Regulating AI and ADM in healthcare and HMR

The scope for the use of Artificial Intelligence and Automated Decision Making is only limited by our imagination. In responding to the Government’s Issues Paper on the regulation of AI and ADM, Research Australia has expressed the view that AI and ADM in healthcare and health and medical research need to be subject to regulation which can cover potential future applications and adapt and develop as AI and ADM change without requiring constant revisitation of the framework.

Research Australia believes the existing regulators and responsible agencies are best placed to regulate the use of AI and ADM in healthcare and in health and medical research and innovation. While a robust national safety framework with common principles is required to guide regulators and promote consistency, existing regulatory bodies should be appropriately resourced to ensure they have the capacity to effectively regulate and support the implementation of AI and ADM now and into the future within their own areas of responsibility.

Read Research Australia’s submission

2022/23 BUDGET UPDATE- 30 March 2022

Summary

With an election due to be called any day now, it is no surprise that the 2022 Budget has contained some significant spending commitments.

The rising cost of living has become a key election issue and this Budget delivers cash payments, extends tax relief and cuts the fuel excise in half for six months. Rising inflation also affects health and medical research, making the cost of undertaking research higher. Disappointingly, the Government has once again failed to address this issue, with increases in funding for the NHMRC failing to even keep pace with inflation. The ARC’s Discovery program is forecast to increase slightly in real terms by around 1% per annum above forecast inflation. The ARC Linkage Program will increase by around the same amount, but is also expected to deliver new Industry Fellowships announced in February as part of the University Research Commercialisation Scheme.

There are big spending announcements in areas as diverse as Defence and infrastructure. While not on the same scale, there is some good news for health and medical research, including:

- A continuation of the important MRFF Frontier Health and Medical Research initiative (designed by Research Australia in partnership with the Department of Health) out to 31-32;
- $28.1 million for a new government agency, Genomics Australia, to support the implementation of genomics as a standard of care in Australia;
- Much-needed funding for primary care research with an additional $70m through the MRFF and $1.9m to the University of QLD for an effectiveness-implementation trial to reduce anti-depressant use; and
- Targeted funding for research of benefit to rural and regional Australia with new University Departments of Rural Health at Edith Cowan University and Curtin University and a new Rural Clinical School at Charles Sturt University.

This year’s Budget also includes the announcement of the Biotechnology in Australia- Strategic Plan for Health and Medicine, which focuses on the health and medical applications of biotechnology. A framework to identify gaps and align future initiatives to support the important biotechnology sector is very welcome news. Research Australia will be watching this initiative closely to understand how it aligns with Vision 2040 the National Strategy for Health and Medical Research announced by Minister Hunt at the Research Australia Awards last year.

The spending in this Budget has been made possible by better than forecast tax revenue, led by high export prices for commodities like iron ore and coal. What the Budget fails to do in any meaningful way is prepare Australia for the post-mining resources economy, where we will need to rely on the production of high-value-added goods and services if we are to maintain our standard of living. Research Australia has been arguing for several years now for a substantial, sustained and long-term investment by the Government in R&D. Once again, this issue has not been addressed.

The innovation focus of this Budget appears to be a continuation of the Government’s research commercialisation agenda, first announced in February, with $988.2m of funding over five years, including $505.2m to establish Australia’s economic accelerator grants to support collaboration between universities and industry.

Please read on for our summary of what this Budget means for health and medical research and innovation.

Health Portfolio

In Research Australia’s Pre-Budget Submission and our Pre-Election Statement we continued to call for increases in funding for the NHMRC’s Medical Research Endowment Account (MREA). This Budget sees the Government’s funding to the MREA continue to decline in real terms. This is of genuine concern to the health and medical research community; it jeopardises our long term research capability and increases the precariousness of research careers, especially for early and mid-career researchers. Addressing these and other issues are at the centre of Research Australia’s advocacy for a truly National Health and Medical Research Strategy, which has been given impetus by Health Minister Greg Hunt’s announcement last year of Vision 2040. We are working with Commonwealth, State and Territory Governments to make this vision a reality.

