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The (virtual) ink on our last newsletter had barely dried before a new document was published by the MHRA
Last Friday, the medicines regulator (the MHRA), signaled its desire to finally end the 40-year anachronism of homeopathic Product Licences of Right (PLRs):
Guidance on the transfer of certain Product Licences of Right (PLRs) to homeopathic marketing authorisations under the National Rules Scheme or to registration certificates under the Simplified Registration Scheme.
A mouthful of a title, but its aim is clear: to encourage homeopathy manufacturers to transfer their PLR products to either the Simplified Homeopathic Rules (HR) Scheme or the National Rules (NR) scheme.
For the past 42 years, these products have been given a free ride in terms of not having to comply with the same rules as other products classed as medicines. As the MHRA says:
Product Licences of Right (PLRs) were issued to all medicinal products on the market at the time that the Medicines Act 1968 was implemented (in 1971). PLRs were envisaged as a temporary arrangement until products were reviewed and, where appropriate, moved to an ongoing regulatory scheme where they would meet the relevant standards. Most categories of medicine, except homeopathic medicines, which were exempted under Directive 75/319EEC, were subsequently reviewed by the early 1990’s and products were either granted a full Product Licence or the PLR was revoked.
Their announcement said:
Product Licences of Right (PLRs) holders are invited to transfer certain homeopathic products with PLRs to either homeopathic marketing authorisations under the National Rules Scheme or homeopathic registration certificates under the Simplified Registration Scheme.
Unfortunately, the MHRA has not given a deadline, and the MHRA say they will transfer for free (for the time being at least), so that the manufacturers will not even have the burden of the usual fees they would have to pay for HR or NR applications.
According to the MHRA's data (obtained through a Freedom of Information Request), there are 406 PLR products, most of which are homeopathic. These include 32 New Era products (that Seven Seas/Merck abandoned earlier this year), 319 Weleda, 54 Nelsons and one product from the (possibly now defunct) Anglo German Homeopathic Centre, based in Hereford.
In many ways this is good move: any PLR products that transfer to the HR scheme will not be allowed indications (ie to say what medical conditions they can be used for) and will all have to have the following text on the product:
Homeopathic medicinal product without approved therapeutic indications
Products that are transferred to the NR scheme will be allowed indications if the manufacturer can provide 'evidence' for therapeutic use for that indication. Of course, no actual evidence at all is required: they just have to show that it’s been used for whatever the condition by homeopaths in the past or provide a 'proving' for it.
However, this means they are brought under control to some extent and are more tightly controlled in terms of advertising. At least NR products have to carry the wording:
A homeopathic medicinal product used within the homeopathic tradition for the relief of or treatment of…
…followed by the conditions it can ‘treat’ as permitted by the product’s Public Assessment Report.
Take Nelsons Teetha Teething Gel that was authorised last year (not to be confused with Nelsons PLR Teetha teething granules, pictured above). This has the official-sounding NR authorisation number NR 01175/0184 and has the 'active ingredients' Chamomilla recutica, Aconitum napellus and Atropa belladonna. Although these may sound dangerous — particularly the belladonna — these are all at 12C dilution, so, as long as they are properly and carefully diluted, under an adequate quality regime, there is just a 60% probability of it containing just one molecule of the original material if one mole of the original substance was used. This product's Public Assessment Report (PAR) give details of the product and its assessment.
Under the heading Evidence supporting the proposed indication, it states:
No new clinical data were submitted and none are required for an application of this type. In support of this application details of homeopathic provings and published scientific literature have been provided. These are adequate evidence to support the indications for which a national rules authorisation is sought.
And what did this 'evidence' substantiate in terms of indications?
A homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of teething pain and the symptoms associated with teething which are sore and tender gums, flushed cheeks and dribbling.
Anyway, at least this limits what therapeutic claims can be made, even if they are not based on any measure of credible evidence. The same will apply to any PLR products transferred to the NR scheme.
Meeting the standards
There are, of course, manufacturing standards to be met even for the HR scheme. Providing the dossier required by the MHRA for an application should be relatively trivial for any competent manufacturer, but some may well struggle. The contents of the dossier required for submission is given here: Homeopathic applications (Simplified Registration Scheme and the National Rules Scheme).
There are ongoing periodic fees, but the periodic fee for a NR product is the same as that for a PLR; this measly £80 is only a tiny fraction of the fee required by the MHRA for 'Big Pharma' medicines and the periodic fee for an HR scheme product is zero.
In the right direction
Allowing any homeopathic product to make therapeutic claims is hardly ideal and unwitting members of the public could still be misled into thinking these homeopathic products are real medicines, but at least this a step in the right direction for consumer protection.
At present, the MHRA have not said when they would like all PLRs to be either ended or withdrawn, but we urge them to scrap PLRs completely as soon as possible. There is no reason why this anachronism should be allowed to continue any longer and we hope that PLR products will finally be consigned to history.
A final word about 'provings': these are used to 'justify' the indications that are permitted for National Rules Scheme products.
However, the word is derived from the German Prüfung, meaning 'a test', and does not mean they provide any kind of proof that the product is effective for these indications. In the words of the Society of Homeopaths:
A pre-defined number of repeated doses of the homeopathic remedy are given to healthy volunteers until symptoms are experienced. These are collated by observers and distinctive symptoms common to multiple participants (which are most likely to be related to the medicine) are identified. According to the central homeopathic principle that ‘like cures like’, the remedy may have the potential to treat these specific characteristic symptoms.
Most readers will be able to spot rather obvious flaws in this thinking. They also like to call them 'homeopathic pathogenetic trials', but they are not clinical trials in the conventional sense or indeed in any meaningful sense.
We have more to say about provings and their status…but you'll need to wait for our next newsletter to find out!
10 November 2013