The time is right to examine access to medicines

07 April 2017

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      Great opportunity exists with next wave of regulatory reform

The Australian Self Medication Industry (ASMI) has commended the TGA for opening up discussions on ways to streamline, speed up and provide incentives for the process of down-scheduling medicines ('switch') so that consumers can have more options for effective self care and the treatment of minor ailments.

ASMI was responding to the TGA consultation document,The Scheduling Policy Framework and Advertising of Pharmacist-Only Medicines (Schedule 3 substances).The current SPF was released in July 2010 and has had minimal review and amendment since this date.

ASMI has welcomed the range of positive options that are outlined in the consultation document:


  • improved governance and transparency
  • oversight to fill a policy vacuum and ensure ongoing improvements
  • a mechanism to identify candidates for switch


  • improved efficiency, transparency and stakeholder engagement
  • improved business processes to allow for concurrent scheduling and associated marketing applications with the TGA
  • improved focus on benefit and greater examination of risk mitigation techniques


  • improvements to advertising controls to allow better access to information about  S3 medicines

ASMI also welcomes the TGA's recognition of decisions made by comparable overseas jurisdictions (e.g. UK, Ireland, Singapore, Denmark, Canada), and the need to incentivise innovation through down-scheduling, as down-scheduling offers a means for innovative approaches to healthcare.

ASMI supports scheduling processes that have less focus on risk and more recognition of the benefits to consumers through increased of access to medicine. ASMI is pleased to see that the consultation discusses increased options for mitigating risks, such as pharmacy training, improved labelling, an increased awareness of medicines available to the consumer over-the-counter, and an increased awareness of the role of the pharmacist.

The consultation document also recognises the synergies possible from streamlining of the processes to switch via the SPF, and the incentive the prospect of more widespread S3 advertising provides to industry. This would provide a win for consumers, who will be subsequently be better informed of their treatment options and have a greater understanding of the role of pharmacists in the provision of healthcare for minor ailments and conditions. 

Submissions to the consultation are open until April 28.                
ASMI would encourage anyone with interests in any of the topics above to review the consultation document and make a submission.