Two steps forward, one step back – ASMI issues government and industry a challenge to change

18 October 2017

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Speaking at the opening of the World Self Medication Industry (WSMI) General Assembly in Sydney today, Australian Self Medication Industry (ASMI) CEO Deon Schoombie has challenged both regulators and industry on the need to change.

The WSMI General Assembly has attracted more than 300 delegates from 26 nations, and will include a Regulators' Forum with representatives from 18 nations.

"This conference is about evidence," ASMI CEO Deon Schoombie said. "What's the evidence to support change? We need evidence that supports the value of self care - and the main target is policy-makers."

Schoombie noted the regulatory reforms that Australia has experienced in the last five to seven years have been "unprecedented in both breadth and depth", with virtually no aspect of the regulation of medicines and medical devices left untouched.

Schoombie said there were very encouraging developments in relation to prescription to over-the-counter switch, with is interest in ASMI's push for the development of an Australian switch agenda through a multi-stakeholder collaboration.

"There also appears to be an appetite to allow more Schedule 3 medicines to be advertised. The existing restrictions on the advertising of S3 medicines are counterproductive. Industry needs to be able to communicate directly with consumers to create awareness of S3 medicines."

However, Schoombie said that in a world moving forwards, Australia sometimes appeared to be going backwards.

"While the global industry is united around the common goal of increasing access to medicines, Australia has seen developments in the opposite direction - greater restriction on the level of access to some medicines."

Schoombie said that response to these developments and threats should be guided by the available evidence, regulatory decisions based on a "balanced assessment of risk as well as benefit", and the adoption of the decision tree model (published by Brass, Loffsted and Renn) in regulatory guidelines.

"While progress has been made to restore the appropriate risk/benefit balance, we still experience a tendency towards over-emphasis on risk and risk-aversion management," Schoombie said.

"These developments raise the question about whether industry could be more vigilant to detect the early signals of such developments, and be more responsive by offering solutions to manage public health and safety concerns in a more proactive fashion."


The World Self Medication Industry General Assembly continues Thursday October 19, and will include the Regulators' Forum and the ASMI Diamond Awards for marketing and sales excellence.