中医药在欧洲的现状和未来

1、 Present Situation and Futureof TCM in Europe中医药在欧洲的现状和未来Dong ZhilinChairman, Pan European Federation of TCM Societies (PEFOTS)Vice-Chairman, World Federation of Chinese Medicine Societies (WFCMS)世界中医药学会联合会副主席全欧洲中医药学会联合会主席董 志 林电子邮件： Traditional medicine is one of the fastest growing industry. More t

2、han 60% of the European population use traditional medicine. With 44.5% of the world traditional medicine market and 500 million people, EU represents a tremendous opportunity for traditional Chinese herbal products传统药品是当今世界发展最快的传统产业，据统计有60%以上的欧洲人使用传统药品，欧洲占全球草药市场的44.5%的份额。现在欧盟扩大到27个国家，总人口近5亿，超过北美自由贸

3、易区，成为全球最大的贸易市场，给中药制品在欧盟流通带来了更多便利。With thousands of years of experience and modern scientific research, TCM has withstood the test of time. TCM has proved to be effective in the prevention and treatment of diseases and well-being. Not only has it made a great contribution to the health and well-being

4、 of the Chinese people, it also plays an increasingly important role in the health and well-being of people elsewhere. 经过几千年实践积累了丰富经验的中医药学，对防治疾病和养生保健都具有明确的疗效，它不仅为中国人民的健康事业做出了伟大的贡献，而且在欧洲医疗保健领域中也表现出它的独特作用和巨大潜力。The Chinese Ministry of Health has signed the Memorandum of Understanding with the health au

5、thorities of 14 European countries, including Italy, Ireland, Austria, Denmark, Ukraine, Moldova, Croatia, Norway, and Bulgaria. 中国卫生部已经与意大利、爱尔兰、奥地利、丹麦、乌克兰、摩尔多瓦、克罗地亚、挪威、保加利亚等14个欧洲国家和地区的卫生部签署了谅解备忘录。There are over 120,000 TCM practitioners and acupuncturists in Europe. Each year over 5,000 TCM student

6、s graduate from about 300 TCM training schools in Europe. More than 5 million people in Europe visit TCM practitioners each year in Europe. There are over 300 TCM products distributors all over Europe.据不完全统计，欧洲目前有中医师、针灸师12万之多，欧洲每年中医药应诊患者已超过500万人次。欧洲现有中医教学机构300多所，每年向各国输送5000多名中医药人员。欧洲各国现有中医药产品批发商300多

7、家。国 家Country中医/针灸师人 数TCM practitioners中 医 药 学 校 TCM Schools中医药学会TCM associations中医药产品供应商TCM product suppliers资料来源Data source全日制Full-time非全日制Part-time年毕业生人数Year graduates毕业要求平均学时Study hours奥地利 Austria650019150140-500610W. Eichwer保加利亚 Bulgaria150120400-80012Z. Goranova比利时 Belgium900480108034V. Herv丹麦

8、Denmark500850250-80035I. Holm芬兰 Finlan国光法国 France7000140500650-3250615-20F. Marguer德国 Germany5000030600140-3502535M. Wark希腊 Greece35076045匈牙利 Hungary3004703-52爱尔兰 Ireland600250-60150033B. Ward意大利 Italy300015250600255C.M. Giovanardi荷兰 Netherlands40007120280-760715M. de Boer拉脱维亚 Latvia960

9、1236048004N. Nickolaev立陶宛 Lituania200130011N. Vitalijus挪威 Norway175010150-20080043N.E. Volden波兰 Poland300015100310A. Curzytek葡萄牙 Portugal20007100-300100-500054P. Choi西班牙 Spain770014801600-300042R.M. Calduch瑞士 Switzerland130030400310F. Urbahn英国 UK1135061131080-36001528张鹏合计合计 TOTAL10169011194318012617

10、1表1. 欧 洲 20 国 中 医 药 概 况 统 计 表 TCM situation in 20 European countries TCM products are available all over Europe and the demand is on the increase year by year. TCM provides remedies for many chronic and difficult medical conditions for which modern medicine has no satisfactory solutions. It also hel

11、ps to lessen the healthcare cost and generate employment. 中药及其制品已遍布欧洲各国，而且需求量正在不断增加，这不仅增强了传统药物与化学药物的互补性，治愈了许多西方医药难以治疗的疑难病、慢性病，同時也减轻了欧洲各国沉重医疗费用的负担，并给社会创造了大量的就业机会。TCM is yet to be officially recognized in Europe. Like other complementary therapies, TCM has no official legal status in most European cou

12、ntries. Chinese traditional herbal products can only be imported and sold as foodstuffs or cosmetics. 中医药尚未得到欧洲各国政府的足够重视，还无应有的法律地位。目前，中医药只能作为民间的一种替代疗法而生存和发展，中草药制品也只能作为食品、营养品或食品补充剂、化妆品等进入西方市场。Although acupuncture cost can be partly reimbursed from the public health insurance in many European countrie

