1、Updates on the Regulation for TCM Practitioners and for Herbal Medicine Products对草药师中医师及草药产品的管理近况介绍,By Hui Jun Shen 沈惠军Vice President ATCM 英国中医药学会副会长ATCM Representative to HMPWG立法管理代表,1. Review on Statutory Regulation of Herbal Medicine and TCM Practitioners (2011-2013)草药和中医师立法管理回顾,DH Announcement o
2、n Statutory Regulation by the then Health Secretary Andrew Lansley - 16th February 2011,2011年2月16日，时任卫生大臣Andrew Lansley 宣布从2012年4月开始对草药从业者实施立法管理Herbal medicine practitioners will be regulated from April 2012. the Health Professions Council (HPC) should hold a statutory register of practitioners who
3、supply unlicensed herbal medicines to people to enable the supply of herbal medicines to continue after 30 April 2011. This will ensure that practitioners have met specified registration standards. Practitioner regulation will be underpinned by medicines legislation which will provide further safegu
4、ards to protect public health.”,1. DH Announcement on SR with HPC from April 2012(16th February 2011)2. ATCM Communications with DH and HPC (March May 2011)3. EU THMPD began in full implementation (30th April 2011 )4. ATCM Presentation at TCM Seminar in the Parliament (15th June 2011)5. ATCM Meeting
5、 with DH(7th July 2011)6. ATCM Further Communications with DH and HPC (Oct-Nov 2011),1。 卫生部宣布从2012年4月开始对草药师中医师由HPC实施立法管理（2011年2月16日）2。 ATCM与卫生部和HPC的交流（2011年3-5月）3。欧盟传统草药产品法令开始全面实施 (2011年4月30日)4. ATCM 代表沈惠军应邀在国会中医论坛上演讲（2011年6月15日）5. ATCM代表应邀与卫生部主管官员开会（2011年7月7日）6。 ATCM 与卫生部和HPC的进一步交流（2011年10-11月）,SR：
6、What happened in 2011？立法：2011年发生了什么？,1. ATCM Meeting with DH, HPC and MHRA 12th January 20122. Communication with DH June 20123. Further communication with DHSept October 20124. Michael Guthrie of HCPC to address ATCM members at AGM14th October 20125. Further meeting with DH proposed for 16th Novemb
7、er， but cancelled by DH one week before,1。ATCM 与卫生部，HPC和MHRA会谈2012年1月12日2。与卫生部的信件往来年月。与卫生部的进一步信件往来年月。官员向年会演讲年月日。与卫生部的进一步会谈定于11 月16 日, 但又被临时取消,SR：What happened in 2012？立法：2012年发生了什么？,SR Standstill Once Again in 20132013年立法进程再次停滞不前,January 2013: ATCM letter to DH: enquiry on SRFebruary 2013: ATCM coun
8、cil call for members and patients to write to local MPsMarch April 2013: Some supportive responses from MPsLegal advice obtained by EHTPA, partially funded by ATCM24th April 2013: Mass lobby at the parliamentMay 2013: ATCM letter to Minister Dr Daniel Poulter MPJuly to Sept: MHRA consultation on End
9、 of Sell Though,2013:一月：ATCM再次给卫生部写信二月：理事会呼吁会员和病人给本地议员写信三- 四月：一些地方议员回信支持立法EHTPA取得律师支持，ATCM支付部分律师费用4月23日：议会前集会示威，部分ATCM会员参加五月：赵会长向卫生部主管部长Dr Daniel Poulter 去信,Demonstration: 23rd April 2013,Response from DH same to all卫生部千篇一律的回复,The Statutory Regulation of Herbal Practitioners The legislation is compl
10、ex as there is an interface both with European law and with medicines legislation and a number of technical issues have arisen DHs appreciation that the delay is frustrating and that the current situation is having an impact on the business of herbal practitioners.,Possible Outcome?可能的结局？,To achieve
