CHF is pleased to make a submission to the consultation on early release of superannuation benefits under compassionate and financial hardship grounds and for victims of crime compensation. CHF’s interest in this issue is related to ensuring Australians have affordable access to the health services and that access to such services is based on need to capacity to pay. For this reason, we focus on comments on the principles and the questions relating to and the arrangements that should govern benefits released on compassionate or hardship grounds for medical treatment.
Early release of superannuation benefits
Codeine - Webinar Slides
These slides were using in the codeine webinar delivered by Policy Manager, Jo Root and CEO of PainAustralia, Carol Bennett in January 2018. A recording of the webinar can be viewed here: https://youtu.be/1sX3gSFG-UU
We welcome the opportunity to make this submission in response to the consultation paper on proposed regulatory changes related to personalised and 3D printed medical devices released by the Therapeutic Goods Administration (TGA) in November 2017.
New manufacturing technologies present many challenges and possibilities. They tend to fit in a more decentralised and distributed system than traditional technologies, and are part of a rapidly evolving and immature market. They also reinforce non-traditional innovation paradigms that are similarly decentralised and distributed. Regulating their use in health effectively is vital both to patient safety and improving health outcomes. Striking a balance between managing risk and enabling growth presents opportunities for the TGA to keep patients safe and promote innovation.
Consumers expect medical devices to be regulated, and would be surprised to learn how many custom- made medical devices currently avoid scrutiny. Confidence in an effective safety and quality regime is essential to maintain a functioning health system, and changes to how custom- made medical devices are regulated is required to maintain this confidence. CHF supports the TGA’s efforts in this area. We believe that including all custom-made products on some form of register is necessary, and recognise that treating custom-made devices in the same regulatory manner as mass-manufactured devices will see fewer such devices see use with consumers. A balance is required, and our recommendations look at ways to maintain the balance between safety and innovation, as well as take advantage of the unique advantages that custom made medical devices present to consumers, health professionals and manufacturers.
The core principles we have followed in developing our submission are based on the issues of access, choice and accountability.
Access
Consumers deserve access to the best healthcare possible. For custom-made medical devices to be accessible, several factors must be addressed. Costs to the patient and the health system must be kept in mind when making regulatory changes. Further, access requires that effective innovation is not stifled, and ideally is promoted and supported.
Choice
A patient-centred approach requires clear communication between consumers, health professionals and manufacturers so the consumer can make an informed choice about their health care. With custom devices of any kind, a clear communication of the benefits and risks is vital, as is communication of the limits to which a device or manufacturing process has been validated scientifically.
Accountability
Consumers can only be protected from harm effectively when there is clarity around who is accountable at each stage of the process. Who is responsible for communication, consent, documentation, adverse event reporting and recalls are only possible when the party responsible is accountable, and the relevant information recorded and maintained.
2018-19 Budget Submission
The Consumers Health Forum in this 2018-19 Budget submission urges the Government to ensure the health system is consumer centred: providing care which is accessible, affordable and for whole-of-person needs.
We acknowledge the commitment from the Government to developing and delivering on a National Health Plan which delivers improved health outcomes and moves to make the health system sustainable.
Consumers Shaping Health, vol 11, Issue 3, December 2017
2018 will be a year of consumers shaping health.
Health Voices, Issue 21, November 2017
The spectacular advances in medical devices and biotechnology are exposing an ever-expanding world of benefits and risks for consumers.
Collaborative Pairs Q&A for Applicants - Webinar Slides
A recording of the webinar can be viewed here: https://www.youtube.com/watch?v=YW492ECVPgI
Annual Report 2016-17
CHF has been active in ensuring that the consumer perspective was included in a wide range of policy deliberations as we work towards a more consumer centred health care system.
CEDA 2017 Health series: patient centred future?
CEO Leanne Wells spoke to the 2017 CEDA forum on the degree to which patient-centred care is a pillar of Australia's health care system. Read the speech here.
Therapeutic Goods Advertising Code
CHF welcomed the Review of Medicines and Medical Device Regulation. Consumers constantly raise with us their concerns about safety and quality of medicines and medical devices often giving us examples of when the system has failed. We have heard some terrible stories. For many people, this is what leads them to be active consumers as they see the need for systemic change and want to be part of that change.