13、s, the cost of herbal remedies can only be partly reimbursed from private insurance. Many people cannot afford to pay herbal cost and are unable to finish the full course of the treatment. 虽然针灸费用能在大部分国家医疗保险公司报销，但中草药及其制品的费用仅在私人医疗保险能得到部分报销，其国民医疗保险仍由患者本人承担，因此导致一部分低收入的病员、或患有慢性病的患者无法坚持而中途放弃治疗。The EU Trad

14、itional Herbal Medicine Products Directive came into force on 30 April 2004. The Directive allows traditional herbal medicinal products to be registered if they have been safely used in the EU for at least 30 years or 15 years in the EU plus 30 years elsewhere. Products to be registered must also co

15、mply with the pharmaceutical quality standards. 为了统一欧盟各国的传统药市场，欧盟传统药品法规定从2004年5月开始在欧盟国家境内使用了30年以上的传统草药制品，或者在欧盟使用15年以上，同时在欧盟以外的国家和地区应用了30年以上，符合药品质量标准的传统草药制品，可以在欧盟各国登记注册作为传统草药制品在欧盟销售和使用。 The Directive aims to ensure the safety and quality of herbal medicinal products in Europe. It also provides legal

16、framework for Chinese herbal products entering therapeutic drug market, opening a new possibility for TCM products entering the mainstream traditional medicines market in the EU. 欧盟传统药品法对保障传统药品的质量和安全有着非常积极的作用，也为传统中药制品以治疗药品身份进入欧盟提供了法律依据，也为传统中药制品进入欧盟主流药品市场的良好机遇。By 2009, more than 140 traditional regis

17、trations have been granted in the EU. However, no regiatration has been granted to TCM products because (1) No Chinese herbal manufacture has obtained EU GMP certification; (2) Difficulty collecting 15 year EU traditional use evidence; (3) Complexity in composition and quality control; (4) Complianc

18、e problem of TCM indications with self-medication indications.截至2009年，已有140多个传统药产品在欧盟成员国获得传统药品注册。但至今还没有传统中药申请注册，主要原因是 (1) 中国还没有一家中药制药厂获得欧盟GMP认证； (2) 中药制品组成复杂、质量控制难度大；(3) 中医传统适应症是否适合传统药品法要求等。 Complex composition and traditional TCM indications are not insurmountable problems because a product registe

19、red in Germany contains 13 ingredients, many of which, such as ginger, black peper, nutmeg, cardamom and cinnamom bark, are also used in TCM. According to some HMPC members, non European traditional indications may also be acceptable. 不过，这些问题不是不可以克服的。 因为德国注册的传统药就是由13味药组成，其中不少成分如生姜、胡椒、肉豆蔻、高良姜、肉桂等也是常用

20、中药。说明组成复杂这个问题是可以解决的。欧盟植物药委员会成员也明确表示传统医学适应症也是可以考虑接受的。EU Food Supplements Directive is another important legislation that will have major impact on TCM products in the EU. Currently, the Food Supplements Directive only governs vitamins and minerals. 除欧盟传统药品法外，欧盟食品补充剂法是又一个将对欧洲中药市场产生深远影响的重要法规。欧盟食品补充剂法目前

21、只管辖维生素和矿物盐类。 The European Food Safety Authority (EFSA) is collecting safety data on herbs and is to propose rules on herbs in accordance with the Food Supplements Directive. 目前欧盟食品安全局正在收集有关草药的安全性资料，为按照食品补充剂法制定草药制品的管理办法提供依据。 In the foreseeable future, Chinese herbal products will enter the EU market

22、as food supplements as they have been in the past. We hope that EFSA will take a practical approach in developing the Negative List so that those already on the EU market will be able to remain on the market. 中药作为食品补充剂进入欧盟市场为中药在欧洲的发展起到了积极的作用，在可预见的将来大部分中药制品将仍然以食品补充剂的身份进入欧盟市场，我们希望欧盟食品安全局根据欧盟草药市场实际情况，制

23、定切合实际的草药制品管理办法，以保证现在已经在欧盟销售的中药能够继续销售。Furthermore, technical requirements such as heavy metal and pesticide residues and microbial limits also pose restrictions on Chinese herbs in Europe. 另外，高门槛的技术壁垒、绿色贸易壁垒给中药产品进入西方市场设置了巨大的障碍，各国政府不断地通过用药安全和环境保护等措施，加强对进口传统药品的规划管理，制订或提高相关的技术要求，如包括重金属含量、农残量、微生物限量等指标。Th

24、ere have been incidents where traders were not aware of the international agreement of the trade of endangered species and toxic plants that are forbidden in the EU market. 还有些进口商、中医药专业人员对于濒危野生动植物受保护的种类和品种不了解，造成执法机关和媒体的误解。 中药名药材拉丁名原动物拉丁名穿山甲Squma ManisManis pentadactyla玳瑁Carapax EretmochelysEretmoche

