The Association of Traditional Chinese Medicine (UK)
Response to DH Consultation Questions
Q1: What evidence is there of harm
to the public currently as a result of
the activities of acupuncturists,
herbalists and traditional Chinese
medicine practitioners? What is its
likelihood and severity?
Harm
Generally speaking, acupuncture, herbal medicine and traditional
Chinese medicine are very safe, especially when practised by
qualified practitioners. However, there are some incidents in the past
years which have caused harm to patients. These are mostly caused
有 什 么 证 据 证 明 目 前 针 灸 师 ， 草 药 by unqualified or substandard “practitioners”.
师及中医师所从事的活动对公众造
成 危 害 ？ 其 可 能 性 和 严 重 性 又 是 什 The activities of untrained or substandard acupuncture practitioners
could cause harm to patients. Such harm could include:
么？







Cross infections, such as HIV, hepatitis B, hepatitis C and
other transmissible diseases
Pneumothorax caused by substandard acupuncture
practitioners
Paralyses caused by incompetent acupuncture practitioners,
the worst being is damages to the spinal cord
Injury to the internal organs and eyes
Severe bleeding due to injuries to main blood vessels
Burns when using moxibustion and heat lamp
Syncope and shock
The activities of untrained or substandard herbal medicine
practitioners could cause harm to patients. Such harm could include:




Poisoning due to using wrong herbs and wrong doses or
inappropriate use of potent or toxic herbs
Make the patients’ condition worse due to ignorance on
contra-indications and side effects of herbs
Causing severe side effects/ and toxicity by inappropriate
combinations of Chinese herbs
Causing adverse drug interaction, eg. Warfarin,
hypoglycemic, cardio glycoside due to ignorance of herbherb interaction and herb-drug interaction
Herbal medicines are medicines, just like any orthodox medicines.
They can treat clinical conditions, and they can also cause toxicity
and side effects. They can interact with other herbs and drugs.
Without proper training and regulation, the harm they can cause to
patients can be significant. There have been examples of harm done
to patients in the past, which are well documented. For example,
Chinese herbs that contain aristolochic acid have caused rapidly
progressive interstitial nephropathy in patients who used them without
prescription from TCM practitioners (Cosyns JP. Drug Safety 2003;26
(1):33-48 ), and hence the name Chinese herbs nephropathy (CHN).
Shou Wu causes acute hepatitis (Cárdenas A et al. J Clinical
Gastroenterology 2006:40 (7): 629-632)
Q2: Would this harm be lessened by
statutory regulation? If so, how?
Yes
这 种 危 害 会 因 立 法 管 理 而 减 轻 吗 ？ Statutory regulation will serve as a safeguard to prevent incompetent
practitioners entering these professions. Statutory regulation of
如果是，怎样减轻？
acupuncture, herbal medicine and traditional Chinese medicine
practitioners would prevent inappropriately qualified people from
joining the profession. Furthermore those already practicing at a
substandard level would be removed from the register. This would
mean that the public could be sure that the practitioners listed on the
register have been educated to the required standards of the
professions and are safe and competent.
At the moment anyone can claim to be an acupuncturist, herbalist or
TCM practitioner. There is no way to prevent people from practicing
acupuncture, herbal medicine or traditional Chinese medicine. Even
those who have been struck off the voluntary registers can still
practise regardless of the harm they may have caused to their
patients, as there is no statutory authority to regulate practitioners.
Q3: What do you envisage would be
Significant benefit
the benefit to the public, to
practitioners and to businesses,
associated with introducing statutory There would be a significant benefit to the public, practitioners and
businesses. As mentioned in the response to question 2, the benefits
regulation?
您 能 设 想 到 立 法 管 理 会 对 公 众 ， 对 would include:

Ensuring the public’s confidence in practitioners
从业人员及其经营有什么好处？

Ensuring that traditional Chinese medicine practitioners are
appropriately qualified and competent in their practice

The potential of harm to the public would be significantly
reduced

Statutory regulation would prevent substandard practitioners
entering the profession

Statutory regulation may increase costs for practitioners, but
the level of professionalism will be significantly improved. In
this way the cost increase will be well worth it.
