Reform of S12(1): Implications for Herbal & Traditional Medicine Practitioners Michael McIntyre Chair EHTPA

Section 12(1) Medicines Act 1968 Section 12 (1) is commonly referred to as the “herbalist exemption” although the word herbalist does not occur... Any herbal remedy which is manufactured or assembled on the premises of which the person carrying on the business is the occupier and which s/he is able to close so as to exclude the public, and 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/her own judgement as to the treatment required.

Order (SI 1977 No.2130) provides further exemptions for herbal remedies. Part 111 of the schedule to SI 1977 No.2130 lists a number of potent herbal medicines and their maximum dosages and strengths as well as restricting some herbs to external use only.

Proposed reforms to S12(1) will: The public will be able to identify qualified, competent practitioners who abide by a professional code of conduct. Give legislators the opportunity to recognise and take advantage of the skills and competence of statutory regulated herbalists and traditional medicine practitioners when deciding on the safety of individual herbal medicines. Since effectively at present anyone can be a herbalist, there is no in-built safety to Part 111 of SI In future, SI 2130 will offer a secure legislative home for remedies considered too potent for general sale so that such remedies will not necessarily have to be banned.

Training standards assured and ensure.... The statutory regulation of herbal/ TM practitioners is predicated on agreed standards of training (Bachelor Degree with honours) and ongoing independent accreditation of courses/ institutions delivering herbal/TM training. Pegging use of 12(1) to practitioners on the statutory register will cut out the cowboys and provide an incentive for those using 12(1) to achieve and maintain standards of training, competency, professionalism & accountability.

12(1) Reform & Implementation of THMPD in April 2011 will mean: Clearer control of herbal medicinal products. High street herbal shops can only sell OTC herbal medicines with a TM licence or.. Shops must have a properly trained and registered herbal/TM practitioner who can only prescribe 12(1) after a consultation. Such interventions can be subject to scrutiny by the regulator who can take disciplinary action should the 12(1) process fall short of acceptable professional standards.

“Authorised Health Professionals” 12(1) proposals envisage that herbal/TM practitioners on the statutory register will be considered “authorised health professionals” via Article 5 of Directive 2001/83 EC. This permits authorised health-professionals on the statutory register to initiate manufacture by a third party of unlicensed herbal medicines to meet the needs of individual patients. Important for any complex formulation that may require “industrial” processing. Also potentially allows use of third-party dispensing since 12(1) function must take place on the premises of which the person carrying on the business is the occupier. This could be important for new practitioners who don’t have the room to do their own dispensing– or where someone works in someone else’s practice and wants to dispense there...

Possible Extension of scope of 12(1) to non-herbal ingredients This would potentially allow the compounding of some non-herbal active ingredients in external remedies such as medicinal clays, zinc oxide, etc Potentially allow the internal use of some non herbal medicines such as propolis and authorised TCM/Ayurvedic minerals such as gypsum.