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 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
• 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.
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.
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.
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.
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.
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.
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.
Update: The Bill was passed by the Parliament on 27 November 2018.
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.
As a strong supporter of the My Health Records (MHR) System, Research Australia is keen to see it succeed. We believe it has benefits for individuals, improving the quality, timeliness and completeness of information about a patient that is available to treating health professionals. It also has benefits for the broader community, through improving the safety, quality and effectiveness of our health system and as an important resource for research.
Research Australia’s submission to the Inquiry into the MHR System has emphasised the need to ensure that the public retains confidence in the MHR, and has called for a sustained public information campaign. This campaign needs to acknowledge that individuals are being asked to provide the MHR system with their personal information, and give them balanced information about this risk; acknowledging that while steps are being taken to mitigate the risks there is no guarantee. The benefits of the MHR should also be presented both for the individual and for the broader community.
The commencement of the Opt Out period for the My Health Records (MHR) in July led to heightened concerns about privacy, and in particular the ability of law enforcement agencies and other third parties to obtain access to an individual’s MHR without a court order. The Government has introduced a Bill to amend the legislation and address this issue. Research Australia has made a submission to the Senate Inquiry considering the Bill. Research Australia supports the Bill and the need to ensure public confidence in the MHR.
Research Australia has a made a comprehensive submission to the consultation on the new MRFF Priorities 2018-2020.
Working with our broad membership, Research Australia’s approach was to start with the Strategic Platforms and examine every Priority and all the existing and proposed funding programs. We looked at how well they were aligned, where the gaps were, and what wasn’t working. Research Australia gratefully acknowledges the contribution made by our members through discussions and the exchange of ideas and proposals.
Research Australia proposes that four Priorities be retained in their current form and that a further seven be retained but amended. We also propose five existing Priorities be discontinued and six new Priorities created. Research Australia’s response to the consultation is available here.
With the consultation period now completed, the next stage rests with the MRFF Advisory Board which is responsible for developing and issuing the next Priorities. We wish the Board well with this important task and look forward to seeing the new MRFF Priorities towards the end of 2018.