..Information to Pharmacists
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Your Monthly E-Magazine
DECEMBER, 2003

VAL JOHANSON

Complementary Healthcare Council Perspective

The Expert Committee's Report -
some initial thoughts

The recall of more than 1600 products manufactured by Pan Pharmaceuticals attracted widespread publicity, and attention was drawn to issues relating to the manufacturing and usage of complementary medicines.
The Government responded by establishing the Expert Committee on Complementary Medicines in the Health System, which was guided by the principles of the National Medicines Policy, including access to medicines, standards of quality, safety and efficacy, quality use and importantly, supporting a responsible and viable industry.

Indeed, in the weeks following the recall, the prospect of preserving industry viability looked severely threatened.
Consumer confidence and belief in natural healthcare , however, has meant that the 70% of Australians who use complementary medicine have returned and continue to purchase, and industry has substantially recovered.
Eight months after the recall, the problem for companies is securing supply and maintaining stock.
Many products are still unavailable.

The findings and recommendations of the committee are now out for public consultation and the Complementary Healthcare Council of Australia (CHC) is preparing its response, in consultation with its members.

The Committee recognised the importance of complementary medicine in the health system and acknowledged that they may offer lower risk and more cost-effective options for the prevention and treatment of some diseases.
The Committee also recognised the strengths of the Australian regulatory model, a model which has been praised by other regulatory bodies; they have recommended that the current two tiered, risk-based system be maintained, but with some enhancements.
CHC has supported an appropriate risk-based system, and has recommended that the system would be strengthened by the recruitment of officers with appropriate skills and training in complementary healthcare.
It is vital that industry is fully involved in the development of proposed enhancements.

The Committee has recommended that a summary of evidence should be submitted to support the efficacy of listed products.
It is currently a legal requirement that sponsors hold evidence to support the claims they make for a product; and provision of a simple bibliography will result in increased administrative costs, but should not be a major impost to sponsors.
It is not clear at this stage, however, as to what format or summary will be required, or what the Therapeutic Goods Administration (TGA) will do with the information.

A number of the Committee's findings reflect some of the recommendations made by CHC in their submission to the review - more appropriate regulation of homoeopathic preparations and herbal ingredients.
* availability of illegal, potentially unsafe complementary medicines has the potential to seriously undermine the whole of the complementary medicine sector, and stronger action is required to remove these products from the marketplace in a timely manner.
* inconsistency between State and Territory legislation provides loopholes that create an uneven playing field; nationally consistent regulations are required.

The Committee has recommended that the Government be more active in ensuring consumers have better access to reliable information about complementary medicines.
CHC believes that provision of balanced, accurate information would empower consumers to take greater responsibility for their health by making informed choices.
Complementary medicines face some unique challenges in being able to present information at the point of sale; CHC recommends that an on-line consumer information service be established in consultation with industry to provide consumers with balanced, factual information on natural health care.

Significant findings by the Committee on research into complementary medicines resulted in a number of worthwhile recommendations that could improve innovation and increase the viability of the industry. The Committee found that incentives are needed to encourage innovation and research in complementary medicines, and recommended that government dedicate funding for this research.
A per capita equivalent to the sort of funding now available in the USA for complementary medicine research is suggested.
CHC would like to see the establishment of a National Centre of Natural Healthcare which focuses on research, education and health economics.
CHC believes that one research priority should be a pharmacoeconomic analysis of the potential cost benefits associated with an increased usage of complementary medicine by Australians.

The Expert Committee's recommendations support the findings of the 1999 Wills Report on medical research in Australia, which reported that complementary medicine is in need of capacity building.
The committee noted the disparity between public funding of drug research and complementary medicine research.

The report of the Expert Committee should result in a number of positive changes to the regulation of complementary medicine/s in Australia.
Complementary medicine has become mainstream and can no longer be viewed as 'alternative' medicine.
This sector now has membership of the Australian Pharmaceutical Advisory Council, and it is likely that representation on the Council will increase.
Registration of natural therapists is now one step closer.
The mechanism for reporting adverse reactions will be enhanced.

With increased regulation will come increased costs.
It is essential that industry be involved in the consultation process and in the implementation of the committee's recommendations, and CHC looks forward to working with all stakeholders to ensure regulation is fair, robust, justified, cost effective and capable of maintaining a viable and innovative industry.

Val Johanson
Executive Director, Complementary Healthcare Council

Looking forward to sharing a peaceful festive season and a rational new year