Australia has committed to investing heavily in its medical future – but will it be ready for the regenerative medicine revolution? John Gardner from Monash University and Michael Morrison from the University of Oxford provide the answer
Regenerative medicine (RM) involves the use of tissues, cells and genetic tools to repair the damage caused by disease and injury.1 It is a relatively new area of medicine that has the potential to produce cures for a wide range of disorders, including cancers, heart disease, and degenerative neurological conditions.
Existing medical innovation pipelines have emerged to support the development of more conventional therapies and are often poorly suited to regenerative medicine. In recognition of this, a number of jurisdictions, including Japan, the UK, Canada and various U.S. states have launched state-level, system-wide strategies aimed at improving their ‘readiness’ for developing and implementing regenerative medicine.2,3 This includes the establishment of new funding mechanisms, facilitative regulatory frameworks, and initiatives to support academic networks and academic-industry-healthcare collaborations. All of these are aimed at accelerating innovation.4
Australia’s approach to its medical future is notably different. Despite asserting a commitment to invest heavily in medical innovation for the purpose of future health and pros-perity, RM has not been identified as a specific national-level strategic priority. Australia thus provides an interesting and contrasting case study for how system-wide readiness for RM may be achieved ‘by other means’.
Australia’s investment in future health and wealth
The foundation of Australia’s commitment to its medical future is the Medical Research Future Fund (MRFF). Revenue from the 20 billion (AUD) MRFF will support medical research and innovation in the long term, with 5 billion in specific grants expected to be allocated over the next ten years. The fund covers basic research, translational medicine, and some supporting infrastructure. Notably, 150 million (AUD) has been pledged to RM via a ‘stem cell therapies’ research mission. Specific RM projects could also be funded via other, more general missions and themes, such as ‘Cardiovascular Health’ or ‘Medical Research Commercialisation’.
Overall, however, the MRFF reflects a national funding approach which appears to assume that RM will be one among many areas of bio-medicine to benefit from general investment initiatives. This is in contrast to the approach of countries such as the UK, where the perceived ‘innovativeness’ of regenerative medicine has justified targeted support for building system-wide readiness.1,2,4
Another example of Australia’s general approach is the Biomedical Translation Fund (BTF), administered by the Commonwealth (i.e. Federal) Government’s Department of Industry, Science, Energy and Resources. The 500 million BTF will facilitate commercialisation by providing venture capital support and business expertise to early-stage biomedical companies. Regenerative medicine projects could fall within the remit of the scheme. However, bringing RM tools and techniques to the market requires highly specialised regulatory, reimbursement and, for example, cell expansion expertise. In other countries, this has justified regenerative medicine-specific commercialisation supporting initiatives with innovative risk-sharing funding mechanisms, such as the UK’s Cell and Gene Therapy Catapult.4
Regulating regenerative medicine
A key element of a jurisdiction’s readiness for RM is the suitability of its regulatory framework.2,6 In order for regulation to both be protective for citizens and facilitative of medical innovation, it needs to be formulated in such a way that recognises the specific harms, challenges and potentials of the tools and techniques in question. For this reason, many OECD countries, including Australia have formulated frameworks specifically for the regulation of cell, tissue or gene-based therapies.
In Australia, RM falls within the definition of ‘biologics’, and are subject to a regulatory framework that recognises the unique challenges of developing and testing cell, tissue and gene-based interventions.5 As with similar frameworks in other countries, the extent to which the regulatory framework suitably balances innovation facilitation with protective harm mitigation is an open question. Unlike relevant ‘facilitative’ frameworks in Japan6, it does not constitute an RM-specific expedited pathway.
Another factor in a jurisdiction’s readiness for RM is the presence of regulatory ‘know-how’. This is the capability of researchers to navigate the regulatory system throughout the innovation pipeline, and also the capacity and willingness of regulators to engage with researchers as they do this. Regulatory know-how is generated via collaborative networks of academics and industry representatives and other stakeholders – the sort of RM-specific collaborations that have been actively fostered by specific government RM initiatives in a number of countries and to some extent in Australia via more general initiatives.
The wider ecosystem
One example is the federal Cooperative Research Centre (CRC) scheme. Within this broad scheme, a specific CRC for Cell Manufacturing was established. It brings together universities, hospitals and industry partners around several project themes aimed at developing cost-effective RMs. State governments are also supporting RM capability building. The Victorian government, for example, has partnered with Monash University to fund the Melbourne-based Australian Regenerative Medicine Institute (ARMI) and the Centre for Commercialisation of Regenerative Medicine, reflecting the state government’s commitment to establishing Victoria’s global reputation in biotechnology and research.7 This shows the emergence of a community of RM practice and expertise in the absence of a specific Federal strategy.
This community of practice is interlinked with an emerging advocacy ecosystem. The influential AusBiotech has established an RM Advisory Group and is actively engaged in surveying the field and advocating for RM-specific issues. One significant development is the recent formation of AusBiotech’s RM consortium. Funded by both industry and the Federal Government, the Consortium will identify a national RM ‘innovation accelerator’ body to address workforce, collaborative, regulation and policy-related challenges.
The degree to which such initiatives will generate the system-wide readiness required for RM in Australia remains to be seen. Many RMs, for example, will require highly specialised clinical infrastructure and training to both trial and implement, and this will require significant, ongoing investment in organisational transformation and professional education. It is not clear that existing mechanisms of research funding and investment – whether they be industry or government – are suitable. Ongoing comparison of developments in Australia, the UK, Japan, and elsewhere can help elucidate the various means by which readiness can be achieved.
References
- Morrison, M. (2020) ‘Targeted policy support for emerging biomedical innovations’. Open Access Government. Feb 24. https://www.openaccessgovernment.org/targeted-policy-support-for-emerging-biomedical-innovations/88436/
- Webster, A. and Terzic, A. (2021) Regenerative readiness: innovation meets sociology. Regenerative Medicine 16 (3): 189-195 https://doi.org/10.2217/rme-2021-0034
- Morrison, M. (2021) ‘Building readiness for innovative health technologies’. Open Access Government. May 17. openaccessgovernment.org/building-readiness-for-innovative-health-technologies/110386/
- Gardner, J. and Webster, A. (2017) Accelerating innovation in the creation of biovalue: The Cell and Gene Therapy Catapult. Science, technology and Human Values 42 (5): 925-946. https://doi.org/10.1177/0162243917702720
- Qui, T., Hanna, E., Dabbous, M., Borislav, B. and Toumi, M. (2020). Regenerative medicine regulatory policies: A systematic review and international comparison. Health Policy. 124 (7): 701-713. sciencedirect.com/science/article/pii/S0168851020301032
- Morrison, M. and Umemura, M. (2021) Japan: A case study of national ‘readiness’ for regenerative medicine. Open Access Government Sept 07. openaccessgovernment.org/regenerative-medicine-2/119300/
- Pulford, J. (2020). Securing the future of regenerative medicine in Victoria. Victoria State Government Media Release Aug 10. premier.vic.gov.au/securing-future-regenerative-medicine-victoria
Australian Research Council Discovery Early Career Research Fellowship DE200100767
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