Regulation of Acupuncture
2024 New Regulation Wales
Mandatory licensing of special procedures in Wales
https://www.gov.wales/mandatory-licensing-special-procedures-wales
Our Summary of the Consultation Results
Consultation currently underway by the government to regulate non-surgical cosmetic procedures
What is the Conversation About?
It is all about acupuncture and how we are licensed. There are two issues:
- There is a consultation currently underway by the government to regulate non-surgical cosmetic procedures.
- There is a consultation that is further ahead to introduce mandatory procedures to include acupuncture in Wales
Will any of this affect me?
Potentially
The Non-Surgical Cosmetic Procedures process is currently at the stage of determining what treatments are in scope. They have told us that, unlike some treatments, it is not obvious as to whether acupuncture will be in scope or not. They have explained the proposed framework and definitions of what is in scope and we can see how it could be argued that acupuncture falls in scope despite it not being a cosmetic procedure. Equally, there is the administration of legislation. If it is hoped that there will be one piece of legislation covering cosmetic procedures and special procedures – this will leave a question about how to control acupuncture.
What will this mean if acupuncture is in scope?
We have been given some insight into the proposed framework. The framework is likely to be very prescriptive concerning treatment modalities/standards/potential oversight by CQC or HCPC.
Acupuncture, could, if in scope, be in the green category which currently does not have plans to require oversight, but given that it is not decided whether acupuncture is planned to be in scope, then it could feasibly end up in the amber category which would require oversight.
We have also been told that it is likely that there will be licensing required for the practitioner and also for the premises.
Why are you telling us about this now?
We want to be transparent about initiatives that may affect us all. It is our aim to be involved in the discussions as much as possible. We are asking questions all the time about plans and objectives from all involved to understand as much as possible and are sharing our concerns as we go along. We hope that we are not adversely affected, but whilst this initiative has components of HCPC/CQC oversight and additional licensing – if acupuncture is in scope then things will change for us.
Whatever happens, it is our duty to be involved as far as possible to highlight where we see something that has the potential to adversely affect how we practice.
Why do we not want oversight?
Ideally, our profession would come together to address standards of training and competency and aim to self-manage through a Royal Charter. We can only do this if we find common ground together and are inclusive. Shutting people out because they don’t have the same training as others just creates a fractured profession. We are working towards improving standards and building bridges to raise training levels. We are well placed to manage our profession without government intervention. Having acupuncture managed by medics is not part of our strategy.
Why is Wales relevant to me?
The Welsh Dept of Health and Social Services have produced the draft regulations for their Mandatory Licensing Procedures. Although this is still part of the consultation – these are draft regulations so there is not much room for negotiation. This means that Acupuncturists in Wales are subject to:
- Undertake Level 2 Award in Infection Control Training and test. Around £100
- A Special Procedures Licence for the Practitioner £203
- A per Premises licence £345 (application must contain scale drawing showing the location of workstation/sinks/facilities)
- 3 yearly Renewal fee of £189
- DBS certificate
- local authorities will inspect premises and visit practitioners as part of the application process, to discuss how they have applied their infection prevention and control knowledge within the workplace and gain assurance that the standards contained in the licence conditions can be achieved.
- people will only be permitted to ‘work from home’ if they have a purpose-built workroom equipped, inspected, and licensed to the same standards as a studio or other business premises.
This applies to anyone who “runs” a premises even if not an acupuncturist.
Exemption
There is no exemption for Acupuncturists regardless of PSA registration.
This is a good and current example of what has happened within the UK. We know that those involved in both of these initiatives are collaborating and although they are different, they tell us that fees are only cost covering and not to make a profit. We have to wonder why councils anywhere else would charge less.
Are we scaremongering?
This is a consultation designed for the aesthetics industry and the aim is to provide far more management over how aesthetics practitioners are trained and supervised. Whatever is applied to this sector would be applied to acupuncture. We are simply potentially being swept up in this because we are an unregulated special procedure. If we did decide to look for regulation for our profession – we would not choose to be governed together within the aesthetics industry.
So What Can I do?
We are telling you what we know. Only to be transparent and to let you know our position when we represent you. We have not yet written to those in charge. We wanted to ensure that we got your support first for the position that we are taking.
We also know that the BAcC has taken a different stance. We have written to each member of the Governing Board in this regard and asked for open dialogue so that we can consider the issues as they come up in this consultation together. We hope that they will agree to a discussion. We know that all membership organisations of BAF support our position but obviously, the BAcC view is an important one also. The Welsh consultation referred to our profession being fragmented. We would like to show that we are capable of coming together to support all of our professions so that we do not need government intervention.
The Acupuncture Society is joining forces with BAF in this regard and fully supports this initiative
A combined Email to those heading this initiative from the Government. sent by BAF Member Organisations and the Acupuncture Society which represent more than half of UK dedicated Acupuncture Practitioners, was sent on 16th February 2024 to express concerns about the possible inclusion of Acupuncture in the scope of Aesthetic treatments, which we are seeking to avoid for our members so that they will not incur excessive red tape, financial burdens and loss of freedom of choice for their clients:
Dear
We understand that you are at the stage of compiling responses. We also understand that there is some discussion about acupuncture and whether it should be “in-scope” despite it not being a cosmetic procedure.
We have been grateful for the opportunity to hear from JCCP about the proposed framework thus far. We have discussed our understanding from those meetings and your presentation at IOL and shared this with our colleagues within the British Acupuncture Federation (BAF) and the wider acupuncture community. We welcome the opportunity to share with you the collective concerns of around half the acupuncture practitioners in the UK at this early stage of the consultation.
