Challenging misleading healthcare claims.

Obeying the rules

Blue GuideSince we started, we've been quietly submitting complaints to the medicines regulator about sellers of homeopathy 'medicines' who appeared to be not complying with various medicines regulations.

It's time to let you know about our 30 successes.

There are rules surrounding the advertising of medicines. There have to be to protect the public from misleading claims. It's illegal in the UK, for example, to advertise prescription medicines to the public. That protects the public being swayed by advertising gloss, spin and downright deception and probably saves many a GP from being bombarded by requests for medicines they do not need.

But there are also rules and regulations surrounding homeopathic medicines. These are enshrined in various EU Directives and transposed into UK laws and regulations. (Unfortunately, those same Directives call them 'medicines' — this is highly misleading in itself, of course, but, when discussing the regulations formally, it is easier to stick to the terms it uses.)

All medicines in the UK are regulated by the Medicines and Healthcare products Regulatory Agency (MHRA) and they publish their guidance on advertising in what they call their Blue Guide: Advertising and Promotion of Medicines in the UK. A special Annex gives guidance on the advertising of homeopathic medicines that also gives useful information on the underlying EU Declarations and legislation.

But first, some background on the categories of homeopathic products that the MHRA 'regulate':

  • Marketing Authorisation (MA)
  • Product Licences of Right (PLR)
  • National Rules Scheme (NR)
  • Simplified Scheme or Homeopathic Registration (HR)

There are no homeopathic medicines that have Market Authorisation because evidence of efficacy is required — a dizzy height homeopathy has never been able to reach, of course. Conventional medicines have MAs.

Product License of Right (PLR)

There are under 500 homeopathic products that have Product Licences of Right, but the only requirement they had to meet to gain this licence was that they were on sale in 1971 when the Medicines Act 1968 came into force: no proof of safety; no proof of efficacy. In fact, all medicines, homeopathic or not, were automatically given PLRs by the MHRA’s predecessor, the Medicines Control Agency. But, by the early 1990s, most conventional medicines had been reviewed and either given a full product licence (MA) if they met the criteria (including evidence for efficacy) or they were withdrawn from the market.

The MHRA allowed homeopathic medicines, Bach flower 'remedies' and Anthroposophic 'medicines' to remain with PLRs and continue to make claims about what medical conditions they can be used for. The MHRA was minded to remove this category a few years ago, but has unfortunately backtracked on that. One possible reason for this might have been pressure from the homeopathy industry, wanting to continue to freely make unevidenced claims about their products. We hope to say more about this and PLRs in a future newsletter.

National Rules Scheme (NR)

The next category is the National Rules Scheme. Homeopathic medicines authorised in this category are permitted to say they can be used for the 'relief or treatment of minor symptoms or minor conditions in humans' — those that 'can ordinarily and with reasonable safety be relieved or treated without the supervision or intervention of a doctor'. In the jargon, they are allowed to claim 'therapeutic indications', but only those that have been permitted by the MHRA for each individual product as stated in their Public Assessment Report (eg this for Nelson's Teetha teething gel). For various reasons, there are just eight homeopathic medicines in this category, with most of them appearing in just this last year, despite the scheme being launched in 2006. The mandatory wording on the product is:

A homeopathic medicinal product used within the homeopathic tradition for the relief of or treatment of…

…followed by the permitted indications. Note that these indications come from historic homeopathic literature of what it's been used to treat or from 'provings'. These 'provings' (from the German Prüfung, meaning a test, not a proof), although called 'homeopathic pathogenetic trials' by some homeopaths, are not clinical trials in the conventional sense — but this yet another topic for a future newsletter.

Homeopathic Rules Scheme (HR)

The final category is Homeopathic Registration: the MHRA has issued fewer than 300 registrations to ten different homeopathy manufacturers. No evidence of efficacy is required, of course, but they are not allowed to make any therapeutic claims either — how could a regulated product be allowed to make claims when it's not been tested for those claims? Instead, they must have the following words on them:

A homeopathic medicinal product without approved therapeutic indications.

Whether or not an unsuspecting member of the public understands what this jargon means is a moot point.

A full list of all NR and HR homeopathic medicines is available from the MHRA.

Any homeopathic medicine not falling into one of the above categories is an unlicensed medicine. As such, there are strict rules on advertising them: it is illegal to advertise an unlicensed medicine to the public.

The double-standards and the extremely low hurdle to be achieved by homeopathic products should be obvious.

In summary, for homeopathic products:

  • PLR homeopathic medicines can advertise with indications;
  • NR homeopathic medicines can advertise those indications that have been authorised;
  • HR homeopathic medicines cannot be associated with any indications;
  • Unlicensed medicines cannot be advertised to the public.

However, we have found may sellers of homeopathic medicines advertising outside these restrictions. We've highlighted a few in the past, mainly Holland and Barrett, but we have been complaining about others too.

Because these have taken time to be resolved and have been resolved at different times, we've said little before now. However, now is the time to publicise our successes.

Boiron's Oscillococcinum

Several UK sellers were advertising Boiron's Oscillococcinum. This is an unlicensed medicine in the UK. The sellers included:

…and the following and/or sellers:

While many of these have been removed after being contacted by the MHRA, there are a few others, including several registered pharmacies, that have yet to make the necessary changes. Further action is being taken and we'll let you know the outcome in due course. Some of these complaints about registered pharmacies were passed to the statutory pharmacy regulator, the General Pharmaceutical Council. However, there are further issues they have yet to deal with.

