The UK is in the midst of a complex debate over herbal product and practitioner regulation that has been raging for decades. The outcome of the debate is likely to have consequences that echo throughout the European Union (EU). But as the claims, counter-claims and controversy fly, perhaps the most important question is in danger of being overlooked: what will the eventual regulation mean for individual UK practitioners who use herbs – many of whom are not herbalists?
Chamerion angustifolium (Rosebay Willow Herb)
Herbs aren’t just for herbalistsHerbal medicine has always been, and remains, humanity’s most widely used healthcare strategy. Every country in the world is the proud possessor of a dizzying range of indigenous herbs, many with powerful healing properties that form the backbone of healing traditions stretching back centuries – even millennia. Naturalised Indonesian microbiologist and conservationist Willie Smits discovered that orang-utans use as many as 4,000 different herbal species for their health-giving properties: an astounding number that must be the envy of herbalists the world over.
However, trained herbalists are not, and have never been, the only ones to use herbs in their practices. In a modern context, some examples include naturopaths, colon hydrotherapists, homeopaths, osteopaths, nutritional therapists, aromatherapists, acupuncturists, kinesiologists and some mainstream medics – and this list is far from being exhaustive. Unfortunately, at present, the ongoing UK discussions over the future of herbal regulation exclude these practitioners almost entirely.
What does it mean for me?The debate over herbal regulation is necessarily complex and multifaceted. In such a context, it’s not surprising that many herb-using practitioners aren’t sure how any change in herbal legislation will affect their access to herbs. This is our attempt to clarify things a little, by outlining the major consequences for three broad groups of practitioners, and the general public, of a shift to SR or VS. For completeness’ sake, we also look at the consequences of doing nothing and sticking to the status quo.
We have collated the information in this table, which should be read in conjunction with our earlier article on UK herbal regulation.
Call to actionWe hope this article, along with our previous piece on SR/VS, helps to guide you through the maze of legislation, arguments and counter-arguments that surrounds this polarised issue. Our call to action remains unchanged from the first article:
- Members of the public and practitioners, from both the UK and beyond, please get involved in the comments and give us your thoughts on this important issue
- UK practitioners of herbal and traditional systems of medicine, please make your association aware of your views so that they can best be represented in the important coming debates within the UK working group.
The manner in which UK herbalists and traditional medicine practitioners succeed – or otherwise – in protecting their right to prescribe herbs that have been associated with a diverse range of very long-standing traditions will have implications that reverberate far beyond the UK.
As UK herbalists gather around the debating table with their government, once more to discuss the ins and outs of regulation, two main options are up for consideration. On one hand, should the country’s herbal practitioners be regulated by the state – or would a system of voluntary self-regulation be more suitable? There is of course a third option: do nothing, or maintain the status quo.
To date, the pro-statutory regulation lobby among the herbalists has made the most noise, and public discussions on the subject have often lacked balance. This piece represents our attempt to air both sides of this polarised debate. In doing so, we aim to help both practitioners and patients make up their own minds over which option might represent the best way forward for their preferred tradition(s).
The options on the tableIn short, the two options on the table at present are statutory regulation (SR) and voluntary self-regulation (VS). A statutory scheme would be administered by a central agency – in this case the Health and Care Professions Council (HCPC) – which would set up and manage a register of state-approved herbal medicine practitioners. The precise terms of access to the herbalists’ register are yet to be decided, and only registered herbalists would be allowed to practice in the UK.
By contrast, under VS, the individual professional associations would shoulder responsibility for policing their own practitioner members, most likely working to a strengthened Code of Practice adopted by all professional associations taking part in the scheme.
For those interested in the results of previous consultations by the UK medicines regulator, the Medicines and Healthcare Regulatory products Agency (MHRA), on reform of the existing herbalists' exemption, currently under Regulation 3(6) of the Human Medicines Regulations 2012, please refer to the 8 informal discussion documents listed on the relevant page of the MHRA website.