From our understanding so far, we do not believe that we are best placed in this new category for aesthetic procedures. Our members within acupuncture are highly skilled generalists and specialists of acupuncture. We are trained to work independently under a governing body to diagnose and treat a patient with symptoms according to our traditional models that have treated patients safely and effectively for centuries. Our methods of working have been made even safer through the advent of disposable needles and the aseptic techniques used in clinic, developed competency standards, audit, CPD and overarching governing bodies. Our insurance safety records underpin this with minimal claims and no settlements.
We have managed our own profession well for decades in conjunction with our current licensing arrangements with a very good safety record and growing popularity due to the effectiveness and safety of treatments. We continue to work hard to increase standard competency levels even further within the acupuncture profession and all our BAF members have a minimum of Level 4 in skills level training but most have level 6. We currently have an initiative to bridge the gap from level 4 training to minimum level 6.
We would ideally remain outside of this category but remain under licensing. The current licensing arrangement although a little inconsistent was becoming much easier with our connections to the local councils and the IOL. We have been involved in training of licensing staff in safe acupuncture practice and have been asked to do this again in the Spring. We are very keen to work with licensing authorities where possible to share our Safe Clinical Practice and Professional Framework to allow for even more transparent working together and easier identification of where risk may occur.
Reasons not to be included in the new legislation for Non-Surgical Cosmetic Procedures
Currently, we understand that the new regulations are to incorporate cosmetic procedures. Acupuncture does not fit into the definition of “cosmetic” and is used as an evidence-based form of medicine to treat a person’s symptoms. Therefore we do not believe that we fit into this category by definition.
The reduction of the availability of acupuncture either in the charitable or private sector through incremental costs of practice or administrative overhead will reduce public choice in seeking alternative treatments to improve health and reduce symptoms. Denying patients access to an alternative cost-effective treatment is likely to increase patient reliance on already stretched NHS services.
Acupuncture is often not used alone. It is within the tradition to use acupuncture, herbs, gua sha, cupping, moxibustion and many other the associated tools and modalities of treatment that come from our broad Traditional East Asian Medicine (TEAM). It is not unusual for an Acupuncturist to use whatever modality of treatment best suits the patient and each of these modalities requires separate training.
Acupuncture is widely used for very unwell patients. It is proving so effective that it is used in Palliative Care, Cardiothoracic units, Neurological, Stroke and Oncology departments and many others in the UK/US/Canada/Israel and around the world. There is much evidence written for policymakers, acupuncturists and the public on www.evidencebasedacupuncture.org.uk There you will see, for example, a study used in a Critical Care Unit in California that saw no adverse events and was declared feasible, safe and effective for this type of patient. Equally, there are reviews of over 4m treatments with 0.003% serious adverse events. From many different studies it is concluded that Acupuncture is safe and effective when used by a well-trained practitioner and the lack of insurance claims and settlements confirms this.
Due to the almost negligible side effects of acupuncture, it can often be used across the population. Many practitioners use acupuncture to assist charities working in post-trauma, addiction recovery, low-cost community clinics and other desperate areas. The incremental fees such as those we are seeing in Wales will make it cost-prohibitive for an Acupuncture Practitioner to offer these low-cost or no-cost treatments to the charitable sector and may prevent these effective treatments from continuing causing further financial burden to other agencies or to society in general. It is also often common to see Acupuncture practitioners working part-time in areas of low income which may remove the ability for treatment completely if part-time working is no longer a financially viable option.
Acupuncture is a profession that allows individuals who are perhaps looking after children or close to retirement to work part-time. Again the incremental fees proposed in Wales will make it no longer viable for practitioners to carry on work part-time with such high set-up and recurring costs for practitioners and premises. As above this may lead to a greater burden on the NHS, but more importantly a reduction in the ability to access healthcare for many people.
Acupuncture has managed its own profession well in terms of safety and professional conduct for decades. Governing membership bodies are in place to continually assess safe working and make recommendations to treat minors, and vulnerable patients, minimum standards and complaints and disciplinary procedures. As a profession, there is no requirement for further overhead oversight through anybody such as CQC or HCPC. In our opinion, such oversight would not be cost-effective in that it will incur incremental cost, time and money without there being a need or risk that warrants it. So as a consequence, it will not reduce a risk to society, but will increase cost. Many practitioners work independently across the Four Nations totalling thousands of practitioners that we membership bodies in the UK manage currently very effectively.
We would welcome discussion at any time to be able to understand the perspective of the DHSC moving forward and we are readily available to work with you to achieve government objectives without damage to the Acupuncture Profession.
This note comprises the views of the governing membership bodies that fall under the umbrella of the British Acupuncture Federation(BAF) and ARA and the wider acupuncture community:
Association of Acupuncture Clinicians (AAC),
Chinese Medical Institute & Register (CMIR),
Chinese Acupuncture & Herbal Medicine Alliance (CAHMA),
British Academy of Western Medical Acupuncture (BAWMA),
Japanese Acupuncture & Moxibustion Association (JAMA),
Acupuncture Association (AA),
Association of Five Element Acupuncture (AFEA)
Association of Naturopathic Practitioners (ANP)
Chinese Medicine Alliance (CMA) ,
Worsley Institute,
Tibetan & Eastern Medicine Association, (TEMA)
Microsystems Acupuncture Society (MAS)
Institute of Scalp Acupuncture (ISA)
The Acupuncture Society
We look forward to a meeting as soon as you can discuss the consultation and implications further.
