Major progress on access to medicines and consumer awareness of pharmacist-only meds

24 January 2018

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The Australian Self Medication Industry has announced its support for the TGA's commitment to change restrictions on the advertising of pharmacist-only (Schedule 3 or S3) medicines, and the establishment of a working group that will proactively identify prescription medicines suitable for downscheduling to pharmacist-only and over-the-counter (OTC) access ('switch').

ASMI has long advocated a relaxation of advertising restrictions for S3 medicines - "the medicines consumers are not allowed to know about" - and a 'switch agenda' that will help enable greater consumer access to medicines by identifying candidate substances for, and facilitating the process of, prescription-only to OTC 'switch'.  

The TGA's updated AHMAC Scheduling Policy Framework for Medicines and Chemicals states that the default position for advertising S3 (pharmacist-only) medicines will shift so that S3 medicines will be allowed to be advertised unless the Scheduling Delegate determines that there are clear and specific reasons they should not be.

There is no specific transition date set for this change yet, as important details still need to be determined, such as clearly defining the criteria that will be applied for deciding when advertising of a S3 medicine is not appropriate.

A newly-created working group will advise the TGA on these matters and several other topics related to medicine scheduling, including proactively identifying candidates for 'switch' and new controls for pharmacist-only medicines, particularly those that have been downscheduled.

"ASMI has already done preliminary work in this area and we anticipate being able to add value to discussions on these factors," said Regulatory and Legal Director Steve Scarff.

ASMI also anticipates that the downscheduling process will be streamlined to encourage more manufacturers to apply for S4 (prescription-only) medicines to be switched to OTC.

This working group will also include representatives from pharmacy, medicine and state and Federal governments.

"This is very welcome and reflects ASMI's long-standing position," Mr Scarff said.

"The ASMI Secretariat will be involved with this group at the initial meeting in February 2018."