Adam Smith, science and communications officer, ANH-Intl; member and special advisor, Association of Master Herbalists; member of UK herbal medicine working group Robert Verkerk PhD, executive and scientific director, ANH-Intl
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 table
In 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 compared
While 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 minds
When 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.
Call to action
- 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.
Comments
your voice counts
06 March 2014 at 8:19 am
Looks to me as if voluntary regulation might be best to maintain access to TCM and Ayurvedic herbal preparations for those practitioners....
06 March 2014 at 11:52 am
If truth be told this issue is splitting the herbal community and as your article rightly states, one side of the debate has been louder than the other.
It is worth considering the longevity of herbal medicine and historical antecedents. The biomedical school of thought has generally been antagonistic to herbalists, creating an 'us and them' scenario of sorts. Researchers (Ernst etc) have tended to look at herbal medicine through the narrow confines of positivist and reductionist perspectives and have to a great extent both misrepresented herbal medicine and alienated herbalists from the modern research community.
Unfortunately the EBM perspective, tied as it is to pharmaceutical interests, bends the ear of government, therefore we have a group of herbalists who claim to represent the majority view (this must be independently analyzed) and seek to ingratiate a certain type of herbal medicine into this paradigm. Those who wish to oversee others are therefore declaring themselves above everyone else - a nondemocratic (so it seems) hierarchy.
For many others who have been quietly working away for years the idea of regulation is strikingly contradictory. Look at what happened to herbal medicine in the UK between 1949 and 1968 before the Medicines Act created an exemption clause! Look at what happened to herbalists in the US after the 1910 Flexner Report!
The need for SR is underpinned by the potential threat it may create for the public, but given the excellent safety record of herbalists in professional associations, the threat is minimal, so the premise is largely unfounded.
A strident and robust system for VS agreed by PAs is the only way forward - the government could recognise herbalists as health care professionals without SR, and herbalists could continue their traditional therapies without needing to have them regulated, trimmed, adjusted, squashed and moulded into an epistemological straight-jacket.
06 March 2014 at 12:57 pm
I would go for self-regulation mainly because I feel that once governments get involved in any area of health, regulations can make life fairly difficult for practitioners whether they practice mainstream or alternative forms of therapy.
06 March 2014 at 1:28 pm
I think self regulation is better than state regulation,as the latter would almost certainly lead to a dumbing down of herbal medicine but Herbalist need to be recognised as legitimate professional health care practitioners, same as GPs, by the Government
06 March 2014 at 3:34 pm
If it is the case (as your article would seem to confirm) that herbalists, by remaining with VR, can benefit from virtually all of the advantages that the pro-SR lobby have been telling us that we must have SR for, then clearly VR is the better choice.
A further point is that VR has to remain what its name says it is - Voluntary Regulation. In this way, those who choose not to opt for it for the purposes of the advantages it will bring them, will still be permitted to practice. There are serious issues of potential discrimination to be avoided in this area.
It is nice to at last be engaging in what appears to be a balanced discussion of this matter.
06 March 2014 at 10:59 pm
Nice article outlining our choices. I have never understood the seemingly desperate need for state regulation. This is particiularly strange given the open hostility towards herbal medicine from government bodies, the medical profession and elements within the NHS.
In my opinion, better to grow and develop outside of formal state regulation. We have made great strides forward in the last 30 years. Why threaten that with an untimely attempt at placing ourselves in a more vulnerable and subservient position.
Perhaps we can have more confidence in ourselves and our chosen therapy. What we do is safe, effective and continues to benefit people. That is what we should focus on. To enter into a state regulated arrangement will mean we risk losing much more than we could possibly gain.
07 March 2014 at 3:03 pm
The alleged benefits of SR are based on blatant disingenuous obfuscations. The concept of regulating the practitioner under a discriminatory regime, to relieve the product manufactures of the cost licensing their products, is unethical to the utmost degree.
It is also unwise, as unlicensed TCM products have already caused severe damage to the unwary consumer, through unlabelled content substitution and toxic heavy metal pollution. The same widespread corruption in their country of origin, that gave us baby milk formula poisoned with melamine to artificially increase its protein rating can give us little reassurance that similar occurrences would not happen again, if an adequate and proportionate form of product regulation is not put in place, without dangerous by-pass strategies to negate their effective implementation.
