Today is the day that the European Union's regulatory noose on herbal products is pulled tight. The result? Thousands of herbal products technically become illegal, simply because they cannot negotiate the regulatory minefield built by the EU over the last 10 or so years. The full implementation of the EU Traditional Herbal Medicinal Products Directive (THMPD) today represents the most recently placed piece of this complex jigsaw that will impact the majority of the most useful and effective herbal products on the EU market. This includes the majority of herbal products associated with very long-standing non-European healthcare systems like traditional Chinese medicine (TCM), Tibetan medicine, Ayurveda, southern African, Amazonian and other traditions.
And if you feel there is something fundamentally wrong with this — whether it frustrates, angers or simply concerns you — please sign the Avaaz petition and ask as many of your contact group as possible to do the same. We need to be able to show the European Commission, the European Medicines Agency, EU governments, European Parliamentarians and others just how strongly people feel about this gross injustice.
Technically, any manufactured herbal medicine that has not been registered under the EU's Traditional Herbal Medicinal Products Directive is banned. And the problem is that only around 200 distinct products have made it through this convoluted regulatory doorway — one that's calibrated specifically to fit only a narrow range of herbal products.
So, which products benefit, and which products get locked out? The winners are mostly products derived from alcoholic extracts of single herbs that are common to the relatively recent European (and particularly Germanic) phytopharmaceutical tradition. The main losers are those products associated with world's longest, most established and most evolved and holistic systems of healthcare, notably Ayurveda and TCM. Less familiar and less globalised traditions such as Tibetan, Korean, southern African and Amazonian traditions also fall victim.
But it's not just herbal medicines that fall victim to the EU regulatory minefield. Other categories of product also get caught, these including complex nutritional and herbal products associated with nutritional and functional medicine modalities. The problem here is as soon as a particular herbal ingredient is deemed as medicinal by a regulator, the whole product becomes illegal and cannot continue to be sold as a food supplement.
If you're expecting to see the shop shelves cleared on Monday 2nd May, you'll have to wait. There are several reasons for this. Firstly, regulators will take time to make determinations about products that are still on the market, selling as botanical food supplements. In some EU countries, such as the Netherlands and the Czech Republic, that have liberal regimes, we will expect to see no change for the time being as these countries seem content to regard TCM and Ayurvedic products as food supplements. Others, such as the UK and Germany, the two countries that have registered the most products under the THMPD, have a different view. For these countries, and others who are following their lead, any food supplement that has any pharmacologically active herbal ingredient is deemed a medicine. As such it must be removed from the market unless registered.
The effects of this policy are far-reaching - and devastating in terms of the range of products that have been on the market prior to May 2011. So to delay the pain - and possibly to reduce the risk of an immediate public outcry, the UK has allowed products that were deemed unregistered herbal medicines before April 30 2011 to be sold through by retailers. Some of these products might have 2 or 3 years shelf life, so this will dampen the effect of the inevitable bans.
The loss of products falling between the various stools of European medicinal and food law is our reason to bring our concerns to a court of law.
We have been working hard with stakeholders across Europe to bring this challenge and we are nearly ready to file. But the complexity of the case has meant that we are taking a little longer than planned, given we'd hoped to file our case by the end of April.
We will keep you closely informed of our progress, but rest assured we are doing our very best, along with our expert European lawyers, to make sure we have the strongest possible case to help to resolve one of the greatest injustices ever wreaked on natural medicine.
For those of you that have donated to our legal fund, we thank you sincerely for your support. For others, who have done their bit to communicate the problems facing herbal products in the EU, we are also very grateful.
Now, please do what you can to get as many signatories on to the Avaaz petition.
In health, naturally
Robert Verkerk PhD
Executive and scientific director
Alliance for Natural Health International
Updated: 1 May 2011
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