The disagreement between herbalists who want to be recognised by the state and those who don’t want to be organised is as old as the hills. Those of you who have willed for statutory regulation (SR) are on the eve of achieving your dream, and we hope you will make the very best you are able of the trials and the opportunities it will present. However, there is one last bit of business to attend to, which might even unite us briefly, in countering the proposal to reform Section 12(1) of the Medicines Act 1968. We hope you will take up this cause as it profoundly affects the future and security of those choosing to work in a regulated environment, as well as the rest of us.
Firstly, here is Section 12(1) itself:
Section 12. Exemptions in respect of herbal remedies
(1) The restrictions imposed by sections 7 and 8 [Licences and Certificates relating to Medicinal Products] of this Act do not apply to the sale, supply, manufacture or assembly of any herbal remedy in the course of a business where—
(a) the remedy is manufactured or assembled on premises of which the person carrying on the business is the occupier and which he is able to close so as to exclude the public, and
(b) the person carrying on the business sells or supplies the remedy for administration to a particular person after being requested by or on behalf of that person and in that person’s presence to use his own judgment as to the treatment required.’
Secondly, here is an extract from the statement released by the MHRA on February 16th 2011:
‘If practitioner regulation is in place for the purposes of creating an Article 5(1) scheme this also opens the way to reform Section 12 (1) of the Medicines Act 1968. Under Section 12 (1), practitioners may prepare unlicensed herbal medicines on their own premises for use following consultation with individual patients. It is intended to move to the position that only registered practitioners would be able to operate under Section 12 (1) after regulation of practitioners is in place.’*
*Greater detail on the background to this, for instance, what Article 5(1) is all about, is covered in ‘Statutory Regulation Facts & Fictions’. Meanwhile, here’s our analysis of the current situation:
Why we all need to keep Section 12(1) of the Medicines Act 1968 unchanged
To the UK Government: Reforming 12(1) is not necessary to comply with the Traditional Herbal Medicine Products Directive (THMPD). Restricting all unlicensed medicines to the exclusive use of regulated practitioners would effectively outlaw the many herbalists who will not register with the HPC. This is not simply a matter of bowing to pressure groups or even the wishes of the majority: it’s also important to protect individual choice, applicable where such choices neither cost the public purse nor cause harm. Those who for whatever reason choose to consult with unregulated herbalists should still be able to do so legally under the caveat emptor principle, thus upholding fairness and common law rights. It also avoids the future potential embarrassment of prosecuting UK citizens for doing no harm.
It is clear from the disclusion of acupuncturists from the regulatory process that the Department of Health sees no need to regulate complementary therapies per se. To regulate herbalists beyond what is required to comply with the THMPD makes a mockery of the principle of proportional legislative impact, and thus inexplicably discriminatory.
To potential HPC-regulated practitioners: The reform of 12(1) is not required in order to achieve a workable regulatory process. It would leave you vulnerable if SR founders on inception or in the future, or if at any stage you personally opt to become deregulated (as so many osteopaths and chiropractors have in recent times). It may also pave the way to the removal of the right of registered practitioners to make their own medicines, and there would be nothing anybody could do about it.
For the time being, you will be party to persecuting a group of your colleagues who have done nothing wrong, may have been your friends hitherto, and who have themselves made many positive contributions to the life of herbal medicine, including most of your dedicated suppliers.
To unregulated practitioners: If section 12(1) remains, we may be inconvenienced in a number of ways (no access to dispensing services or ‘specials’, loss of title & prestige, etc.) – but we can continue to function legally, and of critical interest, can continue to make our own medicines and/or buy in dried herbs and single tinctures. We can continue our work as custodians of traditional knowledge, and to serve those members of the public who continue to choose unregulated herbalists.
To herbal medicine as a whole: Without reform of 12(1), SR still offers a balance of benefit greater to the regulated than the unregulated group, but the latter will be likely to accept it. There need be no residual enmity between the two groups, there is still much we can share, and a spirit of friendly competition will stimulate growth in an erstwhile failing profession.