Table of options: ‘SR’ and voluntary self-regulation comparedWhile the table below isn’t exhaustive, we’ve assembled what we believe to be some of the strongest arguments in favour of each option. Please read and consider with care, especially if you are a herbal practitioner or a practitioner of a traditional system of medicine.
||Statutory regulation||Voluntary self-regulation|
|Professional standing||Herbal practitioners placed on an equal legal footing with, for example, osteopaths, chiropractors and dietitians. Closer legal status to that of doctors and dentists||‘Light touch’ regulatory environment with no direct government intervention, therefore less bureaucracy and ‘red tape’ for professional organisations and herbalists|
|Access to herbs||Clear legal route to maintain herbal practitioners’ access to herbs listed in Schedule 20 (Part II) of the 2012 Human Medicines Regulations (previously Part III of the Schedule in the Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977). Only registered herbal practitioners would be able to use the herbs on Schedule 20. Would be able to commission industrially-produced herbs by third parties manufacturers if manufacturers were licensed.||Access to Schedule 20 herbs presently open to all herbal practitioners via Regulation 3(6) of the 2012 Human Medicines Regulations. Policing via professional associations using strengthened Codes/Standards of Practice|
|Professional title||‘Herbalist’ becomes a protected title||No protected title status|
|Educational standards and routes to knowledge||Excludes herbal practitioners from the register who are not educated to a certain standard – most likely a degree-equivalent qualification in herbal medicine. Grandfathering of certain groups of existing practitioners may be allowed||Allows competent herbalists educated by all relevant routes, e.g. intergenerational knowledge transfer or personal education and experience, to continue practicing. Likely that non-degree standard (e.g. diploma) courses, non-mainstream courses and relevant non-UK qualifications will be accepted|
|Herbalists’ prescribing rights||Enshrined in law via primary legislation. Specific practices and supply chains may be impacted by reform of prescribing rights over time (as previously envisaged under S12(1) of the 1968 Medicines Act).||Government has stated that it has no intention of revoking herbalists' prescribing rights currently enshrined in Regulation 3(6) of the 2012 Human Medicines Regulations. However quality control issues and potential requirements for licensing of exporters, importers and suppliers of industrially produced products may impact availability in time|
|Time to legal implementation||Around 3 (?) years from now. Once a decision is made on regulation, primary legislation will take 18 months to draft, after which the Health and Care Professions Council will start setting up the registration scheme||Secondary legislation required: 6 (?) months to draft|
|EU medicines law exemption||Previously seen by UK government as a legal means to confer ‘authorised health-care professional’ status upon herbal practitioners (via Article 5.1 of EU Directive 2001/83/EC), thereby regaining access to certain manufactured unregistered herbal medicines. It now appears that this exemption would only be applicable to licensed (GMC registered) medical doctors and pharmacists.||Use of the Article 5.1 exemption is no longer considered legally viable under EU law, so the voluntary route may represent a simpler and legally less problematic means of maintaining continued access to unregistered herbal medicines for a wider group of practitioners, including licensed and unlicensed practitioners|
|Continuing professional education||Legal requirement for practitioners to follow a course of continuing professional development (CPD), thereby providing assurance to the public that herbal practitioners are keeping up with developments in their field||CPD is generally already a requirement of professional associations’ professional standards and Codes of Practice. These would need to be reviewed and strengthened as a key element of voluntary self-regulation|
|Public safety||Clear penalties available for incompetent, dishonest or dangerous practitioners, including striking off the register and subsequent inability to practice. SR in itself would not guarantee, without additional legislation, that regulated practitioners were limited to herbal products from licensed manufacturers, exporters, importers or wholesalers||Incompetent or negligent practitioners would be barred from their associations. It should be noted that no current evidence exists of significant public health risks posed by practitioners affiliated to recognised practitioner bodies. To further safeguard public health, practitioner associations would need to modify their professional standards/Codes of Practice so that practitioners were limited to using herbal product suppliers with adequate and relevant standards of quality control|
|Non-UK/EU-trained practitioners||Risk of exclusion from the scheme owing to non-recognition of qualifications||Scheme likely to be more sensitive to non-European traditions such as TCM, Tibetan medicine, Ayurveda, Unani, Kampo, etc., given that self regulation will be overseen by associations with a deep understanding of their respective traditions|
