The ACCM (Advisory Committee on Complementary Medicines) under the TGA should be involved in decisions by the Secretary in relation to herbal materials that have been used in traditional Chinese medicine (TCM) or any other traditional paradigm. The Secretary should always receive specialist advice both in relation to the botanical species as well as the traditional medicine paradigm (i.e. TCM in this case) in which the herbal materials have been effectively used.
On behalf of the Chinese Medicine Industry Council (CMIC) I would like to thank you for the opportunity to provide comment on the review of the arrangements for the scheduling of medicines and poisons in accordance with Section 52EC of the†Therapeutic Goods Act 1989†(the Act).
The Chinese Medicine Industry Council (CMIC)
The CMIC was established in 2009 to promote the development and safeguard the interests of Chinese medicine in Australia. The council is currently the peak Chinese medicine industry body in Australia, whose members are responsible for the import and distribution of over 80% of Chinese herbal medicines in this country. Its primary objectives are:
1 - To unite and support Members for a better, healthier and sustainable development of traditional Chinese medicine in Australia.
2 - To undertake independent research, and foster innovative thinking on issues that may affect Chinese medicine industry in Australia.
3 - To lobby, communicate and liaise with government bodies on issues that concern the Chinese medicine industry.
4 - To enhance the exchange of information and networks for sponsors, dealers, suppliers, researchers, educators, manufacturers, farmers and other related interested groups in the industry.
5 - To encourage research contributions by government agencies, organizations, academics, business people and individuals for Chinese medicine.
An important role of the CMIC is to provide support for the present regulatory framework in the interest of public health and safety. This is achieved by assisting industry members to comply with the regulations, while at the same time acting in an expert advisory capacity, liaising with all stakeholders including government and research agencies.
Comments on the Review
The current scheduling arrangements apply to a broad range of materials, including various chemicals and medicines as well as many plants and materials derived from plants. In many cases scheduled plants and related materials have a long history of traditional use within the paradigm of traditional Chinese medicine (TCM). We believe that in some cases the conditions of scheduling have been unnecessarily restrictive. In order to prevent such occurrences in the future and to redress those that may have occurred in the past, we propose that the Secretary should always receive specialist advice both in relation to the botanical species as well as the traditional medicine paradigm (i.e. TCM) in which the materials have been effectively used. Therefore the ACCM (Advisory Committee on Complementary Medicines) under the TGA should be the most appropriate organization to be involved in this process along with ACMA and ACCS.
There is a growing resource of well conducted studies on many of the currently scheduled TCM herbs, which suggest that the restrictions placed upon them may be unjustified. These herbs are safely and effectively used by qualified healthcare practitioners in China, Japan and Korea; and they are taught in Australian universities as part of tertiary level TCM courses. However, Australian TCM graduates are unable to access these materials. Thus, effective clinical outcomes may be compromised due to the current mode of scheduling of these materials.
Addition, from 1 July 2012, Chinese medicine practitioners are regulated under AHPRA as part of 14 healthcare professions in Australia. Therefore, the scheduling arrangements and the Act should be amended accordingly, to reflect the status of Australian TCM practitioners and entitle them to access some of the scheduled herbs.
Other comments on your consultation questionnaires:
Objectives of the amendments
1 - In terms of the operation of Part 6-3 do you have any suggestions how the scheduling arrangements can be improved?
ACCM should be included as one of the scheduling assessors for plant and plant related materials.
System of access controls for goods containing scheduled substances
Section 52E Secretary to take certain matters into account in exercising powers
1 - Is the process whereby the Secretary has regard to the Scheduling Policy Framework, the recommendations or advice by the ACMS and/or ACCS or another relevant committee or expert clear and transparent?¬† If not, how could the arrangements be improved?
Not very clear and transparent in regard to plant species. Advice should be taken from ACCM and or complementary medicine industries in regard to herbal materials.