Changes to Australian regs will improve access to new medicines

Cancer and other patients in Australia could potentially have access to some new medicines two years earlier than at present under changes to the regulation of medicines and medical devices announced today by the Turnbull government.

Delivering the government’s response to the Review of Medicines and Medical Devices Regulation, chaired by Emeritus Professor Lloyd Sansom AO, Health Minister Sussan Ley said the government had accepted the majority of the recommendations of the Review that will bring significant benefits to consumers, the therapeutic goods industry and health professionals.

“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 Food and Drug Administration and the European Medicines Agency,” Minister Ley said, adding: “Provisional approvals will also be available which could result in certain life-saving medicines such as new cancer drugs coming to market two years sooner.”

This will bring Australia into line with other international regulators and will increasingly see Australia become a ‘world-first’ destination for the registration of breakthrough medicines.

As highlighted in the independent Review’s first report, Australian patients have to wait up to 15 months longer to access some breakthrough medicines than in USA or Europe.

“It is a common complaint that certain high-profile medicines are not brought to Australia and it is expected that implementing expedited pathways for registration of new medicines will result in many new medicines coming onto the Australian market.

“Greater use of assessment of medicines by comparable, trustworthy overseas regulators is estimated to bring medicines from companies that use this assessment pathway to market four and half months earlier than under the current regime.”

Welcomed by Medicines Australia

Medicines Australia welcomes the commitment of the Australian Government to improve the way medicines are assessed for use in Australia. These new reforms should reduce red-tape and help to lower the costs of bringing a medicine to Australia. Implementing these changes will reduce or remove the time lag that can occur between Australia receiving new medicines and vaccines compared to other regions like the USA, Europe and the UK, The trade group said.

These reforms will again see Australia punching above its weight in access to new medicines and will be complemented by the Coalition’s ongoing commitment to list medicines recommended by the PBAC without fear or favour. This has seen the Coalition add about A$4.5 billion ($3.4 billion) worth of new medicines to Pharmaceutical Benefit Scheme (PBS) since coming to government and there’s billions more in the pipeline as advances in technology and treatments continue to grow.