Overall health expenditure reflects the recurrent expenditure needed to maintain our health system as is. While there is some funding for planned growth, there is not the major funding injection that so many from the medical community and State and Territory Governments have been calling for.

Medical Research Future Fund

The amount of funding available from the MRFF is predicted by the Budget to be $650 million per annum over the next four years. The MRFF 10 year Plan, first announced in the 2019 Budget has been extended, committing $6.3 billion across the following themes:

$2.1 billion over 10 years from 2022-23, representing a further $604.8 million for medical translation to support medical discoveries become part of medical practice
$1.5 billion over 10 years from 2022-23, representing a further $114.9 million for medical research to help researchers tackle significant challenges through investment, leadership and collaboration
$1.4 billion over 10 years from 2022-23, representing a further $117.4 million to support patients by funding innovative treatments, supporting clinical trials, and delivering more advanced health care and medical technology
$1.3 billion over 10 years from 2022-23, representing a further $495.4 million for medical researchers to make breakthrough discoveries, develop their skills and progress their careers in Australia.

The Government will extend the Biomedical Translation Fund’s (BTF) initial investments period by a further 3 years to support the commercialisation of biomedical discoveries.

The funding available from the MRFF each year is dependent on the investment return on its capital. Investment returns for the MRFF were adversely affected by the COVID driven economic downturn. In the mid-year budget review in December 2020, the Government committed to delivering additional funding of $172.5 million from consolidated revenue to enable it to meet the spending outlined in the MRFF 10 year Plan for 2021-22. A further ‘top up’ was not required in the 2021-22 Budget because markets bounced back. This Budget forecasts healthy investment returns for the MRFF.

NHMRC Programs

The 2022/23 Budget reveals funding for the NHMRC’s programs continuing to grow very slightly, and slower than was forecast in last year’s Budget. The increase in this financial year is 1.7%, with annual increases of around 1.5% per annum over the forward estimates. This is lower than the forecast CPI of 3.0% for 2022-23 and CPI of 2.75% in 2023-24. It also comes on top of CPI of 4.25% in 2021-22. In effect, NHMRC funding continues to decline in real terms, as it has done for many years now.

NHMRC Medical Research Endowment Account Funding

$m.	20-21	21-22	22-23	23-24	24-25	25-16
Funding to MREA 2022 Budget		863.266	877.952	891.094	905.355	918.985
Funding to MREA 2021 Budget	853,864	863,266	875,362	887,588	899,124	N/A
Funding to MREA 2020 Budget	853,864	862,412	872,770	884,960	N/A
Funding to MREA 2019 Budget	856.250	869.950	883.870	N/A	N/A

Preventive Health Strategy

In December last year, the Australian Government published the National Preventive Health Strategy 2021-2030. The Strategy refers to the ‘need to significantly enhance investment in prevention in order to achieve a better balance between treatment and prevention. A long-term, sustainable funding mechanism is essential to achieving the aims of this Strategy, including that investment in prevention is increased (Aim 4).’

The 2022 Budget includes only a modest $30.1 million over 4 years from 2022-23 to improve health outcomes through preventive and other health initiatives under the National Preventive Health Strategy 2021-2030. Only some of this funding is new, with part being met form ‘within the existing resources of the Department of Health’. None of this funding is directed to research to support preventive health measures.

Elsewhere in the Budget under the heading of preventive health there is funding of $1 million over 2 years from 2022-23 to conduct research to address priority men’s health issues in line with the objectives of the National Men’s Health Strategy 2020-2030.

MND Clinical Trials

Staying with direct Department of Health funding for research, $4 million will be provided over 2 years from 2022-23 to the FightMND Foundation for the delivery of early-phase clinical trials to develop new treatments for Motor Neurone Disease.

Comprehensive Cancer Centre for WA

Earlier this week the Prime Minister announced $375 million to establish a comprehensive cancer centre in WA, modelled on the Victorian Comprehensive Cancer Centre and the Chris O’Brien Lighthouse in Sydney. Proposed by Research Australia member the Harry Perkins Institute of Medical Research, it is also dependent on funding form the WA Government, which has yet to be confirmed.

