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Thursday, October 09, 2008

A challenge on the home front for Federal Health Minister's transparency crusade

Federal Minister for Health Nicola Roxon has been rightfully pushing the states hard on greater transparency in the health sector but things in her own balliwick, at the Therapeutic Goods Administration, need some attention.

In an editorial in Australian Prescriber, Dr Agnes Vitry of the University of South Australia's Quality Use of Medicines and Pharmacy Research Centre says
"the current Australian situation, in which the data used to make decisions (by the TGA) and the reasons behind these decisions remain secret, is no longer tenable.Full transparency is required at all steps in the marketing of medicines, from publication of the trial protocols to assessment of the data by the TGA. It includes public disclosure of the potential conflicts of interest of all external experts involved in the TGA advisory committees. It concerns not only positive decisions, but also negative decisions, for example when a marketing application for a drug has been refused."

Dr Vitry highlights the fact that information readily available in comparable countries such as assessment reports for new medicines, lists of refused or cancelled marketing authorisations, minutes of advisory meetings, and reports submitted by drug companies are not available publicly in Australia.She details how the pharmaceutical industry, which funds the agency has successfully resisted even the modest changes that have been considered so far.

Dr Vitry concludes:
"Transparency requires political will and leadership. This is an active process that needs to be adequately resourced. While drug companies spend millions of dollars on promotion of medicines each year, it seems paradoxical that limited funding and cost recovery could prevent the TGA from appropriately informing the Australian public. The TGA urgently needs to take steps to improve its transparency if it wants to retain its credibility not only with the Australian public and health professionals but also on the international scene."
Thanks to for the lead.

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