Q4: What do you envisage would be
the regulatory burden and financial
costs, to the public, to practitioners,
and to businesses, associated with
introducing statutory regulation? Are
these costs justified by the benefits
and are they proportionate to the
risks? If so, in what way?
您能设想到管理化会给社会，从业
人员和经营造成的财政支出及负
担。 相对立法管理所带来的好处
这些成本是合理的吗？与所降低的
风险是对应的吗？如果是，体现在
哪些方面？
Q5: If herbal and TCM practitioners
are subject to statutory regulation,
should the right to prepare and
commission unlicensed herbal
medicines be restricted to statutorily
Justified
Statutory regulation may put some burden and financial cost to the
public, the practitioners and businesses. The cost will come from the
legislation process and the regulation practice, in other words the
running of the regulatory body. But the benefits will significantly
outweigh the cost incurred by statutory regulation. We believe that the
cost is proportionate to the risks posed by the non-regulation of
practitioners.
Yes
Yes. Statutory regulation would ensure that practitioners of herbal
medicine and Traditional Chinese medicine are appropriately qualified
and competent in their practice. Restriction of the right to prepare and
regulated practitioners?
commission unlicensed herbal medicine to the statutorily regulated
如 果 草 药 及 中 医 从 业 人 员 受 立 法 管 practitioners would ensure the public to have effective and safe herbal
理 ， 应 该 仅 限 于 这 些 被 立 法 管 理 的 medicines.
从业者才有权力制备和使用未取得
执照的草药吗？
Q6: If herbal and TCM practitioners
are not statutorily regulated, how (if
at all) should unlicensed herbal
medicines prepared or
commissioned by these practitioners
be regulated?
如 果草药 及中 医从业 人员不受 立法
管 理，怎 样来 管理这 些从业人 员 制
备和委托制备的非执照的草药？
Q7: What would be the effect on
public, practitioners and businesses
if, in order to comply with the
requirements of European medicines
legislation, practitioners were unable
to supply manufactured unlicensed
herbal medicines commissioned from
a third party?
如果为了和欧盟的医药法规相一
致，从业人员也不能使用由第三方
生产的未取得执照的草药，此举将
会对公众，从业人员，行业造成怎
样的影响？
Q8: How might the risk of harm to the
public be reduced other than by
orthodox statutory regulation? For
example by voluntary self-regulation
underpinned by consumer protection
legislation and by greater public
awareness, by accreditation of
voluntary registration bodies, or by a
statutory or voluntary licensing
regime?
如果没有正确的立法管理，那些有
可能对大众造成的风险和危害会通
过哪些途径降低？例如，消费者保
护条例自我约束，广泛的公众意
识，资格认证自愿注册团体，或是
法规的或自愿的许可证制度等所支
持的行业自愿管理是否可行?
We do not think there are any other effective methods to regulate
unlicensed herbal medicine prepared or commissioned by herbal or
TCM practitioners other than through the statutory regulation of the
practitioners. The reason for this is that regulations may be put in
place to control the quality of herbs or herbal products, but this will not
ensure the efficacy and safety of unlicensed herbal medicines, as only
the qualified and competent herbal and TCM practitioners know the
effective and safe clinical applications of the herbs. These
practitioners should be the only people who are allowed to prescribe
and prepare herbal medicines to patients or to commission unlicensed
herbal medicine according to patients’ needs.
Significant effect
The use of herbal medicines, including the indigenous British herbal
medicine, European herbal medicine, oriental herbal medicine (such
as Chinese, Ayurvedic and Tibetan herbal medicine) would be
significantly compromised. Herbal medicines are very popular in the
UK and Europe for common as well as serious diseases, as
demonstrated by many surveys in the past few years (Ernst E; FughBerman A. Occupational and Environmental Medicine 2002;59:140144; Molassiotis A et al. Annals of Oncology 2005
http://annonc.oxfordjournals.org/cgi/reprint/mdi110v3.pdf ) If herbal
practitioners are no longer able to supply manufactured unlicensed
herbal medicines commissioned from a third party, the profession
would be severely hampered in its ability to do business. Many
practitioners would be out of work which would have a knock-on effect
on the Government as many may resort to claiming benefits or require
re-training at the very least.