Education Portfolio

Nearly half of all Australian health and medical research is undertaken in the higher education sector, and the Department of Education makes a significant contribution to the funding of this research through several programs, as outlined below.

ARC Programs

The Australian Research Council’s Funding Programs are critical to Australian publicly funded research, including to the life sciences and medical technologies.

Discovery Program

Over the forward estimates in this Budget, the funding to the ARC for the Discovery Program increases by 4.5% compared to 2021/22, and by an average of 4.5% per annum over the forward estimates. This means that for the first time in many years the Discovery Program is forecast to increase slightly in real terms (i.e. at a rate higher than inflation). The increase is not significant, perhaps only 1% above forecast inflation, but nonetheless welcome.

Discovery Program

$m.	21-22	22-23	23-24	24-25	25-26
2022 Budget	489.188	511.074	535.915	562.406	585.206
2021 Budget	489.188	494.922	501.162	509.432
2020 Budget	487.016	487.860	490.610
2019 Budget	525.537	538.350	N/A

Linkage

The ARC Linkage Program has been singled out by the Government as an important component of Australia’s innovation system and is delivering the Industry Fellows component of the University Research Commercialisation Scheme. Accordingly, there is a boost to the Linkage Program’s funding in this Budget of around $11 million per annum compared to what was allocated last year. Like the Discovery Program, this equates to annual increases of 4.5% per annum, about 1% per annum ahead of inflation over the forward estimates. At the same time, the Linkage Program is meant to be delivering 800 new Industry Fellowships over 10 years announced in February; the increases announced in the Budget are not enough to enable it to do this and also keep up with inflation. Funding the Industry Fellowships will require savings elsewhere in the Linkage Program.

Linkage Program

$m.	21-22	22-23	23-24	24-25	25-26
2022 Budget	325.454	340.820	357.704	375.595	390.950
2021 Budget	325.454	329.948	334.109	339.622
2020 Budget	323.871	325.240	327.074	N/A
2019 Budget	295.246	301.741	N/A	N/A

Research Support

In addition to providing funding for the ARC research programs, the Department of Education and Training provides funding to universities to help cover the indirect costs of research.

In the 2020 Budget, the Government used the Research Support Program to provide a vital injection of $1 billion into higher education research in the current financial year. No further injection was provided in last year’s Budget and funding in this Budget for 2022-23 is actually lower than was forecast in the 2019 Budget. The increases forecast in this Budget averages 2.5% per annum over the forward estimates. Once again this is less than inflation and represents a decline in funding in real terms.

Research Support Program

$m.	20-21	21-22	22-23	23-24	24-25	25-26
2022 Budget		930.659	951.188	978.674	1,002.668	1,028.230
2021 Budget	1918.298	930.659	942.775	958.326	974.143
2020 Budget	1918.298	926.490	929.270	938.107	N/A
2019 Budget	920.573	941.748	962.455	N/A	N/A
2018 Budget	1018.879	1042.302	N/A	N/A	N/A

Funding for the indirect costs of research funded by the MRFF is provided from the Research Support Program. With the MRFF providing hundreds of millions of dollars in funding to universities, a substantial increase in the Research Support Program is needed just to maintain the levels of research support funding for research projects at their current already inadequate level. The cuts to the Research Support Program beyond the one-off boost in 2020-21 represent a real and continued threat to the capacity of our universities to undertake vital health and medical research.

The issue of indirect research costs remains unresolved for the whole health and medical research sector and indeed publicly funded research more broadly. Research Australia continues to call for a whole of government approach to the issue of funding indirect research costs.

Research Training

The Research Training Program (RTP) provides funding to universities to support higher degree by research students (mostly PhDs). Funding for the RTP also declined in absolute terms between the 2019 and 2020 Budgets, and has only partly recovered in the 2022 Budget. The increase in the next financial year is 2.2% and the average increase over the four year period is 2.% per annum; once again failing to keep up with inflation even as it provides an additional 1800 Industry PhDs over the next 10 years.

