The TGA is calling for comments from interested parties on its review of reforms to advertising of pharmacist-only medicines
A recent review of the Scheduling Policy Framework resulted in proposed reform options, for which the TGA is asking stakeholders to provide comment on and suggest alternatives.
These include policy recommendations, improvements to TGA processes, development of guidance materials, and reformation of S3 medicines advertising.
Each area is detailed in a consultation document that was released on Friday 31 March, and will be open to comment until close of business on Friday 28 April.
Direct-to-consumer advertising of pharmacist-only medicines is currently not permitted in Australia unless all S3 ingredients are substances listed in Appendix H of the Poisons Standard.
As of December 2016, there were 16 substances in Appendix H, which means a significant number of S3 substances are not permitted to be advertised.
The TGA says any decision to reform S3 advertising guidelines will consider:
- The potential public health benefit, for example, more appropriate use of scarce health resources or a better-informed community;
- The likelihood of advertising of the substance leading to inappropriate patterns of medication use;
- Whether the application may result in the advertising of goods for an indication other than those approved by TGA during the registration process;
- The desire of consumers to manage their own medication and the level of patient education necessary to ensure correct use.
Groups such as the Australian Self-Medication Industry (ASMI), the Pharmacy Guild of Australia and the PSA have been pushing for the TGA to relax S3 advertising restrictions, arguing that the restrictions have no public health benefit.
ASMI also commissioned a report, released early this year, which showed positive results for the impact of its proposed S3 consumer advertising model on the Quality Use of Medicines.
ASMI has welcomed the TGA’s invitation for feedback on a move towards more widespread advertising of S3 medicines.
The organisation’s Marketing and Business Development Director Filomena Maiese says she is “very encouraged to see S3 advertising playing such a prominent and overt role in this consultation”.
“ASMI’s default position is that all S3 medications should be allowed to be advertised unless there are good public health reasons why they shouldn’t be,” says Ms Maiese.
“Consequently, our proposed advertising model includes a clearly defined ‘non-advertisable’ list for products that fits certain exemption criteria such as products with a history of misuse, abuse or diversion for illegal use.
“We also propose that S3 consumer advertising should follow a structured format that includes disease awareness and emphasises the role of the pharmacist.”