On April 1 2011, the transition phase of the European Union's Traditional Herbal Medcinal Products Directive (THMPD) will expire, imposing restrictions that seriously limit the fair trade and use of all medicinal herbs. These new sets of laws enforce the same kinds of regulatory requirements on herbal preparations that pharmaceuticals have to undergo in order to be made "legally" available as medicine. In other words, herbs are now going to be treated as drugs.
The implications of this are startling. The preparation, use, and trade of herbs that have been part of humanity's natural pharmacopeia for thousands of years are going to be, by default, illegal, unless they have a regulatory agency's stamp of approval. The cost of getting this kind of approval is very prohibitive--unless you are a megacorporation that can afford to manage the expenses and scientific tedium it takes to satisfy this process. The principles of herbal medicines rests not in their capacity to be standardized or purified, like drugs, but in the nature and complexities of an herb's unique biology. People from virtually every culture have been using herbal medicines for time immemorial not because they can pass rigorous tests deeming them suitable, but because they work. The EU's set of regulations does not discount or trump the validity of other people's methods for maintaining quality and consistency of their products. The proof is in the pudding. Alliance for Natural Health's (ANH) Dr. Verkerk explains:
"Getting a classical herbal medicine from a non-European traditional medicinal culture through the EU registration scheme is akin to putting a square peg in a round hole. The regulatory regime ignores and thus has not been adapted to the specific traditions. Such adaptation is required urgently if the directive is not to discriminate against non-European cultures and consequently violate human rights."
The ANH has been fighting the THMPD since its inception in 2004. Presently, herbal medicines are regulated under food supplement laws which do not enforce the same prohibitions the directive calls for. People who will be most affected are small herb producers, both within and outside the EU, people who rely on herbal healthcare who do not abide by EU medicinal standards, and practitioners of herbal medicine like Ayurveda and Tradtional Chinese Medicine.