Who will oppose such an arrangement?: It has never been clear how much the powerful lobbies of the pharmaceutical industry and the more conservative elements of orthodox medicine have influenced the current proposals, but it would surely serve their interests to see 12(1) scrapped. Likewise one can anticipate opposition from the EHTPA, on the basis that a) they have always worked to achieve a ‘closed shop’ and b) enrolment with the HPC would be maximised the more difficult an unregulated environment appears.
Afterword: In many ways we all look forward to the lines being drawn at last so we can get on with planning for our different views of the future. But unregulated herbalists and their patients stand to suffer appallingly if Section 12(1) is reformed, and this is reason alone to appeal to all herbal practitioners of good conscience to think again. We wish, as we’re sure you all do, that herbal medicine should survive and enjoy a vibrant future. Losing Section 12(1) of the Medicines Act leaves regulated practitioners vulnerable, and could so easily be the first step towards terminating the legal practice of herbal medicine in the UK, as our detractors have always wanted. Are you really prepared to risk it?
The Herbarium 
16 comments
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March 3, 2011 at 11:55 am
philip
This is a brilliant summation of the truth of the situation, and I encourage everyone to take the responsibility of ensuring that the essence of this message gradually gets spread throughout the herbal practitioner community, and among patients, public, and decision-makers.
March 3, 2011 at 2:13 pm
Fiona Morris
I do agree that it is important to keep Section 12(1) of the Medicines Act as it is. As a herbalist I did choose to support SR, certainly not to exclude other herbalists but to promote an integrated public health service, encouraging healthy dialogue with other health professionals, and to promote the importance of the role that herbal medicine can have in all aspects of health care.
I am also part of NIMH and see the value in being part of a PA (professional association), while I can also understand the problems that many individuals have had with their PAs causing them to leave. This issue should be seriously looked at by PAs.
Although I have supported SR in the UK (mainly in response to the threat of losing freedom to access unlicensed 3rd party herbal products), I do agree a lot with much of the content on this site. I myself teach courses in medicine foraging and making. I feel it is important that the public find pathways to connect with nature and herbal medicine in more ways than just through expensive consultations with herbalists. This may seem contradictory according to the view of SR supporters on this site, but I personally love the approach of the permaculture and transition movements, promoting a more healthy way of being on so many levels.
As herbalists, we all know the importance of the need for safety and quality control, particularly when giving medicines to people who are unwell. Some herbs are very potent and must be harvested or administered with care. It is also very important to have a relationship with a health practitioner to identify when a condition is a serious one and not appropriate to self-treat. Herbs are not ‘safe’ per se. For this reason, I do think it is helpful for public peace of mind that herbalists are regulated in some way, whether it is compulsory or voluntary.
I am also inspired by traditional medical practitioners around the world, many of whom are not regulated in any way. How blissful it would be to live in a world free from legislations, rules and regulations, but I imagine this also brings its own problems.
Recently I worked with and interviewed a herbalist from Thailand. Thai herbalists have gone through the process of regulation in the past 10 years, and have had to work through the pros & cons that has brought to them. Many well-known herbalists could not even read or write to pass the exams which they had to do to meet the requirements as a practitioner. In those cases, I believe they made special exceptions based on their experience. The herbalist I spoke to agreed that in the long term it made herbal medicine more reliable in the eyes of the public. This is a country where herbal medicine is very widely accepted.
It is important to learn from the experiences of other countries and health professions, such as osteopaths and chiropracters. I am aware that SR has its drawbacks, but I personally do believe that herbalists are in a stronger position to promote their practice as authorised health professionals and to ensure that we KEEP Section 12(1) and to continue to access unlicensed herbal medicines with the enforcement of THMPD in April this year. I also see the importance of SR based on the history of european public health policy, although this is accompanied the the frustrations of ‘red tape’.
Certainly there are opportunities that SR can bring to the profession of herbal medicine. I do however, feel for herbalists who choose not to support SR or are not or no longer members of a PA for their own reasons. It is very sad indeed the sense of division between herbalists. Although I do support SR, I do not feel that we should consider opposing sides of the SR debate as being against each other as herbalists. I personally have no bad feeling towards herbalists who are against SR. I do sense inflammatory angry attitudes, which is natural given the frustration of individual desires, so I can see how defensive attitudes may arise on both sides. While I understand this, I feel that this undermines our common goals as herbal service providers.
