Unlicensed herbal remedies made up to meet the need of individual patients: Section 12(1) of the Medicines Act 1968

Current requirements
Section 12(1) is commonly referred to as the 'herbalist exemption' and permits unlicensed remedies to be made up and supplied by a practitioner to meet the needs of an individual patient following a one-to-one consultation.

The existence of this regime is greatly valued by herbal practitioners and by many members of the public. However, there are widely acknowledged weaknesses in the public health protection given by the regime.

Section 12(1) remedies are not subject to a regime of specific safety or quality requirements. There are no restrictions in terms of those who operate under the regime. Anyone - irrespective of qualifications or experience - can practise herbal medicine and, after making a diagnosis and forming a judgment about the treatment required, can make up and supply an unlicensed herbal medicine.

A number of public health risks associated with the supply of herbal medicines by practitioners have been identified. Some of the safety concerns that have been identified are highlighted in our 'Herbal Safety News'.

Proposals for reform
The MHRA has been considering proposals for reform of Section 12(1). The proposals for reform are being developed alongside the DH-led work on regulation of the herbal medicine profession.

On 3 August 2009, the DH issued a consultation document (external link) on whether practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be regulated.

The consultation has been published in response to a 2008 report prepared by the Steering Group on the Statutory Regulation of Acupuncture, Herbal Medicine and Traditional Chinese Medicine (external link), chaired by Professor Mike Pittilo, which recommended statutory regulation of those professions.

 The DH consultation explores the link between practitioner and product regulation including the current Section 12(1) arrangements. 
 
Informal discussion papers
In advance of a formal consultation exercise, informal discussion papers on key aspects of the proposals for reform were prepared and circulated to a range of stakeholders in January 2007. Comments on the papers were invited by 30 March 2007. The papers are available here:

› Index and glossary (155Kb)
› Reforms of S12(1) of the Medicines Act 1968: an overview (paper number 1) (180Kb)
› Reforms of S12(1) of the Medicines Act 1968: who should be allowed to operate under S12 (1)? (paper number 2) (177Kb)
› Reforms of S12(1) of the Medicines Act 1968: safety issues (paper number 3) (166Kb)  
› Reforms of S12(1) of the Medicines Act 1968: quality standards where a practitioner prepares unlicensed herbal medicines (paper number 4) (153Kb)
› Reforms of S12(1) of the Medicines Act 1968: the requirement for a face-to-face consultation (paper number 5) (184Kb)
› 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 number 6) (193Kb) 
› Reforms of S12(1) of the Medicines Act 1968: possible extension to non herbal ingredients (paper number 7) (169Kb)
› Reforms of S12(1) of the Medicines Act 1968: issues concerning timing and transitional protection (paper number 8) (138Kb)

A short and full summary of repsonses to these discussion papers have been produced:

› Short summary of responses to S12(1) informal discussion documents (110Kb)
› Full summary of responses to S12(1) informal discussion documents (172Kb)

Background
In March 2004, the MHRA launched a consultation exercise (MLX 299) on proposals for the reform of regulation of unlicensed herbal remedies made up to meet the needs of individual patients. A summary of the responses received is available here. MLX 299 was published in conjunction with a related DH consultation on the regulation of herbal medicine and acupuncture practitioners. 

MLX 299 built on recommendations made by the Herbal Medicine Regulatory Working Group (HMRWG) in its report of September 2003. Following the House of Lords Select Committee report on Complementary and Alternative Medicine in 2000, Ministers invited the HMRWG to make proposal for the possible future statutory regulation of the herbalist profession.

In addition to this, they were also asked to recommend any changes needed to medicines legislation to assure the safety and quality of herbal remedies supplied under Section 12(1) of the Medicines Act. The full report of the HMRWG and a summary is available on the DH website (external link).

Next steps
The DH consultation exercise addresses the issue of whether it is desirable to proceed to statutory regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine and explores various regulatory options. The MHRA will consider possible options for reform of Section 12(1) alongside this initiative. The MHRA website will be updated to reflect progress.

Contact for further information
For further information about Section 12(1) or to obtain further information about proposals to reform Section 12(1), please contact:

Judith Thompson at judith.m.thompson@mhra.gsi.gov.uk or telephone 020 7084 2945 or
Caroline Brennan at caroline.brennan@mhra.gsi.gov.uk or telephone 020 7084 2525.

Question and answer on the consultation on the possible reforms of Section 12(1) of the Medicines Act 1968

Q. What will happen to the reforms of s12(1) if it is decided not to proceed with the statutory regulation of herbal medicine practitioners?

A. It would be necessary for the MHRA to reconsider the reform programme as our proposals until now have been based on the premise that there would be statutory regulation.