Unsure
Voluntary self-regulation (VSR) is the current form of regulation.
There are a number of prominent professional bodies, such as the
Association of Traditional Chinese Medicine, the British Acupuncture
Council and the European Herbal and Traditional Medicines
Practitioners Association. These VSR bodies are trying very hard to
uphold the highest possible standards, but they lack the statutory
power to regulate. For example, if a member of one of the VSR
bodies is struck off from the register, he/she can still practise TCM, as
there is no law to prevent them from doing so. As we stated in
Question 2, anyone can practise acupuncture, herbal medicine and
traditional Chinese medicine. The only way to rectify this situation is
statutory regulation.
Consumer protection, trading standards and local council
administrations have been put in place, but they have not been able
to prevent unscrupulous “practitioners” from harming the public. The
most effective way to protect the public would therefore, in our
opinion, be statutory regulation.
Q9: What would you estimate would
be the regulatory burden and
financial costs, to the public, to
practitioners and to businesses, for
the alternatives to statutory
regulation suggested at Question 8?
如果不立法，而用问题 8 中的约束
方法，您估计其对公众及对从业人
员及其经营造成的财政支出及成本
又是多少？
Statutory regulation would be the most effective and efficient
regulation regime to regulate acupuncture, herbal medicine and
traditional Chinese medicine practitioners. The burden and financial
cost to the public, the practitioners and businesses would not overly
exceed the current voluntary self-regulation regime. This is because
at the moment, the public, the practitioners and businesses are
paying directly or indirectly the voluntary regulatory bodies, the local
councils, trading standard agents and consumer protection agents. If
the statutory regulation of practitioners was in place, they would
simply pay the regulatory body. Most practitioners are paying to their
VSR bodies already, and some of them are paying to more than one
VSR body. Therefore, from the point of view of these practitioners, the
burden may diminish with statutory regulation. In turn practitioners
would be able cut their costs, thus benefiting their patients.
Q10: What would you envisage
would be the benefits to the public, to Statutory regulation is the best option. We can not see any extra
practitioners, and to businesses, for benefit to the public, the practitioners or businesses from what were
the alternatives to statutory
described in Question 8 as the alternatives to statutory regulation.
regulation outlined at Question 8?
您能设想到用问题 8 中的约束方法
会对公众，对从业人员及其经营有
什么好处？
Q11: If you feel that not all three
practitioner groups justify statutory
regulation, which group(s) does/do
not and please give your reasons
why/why not?
如果你认为不是对全部这三个行业
立法都是合理的，究竟哪个或哪些
行业合理或不合理呢？请给出理
由。
Q12: Would it be helpful to the public
for these practitioners to be
regulated in a way which
differentiates them from the
regulatory regime for mainstream
professions publicly perceived as
having an evidence base of clinical
effectiveness? If so, why? If not, why
not?
如果这些从业人员受到管理, 是用
一 种有别 于对 公众普 遍认为有 临床
疗效证据的主流行业的管理体系,
这样会对公众有帮助吗？如果有,
为什么? 如果没有, 为什么?
Acupuncture
Herbal Medicine
TCM
Unsure
None of the above
All three practitioner groups, acupuncture, herbal medicine and TCM,
justify statutory regulation. These three groups are interlinked with
each other, as the practitioners cross-practice according to patients’
needs. It is practically impossible to regulate one group and leave the
others unregulated.