Perhaps there are pros and cons on both sides, it is not about who is right or wrong – these issues are not so clear cut. I feel that if we can find a way to focus on our common ground, hopefully we can find a sense of unity within our inevitable diversity. If we can treat each other with respect and compassion, and attempt to empathise with the other’s point of view, then maybe we can move forwards from this place in a positive way. We are united in our wish to heal others and make them better, after all.
Best wishes,
Fiona
March 3, 2011 at 3:35 pm
MARTIN
Fiona, NIMH is not a responsible organisation and never has been. It is a private limited company and members are shareholders. Therefore, if they are part of the regulation process, I ask how can you expel a shareholder for wrong doing? If a rogue therapist cannot be expelled, then the whole regulation process falls apart.
March 3, 2011 at 5:00 pm
philip
hello Fiona
Can I ask you about a contradiction which appears to occur in your very interesting piece?
You say “I do agree that it is important to keep Section 12(1) of the Medicines Act as it is”, and then later on “I personally do believe that herbalists are in a stronger position to promote their practice as authorised health professionals and to ensure that we KEEP Section 12(1) and to continue to access unlicensed herbal medicines…”.
The latter seems to be saying that you think Section 12(1) should be changed and made for SR herbalists only.
Could you be good enough to reconcile these two for me, as I can’t do so at the moment!?
March 3, 2011 at 6:37 pm
Robert Scott
It remains strange that the “excuse” put forward by the government to introduce SR was to outflank THMPD, while in the same statement Andrew Lansley said that without SR THMPD would be illegal on grounds of discrimination. As only a narrow band of hebal traditions have been put forward for SR, gross discrimination remains. As SR has been used to pseudo ligitimise THMPD and its inherent discrimination. its support is de facto, also an act of cultural and ethnic discrimination.
If THMPD is the problem, that is what should be reformed, in line with the ANH proposals.
SR was never about public safety, as has been confirmed by Lord Howe in his admisssion that their was no proven causal link between hebal medicine and damage to patients.
So what is it all about, other than limiting the practice of herbal medicine to those trained to advize their patients to use HRT rather than herbal medicine, despite the dangers inherent in its use.
It was a matter of note that “a source close to the chairman of the EHTPA” stated at a meeting that I attended in the EHTPA chairman’s house, that it was his opinion that within 10 years of SR coming into force, there would be no private practioners of herbal medicine left in practice. “The sourse” also stated that he did not care about this, as by that time he would have retired.
On this basis it is hard for anyone to defend SR as being either in the interests of the profession or public freedom of choice!
March 3, 2011 at 8:46 pm
herboscy
If we’re going to do anything about the proposed reform of 12(1), we have to have a dialogue with herbalists of all shades of opinion, and I’d like to thank Fiona for being the first to engage with the issue from the perspective of an NIMH member favouring SR, all done with considerable effort of thought and with a clear desire to heal.
Whilst the Herbarium is here, as we say, to ‘hold a safe space for a free exchange of ideas’, I’m nonetheless disappointed that there are already contributors who are taking this as an opportunity to continue to rubbish SR, or NIMH, or both. There may be truth in what you say, it might make you feel better, but how on earth is it going to help? So can we all try and stick to the point – finding if we have common ground in opposing the reform of 12(1)?
Stephen Church
March 3, 2011 at 11:25 pm
sue evans
Hi Fiona
Thanks for your thoughtful post. You reflect many of my own inner tensions about this whole SR business. On the one hand there is the pull to become part of mainstream healthcare, to give practitioners the chance to demonstrate in the public arena the potential for good that herbal practice can be. On the other hand, I have grave concerns as to what mainstreaming is likely to cost us as practitioners, not only financially, but also in terms of the maintenance of our specific contribution to healthcare – and that of course means our philosophy. In addition, as you mention, there is something about the elitism that is inherent in SR that goes against core aspects of herbal medicine.
