Downloadable PDF version of Youth Talks EOI
On 25 February 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 (‘the Regulations’) commenced to introduce a new regulatory framework (the Framework) for medical devices that are designed and manufactured for individual patients (otherwise known as 'personalised' medical devices). The key change introduced under the Framework is a change to the definition of a custom-made medical device.
The TGA received a range of feedback and information during the course of introducing the Framework, including concerns from some sectors about the impact of the changes.
In some cases it was claimed that the regulatory requirements were:
- a duplication of existing regulation already provided by professional accrediting bodies or other regulatory bodies;
- excessive when compared with the actual risk posed by the device; and/or
- unreasonable in terms of regulatory burden.
So in July 2021 the TGA sought feedback on potential refinements to the Framework that could be considered to ensure risks associated with personalised medical devices are appropriately mitigated without imposing unnecessary administrative and regulatory burden. To which CHF submitted the attached response.
In the July 2021 edition of Consumers Shaping Health, we announce the commencement of Collaborative Pairs, a consumer leadership program with five pairs from across Australia and New Zealand.
- Consumer consultation on Primary Health Care reform
- Webinar on COVID vaccine rollout and key messages from the Department of Health's Principal Medical Advisor, Professor Michael Kidd, Rural Health Commissioner, Dr Ruth Stewart and Consumer Representative, Diane Walsh
- Announcement of details for the Youth Health Forum Summit in Sept 2021
The Therapeutic Goods Advertising Code (No.2) 2018 (the Code) is the compliance standard that prescribes the minimum requirements for the lawful advertising of therapeutic goods to the public in Australia. It is an important instrument for a range of stakeholders including advertisers, manufacturers, suppliers and retailers; relevant industry associations; health professionals and peak bodies; and consumers and consumer representative groups. With the potential for serious consequences for non-compliance, it is important that the Code is contemporary and clear.
In this consultation the Therapeutic Goods Administration (TGA) was seeking feedback on options to improve the Code. The proposed improvements were aimed at increasing advertisers’ understanding of the requirements of the Code, ensuring provisions work as intended, and improving advertising compliance. The proposed improvements considered the need to minimise unnecessary compliance costs while continuing to ensure that advertising does not contribute to any unsafe or improper use of advertised products.
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 260 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. This includes our role on the TGA Advertising Consultative Council (TGACC) as consumer representatives.
CHF is pleased to make this submission in response to this TGA Consultation.
CHF submitted this response to the House of Representatives Standing Committee on Health, Aged Care and Sport inquiry into approval processes for new drugs and novel medical technologies in Australia June 2021.
The recommendations, which include feedback from health consumers who are members of CHF’s safety and quality special interest group, confirm that streamlining processes, working collaboratively with consumers and consumer organisations, embracing personalised medications, research and health technologies, supporting equitable access and the revision of the National Medicines Policy are all timely and necessary.
The full submission is available below.
2020-21 was an exciting year for CHF, from working with our growing member base to reach millions of consumers, to launching initiatives that will make a real difference to Australia's healthcare system. See our Report Card to learn more.
- CHF’s impact has continued to strengthen over the past year despite COVID-19’s curbs on face-to-face contacts with our members and stakeholders. Indeed our take-up of Zoom and Teams meetings has enabled more out reach than ever in listening to, and advocating on behalf of health consumers.
- CHF’s virtual interaction came through with flying colours when CHF staged its first Australasian conference --- the Shifting Gears summit on health consumer experience and leadership which attracted 800-plus registrants logging on to the real-time conference sessions from around the world. See coverage of the conference in our Health Voices ejournal and the conference report by Croakey Health Media.
- Another highly successful first for CHF was our inaugural Consumer Commission which, again through largely remote conferencing, brought together 30 health consumer leaders from around Australia and produced a comprehensive report on the future directions for health care post-COVID in its report: Making Health Better.
- We continue to monitor and report on community responses through our Australia’s Health Panel surveys on issues of the moment including COVID face masks, vaccinations and health literacy in the past year.
- And our special interest groups are keeping us in touch and active on issues including: Primary Health Care, Research & Data, Digital Health, Safety & Quality in Healthcare and Rural & Remote Health.
CHF supports vaccination campaign
In this edition of Consumers Shaping Health we ......
- Let you know how to find various tools on the Dept of Health website to help you with your COVID-19 vaccinations
- Tell you what happened at the National Ministerial Cancer Plan Roundtable
- Invite you to get involved in designing the CHF Election Platform for the next Federal Election
Federal Budget 2021-22 analysis
Since the Federal Budget 2021-22 was handed down by the Treasurer, Josh Frydenburg on Tuesday 11 May 2021, we have been working hard to bring you the latest information and expert commentary on how the Budget responds to the needs of health consumers.
Our media release on the Budget is here: Budget’s modest response to aged care and mental health inquiries
Further to this, leaders from the Youth Health Forum also provided commentary in a media release: Budget moves for youth health welcome as a first step
There will be follow-up webinar to discuss the briefing with national health policy leaders to provide further analysis of the measures, and reactions from other organisations and health policy experts. This will be scheduled soon.
Contact Policy Director, Jo Root on email: J.Root@chf.org.au with any questions and feedback
What do we expect and need in this Budget?
As this edition of Consumers Shaping Health goes to press, we await the fine detail of what the Federal Budget will bring, particularly for health care.
- Navigating Telehealth: the Patients’ Perspective
- The Fourth Atlas of Australian Healthcare Variation
- Engaged, informed consumers key in tackling unwarranted variation