It's always fun wading through UK and EU legislation, and many happy hours can be wiled away reading the Shakesperean prose of statutes.
This posting is brought to you by Nelson's Arnica ClikPak, the first homeopathic product to receive approval by the MHRA to be labelled with therapeutic indications (i.e. is allowed to put on the labelling the symptoms that the sugar pill is supposedly to aid). It really is *that* exciting.
Let me give a potted history of homeopathic labelling:
1971: The Medicines Act (1968) comes into force, issuing a Product Right of License (PLR) to all medicines (inc. Homeopathics) on the market. These allowed labelling of therapeutic indications.
1992: The Simplified Registration Scheme (Directive 92/73/EC) came into operation, which did not permit therapeutic indications on the labelling, because of the 'difficulty in demonstrating efficacy in clinical trials'.
2001: DIRECTIVE 2001/83/EC is published, which amends Dir 92/73/EC - the full text of it can be found here (pdf). The important bits (Article 68 & 69) are reprinted here for your nigh-orgasmic delight.
Article 68: Without prejudice to the provisions of Article 69,homeopathic medicinal products shall be labelled in accordance with the provisions of this title and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.
1. In addition to the clear mention of the words homeopathic medicinal product’, the labelling and, where appropriate, the package insert for the medicinal products referred to in Article 14(1) shall bear the following, and no other, information: the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia used in accordance with Article 1(5), name and address of the registration holder and, where appropriate, of the manufacturer, method of administration and, if necessary, route, expiry date, in clear terms (month, year), pharmaceutical form, contents of the sales presentation, special storage precautions, if any, a special warning if necessary for the medicinal product, manufacturer's batch number, registration number,homeopathic medicinal product without approved therapeutic indications’,a warning advising the user to consult a doctor if the symptoms persist during the use of the medicinal product.
2006: Following consultation MLX 312 (pdf here), the National Rules Scheme was introduced in Sept 06 by the MHRA. According to the MHRA website:
The purpose of the Scheme is to enable homoeopathic medicinal products to be registered with indications for the relief or treatment of minor symptoms and conditions (those that can ordinarily be relieved or treated without the supervision or intervention of a doctor).The main changes were that homeopathic products should be allowed to label therapeutic indications, but more importantly, would not have to demonstrate efficacy - due to the difficulty in getting clinical trial success. (In my humble opinion, it shows that the clinical trial system was working, but in good government style it's best to change the system until it gives the answer you want). In this case, the 'efficacy' charge was relegated from clinical trial success to:
provide suitable evidence that the product has been used as a homeopathic treatment in the indications sought.In fairness, that's pretty bonkers. Just so as you know, a 'proving' is when you take a new homeopathic remedy (30c is the concentration normally used, which means there is no possibility of there being a single molecule of the original tincture left in the remedy) and give it to healthy people who then are asked to describe what symptoms it gives. These symptoms are then the symptoms homeopaths use to proscribe this new remedy against. The Materia Medica is the collection of these provings. As I say, it's pretty bonkers - BUT - it's good enough for the UK's Medicines and Healthcare Products Regulatory Agency.
Information provided should be in the form of provings, excerpts from homeopathic materia medica or other
bibliographic data and should be sufficient to demonstrate that homeopathic
practitioners would accept the efficacy of the product for those indications.
OK, due to no real efficacy needing to be demonstrated, the therapeutic indications are limited to self-limiting problems that normally wouldn't require medical intervention, but this is certainly a start at legitimising quackery. (But thankfuly, due to this clause, provings such as the ones for HIV/AIDS (I can't believe it either) cannot be used to make homeopathic products with therapeutic indications for AIDS.
[Just to spell it out, I, Dr* T, think that it is disgusting, immmoral, unethical and disgraceful for anyone to try and give a sugar pill to someone with AIDS and telling them they will be cured. In fact, it's difficult to believe anyone would do it. Step up, Jeremy Sherr. He's also alleged to have recommended people come off the ARV AIDS treatments as part of his trial, but his blog containing the statement was removed. This is the closest I've come to using the c-word on my blog]
When the MHRA announced in 2006 that homeopathic products were going to be issued with approvals for therapeutic indications without having to give any (non-bonkers) evidence of efficacy, understandably there was an outcry from rationalists and skeptics across the land. Sense About Science put out a statement , DC Science had quite a bit to say, amongst others (pdf).
The finalised Homeopathic National Rules Scheme is summed up here (pdf) in this Brief Guidance for Manufacturers and Suppliers.
From that, here is a list of examples of indications that would not be acceptable on a homeopathic product:
Bone diseasesand some that would:
Diabetes and other metabolic diseases
Diseases of the liver, biliary system and pancreas
Joint, rheumatic and collagen diseases
Serious disorders of the eye and ear
Serious gastrointestinal diseases
Serious infectious diseases including HIV-related diseases and tuberculosis
Serious neurological and muscular diseases including epilepsy
Serious renal diseases
Serious respiratory diseases
Serious skin disorders
Sexually transmitted diseases
Treatment and Prevention of malaria
Indigestion, heart burn, hyperacidity, dyspepsia, halitosis (bad breath) or
Colicky pain, stomach ache or nausea, occasional or non-persistent diarrhoea or
Travel sickness or related symptoms
Minor skin infections, relief of pruritus or exanthematous rashes of childhood
infection and boils, athlete’s foot
Common colds, coughs, conditions commonly referred to as influenza and similar
upper respiratory tract infections
Minor acute inflammatory conditions of the buccal cavity and pharynx including
Muscular pain and stiffness including backache, sciatica, lumbago, fibrositis,
rheumatic pain and cramp.
Hay fever, rhinitis and catarrh.
Headache including migrainous headache
Difficulties falling asleep
Agitation, anxiety, irritability, nervous tension, stresses, strains, tenseness
All pretty classic alternative medicine claims - i.e. minor ailments that will get better on their own, and excellently suited to a placebo response.
Next, the labelling. How do you ensure that people know that it is a homeopathic product and not anything that will actually do anything? According to the MHRA,
The labelling should also refer, in clear and legible form, to the homoeopathic nature of the product (article 68 of the 2001 Directive).Nelosn's Arnica ClikPak states it is:
a homeopathic medicinal product used within the homeopathic tradition for the symptomatic relief of sprains, muscular aches and bruising and swelling after contusionswhich as far as I can see, is the standard phraseology that all homeopathic medicines will be required to contain.
[I asked MHRA for a document relating to this, and they sent me one from 2004, which stated that the homeopathic product wasn't allowed to show therapeutic indications! Do try to keep up with your own meddlings, MHRA].
The full dossier for Nelson's Arnica ClikPak has yet to appear on the MHRA website for public assessment reports which means I guess they can't actually put the therapuetic indications on the label and sell them yet, but will do soon. When it arrives, I'll let you.
So that's about it. You can wake up now. Tha's quite enough legislative bodice-ripping for one afternoon.