Some groups of herbalists here in Australia are agitating for SR, and we do have a similar clause to 12 (1) in our own relevant legislation. My concern re possible changes to this clause is twofold. Firstly it makes non-registered practice impossible – it is one thing to give advantages to registered herbalists: it is quite another to ban those who choose not to be so registered. Secondly it is likely that a reformed 12(1) would involve further requirements on dispensing and while these changes are likely to be couched in language about safety and efficacy, in the long term such changes are likely to lead to herbs becoming more like pharmaceuticals (concentrated, standardised) and less like traditional herbal medicines. There is already a very worrying trend of disassociation between herbalists and the plants we use in practice. If that disconnection continues then herbs become little more than quasi-pharmaceuticals, with added environmental disadvantages. For both these reasons, we need to maintain 12(1) in its current form.
March 8, 2011 at 12:51 pm
Fiona Morris
Hi again,
Just to respond to Philip’s question. Apologies if my words were not clear. I am NOT AT ALL saying that Section 12(1) should be changed and made for SR herbalists only. I do find that all the terminology and intricacies of this debate leads to a lot of confusion on both sides. It feels so difficult to explain my position on this forum as clearly there is a strong bias of anti-SR and anti-PA, all for good reasons I’m sure.
Thank you for the comments acknowledging my views. I personally see no reason to change Section 12(1) of the Medicines Act and wish none of these regulations or legislation changes were necessary.
Due to THMPD I felt it was important that there was an avenue for the public to access ‘unlicensed’ remedies (i.e. not forcing herbal suppliers to pay thousands of pounds to continue selling their products), which at the time and still does appear to me only possible with the SR of herbalists so that was my choice as a NIMH registered herbalist. It is bad news that this may exclude good herbalists who are not regulated who currently provide valuable herbal medicine services to the public. So for that reason I support KEEPING Section 12(1) unchanged.
I can only speak for myself as a NIMH member and assume that other members hold their own viewpoints which may differ to mine. I do not agree with THMPD and if this can be repealed through the force of public demand then so much the better. I do not feel that my support for SR is to alienate other practitioners, but to continue to work effectively as a practitioner and to promote herbal medicine to a wider public.
I see regulation of herbalists as a platform from which herbalists can become integrated with other health professions and where herbal medicine knowledge can be shared and made more acceptable to a wider population of people.
Rather than giving in to a bio-medical model, with SR I feel that herbalists can enhance current public healthcare with a herbal approach emphasising the use of and connection with nature to heal, preventative health, and a common sense natural approach to first aid at home.
Completely aside from the THMPD issue, with all respect, for me NOT choosing SR is choosing to remain in the fringes of society and staying out of the mainstream. Offering herbal medicine to supporters of CAM but not extending it to others who may view herbal medicine with suspicion is like keeping herbal medicine to the converted. This is tricky of course for herbalists who do not wish for SR or to be part of a professional association for financial, personal or other reasons.
Regarding the point above about rogue therapists not being expelled as NIMH is a limited company. It is not my understanding that NIMH operates this way and there is a strict code of ethics that members have to adhere to or they are expelled. It is for the sake of having a professional approach to my herbal practice that I chose to join them, if this is not the case then I would have to reconsider. NIMH is not perfect, but it does provide principles and standards for practitioners to adhere to, and to give them some credit, they have a very tough job keeping all their members happy through a very difficult time indeed for herbalists.
This debate is important and it is worth appreciating each other’s different views. I hope that together we can negociate a positive outlook for all herbalists and respectfully work through any misunderstandings which may arise from not seeing the full picture, my own included. Absolutely as Stephen says above: “can we all try and stick to the point – finding if we have common ground in opposing the reform of 12(1)?”
Best wishes,
Fiona
March 8, 2011 at 4:49 pm
philip
thanks Fiona, an excellent reply, I clearly understand your view now. It is great that a pro-SR herbalist does not see any reason for changing Section 12(1). I wish you well if you decide to promote the reasonableness of your view within your professional body.
The current proposal for SR by the government has been put forward specifically to allow SR herbalists to continue to order unlicensed ‘specials’, ie. prescriptions from a third party supplier for their patients, after the THMPD comes in. The MHRA has followed this up by saying that this would open the way to limiting Section 12(1) to these herbalists alone. In terms of logic, however, there is no connection between these two things.
