The first report of the expert review of the regulation of medicines and medical devices has made 32 recommendations for reform.
The report was developed by a panel led by former PBAC Chair Emeritus Professor Lloyd Sansom, with former Commonwealth Chief Medical Officer John Horvath and former MSD Managing Director and Medicines Australia Chairman Will Delaat.
Amongst the recommendations are the adoption of an expedited approval process for breakthrough medicines, allowing sponsors of medicines and medical devices to use submissions to recognised overseas regulators and related evaluation reports and conformity assessments, a review of rescheduling policy and advertising guidelines for S3 medicines, and responsibility for all decisions on inclusions on the ARTG should be moved to the Chief Medical Officer.
It also recommends the Government give consideration to reform of "organisational structures" to facilitate "improved integration of...pre-market regulation of medicines and medical devices with health technology assessment of these products for subsidy and other purposes," and even suggests changes to the TGA's funding model.
On expedited review and approval processes, it says the TGA should adopt similar criteria used by comparable regulators in other countries.
It recommends that where medicines are approved under the expedited process following evaluation of a more limited data set than would normally be required, approval should be provisional and time-limited, with a requirement for the sponsor to collect and submit further data to demonstrate safety, quality and efficacy in order for the product to be granted full registration. Clinicians and consumers should also be informed that the approval is provisional.
In relation to allowing sponsors to use submissions to recognised overseas regulators, the report says it should include an "un-redacted evaluation report...along with a copy of the dossier submitted to that NRA [National Regulatory Authority] and an Australian specific Module 1".
It makes a similar recommendation in relation to medical devices.
It says the use of submissions to recognised overseas regulators should apply to new chemical entities and medical devices, as well as generics and biosimilars.
It recommends the adoption of "transparent criteria for identifying comparable overseas" regulators.
The panel appears to have listened to criticism of existing policy for the rescheduling of medicines and current limits on advertising of S3 medicines.
It recommends that the scheduling policy framework be reviewed to provide for "the development and adoption of a formal risk-benefit methodology to assess scheduling applications", and that the Schedule 3 advertising guidelines should also be reviewed.
The panel recommends changes to the decision-making process for the inclusion of medicines and medical devices in the ARTG.
"The Australian Government’s Chief Medical Officer to be the delegate for decisions," it recommends, suggesting the creation of a statutory committee to make recommendations to the Chief Medical Officer about registration of a medicine and medical device.
In what could be one of the contentious recommendations, the panel says the Government should consider organisational changes that will "facilitate improved integration" of pre-market regulation and post-market monitoring of medicines and medical devices with health technology assessment of these products for subsidy and ongoing cost-effectiveness.
"The Panel has particular concerns about the sustainability of the NRA under a full cost recovery model once its recommendations are fully implemented," says the report.
It recommends the Government review the existing model, "with a view to providing either a dedicated annual appropriation or other appropriate budgetary arrangements on an ‘as-needs’ or routine capacity basis, to enable it to more effectively fulfil its mandate to act in the public interest and to ensure that genuine and systemic improvements to its capacity, expertise and operation are achieved."
The Government says it is considering the report and "is working toward releasing a response towards the end of the year."