Current regulation of herbal medicines in the UK is no longer satisfactory given the rapid explosion in the market in the last 40 years, concluded a group of experts and herbalists commissioned by the UK government.
The Herbal Medicines Regulatory Working Group (HMRWG) proposed significant revision of the laws governing the UK market for herbal medicines, estimated to be worth around £1.6 billion (€2.3bn).
Current law on herbals will be partially replaced by the new European directive on Traditional Herbal Medicinal Products. However Section 12 (1) of the Medicines Act 1968, which exempts those herbal remedies made up by herbalists on their premises after a personal consultation from licensing, will remain in force because these are not industrially produced and therefore not subject to European law.
The HMRWG recommends that potent herbal medicines, the use and dosage of which are subject to restrictions under the Medicines (Retail Sale and Supply of Herbal Remedies) Order 1977 (SI 1977 No. 2130), could in future only be used by herbalists on a statutory register, considered in some detail by the new report.
The group also said that the Medicines (Exemption from Licenses) (Special and Transitional Cases) Order 1971, allowing a third party to make unlicensed herbal remedies for use in one-to-one consultations, is outdated and should be substantially revised.
The statutory register of herbalists proposed by HMRWG would serve to guide non-industrial production of remedies. 'Herbalists on the statutory Register will be subject to a Code of Conduct (analogous to the pharmacists' code) setting out good practice and to disciplinary action including removal from the statutory Register should breaches occur,' noted the report.
The group also issued proposals for those not on the register, allowing for a period of retraining, before transition to the list.
The recommendations, which do not consider efficacy of herbal products, will be reviewed by the Government. A recent House of Lords report (from the Select Committee on Science and Technology in 2000) found that changes to current regulation were needed to protect consumer safety.