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Malleus HomeopathicumA blog about UK regulation of homeopathic medicines and its implications for homeopathy
Jul 3
No Victory for UK Homeopathy
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. The 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.
Posted 9 hours ago by MalleusHomeopathicum
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Jun
29
Homeopathic Pharmacies intend to break the law
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.
Posted 4 days ago by MalleusHomeopathicum
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Jun
28
An Open Letter
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?
Posted 5 days ago by MalleusHomeopathicum
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Jun
26
Nurses and Midwives and Homeopathy Part 1
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.
Posted 1 week ago by MalleusHomeopathicum
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Jun
23
How deep a grave do they want to dig?
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.
Posted 1 week ago by MalleusHomeopathicum
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Jun
19
Wrong Again!
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.
Posted 2 weeks ago by MalleusHomeopathicum
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Jun
18
House of Commons Library Briefing: Updated
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...
Posted 3 weeks ago by MalleusHomeopathicum
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Jun
16
Chiropractors and Osteopaths and Homeopathy
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.
Posted 3 weeks ago by MalleusHomeopathicum
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Jun
14
Prescribing Rights
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.
Posted 3 weeks ago by MalleusHomeopathicum
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Jun
11
Closer but still no Cigar
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?
Posted 4 weeks ago by MalleusHomeopathicum
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Jun
7
The Suicide Notes
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.
Posted 4 weeks ago by MalleusHomeopathicum
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Jun
2
Worse from the Trade Associations etc
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.
Posted 2nd June by MalleusHomeopathicum
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Jun
1
More Misinformation from the Society of Homeopaths
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.
Posted 1st June by MalleusHomeopathicum
