Big Pharma Scores Big Win: Medicinal Herbs Will Disappear in EU
It's almost a done deal. We are about to see herbal preparations disappear, and the ability of herbalists to prescribe them will also be lost.
它幾乎是米已成炊，我們即將看到草藥製劑消失，和中醫的能力去處方它們亦將失去。
by Heidi Stevenson
12 September 2010
translation by Autumnson Blog
Big Pharma has almost reached the finish line of its decades-long battle to wipe out all competition. As of 1 April 2011—less than eight months from now—virtually all medicinal herbs will become illegal in the European Union. The approach in the United States is a bit different, but it's having the same devastating effect. The people have become nothing more than sinks for whatever swill Big Pharma and Agribusiness choose to send our way, and we have no option but to pay whatever rates they want.
大型製藥公司已差不多到達終點線，在其數十年長的戰爭去消滅所有競爭。在2011年 4月1日 - 從現在不到8個月 - 在歐洲聯盟幾乎所有草藥將成為非法。在美國的做法是有點不同，但它具有同樣的破壞性影響。人民已變成豬狗不如給大藥廠和農產業選擇去送我們上路，和我們沒有選擇但只能支付它們想要的任何價錢。
Big Pharma and Agribusiness have almost completed their march to take over every aspect of health, from the food we eat to the way we care for ourselves when we're ill. Have no doubt about it: this takeover will steal what health remains to us.
大型製藥企業和農業產業化經營已差不多完成它們的步操，去接管健康的每一範籌，從我們吃的食物至當我們生病時，我們照顧自己的方式。毫無疑問：這次接管將偷去健康剩給我們的意義。
從下一次4月愚人節開始
It Begins Next April Fools DayIn the nastiest April Fool's Joke of all time, the European Directive on Traditional Herbal Medicinal Products (THMPD) was enacted back on 31 March 2004.(1) It laid down rules and regulations for the use of herbal products that had previously been freely traded.
This directive requires that all herbal preparations must be put through the same kind of procedure as pharmaceuticals. It makes no difference whether a herb has been in common use for thousands of years. The costs for this are far higher than most manufacturers, other than Big Pharma, can bear, with estimates ranging from £80,000 to £120,000 per herb, and with each herb of a compound having to be treated separately.
It matters not that a herb has been used safely and effectively for thousands of years. It will be treated as if it were a drug. Of course, herbs are far from that. They're preparations made from biological sources. They aren't necessarily purified, as that can change their nature and efficacy, just as it can in food. It's a distortion of their nature and the nature of herbalism to treat them like drugs. That, of course, makes no difference in the Big Pharma-ruled edifice of the EU, which has enshrined corporatism in its constitution.
Dr. Robert Verkerk of the Alliance for Natural Health, International (ANH) describes the problem of requiring drug-like compliance on herbal preparations:
Getting a classical herbal medicine from a non-European traditional medicinal culture through the EU registration scheme is akin to putting a square peg into a round hole. The regulatory regime ignores and thus has not been adapted to the specific traditions. Such adaptation is required urgently if the directive is not to discriminate against non-European cultures and consequently violate human rights.(2)
貿易法
Trade Law
To best understand how this can be happening, one needs to see that trade laws have been at the center of the moves to place all aspects of food and medicine under the control of Big Pharma and Agribusiness.
If you've followed what's been happening in the United States regarding raw milk and the Food and Drug Administration's (FDA's) claims that foods magically become drugs when health claims are made, you may have noted that the Federal Trade Commission (FTC) has been part of the process.
Rather than treating food and traditional medicines as human rights issues, they have been treated as trade issues. That makes the desires of large corporations the focus of food and herbal law, rather than the needs and desires of people. It's this twisting that has resulted in the FDA's making outrageously absurd statements, such as claiming that Cheerios and walnuts quite literally become drugs simply because of health claims made for them.
The goal of it all is to make the world safe for the megacorporations to trade freely. The needs and health of the people simply are not a factor in their considerations.