11、 Statutory Regulation in coming years;To abandon SR all together;To take an alternativeAVR (Accredited Voluntary Register) scheme newly introduced by PSA (Professional Standard Authority for Health and Social Care) could be an alternative to SR,再花几年实现立法彻底放弃立法采用替代方案由PSA 新引进的AVR 项目可能是一个替代方案。,2. Review
12、 on End of “Sell Through” of Unlicensed Herbal Products停止无执照草药产品零售的情况回顾,Herbals Directive (EUs THMPD) 欧盟传统草药产品法案European Traditional Herbal Medicinal Products Directive 2004/24/EC amending Directive 2001/83/ECin force in April 2004 2004年4月开始实施With 7 years provisional period 但有7年过渡期THR (UKs MHRA) 英国药
13、管局的传统草药产品注册体系Traditional Herbal Products Registration SchemeBecame available October 2005 2005年10月开始实施Full enforcement of Herbals Directive 传统草药产品法案全面实施in April 2011 2011年4月全面实施 （过渡期届满）,Background 背景介绍,April 2004,October 2005,April 2011,End of the Road?,MHRA Consultation and ATCM ResponseMHRA的咨询和ATC
14、M的回应,MHRA Consultation：9th July to 6th Sept 2013Proposal to end “sell through” by the end of 2013ATCM did a survey among members to demonstrate the negative impactTogether with our response suggesting the “sell though” to 2015,MHRA发起咨询(2013年月日月日）建议年底停止未注册草药产品的零售ATCM作了会员问卷调查，向MHRA 显示其负面冲击ATCM的回应建议零售继
15、续到2015年。,Feedback from ATCM MembersATCM会员的呼声,1. Petition, lobbying and demonstration.(Write to MPs and ask patients to sign the petition letters) 请愿，游说，示威。2. Instruct a solicitor to sue MHRA for compensation (residual of stock, clinic rent if clinic has to be closed at a result of this proposal) 法律索
16、赔3. Urge government to statutorily regulate herbal practitioners. 敦促政府立法4. Work with other organisations and negotiate with MHRA to extend the sell through deadline 与其它团体一道要求MHRA延迟期限5. Boycott MHRA 抵制MHRA 6. Ask SATCM (Chinese authority) and herbal factories to provide evidence of expiry date of Chi
17、nese herbs 要求中国官方和药厂提供中成药有效期的证据7. Provide members a list of wholesalers who sell THR approved (licensed) herbal products. 给会员提供THR产品的供应商名单8. Contact media to express our concerns. 向媒体表达我们的担忧,MHRA Press Release 药管局新闻发布21st November 2013),End of “sell though” by 30th April 20142014年4月30日起停止“售完为止”From
18、30 April 2014, all manufactured herbal medicines will have to be authorised in order to be sold and supplied lawfully in the UK.This means that after this date herbal retailers will no longer be able to sell unlicensed herbal medicines that are not registered under the Traditional Herbal Registratio
19、n (THR) scheme in the UK.,Adverse Impact to TCM Practitioners 对中医行业的负面影响,No any other way to use unlicensed herbal products 没有其它的途径继续使用无执照的草药产品No licensed or THR registered TCM products available 没有执照或THR注册的中药产品Immense waste of stock 库存的巨大浪费Business loss in current economic downturn 当前经济部景气下的营业损失,Di
20、sappointing number of responses from ATCM members ATCM 的会员予以回应的少得可怜,ATCM encouraged members to respondA response template was circulated to members.Only 54 responses received, with 30 against and 24 in favorOnly about 15 responses from ATCM members, accounting for 1/50!,ATCM 鼓励会员积极回应向会员散发了回应样本但MHRA只
21、收到 54 份回应，其中 30 个反对，24 个赞成大约只有 15 回应来自 ATCM 会员,仅占会员总数1/50!,ATCMs Legal Challenge ATCM付诸法律行动,ATCM hired a solicitor in Dec 2013 and sued MHRA to High Court in Feb 2014 Claim for judicial reviewReason: MHRA allowed sell through until the shelf life in Aug 2010However, High Court rejected our claim,ATC
