Consumer advocates say patients could be placed at risk if Australia adopts proposals to rely more heavily on foreign regulators to determine the safety of drugs and medical devices.The proposals have been raised in a discussion paper issued as part of a federal government review of regulation for medicines and medical devices such as breast implants and artificial hip joints.
Consumers Health Forum chief executive Adam Stankevicius said he was concerned the government seemed "intent on meeting the demands of the drug and medical-device industries while giving scant regard to questions of consumer safety and the public interest." Medicines with new active substances must be assessed by the Therapeutic Goods Administration for safety, quality and efficacy before they can be legally supplied in Australia, even if the drug has already been approved by an overseas regulator such as the European Medicines Agency or the United States Food and Drug Administration.
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