Introduction
Are you providing a submission as a representative of an organisation?
If yes, what is the name of your organisation?
University of Newcastle
Findings - Theme 1 - Technical Issues
Findings 3 to 7:
Response
We recognise that the report has taken the "interim approach" to technological advances and emerging applications. Consistent with this, we would like to see the timeline and process outlined to move from interim to formal adoption. We wish to ensure that the Act remains current in its consideration of new technologies and applications while at the same time does not change the focus of the Act. We encourage harmonisation with international regulations where they are in the best interests of Australia. We are concerned about the somewhat open response to the regulation of the application of human gene therapies, including inherited germline therapies and would urge clarity over which government body has regulatory oversight.
Findings - Theme 2 - Regulatory Issues
Findings 8 - 15:
Response
We appreciate the discussion regarding streamlining the regulation, and would encourage the review to reduce the number of proposals (Table 1) to a manageable set that could be implemented to improve, simplify and speed up the regulatory framework without increasing risk. In terms of human health, we would like to see more discussion regarding the process for clinical trials, and how this relates to the tiered risk approach. Any clinical trial approach should be harmonised with global standards. Similarly, we would have liked greater discussion on the utility of post market monitoring and surveillance as a method to increase compliance and knowledge.
Findings - Theme 3 - Governance Issues
Findings 16 - 28:
Response
We support the consideration that the current regulatory framework may not support the best practice globally affecting our ability to attract clinical trials to Australia. Given this, we are concerned about the flow on effects in terms of reduced availability of new products to Australians, together with the impact on our clinical trials economic sector. Regulations should be harmonised (where appropriate) and commensurate with the level of risk. We appreciate the efforts in the review to highlight the importance of continued innovation and importance of global competitiveness.
Findings - Theme 4 - Social and Ethical Issues
Findings 29 to 33:
Response
We appreciate the importance of communication to Australia regarding social and ethical issues in a balanced direction. The higher education sector may be one such channel to consider.