5.86 In evidence we have received, the regulation of herbal products has emerged as presenting particular challenges for public health. We have heard evidence that the use of herbal products makes up a significant proportion of the total consumption of medicines and other health products in the United Kingdom. The Pharmaceutical Society of Great Britain and the Proprietary Association of Great Britain told us that, while the total size of the market was difficult to estimate, in their view total annual sales of herbal products were between £93 million (for the retail sector) and up to £240 million per annum (including direct sales, Internet sales and mail order), with signs of continuing strong growth.

5.87 It was also evident that the regulation of these products is not satisfactory. The Department of Health told us that "…the present regulatory arrangements for herbal medicines have significant weaknesses. The regime for unlicensed herbal remedies does not provide sufficient protection or information for the public. At the same time, some of the regulatory hurdles for licensed medicines may be unnecessarily demanding for relatively benign herbal remedies" (P 108).

5.88 We heard evidence of the potential dangers that arise from inadequate regulation in this area. The Committee on Safety of Medicines (CSM), set up to provide advice to the Government's MCA, told us that in their opinion "the regulation of unlicensed herbal remedies is unsatisfactory and of considerable concern" (p 247). Evidence about the adulteration of various Chinese products with the toxic herb Aristolochia had led to sweeping restrictions on these products by MCA.

5.89 The formal position relating to herbal products was outlined for the European Union as a whole by the European Agency for the Evaluation of Medicinal Products (EMEA) based in London. The founding principles of medicines law, the basis formally of all ensuing legislation across all Member States of the European Union, are set out in European Council Directive 65/65/EEC. This defined medicinal products as "any substance or combination of substances, presented for treating or preventing disease in human beings or animals; or which may be administered with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in human beings or animals." These definitions mean that any product that is supplied with therapeutic intent, for example by having a claim on the label, is a medicinal product and requires a licence (or marketing authorisation) in each Member State.

5.90 The EMEA has established a formal Working Party on Herbal Medicinal Products to advise it and the industry on harmonising licensing procedures for herbal medicinal products across the European Union. This has, among other activities, reviewed the application of European Union regulations on the licensing of herbal medicinal products, and considered the drafts of common standards for herbal medicinal products across the European Union, based on submissions to it of draft monographs by a scientific network: the European Scientific Cooperative on Phytotherapy (ESCOP) whose Chairman also gave evidence to us. It was clear to us from the latter that the supply of herbal products in much of the European Union is well integrated into conventional healthcare, with most herbs being supplied by pharmacists and many recommended or prescribed by physicians.

5.91 Especially in Germany, France, and the United Kingdom, a large number of herbal medicinal products have obtained marketing authorisations, under the terms of Directive 65/65/EEC. However most of these have been on the basis of historical licences of right awarded for products on the market when medicines legislation, such as the Medicines Act 1968 in the United Kingdom, came into force. We have heard that it has been extremely difficult for manufacturers of herbal products to achieve marketing authorisations for new products. As confirmed by the CSM, even a well-researched herb like St. John's Wort, with strong evidence for efficacy in depressive conditions, has not been licensed as a medicine in the United Kingdom. This means that the majority of herbal products, including almost all those originating from China, India and other non-European cultures, are not licensed as medicines and are supplied to the public without specific regulation. In the United Kingdom, the terms of the Medicines Act 1968 allow exemptions from licensing for a herbal remedy which is made up solely of the herb, and is supplied without recommendations as to its use. Thus St. John's Wort products are sold as remedies exempt from licensing, in spite of growing evidence of potential interactions with conventional medication. This exemption is not encountered elsewhere in the European Union, but this anomaly may well be corrected by forthcoming legislation.

5.92 It was generally apparent from evidence submitted, that as well as in the United Kingdom, there are significant inconsistencies in the application of medicines legislation to herbal products across the European Union. We heard further from the EMEA that these notably applied to defining the borderline between a medicine and a non-medicinal product such as a food or cosmetic: "…the choice and decision as to on which side of the borderline [a product lies] in principle is a decision for the Member State and the competent authority of that Member State. Understandably this leads to different decisions taken in different Member States. This is part of the confusion of herbal products today" (Q 125).