As the problem, allegedly at the core of the SR debate, is the continued access to these high potency biochemical products, that do not reflect the balanced properties of medicinal herbs in their natural state ,the appropriate way forward is to create a viable and acceptable regime of licensing. This is exactly what the Under Secretary of State Dr. Dan Poulter suggested during the Early Day Motion Debate, on this subject, in July of last year.
Most tellingly, he also pointed out that under section 3 of the human Medicine Act 2012, practitioners could continue traditional practice, making up prescriptions to meet the needs of their patients, in the genuine traditional way, as had been the case under 12.1 of the 1968 Act. This had already been confirmed by the MHRA. On this basis genuine traditional practice is not, nor ever has been, under threat, except by SR itself. The SR proposal is as discriminatory as THMPD, as both proposals exclude the majority of traditions! Furthermore, since the attempt to use SR under a sub-clause of THMPD, would have been constituted a recognition rather than a challenge to this profoundly flawed directive.
In this country, the MHRA's interpretation and enforcement of THMPD is greatly at odds with the approach used in other EU countries. In the Government report "Review of the Balance of Competences between the United Kingdom and the European Union Health July 2013" it was stated that other countries treated the border area between dietary supplements and "medicine" in different ways and subsequently licensed products under vastly different regulatory regimes. As this was described as a matter of "national competency" the power to resolve this issue lies within our own borders. In effect, our own MHRA is the responsible culprit! This should come as no surprise after the damming report it received in the House of Commons Select Committee Report on the Influence of the Pharmaceutical Industry, which pointed out that, as far as herbal medicine is concerned, the fox has been put in charge of the chicken coup!
The idea of restricting the availability of herbal medicine through an ever-narrowing channel of access is nothing short of the selling out of herbal medicine to the pharmaceutical industry!
The government has already strongly indicated that it is ready to address this problem, so, there is absolutely no justification in using SR as a way of promoting the profession status of a limited group of practitioners, while discriminating against the majority of genuine traditions, which, if they follow genuine traditional practice, have no use for these products in the first place. The concept of high potency standardized extracts cannot be substantiated in any genuine historical context and the 30-year rule only demonstrates a modern fad, not a tradition.
If the rich diversity of genuine traditional medicine is to continue to thrive, under the cultural diversity rules enshrined in the EU rules, SR itself should be deemed as illegal under the EU treaty as is the attempt to use it to bypass other (even if profoundly flawed) directives. In this country, the Working Group on Extending Professional Regulation ruled that using SR as a way of manipulating the professional status of the group involved was not acceptable, but this is exactly what the SR project has been based on. The level of regulation is supposed to reflect the risk posed by the profession to the public. The appropriate level of risk, to justify this level of regulation has never been demonstrated. The only risk has come from unlicensed products, so let them be regulated and leave herbalists to continue to do what they know best, based on the millennia of empirical knowledge that the pharmaceutical industry has sort to denigrate, while at the same time has attempted to highjack through bio-piracy!
Robert Scott
12 March 2014 at 1:35 pm
I do not see this "attempt to air both sides of this polarised debate" as being anything but biased. The major problem with VS is that there is no there is no facility to stop anybody from practising if they are dangerous to the public in any way. That includes people with no training! In this situation (the one that we currently have) there have been tragic cases of poor practice leading to severe injury to members of the public. Those practitioners responsible are still practising. We would not accept a GP or consultant continuing to be allowed to treat patients had they harmed patients. Why should herbalists be allowed to do so?
SR is not interference. It is designed to protect the public, and this is what thousands of people in many proper public consultations have said that they wanted. Further, it is what the majority of herbalists want. I find it really amusing that the ANH describes it as "Government interference". How can the Government be seen to interfere when herbalists have had to press for something that successive Governments have failed to honour? It has hardly been foisted on them!
19 March 2014 at 5:03 pm
Hi Sophy, thanks for getting involved in the discussion. We’re wondering whether you have misinterpreted what you see as bias: this article is simply our effort to provide more information on the VS option, alongside that of SR, bearing in mind that VS has only been raised as an option recently. Moreover, the voluntary option was raised by the UK government – after it discovered that the legal basis with which it planned to underpin SR (i.e. Article 5.1, Directive 2001/83/EC) is no longer available.
Another key point is that the VS option is NOT the status quo. The whole idea would be to use codes of professional practice, these being upgraded where necessary, to ensure that practitioners maintained the highest professional standards. As far as we have seen, the very small number of cases of proven harm caused by herbal or traditional medicine practitioners in the UK have primarily been by ‘cowboy’ operators that do not work to professional standards. Should you have data that contradicts this, we’d be most grateful if you could send it to [email protected] and we will consider it carefully.
