Australia has recently announced the results of its two-year review of medicine and medical equipment regulation. The reforms should help those making TPD claims access life-saving medicine easier.
Due the complexity of the findings, here are three frequently asked questions to help you wrap your head around the reforms.
Why was it implemented?
Back in 2014, the government announced that it would be implementing an independent review of the regulatory environment that governs medicine and medical devices. The Expert Panel Review of Medicines and Medical Device Regulation looked into the ways that the Therapeutic Goods Administration governed medical elements in Australia.
At the time, former Minister for Health Peter Dutton said that a review was needed as technology was ever evolving.
"We need a modern regulatory framework to ensure Australians can access the latest treatments in a timely manner," he said.
What is being changed?
Current Health Minister Susan Ley said that most of the review's recommendations would be adopted. These included greater access to lifesaving medicines and medical devices through a quicker and more streamlined approval system.
The review also lead to more focused punishments for false and misleading advertising.
"Under the reforms sponsors will be encouraged to publish on their website the evidence that it holds to support all indications included on the product as well as information that will assist consumers to compare complementary medicines," Ley said.
What are the limitations?
Speaking to The Guardian, Professor Chris Del Mar said problems can arise from expediting approvals based simply on the views of overseas regulators. The argument stems from the different regulations that can be found in different countries. In other words, standards and thresholds are different depending on where you look.
The Guardian uses the example of neuraminidase inhibitors in antiviral drugs for reducing complications caused by influenza. The US for instance does not use them, while the EU does.
"We think this might be because of different access to confidential trials data," Del Mar said. "But this means that approvals might be based on the least stringent process, in a field we know is fraught with commercial pressures – often subtly worked through unwitting patient groups.
I'm still confused
The changes are understandably complex. The takeaway should be that certain drugs should find themselves in the hands of the public to a greater extent than before.
Whether it is antiviral drug or an immunosuppressant, the costs can be high. A TPD claim with the help of Gerard Malouf and Partners Compensation, Medical negligence and Will dispute lawyers can ensure that you have the money to obtain the medicine you need.