IMB to impose controls on herbal medicines

Regulations: Controversial new controls on the sale of herbal medicines are to be implemented in Ireland by the semi-state body…

Regulations: Controversial new controls on the sale of herbal medicines are to be implemented in Ireland by the semi-state body with responsibility for regulating medical and veterinary products, the Irish Medicines Board (IMB).

The new regulatory system marks another step in the Europe-wide move to limit the availability of herbal medicines and food supplements, say natural health campaigners. At present, there is no regulatory system for such medicines but a recently approved EU directive on traditional herbal medicines requires all member-states to implement a harmonised system.

The Department of Health has responsibility for transposing it into Irish law but it is understood the IMB will regulate the system.

The board has been considering the herbal medicines market for about three years so "it would make perfect sense" to take on this role, according to IMB chief executive Mr Pat O'Mahony. "There's an 18-month lead- in so in that time there will have to be a regulatory regime for herbal medicines in Ireland."

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Unlike other medicines which require clinical trials, the new rules allow for the efficacy of herbal products to be established by the fact that they have been traditionally and successfully used for a particular condition for 30 years and at least 15 years in the EU. This time limit means that many herbs commonly used by people who have recently migrated into the EU will not be legal, according to Erica Murray, spokeswoman for the Irish Association of Health Food Stores.

"Herbal medicine is the chosen healthcare system for 80 per cent of the world's population, so this is severe restriction," she added.

Mr O'Mahony told The Irish Times that two of the IMB's key concerns - quality and safety - would have to be demonstrated by the herbal medicine producers.