R&D Tax Incentive – Clinical Trials Determination

R&D Tax Incentive - Clinical Trials Determination

Unlock the full potential of your R&D tax incentive

for clinical trials

call Bulletpoint on 1300 658 508

for expert guidance.

 

What is a Clinical Trials Determination ?

A clinical trials determination is the process of assessing if your clinical research qualifies for the R&D tax incentive, focusing on innovation and scientific advancement. 

 

Why It Matters to Your Business

Knowing if your clinical trials qualify can help secure financial support for your projects, fuel further research, and drive scientific progress. It’s crucial for maximising your claim’s success and supporting your company’s growth.

 

Background

On 20 January 2022, the Federal Government initiated consultation on the draft Industry Research and Development (clinical trials, Phase 0, I, II, III for an unapproved therapeutic good) Determination 2021 (Determination). This Determination aims to give businesses clearer assurance that investments in clinical trials will qualify for the R&D Tax Incentive. It does so by specifying the conditions under which clinical trials are recognised as “core R&D activities” by Industry Innovation and Science Australia (the Board).

Clinical trials are crucial for advancing innovations in medicines, vaccines, medical devices, and diagnostic therapies. Supporting the clinical trial industry not only provides patients with access to new treatments but also bolsters the Australian research sector and its institutions.

Ensure your clinical trials qualify

for R&D tax incentives

message Bulletpoint for

a comprehensive evaluation.

 

Why does the Government care?

According to MTP Connect’s 2021 Clinical Trials Report:

  • The sector employs 8,000 Australians.
  • Over 95,000 Australians participated in clinical trials in 2019, with about 1,880 trials initiated.
  • These activities contributed to $1.4 billion spent on clinical trials in Australia in 2019.
  • The sector now earns more export revenue than construction, intellectual property charges, and government services.

Enhancing and clarifying the economic incentives for undertaking all clinical trial phases in Australia is anticipated to be beneficial for industry participants. This, combined with the determination that clarifies clinical trials as core R&D activities, simplifies the application process to the R&D Tax Incentive program and provides certainty for companies engaged in eligible clinical trial activities, effective from 1 April 2022.

 

Conditions

Phase 0, I, II, and III clinical trials involving specified, unapproved therapeutic goods “used solely for experimental purposes in humans” are considered core R&D activities if they meet two conditions:

  1. The trials must be for an unapproved therapeutic good not yet listed on the Australian Register of Therapeutic Goods, covering:
  2. The clinical trial must also be either notified to or approved by the Therapeutic Goods Administration (TGA) as per specific regulations and sections of the Therapeutic Goods Act 1989. These stipulations ensure the trials are for goods “used solely for experimental purposes in humans”.

 

Stages

These are the stages you need to be at:

  • Phase 0: Exploratory or pilot studies testing how the body responds to an unapproved therapeutic good before Phase I trials.
  • Phase I: The first time an unapproved therapeutic good is administered to humans, focusing on safety, functionality, tolerance, and identifying optimal administration methods.
  • Phase II: Initial trials in patients with the condition the therapeutic good aims to treat, concentrating on determining its effectiveness and safety.
  • Phase III: Larger scale trials following Phase I and II, aimed at confirming the clinical benefits identified in Phase II and assessing side effects.

 

What is excluded Section 6 of the draft Determination specifies activities that do not qualify as core R&D activities under this specific framework, including:

  1. Clinical Trials of Generic Products: Defined under the Therapeutic Goods Regulations 1990, any trials involving generic products are not considered core R&D activities.
  2. Phase IV Clinical Trials: These are trials conducted in Australia after the therapeutic good has already been approved (either within Australia or internationally) for treating a specific disease and are therefore excluded.
  3. Activities Precluded by the 1997 Act: Specifically, activities outlined under subsection 355-25(2) of the 1997 Act, such as market research, market testing, market development, or sales promotion, do not fall under core R&D activities.
  4. Non-Compliant Activities: Any activities not conducted in accordance with applicable approvals, regulatory requirements, and standards in force during the phase 0, I, II, or III clinical trials are excluded.

It’s important to note that exclusion from this Determination does not automatically disqualify these activities from being recognised as core R&D activities under the 1997 Act. Entities looking to claim the R&D tax offset for such activities will need to independently prove their eligibility outside the support of this Determination.

 

Don’t miss out on valuable R&D tax incentives

for your clinical trials

call Bulletpoint now on 1300 658 508

to start your claim.

 

 

 

Need expert help?

Navigating the R&D tax incentive for clinical trials comes with its set of challenges. From understanding the eligibility criteria to documenting research activities accurately, companies often find themselves in complex situations. Missteps can lead to missed opportunities or even scrutiny under reviews and audits by the ATO and AusIndustry.

That’s where Bulletpoint steps in. With a decade of experience and a track record of over 500 successful R&D lodgements, we stand as the beacon of expertise in the R&D tax incentive landscape. Our success isn’t just in securing claims but also in defending them against the toughest of reviews and audits from both the ATO and AusIndustry.

Don’t just take our word for it; our Google reviews speak volumes about the trust and satisfaction our clients have in our services, highlighting our role as Australia’s highest-rated R&D tax consultant.

Facing challenges with your clinical trial R&D claim? It’s time to turn those challenges into triumphs. Whether you’re seeking clarity on your project’s eligibility, need assistance with your documentation, or require expert defence in an audit, Bulletpoint is here to guide you through every step of the process.

Ready to navigate the complexities of the R&D tax incentive with confidence? Call us on 1300 658 508, send us a message, or book a meeting via Calendly right now. Let Bulletpoint be your partner in maximising your R&D tax incentive claim and overcoming any hurdles along the way.

FAQ

Clinical Trials Determination assesses if clinical research qualifies for R&D tax incentives, focusing on innovation.

Clinical trials are crucial because they represent core R&D activities, eligible for tax benefits due to their innovative nature.

Phases 0, I, II, and III are eligible, as they involve significant research and development efforts.

No, generic product trials and Phase IV clinical trials are excluded from the R&D tax incentive scope.

Your trial must be a specified phase, involve an unapproved therapeutic good, and meet Australian regulatory requirements.

Generic product trials, Phase IV trials, market-related activities, and non-compliant activities are excluded.

You must demonstrate that your trial meets the necessary innovation criteria and regulatory standards.

Detailed records of your research activities, findings, and compliance with regulatory standards are essential.

The focus is on trials that contribute to Australian research and meet local regulatory standards.

Contact Bulletpoint for professional advice on maximising your claim, leveraging our expertise and successful track record.

Myths and Misconceptions

Fact: The eligibility for R&D tax incentives is not based on the success of the clinical trial but on the research and development activities involved.

Fact: Clinical trials may qualify for the R&D tax incentive if they significantly contribute to Australian science and technology, despite where they are conducted.

Fact: While Phases 0, I, II, and III of clinical trials are generally eligible, Phase IV and trials of generic products are excluded, along with non-compliant activities.

Fact: Only specific research activities that meet the criteria for ‘core R&D activities’ and comply with regulatory requirements can be claimed.

Fact: With professional guidance from experts like Bulletpoint, navigating the R&D tax incentive claim process can be straightforward, ensuring you maximise your entitlements efficiently.

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