Certainty and clarity are being offered for clinical trial activities under the R&D Tax Incentive, and AusBiotech is calling for Member feedback as it develops its response to the first draft determination released by the Department of Industry, Science, Energy and Resources.
The determination seeks to provide clarity on the types of clinical trials that will be accepted as core R&D activities, and thereby offer certainty in eligibility and reduce regulatory burden. This is the first determination released that will touch on activity eligibility matters and is being done under the reforms to the RDTI announced in the 2020-21 Budget.
The scope of the draft determination currently states that Phase 0-III clinical trials will qualify as core activities for the purposes of the R&D Tax Incentive; Phase IV and generics clinical trials currently excluded, however, will still be capable of meeting the definition of core R&D activities in particular circumstances.
Clinical trials play a pivotal role in the economy of the future; already supporting more than 8,000 innovative Australian jobs, in 2019 clinical trials contributed more than $1.4 billion to the Australian economy – demonstrating its value in supporting the country’s transition from a post-mining boom.
Ensuring certainty and clarity for clinical trials, which are conducted within rigorous regulatory frameworks, will support the development process of bringing new therapies, devices and diagnostics to patients.
The draft determination has been developed in consultation with the Australian Taxation Office and Department of Health. Following consultation, it will then be approved by Industry Innovation and Science Australia, or its delegate.
AusBiotech is working with its Clinical Trials Advisory Group and a number of tax experts in its membership to develop a response, and encourages its members to submit their feedback to Karen Parr, Communications Director, by Friday 11 February 2022.
The consultation papers can be read here.