Regulation of herbal medicines

This Note outlines the historical regulation of herbal medicines in the UK, regulatory changes due to the EU Directive on Traditional Herbal Medicinal Products, and proposals to introduce statutory registration of herbal practitioners.

Herbal remedies for human use have for some time been regarded as medicines under UK legislation, in principle subject to the same licensing procedures as pharmaceuticals. In particular, efficacy requirements have been difficult to meet and so most EU Member States developed various pragmatic arrangements to tackle this. In the UK herbal remedies have historically been exempted from licensing.

A review of herbal regulation at EU level was prompted by safety concerns and the need for market harmonisation of various national herbal regulatory regimes.

The Directive on Traditional Herbal Medicinal Products (Directive 2004/24/EC) replaces most existing member state regulations and creates a unified licensing system for traditional herbal medicine products (in use for at least 30 years, of which 15 must usually have been in the EU). The Directive came into full effect on 30 April 2011.

The Directive applies to manufactured herbal medicinal products sold over the counter, prohibiting the continued sale of unlicensed products. This note will outline the conditions in which herbal medicines can now be sold in the UK.

The Directive has met with some opposition from suppliers and users of herbal medicines. Objections include perceived disproportionate costs of regulatory compliance and the difficulty some non-European herbal traditions may have in meeting the requirement. There are concerns this will result in threatening the viability of businesses and a reduction in consumer choice.

In February 2011, a statutory regulation scheme for herbal practitioners was proposed which would allow prescribing of unlicensed preparations by registered herbalists under a clause in the 2001 Medicines Directive. It was planned that this scheme would come into force in 2012. In July this year, the Under Secretary of State for Health, Dr Daniel Poulter highlighted issues which have made the introduction of the scheme difficult. He announced the setting up of a working group to further consider evidence and options. It will meet for the first time in early 2014.