如何戰鬥這種對我們健康和福利的侵蝕
How to Fight This Encroachment on Our Health and WelfareIt's not a done-deal, at least, not quite. If you value your access to herbs, or if you care about access to vitamins and other supplements, please take action. Even if these issues seem meaningless to you, consider the people who do care. Should they be denied the right to the medical treatment and health maintenance of their choice?
The ANH has been active in fighting these encroachments. They are currently going to court in an attempt to stop the implementation of THMPD. We can hope that they'll succeed, but recent history shows that no legal maneuver is likely to stop this juggernaut. We cannot afford to sit back and wait for the results of their efforts. We need to see their endeavor as part of a whole, one in which each of us plays a role.
It's up to us—each and every one of us—to take action. If you live in Europe, please, send a letter or message to your Member of European Parliament. Go to this page to find out who is your MEP and the contact information. Then, send a letter that states, in no uncertain terms, that you strongly support the ANH's actions in trying to suspend the implementation of THMPD and that you hope they will also take a stand in support of the people's right to choose herbal treatments.
If you find it difficult to write such a letter, click here for a sample (in the universal .rtf format) suggested by ANH. Feel free to use it.
Denice Delay has kindly translated the letter into Spanish. Thanks!
Try to imagine facing your children or grandchildren when they ask why you didn't. How will you tell them that you really weren't that interested in their welfare? How will you tell them that it was more important to watch the latest fake reality show on television than to take the time to write a simple letter?
It is only by actively protesting that this travesty against our welfare can be stopped. If we sit back in apathy, then it will happen. Our right to protect our health and that of our children is hanging in the balance. If you care for your child's or grandchild's welfare, then you must act. Speak out, for now is the moment of truth. You can sit back and do nothing, or you can speak out.
And then, once you have, talk to everyone you know. Tell them that it's time to act. There truly is no time to waste.
