MYEFO delivers funding for clinical trials reform

Latest News

No health surprises in yesterday's Mid-Year Economic and Fiscal Outlook with the Budget update confirming funding for clinical trials reform and some PBS listings.

MYEFO confirmed $7 million in funding for the Turnbull government's pre-election commitment to "remove red tape that is creating barriers to conducting clinical trials in Australia."

A key feature of the reforms is seed-funding to support a central point of contact for clinical trial sites to significantly improve communication and coordination across sites and jurisdictions.

The central point of contact will work with trial sponsors to address many of the issues identified over a number of years by successive governments.

MYEFO also included $141 million over four years for new PBS listings announced since the May Budget. Health Minister Sussan Ley announced the 1 February listing of Boehringer Ingelheim's SPIRIVA RESPIMAT (tiotropium) and 1 January listing of GSK's NUCALA (mepolizumab) on Sunday.

The Budget update also confirmed $83.7 million over five years from 2016-17, including $20.4 million in 2020-21, for price increases to dozens of off-patent medicines.

The prices increases, which took effect from 1 December, were the product of a process established through the Generic Medicines Working Group created last year under the five-year strategic agreement between government and the Generic and Biosimilar Medicines Association (GBMA).

MYEFO also included a significant upward revision in top line spending on the PBS.

According to the update, spending on the scheme in 2016-17 is expected to be $972 million higher than previously forecast, equating to $745 million over the four years to 2019-20.

"...largely reflecting a higher than anticipated uptake by patients of five Hepatitis C medicines listed on the PBS. This impact is partially offset by an increase in receipts resulting from Special Pricing Arrangements and Risk Share Arrangements with a range of PBS providers," it said.

The upward revision for 2016-17 suggests forecast spending on the scheme could now come in at around $11.4 billion, an increase on 2015-16. However, this top line forecast does not take into account rebates paid by companies under risk-share agreements.

Information recently provided by the Department to the Senate, in response to a question on notice tabled by Senator Richard Di Natale at Supplementary Budget Estimates, suggests the previous forecast for 2016-17 was $10.4 billion. PBS spending in 2015-16 was $11.2 billion, said the Department in the same response.