The federal government is managing a number of proposed amendments in the Senate to the Bill that includes a range of reforms to the TGA and has offered a compromise on one key inclusion.
The Therapeutic Goods Amendment (2022 Measures No. 1) Bill 2022 (Bill) will make a number of amendments to the Therapeutic Goods Act 1989.
Arguably the most significant change is the implementation of a scheme for the mandatory reporting by hospitals of adverse events associated with medical devices.
The scheme was recommended in the report of a 2017 Senate inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters.
The Greens have challenged the decision to only mandate that reporting is required by hospitals. It has proposed an amendment that would make it mandatory for medical professionals to report adverse events associated with medical devices.
Speaking on the Bill, Senator Jordan Steele-John challenged some healthcare professional groups over their opposition to the amendment.
The Bill also proposes expanding the regulator's power to communicate information related to the safety of the therapeutic good.
The change involves the denial of a 'natural justice hearing' where the release of information is in the interests of public health or safety. However, in response to concerns over the broad nature of this power and to ensure Coalition support for the BIll, the government has proposed its own amendment so that a matter relating to 'quality and efficacy' is clearly excluded.
Senators have also criticised the Bill over the creation of an offence for failing to comply with a notice from the Secretary of the Department of Health and Aged Care requiring the production of information or documents.
According to an assessment by the Senate Standing Committee for the Scrutiny of Bills, this reversal of the burden proof goes against a longstanding common law principle.
"At common law, it is ordinarily the duty of the prosecution to prove all elements of an offence. This is an important aspect of the right to be presumed innocent until proven guilty. Provisions that reverse the burden of proof and require a defendant to disprove, or raise evidence to disprove, one or more elements of an offence, interferes with this common law right."
It sought an explanation from health minister Mark Butler.
The Bill also aims to promote investment in Australia by introducing a new pathway for the marketing approval of biologicals that are for export only. It effectively extends an existing framework that is limited to medicines and export only medical devices.
It will also allow the government to approve the importation or supply of an unapproved medicine that could act as a substitute for medicine that was previously approved in Australia.