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.
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The TGA has developed draft guidance to assist with the interpretation of the new Code, and discusses ‘puffery’, a claim so exaggerated that no reasonable person could take it seriously.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.
The Productivity Commission has recommended that if Australia is to make better use of Government held data, including for research purposes, the law needs to be changed. The Government has acted on three key recommendations of the Productivity Commission in its proposal for new Data Sharing and Release legislation. This includes providing a new framework and guidance for the release of data by Government departments and agencies; creation of a new National Data Commissioner (NDC), to oversee the Framework and champion the release and use of data; and the creation of accredited ‘trusted users’ to facilitate access to data by researchers.
Research Australia’s submission is broadly supportive of the proposals in the Paper but has suggested an expanded role for the NDC and raised some concerns about how the accreditation of ‘trusted users’ will be implemented. The Department of Prime Minister and Cabinet has committed to further consultation and we await the development of draft legislation by the end of 2018.
Research Australia has made a submission in response to the draft amendments to the R&D Tax Incentive legislation, the latest round of changes since the legislation commenced seven years ago. Research Australia’s submission addresses two key issues.
The first is our concern that the definition of clinical trial is not broad enough to ensure the exemption from the $4 million cap on R&D expenditure will apply to all clinical trials activity, particularly for medical devices. We have worked with other peak bodies, including Ausbiotech and BioMelbourne Network, to propose an alternative and more inclusive definition.
The second main concern relates to the proposed reduction in the rate of the R&D Tax Incentive. For early stage companies seeking to commercialise new pharmaceuticals, biotechnologies and devices, this has the effect of directly reducing their cashflow at a critical stage in their development. Research Australia has opposed the rate reduction.
Research Australia’s submission to the Parliamentary Inquiry into Research Funding has proposed a review across all funding agencies and government departments to eliminate unnecessary inconsistencies in application guidelines, processes and acquittal procedures. We also called for the development of a common approach to the calculation and payment of funding to cover the indirect costs of research.