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 on 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 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 safeguards to protect public health.”

SR：What happened in 2011？ 立法：2011年发生了什么？ 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 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：What happened in 2012？ 立法：2012年发生了什么？ Sept –October 2012 1. ATCM Meeting with DH, HPC and MHRA 12th January 2012 2. Communication with DH June 2012 3. Further communication with DH Sept –October 2012 4. Michael Guthrie of HCPC to address ATCM members at AGM 14th October 2012 5. Further meeting with DH proposed for 16th November， 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。ＡＴＣＭ与卫生部的信件往来 ２０１２年６月 ３。ＡＴＣＭ与卫生部的进一步信件往来 ２０１２年９－１０月 ４。ＨＣＰＣ官员向ＡＴＣＭ年会演讲 ２０１２年１０月１４日 ５。与卫生部的进一步会谈 定于11 月16 日, 但又被临时取消

SR Standstill Once Again in 2013 2013年立法进程再次停滞不前 January 2013: ATCM letter to DH: enquiry on SR February 2013: ATCM council call for members and patients to write to local MPs March –April 2013: Some supportive responses from MPs Legal advice obtained by EHTPA, partially funded by ATCM 24th April 2013: Mass lobby at the parliament May 2013: ATCM letter to Minister Dr Daniel Poulter MP July to Sept: MHRA consultation on End 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 complex as there is an interface both with European law and with medicines legislation and a number of technical issues have arisen DH’s 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 Statutory Regulation in coming years; To abandon SR all together; To take an alternative AVR (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 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

Background 背景介绍 Herbals Directive (EU’s THMPD) 欧盟传统草药产品法案 European Traditional Herbal Medicinal Products Directive 2004/24/EC amending Directive 2001/83/EC in 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 (UK’s MHRA) 英国药管局的传统草药产品注册体系 Traditional Herbal Products Registration Scheme Became 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） 11

End of the Road? October 2005 April 2004 April 2011 Medicines Act 1968 英国1968年药品法 THMPD: 7 year transitional period starts 欧盟法案：7年过渡期 Herbal Medicinal Products Registration Scheme (THR) 英国药检局传统草药产品注册体系 THMPD Full Implement 欧盟法案全面实施 Section 12(2) 12（2）条款 Section 12(2) (Transitional Protection) and THR/MA 12（2）条款（过渡期保护）和THR/MA并存 No more Section 12(2) THR/MA only 12（2）条款终止 仅存THR/MA OK to Unlicensed HM products 非执照草药产品可流通 Still OK to Unlicensed HM products 非执照草药产品仍然可流通 Not OK any more to Unlicensed HM products 非执照草药产品不可再流通 12

MHRA Consultation and ATCM Response MHRA的咨询和ATCM的回应 MHRA Consultation：9th July to 6th Sept 2013 Proposal to end “sell through” by the end of 2013 ATCM did a survey among members to demonstrate the negative impact Together with our response suggesting the “sell though” to 2015 MHRA发起咨询(2013年７月９日－９月６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的回应建议零售继续到2015年。

Feedback from ATCM Members ATCM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 Chinese 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 2014 2014年4月30日起停止“售完为止” From 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 Registration (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

Disappointing number of responses from ATCM members ATCM 的会员予以回应的少得可怜 向会员散发了回应样本 但MHRA只收到 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! ATCM encouraged members to respond A response template was circulated to members. Only 54 responses received, with 30 against and 24 in favor Only about 15 responses from ATCM members, accounting for 1/50!

ATCM’s 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 review Reason: MHRA allowed sell through until the shelf life in Aug 2010 However, High Court rejected our claim ATCM 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 legal. 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 – HMPWG 2014年的新进展－草药及草药师工作组

Herbal Medicines and Practitioners Working Group 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。 Established by the Department of Health in December 2013 Administrated by MHRA Chaired by Prof David Walker, the DH Deputy Medical Director, and David Tredinnick MP being vice chair 22 Membership, including some anti-cam figures

HMPWG Four meetings in a year: 一年中开了四次会： 1st meeting: 30/01/2014 2nd meeting: 01/05/2014 3rd meeting: 10/07/2014 4th and final meeting: 06/11/2014 HMPWG report will be drafted in December 2014, and published in March 2015 一年中开了四次会： 1st meeting: 30/01/2014 2nd meeting: 01/05/2014 3rd meeting: 10/07/2014 4th 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 SR AVR as an option was discussed The Chair seems not keen on SR Looking for alternative SR being 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 exceptional MHRA is considering Re-categorisation of HM products HM products could be re-categorised as Food Supplements Suppliers offering dispensary services could be given a green light All above is likely to be recommended in the report Final 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 Shen’s letter to HMPWG 1. We should not abandon the work by two previous working groups supported by two consultation results 2. Only SR can best ensure the public safety 3. Article 5.1 should not be an excuse to abandon SR 4. HMPWG should stand for the majority of its members 5. TCM sector support SR 6. Even social workers are now statutorily regulated, why not HM 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 Zhao’s letter to Jamire Hunt Malpractice of HM/TCM can cause Risk to public safety Need to ensure properly qualified practitioners Need to ensure the safety of formulated herbal medicines Need high quality professional education The 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 ＨＭＰＷＧ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.