February 15, 2022
15 February 2022
AusIndustry
Department of Industry, Science, Energy and Resources
The Go8 welcomes the opportunity to provide a submission to AusIndustry’s consultation on the draft Industry Research and Development (clinical trials, Phase 0, I, II, III for an unapproved therapeutic good) Determination 2021.
Relevant to this submission is that:
- The Go8 undertakes 70 percent of university-based research in Australia and secures research funding from industry and other non-government sources which is twice that of the rest of the sector combined.
- The Go8 invests over $2.4 billion[1] in medical and health sciences each year and undertakes a range of activity in doing so, from fundamental or discovery research through to the development of new medical products and therapeutic goods.
- In 2020 the Go8 collectively earned $95.5 million in research commercialisation income and was collectively responsible for the majority of Australia’s new and active start-ups and spinouts attributable to public research as well as active licences, options and assignments (LOAs).
Key points:
- The Go8 supports the introduction of determinations as a new measure under subsection 31D(A) of the Industry Research and Development Act 1986 to provide increased detail and clarity around the function of the Industry Innovation and Australia (IISA) Board, including where it relates to the administration of the R&D Tax Incentive (RDTI).
- The Go8 supports this first determination’s establishment of how clinical trial phases are to be defined for the purpose of the IISA Board’s decision making in the expectation that they will assist to set clear parameters for the eligibility of clinical trial related activities for the R&D Tax Incentive.
- The Go8 supports the appropriate consideration outside this determination by the IISA Board of whether some activities of phase IV clinical trials or clinical trials of generic medicines can meet the definition of core R&D activities, and therefore attract benefits of the RDTI.
Discussion
The opportunity exists for clinical trials and onflow investments both from domestic and overseas sources to occur with more frequency and certainty to support commercialisation activity and the development of new markets and manufacturing bases in Australia.
Stronger incentives for researchers and partners to engage in clinical trials are of paramount importance if Australia is to build the sovereign capacity to undertake partial or end-to-end development of drugs and medical devices in those areas where these are most needed, where we have the potential to be world leaders, or where the economic opportunities arising from manufacture in Australia are strong. In that respect the Go8 has previously advocated for a collaboration premium as recommended by the 2016 Review of the RDTI (Recommendation 2) and further by Innovation and Science Australia’s Australian 2030: Prosperity through Innovation roadmap (Recommendation 19).
The Go8 supports the clarity and certainty that the proposed R&D Tax Incentive Determination on clinical trials (Phase 0-III) for an unapproved therapeutic good provides, in the expectation it should assist industry partners and research colleagues better ascertain if their R&D activities may be eligible for the RDTI and will provide for streamlined recommendations by IISA including for entities who apply for advance findings on clinical trials.
- The Go8 recognises that the support environment for commercialisation in Australia can be difficult to navigate and understand, and that the RDTI itself is perceived as a complex initiative, making any simplification for both user and decision-maker highly welcome
- The removal of doubt regarding what – for the purposes of eligibility for the RDTI – constitutes a clinical trial is highly welcome, particularly as the definitions proposed are standard and generally accepted
- For the Go8, this simplification can impact positively on our researchers engaging in translation and commercialisation activities, including via spin-offs or startups created to further develop a new technology or discovery
In relation to the exclusion of phase IV clinical trials and clinical trials of generic medicines, the Go8 notes:
- Where generic medicines address an area of unmet need, provide cheaper alternatives to more innovative products, or provide a new indication (thus can be prescribed off label), their development should be encouraged (through eligibility of relevant clinical trials for the RDTI) as contributing to the evidence base and therefore health outcomes.
- Phase IV post marketing studies are often seen in the context of drugs that are successful for the big pharmaceuticals, therefore not necessarily needing RDTI. However, Phase IV clinical trials can also serve to investigate further the safety and efficacy of a newly registered medicine and should therefore be considered where appropriate for RDTI eligibility and consideration.
Relevant background
While the RDTI does not directly benefit universities, it supports university partnerships with industry who wish to engage with universities in undertaking R&D. Although only four per cent of clinical trials in public health organisations are reportedly sponsored by universities[2], this does not reflect the proportion of clinical trials in which universities engage, including those that are commercially sponsored or conducted via medical research institutes with whom university researchers may affiliate.
MTP Connect notes that, ‘universities are typically involved in early-stage trials where the financial trade-offs are too great for MTP companies or the level of investment is not prohibitive, or in trials relating to clinical practice, behavioural therapies and preventative care’[3]. It is therefore imperative that systemic support exist to foster this valuable activity where the risk remains high for industry and investors, in addition to sending signals that Australia is receptive to attracting clinical trials while creating and enabling new economic and health benefits for Australians.
Well-known products to emerge from Go8 biomedical research and related clinical trials include the Cochlear hearing implant (University of Melbourne), ResMed’s sleep apnoea non-invasive treatment (CPAP) (University of Sydney), the Vaxxas needle-free vaccine delivery (University of Queensland), Gardasil (University of Queensland), and Elastagen’s elastin technology (University of Sydney), among others. Go8 universities are currently associated with numerous clinical trials including of new medicines and devices, though not all are being trialled in Australia. The Go8 would be pleased to provide further detail as required.
VICKI THOMSON
CHIEF EXECUTIVE
[1] ABS 2020 Research and Experimental Development, Higher Education Organisations, Australia
[2] NHMRC 2020, Clinical Trials in Australian Public Health Institutions 2018-19
[3] MTPConnect 2021, Australia’s Clinical Trials Sector