有什么证据证明目前针灸师.doc

ATCM Guidance for Responding to the ConsultationQ1: 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?有什么证据证明目前针灸师，草药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么？Answer: HarmComments: unqualified or incompetent practitioners can cause harm to patients; incidents have happened in the past; Money-driven people only care about making money from the activities of these professions and put public safety in great risk. .Q2: Would this harm be lessened by statutory regulation? If so, how?这种危害会因立法管理而减轻吗？如果是，怎样减轻？Answer: yes.Comments: Statutory regulation (SR) can safeguard patients by disallowing unqualified/incompetent “practitioners” to practise, preventing money-driven activities. In fact, most harmful incidents happened in the past are caused by those “practitioners” and business owners due to lack of statutory regulation. Q3: What do you envisage would be the benefit to the public, to practitioners and to businesses, associated with introducing statutory regulation?您能设想到立法管理会对公众，对从业人员及其经营有什么好处？Answer: Significant benefitComments: Ensure practitioners to be appropriately qualified and competent; significantly reduce risks of harm to the public; prevent the unqualified from practicing; prevent money-driven activities; improve clinical efficacy. 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？Answer: JustifiesComments: there will be a financial cost for statutory regulation, but the benefits will significantly overweigh the cost.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 regulated practitioners?如果草药及中医从业人员受立法管理，应该仅限于这些被立法管理的从业者才有权力制备和使用未取得执照的草药吗？Answer: Yes.Comments: Statutory regulation will ensure the proper qualification and competence of the practitioners. The right of using unlicensed herbal medicines should be restricted to registered practitioners to ensure the public to access effective and safe herbal medicines.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，怎样使他们得以(如果可行的话)制备和使用未取得执照的草药？Answer: There is no option other than statutory regulation.Comments: Only statutory regulation can ensure that practitioners are qualified and competent to use unlicensed herbal medicines. They should be the only people to be allowed by SR to use such herbal medicines. Without SR (such as current situation), harmful incidents can not be avoided and public safety can not be ensured. 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？Answer: Significant effect.Comments: it would be a disaster. Public would be denied for access to herbal medicines, practitioners would be forced to discontinue their practice and herbal medicine would be dead. 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?Answer: Unsure.Comments: All the options given in this question are meant to keep the current situation, in which public safety can not be secured, risks and potential harms can not be prevented as argued in our responses to above relevant questions. The most effective way to protect public is 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？Answer: Not applicableComments: Statutory regulation is the most effective and efficient way. Currently, several regulatory regimes co-exist as listed in Question 8 and they cause more burden and cost to the public, practitioners and businesses, directly or indirectly. After SR, practitioners will simply pay for their registration; therefore licensing fee, cost to trading standard agents etc will be avoided.Q10: What would you envisage would be the benefits to the public, to practitioners, and to businesses, for the alternatives to statutory 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？Answer: not applicable. Comments: The alternatives to statutory regulation as described in Question 8 do not offer any benefits more than SR does to the public, practitioners and businesses. 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。Answer: None of the aboveComments: All three practitioner groups justify statutory regulation. They are interlinked with each other in a form of cross-practice. It is practically impossible to regulate one practice or one group and leave the others unregulated. A joint regulation for all three groups has been on DH agenda since 2005 and it is the right direction to keep.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?Answer: No.Comments: The aim of statutory regulation is to protect public from harms caused by incompetent practitioners, it is not about evidence. The current situation has proved that without SR, public safety can not be secured as it does not prevent unqualified and incompetent practitioners causing harms to their patients.Q13: Given the Governments 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？Answer: No.Comments: All three professions bear risks to the public if they are not properly regulated. We can not think of any alternatives which can offer the same level of protection as statutory regulation.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？Answer: Yes. Comments: This is a pointless question. A joint regulation under HPC for all three professions has been in the DH agenda since 2005, and it was strongly recommended in Steering Group report. We do not see the point why any of them should be regulated separately. 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？Answer: HPC.Comments: As a joint regulation, only HPC can regulate all three groups. GPC or PSNI can not regulate herbal medicine and TCM practitioners as we are practitioners, not pharmacists. We treat patients using not only herbal medicines, but acupuncture as well. The herbal medicines we use usually are tailor-made according to patients need; this is totally different from selling medicines to customers. It is against the basic principles to regulate herbal medicine and TCM practitioners in the same regulatory body as for pharmacists. Q16: If neither, who should and why?如果以上都不是，应由哪个组织来担当？为什么？Answer: not applicable.Comments: The first option for regulating three professions is HPC. The second option could be a joint CAM Council as recommended by DH prior to 2005. 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？Answer: No. Comments: three professions should be regulated under one regulatory body. All TCM practitioners also practice acupuncture. A separate regulation will cause a lot of problems to us. 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？Answer: No.Comments: All the local means mentioned here are basically the current situation which does not ensure the authority to check the qualification and does not offer and national standards for acupuncture practice. Therefore a good practice and public safety can not be guaranteed. Only a statutory regulation can offer such guarantee.Q18. a) Should the titles acupuncturist, herbalist and traditional Chinese medicine practitioner be protected? 针灸师，草药师及（传统）中医师这些称谓应受法律保护吗？b) If your answer is no which ones do you consider should not be legally protected?如果你认为不是，那是哪些不应受保护？Answer: Yes. Comments: Through title protection, unqualified “practitioners” will not be allowed to practice, public can be ensured that they receive treatment only from qualified and registered practitioners. This is best for the interest and safety of the public. For this reason, the titles of all three professions should be protected.Q19: Should a new model of regulation be tested where it is the functions of acupuncture, herbal medicine and TCM that are protected, rather than the titles of acupuncturist, herbalist or Chinese 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？Answer: No.Comments: There is not any better model of regulation than statutory regulation. Ideally both title and function of the three professions should be protected. Statutory regulation can protect function through protecting title, and it is the most feasible model.Q20: If statutory professional self-regulation 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？Answer: Yes. Comments: There should be a “Grandparenting” scheme in place when introducing a new regulation for existing practitioners to get registered in a more favorable and convenient way. However, the Pittilo report recommended a “Grandparenting” with favorable arrangement for professional qualification as minimum requirement), but not for English language competence. This is not fair to many Chinese TCM practitioners. 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？Answer: No. Comments: We agree that for any future practitioners there should be an English language requirement such as IELTS 6.5 after the regulation takes place. However, for existing practitioners who have safely practised in the UK for more than 5 years, there must be some favorable arrangement on language. We do not understand why the “Grandparenting” recommended by Pittilo report offers favorable arrangement on anything else but not on language. We strongly urge that for existing practitioners, especially the members of those organizations that met the criteria set up by Steering Working Group for recommending to HPC for automatic registration, there should be some favorable arrangement on English language.Q22: Could practitioners demonstrate compliance with regulatory 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？Answer: Yes. Comments: Many TCM practitioners can still communicate effectively with their patients and other health professionals, even 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 language test can be much more difficult to adults. For those with poor English competence, they have been using interpreters help in their practice in the past years and this should be allowed in the new regulation for these existing practitioners.