Friday, October 23, 2009

Totally Hypothetical Remedy? - MHRA introduce certification mark for herbal remedies.

This is the new Traditional Herbal Registration certification mark. Well, it is apart from the 'Warning', which is what I think it is lacking.

According to the MHRA, this
indicates that the herbal medicine has been registered with the MHRA under the Traditional Herbal Registration (THR) scheme and meets the required standards relating to its quality, safety, evidence of traditional use and other criteria as set out under the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC.
There have been 92 applications since the scheme began in March 06.

The most important line is this one:
Under this scheme, the permitted indications for the medicine are based on traditional usage and not on evidence of effectiveness of the product.
My bold. So, as I wrote before with homeopathy, as long as the seller can demonstrate safety of the product and a history of use for the particular therapeutic indication, then it can receive the THR stamp and be sold legitimately, despite there being no investigation into whether it works or not.

[The MHRA guidance states:
European Directive 2004/24/EC on traditional herbal medicinal products was brought forward specifically in recognition of the position that for many herbal medicines it was difficult for companies to meet the full requirements for a marketing authorisation, particularly in relation to efficacy.
So, because it was difficult to prove they had any efficacy, it was deemed best to create a class of 'pseudo-medicines' that could pretend to be effective, but didn't have to prove it.]

On a positive note, any product with this mark on it will single it out clearly and obviously to me as snakeoil - if it were a *real* medicine that, you know, actually had some effect, then it would be marketed as such and would have some evidence to back it up.

So, perhaps we should look at this stamp as a victory for evidence-based medicine, as it singles out products without any provable efficacy for all to see.



  1. I wonder at the long-term legal ramifications of these registrations and the legitimacy they infer.

    Most readers of your blog would be familiar with the case of Australian baby Gloria Sam who died after her homeopath father ignored medical advice and treated her severe eczema homeopathically. Both mother and father were sent to jail for manslaughter.

    If someone chooses to use a medicine which is registered for "traditional use" and suffers serious consequences as a result of the fact it is medically useless, will they be in a position to press charges or will the labelling act as a legal loophole for the manufacturers and distributors? A sort of "we never said it WOULD work".

  2. Hi Andy,

    Point 8 in the Guidance document mentioned above says:
    "The CRM (Committee on Review of Medicines) recognised that these traditional products could not be assessed in the normal way and agreed that provided the product was intended for a minor condition, suitable for self-diagnosis, then evidence documenting the use of the product would be accepted in place of results of pharmacological tests and clinical trials. Where licences were granted in such circumstances they were required to be labelled with a statement along the lines of 'a herbal remedy, traditionally used for the symptomatic relief of …If symptoms persist, consult your doctor.' In the case of more serious disease conditions the CRM advised that it was not appropriate to relax the requirements for proof of efficacy."

    So I guess there is some admission of "it'll be ok as a placebo".

    Also, I meant to write it in the blog, but the THR mark is not obligatory, which dilutes is use even further.

    [Fill in homeopathy gag here]

  3. these traditional products could not be assessed in the normal way

    I see that this was just stated as bald fact in the guidance document, with no supporting evidence.

    Why are these remedies not amenable to assessment? And why, given the lack of assessment, are they presumed to be appropriate for sale?

  4. Hi Sean,

    Sounds like classic 'special pleading' doesn't it?

    Snakeoil-person :"Oh yes evidence is good, but our products don't yield evidence in the same way, so you have to accept my word, that I really really *promise* they work".

    MHRA:" Fair enough"


  5. Another possible effect of substances taken as medicines is interaction with conventional drugs. For example, there is some evidence that St John's Wort helps with mild depression, but it can adversely affect any of a long list of modern drugs (try Googling "St John's Wort risks"). The fact that a herbal remedy has a long traditional usage history is no comfort at all in this respect for the obvious reason that modern drugs have not been around that long. Is this assessed as part of the 'safety' issue by MHRA and if a new drug appears on the market where a serious mal-interaction occurs, can the certification mark be withdrawn?

  6. This is a European directive that the MHRA were powerless to stop.

    What will be interesting is when these LTHRs are advertised. With MHRA approval they can be advertised, but only as far as their licensing allows; i.e. in relation to the condition referred to in the license, and a rather unwieldy tag making it clear on what basis the remedy is being offered (i.e. exclusively based on use as a traditional remedy). But this is an implied claim of efficacy, and so is forbidden by the CAP codes.

    What we have is CAP saying its unacceptable, the advertising clearance bodies agreeing, and the ASA agreeing. The MHRA are totally aware of the fact, but can't do anything to stop it. This is a massive regulatory contradiction It will probably only take a single complaint for the whole thing to unravel.

  7. CHeers for that Beacon, perhaps we can ensure when the time comes that there won't just be one complaint, eh?



  8. I complete agree with your commentary on this issue. However, isn't it the case that the efficacy of some conventional medicines has likewise never been established?