The issues around the regulation of herbal medicines and practitioners are longstanding and complex. To understand and fully consider all the relevant issues, the Coalition Government commissioned an independent working group, led by Professor David Walker, to provide advice on options for the assurance of herbal medicines and practitioners. This report was published in March 2015.
I thank Professor Walker for his report, as well as the Hon. Member for Bosworth (David Tredinnick) and other members of the Herbal Medicines and Practitioners Working Group whose work informed the report. I would also like to thank those individuals and organisations who contributed to the report by providing information and advice to Professor Walker.
This statement sets out the appropriate level of assurance for herbal medicines supplied by herbal practitioners based on available information and advice, including that provided by Professor Walker’s report. Any system of assurance needs to be proportionate and appropriate to the risks presented to public safety and be enforceable and effective.
Professor Walker recommended: more research into the level of assurance required to ensure public protection (recommendation 6); and that the sector considers seeking accreditation of its voluntary registers by the Professional Standards Authority (recommendation 5).
The Government supports these recommendations and encourages the sector to take them forwards. Delivery of recommendation 5 and 6 by the sector supports the development of standards for education, training and conduct, and would allow for collaboration on the collection of safety data and the establishment of an academic infrastructure to develop training and research into herbal medicines.
The Report, whilst recognising the value of the current system for regulating the supply of herbal medicines, explored the scope for further changes to enhance public protection and access, and made recommendations for more work to: identify known potent or toxic herbs (recommendation 1); and consider if learning can be applied from a review of food lists (recommendation 2).
In response to recommendation 1, the Government is proposing a review to identify potentially potent or toxic herbal ingredients. This is with a view to restricting the use of potent or toxic ingredients through existing mechanisms such as the Human Medicines Regulations 2012. This would link to a scheduled review of toxic ingredients of Schedule 20 of the Medicines Regulations 2012 enabling for a targeted approach to be taken with a clear focus on protecting the public. Scoping work will commence in 2017 with a view to commencing any detailed scientific assessment work as soon as practicable thereafter.
While it accepts the intention of recommendation 2, the Government believes that existing food lists have little relevance when considering substances used by herbal practitioners, which can be significantly more potent. Case law requires that the classification of a medicinal product must proceed on a case-by-case basis, a point which is made in the body of Professor Walker’s Report. The suggestion that food lists (which relate to the safety and availability of products under food law) could be used to classify medicinal products conflicts with this.
Rather than reviewing food lists, which are not applicable to herbal remedies, the Government believes that more benefit will be gained by working with the sector to increase understanding of existing regulatory controls. To deliver this, the Medicines and Healthcare products Regulatory Agency and the Department of Health will produce a joint communications and engagement plan setting out proposed work with the sector in 2017.
The Report also recognises the impact of the EU’s Herbal Directive on access to some herbal medicinal products by recommending consideration of: a system to allow small scale assembly of products off-site on a named patient basis (recommendation 3); and inviting a review by the European Commission on the operation of the Herbal Directive (recommendation 4).
In due course, the United Kingdom will be leaving the European Union. The outcome of the exit negotiations will determine what arrangements apply in relation to EU legislation in future once the UK has left the EU.
The Government does not accept recommendation 3. The UK already operates a permissive regime for herbal practitioners which allows them to make up preparations on their own premises for named patients following one to one consultations. Those that are permitted to dispense (pharmacists, other registered medical professionals), and the premises they use, are heavily regulated for safety reasons.
The Human Medicines Regulations 2012 permit herbal medicinal products to be manufactured or assembled by people other than registered nurses, midwives, doctors and dentists provided that preparations are made up on premises they occupy and from which the public can be excluded, that preparations are made up on a named patient basis, and that these preparations do not contain specifically prohibited substances as listed in domestic legislation.
Practitioners therefore may make up preparations on their own premises for individual patients but they may not import or sell any mass-produced products which do not hold a Traditional Herbal Registration or Marketing Authorisation. Allowing people with no qualifications to put together medicines and carry this out on unregulated premises conflicts with everything else the MHRA does and could cause confusion to the public.
The Government notes recommendation 4. The Government is open to further consideration of the case for statutory regulation once there is further evidence to understand the risk and confirm what level of assurance is appropriate and proportionate. This evidence would be obtained from experience of voluntary registration accredited by the Professional Standards Authority and further research undertaken by the sector.
One reason for wishing to consider the evidence is because the range of products has changed following amended regulations in 2011. This has revised the risks presented. Another change is the development and delivery of the process for independent accreditation of voluntary registers provides an alternative option for the assurance of herbal practitioners.
Consideration of the evidence will support the public, employers and commissioners to make an informed choice about an individual practitioner as they will have demonstrated their commitment to upholding standards relevant to their practice.
This statement has also been made in the House of Lords