EU herbal directive faces legal challenge
ANH-I said the two firms – Cheney Goulding and 11KBW – had provided advice that showed a, “solid way forward” to challenging the Directive, eventually in the European Court of Justice (ECJ), but via the UK and maybe Germany and Hungary as well.
A date had not been confirmed but an action is expected before year's end. The two legal firms were unavailable for comment at the time of publication.
The case is believed to be based on the infeasibility of applying a clinical trial regime to botanical extracts.
“We are now confident that our legal counsel has found a solid way forward that will be in the long-term interests of European and non-European citizens alike,” said Dr Robert Verkerk, ANH-I executive director.
“We are now assured that a diverse range of interests are willing to work with us to initiate the judicial review process.”
He added: “The regulatory regime ignores and thus has not been adapted to the specific traditions. 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. Such adaptation is required urgently if the directive is not to discriminate against non-European cultures and consequently violate human rights.”
The UK Health Food Manufacturers’ Association (HFMA) said it had no comment about the mooted action.
The pharma model
ANH-I has been a vocal critic of EU food law in the supplements area which it views as being weighted against smaller players due to what it sees as an over-reliance on costly, pharma-styled trials.
It is these concerns and the knock-on effects on innovation and consumer freedom of choice that has spurred its intention to bring the THMPD before European courts.
ANH-I formally announced its legal intentions at a weekend meeting convened by the European Ayurvedic Association in Hungary, where concerns were voiced about a large number of Indian, Chinese and other herbals that could be wiped from shelves come April 30, 2011.
At that time, all herbal products in the EU’s 27 member states seeking to make claims must be registered through the appropriate national medicines agency, or face market prohibition.
Qualifying the reasons for its challenge, the ANH said:
“The ANH argues that the EU authorities should respect the equivalence of non-European standards as set by their respective pharmacopoeia, rather than force non-European herbs through western scientific standards that are neither appropriate nor relevant.”
No Ayurvedic or Chinese botanical has yet won THMPD approval nor approval under the EU nutrition and health claims regulation.
“To-date, not a single product from either the Ayurvedic or Chinese tradition has been registered.”
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