Well, it’s about time.
Nearly 8 years since the Traditional Herbal Medicinal Products Directive (THMPD) became law, and nearly 12 months since it came into full force across the European Union (EU), the first herbal product associated with traditional Chinese medicine (TCM) has been registered in the Netherlands. We wait for the EU to spin this story as proof that the THMPD is working for non-European herbal products, but let’s take a look at why nothing could be further from the truth.
THMPD clearly not working
According to the European Commission (EC), the THMPD was designed, “Precisely with the objective to facilitate the placing on the EU market of traditional herbal medicinal products”. If it were working as intended, then, a steady stream of herbal products from all traditions would be gaining registrations – but this is absolutely not the case. In the UK, for example, the country with the most THMPD-registered products as of December 2010, only a single Chinese herbal product has been registered, a Ginkgo biloba product marketed by Bioforce.
Stark reminder of the problems
Manufacturers of Chinese herbal products – and products used by the Indian Ayurvedic, Japanese Kampo, Amazonian and other non-European traditions – face an enormously uphill struggle to get them registered under the THMPD scheme. The THMPD is particularly unsuitable for multi-herb products of the type that make up the overwhelming majority of the non-European Materia Medica, and it is no surprise whatsoever that the newly approved product is a single-herb extract of Japanese Yam (Dioscorea nipponica Makino). Once more, we see the THMPD approving products that have very little to do with herbal medical traditions as they actually exist.
Even for those involved with Western herbal traditions, the THMPD’s shortcomings translate into very real-world problems for the herbals sector, whether manufacturer, supplier, retailer, distributor, practitioner or consumer. A single approval of a single TCM product containing a single herb changes none of that – in fact, it only serves to throw the flaws of EU herbal regulations into sharp relief.
For more up-to-date information regarding the THMPD, please see the stories below:
ANH start data collection for UK medicines regulator's Red Tape Challenge
ANH Feature: From confusion to chaos: the poisoned legacy of the THMPD
Frequently asked questions about quality and regulation of herbal products
EU herbal directive forces predictable price rises and customer discontent
Comments
your voice counts
30 March 2012 at 9:42 pm
You are quite right in saying that the single registration of a herb associated with Chines herbal tradition (which uses hundreds of different herbs in various combinations) a full eight years after the approval of the directive is a stark demonstration of the failure of the European Traditional Herbal Medicines directive.
If I may venture an opinion for the reason of this failure - the THMPD was specifically tailored to "save German natural medicines" from being suppressed under the laws of pharmaceutical registration for medicines.
Around the year 2000, German herbal tradition risked being wiped out under those medicinal registration laws - all to be taken off the market because they could not be registered as medicines under laws that were made for the registration of chemical medicine, or Western pharmaceutical products. It was the Germans that pushed through the THMPD, in a desperate attempt to save what was previously called "Natural Medicines" and which, in Germany, had a regime that allowed simplified registration.
There was NO thought of finding a place for any other herbal traditions in that directive, and the failure of Chinese medicinal tradition to qualify is no accident.
THMPD is actually a misnomer. It should have been called the "Save German Natural Medicines Directive", if anything.
31 March 2015 at 3:40 am
Thank you for the valuable information :) Herbal Medicines are the best ! no side effects.
Keep posting !
Your voice counts
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