Research Training Program

$m.	20-21	21-22	22-23	23-24	24-25	25-26
2022 Budget		1069.182	1092.766	1124.344	1151.909	1181.153
2021 Budget	1054.981	1069.182	1083.160	1100.967	1119.137
2020 Budget	1054.981	1064.392	1067.585	1077.738	N/A
2019 Budget	1057.595	1081.921	1105.710	N/A	N/A

Research Commercialisation

In addition to the Industry PhDs and Industry Fellows, the University Research Commercialisation Action Plan committed to implementing Australia’s Economic Accelerator. This is a $1.6 billion program over 10 years, administered by the Department of Education to overcome the valley of death that currently exists between the point at which public research funding ceases (typically publication) and the point at which commercial investors are prepared to get involved. It requires an amendment to the Higher Education Act before it can be implemented, so can only really progress after the election, and if the amendments to the Act are adopted.

National Critical Research Infrastructure (NCRIS) Program

The NCRIS Program funds vital national research infrastructure needed to support Australian research. The 2021 National Research Infrastructure Roadmap is yet to be finalised, with a draft Roadmap released in December 2021. Finalisation of the Roadmap will inform the 2022 Research Infrastructure Investment Plan.

This year’s Budget maintains the forecast $100 million boost to NCRIS from 2023-24. The 2022 Research Infrastructure Investment Plan should provide more detail about how this funding will be allocated once it is completed, hopefully later this year.

National Critical Research Infrastructure Strategy

$m.	21-22	22-23	23-24	24-25	25-26
2022 Budget	273.567	286.043	396.826	496.739	454.441
2021 Budget	273.565	283.922	391.092	491.265

Industry, Innovation and Science Portfolio

CRC Program

The Cooperative Research Centre (CRC) Program is important to health and medical research and innovation, with many of the CRCs funded over the 30-year life of the program being health related. Current CRCs include the Digital Health CRC and the Autism CRC.

The smaller CRC projects program is also relevant, with recently funded projects including the creation of better brain electrodes and development of a bionic medical device that delivers high-fidelity visual-spatial perception for blind people. Funding for the CRC Program is scheduled to increase slightly faster than forecast in last year’s budget, but is still lower than the expected CPI.

CRC Program $million

$m.	20-21	21-22	22-23	23-24	24-25	25-26
2022 Budget		189.395	199.374	193.117	197.070	193.540
2021 Budget	222.777	189.980	197.815	191.042	193.807	N/A

Modern Manufacturing Initiative

The Modern Manufacturing Initiative was a major announcement in the 2020 Budget and part of the Government’s response to COVID-19. The program continues pretty much as planned over the next three years.

Modern Manufacturing Initiative

$m.	20-21	21-22	22-23	23-24	24-25	25-26
2022 Budget		420.901	520.00	340.00
2021 Budget	40.000	380.000	520.000	340.000	Nil

CSIRO

The CSIRO has Flagship Programs relevant to health and medical research and is a key collaborator and partner in research. While it generates much of its own revenue it is also funded by the Government. The Government contribution to the CSIRO outlined in the Budget rises in the next two financial years before dropping back again.

CSIRO

$m.	21-22	22-23	23-24	24-25	25-26
2022 Budget	949.037	991.289	985.625	899.352	904.477

Conclusion

Research Australia will continue to provide analysis and commentary in the coming days and weeks. We invite your responses and reactions to how the 2022 Budget affects you and your work.

Please contact Greg Mullins, Head of Policy, greg.mullins@researchaustrlaia.org

Draft National Medicines Policy acknowledges research is key

Following on from our submission last year to the Discussion Paper, Research Australia has welcomed the acknowledgment of the importance of research in the new draft National Medicines Policy (NMP). Research Australia has used our submission to highlight further areas under the policy’s pillars where research can play a critical role, and has called for a dedicated stream of funding for research to support the Policy’s implementation and objectives.

Research Australia believes the Governance and Implementation sections of the draft policy need more work and has joined with the medicines sector and consumer groups to call for further consultation before the NMP is finalised. The Government has now heeded this call, with the Minister for Health announcing on 23 March that there would be further consultation before the Policy is finalised.

Read Research Australia’s submission here.

