Statutory Regulation Facts & Fictions

Since the publication of the Department of Health (DH) consultation document on statutory regulation (SR) on 3 August 2009 a number of practitioners of traditional western herbal medicine have been gripped by, what can be best described as, regulation hysteria. A pro-SR demonstration was held outside the Houses of Parliament, letters demanding SR have been fired off to MPs, and an article entitled ‘Herbal drug crackdown: Millions face having to buy remedies on black market as Europe tightens the rules’ recently appeared in the Daily Mail. The European Herbal and Traditional Medicine Practitioners Association (EHTPA) and its members are offering herbalists a stark choice: get behind SR or face oblivion from European legislation! But is herbal medicine really on brink? Below we attempt to separate fact from fiction (with a little help from the MHRA).

Fiction: Unless SR is implemented by 2011, section 12(1) of the Medicines Act 1968 will be superseded by the Traditional Herbal Medicinal Products Directive (THMPD) and European medicines legislation, effectively banning the practise of herbal medicine in the UK.

Fact: Section 12(1) of the Medicines Act 1968 remains available to herbalists in the UK beyond 2011, whether SR is implemented or not.

In an email (dated 6 November 2009), Richard Woodfield of the MHRA clearly stated that beyond 2011 ‘the s12(1) exemption [will remain] available where herbal practitioners are carrying out activity in accordance with the terms of that exemption.’

What exactly are the terms of the section 12(1) exemption? The exemption appears in statute in the following form:

’12. Exemptions in respect of herbal remedies

(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates relating to Medicinal Products] of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—

(a) the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and

(b) the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgment as to the treatment required.’

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