| Directive 2004/24/EC on traditional herbal medicinal products offers regulation of over-the-counter herbal medicines. Richard Woodfield of the MHRA considers the Authority’s approach to implementation in the UK and weighs up the likelihood of greater harmonisation of the European market in herbal medicines
For many years, most herbal medicines on the UK market were subject to the minimal level of regulation provided by section 12 of the Medicines Act 1968. This legislation permitted unlicensed herbal remedies to be marketed with very few controls on safety, quality and patient information and this unlicensed sector sat alongside several hundred licensed herbal medicines. Most of these latter products had been on the market when the medicines licensing system was first introduced. They were originally given a product licence of right that was subsequently reviewed and converted into a full product licence.
For a number of years there were few obvious public health issues; however, with the growth in popularity of herbal medicine that began in the 1990s, international awareness of safety issues also increased. A major incident in Belgium following the supply of slimming aids containing the toxic herb Aristolochia was, arguably, a watershed. On this occasion, over a hundred women suffered kidney damage and many went on to develop cancer.
Much international trade continues in low grade, largely unregulated herbal medicines, and this manifests itself in the persistent discovery of undeclared pharmaceutical substances in unlicensed herbal medicines. High levels of heavy metals as well as bat excreta or human placenta have been found in a number of ethnic medicines, posing a risk of infection. The supply chain in the traditional Chinese medicine sector seems particularly prone to infiltration by low grade products, and the MHRA has issued a number of public warnings about this. |
