List of Advisors to Claim Australia’s R&D Tax Incentive in Clinical Trials

Engaging with experienced tax advisors and R&D specialists is crucial for biotech companies aiming to navigate Australia’s R&D Tax Incentive program effectively, in the context of clinical trials.

These consultants offer expertise in identifying eligible clinical trial activities, preparing claims, and ensuring compliance with regulatory requirements.

Here are some advisory firms in Australia that specialize in assisting clinical trial sponsors with the R&D Tax Incentive:

• Sofpromed
• Corp Global
• Azure Group
• Acclime
• Rimon
• Treadstone
• FB Rice
• Bentleys
• Swanson Reed
• William Buck
• Bell Partners
• Intellect Labs
• prpmt

Claiming Australia’s Research and Development (R&D) Tax Incentive for clinical trials offers a valuable opportunity for biotech companies to offset the costs associated with innovative medical research.

This government-backed initiative is designed to encourage investment in R&D activities, including clinical trials, by providing eligible businesses with tax offsets or cash refunds.

Australia’s favorable regulatory environment, high-quality healthcare infrastructure, and internationally recognized clinical trial expertise make it an attractive destination for conducting medical research.

The incentive not only reduces the financial burden on biotech companies developing new treatments or medical technologies but also helps accelerate the process of bringing innovative solutions to market.

By leveraging the R&D Tax Incentive, trial sponsors can significantly improve their cash flow, which is critical during the high-cost phases of clinical development.

Understanding the eligibility criteria, compliance requirements, and application process is essential for maximizing the benefits of this program and advancing groundbreaking research in the healthcare sector.

Eligibility Criteria for Clinical Trial Sponsors to Get Australia’s R&D Tax Incentive

To qualify for Australia’s R&D Tax Incentive as a clinical trial sponsor, biotech companies must meet specific eligibility criteria.

These criteria ensure that the claimed activities align with the program’s purpose of fostering innovation and contributing to scientific and technological advancements.

The main requirements include:

1. Entity Eligibility

• The applicant must be a company incorporated in Australia or an Australian resident company.
• Foreign companies can also be eligible if they conduct R&D activities through a permanent establishment in Australia.
• Certain entities, such as trusts, partnerships, and sole traders, are not eligible.

2. Activity Eligibility

• The clinical trial must involve Core R&D Activities or Supporting R&D Activities as defined by the program.
• Core R&D Activities: Experimental activities conducted to generate new knowledge in the form of improved or new medical interventions, treatments, or technologies. These activities must have an element of technical uncertainty that requires a systematic investigation.
• Supporting R&D Activities: Activities that are directly related to core R&D activities and necessary for their conduct, such as patient recruitment or data analysis.
• Activities must be conducted within Australia to be eligible for the full benefit, though some overseas activities may qualify under limited circumstances with pre-approval.

3. Expenditure Thresholds and Conditions

• Companies must incur eligible R&D expenditure of at least $20,000 in a financial year.
• If the R&D expenditure exceeds $150 million in a year, the offset is limited to the amount claimable against that cap.

4. Documentation and Record-Keeping

• Companies must maintain detailed records demonstrating how the activities meet the definitions of core or supporting R&D activities.
• Documentation should include evidence of planning, methodology, and results, as well as financial records showing the incurred costs.

5. Compliance with Australian Regulations

• The clinical trial must comply with relevant ethical and regulatory standards, such as approval by a Human Research Ethics Committee (HREC).
• Sponsors must ensure that all research complies with applicable Australian laws, including those governing clinical trials and medical research.

6. Registration with AusIndustry

• Companies must register their R&D activities annually with AusIndustry, a division of the Department of Industry, Science, and Resources, to be eligible for the tax incentive.

7. Tax and Reporting Requirements

• The company must lodge an income tax return with the Australian Taxation Office (ATO), including the R&D Tax Incentive Schedule.
• The benefit is applied either as a refundable tax offset (for smaller entities) or a non-refundable offset (for larger entities), depending on the company’s turnover and tax position.

Meeting these criteria requires careful planning and adherence to regulatory guidelines, making it essential for sponsors to consult with tax advisors or R&D specialists to ensure compliance and maximize the benefit.

Why Should Clinical Trial Sponsors Consult with Tax Advisors in Australia?

Clinical trial sponsors should consult with tax advisors or R&D specialists to maximize their chances of successfully claiming Australia’s R&D Tax Incentive and to ensure full compliance with the program’s complex requirements.

The process of identifying eligible R&D activities and expenditures can be challenging, particularly given the technical definitions and specific criteria that must be met.

R&D tax experts have the knowledge and experience to interpret these guidelines and determine whether the clinical trial activities qualify as Core or Supporting R&D Activities under the program.

In addition to eligibility assessment, tax advisors can help sponsors navigate the detailed registration and claim submission process.

They ensure that the required documentation is prepared accurately and comprehensively, minimizing the risk of errors that could result in delays, penalties, or denied claims.

Specialists also provide valuable guidance on structuring financial records to clearly track R&D-related costs, which is crucial for substantiating the claim during a compliance review by AusIndustry or the Australian Taxation Office (ATO).

Moreover, consulting with professionals can help biotech companies identify opportunities to claim additional eligible activities or expenditures that might otherwise be overlooked.

For multinational companies conducting clinical trials partially outside Australia, experts can assist in securing advance approval for overseas activities, ensuring these also qualify for the tax incentive.

By engaging with tax advisors or R&D specialists, clinical trial sponsors can focus on their core research objectives while confidently navigating the regulatory and financial aspects of the R&D Tax Incentive program.

This strategic partnership not only mitigates risks but also maximizes the financial benefits available, supporting the overall success of the clinical trial.

You can contact Sofpromed (info@sofpromed.com) if you need expert advice about Australia’s R&D Tax Incentive program for clinical trial sponsors