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1、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？
2、 Answer: Harm Comments: 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 statuto
3、ry 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
4、 “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 benefit Comments: Ensure pra
5、ctitioners 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, t
6、o 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: Justifies Comments:
7、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 pract
8、itioners? 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 t
9、o 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
10、 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 inciden
11、ts 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 f
12、rom 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
13、: 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 voluntar
14、y 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
15、 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 st
16、atutory 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 applicable Comments: 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 registrati
