On the 23rd of June, the Australian Medical Professionals Society hosted a public forum for key stakeholders to express their concerns about the debilitating effects of our current legilation.
The National Law and Therapeutic Goods Act have precipitated disastrous and preventable outcomes for patient safety and public health during the recent time of Covid.
In light of these failings, the Australian Medical Professionals Society are demanding legislative amendments to the Health Practitioner Regulation National Law and Therapeutic Goods Act.
These reforms are vital for protecting the health and safety of all Australians, while securing rights for health practitioners to function without undue interference, being a package of reforms that will implement safeguards preventing government and agency overreach, witnessed during the time of Covid.
You can watch the entire three and a half hour summit below, or alternatively scroll down to find links to each individual speaker from the summit. For the entire list of proposed ammendments, please click here.
The safe-to-sign Declaration for Health Professionals and Scientists supporting health law reform can be viewed here (note over 200 signatures to date): https://amps.redunion.com.au/healthreformdeclaration
Shorter videos for each presenter are as follows:
The proposed amendments to the National Law and Therapeutic Goods Act are for:
- Protecting and ensuring Informed Consent
- Protecting Health Professionals for providing information that assists Informed Consent, despite government messaging claims .. indeed new prohibitions on National Boards and AHPRA preventing them from interfering with a Health Professional expressing their expert views on a treatment or therapy
- Forbidding politicians and public officials and government agencies from promoting drugs that are only Provisionally Approved (no more chants of ‘Safe & Effective’ where insufficient data exists)
- Heightened procedures and information requirements placed on the TGA when considering providing Provisional Approval for a new drug, especially for instance, adequate studies on Carcinogenicity and Genotoxicity, and a requirement to make all clinical trial data available prior to any Provisional Approval, so Health Professionals can assess such themselves, without having to obtain Court orders for the release of such information after approval
- Requirement for greater and detailed Warning information on Product Information for Provisionally Approved drugs, specifically detailing possible Risks associated with any missing clinical trial data, and the particular warning: THIS IS AN EXPERIMENTAL DRUG FOR WHICH THERE IS NO MEDIUM OR LONG-TERM SAFETY OF EFFICACY DATA
- No Provisional Approvals where existing drugs used off-label demonstrate significant therapeutic outcomes in the treatment, prevention or diagnosis of the condition, while maintaining the safety and efficacy of the therapeutic goods when so used off-label
- Establishment of an independent and non-government expert Safety Monitoring Board able to recall a dangerous Provisionally Approved drug, overriding the Secretary of Health
- Increased requirements on the Secretary of Health to suspend or cancel a Provisionally Approved drug when any sources of verified information evidence that the registration or listing has causally resulted in death, serious illness or serious injury
- Protecting a Doctor’s right to issue Exemptions in respect of Provisionally Approved drugs
- Requiring any Provisionally Approved drug to be pulled from the market should a State or Territory threaten to Mandate that drug
- New procedures to ensure all Health Professionals directly determine what codes of conduct, standards, and health messages their National Board or AHPRA adopt