The 2022 National Medicines Policy was subsequently published on 20 December 2022, and the role of research is recognised in several areas, including as an enabler of the Policy. The Policy is available from the Department of Health’s website here.

Research Australia supports ARC’s independence

The Senate Employment and Education Legislation Committee is undertaking an Inquiry into the Australian Research Council Amendment (Ensuring Research Independence) Bill 2018, which lapsed when the 2019 election was called and has recently been revived. The renewed interest has been prompted by the decision of the acting Minister for Education to reject some proposed ARC grants in December 2021.

As stated in the Bill’s explanatory memorandum, ‘The intent of the Bill is to remove Ministerial discretion from research grants administered by the Australian Research Council (ARC).’ While Research Australia accepts the right of the Government to set the criteria for research funding programs, including the eligible applicants and research areas, and the amounts of funding available, Research Australia does not believe the Minister should have the power to refuse to fund individual research proposals that are recommended by the CEO of the ARC under an approved funding program.

Research Australia’s submission is available here.

The Senate Committee’s report was released on 21 March. The majority report, by ALP and Coalition Committee members recommended against passage of the Bill. The report is available here. A dissenting report from the Australian Greens senators is available here.

RESEARCH AUSTRALIA WELCOMES AUSTRALIA’S ECONOMIC ACCELERATOR TO SUPPORT MEDICAL RESEARCH AND INNOVATION

2 February 2022

Research Australia welcomes the announcement by Prime Minister Scott Morrison of the new $1.6b Australia’s Economic Accelerator (AEA) to enhance the commercialisation of Australia’s world-leading research and innovation.

Seamless support for research from discovery to commercialisation has been a key priority for Research Australia on behalf of its membership across the entire research pipeline, and a significant focus of Research Australia’s national consultation on a future National Health and Medical Research Strategy.

“The AEA program announced by the Prime Minister at the National Press Club is a solid step forward in addressing the well-known problem of the ‘valley of death’,” said Research Australia CEO Nadia Levin.

“Sustainable government funding like this moves us that bit closer towards developing a thriving research commercialisation and manufacturing ecosystem that benefits our health and economy,” Ms Levin said.

“At the moment we have a real issue with public funding not taking research far enough along the pipeline to make it attractive to commercial investors and/or commercial investors who are reluctant to invest in research at an earlier stage.

“Stronger connections between industry and research development along with encouraging mutually beneficial commercialisation partnerships between Australian universities, industry, and funders, can bring significant value for our innovation and export capabilities, and government plays a huge role in facilitating this,” Ms Levin said.

Research Australia also welcomes the announcement of industry PhDs and Fellowships, an initiative Research Australia has advocated for in the past. This is an important step in changing the research culture in Australia to give more researchers experience in industry.

“Our sector has long said there is a pressing need for training for university research staff in commercialisation, business development and developing research with industry and government. We’re hopeful that beyond the industry fellowships program, these issues can be addressed as part of a National Strategy for Health and Medical Research, announced by Health Minister, Greg Hunt at the Research Australia Awards in December.

“Research Australia looks forward to seeing the detail on how these programs will work and integrate with existing programs to provide effective and sustainable support across the entire pipeline of research from discovery to translation,” Ms Levin said.

Ensuring nationally coordinated, strategic investment in all stages of research has strong support from the sector under a future National Health and Medical Research Strategy.

“We are pleased to see the University Research Commercialisation Action Plan reinforce the importance of funding for basic research, however funding the full cost of research across the pipeline remains an issue.

“We will continue to advocate for increased funding across the research pipeline and the inclusion of Medical Research Institutes in the Accelerator, Industry PhD and Fellowships programs to ensure industry is able to engage more effectively with all of Australia’s publicly funded researchers,” Ms Levin said.

