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International Clinical Trials

Restricting Remedies

Herbal medicine has been practised in many countries for centuries. The 2004 European Traditional Herbal Medicinal Products Directive took full effect in the UK in 2011. This legislation effectively banned the importation and sale of large-scale manufactured herbal medicine products and severely limited the scope of some herbal practitioners to continue practising. At present, under UK law, a herbal practitioner is permitted to see individual patients, offer diagnoses, and prepare herbal treatments on their own premises, as long as these preparations do not contain banned or restricted substances. Thus, where ‘herbal’ products derived from the cannabis plant are concerned because they are banned or restricted substances, they cannot be prescribed by herbal practitioners. Herein lies the problem of the use of cannabis oil for the treatment of rare forms of childhood epilepsy, which has gripped the media of late.

In a review into cannabis-related medicinal products, the UK’s Chief Medical Officer and Advisor, Professor Dame Sally Davies, has concluded that evidence shows the therapeutic benefit of cannabis-based medicines for some conditions. The finding has prompted Home Secretary Sajid Javid to commission the second part of the UK’s review into cannabisrelated medicinal products, led by an independent advisory committee. However, prior to this review, cannabis oil had been prescribed to a young boy with epilepsy on the NHS. Reports have called this the “first case of its kind” in the UK.

Cannabis oil is a medicine containing a part of the cannabis plant called cannabidiol (CBD). It does not contain the ‘psychoactive’ part of cannabis – the part that causes the feeling of being high. Last year, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) classed CBD as a medicine in the UK and not a herbal. The agency has thus said that CBD products are required to be licensed, meaning they “have to meet safety, quality and efficacy standards,” as would be the case for any therapeutic drug prescribed in the UK.

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