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Audit Office report highlights Howard Government's failure to ensure the safety of non-prescription medicines.

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M Me ed di ia a R Re el le ea as se e - -A An nn n C Co or rc co or ra an n M MP P

S Sh ha ad do ow w P Pa ar rl li ia am me en nt ta ar ry y S Se ec cr re et ta ar ry y f fo or r H He ea al lt th h ______________________Federal Member for Isaacs


Thursday December 16, 2004


Ann Corcoran, Shadow Parliamentary Secretary for Health today welcomed a report by the Australian National Audit Office (ANO) into the Therapeutic Goods Administration’s (TGA) regulation of non-prescription medicines.

The report found that the TGA needs to do much more to ensure the safety and effectiveness of these products.

Ms Corcoran said, “The ANAO report released today makes an unprecedented 26 recommendations to strengthen the regulation by the TGA of complementary and over-the-counter medicines. It is clear that the TGA has been inadequately resourced for this critical work and consequently has allowed too many important regulatory tasks to fall behind schedule or even off the list completely. It is also clear that the TGA has not learned from the Pan Pharmaceutical crisis.”

The report criticised the TGA for the lack of consistency, transparency and accountability in its monitoring arrangements.

“It is shocking to realise that although 20 per cent of TGA audits assess the manufacturers’ level of compliance with public health and safety regulations, the TGA has no systematic monitoring arrangements in place to ensure that actions it proposes to address non-compliance are undertaken. It is only this year that the TGA began a practice that requires documentation of risk assessments of defective products.

“Australians spend billions of dollars every year on non-prescription medicines. It is important that we know that the products we buy are safe and effective,” Ms Corcoran said.

The Department of Health and Ageing has agreed to all the recommendations the ANAO has made to improve the current situation. It is now up to the Minister to ensure that the recommended changes are made to provide this assurance.