Bearing in mind its popularity, cases of herbal medicine causing injury to members of the public are extremely rare. Subsequent investigation in such cases invariably reveals the culprit as substitution of herbal species in the products used, or adulteration of herbal medicines with things like pharmaceutical drugs or heavy metals. Unfortunately, like the Traditional Herbal Medicinal Products Regulation (THMPD), SR will do nothing to prevent similar problems in the future.
It’s also worth remembering that orthodox medical doctors operate under what is in effect a system of SR, which does absolutely nothing to prevent a shocking catalogue of injury and death being caused to many thousands of patients every year. Even the most famous example of injury ostensibly attributed to herbal medicine, the Belgian ‘Aristolochia case’ – http://maciociaonline.blogspot.co.uk/2013/05/an-important-article-by-chris-dhaenens.html – was due to insufficiently trained orthodox medics prescribing herbal medicines under the off-label exemption (now cemented in Article 5.1, Directive 2001/83/EC), outside their competence.
It is impossible to deny that SR will put the government in charge of both herbalists and herbal medicine. The very name – ‘statutory regulation’ – means regulation by the State! If you prefer the word “intrusion” rather than “interference”, that’s fine by us. But it amounts to the same thing. The history books record that the British government has rarely had much warmth for herbal medicine, and only widespread public and practitioner activism has preserved it as a visible and accessible health modality up to this point. It’s worth repeating: the government itself raised the possibility of some form of voluntary regulation in its correspondence with members of the latest Working Group. On that basis, we think it’s entirely possible that the UK government has concluded that SR is not legally feasible, and neither would it help the government in the popularity stakes if SR results in significant numbers of experienced practitioners being forced out of business.
27 March 2014 at 9:06 am
I was interested in the comment by another contributor that "In this situation (the one that we currently have) there have been tragic cases of poor practice leading to severe injury to members of the public": this is an argument that has often been put forward in favour of SR, and indeed it has been the main thrust of the pro-SR lobby for many years. But can it be substantiated? Who, precisely, are the people that have been severely injured by herbalists? When did such harm occur? Where did it take place? What surveys have been carried out to establish whether this is actually the case?
In the absence of the presentation of any such proof of harm being done by herbalists, it has to be regarded as mere rumour (some might even call it scaremongering). The problem with this approach is that, unless the claims can be substantiated, it amounts to a severe disservice to the honourable practice of herbal medicine.
01 October 2014 at 10:27 am
Given the discussions going on in this latest Working Group, it is surely about time that all practitioners using herbs realised that they are on the same side, and acted that way, standing together for the purpose of safeguarding their future.
The drive for practitioner regulation has been characterised up to this point by organisations like the EHTPA (European Herbal and Traditional medicines Practitioners' Association) and the NIMH (National Institute of Medical Herbalists) making out that some practitioners are dangerous, in order to suit their own agenda to have SR brought in. Herbal medicines and the practitioners who use them have a record of safety that is incomparable, and this is why there exists no evidence base to show that herbs or herbalists are dangerous. The claim of "we're safe, but they aren't" is surely one that must now be moved on from. As the ANH has pointed out elsewhere, even the Aristolochia case so often cited by those who are pro-SR as an example of the risks to public health posed by herbs, and which largely led to the drive to regulate herbal medicines, was founded on a mistaken premise.
Those who have sought to create a dichotomy between herbalists in order to serve their own ends have done a disservice to the herbal profession, and I would call upon them to now unite with their fellow practitioners in the interests of the public good.
01 July 2017 at 10:36 am
The public need regulation obviously on this one as most have no idea what to use and suppliers and supplies should pass scrutiny
30 December 2021 at 5:53 pm
i feel herbal practitioner's should be subjected to degree qualifications and regulated the same way as big pharma companies. 1. it would allow for better partnership and collaborative working between NHS services and herbal specialists. 2. it reduces the risk of poly pharmacy as some patients can receive 1:1 consultation with a herbalist and not inform their GP and then be complaining of side effects. However, these side effects are less likely to be reported to the yellow card scheme if herbal related as their is an assumption by many that herbal remedies are natural and safe. whereas, there is always an expectation with mainstream drugs to always be side effects. i agree with Alan porter herbal specialists should be scrutinised. Particularly, on treating symptoms associated with depression as depression is a complex condition and can be affected by different factors. in some cases some herbs can aggravate the condition if taken with psychiatric drugs
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