22、M 于2013年底雇用了律师，并在2014年2月向最高法院起诉了 MHRA Claim for judicial review理由： MHRA 曾经允许零售到产品有效期为止。然而，最高法院拒绝了我们的起诉。,Any way-out? 有何出路？,Section 12(1) of Medicines Act 1968 still in effect. 1968年药品法第12(1)条款仍然有效Herbal decoctions, self-made herbal products are in the scope of Section 12(1), therefore are still lega
23、l. 汤药和自制产品归12(1)条款管辖，因而仍然合法Herbal products may be considered for a re-category as food supplement. 有可能将草药产品归入食品类，作为食品添加剂进行管理。Dispensary Services by suppliers could be given a green light供应商提供的配方服务可能会绿灯放行,3. New Development in 2014 HMPWG2014年的新进展草药及草药师工作组,Established by the Department of Health in De
24、cember 2013Administrated by MHRAChaired by Prof David Walker, the DH Deputy Medical Director, and David Tredinnick MP being vice chair22 Membership, including some anti-cam figures,由卫生部于2013年12月成立。由MHRA 管理和运作组长为David Walker 教授，卫生部的副医疗首席官。副组长为David Tredinnick 国会议员。成员有22人，包括一些反对辅助医学的人士。,Herbal Medicin
25、es and Practitioners Working Group,HMPWG,Four meetings in a year:1st meeting: 30/01/20142nd meeting: 01/05/20143rd meeting: 10/07/20144th and final meeting: 06/11/2014HMPWG report will be drafted in December 2014, and published in March 2015,一年中开了四次会：1st meeting: 30/01/20142nd meeting: 01/05/20143rd
26、 meeting: 10/07/20144th and final meeting: 06/11/2014工作组将在12月份写出报告草案，明年三月出正式报告。,HMPWG on regulation of HM/TCM practitioners 工作组讨论执业人员的管理,Vast majority supporting Statutory Regulation (SR)Small minority against SRAVR as an option was discussedThe Chair seems not keen on SRLooking for alternativeSR be
27、ing abandoned?,绝大多数支持立法管理极少数反对立法AVR 方案作为一个选项赋予讨论组长表现对立法没有兴趣。讨论被迫于寻找替代方案立法管理可能会被放弃,HMPWG on unlicensed/unregistered herbal medicine products,EU Directive: Article 5.1 is only conditional and exceptionalMHRA is considering Re-categorisation of HM productsHM products could be re-categorised as Food Sup
28、plements Suppliers offering dispensary services could be given a green lightAll above is likely to be recommended in the reportFinal decision will be by DH,欧盟法令的5.1条款是有条件的和近适用于特殊情况MHRA 正考虑草药产品的重新归类供应商提供配方服务可能会开绿灯以上会被列入报告的建议中最后决定将由卫生部做出。,Dr Shens letter to HMPWG,1. We should not abandon the work by t
29、wo previous working groups supported by two consultation results2. Only SR can best ensure the public safety3. Article 5.1 should not be an excuse to abandon SR4. HMPWG should stand for the majority of its members5. TCM sector support SR6. Even social workers are now statutorily regulated, why not H
30、M practitioners?,我们不应该放弃前两个工作组的工作和两次公众咨询的结果只有立法管理才能最好地保护公众5.1条款不应该被用作放弃立法的借口工作组应该代表大多数中医界支持立法连社会工作者都立法管理了，为什么我们不可以？,Dr Zhaos letter to Jamire Hunt,Malpractice of HM/TCM can cause Risk to public safety Need to ensure properly qualified practitionersNeed to ensure the safety of formulated herbal medicinesNeed high quality professional educationThe HMPWG should focus on the statutory regulation,草药中医的行医不当可以造成危害行医人员的资历要有保障草药产品的安全性应该有保障应该保障业者的高质量教育应该集中精力于立法管理,Any Questions？Although I may not be in the position to give the answers.,
