Consumer input into medicine and device approval processes urgently needed

Painaustralia

Painaustralia has today called for meaningful and greater input for consumers as part of the approval processes for new devices and medicines in Australia.

Appearing at the House of Representatives Standing Committee on Health, Aged Care and Sport – Approval processes for new drugs and novel medical technologies in Australia, Painaustralia CEO Carol Bennett said there must be a better way to consult consumers throughout the regulatory process as the current processes are leaving consumers disappointed and bereft of hope.

“Consumer input needs to be considered, valued and adopted when making decisions that have a real impact on the quality of life of those living with pain and other health conditions,” she said.

Ms Bennett said the recent changes to opioid regulation and the decision of the PBAC to restrict access to opioids for chronic pain at short notice and without alternative treatments and appropriate information for clinicians and consumers in place had been extremely difficult for many people.

“It goes to the heart of the context in which these decisions are taken. While it may be important to restrict opioids in order to manage increasing levels of harm, this decision has had an enormous impact on people who have relied on opioids for managing chronic pain (often for many years) in the absence of other accessible and affordable treatments. It’s no wonder this has led to significant distress and in many instances, suicidal intentions.

“The limited timeframe, quick turnaround and lack of transparency around decisions when consumers are consulted highlights the weaknesses in the current system.”

Ms Bennett said listening to consumers and gaining insight into how best to develop policy and practice goes well beyond consumer representation on decision-making bodies or ad hoc consultation.

“The tick-the-box approach to consumer consultation, compounded by limited timeframes, minimal ongoing engagement and limited response options are just some of the current weaknesses of what is called consumer consultation,” she said.

“Unless we provide consumers with access to affordable, best practice alternatives, medicines will continue to play an important role in chronic pain management. That means we need systematic and genuine consultation with consumers who will be most impacted by these decisions.”

Painaustralia has also called on the Australian Government to reinstate the review of the National Medicines Policy which has been put on hold due to the pandemic, with a brief to include diverse consumers and key stakeholders in the consultation process.

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