New rules complicate EU herbal medicine market

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    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）

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