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1 April 2022

R&D Tax Incentive determination on clinical trials

 
Industry Innovation and Science Australia (the Board) has made its first determination for the R&D Tax Incentive program: Industry Research and Development (clinical trials, phase 0, I, II, III, pre-market pilot stage, pre-market pivotal stage, for an unapproved therapeutic good) Determination 2022, available here.

It commenced today, Friday 1 April 2022, and can now be used when applying to the R&D Tax Incentive program. If you want to know how to use the determination when applying, we've published guidance, which explains the determination and how it will reduce the time it takes you to complete an application if you are conducting a clinical trial.

What are R&D Tax Incentive Determinations?

R&D Tax Incentive determinations are notifiable instruments that set out how the law is interpreted and applied when administering the R&D Tax Incentive program. Determinations are binding on the Board or its delegate, providing certainty for program participants and facilitating the work of administrators. If an application or registration is examined, any applicable determinations will be applied.

Determinations reduce regulatory burden for companies, making access to the R&DTI easier, quicker and more certain. They reduce the need for lengthy assessment processes and help companies better manage planning and undertaking R&D activities they wish to register under the program.
 
Matters for future determinations will be decided based on the analysis of trends in program registration and compliance, national and global priorities, input from stakeholders, and the potential positive impacts of a determination.
 
Determinations align with the Government’s productivity, growth, and manufacturing agendas, including the overarching objective of improving Australia’s international competitiveness. Determinations are an opportunity to strengthen Australia’s reputation for competitive R&D support: the streamlined and stable regulatory environment they facilitate will help attract more investment.

The clinical trials determination is aligned with the Government's Medical Products National Manufacturing Priority road map. The determination will help government efforts to position Australia as a global destination for clinical trials and attract more health and science-related investment in Australia.
 
Watch the Australian Investment Council or BioTome, a biotech company, discussing the clinical trials determination. 

The development of the determination benefited from a public consultation process. A report on that process is available through the consultation hub.

business.gov.au  |  13 28 46
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