Friday, January 14, 2011

Traditional Herbal Medicines in the EU

When the Traditional Herbal Medicinal Products Directive was passed in 2004, many herbal producers, including those producing herbs for the great and ancient traditions of Ayurveda and Traditional Chinese Medicine, saw the Directive as a ‘godsend’.
Here was a piece of law that would give these herbal products a proper medicinal classification, meaning they could actually be used to help make sick people healthier. The food supplements regime, under which most of these products have been sold in Europe, of course doesn’t allow any claim to be made about the treatment or protection against disease. In fact, food supplements are intended only for healthy persons (so they say)!

We are now 6 years into the implementation of the Directive, and only there’s only a year before it’s all-important transition phase runs out.

The American Botanical Council approached the ANH with three questions, asking its views on this issue that is of great importance to natural health, especially in the European Union. But obviously it has a major impact on suppliers from all around the world, and given the way in which European regulatory models are viewed in other regions, the practical workability of the system is crucial if it’s going to be adopted elsewhere.

Here’s what we had to say in response to the questions (in bold text) from the American Botanical Council:

1) Is ANH continuing its campaign for the amendment of the EU’s THMPD? If so, on what grounds, and how has the European Commission been responding to such calls?

The ANH is dealing with the full scope of issues raised by the THMPD (EC Directive 2004/24/EC), as well as looking for ways of rectifying some of the Directive’s fundamental flaws. We are now only around a year away from the end of the transition phase of the Directive. After March 31, 2011, the Directive will be fully implemented and any products that are deemed by EU regulators as “traditional medicinal products” (THMPs) will not be allowed to be sold or marketed in the EU unless they have been successfully licensed under the Traditional Herbal Medicinal Products Registration Scheme. In essence, there are so many deficiencies in the scheme that, if you look at the two great traditions that were central to the development of the scheme in the first place, that of traditional Chinese medicine (TCM) and the herbal products associated with Ayurveda, not a single product from either of these traditions has yet to be registered! Some will say this is because Indian and Chinese interests have not submitted applications, but there is a good reason for this. In the majority of cases, company’s have found it very difficult to provide the data required. The ANH has worked with a number who have been trying or are still trying.

In essence, it’s akin to trying to put a square peg in a round hole. The scheme is simply not built for complex polyherbal products and the requirement for proving 15 years EU usage out of a total of 30 years traditional use (the ‘30 year rule’), 6 months stability data and genotoxicity data put a huge barrier in the way of registration for many products and many companies. It’s not just a question of cost, which obviously impacts smaller companies much more than larger ones, it’s also that some of the requirements are simply very difficult to meet from a technical perspective, especially for complex herbal products typical of these traditions.

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