|‘Approved practitioner’ schemes||Possibility has been raised of British Herbal Medicine Association (BHMA) administering an ‘approved practitioner scheme’||No requirement for a further layer of bureaucracy, since responsibilities would remain with practitioner associations|
|Legal standing||Improved legal standing and potentially enhanced reputation||Herbalists’ long-standing prescribing rights would become a government-bestowed privilege|
|Magistral prescriptions/’specials’||May eventually result in a system of ‘commissioning’ of herbal remedies following a one-to-one consultation with a herbal practitioner – i.e. magistral prescriptions. Commissioned herbal remedies, possibly representing ‘specials’ or all herbalist-prescribed formulae, would be made up by facilities complying with strict pharmaceutical Good Manufacturing Practice (GMP) standards||System of licensed suppliers of unregistered herbal medicines ('specials') may apply in the longer term. These would need to meet typical EU GMP standards or equivalent. However, primary legislation would be required to implement it|
|Cost of membership to herbalists||Likely to be more expensive than VS in order to offset costs of setting up and managing a centralised scheme||Likely less expensive than SR, due to administration via professional associations|
|Proper consideration of all herbal traditions||Danger of ‘one size fits all’ mentality when appointing a single, centralised government regulator. May be insensitive to ‘minor’ traditions||Likely more responsive to the requirements of individual systems of medicine, since associations relevant to particular traditions will build requirements for safe and effective practice and supply of herbal medicines around their relevant pharmacopoeia, Materia Medica, etc.|
|Allied healthcare professions||Non-herbalists, e.g. naturopaths, nutritional therapists, unlikely to be able to maintain access to unregistered herbal medicines||May provide avenue for non-herbalists using herbs, e.g. naturopaths, colon hydrotherapists, homeopaths etc., to continue their herbal/integrated practices|
|Independence of herbal medicine||Profession would become state sanctioned and government regulated, perhaps ensuring its survival as an officially approved healthcare modality||“Herbalists have a long tradition of being independent of orthodox medical structures. This attracts many patients, particularly those that have been failed by orthodox medicine. If implemented, SR would make herbalists part of, yet subservient within, the orthodox medical hierarchy, thus denigrating its reputation for autonomy and diminishing its status in the eyes of many patients”|
|Government interference||Theoretically possible for hostile elements within government or their appointed agencies to weaken herbal medicine through over-regulation of herbal practitioners or the sup or by ‘picking off’ innovative or maverick practitioners||No such direct route for government interference|
Is doing nothing an option?In short: yes, but herbalists would run a grave risk of losing their patent formulae forever. Since the exemption under Section 12(2) of the 1968 Medicines Act was revoked in 2011 with the full implementation of the Traditional Herbal Medicinal Products Directive (THMPD), manufactured herbal products can no longer be sold without a Traditional Herbal Registration (THR) number in the UK. It’s worth bearing in mind that, under the former exemption, herbal practitioners dispensed many of these manufactured products. The THMPD, by contrast, is specifically intended for herbal products that “are intended and designed for use without [our emphasis] the supervision of a medical practitioner” (Article 16(a)1(a), THMPD, Directive 2004/24/EC).
One of the major tasks for the present working group is to explore how to maintain or regain herbalists’ access to these products, now that the UK government insists that it cannot use Article 5.1 of EU Directive 2001/83/EC. By taking this position, the government has whipped away one of the main planks supporting SR, as there’s no longer any need to use primary legislation to confer upon herbalists the status of ‘authorised health-care professional’.
Let’s make up our mindsWhen the various pros and cons of SR and VS are lined up alongside one another, the contrasting character of the two schemes becomes clearer. SR will preserve some form of herbal medicine in primary legislation, with herbalists likely gaining improved standing in the public’s eye, as well as improved legal standing, as compared with the status quo. On the other hand, educational standards will probably be inflexible, mirroring the likely approach of the regulator and the attitude of the ‘new herbalism’ toward non-herbalists and non-EU-trained practitioners. Crucially, if SR is to work, the relationship between herbalists and the government must be one of reciprocated trust by the former of the latter – hardly how the relationship has worked in the past.
By contrast, it appears that a voluntary scheme may be considerably closer to the historical spirit of herbal and traditional systems of medicine: open and responsive to all recognised traditions and practitioners, operating at a respectful distance from the government to provide a safe and effective service to the public, at reasonable cost.
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