New rules complicate EU herbal medicine market

     BRUSSELS, April 29 (Xinhua) -- As a 2004 European Union (EU) directive on herbal medicine is to be fully¹ implemented(实施,执行) on May 1, herbal medicinal products without a license² will no longer be allowed in the EU market, the European Commission said in a press release Friday.

    The Traditional Herbal Medicinal Products Directive, adopted by the EU member states in 2004, introduced a so-called simplified registration³ procedure with a seven-year transition period for traditional herbal medicinal products to obtain a medicine license.

    As the transition period is to expire on Saturday, herbal medicinal products from home and abroad, most of which have been sold as food supplements for decades, need to be medically registered or authorized⁴ by EU governments in order to remain in the market after May 1.

    Instead of going through safety tests and clinical trials as regular chemical drugs, applicants⁵ are required by the directive to provide documents showing the herbal medicinal product is not harmful in the specified⁶ condition of use, as well as evidence that the product at least has a 30-year history of safe use, including 15 years in the EU.

    However, a wide range of eligibility⁷ and technical challenges along with prohibitive costs have so far prevented both local and outside herbal medicinal products from being granted the license.

    Only a small proportion of indigenous⁸ herbal medicinal products have been approved for registration while not a single Chinese or Indian traditional herbal medicinal products have been licensed⁹.

    Lack of pan-European rules, EU member states had adopted different approaches to herbal medicine, thus creating a "state of anarchy¹⁰" in the markets despite the fact that indigenous herbs had a 700-year history of use in Europe.

    Although the directive was intended to harmonize rules of member states and build a level-playing field across the EU, critics argued that the directive may fall short of the aim and create more chaos¹¹ and uncertainties¹² for the industry.

    DRAWBACKSThe directive has been under attack for being neither "adequate " nor "appropriate" due to its high registration cost for a single product and its lack of consideration about the Chinese and Indian traditional herbal medicine.

    Chris Dhaenens, a licensed herbalist in Belgium and a shareholder¹³ of a medium-sized herbal importing company doing business with China and ten European countries, said the directive was only appropriate for companies carrying a few products and who could afford the registration costs.

    "It is simply inaccessible¹⁴ to most players distributing high- quality Chinese or Indian herbal products in Europe," he said, adding that the registration fee for a single product could be as high as 150,000 euros.

    The Alliance for Natural Health, a British-based group representing herbal practitioners¹⁵, estimated the cost of obtaining a license at between 80,000 and 120,000 pounds (90,000 to 135,000 U.S. dollars) per herb.

    Dhaenens, who is also the president of the European Benefyt Foundation, a leading traditional medicine group in Europe, argued that the directive only tried to regulate herbal products instead of its practitioners and the whole herbal system, as well as fell short to take the Chinese and Indian traditional medicine into full consideration.

    Even the European Commission had admitted that the directive was not fit for the registration of Chinese and Indian medicine in an earlier exchange with the European Medicine Agency in Dec. 2008, Dhaenens revealed in an exclusive interview with Xinhua.

    "But they had no money or time to work out an alternative, and so it was left to the member states," he said.（本文由在线英语听力室整理编辑）

1 fully   

adv.完全地，全部地，彻底地；充分地

参考例句：

• The doctor asked me to breathe in,then to breathe out fully.医生让我先吸气，然后全部呼出。
• They soon became fully integrated into the local community.他们很快就完全融入了当地人的圈子。

2 license   

n.执照，许可证，特许；v.许可，特许

参考例句：

• The foreign guest has a license on the person.这个外国客人随身携带执照。
• The driver was arrested for having false license plates on his car.司机由于使用假车牌而被捕。

3 registration   

n.登记，注册，挂号

参考例句：

• Marriage without registration is not recognized by law.法律不承认未登记的婚姻。
• What's your registration number?你挂的是几号？

4 authorized   

a.委任的，许可的

参考例句：

• An administrative order is valid if authorized by a statute.如果一个行政命令得到一个法规的认可那么这个命令就是有效的。

5 applicants   

申请人，求职人( applicant的名词复数 )

参考例句：

• There were over 500 applicants for the job. 有500多人申请这份工作。
• He was impressed by the high calibre of applicants for the job. 求职人员出色的能力给他留下了深刻印象。

6 specified   

adj.特定的

参考例句：

• The architect specified oak for the wood trim. 那位建筑师指定用橡木做木饰条。
• It is generated by some specified means. 这是由某些未加说明的方法产生的。

7 eligibility   

n.合格，资格

参考例句：

• What are the eligibility requirements? 病人被选参加试验的要求是什么？ 来自英汉非文学 - 生命科学 - 回顾与展望
• Eligibility for HINARI access is based on gross national income (GNI). 进入HINARI获取计划是依据国民总收入来评定的。

8 indigenous   

adj.土产的，土生土长的，本地的

参考例句：

• Each country has its own indigenous cultural tradition.每个国家都有自己本土的文化传统。
• Indians were the indigenous inhabitants of America.印第安人是美洲的土著居民。

9 licensed   

adj.得到许可的v.许可，颁发执照(license的过去式和过去分词)

参考例句：

• The new drug has not yet been licensed in the US. 这种新药尚未在美国获得许可。
• Is that gun licensed? 那支枪有持枪执照吗？

10 anarchy   

n.无政府状态；社会秩序混乱，无秩序

参考例句：

• There would be anarchy if we had no police.要是没有警察，社会就会无法无天。
• The country was thrown into a state of anarchy.这国家那时一下子陷入无政府状态。

11 chaos   

n.混乱，无秩序

参考例句：

• After the failure of electricity supply the city was in chaos.停电后，城市一片混乱。
• The typhoon left chaos behind it.台风后一片混乱。

12 uncertainties   

无把握( uncertainty的名词复数 )； 不确定； 变化不定； 无把握、不确定的事物

参考例句：

• One of the uncertainties of military duty is that you never know when you might suddenly get posted away. 任军职不稳定的因素之一是你永远不知道什么时候会突然被派往它处。
• Uncertainties affecting peace and development are on the rise. 影响和平与发展的不确定因素在增加。 来自汉英非文学 - 十六大报告

13 shareholder   

n.股东，股票持有人

参考例句：

• The account department have prepare a financial statement for the shareholder.财务部为股东准备了一份财务报表。
• A shareholder may transfer his shares in accordance with the law.股东持有的股份可以依法转让。

14 inaccessible   

adj.达不到的，难接近的

参考例句：

• This novel seems to me among the most inaccessible.这本书对我来说是最难懂的小说之一。
• The top of Mount Everest is the most inaccessible place in the world.珠穆朗玛峰是世界上最难到达的地方。

15 practitioners   

n.习艺者，实习者( practitioner的名词复数 )；从业者（尤指医师）

参考例句：

• one of the greatest practitioners of science fiction 最了不起的科幻小说家之一
• The technique is experimental, but the list of its practitioners is growing. 这种技术是试验性的，但是采用它的人正在增加。 来自辞典例句