Supporting further research in mitochondrial donation

Research Australia’s submission to the Senate Inquiry into the Mitochondrial Donation Law Reform (Maeve’s Law) Bill 2021 has endorsed the cautious and rigorous approach the legislation takes to permitting research into the development of mitochondrial donation techniques. The approach of initially allowing mitochondrial donation as part of a clinical trial is an appropriate recognition of the stage of development of this technology. It ensures that mitochondrial donation will only occur with the informed consent of participants and in a highly regulated environment.

Read Research Australia’s submission.

The Senate Committee tabled its report in the Senate on 18 August. Read the report.

The legislation was passed by the Parliament on 30 March 2022.

Budget Update 2021

Summary

The economic impact of COVID-19 continues to dominate the Australian Budget, with tonight’s Budget, the second handed down in just seven months. Like the last one, this is a big spending Budget, but the focus has shifted from providing immediate stimulus to longer term recovery and Australia’s future prosperity. In the health sector, policy reform is focused on aged care and mental health.

Apart from COVID, the biggest health issue the Australian Government has had to grapple with in the last 12 months is aged care. The Royal Commission into Aged Care Quality and Safety provided the Government with 148 recommendations earlier this year. Until tonight, the Government had not provided a substantial response to the report.

This Budget outlines an additional $17.7 billion over five years, seeking to address the needs of aged Australians living at home and those in residential care. This equates to around half of what is called for overall in the Royal Commission’s Final Report. The Prime Minister’s press release states the Government has accepted 126 of the 148 recommendations, we are awaiting the Government’s detailed response to the Royal Commission – particularly the recommendations for dedicated funding for aged care and ageing research. The proposals from the Royal Commissioners in relation to funding for innovation and research have not been funded in this Budget.

Mental Health has also been under the spotlight, including the impact of COVID-19 on mental health. The Productivity Commission provided the Government with a report last year on what could be done to improve mental health, and earlier this year the Department of Health and Ageing consulted on what measures from the report should be implemented, and when.

Tonight’s budget provides $2.3 billion over four years from 2021-22 for the National Mental Health and Suicide Prevention Plan, including initiatives to be progressed with states and territories for a new national agreement on mental health and suicide prevention. The Government has indicated that it has accepted all the recommendations of the Productivity Commission Report on Mental Health and that the funding announced tonight is only phase one of its response. The only research specific funding announced as part of this package is establishment of an Eating Disorders Research Centre as part of a $26 million package of funding for eating disorders. Further funding for research-related aspects of the Productivity Commission’s recommendations may follow in future budgets. There is $117.2 million for data collection, in part to establish the evidence base for reforms. We will be seeking the advice of key mental health research experts to understand how this data can inform continuous, evidence-based improvement in mental health care for Australians.

While Preventative Health has gained attention from the Government in the last couple of years, the National Preventive Health Strategy is still very much a work in progress and there is only very limited additional funding for preventive health in tonight’s Budget. There is $1.9 million in 2021-22 for preventive health research and scoping activities, including a national health literacy strategy, to inform the National Preventive Health Strategy. Research Australia has previously advocated the need to improve health literacy (and digital health literacy) as a key measure to address health inequity and enable all Australians to better use technology to manage their health.

One of the key lessons from the COVID-19 pandemic is that we have become overly reliant on global supply chains for vital materials. This drove a new focus in last year’s Budget on manufacturing, with the announcement of $1.3 billion over five years from 2020-21 for the Modern Manufacturing Initiative. While the Government seems satisfied this is enough, Research Australia believes more needs to be done, and has proposed raising annual Government spending on R&D to 0.75% of GDP, setting a target for Australia to become a net exporter of pharmaceuticals by 2035, and using the Government’s influence as a key buyer of products and services to boost Australian innovation.

A key measure in this regard is a patent box; a tax deduction provided to companies that manufacture in Australia using Australian developed IP (patents). The patent box will only apply to income derived from Australian medical and biotechnology patents, with consideration to be given to the clean energy sector. It provides a concessional effective corporate tax rate of 17 per cent, with the concession applying from income years starting on or after 1 July 2022. Such a scheme has operated in the UK for many years and is designed to support high value manufacturing in Australia, complementing the R&D Tax Incentive. Research Australia has been a long-term advocate of patent box tax treatment, along with CSL and others in our sector, and this is a significant win for health and medical research.

Much has been said recently about mRNA manufacture of vaccines and therapeutics, with the Victorian and NSW Governments both announcing support and Victoria proposing to invest $50 million. In the Budget tonight the Government has announced that it, too, is acting. It will provide an undisclosed amount of funding (commercially sensitive) to the Department of Industry, Science, Energy and Resources to work with the Department of Health to develop an onshore mRNA vaccine manufacturing capability in Australia. Research Australia called for  such a commitment from the Government in our Pre-Budget Submission and we have been calling for this facility privately and publicly, to encourage this sovereign capability .