http://gaia-health.com/articles301/000301-big-pharma-scores-big-win-medicinal-herbs-disappear-eu.shtml
中國目前尚無中藥在歐盟以藥品身份成功註冊
2010年06月10日 09:02
目前，在歐洲，中藥一直是以保健品或食品的身份存在，我國還沒有一種中藥以傳統草藥身份在歐盟註冊。中藥能否以其“本來面目”進入歐盟市場？
答案應是肯定的，然而如何進入，是一個複雜的問題。
“中醫藥發展暨中藥在歐洲註冊國際論壇”日前在上海世博會上舉行。
該論壇由荷蘭海牙市政府和世界中醫藥學會聯合會共同主辦，專門邀請歐洲有關藥品註冊評估專家來華探討中藥在歐洲註冊藥品的可能性。
據了解，這是首次由西方國家政府機構出資並與中醫藥國際學術組織舉辦的大型專題會議。
尷尬：歐洲中醫面臨有醫無藥
國家中醫藥管理局副局長于文明說，中醫藥是中華民族的優秀文化瑰寶，對世界文明進步產生了積極影響。據統計有60%以上的歐洲人使用過傳統藥品，歐洲佔全球草藥市場的44.5%的份額。現在歐盟擴大到27個國家，總人口近5億，超過北美自由貿易區，歐盟對中醫藥將會有更大的市場需求，中醫藥將會在歐洲人民醫療保健中發揮獨特的作用。
然而，目前，我國還沒有一種中藥產品在歐盟以傳統草藥的身份成功註冊。
2005年10月，歐盟成員國開始實施《歐盟傳統藥品法》，規定過渡期截至2011年3月31日。世界中醫藥學會聯合會副主席兼秘書長李振吉表示，“在過渡期內，如果某種草藥產品已經在歐洲共同體使用了足夠長的時間(至少15 年)，那麼該產品可以基於這段時間的使用，僅進行簡單的登記即可。”
據介紹，過渡期後，中藥登記註冊的程式就比較複雜。如果該法令按期執行，中藥將不能以保健品或食品的身份存在，若不進行註冊登記，將被視為違禁品。這將對我國中藥出口十分不利，也將給中醫藥在歐洲的發展帶來嚴峻挑戰，歐洲中醫將面臨有醫無藥的尷尬境地。
因此，與會專家都提出，中藥產品要抓住這寶貴的過渡期。
中國一直沒有中藥品種在歐盟成功註冊，原因是多方面的。世界中醫藥學會聯合會副主席黃建銀分析，傳統草藥產品登記應向歐盟成員國的相關機構提出申請。評估第一步的問題集中在是否有足夠的證據證明“傳統的使用”。如果不是“傳統的使用”，申請將被駁回，並且必須通過其他程式以更嚴格的要求進行評估。一方面，歐盟對中藥註冊需要滿足至少30年的用藥歷史，中國企業提供不了有關證明；另一方面，中藥企業缺乏對該法令準確和全面的了解，因而望而卻步。
註冊：中草藥進歐盟當務之急
進入歐洲市場，中藥產品首先必須符合歐洲的品質、安全和療效標準。對於中醫藥的全球化，這是一個真正的挑戰。
“與其他藥品一樣，草藥產品也需要獲得上市許可。這意味著只有在獲得主管部門上市許可後，它們才可以投放市場。”荷蘭海牙藥品評估署委員會植物藥品與新型食品評估部部長艾米爾·范·蓋倫表示，當然，傳統藥品並不需要像西藥那樣根據臨床試驗結果進行註冊。這些藥品的療效要根據病人的使用情況和藥理情況作出證明，並提供長期歷史使用記錄。
註冊傳統中藥將使歐洲中醫藥進入一個新的發展階段。李振吉認為，《歐盟傳統藥品法》為中藥以治療藥品身份進入歐盟藥品市場提供了法律依據，也為中藥進入歐洲主流植物藥市場和歐洲藥品分銷渠道提供了可能。這將有利於擴大歐洲中藥市場，規範目前分散零亂的歐洲中成藥市場，保證中成藥品質，提高中藥的聲譽，是中藥在歐洲正常健康發展的一個難得機會。
艾米爾·范·蓋倫介紹說，一些非歐洲傳統藥和復方製劑的成功註冊為傳統中藥製劑註冊傳統藥提供了一些借鑒經驗。建議中國企業在歐盟藥品註冊程式相對靈活的國家率先註冊，從而打開中藥在歐盟的市場。
于文明說，中國醫藥企業應該把中藥製品歐盟註冊作為企業國際發展重點，加大投入力度，進行多層次的探索和研究，加強橫向聯合，積極在歐盟註冊中藥品種，推動中醫藥產業國際發展。
破壁：提升產業國際競爭力
據世界中醫藥學會聯合會副主席、歐洲中醫藥聯合會副主席董志林介紹，目前，在歐盟市場上，沒有日本的漢方藥，也沒有南韓的韓藥，只有內地和台灣的中藥。但都是以食品和保健品名義進入的。
董志林認為，對食品和藥品要求標準不同。以食品的標準要求中藥，成為中藥進入國際市場的最大障礙，也成為許多國家對我國中藥出口設置技術貿易壁壘，阻礙我國中藥產業參與國際競爭的藉口。
此外，我國整個中藥產業都缺乏國際市場競爭力。表現在生產企業多、規模小、效益低，比如，全國有300多家企業在做一個六味地黃丸。據國家中醫藥管理局統計，中小型企業佔96%。造成了國產中醫藥面臨著“中國原產，南韓開花，日本結果，歐美收穫”的尷尬現狀。
董志林提出，國內企業多數滿足於國內市場，不去開拓國際市場。中成藥要想以藥的身份進入歐盟主流市場，通過註冊是最省錢、最快、最有效的途徑。政府可設立專項資金配合企業把握最佳註冊良機。
黃建銀認為，中藥在歐盟以藥品註冊，需要國內企業聯合起來，分攤成本、共同完成註冊，推動中藥走出國門。在目前，歐盟對傳統藥品過渡期還沒有結束之前，應充分運用技術途徑、國際規則、法律手段與相關國家談判，為中藥進入歐盟提供更為有利的條件。
來源：人民日報
http://www.cns.hk:89/jk/jk-hyxw/news/2010/06-10/2334287.shtml
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