However, the MHRA were unable to take action against one seller, Doc Simon, because, although they have a UK domain name and look to all intents and purposes like a UK company, they appear to be based in the Czech Republic. It is not illegal to import unlicensed medicines into the UK for your own personal use, so there was nothing the MHRA could do about this website, even though they are advertising and selling to the UK.

Unfortunately, the MHRA have not published the outcomes of these complaints, so it's been left to us to make people aware of them.

We will continue to monitor all those websites, of course.

Main homeopathy manufacturers

Some of the major homeopathy manufacturers have already had to make changes to their websites after we submitted complaints to the MHRA, including Nelsons. We currently have several other complaints running — these are proving more time-consuming to resolve, but progress is being made and we will let you know when these are concluded.

investigationOther sellers of homeopathy

We've submitted complaints to the MHRA about many other advertisers of homeopathic medicines, including one ebay seller, Wingate, where we questioned several aspects of their advertising, including incorrect labelling of re-branded products. Again, the MHRA chose not to publish the outcome of these complaints on their website.

However, the outcomes of our latest batch of complaints to the MHRA were recently published.

As we've seen, the MHRA do not always announce the results of their investigations, so we welcome this publication that stands as a marker for other sellers that they have to check that their advertising is compliant.

The common issues we found were:

  • Advertising HR registered products with indications
  • Advertising NR products with indications not permitted by the product's PAR
  • Advertising unlicensed medicines;
  • Advertising of kits of homeopathic medicines not authorised by the MHRA.

The sellers we complained about included:

We have since checked these websites and have notified the MHRA that we believe some of them are still in breach of the advertising regulations. Others are no longer advertising any homeopathic products.

We believe this is good progress and we hope the MHRA will publish the outcomes of future complaints.

However, the MHRA is still dealing with some seven others, including some Registered Pharmacies and homeopathy manufacturer. Once these have been concluded, we'll publicise the results.

Out of this last batch, there are a couple of particular interest.

Dr Reckeweg

This website was one of the main sellers of a homeopathic product called Schüssler (Schuessler) Tissue Salts. These have been touted as the replacement to New Era — owned by Seven Seas, who in turn are owned by pharmaceutical giant Merck — tissue salts (which had a PLR) that were withdrawn earlier this year. The New Era brand seems to have been sold to Olimed Limited, a subsidiary of Italian company Named SpA, so we can probably expect to see these products re-appear in the future.

However, Schüssler products are not registered or authorised and are therefore unlicensed medicines. Many other retailers have been selling them, but this appears to be their main website in the UK. This shop now displays the message:

Dr ReckewegTraumeel Remedy

This website was selling products manufactured by Heel GmbH, but the shop facility closed after our complaint. This range includes all sorts of homeopathic products, some of which are injectable. As these are neither registered nor authorised by the MHRA, they are unlicensed medicines.

After our initial complaint, the owner, Sarah Bell, sent out an email to her mailing list (all typos as in the original):

Recently I have been hassled by the never ending growing body of rules and regulations which are set out here in the UK regarding homeopathic remedies and the Heel remedies. It is a vicious monster in my opinion and does a great deal of harm.

Fortunately we have set up a system which enables me to contiue to supply and help you obtain the Heel remedies. So, do not worry. I have your back.

Although I now understand why many practitioners in the UK baulk at the prospect as it is difficult and requries stamina to say the least. Thick skin?! I think so!

However this is my problem not yours.

I will continue to provide access to you of the complete Heel range of remedies. I may in future be updating the blog in the private shop site and not the public site in order to comply with their regulations.

I get very annoyed as due to their regulations they make it extremely difficult and expensive for most people to obtain what I think is an outstanding range of homeopthic remedies which go such a long way to helping people maintain phenomenal health - so how dare they do everything they can to make them extremely difficult to buy and obtain?

C'est la vie - we are in a society run by so many rules that they counteract all the good they are supposed to do.

The quote I read was:-

Every adversity, every failure, every heartache carries with it the seed of an equal or greater benefit. - Napolen Hill

Do you have any inspiring quotes that help you get through tough situations? If you do, just reply to this email! I'd love to hear what helps you when times are tough. I think of it as fighting an ongoing battle - you and I together. 

We will live on another day and keep on fighting this battle!

And finally my "call to arms" - please pass on the private shop link to friends and family and colleagues. Help me continue to keep helping those who know drugs are not the answer.

Lastly, to quote a great man...

"Never, ever, ever, ever, ever, ever, ever, give in. Never give in. Never give in. Never give in." - Winston Churchill (but you already knew that!)

She even Tweeted about her new 'private' shop:

Struggling with Bronchitis & chest infections? Contact me - I will send you a private shop link so you can buy Heel Homeopathic Remedies

So, instead of simply obeying the statutory medicines regulator, Bell opened up a new 'private' shop where she could carry on selling the unlicensed homeopathic medicines to her customers. We passed her email on to the MHRA; the shop facility no longer exists.

However, the website still contains an advert for Heel products and a contact form

Although she is the main seller in the UK, Heel GmbH homeopathic products are still available from some other suppliers, so we’ve pointed these out to the MHRA.

Obeying the rules

As we have explained above, the regulation surrounding the advertising of homeopathic 'medicines' are fairly straightforward and easy to understand. They are not arbitrary and complying with them is not optional: they are legal requirements. That so many homeopathy traders and advertisers have been found to be non-compliant suggests a wide-spread disregard for the medicines regulations, which are there to protect the public from misleading, false and unsubstantiated claims.

All homeopathy manufacturers, advertisers and sellers have an ethical and legal obligation to abide by them — whether they like them or not.

01 November 2013