I’d like to know exactly what problem it is that the MHRA thinks it needs to be dealing with, in seeking to limit herbal practice in this way, as the relevant documentation repeatedly states that regulation should be proportionate to risk.
March 11, 2011 at 10:21 am
Caroline
many thanks for this post which clarifies the issue a lot, and for the plea for moderation from stephen, as well. fiona’s posts express my own views and concerns far better than i could, at this stage in my training! i would still find it helpful if there was a summary of the potential risks / likely / best outcomes possible around section 12(1) are, in terms of what regulated and unregulated herbalists can currently do and might not be able to do in future if that section was changed.
i still find it very confusing as to how far section 12(1) is/will be neccessary in allowing herbalists to buy and / or grow and / or make different types of products and how much (if at all) this varies by the level of processing/manufacture required.
the shops seem confused as well. i went to baldwins a week or so ago and they said their understanding was they could continue to supply dried herbs to the public, but not tinctures in future, but they weren’t sure. i had thought there was a question mark over tinctures.
it would also be helpful to me if there was greater clarity over the issue of money, and where it is intersecting with this debate. for example i’m really unclear where the border lies between treating friends and family (which presumably lies outside of regulation? or am i being naive?) and charging for treatment.
March 14, 2011 at 9:34 pm
timbolane
We have to this point been repeatedly told by the State and the EHPTA that SR and all the preceding variants were exclusively for issues of public safety and protection. I really do find it acutely disingenuous that all of a sudden, SR is now being mooted as a way to get around the limitations on commissioned third party preparations only being available to authorised health care personnel. Seems like public safety is an issue that has conveniently been sidelined- there’s nothing like moving the goalposts to suit your own agenda, is there?
March 15, 2011 at 12:53 pm
philip
hello Caroline
I’d like to have a go at replying to some of your questions.
– “what regulated and unregulated herbalists can currently do and might not be able to do in future if that section was changed” – what the government has proposed is that unregulated herbalists would not be able to practise at all. What regulated herbalists would be able to do, would depend entirely on what changes were made to section 12(1), and even that would be liable to further restriction if further changes were made to it down the line. This is why many of us consider it so important to retain section 12(1) as it is. We are saying this not in our own self-interest, but in the interest of the people of this country, both herbalists and patients.
– “i’m really unclear where the border lies between treating friends and family (which presumably lies outside of regulation? or am i being naive?) and charging for treatment” – I don’t see that it can be assumed that the government proposals would permit the treatment of friends and family as long as money was not charged. Again, this is why many of us think there is nothing wrong with the current situation.
– “i still find it very confusing as to how far section 12(1) is/will be neccessary in allowing herbalists to buy and / or grow and / or make different types of products and how much (if at all) this varies by the level of processing/manufacture required” – section 12(1) allows a person/herbalist to give a medicine that they have prepared personally for someone after a consultation. The proposal is to change section 12(1) and restrict it to SR herbalists only. Such medicines are not classified as industrially produced, and therefore fall outside the scope of the THMPD. The rationale given for the proposals for SR, as timbolane points out above, is now no longer public safety, but is to allow SR herbalists to order unlicensed preparations from outside suppliers and thus sidestep the THMPD. I would probably agree that shifting the goalposts like this is disingenuous, if I knew what it meant!
March 15, 2011 at 10:36 pm
Lesley
This is a fantastic wesite – this was a great piece of written information – but I was left with the question – how does anyone go about trying to stop 12(1) being amended – who to write to effectively, who going to be doing the amending – I think its criminal to let it be changed – we have all come to this point throught the benefit of its existence and secondly it needs to remain there to help protect whatever is left of peoples rights to choose their own means to maintain their health.
December 3, 2011 at 3:40 pm
Energetic
Hi
the main body that has been carrying out small consultations on changing section 12 (1) of the medicines act is the Medicines and Healthcare Regulatory Agency (MHRA). The medicines act is going to reviewed anyway because it was passed in 1968 and has loads of amendments, so it confusing for even the regulators to interpret. I did a report on the Statutory Regulation of Herbalists in the UK back in 2009 and even then the MHRA had been holding mini consultations on section 12 (1) since 2002. (Consultation MLX 299). They were at first happy with section 12 (1), but by 2007 after consulting organisations ranging from NIMH, individual practicioners to the Royal College of Physicians and the Royal Pharmaceutical society (remember they always get a say to!) their position was that Section 12 (1) should be restricted to regulated practicioners. The MHRA advise the Dept of Health on all this stuff.
