The government has agreed to extend the orphan designation period in response to concerns over the impact on patient access to medicines that treat small numbers of patients.
Health minister Greg Hunt and shadow minister Catherine King raised the possibility of change after the implementation of reforms that cut the TGA orphan drug designation to six months.
The orphan designation exempts companies from registration fees and had also exempted it from fees for submissions to the Pharmaceutical Benefits Advisory Committee (PBAC).
The fee waiver is designed to remove a financial disincentive for companies to pursue registration and reimbursement for medicines that treat small numbers of patients.
Under the old system, orphan designations did not lapse, while under the six-month system even submissions made under the parallel-process are unlikely to qualify for the PBAC submission fee waiver.
Department of Health officials confirmed at yesterday's stakeholder briefing in Sydney on new PBS cost-recovery fees that the government had agreed to changes that will mean medicines with an 'orphan designation' will be eligible for a fee exemption for the first PBAC submission within 12 months of TGA registration.