News & Trends - Pharmaceuticals
Government under fire as Senator Ruston slams decision to defer access to new medicines
Pharma News: Revelations that as many as 44 new medicines are facing months-long delays under the Albanese Government have sparked significant backlash, with a petition now launched to challenge the move.
Shadow Health Minister Senator Anne Ruston voiced alarm, stating, “We are really concerned that almost 50 medicines have been deferred from consideration for listing on the PBS. There is no doubt that this will result in serious delays for patients waiting to have access to these potentially lifesaving or life-changing medicines at an affordable price.”
The Department of Health announced on October 22 that 44 out of 77 Pharmaceutical Benefits Advisory Committee (PBAC) medicine submissions set for review at the March 2025 PBAC meeting would be deferred to July 2025 or later due to capacity issues. The delays include crucial cancer treatments and chronic-disease medications, raising alarms across the healthcare community.
Greg Cook, Senior Director of Access, Policy & Advocacy at Bristol Myers Squibb (BMS), weighed in on the troubling trend.
“The recent deferral of 44 submissions from the March 2025 PBAC meeting is not unsurprising,” Cook noted. “Increasing research and development speed combined with faster and provisional regulatory approval has led to the PBAC bottleneck we now face.”
He further added, “The introduction of PBAC intracycle meetings and increasing use of ‘out-of-session’ PBAC meetings across the last decade have been band-aids for the increasing workload. However, the system has now officially broken.”
Medicines Australia has been calling for greater transparency, challenging the Department of Health’s claims regarding capacity constraints. Concerns centre around the lack of industry consultation in prioritising deferrals, the absence of a platform for sponsors to contest the decisions, and scepticism about the PBAC’s assertion that it can assess only 32 submissions per meeting.
This is not the first time a deferral of PBS listings has sparked controversy. In 2011, the Rudd Government faced backlash for deferring the listing of seven medicines, framing the decision as a cost-saving measure for the long-term sustainability of the PBS. A report by the Senate Finance and Public Administration References Committee at the time sharply criticised the government, highlighting the adverse impact on patient access to affordable and essential treatments.
Better Access Australia, who has initiated the petition, noted that all submissions to the PBAC must be considered as per their notice of intent and consistent with the processes industry and government determined on patient access in their 2017 Strategic Agreement, which were reflected in the legislation passed by Parliament in 2018.
“Access to new medicines is not a privilege. It is a right that the Australian government should dutifully uphold,” Better Access Australia added. “The deferral of new medicines approvals leads not only to delayed access but also hinders the progress of innovative treatments that could greatly contribute to the welfare and recovery of numerous patients across the country.”
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