Alternative medicine: Regulation
Regulation of alternative medicine depends on the type of agent involved: herbal medicine, homeopathic medicine, or dietary supplement.1. Herbal medicines
The regulation of herbal medicines in the UK is complicated. Currently there are three classes:- Licensed herbal medicines. These hold a full marketing authorisation (formerly called a ‘product licence’) based on the safety, quality and efficacy of the product, as with any regular medicine.
- Medicines with traditional herbal registration (THR). As it may be difficult for some companies to provide all of the evidence required for a marketing authorisation, the THR scheme was introduced as an alternative route for herbal medicines to be registered with the MHRA. The scheme helps to protect patients by requiring specific standards of safety and quality for traditional herbal medicines.
- Unlicensed herbal medicines supplied by a practitioner following a one-to-one consultation. Herbal medicines that fall into this category are not subject to any specific safety or quality requirements. Practitioners are not currently regulated in the UK.
There are other forms of regulation which restrict the use of certain plant species (e.g. digitalis) and some products containing plants are marketed as dietary supplements (see below).
2. Homeopathic medicines
In the UK there are two regulatory schemes for homeopathic medicines:- Under the simplified scheme, manufacturers must submit data on the quality of the product and show that it is dilute enough to guarantee safety. Products must be for oral or external use and make no therapeutic claims.
- Under the national rules scheme manufacturers must submit data that demonstrates quality, safety and use within the UK homeopathic tradition. They are allowed to claim that the product is used within the homeopathic tradition for the relief or treatment of minor symptoms and conditions which don’t require the supervision of a doctor.
Homeopathy is practised by two separate groups. Medical homeopaths are medically qualified practitioners regulated by the General Medical Council. Non-medical homeopaths only use homeopathy and are represented by a number of bodies (e.g. Society of Homeopaths)
3. Dietary supplements
In the UK, the majority of dietary supplements are legally classified as foods, and as such are sold under food law. The exceptions include some branded products (e.g. Maxepa, Pregaday) and some generic vitamin and mineral preparations, which are classed as licensed medicines. Supplements that fall under food law do not have to undergo the same rigorous clinical testing as conventional medicines.Dietary supplements are not allowed to make medicinal claims but can make health claims. For more information refer to Dietary Supplements by Pamela Mason (Pharmaceutical Press 4th edn).