Many thanks in advance
Kind regards
BAF AA AAC
Here is the BACC position
“The current proposal specifically precludes acupuncture from the remit of the new legislation. We believe this should be reconsidered for two reasons. Firstly, acupuncture is used by some for cosmetic purposes in the UK. The definition of ‘cosmetic procedure’ is not sufficiently delineated: for example, c) the insertion of needles into the skin, could include acupuncture. This may lead to ambiguity and difficulties in administering the law in the future. Secondly, we believe the current acupuncture licencing legislation, the Local Government (Miscellaneous Provisions) Act 1982, urgently needs to be reviewed.”
Email to us from BAF Member Organisations
Dear Paul
Thank you for taking the time to consult and provide your individual organisational support to the communication to the govt regarding the Non-Surgical Cosmetic Licensing Process.
We have had a positive response to our communications. We have had acknowledgement of our position and confirmation that, at this point in time, acupuncture can remain out of the scope of this process. It is also acknowledged that the current licensing arrangements provide some control for acupuncture and that the Non-Surgical Cosmetic Licensing process is driven by the need to manage high risk cosmetic treatments.
We have also had confirmation that we will be notified of any changes to this position as they move forward.
At this point in time, this is very reassuring. We remain in contact with those heading this project and will proactively continue to verify where acupuncture sits, not only in terms of the scope of the process, but also in terms of what happens to the out-going legislation that we are currently governed by.
In terms of our communications to the BACC, we wrote to each individual governing board member but have had no reply. We have also presented to the members within the Association of Acupuncture Clinicians and by raising awareness within the acupuncture practitioner community, questions have been asked of the BACC as to why they chose to opt into this process. They have since released a video regarding their position. Cosmetic procedures consultation – BAcC update (youtube.com). Their position isn’t clear as to why they have asked for acupuncture to be included. They have talked about the need for changes in the outgoing legislation (ie us being in the same category as tattooing etc) and want to be healthcare workers but they don’t really address the fact that they would be in-scope of a framework designed for the cosmetic industry. Although they remain very relaxed about it in their video – the fact remains that they have asked for acupuncture to be included in their response to the consultation – see below an excerpt from their response which is on their website:
Regardless of the BACC position, it seems as though we have bought some time to continue to build and demonstrate a cohesive acupuncture profession.
We look forward to further discussions about how we might work together in this regard
The Acupuncture Society views this as a very positive outcome for the continuation of the exemption of the Non-Surgical Cosmetic Licensing Process
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Current Position on Regulation in the EU and UK as of February 2011
by Paul Robin Chairman of the Acupuncture Society
The entry of Microsystems Detox Auricular Acupuncture to the Complementary & Natural Health Care Council (CNHC) register and Chinese Herbal EU regulation
This is rather an interesting time with Microsystems Acupuncture stealing the ‘regulation’ (voluntary regulation) first place position since the statutory regulation process was scuppered by the Orthodox medical profession early last year. Western trained scientists and researchers could not wrap their heads around the alien TCM medical theories, even though they are often used foremost in medicine by millions of people within China, Japan, Taiwan Korea and all East Asia.
There has been resistance to voluntary regulation by MARWG from some organizations. Also the major Acupuncture and Chinese Herbal groups which are not involved in the CNHC voluntary registration process and are still in shock over the lack of government interest in statutory regulation.
The Acupuncture Society has fully supported CNHC voluntary registration process for Auricular detox therapists through our active involvement within the Microsystems regulatory working groups (MARWG). Membership of the CNHC voluntary registration is likely in the future become a requirement for those microsystems practitioners wishing to offer detox services within the NHS environment.
As for statutory regulation of Acupuncture, this has not happened and any future regulation is likely to be voluntary and to allow for applied acupuncture and TCM skills. The Acupuncture Society who accredit CCM and other TCM courses are active members of the ASG and Microsystems regulatory working groups (MAcRWG) .
MARWG has almost completed its initial role, with a voluntary self regulatory register scheduled to open early in the new year under the governance of the Complementary & Natural Health Care Council (CNHC). The Acupuncture Society has representation on the Profession Specific Board (PSB) of the CNHC in respect of Microsystems.
Microsystems (auricular detox acupuncturists) or whole body acupuncture practitioners wishing to join CNHC register (Whole body acupuncturists who practice auricular detox acupuncture can have this aspect of their qualification verified by the society for inclusion in CNHC but must be aware that their main acupuncture practice will remain outside of the scope of practice covered by the register) can be verified by the Acupuncture Society which will enable them to be ‘grandparented in’.
They will retain their Acupuncture Society membership along side their CNHC registration. Practitioners wishing to be verified for access to the CNHC register should contact Dragomir at dragomirl@btinternet.com directly for training or skills update/assessment verification certificate.
At the moment many UK Universities have stopped their Acupuncture and Chinese Herbal courses and some BAAB/BAcC schools have had to cease tradingk due to the hard economic times that we face.
Consequently many surviving Colleges are moving to Applied Practical Courses like those run at CCM and some other professional training schools around the UK in preference to university accredited degrees courses. The new proposed university fee structures are likely to exacerbate this situation
The Society is of the view that Acupuncture and Chinese medicine and other TCM and oriental medicine techniques are best learned in the clinical environment and taught by experienced practitioners. Academic degree courses offered by UK universities appear, in our experiance, to be lacking in the practical clinical skills area with over complication of Acupuncture and TCM theory causing confusion amongst students.
The Society is promoting Applied Acupuncture Training as the best way to attain expert skills in these therapies in order to have the practical skills to practice acupuncture correctly and be able to treat patients with competence, practical skill confidence and safety.
The EU laws concerning Herbal medicine came into force in April 2011 and contrary to popular belief only apply to patent medicines and preparations made up in factories for thirds parties.
Those practitioners and retail outlets who are trading in patent medicines can soon apply for a licence to continue to supply these patent or factory prepared formulations from the HPC (see the written ministerial statement below published on 16 February 2011).
