Fast track for new drugs will need faster subsidy decisions
The Federal Government’s plans to fast track the approval of new drugs will mean medications may come on to the Australian market sooner but they will remain out of reach for most people until and unless they are subsidised, the Consumers Health Forum says.
The Government’s response to the review into the regulation of medicines and medical devices includes steps to streamline the regulation of medicines and medical devices, the CEO of the Consumers Health Forum, Leanne Wells, said.
“We welcome fast tracking and the Government’s commitment to the integrity of our regulatory arrangements for drugs and devices”.
“We would encourage the Government to develop more timely assessment processes so that approvals for use in Australia and the separate decisions over subsidising the new drugs are better coordinated,” Ms Wells said.
“The time it takes for new drugs to be listed in Australia has been a matter of debate for years. This has partly been because of Australia’s slower processes of evaluation of new products, but also because of budgetary restraints.
“Of course everyone wants to see the latest proven drug available to Australians as quickly as possible. But the continuing strength of the Pharmaceutical Benefits Scheme in ensuring equitable access to medicines has been largely due to the rigorous evaluation of new drugs’ cost effectiveness.
“While new drugs may be able to come on to the market sooner as a result of the recommended changes, the decision of which drugs will be subsidised will still remain and will still challenge Government budgetary choices,” Ms 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.
“Without PBS subsidy only people who can afford the very high cost of new drugs will get access to these medicines, resulting in the prospect of more inequitable outcomes.
“The Government responses to the regulatory review covers a wide range of issues covering therapeutic products.
“CHF is concerned that regulation of complementary medicines, which have been the subject of ongoing controversy concerning questionable advertising, has not been tightened up sufficiently.
“We support a simpler pathway to “register” evidence-based complementary medicines this will need more public education to convey the difference between “listed products” which do not have evidence of efficacy, the proposed new approval category of products backed by some evidence and “registered” products which are backed by good evidence of efficacy,” Ms Wells said.