The Pharmaceutical Journal
Vol 270 No 7235 p206
8 February 2003

Society summary

Society's concern over control of traditional herbal medicines

The Royal Pharmaceutical Society has expressed concerns to the Government about the inadequacy of existing arrangements for controlling the supply of herbal medicines. The Society supports the European Commission's proposals for a directive on the regulation of traditional herbal medicinal products.

In a recent letter to Lord Hunt (Parliamentary Under Secretary of State with responsibility for medicines), the Society's President, Marshall Davies, cites a number of incidents that illustrate the Society's concern. They include reports over the years of toxic heavy metals in some products and therapeutic substances in others. Other concerns are interactions between St John's wort and certain prescribed medicines and the absence of any requirements for warnings about these on the label of this herbal product. More recently, the letter says, the Society has been alarmed by reports of toxicity due to aristolochia and kava kava products.

Mr Davies said: "The Royal Pharmaceutical Society has taken the view that a simple, harmonised legislative framework, within which the marketing of herbal medicinal products could be licensed for sale, would be a major step forward in protecting citizens of the European community. The Society has enthusiastically welcomed the development of the draft directive and it firmly believes that the directive is needed in the public interest. The current situation whereby unlicensed products — used very widely by the public — are not subject to regulatory control of quality and safety should not be allowed to continue."

The European Commission first adopted formal proposals for the directive in January 2002. The directive would introduce a simplified registration procedure for herbal products. Manufacturers would have to provide evidence of prolonged traditional use but would not have to demonstrate efficacy. Instead, products would carry a statement that efficacy has not been clinically proven but relies exclusively on long-term use and experience. A bibliographic review of safety data would be needed and registration could be refused if safety data were inadequate or the product was found harmful in normal conditions of use.

Consultation on the draft directive took place early last year (PJ, 6 April 2002, p454) and in November 2002 the European Parliament approved the directive subject to a number of amendments. The Commission is expected to introduce an updated text within the next few weeks.

The directive is not likely to become law before 2004 and, because of a probable five-year transition period, is unlikely to be fully operational before 2009.