UK legislation due in early 2013 is likely to require registration of Herbal Practitioners with the HPC, it’s anticipated that this will greatly increase our acceptance within the orthodox medical community. There will be a consultion process begining in late 2012 leading to legislation expected in 2013. There will be grandparenting arrangements for all those in practice prior to the legislation coming into force. The White Paper is expected to follow simillar processes to those which were required when previous aspirant therapies attained registration to the HPC in the past. The Acupuncture Society is seeking to attain automatic grandparenting for all its Herbal Members.
Follow this link to the hpc website page on herbal regulation http://www.hpc-uk.org/aboutregistration/aspirantgroups/aspirantgroups/
Herbalists must not use endangered species animal and mineral substances in their formulae nor use patient medicines nor ask third parties to prepare them or their insurance may be void.
List of Banned Herbs and legal implications of new EU herbal regulation
A: RESTRICTED UNDER THE CONVENTION ON INTERNATIONAL TRADE IN ENDANGERED SPECIES (CITES)
Herbs which are endangered in the wild are restricted but may be traded with the appropriate CITES certification. In the case of Appendix I this is
normally only permitted for scientific purposes if at all. Suppliers can trade in Appendix II herbs but only from authenticated cultivated supply. An
example of this is XI YANG SHEN which is available from farmed sources.
APPENDIX I
HU GU (Os tigris)
SHE XIANG (Secreto Moschus)
XI JIAO (Cornu Rhinoceri)
XIONG DAN (Vesica Fellea Ursi)
BAO GU (Os Leopardis)
DAI MAO (Carapax Ertmochelydis)
MU XIANG (Saussurea lappa) NOTE: Vladimira species are permitted as a substitute herb.
APPENDIX II
CHUAN SHAN JIA (Squama Mantis Pentadactylae)
HOU ZAO (Calculus Macacae)
LING YANG JIAO (Cornu Antelopis)
GUI BAN (Chinemys reevesii)
SHI HU (Dendrobium species)
BAI JI (Bletilla striata)
TIAN MA (Gastrodia elata)
GOU JI (Cibotium barometz)
LU HUI (Aloe ferox)
XIAO YE LIAN (Podophyllum emodii)
ROU CONG RONG (Cistanches deserticola)
XI YANG SHEN (Panax quinquefolius) NOTE: Only applies to the whole and sliced root.
HU HUANG LIAN (Picrorrhiza kurroa)
B: RESTRICTIONS UNDER STATUTORY INSTRUMENTS
SI 2130 1997
These herbs were listed as an addition to the 1968 Medicines Act as being potent and hence in need of dosage regulation. In some cases they are
forbidden at any internal dosage.
MD= Maximum single dose MDD=Maximum Daily Dose
FU ZI/CAO WU (Aconitum species) NOTE: Permitted to use externally at a dose of 1.3% or below. Internal use prohibited.
SHI LIU PI (Punica granitum). Internal use prohibited.
BING LANG (Areca catechu) Pharmacy use only.
DA FU PI (Areca catechu) Pharmacy use only
MA HUANG (Ephedra sinica). MDD: 1800 mg. MD: 600 mg.
YANG JIN HUA (Datura stramonium). MDD: 150 mg. MD: 50 mg.
DIAN QIE CAO (Atropa belladona). MDD: 150 mg. MD: 50 mg.
TIAN XIAN ZI (Hyocyamus niger). MDD: 300 mg. MD: 100 mg.
NOTE: SI 2130 also applies to other herbs not employed in Chinese medicine.
S1 1841 2002
This ban relates to all Aristolochia species but also includes herbs which have been confused with Aristolochic species due to poor quality assurance.
The sale, supply and importation of the following is banned:
MU TONG (Aristolochia manshuriensis). NOTE: this ban also applies to Akebia quinata, Akebia trifoliata, Clematis montana and Clematis armandii.
FANG JI (Aristolochia fangji). NOTE: this ban also applies to Stephania tetrandra, Cocculus laurifolius, Cocculus orbiculatus and Cocculus Trilobus
MA DOU LING (Aristolochia contorta, Aristolochia debilis)
TIAN XIAN TENG (Aristolochia contorta, Aristolochia debilis)
QING MU XIANG (Aristolochia debilis)
SI 548 2008
All species of Senecio are prohibited for internal use due to the presence of toxic pyrrolizidine alkaloids (PA). This mainly applies to the use of Senecio
scandens QIAN LI GUANG
C: VOLUNTARY RESTRICTION
Due the presence of Aristolochic Acid in Asarum species there is a voluntary ban on the use of:
XI XIN (Asarum species)
D: RESTRICTIONS UNDER THE 1968 MEDICINES ACT
Under Section 12(1) of the 1968 Medicines Act, ‘herbal remedies’ which are administered after a one-to-one consultation with a practitioner do not
require a medicines licence (marketing authorisation). This legislation was enacted before traditional medicines from non-European cultures, which use
non-plant substances, had any significant presence in the UK.
Since the term ‘herbal remedies’ refers to plant materials, the MHRA has stated in its guidance on medicines law that the use of mineral and animal
substances, which do not have a marketing authorisation, is illegal.
Section 12(1) is currently under review and the RCHM is working to re-establish the use of animal and mineral products. It is also expected that this
redefinition of what constitutes a ‘herb’ will be clarified in European and UK legislation in the near future to include non-plant medicines.
In the meantime, members are warned that the use of these products may result in legal action by the MHRA and absence of insurance cover in the case
of a claim. Hence all animal and mineral products should not be used until otherwise informed.
