Herb Clip Alternative Medicine Information Form 011985-134

H ERBC LIP FILE: • AustraliaHerb Regulations DATE: Post Office Box 144345 Austin, Texas 78714-4345 Phone 512/926-4900 Fax 512/926-2345 Email: abc@herbalgram.org www.herbalgram.org Mark Blumenthal Editor Wayne Silverman, PhD Underwriting Coordinator Betsy Levy Densie Webb, PhD Leela Devi, MSN, RN Summary Writers Karen Newton Database Manager Susan McFarland Ginger Webb Co-coordinators Dawnelle Malone Research Assistant The American Botanical Council provides this summary and the enclosed article as an educational service. By providing this article, ABC does not warrant that the data is accurate and correct, nor does distribution of the enclosed article constitute any endorsement of the information contained or of the views of the authors. ABC does not authorize the copying or use of the original articles. Reproduction of the summaries is allowed on a limited basis for students, colleagues, employees and/or customers. Other uses and distribution May 6, 1998 HC 011985 RE: Australian Herbal Regulatory Update Khoury, Raymond. Government Watch: Progress Report on the Review of Traditional Chinese Medicine in Australia. Journal of the Australian Traditional-Medicine Society, June 1997, Volume 3, Issue 2, pp. 61-62. Khoury, Raymond. Government Watch: Government Response to the Review of the Therapeutic Goods Administration. Journal of the Australian Traditional-Medicine Society, June 1997, Volume 3, Issue 2, pp. 63-64. As the U.S. government grapples with some of the fine points of herb supplement regulation, other governments around the world are doing the same. It is instructive to read about the resources Australian government agencies have allocated to setting policy and developing regulations for herbs and other nontraditional medicines. Industry, academics, consumers and others are involved in the process of developing workable regulatory guidelines. One in ten Australians uses herbal medicines, according to this article. Traditional Chinese Medicine (TCM) seems to have an exceptionally strong Australian presence, judging by the extent to which the Australian government differentiates between it and other "complementary" medicines. Three Australian government agencies jointly commissioned and published a review of TCM entitled Towards a Safer Choice to examine these issues: 1) Does TCM work? 2) Adverse reactions associated with TCM; 3) TCM education in Australia and China; 4) Professional TCM associations; 5) Regulation of TCM in Australia and overseas; 6) Australian regulatory framework; 7) Is there a need to regulate TCM? The traditional medicine journal (ATMS) in which this article appears endorses several of the government review's recommendations, including those that establish standards for TCM education and practitioner qualifications, research into herb and drug interactions, and policies for responding to consumer complaints. ATMS advocates for governmentmonitored self-regulation (GMSR) of TCM, contending that government policy at all levels encourages it by seeking to reduce "unnecessary regulation of occupations," unless, in the case of health occupations, there is a "significant threat to public safety" in not doing so. The Australian Department of Human Services has established three more committees to explore TCM regulatory options -- the Ministerial Advisory Committee and two subcommittees, the Primary TCM Practitioners Subcommittee and the Generalist Health Care Practitioners Subcommittee, on the last of which ATMS will be represented. This last committee will advise on standards of TCM practice for generalist practitioners, regulatory approaches to TCM, and outside consultation. This article also discussed a 1997 government-commissioned review of "therapeutic" goods, including 15,000 "complementary medicines." The review made recommendations bearing directly on herbal medicine, to which the government responded. On the proposal that herb supplements be capped at a maximum ten-fold concentration, the government responded that while such a cap may be safe for the majority of herbs, it is "not necessarily appropriate for all herbs." [Since the appearance of this article, the proposed ten-fold cap has been abandoned.] The government expressed concern about the lack of a "general standard to ensure that herbal products marketed to the Australian public are of a consistent quality." Australia's newly formed Complementary Medicines Evaluation Committee (CMEC) (replacing the Traditional Medicines Evaluation Committee) will liaise and share sitting members with several government committees overseeing drug, medicine, poison, and food policy, and advise on complementary medicine import, export, manufacture, sale, regulation and registration. Meanwhile, the ongoing Therapeutic Goods Committee will develop herb quality standards which set "modest safety standards for all herbs used therapeutically, drawing on comparable standards (including pharmacopoeia) and monographs from other countries or the country of origin of herbal materials." The first objective of this effort, as stated by the government, is to help the public "feel confident that they are buying high quality products." The government's Adverse Drug Reactions Advisory Committee (ADRAC) will extend its jurisdiction to actively monitor adverse complementary medicine reactions as well. Perhaps the most interesting Australian government resolution, based on a comparison with the U.S., is its decision to encourage "the relevant [complementary medicine] industry groups to develop a proposal" for the establishment of a "Key Centre for Teaching and Research at a suitable institution, to undertake teaching and research on complementary medicines." Betsy Levy Bin #134