ASMI says that the Expert Panel report on the regulatory framework for medicines and medical devices falls short in its recommendation to retain restrictions on the advertising of S3 medicines.
ASMI’s Executive Director, Deon Schoombie, welcomed the Panel’s recommendations on the scheduling framework for non-prescription medicines, saying that suggested changes are long overdue.
“However, while the Panel recognised the value of a formal risk-benefit methodology and enhanced opportunities for input – both of which were suggested by ASMI – it missed an opportunity to remove a long standing regulatory obstacle which is preventing the advertising of Schedule 3 medicines,” Dr Schoombie says.
“The Panel acknowledged there was no evidence that advertising of Schedule 3 medicines would lead to harm and noted the efforts of the non-prescription medicines industry in developing a world-first information-based model for Schedule 3 advertising.
“Despite this, the Panel recommended retention of existing advertising restrictions.”
This means that Australia’s approach to the advertising of Schedule 3 medicines will remain out of step with many comparable overseas jurisdictions, he says.
“ASMI welcomes the strong emphasis on a risk-based approach to all aspects of regulation and the recommendation around comprehensively reviewing the legislative framework.
“Also the suggestion of an alternative funding model for the Therapeutic Goods Administration’s activities undertaken in the public good,” he says.