30 November 2020 — Submission

Submission to TGA consultation "Proposed enhancements to adverse event reporting for medical devices"

CHF

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA conducted this consultation as part of the reform program. This consultation related to proposed enhancements to post-market adverse event reporting and improving communication with the consumers of medical devices.

The aim of a post-market monitoring and vigilance system for medical devices is to maintain the safety of patients and, through the collection, analysis, and action taken in response to adverse event reports, reduce the likelihood of adverse events recurring. Adverse event reporting allows the TGA to monitor medical device performance in the real world and identify emerging safety and performance issues. A number of reviews and inquiries have highlighted the safety of medical devices and the process for monitoring them once supplied on the market. While Australian regulatory practices are comparable to other regulators around the world, this consultation seeks feedback on proposals to strengthen them further. Improving Australia’s adverse event reporting system will more promptly address threats to patient safety and to take quicker action.

The focus of this consultation was to seek feedback on five proposals. The proposals aim to improve access to information about medical device safety. In addition to making it easier to report problems with a medical device, information about known or suspected problems with devices must be accessible and be understood by consumers, their families and their health professionals.

The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, including health-based research. We have over 250 members reflecting a broad spectrum of organisations including state-based consumer peaks, condition-specific groups, volunteer patient groups, professional associations, Primary Health Networks (PHNs) and the research community.

We work in collaboration with our members, national partners and research collaborators to influence policy, programs and services to ensure they are in the consumer and community interest. CHF is pleased to make this submission in response to this TGA Consultation on enhancing medical device adverse event reporting.

Note that this consultation was administered as an online survey and this document has been adapted from the CHF submission to that survey.

27 November 2020 — Submission

Submission to TGA consultation on "Exploring options for the introduction of an Australian Unique Device Identification (UDI) System"

CHF

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. The reforms will continue to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. The TGA conducted this consultation as part of the reform program.

This is the second TGA consultation published relating to the proposed Australian implementation of a Unique Device Identification (UDI) System for medical devices. It builds on the first consultation paper, Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia, The potential implementation of a UDI System in Australia is a significant undertaking, involving a broad range of stakeholders, changes to business processes and IT systems, and with a significant level of complexity; particularly around the areas of labelling, provision of data, transition periods, and the management of legacy devices.

Whilst acknowledging the benefits of a globally aligned UDI System, there is the need to consider characteristics unique to the Australian environment. Some of those characteristics include potential linkages between the AusUDID and the ARTG, and the number of manufacturers who supply devices across Australia and other international markets, who may be required to be compliant with other jurisdictions’ regulations (the European Union (EU) and United States Food and Drug Administration (U.S. FDA) requirements in particular).

The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, including health-based research. We have over 250 members reflecting a broad spectrum of organisations including state-based consumer peaks, condition-specific groups, volunteer patient groups, professional associations, Primary Health Networks (PHNs) and the research community.

We work in collaboration with our members, national partners and research collaborators to influence policy, programs and services to ensure they are in the consumer and community interest. CHF is pleased to make this submission in response to this TGA Consultation on enhancing medical device adverse event reporting.

Note that this consultation was administered as an online survey and this document has been adapted from the CHF submission to that survey.

20 November 2020 — Submission

Submission to the Senate Select Committee on Tobacco Harm Reduction

On 6 October 2020, the Senate resolved to establish a Select Committee on Tobacco Harm Reduction. The committee will inquire into a range of tobacco reduction strategies and is due to report by 1 December 2020.

Prevention and cessation of smoking has been a remarkable public health achievement in Australia, which is attributed to the regulatory and population-based approach of the Tobacco Control Regulations and guidelines. Despite the progress that has been made, 11% of Australians still smoke daily, though this number is continuing to decline. There is a duty of care to regulate products that encourage smoking from being sold and advertised alongside everyday items as the addictive and dangerous nature of these products limits the ability of consumers to make an informed choice. We also need to continue to provide evidence-based smoking cessation programs and supports across the community.

CHF believes that there is a need for more research on various aspects of e-cigarettes, including their safety, efficacy as a harm reduction tool and potential to undermine smoking cessation efforts. We support a precautionary approach while there remains a lack of high-quality evidence on the long-term consequences of e-cigarette use.

CHF's full submission to the Committee can be accessed below, and further information about the Tobacco Harm Reduction inquiry is available on the Committee's website.

17 November 2020 — Health Voices

Health Voices — Issue 27, November 2020

Consumers Health Forum

The pandemic is bad but it has also brought some good news for consumers and the health system, forcing many of us to think afresh.

Read the November 2020 issue of Health Voices

13 November 2020 — Submission

Submission on the National Preventive Health Strategy public consultation

Preventive health is a key pillar of Australia’s Long Term National Health Plan. A 10-year National Preventive Health Strategy is being developed and will be completed by March 2021. In late August 2020 the Department of Health released a Consultation Paper which outlined the key themes from consultations held to date, as well as what the National Preventive Health Strategy aims to achieve and conceptually, how this might be done. The consultation was open from 28 August - 28 September 2020.