5.93 The difficulties faced by the public in identifying products that are adequately regulated were clearly demonstrated by the Proprietary Association of Great Britain (PAGB). They brought before us examples of similar proprietary health products available over the counter. Some were licensed as medicines by the MCA and thus met rigorous pharmaceutical standards of quality, safety and efficacy. Others, perhaps even produced by the same manufacturer, had no such licence and were not required to meet such standards. Only an inconspicuous licence number differentiated the two products. In the words of the PAGB, the consumer has "no way of knowing at all" (Q 1374) if a herbal or other natural product is licensed or unlicensed, sold as foods, or as exempt products. We recommend that the MCA find a mechanism that would allow members of the public to identify health products that had met the stringent requirements of licensing and to differentiate them from unregulated competitors. This should be accompanied by strong enforcement of the law in regard to products that might additionally confuse the customer with claims and labelling that resemble those permitted by marketing authorisations.

5.94 Particular concern was raised about the import of herbal products from parts of the world where standards of quality might be harder to assure. The public in the United Kingdom consumes increasing quantities of herbal products from China, India and other parts of Asia, and Africa. The case of Aristolochia highlighted the difficulties in assuring quality where European Union regulations and audit procedures did not apply. We have also heard that herbal products from the USA are generally produced as dietary supplements without the regulatory controls applied to medicinal products.

5.95 In response to the increasing unease across the European Union about the inadequate regulation of herbal products, a working group was set up by the Pharmaceutical Committee of the European Commission. This Committee is currently considering draft proposals from the United Kingdom MCA for a new Directive for the regulation of herbal medicinal products, that would allow licensing of herbal medicines with evidence of traditional use, in lieu of new clinical or other evidence of efficacy, provided normal medicinal quality and safety standards are applied. We understand that the formal draft of such a Directive will be published around the time of our Report. We strongly recommend that the Government should maintain their effective advocacy of such a new regulatory framework for herbal medicines in the United Kingdom and the rest of the European Union, and urge all parties to ensure that new regulations adequately reflect the complexities of the unregulated sector.

5.96 We were encouraged that there was consensus that any new legislative framework for herbal medicinal products would remain within the framework of 65/65/EEC and subsequent medicines legislation, rather than in some less regulated environment. In particular all witnesses agreed that there could be no compromise with medicinal standards of quality for the regulation of herbal products. As the CSM put it, regulation should be "…based on the belief that good manufacturing practices are at the heart of the matter and that this is accepted by the industry and adopted. That the constituents, particularly, are authenticated carefully and that proof of product quality with appropriate specifications of both the raw materials and the finished products is available. There should be adequate testing to restrict the level of potentially hazardous constituents, and warnings about safe and correct use" (Q 1281).

5.97 Amongst our witnesses there was some debate, but no consensus, about the possibility of the United Kingdom developing national mechanisms for regulating the supply of herbal products if moves across the European Union were unsuccessful. The Proprietary Association of Great Britain considered that residual powers remained for effective regulation, without recourse to primary legislation. We are concerned about the safety implications of an unregulated herbal sector and we urge that all legislative avenues be explored to ensure better control of this unregulated sector in the interests of the public health.

5.98 We have also heard that many complementary practitioners use herbal products as part of their professional activities. The European Herbal Practitioners Association, which is co-ordinating a move among the professions towards statutory regulation for the herbal practitioner, told us that the major incentive for this move was to protect their role in law as suppliers of herbal medicinal products (Q 728). They also told us that they were concerned that too rigorous an application of medicines licensing requirement to their dispensing supplies could restrict their practice to untenable levels. We support the view that any new regulatory regime should respect the diversity of products used by herbal practitioners and allow for simplified registration of practitioner stocks. Nevertheless, any such regime must ensure that levels of quality and assurance of safety are not compromised.