No
The aim of statutory regulation is protect the public from harms
caused by incompetent “practitioners”. It is not a question of an
evidence base of clinical effectiveness, although there is plenty of
evidence that acupuncture, herbal medicine and traditional Chinese
medicine are effective in treating many clinical conditions. Herbal
medicine, acupuncture and traditional Chinese medicine can cause
harm to people who use them. These risks are real, as with medicines
used in 'orthodox' medicine. Therefore, statutory regulation on these
practitioners should be the same as that of orthodox medicine.
Q13: Given the Government’s
commitment to reducing the overall
burden of unnecessary statutory
regulation, can you suggest which
areas of healthcare practice present
sufficiently low risk so that they could
be regulated in a different, less
burdensome way or de-regulated, if
a decision is made to statutorily
regulate acupuncturists, herbalists
and traditional Chinese medicine
practitioners?
因 为政府 有责 任减轻 对不必要 立法
管理所带来的负担，如果一旦(政
府)作出决定对针灸，草药及中医
进 行立法 管理 ，您能 否建议在 保健
行 业的哪 些领 域有足 够低的风 险以
致 于可用 另一 种方式 来管理或 减少
管理？
Q14: If there were to be statutory
regulation, should the Health
Professions Council (HPC) regulate
all three professions? If not, which
one(s) should the HPC not regulate?
如果要立法管理，健康职业委员会
(HPC) 应 该 对 所 有 三 个 行 业 进 行 管
理 吗 ？ 如 果不 是 ， 哪个 ( 些) 不 应 由
HPC 进行管理？
Q15: If there were to be statutory
regulation, should the Health
Professions Council or the General
Pharmaceutical
Council/Pharmaceutical Society of
Northern Ireland regulate herbal
medicine and traditional Chinese
medicine practitioners?
如果要立法，应该由健康职业委员
会或药剂师管理委员会/北爱尔兰
药剂师管理委员会来管理草药师及
中医师？
No
This is surely a matter for the DH rather than us to determine but it is
fair to question the notion that because one sector clearly qualifies for
statutory regulation another type of healthcare practice should be
removed from statutory regulation.
Public protection, not financial expediency, is at the heart of
regulation. All three professions bear high risks if they are not properly
regulated. In fact, incidents have happened in which patient safety has
been compromised by under-qualified or unqualified practitioners.
Statutory regulation would ensure the proper qualification of registered
practitioners and those who were not properly qualified would not be
allowed to practise. This is the best way to ensure public safety.
Yes
This question has been raised and debated repeatedly and we have
answered this question already (Question 11). Both the Department
of Health and the HPC have indicated that the three professions
should be regulated by HPC. It is also strongly suggested in the Pittilo
Report. We do not think that the three professions should be
regulated separately. The HPC should regulate all three.
HPC
Since 2005 the Department of Health and the HPC have indicated
that the HPC should be the body to regulate three professions. We
are unsure as to why other organizations are being suggested in this
consultation. Herbal medicine and traditional Chinese medicine
practitioners are not pharmacists, and therefore the General
Pharmaceutical Council and the Pharmaceutical Society of Northern
Ireland are not wholly relevant to the profession. We treat patients by
doing a consultation, making a diagnosis, and prescribing herbal
medicine. We do not just sell herbal medicine to patients. Furthermore
TCM practitioners also use acupuncture and other TCM therapies to
treat patients. Statutory regulation should take this into account. The
General Pharmaceutical Council and the Pharmaceutical Society of
Northern Ireland are not the suitable regulating bodies to oversee
acupuncture
The HPC has the knowledge and experience in regulating diverse
professions and is therefore the best suited body to regulate
herbalists, acupuncturists and TCM practitioners. The Pittilo Report
reviewed the question of which regulator would be most appropriate.
The HPC has already made a clear and unequivocal recommendation
to the Secretary of State for Health that Medical Herbalists,
Acupuncturists and Traditional Chinese Medicine Practitioners should
be regulated under Article 17 (a) of the Health Professions Order
2001.
For all the above reasons, we believe that the most suitable regulator
to regulate practitioners of acupuncture, herbal medicine and
traditional Chinese medicine is the HPC.