While the MRFF funding proceeds as outlined in the Government’s MRFF 10 year Plan, the funding to the NHMRC’s Medical Research Endowment Account continues to decline in real terms.

Medical Research Future Fund

Funding from the MRFF

The MRFF reached the target of $20 billion of capital in August 2020. Tonight’s Budget sees this balance maintained over the forward estimates.

Forecast spending from the MRFF remains largely as expected over the forward estimates. While only $455 million is available from the MRFF to fund research and innovation in 2021/22 due to lower-than-expected investment returns, the Government is maintaining spending this financial year by providing an additional $175 million for MRFF funding from consolidated revenue (announced in the December 2020 mid-year budget). At this stage the Government expects the investment returns to recover this financial year, with $650 million available to fund medical research and innovation in 2022/23.

MRFF expenditure

$m. 20-21 21-22 22-23 23-24 24-25
MRFF Funding 2021 Budget 579.9 455.0 650.0 650.0 650.0

NHMRC and ARC Funding

In Research Australia’s Pre- Budget Submission and our Pre-Election Statement we continue to call for increases in funding for the NHMRC and ARC’s research programs. This Budget sees both schemes continue to decline in real terms, which is of genuine concern to the health and medical research community.

NHMRC Programs

The 2021/22 Budget reveals funding for the NHMRC’s programs continuing to grow very slightly, and only slightly faster than was forecast in last year’s budget. The increase in this financial year is 1,1%, with annual increases of around 1% thereafter. This is lower than the forecast CPI of 3.5%% for 2020-21 and CPI of between 1.75% and 2.5% expected in subsequent years. In effect, NHMRC funding continues to decline in real terms, as it has done for many years now. Research Australia remains concerned about this deficit because research and its outcomes is a long-term commitment.

NHMRC MREA Funding

$m. 20-21 21-22 22-23 23-24 24-25
Funding to MREA

2021 Budget

853,864 863,266 875,362 887,588 899,124
Funding to MREA

2020 Budget

853,864 862,412 872,770 884,960 N/A

ARC Programs

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

Over the forward estimates, the funding to the ARC for the Discovery Program increases slightly each financial year and while higher than in last year’s Budget, the funding is at significantly lower levels than forecast in the 2019 Budget. In real terms funding to the Discovery Program declines over the forward estimates. Again, a cause for concern.

$m. 20-21 21-22 22-23 23-24 24-25
Discovery 2021 Budget 483,272 489,188 494,922 501,162 509,432
Discovery 2020 Budget 483.272 487.016 487.860 490.610
Discovery 2019 Budget 513.542 525.537 538.350 N/A

The ARC Linkage Program has been singled out by the Government as an important component of Australia’s innovation system, and it was announced that from 1 July 2016 the Program would be open to continuous applications and decision making would be fast tracked.

Funding over the forward estimates is higher than forecast in last year’s budget, but future years fail to keep pace with inflation.

$m. 20-21 21-22 22-23 23-24 24-25
Linkage 2021 Budget 323.166 325.454 329.948 334.109 339.622
Linkage 2020 Budget 322.181 323.871 325.240 327.074 N/A
Linkage 2019 Budget 288.788 295.246 301.741 N/A N/A

 While not funding ‘medical and dental research’, the ARC Linkage program remains important to the health and medical research and innovation sectors.

Research Support

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

In last year’s 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 is provided in this year’s Budget and funding in is actually lower than was forecast in the 2019 Budget.

Research Support Program

$m. 20-21 21-22 22-23 23-24 24-25
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 1,018.879 1,042.302 N/A N/A N/A

Funding for the indirect costs of research funded by the MRFF is now provided from the Research Support Program. With the MRFF providing hundreds of millions of dollars in funding to universities over the next few years, beyond this financial year, 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 Australia proposes that the Chief Scientist lead a review of the funding of indirect research costs to establish a sustainable and equitable funding program. In the short term, the pool of funding for the Research Support Program must be increased substantially.

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 have only partly recovered in this year’s Budget.

Research Training Program

$m. 20-21 21-22 22-23 23-24 24-25
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

Industry PhDs

The Department of Industry will provide $1.1 million over two years from 2020-21 to create new employment pathways for students and boost financial incentives for universities to enrol students in ‘Industry PhDs’. This measure will introduce an additional weighting in the Research Training Program funding formula for PhD students who undertake an industry placement.

