Wednesday, 9 December 2020
Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020; Second Reading
That this bill be now read a second time.
I am pleased to introduce the Therapeutic Goods Amendment (2020 Measures No. 2) Bill 2020.
This bill amends the Therapeutic Goods Actto remove a potential impediment to the Australian government's response to the COVID-19 pandemic in relation to the importation and supply of COVID-19 vaccines in Australia; to support continued access to prescription medicines during a serious scarcity of such medicines in Australia; to improve access to therapeutic goods for Australians; and to enhance patient safety.
In particular, the bill allows pharmacists to substitute a medicine for which there is a serious scarcity with a suitable alternative medicine, to avoid the risk of disruption to treatment for Australians that may be caused by a medicine shortage and the major impact that can have on patient health. Pharmacists will be able to substitute medicines without prior authority from a prescriber, but only where it is safe and appropriate to do so.
The bill supports patient safety by allowing regulations to establish a unique device identification database for medical devices in Australia. This will improve monitoring and traceability of devices supplied in Australia and enable quicker responses to safety issues and device defects.
The bill strengthens the capacity to scrutinise emerging trends in the supply of dangerous and counterfeit therapeutic goods by allowing departmental officers to obtain and possess goods to find out if the Therapeutic Goods Act is being complied with, without contravening state or territory laws that prohibit such obtaining and possession except in specified circumstances.
The bill supports human health and Australia's compliance with international agreements relating to therapeutic goods. The bill has the effect of enabling regulations to prohibit the import, export, manufacture and supply of products that are prohibited under international agreements to which the Australian government is a party.
It may not be possible for some COVID-19 vaccines to comply with the obligation in the act to not import or supply registered therapeutic goods without the registration number on the label—for example, if they need to be stored at particularly low temperatures.
The bill allows the secretary to consent to the importation and supply of such goods that do not comply with this requirement, to ensure the risk of civil penalties does not impede the timely availability of such vaccines in Australia. The TGA will ensure that the registration number of a vaccine is published for the benefit of health practitioners and consumers.
The bill also makes some minor amendments to improve the clarity and the consistency of regulation.