The issues facing funding for health and medical research are explored further by Research Australia here as part of our work on a new National Health and Medical Research Strategy. https://researchaustralia.org/health-and-medical-research-australia-can-do-better/strategic-coordination-of-funding-for-health-and-medical-research/

ENDS

Research Australia is the national peak body for health and medical research, representing stakeholders across the entire health and medical research pipeline. For more on Research Australia, go to: www.researchaustralia.org

Media contact: Peta Garrett – 0400 011 394

2022-23 Pre Budget Submission- a way forward

Research Australia’s 2022-23 Pre Budget Submission acknowledges the COVID-19 pandemic has had an enormous toll on the Australian community and globally, but also recognises that as a consequence of the way Australian governments and the community have responded, the impact in Australia has been comparatively mild.

Australia’s response to COVID-19 has been so broad and deep because of previous investments in the nation’s research and innovation capacity. This capacity, and the funding that underpins it, cannot be taken for granted. There is no guarantee that Australia’s health and medical research and innovation community will be equally well placed to respond to a future pandemic.

Research Australia’s submission makes the case for why maintaining and expanding this existing capacity for health and medical research and innovation is in the national interest.

In addition to raising national prosperity and diversifying our economy, smarter investment in health and medical research and innovation can improve the effectiveness of our health system; constraining the rise in health costs that accompany an ageing population. It can also provide a sustainable pathway to addressing modern lifestyle factors such as obesity. Smarter investment also drives skilled employment in vibrant new pharmaceutical, medical device and biotechnology industries.

Research Australia is advocating for an overarching national health and medical research strategy which ensures smarter, coordinated, strategic public investment in all stages of research; maximises impact on national priorities such as burden of disease, and the stronger translation of evidence-based research into healthcare delivery; and exploits areas of international competitive advantage. Imagining and preparing for the Australia we want in 50 years’ time has to start today.

Research Australia’ s submission is available here.

Privacy Act Review- implications for research

The Attorney General’s Department is currently undertaking a review of the Privacy Act 1988. Several of the proposals for change to the Act, including introducing the concept of anonymisation, have implications for research, but the Discussion Paper does not directly include the way the Privacy Act affects the use of information for research purposes.

Research Australia’s submission highlights these areas and proposes that an expert group be formed specifically to work on the redevelopment of the NHMRC guidelines in parallel with drafting of proposed amendments to the Act.

Research Australia’s submission is available here.

The Review has been completed and the findings are expected to be released in the first half of 2023.

Research must support Primary Health Care 10 Year Plan 2022-2032

Research Australia’s response to the Department of Health’s consultation endorses the direction of the draft Primary Health Care 10 year Plan and welcomes its recognition of the key role research can and must play if reforms are to be achieved. Research Australia has recommended a sustained investment in translational primary care research that is commensurate with the reform task outlined by the 10 Year Plan.

Research Australia has recommended the creation of an Institute for Primary Health Care Translational Research and Innovation and we have outlined in our response to specific questions the critical role this Institute could play in the implementation of the 10 Year Plan. We propose the development of a primary health care research agenda, supporting each action area of the 10 Year Plan. The Institute would be responsible for delivery of this research agenda.

Read Research Australia’s submission here.

Preparing for the next Digital Health Strategy

Research Australia has responded to an invitation from the Australian Digital Health Agency to provide input to the Agency’s planning for the next digital health strategy, due to commence in 2022.

Reflecting on the current Digital Health Strategy, Research Australia has suggested the existing seven pillars are still relevant, and proposed consultation on the new strategy be accompanied by an update on progress on the 2018 Framework for Action. We have also suggested there are some lessons to be learned from the COVID-19 pandemic about the role digital technologies play in health and the capacity for greater advances when the Commonwealth, State and Territory governments share data and cooperate. An example from the pandemic is national vaccine certificates able to be loaded on State government check in apps.

Research Australia’s submission is available here.

Research can help address obesity

Research Australia has used its submission to the Australian Government’s draft Obesity Prevention Strategy 2022-2032 to make the case for a specific research strategy to support the Obesity Prevention Strategy.

An Obesity Research Strategy would identify research priorities and could include research to test and develop interventions and undertake comparative effectiveness studies and clinical trials. The research strategy should be developed with the relevant stakeholders: consumers, care providers and policy makers.

Research Australia’s submission is available here.

The final National Obesity Strategy 2022-32 was released on 4 March 2022 and is available here. Research remains a key enabler, but there is no research strategy and no research funding.