Tuesday, October 12, 2010

Can you help the MHRA make sense of UK homeopathy advertising?


In August 2009 (that's 1 year and 2 months ago), a complaint seen by this blog went to the Medicines Healthcare Products and Regulatory Agency (MHRA) regarding a number of websites who were breaching the UK National Rules on homeopathic product advertising. (You may or may not know that there are a very limited number of homeopathic products which are allowed to claim benefits against therapeutic indications).

In some cases, the MHRA took action, with Boots, Nelson's, Neal's Yard and Holland & Barrett all being forced to remove therapeutic indications from their websites.

In the three months that followed, more complaints went in with little response, except an email in December from MRHA last year to say:
We are currently working on producing additional advertising guidance specifically for homeopathic products.
...followed by the sound of something being kicked into the long grass.

Today, a full year after the majority of complaints went to the MHRA, they have produced a draft document, which will be on their website soon, but you can download from here. Perhaps I'm being harsh, but doesn't read like it has been worked on for a year, more like a week.

To recap briefly, there a three homeopathic registration schemes;
1. PLRs - these registrations ran from 1971 to 1991 and allow products to have therapeutic indications, and are *not* covered by advertising regulations (see later), according to Medicines (Labelling and Advertising to the Public) Regulations 1978 (SI 1978/41).

2. Simplified scheme (HR license) - these ran from 1992 to 2006, and mean that homeopathic products could be licensed, but with no therapeutic indications.

3. National Rules Scheme - this is how new licenses are granted and may include therapeutic indication, but no efficacy needs to be demonstrated. It is 'hoped' that manufacturers holding PLRs will update them to NR licenses. (Fat chance, as the PLRs allow the manufacturers to claim all sorts of benefits according to the original license).

So you can see why there is some 'guidance' needed on the advertising.

This leads to all sorts of silly shenanigans - for example, Nelson's Coldenza, a homeopathic remedy for the relief of the symptoms of cold and flu, contains Gelsemium and has a PLR license, so can promote its therapeutic indications. Nelson's Homeopathic Gelsemium however, has a modern HR license, and so can't provide any indication for what it might be used for.

Nothing to do with evidence or efficacy, just a quirk of silly legislation.

The myriad complaints that were provided to the MHRA which helped prompt this document, were made because of the UK legislation and this is reiterated:
Only the information included on the product labelling registered with the MHRA, listed in Schedule 5 of the Regulations, may be included in advertisements for the product. No mention of a specific indication or therapeutic claims may be made.

Then, on top of page 4:
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 the MHRA are consulting on a document which has taken them over a year to form, which states that the some of the homeopathic products on sale must not include therapeutic indications and that these rules cover the internet. It also says that some may include therapeutic information, but give no idea as to which are allowed and which aren't. For instance (although this needs checking), Weleda Sulphur 30c can be sold with the indication for skin irritation, whereas Nelsons ClikPak Sulphur 30c can't. Both exactly the same product, i.e. sugar.

This means that AltHealth, WWSM, ChemistDirect, Express Beauty, Garden.co.uk to name a small few amongst the sea of UK homeopathic vendors are not adhering to the UK regulations and therefore appear to be breaking the law.

The MHRA don't seem too interested in dealing with them. Luckily, these products have no effect, and possibly the worst that could happen is that someone delays getting real medicine, but I can't imagine the MHRA being this lackadaisical about medicinal products that actually have an effect.

Annex 1B reminds us that
"Manufacturers and suppliers must not provide free sample(s) of a homeopathic product to any member of the public."
Who on earth would do a thing like that? *cough* Napiers of Edinburgh *cough*

Annex 1C of the document gives a recap of what Regulation 9 states as the rules of advertising (although these don't apply to the products with PLRs).
Regulation 9 provides that advertising to the public must not:
• give the impression that a medical consultation or surgical operation is unnecessary, in particular by offering a diagnosis or by suggesting treatment by post, FAX or telephone;
• suggest that the effects of taking the medicinal product are guaranteed, are unaccompanied by side effects or are better than, or equivalent to, those of another identifiable treatment or medicinal product;
• suggest that health can be enhanced by taking the medicinal product;
• suggest that health could be affected by not taking the medicinal product;
• be directed exclusively or principally at children;
• refer to a recommendation by scientists, health professionals or persons who because of their celebrity, could encourage the consumption of medicinal products;
• suggest that the medicinal product is a foodstuff, cosmetic or other consumer product;
• suggest that the safety or efficacy of the product is due to the fact that it is natural;
• might, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
• refer, in improper, alarming or misleading terms, to claims of recovery;
• use, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, or of the action of a medicinal product on the human body or parts of it.

Feel free to play "Regulation 9 Bingo" on your homeopathy site of choice, but remember that these regulations apply on one website but not another, they can even apply and not apply in the same shop.

To wrap this rather rambly and confusing post, the guidance document does provide some clarity on a very confusing and pretty laughable piece of legislation. With regards to a response, I think they could sharpen it up a bit and provide more information, but it's obvious that they are trying to disentangle a hairball, when it's clear that a more fundamental look at the legislation is needed.

I'll be giving them my view, and I'm sure they'd be very keen to hear yours.

(H/t to @zeno001 & @landtimforgot)


BPSDB

2 comments:

  1. The UK legislation and regulations regarding medicines full stop are a mess. In the sense that they are spread over multiple documents including primary and secondary legislation and various bits of guidance.

    Having said that, the guidance I have seen on advertising for the Simplified Scheme is pretty clear and predates the document you link to.

    "Only the information specified in labelling requirements may be used in the advertising of registered homoeopathic products. No mention of a specific indication may be made. Leaflets available at the point of sale are subject to the same restrictions. Reference books and periodicals available at the point of sale may describe the use of homoeopathic substances but must not promote any particular registered product."

    It's worth pointing out that -
    i) PLRs were given to all homeopathic medicine on the market in 1971. No new homeopathic remedies could be placed on the market until 1992.
    ii) The Simplified Scheme is still ongoing. It is driven by EU regulation and a desire for harmonisation of regulation.
    iii) The National Rules scheme hasn't replaced the Simplified Scheme - it runs along side it.

    ReplyDelete
  2. Interesting stuff.

    I've currently got a vaguely similar complaint lodged with Trading Standards regarding Nelsons, on the grounds that the claims they make for Coldenza et al are a clear breach of the Consumer Protection Against Unfair Trading Regs. After some fairly sustained efforts to wriggle out of enforcing it, Trading Standards now seem to have accepted that there is at least an argument to have, and are apparently seeking legal advice on it.

    This has been rumbling on for a good 8-10 months now, so not exactly turbo-charged, but I do feel like I'm slowly getting somewhere.

    ReplyDelete

Share it