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A Damaging Directive

The traditional medicines directive of the European Union is discriminatory.

Beginning from 1 May, ayurvedic and herbal medicines will be banned across Europe following the European Union’s (EU) “Traditional Herbal Medicinal Products Directive” (THMPD). As per this directive, a company needs to prove the efficacy and safety of a herbal medicine through traditional use in the EU over a minimum of 30 years or such use within the EU over 15 years and over 30 years outside the EU. While on paper, this does not seem like an impossible-to-fulfil requirement, herbal medicine manufacturers are at a decided disadvantage in many ways as compared to the allopathic pharmaceutical companies. In fact, the former have termed the directive “discriminatory and disproportionate”. This could also end up as a one-way trade barrier against developing countries.

The THMPD was passed in 2004 but the intervening seven years were meant to give herbal medicine manufacturers time to register themselves. While there are no official figures available for how many have done so, the alternative medicine advocacy group, Alliance for Natural Health International (ANHI), says that no medicine of a non-European medicinal system has succeeded in registering under the directive. Again, individual countries in the EU seek standards of “quality” that do not take account of the characteristics of these medicines. The ANHI, which is planning to initiate judicial review proceedings of the EU directive, notes: “A major flaw in the legalisation is that, unlike pharmaceuticals, herbal products are made from biological sources, and as such do not react in the same way that conventional pharmaceuticals do in a laboratory environment. Trying to push these ancient traditions into a European straitjacket based around synthetic drug manufacture is like trying to push a square peg into a round hole.”

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