The 2016 Budget confirms the significant ongoing PBS savings provided by generic medicines, and signals the government’s intent to streamline medicine regulation processes, says GBMA.
The absence of further PBS reform honours the commitment in the 2015 Strategic Agreement between GBMA and the Australian Government, the organisation says.
“Since 2007, the pharmaceutical industry has gone through a period of unprecedented change. In this time, the generic medicines industry has consistently delivered significant PBS savings – first through competition and then through price disclosure,” says GBMA Chair Allan Tillack.
“We are pleased to have confirmation in the 2016 Budget that the Strategic Agreement between GBMA and the Australian Government has been honoured and no further savings measures have been introduced into the F2 formulary,” he says.
The Budget papers outline a commitment to implement recommendations made in the Review of Medicine and Medical Device Regulations. GBMA says it supports improvements in the regulation of generic and biosimilar medicines that will result in faster approval times for new generic and biosimilar medicines, streamlined administrative requirements and reduced costs for industry.
“Initiatives to drive regulatory efficiency and reduce the administrative and cost burden for generic and biosimilar medicine suppliers, without compromising on quality or safety, benefit patients, taxpayers and industry,” says Tillack.
“It takes just over a year for the Therapeutic Goods Administration to evaluate and approve a generic medicine. Reducing this time will bring new affordable medicines to patients sooner, increase treatment options for doctors and deliver savings for the PBS.”