The review was conducted by a specially convened Expert Committee on Complementary Medicines in the Health System and was chaired by Dr Michael Bollen AM, a former member of the National Health and Medical Research Council and Australian Pharmaceutical Advisory Council.
The committee of 18 experts comprising representatives of the complementary medicines industry along with academics and clinicians, focused on issues around the supply of safe, high quality complementary medicines, quality use of and timely access to these medicines, and the maintenance of a responsible and viable complementary medicines industry.
The review also looked closely at the role of the national regulator of complementary medicines, the Therapeutic Goods Administration (TGA).
One of the major recommendations of the committee compels the TGA to ensure that quality standards for all ingredients for use in complementary medicines are legally enforceable and that the evidence required to be held by companies (sponsors) to substantiate claims be subject to much more rigorous assessment.
The review recommends that homoeopathic medicines and related remedies making therapeutic claims also be regulated to ensure they meet appropriate standards of safety, quality and efficacy.
The Committee recommends that the Government take a more active role in ensuring that consumers have access to reliable information about complementary medicines, and the skills to interpret this information to be able to make informed decisions.
The review makes a number of recommendations to counter adverse reactions to complementary medicines, including creating a greater awareness among all health professionals and consumers of the potential for complementary medicines to interact with other medicines, and ensuring consumers are better informed about the potential risk of importing medicines for personal use.
The review calls on States and Territory Governments to introduce legislation to regulate practitioners of traditional Chinese medicine and dispensers of Chinese herbs, based on existing Victorian legislation as soon as possible.
It also recommends that internet advertising be considered part of mainstream advertising and be subject to mainstream advertising requirements and protocols, including complaint resolution through a centralised complaints and appeals process.
The review makes a number of recommendations about improving the level of research and funding available for complementary medicines, and calls on the National Health and Medical Research Council to convene an Expert Working Group to identify the research needs, including issues around safety, efficacy and capacity building. Ms Worth said she was impressed with the depth and thoroughness of the Review and thanked the committee for its efforts.
“In 2000 it was estimated that 52 per cent of Australians used at least one non-medically prescribed complementary medicine and 23 per cent consulted at least one complementary medicine practitioner,” Ms Worth said.
“This industry is estimated to be worth $800 million, so it is vital that Australians feel confident in the industry and its products.
The review points out that, unlike medical practitioners who need to be registered, most practitioners of complementary medicines do not have to meet such standards.
I will be urging my counterparts in the States and Territories to introduce nationally consistent regulations to licence practitioners of complementary medicines. It will go a long way towards maintaining consumer confidence.
I am also expecting that the implementation of many of the recommendations in the review will ensure that complementary medicines are assessed more rigorously by the TGA and that companies are compelled to adhere to best practice standards.”
Ms Worth said the Australian Government would move to strengthen the powers of the TGA to ensure that action would be taken immediately against any manufacturer who is not fully complying with the highest standards of Good Manufacturing Practice. This should avoid another incident like the recall of products from Pan Pharmaceuticals.
“I intend to consult widely on the Committee’s findings and recommendations to help inform the Government’s response to the report,” Ms Worth said.
“I will be sending copies of the report to more than 80 stakeholder groups, including members of the complementary medicine industry, practitioner and consumer groups, seeking their comments on the Committee’s report by the end of January 2004. In addition, a copy of the report will be available on the TGA’s web site inviting comment from interested groups or individuals.
I will then be in a position to bring forward an informed response to the Committee’s report for consideration by the Government.”
copy of the Committee’s Report – Complementary medicines in the Australian health system – is available on the TGA’s web site at – http://www.tga.gov.au/docs/html/cmreport.htm
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