Better regulation of complementary and unconventional medicine and emerging treatments

Health and medical research enjoys strong public support because people recognise that health and medical research leads to safer, higher quality and more effective healthcare. Research Australia’s members work hard to contribute to an evidence-based healthcare system that is continually improving the healthcare delivered to patients. This is achieved through the development of new treatments based on scientific evidence which have been rigorously tested and evaluated to ensure they are safe and effective.

In doing so, our members have helped create the impression that all existing healthcare is evidence-based, safe and effective. When this is not the case, we have an obligation to ensure that people are aware that what they are receiving is not routine care, and to alert them to the associated risk and other matters they should consider. Research Australia’s submission to the Medical Board of Australia has called for clear and prominent consumer warnings to be provided when consumers are being offered complementary and unconventional medicine and emerging treatments by medical practitioners that aren’t part of a registered clinical trial.

Research Australia’s submission

 

 

Supporting Clinical Quality Registries – towards a national strategy

Clinical Quality Registries (CQRs) collect and use data about patients’ treatments to improve the delivery of healthcare. CQRs already play a vital role in helping Australia deliver safer, higher quality healthcare, but the approach to CQRs in Australia is ad hoc and fragmented. The Australian Commission for Safety and Quality in Healthcare has been working for more than a decade to improve this situation and the Australian Government has recently released a draft National CQR Strategy for the next 10 years.

Research Australia made a submission in response to the Draft Strategy, welcoming the progress being made in this area, and making suggestions for how the Draft Strategy could be improved. These include broadening the focus from the clinician/patient relationship to capture other patient interactions with staff that affect health care. Accreditation of CQRs and a sustainable national funding model with the support of state and territory governments are also critical elements for the Strategy.

Research Australia’s submission is available here.

2019 Budget Update

Summary

Notwithstanding a slowing global economy, the 2019 Federal Budget provides an optimistic forecast for Australia’s economic future, with a forecast return to Budget surplus, tax cuts and several new funding announcements, as might be expected with an election to be held within weeks.

The imminent election means less certainty than usual around whether all Budget announcements will be implemented. While health and medical research is fortunate to have strong bipartisan support, if the Government changes at the next election so could some spending priorities. With that proviso, the following is what we know about Budget announcements tonight relating to health and medical research.

The Medical Research Future Fund (MRFF) remains on track to receive a massive $7.8 billion capital injection in 2019/20 and to reach its capital target of $20 billion by 2020/21.

Since January we have seen more than $800 million in MRFF funding announcements committed to new programs spanning up to a decade, and a 10 year plan for nearly $5 billion in MRFF funding has been announced tonight.

The NHMRC funding announced tonight provides for continued small increases in funding over the four year budget estimates, at less than the rate of inflation. While the same is largely true for the Australian Research Council Funding programs, funding for the Research Support Program has been cut significantly, hampering the ability of our universities to conduct research.

Read on for more detail.

Medical Research Future Fund

$20 billion in capital by 2020/21

As at 31 December 2018 the Medical Research Future Fund (MRFF) had $9.4 billion in capital. Tonight’s Budget maintains the Government’s commitment to reach the target of $20 billion in capital by 2020/21, with a forecast balance of $20.2 billion at 30 June 2021. $7.8 billion is scheduled to be added to the capital in the next financial year, by far the single largest capital injection since the MRFF’s inception. A further $2.5 billion in 2020-21 would take the balance to a little over $20 billion. We will watch with interest to see how the commitment to $7.8 billion in 2019-20 plays out.

MRFF Capital Injections

$m. 18-19 19-20 20-21 21-22
Capital to the MRFF 2,288.550 7,830.490 2,522.178 Nil

Funding from the MRFF

Forecast spending from the MRFF remains largely as expected, over the forward estimates, with $396 million available to fund medical research and innovation in 2019/20, rising to $650 million by 2022/23. The forecast for 2020/21 is $579.9 million, some $70 million less than was forecast in the Budget last year. The likely explanation is that the Department is unable to keep up with the rapid increase in the funding available, and is opting to spend wisely rather than quickly. Any funds not spent remain in the MRFF and are available in following years.

MRFF expenditure

$m. 18-19 19-20 20-21 21-22 22-23
MRFF Funding 2019 Budget 222.4 396.0 579.9 646.0 650.0
MRFF Funding 2018 Budget 222.4 392.7 650.2 646.0 N/A

MRFF Funding Announcements

The Budget included numerous announcements of further funding to be made in the next financial year and further years, with a plan over 10 years, allocating nearly all available MRFF funds over that period. Nearly all of this is the continuation of programs and Missions that have already been funded, including providing funding of $70 million per annum for the Frontiers program instigated by Research Australia from 2021-22.

The surprise inclusions in the MRRF funding announcements are two programs funding research and innovation infrastructure. The first of these is $605 million over 10 years for National Critical Infrastructure. Starting with $5 million in 2019-20, it rises to $75 million per year from 2022-23. This is the Health Portfolio’s contribution to funding of the 12-year National Research Infrastructure Investment Plan announced in last year’s Budget.

