Effect of herb medicine regulation on industry likely to be minimal
Only a small number of herbal products could be banned under a proposed
European directive aimed at regulating the herbal industry, according
to the Government.
The proposed directive on traditional herbal medicinal products, which
could come into force by the end of 2004, will require manufacturers to
provide evidence of at least 30 years of traditional use of a product.
Following a broad assessment of 270 herbal ingredients, the Medicines
Control Agency has initially concluded that only two or three cases would
have a problem in demonstrating traditional use. In addition, consultations
with herbalists on some 200 or so herbal combination products have indicated
that these are also likely to fall under the definition of traditional
use.
Although regulatory decisions will only be made on actual applications,
the MCA says the potential for registering single ingredient and combination
products under the directive will be wide, although a limited number of
products might need to make some adjustment in their combination.
Commenting on the proposed directive last week, Health Minister Lord
Hunt said it would protect public health and boost public confidence in
herbal medicines: “Across the herbal sector there is broad support
for a scheme that will systematically prevent poor quality and unsafe
medicines reaching the UK market. It could cut through much of the hype
and exaggeration about products which is still prevalent in some parts
of the sector,” he said.
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