Research Australia has made a submission to the Senate Committee inquiring into the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017. This Bill is the latest instalment in amendments to implement the recommendations of a Review conducted in 2015 with the aim of improving the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration (TGA), and to provide consumers with better information.
Research Australia has supported the amendments to improve access to potentially lifesaving medicines for patients with few or no other options. In doing so, it will implement a scheme that is similar to those already operating in the USA and European Union.
Research Australia has also supported the proposed changes to the marketing of complementary medicines, although we have urged the Senate Committee to recommend the legislation be amended to include disclaimers to the effect that the efficacy claims for the products have not been independently assessed and/or are based on traditional use rather than scientific evidence.
Research Australia Submission on the TGA amendments.
Research Australia’s submission to the Treasurer has urged him to use next year’s budget to invest in the implementation of the many forward looking policy initiatives the Government has undertaken in the past two years. From increasing access to data, developing a research infrastructure investment Plan and fully capitalising the MRFF, there are plenty of opportunities to lay the foundations for the knowledge based economy Australia needs to prosper in the future.
Our submission also emphasises how further investment in health and medical research and innovation is central to this plan for a healthier and more productive population, a more efficient healthcare system and a more prosperous Australia.
Research Australia’s Pre-Budget submission
Research Australia’s submission in response to the NHMRC’s Peer Review Consultation has urged the NHMRC to consult further on options for a two stage application process for the Ideas Grants.
There is considerable interest within our membership and across the health and medical research sector in a two-stage application process, and while there is not yet agreement on the approach, there is an appetite for change. Research Australia believes that a two-stage application process for Ideas Grants, incorporating an abbreviated application at the first stage, provides the chance to reduce the burden on applicants and reviewers alike, while better supporting the objectives of Ideas Grants to promote innovative and novel research.
In particular, the process could provide the focus on novel and innovative ideas and reduced emphasis on track record that the NHMRC is seeking. Research Australia’s submission explores the opportunity to adopt a two-stage application process for Ideas Grants and puts forward some considerations for further investigation and consultation.
Research Australia’s submission
Research Australia’s submission to the Department of Industry, Innovation and Science’s consultation on a Digital Economy Strategy has emphasised the importance of digital innovation in the heath sector to Australia’s economy, national wellbeing and future prosperity.
It highlights a number of current initiatives in the health sector that are relevant to digital innovation and makes twelve recommendations to improve the adoption of digital technologies in health; increase innovation in healthcare delivery; and make better use of health data.
Research Australia’s submission
With the My Health Record gaining wider acceptance, the Australian Government has commenced a consultation on how this data should be used in future for research and public health purposes. The challenge is to establish a Framework that adequately protects individuals’ identities without unnecessarily restricting who can access the data for research purposes, how they can use it, and the time it takes to get access. This is the balance that Research Australia’s submission emphasises- datasets should be as available as possible to researchers, subject to adequately protecting individuals.
The consultation paper on the Framework ruled out the use of My Health Record data for commercial purposes, which is contrary to Government policy as outlined on the Australian Government Public Data Policy Statement. Another complication is that the Framework is being developed in advance of the Government’s response to the Productivity Commission Report on Data Availability, which has proposed a range of significant changes including creating a new National Data Custodian and allowing ‘trusted researchers’ to access identified data. Research Australia’s submission has emphasised the need for the Framework to be forward looking, so as to accommodate future developments is what is a fast moving policy area.
The changes in April this year to occupation lists for temporary work visas highlighted how important both temporary and permanent migration are to Australia’s knowledge economy. While our world is increasingly reliant on electronic forms of communication, the capacity of people to travel from one country to another for the exchange of knowledge and expertise remains essential.