The second is a smaller program of funding for Data Infrastructure, expected to fund registries, biobanks and data linkage. This Program provides $10 million a year from 2020-21, and applications for funding are expected to be called for soon.

Together these programs represent a very significant investment in infrastructure, totaling $685 million over 9 years, and nearly $1 in every $7 of MRFF funding over the 10 year plan.

Health and Medical Research Office

Tonight’s Budget also includes $20 million over the next four years to create the Health and Medical Research Office (HMRO) within the Department of Health. The new HMRO will oversee the rapidly increasing level of investments made by the MRFF. It will have its own CEO, appointed by the Secretary of Health, ensuring the MRFF continues to have ‘the right administrative support.

‘The new CEO will be a contact point for greater community and international engagement, provide greater expertise around investments from the MRFF and ensure greater expertise around developing HMR strategy and policy.’

NHMRC and ARC Funding

In Research Australia’s Pre- Budget Submission and our Pre-Election Statement we have called 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 2019/20 Budget reveals funding for the NHMRC’s programs falling in real terms. Funding to the Medical Research Endowment Account (MREA) for the NHMRC’s research programs is $842.766 million for 2018-19. Continuing the pattern of last year’s budget, the estimates for the following three years have the funding remaining virtually stable with increases of roughly 1.5% each year.

The CPI was 1.8% for the year to 31 December 2018, so in real terms Government funding to the MREA continues to decline over the forward estimates, as it has for several years now.

(In Budget Paper 1 at page 9, the following forecast for CPI is provided. ‘Consumer price inflation is forecast to be 2¼ per cent through the year to the June quarter 2020 and 2½ per cent through the year to the June quarter 2021.’)

NHMRC MREA Funding

$m. 18-19 19-20 20-21 21-22 22-23
Funding to the MREA 2019 Budget 829.324 842.766 856.250 869.950 883.870

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 declines slightly in later years compared to the estimates in last year’s Budget, a trend that has been continuing for three years now. The increases year on year are a little greater than the current inflation rate of 1.8% and around the forecast CPI.

$m. 18-19 19-20 20-21 21-22 22-23
Discovery (2019 Budget) 493.951 507.044 513.542 525.537 538.350

The Linkage Program was singled out in the Government’s National Innovation and Science Agenda (NISA) 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 lower than forecast in last year’s budget and shows increases at around the rate of CPI.

$m. 18-19 19-20 20-21 21-22 22-23
Linkage (2019 Budget) 265.974 279.168 288.788 295.246 301.741
Linkage (2018 Budget) 273.990 285.432 293.492 297.862 N/A

 While not funding ‘medical and dental research’, the ARC Linkage program remains important to the health and medical research and innovation sectors. For example, the latest round of ARC Linkage Program grants included funding for tissue engineering of blood vessels and the reduction of anxiety in children with autism.

Research Support

In addition to providing funding for the ARC Program, the Department of Education and Training also provides funding to universities to help cover the indirect costs of research. The Research Support Program has suffered significant cuts compared to the Budget forecasts for last year; funding for 2019-20 is more than $50 million lower than forecast last year, and nearly $100 million lower in 2021-22.

Research Support Program

$m. 18-19 19-20 20-21 21-22 22-23
2019 Budget 894.016 902.062 920.573 941.748 962.455
2018 Budget 903.425 959.816 1,018.879 1,042.302

Funding for the indirect costs of research funded by the MRFF is now to be provided from the Research Support Program. With the MRFF providing hundreds of millions of dollars in funding to universities over the next few years, 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 represent a real 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.

CRC Program

Funding forecasts for the CRC Program are largely in line with last year’s budget. The program is forecast to receive $922 million over the period from 2018/19 to 2022/23.

CRC Program $million

$m. 18-19 19-20 20-21 21-22 22-23
2019 Budget 167,341 184,150 187,356 192,239 191,223

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. The most recent round of CRC funding included $55 million over 7 years for the Digital Health CRC.

A new Framework for Clinical Trials

Research Australia has responded to the draft National Clinical Trials Governance Framework developed by the Australian Commission on Safety and Quality in Health Care. The subject of an extensive consultation, Research Australia is confident the final Clinical Trials Governance Framework will be an important step forward in improving Australia’s capacity to undertake clinical trials and to improve safety, quality and effectiveness. Research Australia’s submission addresses three areas where further clarity can be provided and improvements made.

Research Australia’s response to the Clinical Trials Governance Framework

Research to support Victorian Mental Health Royal Commission

Research Australia has responded to the Victorian Government’s consultation on the Terms of Reference for the Victorian Royal Commission into Mental Helath.