Research Commercialisation

In last year’s Budget the Government committed funding for a scoping study for a University Research Commercialisation Scheme to better translate and commercialise university research outputs. The development of the Scheme is still in train and there is no funding for the Scheme in this year’s Budget. It looks like this might have to wait until next year. Research Australia remains actively engaged in consultation with the Department of Prime Minister and Cabinet on this Scheme.

CRC Program

Funding forecasts for the CRC Program reflect a shift in some funding between 2019-20 and 2020-21. Beyond that, they are slightly lower over the forward estimates.

CRC Program $million

$m. 20-21 21-22 22-23 23-24 24-25
2021 Budget 222,777 189,980 197,815 191,042 193,807
2020 Budget 234,168 189,040 186,378 188,599 N/A
2019 Budget 187,356 192,239 191,223 N/A N/A

The CRC Program is important to health and medical research and innovation with about one third of the CRCs funded over the life of the program being health related.

Conclusion

Research Australia will continue to provide analysis and comment in the coming days and weeks as well as seek further input from across the membership for your reactions and insight into the policy and funding announced for our sector; and how it affects or enhances your research and related activities as a result.

Ends …..

 

 

 

 

 

A Preventive Health Strategy for Australia enabled by research

Following a Discussion Paper released in 2020, the Australian Government released a draft National Preventive Health Strategy for consultation in early 2021.

Research Australia’s response to the consultation emphasises:

    • the critical role of research in supporting the evaluation of existing programs and measures and the development and implementation of new programs;
    • the importance of the proposal to increase funding for preventive health measures to 5% of health expenditure by 2030; and
    • while providing information is an important tool to empower and support people, supporting people to make the best possible decisions also require practical strategies and programs that can support and incentivise behaviour change, and policies that make it easier for people to make healthy choices.

Research Australia’s submission is available here.

Our response to the earlier 2020 Discussion paper is available here.

University Research Commercialisation

The Australian Government is undertaking a scoping study to understand how to best implement a University Research Commercialisation Scheme to better translate and commercialise university research outputs. It has appointed an Expert Panel and issued a Discussion Paper.

Research Australia’s response to the Discussion Paper addresses the role of ‘Missions’, the use of stage-gating and the role of co-funding by Governments, universities and industry. It highlights the critical need to better align existing funding programs and fill the gaps to provide a more seamless approach to research funding from basic research through to commercialisation.

Research Australia’s submission is available here.

Better Use of Commonwealth Data

The Data Availability and Transparency Bill is intended to improve researcher access to datasets held by Commonwealth Government Departments and Agencies.  Its introduction to Parliament follows a three year consultative development process triggered by recommendations for legislative reform contained in the Productivity Commission’s report on the Availability and Use of Commonwealth Government Data. The Bill is the subject of an Inquiry by a Senate Committee.

Research Australia has been closely engaged with the development of the Bill and is supportive of its passage through Parliament. Our submission includes case studies of the public benefits that can be achieved from the use of health data, and the current barriers to access and use of data.

Research Australia’s submission is available here.

 

Medical Products Roadmap Consultation

Research Australia has responded to the consultation being undertaken by the Department of Industry, Science, Energy and Resources to support the development of a Medical Products Manufacturing Roadmap under the Modern Manufacturing Initiative announced in the October 2020 Budget. Medical products is one of six strategic areas being targeted under the MMI for Government spending of $1.3 billion over five years.

The Consultation was undertaken using an electronic survey restricted the length of the response to each question. Research Australia’s response emphasises:

    • the opportunity to support the manufacture of products and materials for clinical trials;
    • the opportunity this provides to scale to full scale manufacturing, keeping the full scale manufacturing of medical products developed in Australia on shore; and
    • the opportunity to support manufacturing in high value medical products.

Research Australia’s submission is available here.  These proposals were further developed in Research Australia’s January 2021 Pre Budget submission, available here.

The Government subsequently released the Medical Products National Manufacturing Priority Roadmap in February 2021. Research Australia’s proposal to support manufacturing for clinical trials as part of the Roadmap was adopted, and identified as a pathway to scaling up of manufacturing capability. The Roadmap is available here.

Improving approval processes for new drugs and medical technologies

Research Australia has responded to the Parliamentary Inquiry into the Approval Processes for New Drugs and Medical Technologies.

Opportunities exist to change our approval processes to benefit patients and better support research and development in Australia. Faster and more effective approval processes mean new medicines and technologies reach patients faster. Improving the environment for clinical trials enables Australian patients to benefit from the latest medicines and technologies developed overseas while also helping Australian health and medical research to flourish in a competitive and lucrative world market. Research Australia’s submission identifies some of these opportunities with the twin objectives of improving Australians’ health and prosperity.

Research Australia’s submission is available here.

The Committee is expected to hold public hearings in early 2021.