Q16: If neither, who should and why? This question is not applicable as we support regulation by the HPC,
如 果 以 上 都 不 是 ， 应 由 哪 个 组 织 来 as this is the best option. However a joint CAM Council, as
recommended in the Herbal Medicine Regulatory Working Group
担当？为什么？
report and widely supported at the DH consultation in 2004, could be
an alternative, although it is not on the table in this consultation.
Q17:
a) Should acupuncture be subject to
a different form of regulation from
that for herbalism and traditional
Chinese medicine? If so, what?
针灸应以有别于草药及中医的管理
模式来管理吗？
No
The three professions should be regulated together under one
regulatory body. All TCM practitioners also practice acupuncture and
therefore as the profession is multi-disciplinary, the regulation needs
to be all-encompassing. Furthermore, separate regulation would be
burdensome and expensive. Issues such as which register should
practitioners sign up to; do they have to take part in a separate
acupuncture registration or can they still practice acupuncture while
being registered as TCM practitioners, will create a very confusing
situation.
Lastly, the question posed was agreed as per our answer in 2005
when DH decided to have a joint regulation for all three professions
either with CAM Council or with HPC. We do not see why this debate
is being raised again.
b) Can acupuncture be adequately
regulated through local means, for
example through Health and Safety
legislation, Trading Standards
legislation and Local Authority
licensing?
是不是针灸的管理只通过地方执行
就可以，比如由地方政府的卫生与
安全管理条例，交易标准条例，地
方政府许可证发放来管理？
No
b). All the 'local means' mentioned in this question indicate the current
situation. In practice this means that the local Authority often does
not check the qualifications of the practitioner and therefore there are
not good national standards for the practice of acupuncture. Therefore
good practice and public safety can not be guaranteed. Only statutory
regulation of the industry can offer such guarantee.
Acupuncture is currently regulated via local authority licensing that
lumps acupuncture in with tattoo artists, cosmetic piercing and
electrolysis (hair removal), a regime that is rudimentary in the extreme
and is only concerned with acupuncture needle sterilisation and safe
disposal. It plays no role in overseeing training standards, fitness to
practise schemes etc and in conjunction with voluntary regulation has
no jurisdiction in removing failing practitioners from practice. The
assertion that this scheme “Could work well for acupuncture in
combination with voluntary professional self-regulation” seems totally
mistaken. In addition, such a scheme would not provide protection for
the public in relation to herbal medicine.
Q18.
a) Should the titles acupuncturist,
herbalist and [traditional] Chinese
medicine practitioner be protected?
Yes
Protection of titles will prevent substandard practitioners from
b) If your answer is no which ones do practicing and this further ensures public safety. For this reason, the
you consider should not be legally
titles of all three professions should be protected.
protected?
a) 针 灸 师 ，草 药 师 及 （ 传统） 中 医
师这些称谓应受法律保护吗？
b) 如 果 你 认为 不 是 ， 那 是哪些 不 应
受保护？
Q19: Should a new model of
regulation be tested where it is the
No
functions of acupuncture, herbal
medicine and TCM that are
Ideally both title and function of the three professions should be
protected, rather than the titles of
protected. Statutory regulation can protect function through protecting
acupuncturist, herbalist or Chinese
title, and it is the most feasible model at this stage.
medicine practitioner?
应不应该试用一种新的管理模式，
那就是保护针灸，草药及传统中医
的功用，而不是保护针灸师，草药
师及（传统）中医师这些称谓？
Q20: If statutory professional selfregulation is progressed, with a
model of protection of title, do you
agree with the proposals for
“grandparenting” set out in the Pittilo
report?
一旦立法职业自我表现管理推进，
其模式是保护称谓，你同意 Pittilo
报 告 (注 :即 卫 生 部针 灸 草药中 医 立
法工作组报告)中建议的‘祖父条
例’吗？
Q21: In the event of a decision that
statutory or voluntary regulation is
needed, do you agree that all
practitioners should be able to
achieve an English language IELTS
score of 6.5 or above in order to
register in the UK?
