Rebecca White
Lyons · Australian Labor Party · Australia
“The bill will enable this information to be requested regarding any approved medicine, not just reportable medicines. This is important, as shortages of any approved medicine can have a significant impact on the health and wellbeing of people in Australia.”
“The existing clause'or as soon as practicable after the decision is made' will be maintained, acknowledging that unforeseen circumstances can impact a sponsor's ability to report a discontinuation 12 months in advance.”
“This amendment will ensure that the list of critically important medicines specified in the instrument remains as current as possible at all times, for the purposes of mandatory reporting requirements and timeframes.”
“I move: That this bill be now read a second time. Today, I introduce the Therapeutic Goods Amendment (Medicines Shortages and Other Measures) Bill 2026.”
“This bill introduces legislative changes designed to address key challenges raised by stakeholders across the medicines supply chain in their consultation feedback.”
“Medicine supply chains are complex global systems and there are numerous points in the supply chain where problems can cause a medicine supply disruption, each requiring a different response.”
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“The accreditation requirements impose obligations on approved practitioners, accredited laboratories and approved authorities to undertake to meet, or demonstrate compliance with, quality assurance standards for pathology services provided under Medicare. The Health Insurance (Pathology) (Fees) Act 1991 (pathology fees act) specifies the fees which must be paid for the acceptance, and approval of, applications for the approved practitioner, approved authority and accredited laboratory. This allows approved providers to be identified in the Services Australia billing system of Medicare eligible services. These fees were arbitrarily set to be between $500 and $2,500 in 1991.”
“Practitioners (pathologists) are required to sign an undertaking to the minister that they will comply with the requirements of the legislation and certain administrative arrangements. They must pay an acceptance fee to become an approved practitioner. Similarly, the proprietor of a laboratory must sign an undertaking and pay an acceptance fee to become an approved authority. Laboratory premises may be approved by the minister as an accredited laboratory following the submission of an application and relevant supporting documentation. This includes an accreditation assessment and payment of the accreditation fee once the premises are provided with an in-principle approval.”
“I move: That this bill be now read a second time. The Health Insurance (Pathology) (Fees) (Repeal) Bill 2025 relates to the fees imposed on the pathology sector for certain categories of pathology applications. This bill provides reforms for the current charging arrangements imposed on the sector for categories of accreditation applications. Under the Health Insurance Act 1973, pathology services must be rendered by or on behalf of an approved pathology practitioner (approved practitioner), in an accredited pathology laboratory (accredited laboratory) operated by an approved pathology authority (approved authority) to be eligible to receive Medicare benefits.”