Budget Update 2020

Summary

The global economic impact of COVID-19 has been the overwhelming influence on the Budget handed down tonight. This is a big spending Budget, the biggest Australia has seen, focused on providing immediate stimulus to the economy but also laying the foundations for a future Australia, shaped by the lessons of the last nine months.

Most relevant to health and medical research are the following key announcements:

    • Last year’s forecast budget spending on health for 2020-21 was $82.5 billion. This forecast has been revised up to $115.5 billion, as we begin to see just how much COVID-19 is driving up healthcare costs. In the coming months and years, Australians will look to health and medical research and innovation to deliver more effective treatments and more efficient pathways of care to curtail these costs. Research Australia will continue to work with Government to ensure support for the crucial role all parts of the health and medical research pipeline have to play in delivering better, more sustainable care.
    • An extra $1 billion this financial year through the Research Support Program for our university researchers will be critical to maintaining Australia’s national health and medical research capability. More than half of all Australian health and medical research in Australia is undertaken in the higher education sector. It is clear that Australia can no longer rely so heavily on international student fees to subsidise research. In the long term, we need to look at effective partnerships between higher education, government, industry and philanthropy. The commitment in this Budget to supporting university research jobs is a welcome interim step towards establishing a more sustainable higher education sector.
    • The Government will restore an additional $2 billion over 4 years through the Research and Development Tax Incentive to help innovative businesses that invest in research and development. It is doing this by reversing some of the changes to the R&DTI legislation that are currently before the Senate.
    • The budgets for the NHMRC and MRFF remain virtually unchanged. At the same time, researchers are dealing with extra costs to their funded project due to the delays and disruptions caused by COVID-19. While the universities benefit from the one-off increase in the Research Support Program, there is no similar support for researchers in Medical Research Institutes. Research Australia remains concerned that NHMRC funding has not increased over the forward estimates to keep pace with inflation, with the net effect that NHMRC funding continues to decline in real terms.

Broader Context:

One of the key lessons from the COVID-19 pandemic is that we have become overly reliant on global supply chains for vital materials. This is driving a new focus on manufacturing and there are new roadmaps being developed which will, hopefully, join the dots between research, product development and manufacturing more successfully than has been done in the past. $1.3 billion over five years from 2020-21 will establish the Modern Manufacturing Initiative to: support manufacturing projects focused on building long-term business collaboration at scale; translating research into commercial outcomes and bringing new products to market; and integrating local firms to deliver products and services into global value chains. New roadmaps to guide the Modern Manufacturing Strategy are due in time for the 2021 Budget, in six months’ time, including for medical products.

Manufacturing accounts for around 6% of Australia’s economic output but is responsible for a quarter of all industry spending on R&D. However, Australia’s business spending on R&D is low by world standards. If Australia is to achieve the objectives of the Modern Manufacturing Strategy this will have to change, and we have to better connect business with Australia’s powerhouses of research, our universities and medical research institutes.

The Government has made several attempts to reform the R&D Tax Incentive in recent years, and tonight’s Budget is no exception. The R&DTI is critical to increasing business expenditure on R&D in Australia, and thus to the Modern Manufacturing Strategy. The Government is reversing several of the measures which are currently sitting before the Senate. For small business, the $4 million cap goes, and the rate is fixed at 18.5% above the company tax rate. For large companies the number of tiers in the intensity threshold will be reduced to two, with the RDTI paid at a rate 8.5% and 18.5% above the company’s tax rate for tiers one and two respectively. This is expected to increase the amount of R&DTI paid to industry by $2 billion over the forward estimates, compared to the amounts that would have been paid if the legislation had been amended in accordance with the Government’s previous plan.

 

Continue reading “Budget Update 2020”

Doherty Institute first to share successfully grown Wuhan Coronavirus

Scientists from the University of Melbourne and The Royal Melbourne Hospital’s Doherty Institute are the first to share successfully grown Wuhan Coronavirus in a laboratory setting. As a member of Research Australia, we commend the University of Melbourne and the Doherty Institute for their important breakthrough that will play a key role in speeding up diagnosis and aid in the development of a vaccine.

Click here to view the Doherty Institute’s media release.

Data Sharing- developing new legislation

Research Australia has responded to the Australian Government’s latest Discussion Paper on the development of Data Sharing legislation. The legislation aims to improve the sharing of data by Australian Government departments and agencies.

Research Austrlaia’s submission has urged further consideration be given to how public benefit and commercial use are to be defined and how tests for these might be applied. It has also supported the approach to the accreditation of research institutions and individuals, and  cautioned against ethics approval by an HREC becoming a default requirement for all data sharing applications.

Research Australia’s submission is available here.

The next stage will be the release of draft legislation for consultation, expected in early 2020.