Whatever the outcome of this process, the following must never be used in any form:
ZHU SHA (Mercuric sulphide) Cinnabar
QING FEN (Mercuric chloride) Calomel
HONG FEN (Mercuric oxide) Realgar
HEI XI Lead
PRESCRIPTION ONLY MEDICINES (POM)
It is strictly prohibited to include any drug which is made available only through prescription by a registered medical doctor.
This includes the following:
YING SU KE (Papaver somnifera)
MA QIAN ZI (Strychnos nux vomica)
STEROIDS Including external use in creams such as PI YAN PING or 999 SKIN CREAMS.
FU ZI Internal use
E: PATENT FORMULAE
It should be noted that several patent formulae traditionally contain some of the above restricted herbs and toxic minerals, and recently some have been
found to contain drugs. These include the following, which may present a health risk if used as a patent:
NIU HUANG JIE DU PIAN (May contain arsenic)
TIAN WANG BU XIN DAN (May contain mercuric salts)
It is the responsibility of the practitioner to ensure that all patent formulae are obtained from ‘bonafide’ suppliers. In practice this means that all
ingredients are listed and none of the above are included in the formula.
There are many Acupuncture Society CPD accredited , Under graduate and Post graduate TCM Acupuncture,Herbal and Oriental Diagnosis courses being run at the College of Chinese Medicine London. Visit www.ccmlondon.com for more info.
I wish you well in the continued wonderful healing work in which you are involved in
Kindest regards to all
Paul Robin FAcS TCM
Chairman of the Acupuncture Society
Below is the latest Government regulation statement which we are happy with in its wisdom, it allows for the continuation of voluntary regulation of Acupuncture although Auricular Detox Acupuncturists can also have their qualifications verified by the Acupuncture Society and be included on the CNHC Register.
Chinese herbal medicine practitioners who do not use patent medicines and prescribe tailor made formulas specifically to their clients are also omitted.
Those who supply or prescribe patient medicine which pre manufactured or prepared by third parties will need licences from the HPC after April 2012
Written Ministerial Statement
DEPARTMENT OF HEALTH
Practitioners of acupuncture, herbal medicine and traditional Chinese medicine
Wednesday 16 February 2011
The Secretary of State for Health (Mr Andrew Lansley): The issue of whether or not practitioners of acupuncture, herbal medicine and traditional Chinese medicine should be statutorily regulated has been debated since the House of Lords’ Select Committee on Science and Technology’s report in 2000 recommended statutory regulation for the first two of these groups.
We have today published an analysis of the 2009 consultation by the four United Kingdom Health Departments which sought views on the possible regulation of practitioners of acupuncture, herbal medicine and traditional Chinese medicine. This factual report has been placed in the Library and can be found on the Department of Health’s website at:
www.dh.gov.uk/en/Consultations/Responsestoconsultations/DH_124337
Copies are available to hon Members from the Vote Office and to noble Lords from the Printed Paper Office.
The Government has now had the opportunity to consider its overall strategy on professional regulation in light of the consultation response and I can now set out how we intend to take forward the regulation of herbal medicine practitioners and traditional Chinese medicines practitioners, specifically with regard to the use of unlicensed herbal medicines within their practice. As this matter is a devolved matter in Scotland and Northern Ireland we have had discussions with Health Departments in the three Devolved Administrations which have been constructive and we are committed to a unified UK-wide approach to the regulation of these practitioners.
When the European Directive 2004/24/EC takes full effect in April 2011 it will no longer be legal for herbal practitioners in the UK to source unlicensed manufactured herbal medicines for their patients. This Government wishes to ensure that the public can continue to have access to these products.
In order to achieve this, while at the same time complying with EU law, some form of statutory regulation will be necessary and I have therefore decided to ask the Health Professions Council to establish a statutory register for practitioners supplying unlicensed herbal medicines. This will ensure that practitioners meet specified registration standards. Practitioner regulation will be underpinned by a strengthened system for regulating medicinal products. This approach will give practitioners and consumers continuing access to herbal medicines. It will do this by allowing us to use a derogation in the European legislation to set up a UK scheme to permit and regulate the supply, via practitioners, of unlicensed manufactured herbal medicines to meet individual patient needs.
The Health Professions Council is an established and experienced statutory regulatory body which has the necessary experience to be able to successfully establish and maintain a statutory register for practitioners wishing to supply unlicensed herbal medicines. Subject to Parliamentary approval, such practitioners who wish to supply unlicensed herbal products will be required by law to register with the HPC.
The four UK Health Departments will consult jointly on the draft legislation once it is prepared. This will give practitioners and the public the opportunity to comment. Subject to Parliamentary procedures we will aim to have the legislation in place in 2012.
Until the new arrangements are in place the Medicines and Health care products Regulatory Agency (MHRA) will continue to take appropriate compliance and enforcement action where products are in breach of the regulatory requirements. In line with the MHRA’s normal approach, the action taken will be proportionate and will target products which pose a public health risk. Guidance issued by the MHRA makes clear their view that, where practitioners hold stocks of unlicensed products on 30 April 2011 that legally benefited from transitional arrangements under the European Directive, the practitioner can continue to sell those existing supplies to their patients.
The 2009 consultation also looked at practitioners of acupuncture. The practice of acupuncture is not affected by the EU Directive and, therefore, compliance is not required. I am confident that acupuncturists have their own voluntary regulatory measures in place, which are sufficiently robust. Additionally, local authorities in England have powers to regulate the hygiene of the practice of acupuncture, to protect against the risk of transmission of certain infectious diseases. Similar measures are also in place in Scotland, Wales and Northern Ireland.
I am pleased to say that this decision marks a significant milestone. I am confident that this is the right decision, which will benefit both practitioners and the public who use herbal medicines.
