Australia backs tougher regulation for complementary health products
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《英国医生杂志》
The Australian government has backed increased regulation of the complementary health sector after the recommendations of a review, which was initiated after a crisis in the industry. Pan Pharmaceuticals had its licence suspended for six months, and more than 1600 of its products were recalled (BMJ 2003;326:1001).
Parliamentary secretary for health Christopher Pyne said that Australia was "very fortunate to have such a high quality complementary medicines industry" while endorsing stricter regulations outlined in a report by the Expert Committee on Complementary Medicines in the Health System, published last year.
The government has agreed to review the quality of the ingredients used in complementary health products by the $A800m (?29m; $633m; �472m) a year industry and develop enforceable standards governing the evidence of the claimed benefits.
Manufacturers will have to submit evidence of claimed health benefits to the Therapeutic Goods Administration, the government regulator. The government will also modify information systems to enable easier reporting and tracking of adverse reactions to complementary health products.
The government said that whether it instituted a voluntary code of conduct or regulation of homoeopathic medicines, the new system "would result in many products having to be reformulated or relabelled, and some may need to be removed from the market." The proposal that complementary health practitioners be certified has been referred to state governments.
While welcoming the government抯 response to the review, the Australian Self-Medication Industry, the leading body representing the complementary products industry, expressed its disappointment that the government had not made an explicit commitment to fund research.
Although the government has backed nearly all of the report抯 49 recommendations, it has added the qualification that implementation is subject to reaching agreement on common standards with the government of New Zealand. A joint medicines regulatory agency is scheduled to come into effect by 1 July 2006. Many of the accepted recommendations are also qualified with a commitment to "consultation with affected stakeholders in Australia and New Zealand."
The Australian Consumers Association抯 health policy officer, Nicola Ballenden, supports greater regulation but fears that the government may yet baulk at implementing the recommendations: "It is all heavily qualified. They delayed their response for six months and then, when launching the report, Pyne says how wonderful the industry is and that all the recommendations are tied to the harmonisation process with New Zealand. If they want to lose the recommendations they have ample opportunity to do so."
The association has argued that although mainstream drug makers have to prove quality, safety, and efficacy of their products, manufacturers of complementary medicines do not have to show that their products deliver the claimed benefits.
The report of the Expert Committee on Complementary Medicines in the Health System is available at www.tga.gov.au/docs/pdf/cmreport.pdf and the government抯 response is at www.tga.gov.au/cm/cmresponse.pdf(Canberra Bob Burton)
Parliamentary secretary for health Christopher Pyne said that Australia was "very fortunate to have such a high quality complementary medicines industry" while endorsing stricter regulations outlined in a report by the Expert Committee on Complementary Medicines in the Health System, published last year.
The government has agreed to review the quality of the ingredients used in complementary health products by the $A800m (?29m; $633m; �472m) a year industry and develop enforceable standards governing the evidence of the claimed benefits.
Manufacturers will have to submit evidence of claimed health benefits to the Therapeutic Goods Administration, the government regulator. The government will also modify information systems to enable easier reporting and tracking of adverse reactions to complementary health products.
The government said that whether it instituted a voluntary code of conduct or regulation of homoeopathic medicines, the new system "would result in many products having to be reformulated or relabelled, and some may need to be removed from the market." The proposal that complementary health practitioners be certified has been referred to state governments.
While welcoming the government抯 response to the review, the Australian Self-Medication Industry, the leading body representing the complementary products industry, expressed its disappointment that the government had not made an explicit commitment to fund research.
Although the government has backed nearly all of the report抯 49 recommendations, it has added the qualification that implementation is subject to reaching agreement on common standards with the government of New Zealand. A joint medicines regulatory agency is scheduled to come into effect by 1 July 2006. Many of the accepted recommendations are also qualified with a commitment to "consultation with affected stakeholders in Australia and New Zealand."
The Australian Consumers Association抯 health policy officer, Nicola Ballenden, supports greater regulation but fears that the government may yet baulk at implementing the recommendations: "It is all heavily qualified. They delayed their response for six months and then, when launching the report, Pyne says how wonderful the industry is and that all the recommendations are tied to the harmonisation process with New Zealand. If they want to lose the recommendations they have ample opportunity to do so."
The association has argued that although mainstream drug makers have to prove quality, safety, and efficacy of their products, manufacturers of complementary medicines do not have to show that their products deliver the claimed benefits.
The report of the Expert Committee on Complementary Medicines in the Health System is available at www.tga.gov.au/docs/pdf/cmreport.pdf and the government抯 response is at www.tga.gov.au/cm/cmresponse.pdf(Canberra Bob Burton)