The UK legislative provisions for herbal medicine are to be found in the Medicines Act 1968, Section 12, paragraphs 1 & 2, and Section 56, paragraphs 1 & 2.
Section 12.1 specifies an exemption for herbal medicines from licensing provided that they are supplied subsequent to a one-to-one consultation.
Section 12.2 exempts herbal medicines provided that they are produced according to standard traditional, non-industrial methods. It also specifies that no written claims may be made for the use of the remedy. These products will now need to be registered as part of the Traditional Herbal Medicines Registration Scheme required by Directive 2004/24/EC, which came into effect on 30 October 2005. This Directive amends Directive 2001/83/EC, the Community code on medicinal products for human use. A seven-year year transitional period will mean that products do not need to be registered until 30 April 2011. Products registered under the scheme will however need to meet specific standards of safety and quality and be accompanied by agreed indications and systematic patient information allowing the safe use of the product.
Section 56 reiterates and expands upon the provisions of 12:1. In addition, Statutory Instrument 2130 1977 lists several herbs "in respect of which the exemptions conferred by section 56 (2) do not have effect". This removed the herbs so identified from general sale and specified that they may only be prescribed on consultation, or supplied under the supervision of a pharmacist. This list also specifies maximum permitted doses and daily doses for those herbs.
The obvious shortcoming of these provisions is that there is no definition of who or what a practitioner may be. It is this shortcoming that the imminent revisions to Section 12.1, alongside the statutory regulation of the herbal profession, seeks to redress.
The MHRA ran a consultation on Section 12.1 reform in March 2004 MLX299: Proposals for the Reform of the Regulation of Unlicensed Herbal Remedies in the United Kingdom made up to meet the Needs of Individual Patients and published the results in January 2005 as Summary of responses to consultation document MLX299.
A new Steering Group was set up by the Department of Health in June 2006 primarily to consider statutory regulation of the profession, but also to continue the discussions around reform of this piece of medicines legislation.
In December 2006, the MHRA produced the following discussion papers. Any written comments on the proposals should be sent by 30 March 2007 to Caroline Brennan at the MHRA by email email@example.com:
- Index of Discussion Papers
- Paper 1: Reforms of s12(1) of the Medicines Act 1968: An Overview
- Paper 2: Reforms of s12(1) of the Medicines Act 1968: who should be allowed to operate under S12(1)?
- Paper 3: Reforms of s12(1) of the Medicines Act 1968: safety
- Paper 4: Reforms of s12(1) of the Medicines Act 1968: quality standards where a practitioner prepares unlicensed herbal medicines
- Paper 5: Reforms of s12(1) of the Medicines Act 1968: the requirement for a face to face consultation
- Paper 6: Reforms of s12(1) of the Medicines Act 1968: the regulation of unlicensed herbal medicines commissioned by a registered practitioner from a third party to meet the needs of individual patients
- Paper 7: Reforms of s12(1) of the Medicines Act 1968: possible extension to non herbal ingredients
- Paper 8: Reforms of s12(1) of the Medicines Act 1968: issues concerning timing and transitional protection
As they become available, further discussion papers relating to these issues will be posted here.
Traditional Herbal Medicinal Products Directive
Examples of permitted indications under THMPD: