Better, not more CM regulation: ASMI


complementary medicines spill out of bottle

ASMI has urged the Federal Government to fine-tune the regulatory system for complementary medicines, calling for better rather than less regulation of complementary medicines.

Dr Deon Schoombie, ASMI Executive Director, says ASMI’s submission to the complementary medicines section of the Federal Government’s Review of Medicines and Medical Devices Regulation advocates for a best practice risk-based regulatory system.

“ASMI is broadly supportive of the current Australian regulatory system for complementary medicines,” says Dr Schoombie.

“The current system does not need dismantling, but should be improved to streamline processes, increase transparency and ensure that regulatory requirements are commensurate with risk.”

ASMI’s submission urges the Federal Government to apply the COAG principle of “minimum effective regulation” to the regulation of complementary medicines, while maintaining appropriate safety standards for consumers.

In its submission, ASMI says that regulatory processes such as those applying to the approval of new ingredients or registering complementary medicines should be reformed to make them more transparent, predictable, certain and capable of review.

“In cases where a new ingredient has been assessed by a comparable overseas evaluator, the Therapeutic Goods Administration (TGA) should recognise the outcomes of the overseas assessment and not duplicate regulatory processes by re-evaluating the ingredient,” says Dr Schoombie.

“Where an ingredient has not been approved in a comparable market, the regulatory processes should be streamlined.”

ASMI’s submission calls for substantial reforms to the advertising of therapeutic goods, to clarify, simplify and streamline regulatory processes.

“The pre-approval of consumer advertising should be expanded to include all media (from all sponsors) directed to consumers,” Dr Schoombie says.

“Expansion of the pre-approvals system would be conditional upon the implementation of a self-regulatory pre-approvals system along the lines of the New Zealand Therapeutic Advertising Pre-vetting System (TAPS).”

ASMI advocates for the jurisdiction of the Complaints Resolution Panel (CRP) to be expanded to include all media and all advertisers.

“The CRP should be able to impose sanctions which are meaningful and effective and there should be a formal appeal mechanism in relation to CRP determinations,” Dr Schoombie says.

“TGA imposed sanctions need to be meaningful, but the TGA already has a range of enforcement powers available and it is simplistic to assume that the problems with the current system can be fixed by merely increasing the size of the penalties.”

In its submission ASMI notes that the regulation of therapeutic goods is unavoidably complex.

Dr Schoombie says: “While it is the responsibility of all sponsors to understand and comply with regulatory requirements, the TGA has an obligation to make them proportionate to risk and as clear as possible.”

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