Australian patients are being forced to wait up to 15 months longer than the US or Europe to access the latest breakthrough medicines because drug companies are delaying bringing them to Australia, the Health Minister has said in a statement.
Commenting on a review published today of the TGA’s medicines and medical devices regulatory framework Ley said it showed Australia’s safety regulator had “one of the most efficient and consistent approval processes in the developed world.”
However, she said it also confirmed Australia was being “unfairly categorised as slow” when compared to the rest of the world because some drug companies were making Australians wait up to six months for medicines while they first tested them in bigger markets like the US and Europe.
“This is a trend I want to turn around because it’s important Australians get fast access to new breakthrough medicines and I’m committed to working closely with medicines manufacturers to make our world-best approval system even better,” she said.
The TGA Review was conducted by a panel of three independent experts Emeritus Professor Lloyd Sansom AO, Mr Will Delaat AM and Professor John Horvath AO.
It makes 32 recommendations, including:
- expanding the pathways by which sponsors can seek marketing approval for a medicine or medical device, including making provision for utilisation of assessments conducted by comparable overseas regulators, and for expedited assessments in defined circumstances;
- identifying comparable overseas regulators using transparent criteria;
- enhancing post-market monitoring of medicines and medical devices and streamlining post-market requirements in respect of products in the Australian Register of Therapeutic Goods; and
- improving transparency and predictability of processes and decisions, to ensure Australians have timely access to high quality, safe and efficacious products.