New EU regulations on herbal medicines come into force

歐盟對草藥新法規正式生效

By Dominic Hughes Health correspondent, BBC News

記者多米尼克休斯;

New regulations mean many herbal remedies will no longer be available over the counter

新法規意味不再能輕易獲取許多非處方藥草

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New European Union rules have come into force banning hundreds of traditional herbal remedies.
歐洲聯盟新規則禁止數百種傳統草藥處理方式已經生效,。

The EU law aims to protect consumers from possible damaging side-effects of over-the-counter herbal medicines.

歐盟的法律,旨在保護消費者免受於非處方藥草本植物可能引起的副作用。

For the first time, new regulations will allow only long-established and quality-controlled medicines to be sold.

第一次,新規定只允許已長期建立和質量控制藥品販售。

But both herbal remedy practitioners and manufacturers fear they could be forced out of business.

To date, the industry has been covered by the 1968 Medicines Act, drawn up when only a handful of herbal remedies were available and the number of herbal practitioners was very small.

但無論是草藥開業者醫生或製造商都擔心他們可能會被迫停業。
迄今為止,該行業在1968年藥物法令已被包括,制定了當時只有極少數人提供草藥和草藥開業醫生的數量是非常小。

But surveys show that about a quarter of all adults in the UK have used a herbal medicine in the past two years, mostly bought over the counter in health food shops and pharmacies.

但據調查顯示,在英國大約有四分之一的成年人在過去的兩年裡使用過草藥,,主要是在保健食品商店和藥店買了非處方籤的草藥。

The regulations will cover widely used products such as echinacea,St John’s Wort and valerian, as well as traditional Chinese and Indian medicines.

條例將包括廣泛使用的產品,如紫錐花,聖約翰草和纈草,以及傳統的中國和印度的藥品。

注釋:

紫錐花 (Echinacea) 紫錐花屬紫苑家簇,生於北美草原地區。是極受歡迎的天然草藥。大量研究證實,紫錐花能增強及刺激人體免疫系統,有助消炎殺菌,抵抗病毒。對發燒、流感、過敏症、關節炎、喉嚨發炎等病症,紫錐花均能有預防及治療效用。

金絲桃 (St. John’s wort,學名 hypericum perforatum)。在歐洲用金絲桃來消除憂鬱已超過 15 年根據德國研究人員所進行的研究顯示, 全球目前最受歡迎的草藥之一 St John’s Wort (金絲桃科, 聖約翰草) 對於輕度到中度的憂鬱症的治療效果, 和常見的精神科處方藥 imipramine 效果幾乎一樣好, 而且臨床上面所見到的副作用更少過許。多學者認為, 雖然St John’s Wort 具有很好的療效, 它也會帶來白內障等等副作用

Valerian 纈草根是一種自然而且相當溫和的鎮定劑.纈草是一種長得高高的、似羊齒狀的植物,原產於歐洲,它的植物名稱為 Valerian Officinalis,L. 它是千餘年來的常用草藥,後來移植於中國而成為中藥,普通的中醫書裡不常見此藥。Valerian現在普遍地生長於中國各地及台灣、中國東北,稱它的土名為「媳婦菜」。在沒有發明現今的鎮靜劑或者安眠藥之前,它的根是幾千年來歐洲各國普遍使用解除不安的催眠草藥。現在的歐洲各國仍然盛用Valerian。

Herbal remedies that have been approved for sale under the new regulations will come with this logo 

  • 新規定已批准出售的草藥將貼以這個標誌But safety concerns have focused on the powerful effects of some herbal remedies, as well as the way they interact with conventional drugs.For example, St John’sWort can interfere with the contraceptive pill, while ginkgo and ginseng are known to have a similar effect to the blood-thinning drug warfarin.
     
  • 但安全問題主要集中在一些有強大影響的草藥,以及它們與傳統的藥物相互作用的方式。
    比如,聖約翰草可能會干擾避孕藥,而銀杏,人參,對抗凝劑(血液稀釋藥物)華法林已知有類似干擾的效果。

    From now on only products that have been assessed by the Medicine and Healthcare products Regulatory Agency (MHRA) will be allowed to go on sale.

    Manufacturers will have to prove that their products have been made to strict  standards and contain a consistent and clearly marked dose.

    And to count as a traditional medicine, products must have been in use for the past 30 years, including 15 years within the EU.

    從現在開始只有被醫藥及保健產品監管署(英國 MHRA)評定的產品將被允許上市銷售。
    製造商將必須證明其產品是以嚴格的標準製作出,並包含一個一致和清晰的一劑使用劑量。
    要算作一種傳統藥物,其產品必須在過去已被使用30年,其中包括需在歐盟範圍內使用15年。

    They will also only be approved for minor ailments like coughs and colds, muscular aches and pains, or sleep problems.

    Remedies already on sale will be allowed to stay on the shelves until they reach their expiry date.

    他們也將只核准對輕微的疾病如咳嗽,感冒,肌肉疼痛,或睡眠問題有效用的藥方。

    藥品處方已經開始銷售者將被允許留在貨架上,直到到期日為止。

    Free from contamination

    Richard Woodfield, head of herbal medicine policy at the MHRA, says so far there have been 211 applications, of which 105 have been granted registration.