Research Australia has recommended the adoption of two specific Terms of Reference. Firstly, we recommended a Term of Reference to identify how health and medical research can be better utilised to:

• identify quality, effective mental health interventions (including for prevention and

early intervention);

• support the more rapid and comprehensive adoption of evidence-based

interventions and models of care in Victorian mental health services;

• improve the safety and effectiveness of Victorian mental health services; and

• develop effective quality care indicators and quality assurance mechanisms.

Secondly, we have recommended the adoption of a Term of Reference requiring the Commissioners to identify specific areas, where it becomes evident during the course of their Inquiry, that more research is needed. Research Australia’s submission is available here.

Research Australia is now awaiting the commencement of the Royal Commission, and the opportunity it provides to highlight the role research can play in improving the mental health of all Victorians.

Pre-Budget Submission calls for smart investments in research and innovation

Research Australia’s Pre-Budget submission to the Australian Treasurer recognises the positive policy developments in the last 12 months and the not so positive. It provides 16 recommendations across 8 broad themes for implementation in the 2019/20 Budget.

These include fully capitalising the MRFF; reversing funding cuts to NHMRC and ARC funding programs and the research block grants; finalising and implementing the Digital Economy Strategy; and leaving the R&D Tax Incentive alone.

Better use of data is once again a key theme of Research Australia’s submission. If we are to make the most of our national investment in digital health we need to increase data capability in Government departments and agencies. Beyond this we need to raise levels of digital health literacy across the community to enable all Australians to better manage their health and avoid exacerbating existing health inequities in Australian society.

Read Research Australia’s submission

Research Australia opposes cuts to R&D Tax Incentive

In the May 2018 Budget the Government  proposed a series of changes to the R&D Tax Incentive which would further reduce the support it provides to private sector R&D activity. While advocacy by Research Australia and others has succeeded in having clinical trial expenditure by small companies exempted form the cuts, several of the other changes remain a concern. Research Australia’s submission to the Senate Inquiry on the new legislation has put the case for why the cuts should be rejected by the Senate.

Research Australia’s submission

On 11 February 2019, the Senate Committee handed down its report. It recommended that ” that the Senate defer consideration of the bill until further examination and analysis of the impact of schedules 1–3 is undertaken. In particular, the committee recommends that:
• the approach to the cap on the refundable portion of the Research and Development (R&D) tax incentive is refined, noting investment decisions already taken; and
• the formula for R&D intensity is refined, noting inherent differences in R&D intensity across industries and impacts on businesses with large operating costs.”

Research Australia welcomes the decision and is pleased the legislation is not proceeding in its current form.

 

No place for exaggeration in advertising medicines

The advertising of medicines in Australia is subject to strict controls. The new Therapeutic Goods Advertising Code, due to commence on 1 January 2019, emphasises the importance of truthfulness and accuracy in all claims made in advertising for medicines, and the need for advertising to support consumers’ informed decision making.

The TGA has developed draft guidance to assist with the interpretation of the new Code, and discusses ‘puffery’, a claim so exaggerated that no reasonable person could take it seriously. The Guidance suggests that puffery may be permissible in the advertising of medicines. Research Australia’s position is that this should not be the case. It is both inconsistent with the Code and the low levels and wide variability of health literacy in Australia.  Some vulnerable consumers can be misled and unduly influenced by exaggerated claims that would be dismissed by most consumers as unbelievable and just ‘marketing’. It is our position that puffery should not be permitted in the advertising of medicines.

Research Australia’s submission

Update: The TGA issued a final version of the Guidance on the Advertising Code (and an amended Therapeutic Goods Advertising Code) on 31 October. The new Guidance states ‘Puffery by its nature is not truthful. It is exaggerated, inaccurate and unsubstantiated and should not be used in advertisements for therapeutic goods.’ 

The Code and the Guidance are available from the TGA website.

New Electoral Act amendments remove red tape for charities

Research Australia’s submission to the initial draft of the Electoral Legislation Amendment (Electoral Funding and Disclosure Reform) Bill 2017, in January 2018, highlighted that the Bill would have a disproportionate and unintended impact on the not for profit sector, including many health and medical research organisations. We called for the Bill to be amended to avoid these unintended consequences, and are gratified to see that this outcome has been achieved with the latest amendments.

The health and medical research sector is regularly invited to respond to reviews and consultations by Government departments and agencies and to Parliamentary inquiries. We are pleased to see that these activities do not fall within the new definition of electoral matter or the associated definition of electoral expenditure, effectively resolving our concerns with the previous iteration of the Bill.

Research Australia’s submission

Update: The Bill was passed by the Parliament on 27 November 2018.

Research to improve the safety and quality of Aged Care

Australians have been shocked by the recent revelations of abuse in our Aged Care System, and have welcomed the announcement of a Royal Commission.

Research Australia believes research can play a critical role in delivering safe, high quality aged care and has urged the Government to consider the role for research in developing the Terms of Reference.

Our submission to the Government, responding to the two specific questions posed in the electronic form, is available here.