The long wait for breakthrough medicines to make their way to our shores may soon get shorter
Drugs approved by US and European authorities will be fast-tracked into the Australian market under a new regulatory regime, but consumer advocates warn most patients won’t benefit unless subsidies keep pace.
Health Minister Sussan Ley said the reforms struck the right balance between consumer protection and reducing red tape for importers and manufacturers of new medicines, medical devices and complementary medicines.
New pathways would be in place for some medicines within12 months, while other reforms would be rolled out progressively over two years, she said, announcing the reforms on Thursday.
“Bringing medicines onto the Australian market quicker will be achieved, in part, by greater use of assessment of medicines by comparable overseas regulators like the US FDA and the European Medicines Agency,” Ms Ley said.
Sharing the workload with “comparable, trustworthy overseas regulators” would speed up access to medicines in Australia by about four and half months on average.
Provisional approvals would also be available, permitting certain life-saving medicines such as new cancer drugs to be available two years sooner.
But the Consumer Health Forum said the new drugs would remain beyond reach for most patients unless they were put on the PBS.
“The decision of which drugs will be subsidised will still remain and will still challenge government budgetary choices,” CEO Leanne Wells said.
“The Senate inquiry into cancer drugs has looked at ways to make drugs affordable and/or to fast track subsidisation. The government has still to table its response to that report.”
The changes are in line with recommendations by the independent Review of Medicines and Medical Devices Regulation, chaired by Emeritus Professor Lloyd Sansom, submitted more than a year ago.
Ms Ley said the revamp would bring Australia into line with other international regulators and make it a “world-first” destination for the registration of breakthrough medicines. According to the Sansom review, Australian patients have to wait up to 15 months longer to access some breakthrough medicines than patients in the US or Europe.
The TGA will also adopt an online system for making and tracking special-access scheme applications and increase the number of medicines subject to streamlined approval.
The TGA handles 60,000 notifications and approvals annually for patient-specific access to unapproved products.
The overhaul of the therapeutic goods market also promises tougher post-market monitoring, stricter penalties for advertising breaches and more information about complementary medicines.
There is concern, however, that easing rules on the pre-clearance of advertisements for complementary medicines could open the way for exaggerations and false claims.
“The worst offenders of misleading and deceptive claims are not members of industry associations, so self-regulation offered by industry associations will not pick these up,” Monash University Associate Professor Ken Harvey said.
“The horses will bolt!”
Professor Harvey also said it was not known whether the new regulatory regime would have the power and the resources to enforce advertising violations.
Among the reforms, the TGA will develop a catalogue of approved ingredients for “listed” complementary medicines and a list of “permitted indications” to describe their therapeutic use.