History of UK Regulation of Acupuncture and Chinese Herbal Medicine in the UK
We are approaching the end of 2007 and there is still not a single governing body for acupuncture, TCM and Chinese herbal medicine in the UK. There are many different organizations all practising different versions of acupuncture, TCM and Chinese herbal medicine all with different lengths to their training courses. At present all these different organizations have equal standing under the law.
Students who have graduated from the College of Chinese Medicine, an ASA accredited course, are entitled to be admitted as members of The Acupuncture Society and are obliged to maintain its high professional standards and adhere to its code of ethics, rules and regulations and professional requirements.
Society involvement in the future regulation of the profession
The Acupuncture Society were asked to contribute towards the draft National Professional Standards for Acupuncture and the Department of Education has also sort the advice of The Acupuncture Society relating to how the public can best be informed about the benefits of the acupuncture profession. The Acupuncture Society are currently attending the Acupuncture Stakeholders Group meetings and are participating in the future regulation of acupuncture and Chinese herbal medicine in the UK.
Here is an article from the April 2007 issue of The Chinese Medicine Times which clearly explains the current situation.
The Statutory Regulation of Acupuncture in the UK
by John Wheeler
Introduction
Statutory self-regulation (SSR) had become something of a holy grail for traditional acupuncturists in the UK. It had always been seen as the last step in a process of gaining true professional recognition alongside orthodox western medicine, and had achieved almost iconic status. The last decade, however, has seen fundamental changes in the structure of statutory regulation in the UK, and the original intended outcome of SSR is no longer possible. The irony of this situation is that this may well be to the longer-term advantage of the acupuncture profession, although many of its current practitioner members will feel cheated of their original goal. This paper examines briefly the historical background of the pursuit of statutory regulation, and then considers the opportunities which the current situation offers.
The long haul to regulation
Acupuncture had always been grouped alongside osteopathy, chiropractic, herbal medicine and homeopathy as the so-called Big Five’ in the complementary and alternative medicine (CAM) world. Together these groups formed the Council for Complementary and Alternative Medicine, and the understanding between them was that each in turn would move forward to statutory regulation. Without direct government support, the only process available was by the parliamentary mechanism of a Private Member’s Bill, a costly and time consuming route. However, the osteopaths (1993) and the chiropractors (1994) managed to achieve their goals by this means, and after a gap of several years while the regulatory infrastructures were created, both opened registers in the late 1990s.
It was widely assumed that acupuncture would be the next profession to follow suit. This had been anticipated in the creation of the British Acupuncture Council (BAcC) in 1995 by the merger of five acupuncture schools. With the British Acupuncture Accreditation Board (BAAB), an independent accreditation body formed in 1991, providing a guarantee of common educational standards, discussions with the UK Department of Health were very positive.
As well as the traditional acupuncture associations, there also existed three associations of medical professionals using acupuncture alongside their primary statutorily regulated activity. The key word in use at the end of the 1990’s in regulatory discussions was Inclusivity’, and the Department of Health was concerned that any statutory self-regulation scheme would embrace all of those using substantial amounts of acupuncture in their day to day practice. It encouraged the creation of a forum involving the BAcC, the British Medical Acupuncture Society (BMAS), the Acupuncture Association of Chartered Physiotherapists (AACP), and the British Academy of Western Acupuncture (BAWA), these groups representing the doctors, physiotherapists and nurses.
It would be fair to say that the early meetings of this forum were somewhat bad-tempered affairs. Accusation and counter-accusation about lack of acupuncture training and lack of medical training were very much to the fore. Whereas other groups, notably the herbal medicine associations who were following a similar path, shared equivalent levels of entry standard training, there were wide variations in the amount of training undertaken by people claiming to be Acupuncturists’, and very little by way of concession to each other’s positions. Even where the representatives themselves began to establish a healthy respect for each other, their constituents were largely implacable.
The defining change came with the House of Lords Science and Technology Select Committee Report on Complementary and Alternative Medicine published in 2001. This was the result of a long investigation by the Committee into the huge range of CAM provision in the UK, one outcome of which was to assign therapies to three distinct groups depending on the levels of independent practice which they supported and the evidence base for their efficacy and effectiveness. Acupuncture and herbal medicine were in Group 1, described in the Report as those professionally organized therapies for which there was a good evidence base. Ironically Traditional Chinese Medicine (TCM), considered in its integrated form as a combination of acupuncture, herbal medicine, tui na and dietary advice based solely on Traditional Chinese therapeutic principles, was placed in Group 3, those therapies with the least scientific evidence bases and resting largely on philosophical rather than scientific beliefs. It was clear that it was the limited evidence base created largely by scientific research using western medical acupuncture, as well as the fact that acupuncture was diverse enough to span several paradigms, which had unwittingly becomes traditional acupuncture’s Passport’ into the higher Group.
At the same time as the House of Lords Report was published, however, there had been a number of problems with herbal medicine and toxicity, arising mainly from covert imports of adulterated raw herbs, and also a fairly rancorous campaign by a leading academic with a university Chair in complementary medicine about the safety of acupuncture, drawing on world-wide statistics which bore little relation to the high standards espoused by UK practitioners. The resulting perception was that both acupuncture and herbal medicine represented a serious safety risk and should, according to the recommendations of the Report, be moved forward to statutory regulations as soon as was practicable for the protection of the public.
This recommendation followed shortly after the passing of the 1999 Health Act, in which a new fast-track legislative procedure was introduced, the so called Section 60 Order, by which statutory regulation could be introduced without the expense and time involved in the older parliamentary methods. Drawing on the House of Lords Report’s recommendations, the Department of Health, in partnership with the (then) Foundation for Integrated Medicine, established two working groups in 2002 to draw up plans for the statutory regulation of acupuncture and herbal medicine.
