2012 at 6:37 pm
Hello everyone! This article certainly stirred some interest and controversy, and to further clarify our position we've just posted a blog piece by Adam Smith, ANH-Intl science & communications officer and the original author of the piece. You can find it here: http://anhinternational.org/blog/uk-homeopathy-a-clarification-of-a-clarification.
Your voice counts
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