Medicinal Cannabis regulatory reform

Question

A consistent concern raised by peak representative bodies like the AMA, RACGP and RANZCP is that higher levels of THC have no therapeutic value and are associated with an increased risk of psychosis. However, many other stakeholders believe this position refl ects a fundamental misunderstanding of how THC is measured and used in clinical practice. 1. Does the Minister and TGA accept the proposition that the way THC levels are expressed, whether by percentage, ratio or milligram dose, does not translate simply into risk or therapeutic value? 2. Does the Minister and TGA accept that there appears to be either confusion or a mischaracterisation of this within the TGA and the Department of Health? - If not, why not? 3. Does the Minister and TGA accept the proposition that no other class of medicine is regulated in this binary way (I.E. regulation based on a single component) and that this argument is inconsistent with existing regulatory decisions and precedents? - If not, why not? 4. What new research (not meta analysis, but primary research) has been conducted or referred to by the TGA to drive the proposed regulatory reforms? - Could you please kindly provide specific details, and links to, this primary research?

Answer

Please see attached answer.

Documents

• Question with answer (PDF) (opens in a new tab)
• DHDA SQ26-002814.pdf (opens in a new tab)