Research Australia’s submission to the Department of Immigration and Border Protection’s visa and immigration review has highlighted the need for reforms that ensure Australia remains open to the permanent and temporary migration of researchers; and for faster, simpler processes for the issue of temporary visas to researchers coming to Australia to collaborate with Australian colleagues or to use Australian research facilities. It proposes that individuals with PhDs are a valuable and scarce global resource, and that subject to normal background checks there should be a presumption that an individual with a PhD will be allowed entry to Australia. Age limits and restrictions should not be applied to individuals with PhDs and/or with commercialisation expertise, particularly where they have an employer sponsor and/or the application is for temporary residency.
Response to the Policy Consultation paper on Visa Simplification
As we are all too aware, Australia scores poorly on the translation of its research discoveries into new products and services. We need to improve the extent to which Australia’s research effort is directed to the questions and problems of greatest importance and how effectively our research is applied to provide solutions.
Bringing research and innovation together in the one Strategic Plan provides an opportunity to drive these improvements and to overcome some of the historic divides between programs to invest smartly in research and in programs to support and drive innovation. In addition to the research, innovation and investment communities, active engagement with the state and territory governments will be vital; it needs to be a ‘whole of governments’ strategy.
Just as importantly, the 2030 Strategic Plan needs a whole of community communication strategy to ensure all levels of society understand the imperative for a greater and more strategic investment in research, technology and innovation, and the benefits this can bring as we plan for the Australia we want in 2030.
Download Research Australia’s submission here.
Research Australia has made a submission to the Senate Select Committee Inquiry into Funding for Research into Cancers with Low Survival Rates. Many of the Terms of Reference have relevance beyond brain cancers, cancers with low survival rates and low incidence cancers; our submission approaches the Inquiry from this broader perspective.
Government funding available for health and medical research is finite. While cancers with low survival rates are undoubtedly worthy of more funding, any increase in funding for one area has implications for the funding available to other disease areas. Improvements in survival are related to global research rather than specifically to the volume or subject of Australian research, and it is important that Australian researchers and patients have access to, and contribute to this global effort. This is particularly relevant for low incidence cancers and other rare diseases, because the number of patients in Australia is likely to be low and appropriate research collaborators are in many cases likely to be based overseas. Thus, when allocating funding we also need to consider the level of funding available and the research activity undertaken globally.
Research Australia also suggests there is merit in looking at approaches taken by other countries. This includes strategies such as rare disease policies that have been established in more than 20 countries as a means of providing a policy framework for a considered and comprehensive approach to the provision of research, diagnosis and access to treatment for rare diseases. In an area where the only available therapies are often experimental, a single policy that brings research, diagnosis and treatment together is valuable.
Read the full Research Australia submission today.
The Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 (the Bill) is part of the Government’s response to the recommendations of the review of Medicines and Medical Devices Regulation (MMDR), and the legislation is supported by Research Australia’s submission to the inquiry by the Senate Standing Committees on Community Affairs.
The aim of the Review’s recommendations is to improve the processes for the approval of medicines and medical devices by the Therapeutic Goods Administration. Together the regulatory reforms are expected to reduce the administrative burden on applicants and make the approval process faster without jeopardising the safety of consumers.
Achieving this aim will provide consumers with earlier access to potentially lifesaving new medicines and devices. It is also an effective means of supporting Australia’s medical device and medicines industries; by accelerating their pathway to market it will enable them to become profitable more quickly, providing them with more resources to pursue the international markets needed to be truly successful and profitable.
Research Australia submission TGA Bill
Research Australia’s submission to Treasury in response to the discussion paper on Social Impact Investing has advocated that interventions designed to improve health outcomes be explicitly acknowledged as within the scope of the proposed social investing framework.
Research Australia believes that Social Impact Investing could be an effective mechanism for funding and evaluating some pilot projects and clinical trials designed to implement and evaluate new evidence based practices and interventions. The benefits of implementing successful new interventions include better population health, improved patient care, and efficiency gains in the Australian healthcare system. These provide quantifiable social and financial gains that make the funding of these measures amenable to Social Impact Investing.
Research Australia Submission Social Impact Investing