Link to the MHRA page about section 12 (1)
http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/Unlicensedherbalmedicinessuppliedbyapractitionerfollowingaonetooneconsultation/index.htm
It is at consultation stage between DH and MHRA at present, so if you want to have your say get in there now…. apparently there will be a public consultation on this in late 2011, I could not find such a consultation on the MHRA or DH website, so prehaps they have not got round to it yet. Maybe the DH is too busy dealing with the new Health and Social care bill..
So will section 12 (1) be made obsolete? or will it be restricted to SR practicioners? would be my Q to the DH.
I think it is also worth bearing in mind, that we are not seen as trained herbalists of western herbal medicine, but part of a group of TCM, kampo, ‘herbologists’, people selling chinese medicines in shoppping malls, etc etc, we are all seen as the same people by our general opponents, because we are so busy in-fightening to effectively explain ourselves and who we are to the wider heathcare and medicines community, which apparently we don’t want to be part of anyway. Because bringing herbal medicine and its wonders to wider healthcare practice would just be plain wrong : ) because it will be hard?
May 21, 2013 at 6:59 am
Belfast
Been a while but thought this section could do with an update:
The Human Medicines Regulation Act 2012, according to MHRA: replaces nearly all UK medicines legislation – most of the Medicines Act 1968 and over 200 statutory instruments.
The so-called ‘herbalist’s caveat’ is found in Regulation 3(6) of The
Human Medicines Regulations 2012 which allows a ‘person’ the right to manufacture or assemble herbal medicines at the request of individual patients.
A ‘person’ is not defined per se. At face value it means that anyone, whether a herbalist, or not, (whether qualified to do so or not) can manufacture or assemble herbal medicines (though herbal products comes under THMPD otherwise).
Rumours that the UK government may do a u-turn on SR (which would likely have defined a ‘person’ as, potentially, a ‘qualified herbalist’) remains to be seen.
May 21, 2013 at 12:40 pm
herbalistic
This completely passed me by – thanks for the heads up.
MHRA site (http://www.mhra.gov.uk/Howweregulate/Medicines/Overviewofmedicineslegislationandguidance/TheHumanMedicinesRegulations2012/) states that the Human Medicines Regulations 2012 came into force on 14 August 2012 (I must have been on holiday!).
It appears that S12(1) has been repealed – link: http://www.legislation.gov.uk/uksi/2012/1916/schedule/35/made
Link to Part 3 ‘Special Provisions’: http://www.legislation.gov.uk/uksi/2012/1916/regulation/3/made
‘(6) This paragraph applies where a herbal medicinal product is manufactured or assembled by a person (“A”) if—
(a)the manufacture or assembly takes place on premises occupied by A and from which A can exclude the public;
(b)the product is for administration to a person (“B”) and A has been requested by or on behalf of B, and in B’s presence, to use A’s judgment as to the treatment required;
(c)the product does not contain a substance specified in Part 1 of Schedule 20;
(d)the product does not contain a substance listed in Part 2 of that Schedule, unless the product is sold or supplied—
(i)in or from containers or packages labelled to show a dose not exceeding the maximum dose or maximum daily dose specified in column 2 of that Part, or
(ii)in the case of a product for external use only, with a percentage of the substance in the product that does not exceed the percentage specified in column 3 of that Part; and
(e)the condition in paragraph (9) is met.’
Link to Schedule 20 Part 1 & 2: http://www.legislation.gov.uk/uksi/2012/1916/schedule/20/made
Part 1 looks like a proscribed list of herbs & Part 2 looks like the old Schedule 3 list.
Paragraph 9 (same link as Paragraph 6 above):
‘(9) This condition is that the medicinal product is not manufactured or, as the case may be, assembled—
(a)on a large scale; or
(b)by an industrial process.’
Another useful MHRA link: http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/Unlicensedherbalmedicinessuppliedbyapractitionerfollowingaonetooneconsultation/index.htm