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 afforded 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 under Section 12(1). 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
MHRA has been considering proposals for reform of Section 12(1). The proposals for reform are being developed alongside proposals for the statutory regulation of the herbal medicine profession and build on the responses received to the consultation exercise which took place in 2004.  The Department of Health (DH) is leading on regulation of the herbal medicine profession.
 
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
› Reforms of S12(1) of the Medicines Act 1968: an overview (paper number 1)
› Reforms of S12(1) of the Medicines Act 1968: who should be allowed to operate under S12 (1)? (paper number 2)
› Reforms of S12(1) of the Medicines Act 1968: safety (paper number 3)  
› Reforms of S12(1) of the Medicines Act 1968: quality standards where a practitioner prepares unlicensed herbal medicines (paper number 4)
› Reforms of S12(1) of the Medicines Act 1968: the requirement for a face to face consultation (paper number 5)
› 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) 
› Reforms of S12(1) of the Medicines Act 1968: possible extension to non herbal ingredients (paper number 7)
› Reforms of S12(1) of the Medicines Act 1968: issues concerning timing and transitional protection (paper number 8)

› A short (110Kb) and full (172Kb) summary of repsonses to these discussion papers have been produced.

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 consultation undertaken by the DH 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).

In 2006 Ministers asked a Steering Group, chaired by Prof Mike Pittilo, to make recommendations to progress the statutory regulation of acupuncture, herbal medicine and traditional Chinese medicine practitioners. This Department of Health Steering Group reported in May 2008. The Report can be viewed via the following web link: https://openair.rgu.ac.uk/handle/10059/176 (external link).

Next steps
The Department of Health plans to hold a public consultation on the 2008 report of the Steering Group. This will address the issue of whether it is desirable to proceed to further areas of statutory regulation. The MHRA website will be updated to include a link to this consultation when available.

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 s12(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.