1.The time is right to examine access to medicines Great opportunity exists with next wave of regulatory reform
7 April 2017 –

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:

POLICY

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

PROCESS
* 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 S3

ADVERTISING
* 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 downscheduling, 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.

At last – opportunity to overhaul scheduling and S3 advertising for today’s consumer
5 April 2017 –
The Australian Self Medication Industry (ASMI) has welcomed the TGA’s invitation for feedback on a move towards more widespread advertising of S3 (pharmacist only) medicines.
In the consultation document that calls for responses on six different questions on the subject, the regulator noted that “it was widely acknowledged that a ban on advertising of pharmacist-only medicines to the public was unique to Australia”.

ASMI’s Marketing and Business Development Director Filomena Maiese said she was “very encouraged to see S3 advertising playing such a prominent and overt role in this consultation”, as the six questions open for discussion represent different facets of ASMI’s own proposed model for S3 advertising.

“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.
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,” Ms Maiese said.

“We also propose that S3 consumer advertising should follow a structured format that includes disease awareness and emphasises the role of the pharmacist.”

The proposed advertising model was tested through a discrete choice experiment conducted by the Centre for Health Economics Research and Evaluation (CHERE) at the University of Technology Sydney.
The experiment involved 1300 consumers, 500 pharmacists and 500 pharmacy assistants in a randomised study to assess the impact of a ‘mock S3 product TV advertisement’.
The results made it clear that this advertising format positively influenced consumers’ health-seeking behaviour.
Professor Rosalie Viney, Professor of Health Economics and Director of CHERE said there appeared to be no public health benefit from the current restriction on S3 advertising and that the evidence suggested ASMI’s alternative model could have a positive impact on the Quality Use of Medicines.

“Unfortunately, there is limited consumer awareness of S3 medicines, so many people don’t think to go to a pharmacist for minor ailments that could be treated fairly easily with an OTC, without the need for a GP visit.
“Our research showed that the proposed advertising model significantly increased the likelihood of consumers engaging in more conversations with pharmacists about their health conditions and treatment options,” Professor Viney said.

“Importantly, the pharmacists and pharmacy assistants involved in the study were not influenced by the advertising and regularly chose the most appropriate treatment for the consumer.”

The TGA consultation also addresses the Scheduling Policy Framework, which determines how different medicines are accessed.

The document discusses the possibility of incentives for switching medicines from prescription only (S4) to OTC (S3).
Some of these incentives include mechanisms that ASMI has previously submitted to Government, such as:
* a proactive S4 to S3 switch committee, which would carry out a “proactive review” of potential candidates for scheduling change (similar to arrangements in the UK, Denmark, Singapore, Ireland); and
* a period of market exclusivity for the applicant that initiated the rescheduling decision.

ASMI believes that measures such as these, coupled with an alternative set of controls to the current restrictions on S3 medicine advertising, have the potential to reignite both the S3 category and ‘switch’ – the process of downscheduling prescription medicines to S3.
More switches for Australia will drive greater public health savings.

According to research by The Macquarie University Centre for the Health Economy (MUCHE)i in 2014, switching 11 prescription-only medicines to OTC showed the potential to produce a direct cost savings of $1.1 billion to the Australian healthcare system – almost $730 million for Medicare and $300 million for consumers.

The indirect value of productivity gains (e.g. reduced sick leave, travel time) was estimated at almost $1 billion per annum.
ASMI’s proposed S3 advertising model encourages industry to reinvest back into the S3 category (often considered a ‘dead zone’ because of the lack of options to increase consumer awareness of products) and provides motivation to ‘switch’ prescription medicines to OTC.

S3 advertising is also an important driver to maximizing the potential health benefits from a class of nonprescription medicines that are available from pharmacies, but largely invisible to the wider public.
S3 medicines are used to treat everyday conditions including, cold sores, conjunctivitis, mouth ulcers, travel sickness, and nausea and vomiting associated with migraine.

See the UTS CHERE report, ‘Estimating the impact of schedule 3 consumer advertising’.
Also: ‘Informing consumers about S3 medicines’ (infographic) and ‘Topline results – S3 advertising research’
See the ASMI mock advertisement designed for S3 advertising. More about CHERE.

References:
1 The Value of OTC Medicines in Australia, The Macquarie University Centre for the Health Economy, March 2014