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TGA’s surprise move to allow easier advertising of S3 medicines catches the industry and health professionals by surprise

A new Scheduling Handbook, announced by the TGA late on Thursday (18th) has flagged a liberalising of the rules for advertising Schedule 3 medicines.

The move appears to have caught industry and healthcare groups by surprise, with a number of stakeholders telling AJP they were still awaiting clarification of details with the new arrangements, and related changes.  

“The default position regarding advertising of Schedule 3 substances has shifted to allow substances to be advertised unless the Scheduling Delegate determines they should not be,” the TGA said in its website listing of the changes.

“Substances that can be advertised will still be included in Appendix H of the Poisons Standard”.

A new ‘Scheduling Working Group’ working group is planned to consider substances currently in Schedule 3 but not in Appendix H for suitability for advertising, and provide advice to the scheduling delegate to inform his/her final decision.

“This group will also provide input to the factors for determining suitability for advertising, which will be published in the new ‘Guidelines for advertising substances included in Schedule 3 of the Poisons Standard’,” the TGA said. “They will also provide input to the mandatory requirements for advertisements for these substances which will be incorporated in the Therapeutic Goods Advertising Code, which will undergo public consultation in early 2018”.

The group, to be convened for an initial meeting in February, will consist of representatives from the states and territories, the medicines and chemical scheduling advisory committees, industry groups and professionals from the medicine, pharmacy and chemicals sectors as well as consumer representatives.

The Australian Self-Medication Industry (ASMI) has welcomed the “shift in the default position, such that new S3 medicines will be allowed to be advertised unless the Scheduling Delegate determines that they should not be,” said its Regulatory and Legal Director, Steve Scarff.

“ASMI welcomes this approach, and looks forward to further work being conducted to more clearly define the criteria that will be applied for determining when advertising of a S3 medicine is not appropriate,” he said.

A spokesperson for the Pharmacy Guild of Australia said this was a positive policy principle shift but what medicines can be advertised were yet to be worked through.

“As stated in previous submissions on this topic, the Guild supports reforms to the Pharmacist Only Medicine advertising regulations, so as to enable these products to be advertised under a range of conditions.”

These conditions include allowing sufficient time for pharmacists to become familiar with the increased availability, demand and associated professional responsibilities when products are rescheduled from S4 to S3, and industry assistance to pharmacy through consultation and funding to develop relevant professional support materials for the supply of S3 medicines.

The Guild also wants all advertisements to inform consumers that S3 products are only available in consultation with a pharmacist.

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