Potential Reforms to the Medicinal Cannabis Manufacturing, Labelling and Packaging Requirements
In January, Painaustralia provided a response to the Potential Reforms to the Medicinal Cannabis Manufacturing, Labelling and Packaging Requirements Consultation Paper.
The response noted that, when assessing the impact of regulatory changes relating to medicinal cannabis, consumers and prescribers should be considered as the ultimate end users of the products. End users of therapeutic goods need to be front of mind when updating regulation or developing policy.
In response to the overarching issues raised in the Paper, Painaustralia supports changes to the TGA’s regulatory instruments that would lead to a unified, consistent approach to regulating medicinal cannabis nationally, provided it doesn’t unnecessarily limit access for consumers.
In December, Painaustralia provided input to inform the Royal Australian and New Zealand College of Obstetricians and Gynaecologists for the draft Australian Clinical Practice Guideline for the diagnosis and management of Endometriosis.
Painaustralia’s input was focused around three main points:
Efforts to improve the quality of life for women and girls living with endometriosis would be best underpinned by the full implementation of the National Pain Strategy (NPS) and its blueprint, the National Strategic Action Plan for Pain Management (National Action Plan).
The Guideline should focus on the biopsychosocial approach to pain management.
The draft Guideline is too technical and could be revised to be better understood by non-healthcare professionals.
Consultation around medical devices
Painaustralia provided input to the Therapeutic Goods Administration’s (TGA) consultation around medical devices and in particular the use of an Australian Unique Device Identification System (the UDI system).
Painaustralia has called for stronger safety measures, including more stringent and thorough testing and tighter regulations before medical devices are approved and used in Australia.
There needs to be greater accountability placed on the medical devices industry by the regulator including the reporting of device performance. The implementation of a UDI system in Australia is a necessary first step in protecting consumers and enhancing the safety of the medical device industry.
Painaustralia also provided input to the TGA for their consultation around medical devices and its aim to improve consumer medical safety.
Painaustralia supports the need for improved regulation of medical devices in Australia to reduce the alarming number of failures as we have seen with hip replacement implants, breast implants, surgical mesh and other devices in recent years.
These failures point to the need to strengthen reporting requirements, including independent audits and inspections, improve consumer and health professional education and awareness, define post-market definitions in Medical Device Regulation and enhance awareness and reporting faults by consumers to the regulator.
These improvements will ensure that consumers can have confidence in the regulatory system to protect their safety and make more informed choices around their treatments and subsequent outcomes.