Herbal medicines and the EU Directive (page 1 of 5)
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Abstract
On 22 December, Lord Warner, the Health Minister, announced a number of new measures to regulate complimentary medicine in response to report of a House of Lords Select Committee and a Department of Health (DoH) Consultation Document published in 2003. Although the final paper, describing the way in which the government proposes to regulate herbal medicines and complementary healthcare professionals, has yet to be published, the DoH has announced that it will make £900,000 available to The Prince of Wales’s Foundation for Integrated Health over the next three years to develop robust systems for the regulation of the main complementary healthcare professionals. A new Herbal Medicines Advisory Committee will be set up to advise the Medicines and Healthcare Products Agency on the safety and quality of herbal medicines. The present Advisory Board on the Registration of Homeopathic Products will retain its status as a free-standing committee, able to advise the government directly. This paper reflects on current attitudes and legislation in the herbal arena.
Herbal medicines and the EU Directive
The introduction of the Traditional Herbal Medicinal Products Directive by the European Union (EU) on 31 March 20041 is a major step in the process of harmonisation of the regulation of medicines in Europe. It has broken new ground in the UK by, for the first time, providing a framework for the control of herbal medicines in one piece of legislation rather than the fragmented use of regulations mostly deriving from the Medicines Act 1968. In the UK, the emphasis has been to have a regulatory framework to control the safety and quality of herbal remedies which have been uncontrolled to date except for approved medicines under the Medicines Act or those which have had pharmacopoeia entries with appropriate standardisation. The House of Lords Select Committee on Complementary and Alternative Medicine2 made strong recommendations in this area. It has been recognised that the evidence base for efficacy of herbals is variable and in most cases is not able to meet the requirements of a modern medicine submitted for approval to the national regulator, the Medicines and Health Products Regulatory Agency (MHRA)3 or to the European Medicines Evaluation Agency (EMEA).
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