CHF believes there are a number of systemic shifts that are needed across government and society to prevent poor health outcomes, reduce health inequities and address the social, cultural, environmental and commercial determinants of health. The COVID-19 pandemic and emerging knowledge about the links between conditions such as obesity and coronavirus and its effects, are added impetus for a sound Strategy. The development of a 10 Year National Preventive Health Strategy is a significant opportunity to take a more holistic approach to address the underlying causes of poor health. CHF is seeking an ambitious, implementation focused National Preventive Health Strategy with explicit investment targets.

A copy of CHF's submission is provided below. The National Preventive Health Strategy Consultation Paper can be accessed here.

9 November 2020 — Submission

Submission to the Office of the National Data Commissioner Data Availability and Transparency Bill: Exposure Draft Consultation

CHF

The Australian Government is committed to modernising how we use public sector data. Improving how we share and use this data, with safety, integrity and appropriate consumer protection measures, will benefit Australians through more effective government policies, programs, and service delivery, and through improved research outcomes.

The Exposure Draft of the Data Availability and Transparency Bill 2020 (the Bill) is a step towards modernising the use of data held by the Australian Government. The data reforms presented in the draft Bill are an opportunity to establish a new framework that can proactively assist in designing better services and policies. The reforms encourage our academics and the research community to innovate and find new insights from public sector data without having to go through stifling and vague bureaucratic processes when working with data custodians.  

The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, including health-based research. We have over 250 members reflecting a broad spectrum of organisations including state-based consumer peaks, condition-specific groups, volunteer patient groups, professional associations, Primary Health Networks (PHNs) and the research community.

We work in collaboration with our members, national partners and research collaborators to influence policy, programs and services to ensure they are in the consumer and community interest. In developing our submission we provided our members the opportunity to input into our responses and consulted with our ‘Research and Data Special Interest Group’, a group of nearly two-dozen everyday consumers with an interest in health research and data.

CHF is pleased to make this submission in response to the Office of the National Data Commissioner (NDC) Data Availability and Transparency Bill (DATB) exposure draft consultation.

9 November 2020 — Consumers Shaping Health

Consumers Shaping Health - November 2020

Consumers Health Forum

How COVID strengthens Shifting Gears

CHF was obliged to postpone our Shifting Gears Australasian summit to March 18-19 next year --- and transform it to a virtual event --- because of COVID. Yet the influence of COVID has made our conference theme of consumer leadership and experience and consumers as agents of change more timely and relevant.

Rarely does a health crisis impact on an entire society in the way COVID has. It has made many more consumers take an active role in their own health care, like wearing masks and taking more hygiene measures. Governments have been urged to involve the community in decision-making more, the medical science community has recognised the importance of communicating to consumers on risks and therapies. ...

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30 October 2020 — Submission

Submission to the NHMRC Public Consultation on the National Statement on Ethical Conduct in Human Research Sections 4 and 5

CHF

The NHMRC proposed to include new and revised chapters in Section 4 and Section 5 of the National Statement on Ethical Conduct in Human Research, 2007 (updated 2018) (the National Statement). Developed by the Australian Health Ethics Committee (AHEC), the revised sections provide advice for both researchers and Human Research Ethics Committees (HRECs) addressing ethical considerations related to potentially vulnerable participants in research (Section 4) and research governance and ethics review (Section 5).

Under Section 13 of the National Health and Medical Research Council Act 1992, NHMRC is required to undertake public consultation prior to finalising its human research guidelines. NHMRC is keen to ensure that the Australian community has the best opportunity to participate in developing guidance on the ethical design, review and conduct of human research, and seeks your feedback on the proposed changes to the National Statement.

The Consumers Health Forum of Australia (CHF) is the national peak body representing the interests of Australian healthcare consumers and those with an interest in health consumer affairs, including health based research. We have around 200 members reflecting a broad spectrum of organisations including state-based consumer peaks, condition-specific groups, volunteer patient groups, professional associations, Primary Health Networks (PHNs) and the research community. 

We work in collaboration with our members, national partners and research collaborators to influence policy, programs and services to ensure they are in the consumer and community interest. In developing our submission we provided our members the opportunity to input into our responses and consulted with our ‘Research and Data Special Interest Group’, a group of nearly two-dozen everyday consumers with an interest in health research and data.

CHF is pleased to make this submission in response to the NHMRC Public Consultation on the National Statement on Ethical Conduct in Human Research Sections 4 and 5.

20 October 2020 — Fact Sheets

Western NSW PHN Collaborative Pairs Program - invitation to apply

Consumers Health Forum

Invitation to the Western NSW PHN Collaborative Pairs Program, closes Friday 29 January 2021 

12 October 2020 — Consumers Shaping Health

Consumers Shaping Health - October 2020

Consumers Health Forum

A healthy budget that raises hopes for the future

There is much to appreciate about the level of support for health in the Federal Budget. The solid funding increases for Medicare, PBS and public hospitals; and the substantial financing of the COVID emergency response and the significant commitment of funding to ongoing development of telehealth have opened new and substantial fields of spending.

We are benefiting from the sound basis that the Australian health system provides and by the force of circumstance that has prompted the Government to pour extraordinary amounts of money into health. The response from the health community has been largely positive although laced with a measure of concern about wider community needs that so often lead to poor health. ...

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