After donations of about £100,000, the alliance is making final preparations to its legal case for a judicial review of the EU’s Traditional Herbal Medicinal Products Directive (THMPD) at the Royal Courts of Justice in London. After an initial hearing in London, the case will be referred to the European Court of Justice in Luxembourg.
The new legislation requires that traditional herbal medicinal products, many of which have been used in Europe for decades, must be licensed or prescribed by a registered herbal practitioner in order to comply with a directive passed in 2004.
In the UK over-the-counter herbal medicine products require either a Traditional Herbal Medicines Registration (THR) or a full marketing authorisation. To be eligible for a licence, products must have been on the market for 30 years, including 15 within the EU.
So far, about 100 herbal products have been registered under the THR scheme, which is run by the Medicines and Healthcare Products Regulatory Agency (MHRA).
The alliance fears the law will have the effect of banning thousands of herbal medicines and drive consumers on line to buy unregulated products.
“The main losers are those products associated with world's longest, most established and most evolved and holistic systems of healthcare, notably Ayurveda and traditional Chinese medicines,” according to a Robert Verkerk, the alliance’s executive and scientific director. “Less familiar and less globalised traditions such as Tibetan, Korean, southern African and Amazonian traditions also fall victim.”
Only about 200 herbal products are thought to qualify for use under the new legislation. Most are products derived from alcoholic extracts of single herbs that are common to the European phyto-pharmaceutical tradition, claims the alliance.
Despite the implementation of the legislation on May 1, existing herbal medicines stocked before April 30 this year can still be sold until the expiry date on the label. That may extend their shelf life for up to three years.
The interpretation of the legislation seems to differ around Europe. The UK and Germany take the view that any food supplement that has any pharmacologically active herbal ingredient is deemed a medicine and should be removed from the market unless registered, report the alliance.
But other EU countries, such as the Netherlands and the Czech Republic appear to regard traditional Chinese medicines and Ayurvedic products as food supplements.
Meanwhile, MHRA has advised caution when buying herbal medicines over the internet.
“There is an international trade in poor-quality, unregulated and unlicensed herbal products,” according to a MHRA statement. Some of these have been found to contain banned pharmaceutical ingredients or heavy metals which are poisonous.
“Products may also contain harmful herbs that are not permitted in the UK, and you should be aware that unlicensed herbal medicines manufactured outside the UK may not be subject to any form of effective regulation.”