25、lys imbricata鳄鱼Crocodylia spp.龟板Carapax et Plastrum TestudinisChinemys reevesii海马HippocampusHippocampus spp.猴枣Calculus MacacaeMacaca mulatta虎骨Os TigrisPanthera tigris羚羊角Cornu AntelopisSaiga tatarica麝香MoschusMoschus spp.犀牛角Cornu RhinocerotisRhinoceros spp.象牙Dens ElephantisElephas spp.熊胆Fel UrsiUrsida

26、e spp.眼镜蛇Naja spp.欧欧 盟盟 违违 禁禁 动动 物物 类类 中中 药药Forbidden Chinese herbs from protected animals中药名药材拉丁名原植物拉丁名备 注白及Rhizoma BletillaeBletilla striata沉香Lignum Aquilariae ResinatumAquilaria sinensis狗脊Rhizoma CibotiiCibotium barometz胡黄莲Rhizoma PicrorhizaePicrorhiza kurrooa中国药典品种Picrorhiza scrophulariiflora不受保

27、护芦荟AloeAloe ferox库拉索芦荟Aloe barbadensis不受保护木香Radix AucklandisAucklandia lappa别名Saussurea lappa, S. costus人参Radix GinsengPanax ginseng仅限于俄罗斯种群的根部肉苁蓉Herba CistanchesCistanche deserticola石槲Herba DendrobiiDendrobium cruentum桃耳七（龟臼）Radix PodophylliPodophyllum emodi别名Podophyllum hexandrum天麻Rhizoma Gastrodi

28、aeGastrodia elata西洋参Radix Panacis QuinquefoliiPanax quinquefolium仅生药（根和能辨认出是根的部分）受保护，其制品（冲剂、丸、片、茶、提取物等不受保护）欧欧 盟盟 违违 禁禁 植植 物物 类类 中中 药药 Forbidden Chinese herbs from protected plants中药名药材拉丁名原植物拉丁名草乌Radix Aconiti KusnezoffiiAconitum kusnezoffii川乌Radix AconitiAconitum carmichaeli附子Radix Aconiti Preparata

29、Aconitum carmichaeli关木通Caulis Aristolochiae ManshuriensisAristolochia manshuriensis广防己Radix Aristolochiae FangchiAristolochia fangchi火麻仁Fructus CannabisCannabis sativa厚朴Cortex Magnoliae OfficinalisMagnolia officinalis马兜铃Fructus AristolochiaeAristolochia contorta, Aristolochia debilis麻黄Herba Ephedrae

30、Ephedra spp.马钱子Semen StrychniStrychnos nux-vomica青木香Radix AristolochiaeAristolochia debilis细辛Radix et Rhizoma AsariAsarum heterotropoides, A. sieboldii天仙藤Herba AristolochiaeAristolochia debilis, Aristolochia contorta洋金花Flos DaturaeDatura metel罂粟壳Pericarpium PapaverisPapaver somniferum由于毒性等原因被禁的中药品种由

31、于毒性等原因被禁的中药品种 Forbidden “toxic” Chinese herbs重金属 Heavy metals限量 Limits铅 Pb5.0 mg/kg镉 Cd0.2 mg/kg汞 Hg0.1 mg/kg中草药、中成药重金属限量Limits of heavy metals in herbs霉菌毒素 Mycotoxins限量 Limits黄曲霉毒素AflotoxinsB12.0 g/kg B1 B2 G1 G24.0 g/kg赭曲霉毒素A Ochratoxin A10.0 g/kg中草药霉菌毒素限量Mycotoxins limits in herbsMost EU member s

32、tates do not allow irradiated foods on the market whereas many Chinese herbal manufacturers use irradiation to reduce microbial contamination. Chinese herbal manufacturers need to find non-irradiation methods for this purpose in order to export their products to the EU.绝大部分欧盟成员国不允许经过钴60或其它放射性同位素辐照灭菌

33、的食品上市销售。有些中药材和中药制品是经过辐照灭菌消毒的，因此不可以在欧盟市场销售。为了保证中药进入欧盟市场，中国中药生产企业必须采用非放射性灭菌法消毒中药。TCM research is on the agenda of EU Research Framework Program. FP7 allocates special fund to set up a TCM research network in the EU. Chinese Ministry of Science & Technology, EU DG Research and Italian Ministry of H

34、ealth jointly organized the Sino-European Conference on Traditional Chinese Medicine in Rome last year. 值得指出的是，中医药研究已经引起欧盟的重视。在欧盟第7个框架研究计划中专门拨款支持中医药研究。中医药研究成为中欧科技合作的重要主题。中国科技部、欧盟科研总局和意大利卫生部还在去年共同组织专门在意大利罗马召开了由中欧各国政府有关部门和大学、研究机构参加的规模盛大的中欧中医药大会。Quality standards for Chinese herbs in Europe are also on the agenda. British Pharmacopoeia has published monographs for Chinese herbs Dasngui, Huangqi, Baishao, Shenshen and Gancao. 60 Chinese herb monographs are ready for publication in the French Pharmaco