Monday, March 7, 2011

How will the Ministers overruling of the EU Traditional Herbal Medicines Directive effect availability of over the counter herbal products

Under an EU directive passed in 2004 means that from May 1st this year, consumers will no longer be able to purchase unlicensed traditional herbal products.

However, a last minute overruling by ministers means that these unlicensed herbal products, will still be available only when prescribed by a registered professional. This over-ruling is ‘to meet individual patient needs’, and plans are in motion for the Health Professions Council to establish a compulsory register of practitioners supplying unlicensed herbal medicines, which should be in place in 2012.

Why has this happened now?
The Medicines and Healthcare Products Agency has issued more than a dozen alerts in the past two years, an indication that stricter guidelines are needed in obtaining herbal products.

Why don’t more herbal products have a licence?
In order for a herbal product to be licensed, the EU directive demands that it is shown to be in use for 30 years in the EU, or 15 years in the EU and 15 years elsewhere. Even if this can be proved, the process in obtaining a licence costs £80,000 to £120,000, which is a cost most companies can not meet the expense of.

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