    英國 MHRA草藥政策的主管理查德伍德菲爾德,聲稱,到目前為止,已有211份申請,其中105個已獲准註冊。


    We’re very concerned that patients appreciate they must be very careful when they take these medicines and ideally should talk to their doctor or pharmacist”

    End Quote Prof Jayne Lawrence Royal Pharmaceutical Society

    我們非常關心患者能領會當他們使用這些藥物必須非常小心,最好應該跟他們的醫生或藥劑師討論。“結束引用英國皇家藥學會傑恩勞倫斯教授

    "Crucially, this EU directive and the registration scheme puts consumers in the driving seat so they can identify that a product meets assured standards on safety, quality and information about safe use.

    "Safety speaks for itself, but quality means, are they using the right part of the plant? Is it free from contamination? Is the claimed shelf life suitable?"Product information will include possible side effects and interactions with other drugs, but above all it must make very clear that it is based on traditional use." 

    “重要的是,這一歐盟指令和登記計劃把消費者置於駕駛座位,使他們能夠確定一個標準,以保證產品符合安全,質量和安全使用的訊息。
     
    “安全不言自明,但質量的平均,他們是否正確使用植物的部分?是否不受污染?所聲稱的保存期限是否適當呢?
     
    “產品信息將包括可能出現的副作用及與其他藥物的相互作用,但首先它必須非常清楚,這是基於傳統的使用。

  • And that is a key point for the Royal Pharmaceutical Society, which believes the new regime is a step forward in improving safety and quality.

    But Prof Jayne Lawrence, chief science adviser to the society, says there are still some concerns about herbal products.

    這是皇家藥學會的一個關鍵點,認為新政策是作為改善安全和質量的一步。
    但是首席社會科學顧問勞倫斯傑恩教授說,還有一些關於草藥產品顧慮。

    "They certainly haven’t been tested on the same basis as a conventional medicine and some of these compounds are very potent.

    他們確實不像傳統的藥物會在相同的標準下測試 有些複方效果是非常強效的

    "Patients might not realise that in some cases they should not take other medicines with them, or if they’re going for surgery they should tell their doctors they are taking these particular medicines because there may be complications.

    “病人可能沒有意識到,在某些情況下,他們不應該把草藥和其他藥品一起使用,或者如果他們要進行手術,他們應該告訴醫生,他們正採取這些特殊的藥物,因為可能會有併發症。

    "So we’re very concerned that patients appreciate they must be very careful when they take these medicines and, ideally, should talk to their doctor or pharmacist."

    The manufacturers of herbal remedies have had seven years to prepare for the new rules after the European Directive on Traditional Herbal Medicinal Products was introduced in 2004.

    我們非常關心患者能領會當他們使用這些藥物必須非常小心,理想上最好應該跟他們的醫生或藥劑師討論。

    歐洲自關於傳統草藥產品指示於 2004年推出後迄今,草藥的製造商有七年的時間準備適應此新的規則。

    Too onerous? 過於沉重?

    These regulations apply to over-the-counter sales, which form the bulk of herbal remedies sold in theUK.

    這些規定適用於對非處方銷售,在英國大部分草藥這樣銷售。

    But some manufacturers and herbal practitioners have expressed concern, arguing the new rules are too onerous for many small producers.

    但是一些製造商和草藥從業者表示關注,認為新規則對許多小生產者過於繁重。

    Michael McIntyre, chairman of the European Herbal and Traditional Medicines Practitioners Association, says there will be a significant impact on herbal medicine practitioners and their suppliers, but admits the rules do need bringing up to date.

    歐洲草藥和傳統醫藥從業者協會董事長克爾麥金太爾表示,這將會對草藥開業醫和他們的供應商有重大影響,但是他也承認確實需要新式的規則。

    "Products that go on the market now will definitely do what it says on the bottle, while we didn’t know how good they were in the past.

    “現在上市的產品將明確的在瓶子上方標示說明,這在過去我們不知道有多好用。

    "But registration is expensive so perhaps there may be fewer products on the market and a smaller range.

    "It’s difficult to argue that the market should stay as it is, without any regulation, but how many businesses will pack up and walk away? I can’t say."

    A Department of Health spokesperson said: "We have swiftly introduced a system to register herbal practitioners using unlicensed herbal medicines, so consumers will be able to continue to use unlicensed herbal medicines if they wish."

    “但註冊是昂貴,因此也許有可能會減少上市的產品和變為個較小的範圍。

    “市場是否應保持原樣,是很難爭論,沒有任何規例,但有多少企業將收拾行裝,離開?我無法確認。”

    衛生署發言人一說:“我們已經迅速推出了一個系統去登記草藥醫生所使用的草藥處方,所以消費者如果希望的話將能夠繼續使用無執照的草藥材。”

    參考資料:

  •  行政院衛生署中醫藥委員會 
  • 天然草藥知多少
  • 台灣中草藥網 
  • 消暑青草茶

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