Health minister Greg Hunt says he is reviewing the impact of recent changes that cut the TGA orphan drug designation to six months.
The orphan designation exempts companies from registration fees and then also exempts it from PBAC submission fees.
The fee waiver is designed to remove a potential financial disincentive for companies to pursue registration and reimbursement for medicines that treat small numbers of patients.
Under the previous system, orphan designations did not lapse, while under the new six-month system even submissions made under the parallel-process are unlikely to qualify for the PBAC submission fee waiver.
The impact of the change has raised significant concern across the industry and patient groups.
Shadow health minister Catherine King raised the issue at CanForum 2018 in Canberra yesterday.
"This change - while well-intentioned - has threatened the viability of this program so it’s a no-brainer to fix it," said Ms King.
"Today, I can commit that a Labor Government will do just that.
"We’ll work with you and the TGA and the PBAC and drug companies to get the balance right. Rare Cancers Australia has proposed an 18-month designation; others have different suggestions.
"But I’m committing today that if the Government doesn’t fix this issue before the next election, we will."
In a statement, a spokesperson for Mr Hunt said, “The Minister is already reviewing the implementation of recent changes to orphan drug designation assessment to ensure that the scheme continues to facilitate and incentivise patient access to orphan drugs.”