The Acupuncture Regulatory Working Group (ARWG) and the Herbal Medicine Working Group (HMRWG) worked in relative isolation from each other, a decision which with the benefit of hindsight was a strategic error. The ARWG, better re sourced by virtue of the numbers and finances involved in their associations, dealt with the thorny problems of different entry routes into the acupuncture profession, the problems of establishing equivalences of educational standards and outcomes and the manner in which dual registration, as for example a doctor and an acupuncturist, could be managed and funded. The HMRWG, by contrast, were able to settle their differences relatively quickly by accepting a range of titles and curricula based on equivalent training standards, but rapidly concluded that statutory regulation was not financially viable for them as an independent body unless the acupuncture and herbal medicine professions were jointly regulated.
When this merger was initially proposed, it took the ARWG by surprise, especially since the two professions were being described as the first entrants in what might become over time a CAM Council. For the BAcC, in particular, these proposals caused some fairly serious rifts amongst its practitioner members, with many believing that a CAM Council was their natural Home’ while others felt that the Self’ in Self regulation’ would ultimately be diluted to the point where control of the traditional acupuncture profession was handed over to a majority of non-acupuncturists. This antipathy to what was perceived as Outside control’ had already gained momentum in acceding to the possibility of sharing control with the western medical acupuncturists. Having now potentially one seat at a twenty-four seat table was seen as the ultimate sell-out.
However, by this stage the regulation of acupuncture and herbal medicine was being overtaken by a much wider and far-reaching review of health care regulation in the UK. This had been initiated with the creation of the (then) Council for the Regulation of Health care Professionals (CHRP), a statutory body with over arching powers to harmonize standards across the statutory regulators and to challenge decisions which it believed to be unduly lenient to registrants. The Shipman tragedies, where a GP was discovered to have murdered up to 300 of his elderly patients, together with a number of high profile cases where statutory regulators had been perceived to fail in the actions which they took against errant practitioners, led to the commissioning of several reports under the chairmanship of Dame Janet Smith. Many major reforms of health care were put on hold until these reports had been prepared and published.
This, indeed, had been the case with the regulation of acupuncture and herbal medicine. As early as 2004 the Department of Health announced the formation of a Joint Working Group (JWG) to deliver a proposal for the regulation of acupuncture and herbal medicine. The brief of the JWG and its representation had been published after consultation with the main players, but then, as a consequence of the general hiatus while everyone awaited the outcome of the Shipman Reports, in the words of a famous review of a Samuel Beckett play, Nothing happened twice.’ Indeed, the situation was then further compounded by the announcement of two further commissioned reports, a review of non-medical health care by Sir Andrew Foster and a review of the General Medical Council by Sir Liam Donaldson. Both of these were aimed at taking on board the recommendations of the Shipman Reports and reviewing the overall state of health care regulation in the light of these recommendations.
While this process had unfolded in the wider world of regulation, the division of acupuncture and herbal medicine regulation into two was being strongly challenged by the Chinese associations who argued that TCM, or CM as they now described it, was an authentic discipline in its own right, and that there should be a third Œwing.’ This move coincided with an increasing proliferation of High Street outlets for TCM in many cities and towns across the UK, and an upsurge in reports of sharp business practices and unchecked import routes leading to yet more problems with adulterated herbal medicines. This in turn led to a perception that a third working group for Chinese medicine might be an effective mechanism for bringing this whole sector under better control.
This task became all the more pressing with the realization that many of the reforms in the use of herbal medicines which would be necessitated by the implementation of the European Union Directives on Traditional Medicine in 2011 depended on the statutory regulation of herbal medicine, since many of the herbs would only be available to registered practitioners. Continuing fears about the safety and toxicity of herbs, together with the realization that waiting for the Donaldson and Foster Reviews would leave scant time for introducing a regulatory scheme, meant that the JWG began its work in late 2006 before the Reviews were completed. The creation of a Chinese Medicine Working Group (CMWG) to sit alongside the expanded ARWG, now called the Acupuncture Stakeholders Group (ASG), and the Herbal Medicine Working Group (HMWG) gave the JWG the three Workhorses’ of regulation to generate material for assembling into regulatory proposals, which are due to be presented at the end of 2007.
The current situation
This route march through the history of the last decade’s movement towards regulation, while much briefer than would do full justice to the complex intertwining of factors, is intended primarily to demonstrate how the current position for traditional acupuncturists is vastly different from what they aspired to as little as ten years ago. The main outcomes of the Donaldson and Foster Reviews are concerned primarily with patient safety, with the accountability of health professionals, the standardization and streamlining of conduct systems, and the increase in lay representation in committees to ensure that professions do not favour their own. The older model of professional regulation is long gone, and statutory self-regulation as a concept is now moribund.
Indeed, there are two consequences of the current reforms which dilute still further the Self’ which had been for so long the primary aim of regulation for acupuncturists. Foster concluded that there should be no new regulatory bodies, and identified the Health Professions Council (HPC) http://www.hpc-uk.org/aboutus/, a body which had developed from the former Council for Professions Supplementary to Medicine, as an effective conduit for any emerging professions. The JWG is currently being given a very clear indication that this is where any emerging acupuncture and herbal medicine council will be Housed.’ In order to deal with the expansion of this body to accommodate more professions, there already being fourteen in the HPC, the structure of the HPC would itself need to be reviewed, since its current constitution, with one representative from each profession on the governing council and a lay majority, would lead to an unwieldy and unworkable governing council. There has been much talk of the Ontario model’, a structure pioneered in the Canadian state where governing boards in health care consist primarily of non-professionals with expertise in areas such as finance and management but with little professional representation.