一旦决定立法或自愿管理是必需
的，你同意所有的从业人员都应该
能达到英语雅思 6.5 或以上水平才
可以在英国注册吗？
Q22: Could practitioners demonstrate
compliance with regulatory
Yes
We agree that there should be a “Grandparenting” scheme in place
when introducing statutory regulation. This would provide a “vehicle”
for existing practitioners to get registered in a more favorable and
convenient way.
The Pittilo report recommended a helpful “Grandparenting” scheme
for minimum professional qualification standards, however it
recommended a less accommodating scheme for English language
competence (it suggests IELTS 6.5). We would argue that the level of
language competence is very high, and it sets an unfair precedent for
many practitioners whose first language is not English. We would
recommend that at the very least, if the standard is not met by the
practitioner, the provision of a translator would be an acceptable
alternative.
No
We agree that after the regulation takes place, for any future
practitioners, there should be an English language requirement such
as IELTS 6.5. However, for existing practitioners who have safely
practiced in the UK for more than 5 years, there must be some leeway
on the level of language required, in the form of being allowed to
practice if a translator is present.
requirements and communicate
effectively with regulators, the public
and other healthcare professionals if
they do not achieve the standard of
English language competence
normally required for UK registration?
What additional costs would occur for
both practitioners and regulatory
authorities in this case?
如果从业人员达不到在英国注册通
常的英语能力要求，他们是否能够
显示出他们遵守立法规定，且能有
效地与立法机构，公众及其他保健
专业人员进行有效的沟通？在这种
情况下，对从业人员及立法机构双
方面的额外性费用将会是什么？
Yes
Comments
Many non-native British practitioners communicate effectively with
their patients and other health professionals, even if their English
does not reach IELTS 6.5.
IELTS is a test mainly for young English language learners. Many
non-native British practitioners have lived and practised in the UK for
many years, their English is good enough for them to communicate
with their patients, public and other health professionals, but they may
never reach IELTS 6.5, as the language test can be much more
difficult for older people. Further to this, communication competence
does not always comply with language test results.
For those with poor English competence interpreters are often used
and this should be taken into account when discussing the minimum
language requirements concomitant with the statutory regulation of
the profession.
Having an interpreter obviously does necessitate an extra cost, but
this is generally absorbed by the practitioners themselves.
Q23: What would the impact be on
the public, practitioners and
businesses (financial and regulatory
burden) if practitioners unable to
achieve an English language IELTS
score of 6.5 or above are unable to
register in the UK?
如果达不到英语雅思 6.5 或以上的
从业人员无法得以在英国注册，这
将会对公众，从业人员以及经营业
( 财 务的 和 管 理开 销 负 担 )产生 怎 样
的影响？
Significant impact
There would be a huge impact on those practitioners unable to reach
the required standard, as they would be removed from the register
and would therefore have to discontinue their practice and lose their
livelihoods.
Many of these practitioners unable to achieve an English language
IELTS score of 6.5 or above, have permanent residency in the UK or
British citizenship. Their job loss due to imposed regulation could be a
very serious issue and could encourage questions concerning human
rights and EU and UK Employment law, etc.
If these practitioners are not able to register in the UK, it could cause
a negative impact on the public too, as patients would lose a valuable
service (bear in mind that these practitioners are often highly qualified
and well experienced). Also, some patients speak the same language
as their practitioners and may be denied to access acupuncture,
herbal medicine and TCM treatment with their preferred practitioner
whom they trust.
The impact on businesses could be devastating as many practitioners
would have to discontinue their practices, which would lead to more
unemployment, and many people becoming a burden on the state.
Q24: Are there any other matters you We would like to highlight ATCM’s response as below:
wish to draw to our attention?
1. Statutory regulation is our No1 choice;
您还有什么需要提请我们注意的？ 2. HPC is our favourite regulatory body;
3. All three professions should be regulated jointly under the same
regulatory body. Acupuncture should not be regulated separately.
4. Titles of all three professions should be protected;
5. A “Grandparenting” scheme should be in place
6. There should be a favourable arrangement on English language
for existing practitioners.