For many practitioners, this seems to be the ultimate betrayal of their original aspirations. Where they had believed that a General Acupuncture Council governed by a majority of traditional acupuncturists would be the ultimate guarantee of the future of traditional acupuncture, they are confronted with a picture in which they are simply one amongst many professions governed by a health care regulator which, through having just taken on the psychotherapists, now oversees over a quarter of a million practitioners. They have no guarantees of any effective representation on the governing councils, and by virtue of the tripartite grouping of acupuncture, herbal medicine and Chinese medicine, may not even have effective control of the small sub-section which they may become within the HPC as an over arching regulator.
However, far from being a picture of decline, I believe that the likely outcome maybe to the advantage of the acupuncture profession in ways which its members have not yet thought through with any clarity. The history of SSR bodies is not necessarily one about which people should feel particularly nostalgic. The conclusions of the Shipman Report, that health care professionals tend to look after their own, was an extrapolation based on an analysis of just one major SSR body, the General Medical Council. Other bodies disputed this, and the experience of registrants is often that elected representatives more often than not go native’ very quickly on governing councils, and are not reliable defenders of the professionals’ position, either in standard setting or in determining ethical and conduct matters.
In broad terms, the lighter the regulatory touch, the more autonomy rests with the professions in matters of greatest significance to them. Where there is less representation of professionals, there is a greater need to work in partnership with them to achieve the overall objectives of regulation. This has certainly been the case where the Ontario model has been tested, and given that in an internal questionnaire of acupuncture associations control of educational standards was the single most important factor for every group, any structure which allows this to happen is to be encouraged.
Indeed, the Register itself is a good example of how times have changed, and how the perceptions of potential registrants need to be guided through these changes. In the older models of regulation appearing on the register was seen as a professional achievement in itself, one which distinguished the registrant from those whose standards were not as high and one which could be used as a means of attracting custom. In the modern regulatory systems the register is just a list, and probably one to which the public would only refer by way of instigating a complaint. The register for the combined acupuncture, herbal medicine and Chinese medicine professions may even benefit from being a joint list without distinction except by way of secondary differentiation. The less it looks like a mark of distinction for each individual discipline, the more it will appear to be only an administrative device, which provides basic information and guarantees of minimum and continuing competence. The profession and its professional associations will be where the public goes to find out the information on which it will base its treatment choices.
New Opportunities
The obvious question to pose, given the fundamental change in the structure of health care regulation, is what benefits statutory regulation now offers to practitioners. Rather than creating a route to professional recognition and self-management, the current model looks more like a mechanism for external control in which the professionals themselves have little say.
Many practitioners see statutory regulation offering some of the direct marketing opportunities which voluntary self regulation has denied them. Principal amongst these are the possibilities for being recognized and reimbursed by the major health insurance schemes, such as BUPA and PPP, and for finding employment within the NHS. The former certainly does offer scope for development. Many of the larger providers have bulked at funding acupuncture treatment because they have lacked the resources to check the credentials of every practitioner to whom a subscriber may have been. The experience of the osteopaths and chiropractors has been very positive in this respect. The one factor with which the traditional acupuncture profession may have to contend is the demand for evidence-based treatments with a definite prognosis in terms of time taken and money spent. Models of acupuncture which favour open-ended commitments to balance’ are not a favorite with the actuaries who determine funding policy. There are, however, enough proven protocols in popular areas such as the treatment of migraine and back problems to allow considerable funding, and statutory regulation should, in theory, make it easier to find funding for further trials, which build up the evidence base.
The experience of osteopaths in respect of NHS funding is illustrative for the wrong reasons, however, insofar as the cash-strapped NHS may be able to identify suitably regulated professionals but has no additional funding to provide openings for them. Few osteopaths have reported any significant increase in their NHS work as a consequence of statutory regulation. That said the barriers to work in GP practices and at a more local level may be considerably lifted by the reassurance which regulation brings to potential service purchasers. There are already indications that at a local level providers are awaiting statutory regulation to underpin the case which they wish to make to their Primary Care Trusts for adding acupuncture to the treatment mix.
By far the greatest benefit, however, aside from the structural control of educational standards which the new system should provide, is the confidence which regulation and the use of protected title will give to the public. The proliferation of practitioners and high street retail outlets has left the public confused about standards and accountability. The advent of statutory regulation will bring that element of control to the sector which encourages the general public to feel that they are not dabbling with fringe medicine but benefiting from the work of properly trained and fully accountable health care professionals.
Summary
There is a great deal more which needs to be written about the actual structure of acupuncture regulation, the grand-parenting schemes whereby existing practitioners can be taken on to the new registers, and the innovations in setting educational standards which are likely to be necessitated by having as diverse a range of practitioners as the acupuncture profession does. However, as a member of the Acupuncture Stakeholders Group it would be unfair for me to comment on these while they are still under discussion. I shall be happy to give you an update in the near future, however, as the process unfolds.
Biography
John Wheeler has been an acupuncture practitioner since the late 1980’s, having trained at the College of Traditional Acupuncture in the UK. He has a long history of involvement in the political development of the acupuncture profession, having sat on the Council for Acupuncture and Council for Complementary and Alternative Medicine in the early 1990’s, and having been a member of the Acupuncture Regulatory Working Group and the Acupuncture Stakeholders Group. He has been a long-standing member of the Executive Committee of the British Acupuncture Council, and is currently its Secretary, Chair of its Finance Committee, and a member of its Admissions and Ethics Policy committees. He has no spare time.
This article was originally published in The Chinese Medicine Times
Online journal for health care professionals covering all aspects of Chinese medicine and acupuncture.