This Supplementary Order Paper amends the Therapeutic Products Bill by effectively deleting clause 65(2)(b) and (3). Clause 65(2)(b) currently adds an additional and imprecise requirement of “appropriateness” that risks adversely interfering with the exercise of professional judgement and, accordingly, patient treatment and outcomes. Under clause 65(3), the health practitioner or veterinarian must also have regard to regulations about how affordability and appropriateness are to be assessed. However, regulation-setting criteria for the determination of “appropriateness” is liable to unduly interfere with the critical role of health practitioners and is contrary to the stated allowance for the exercise of professional judgement by a health practitioner. Similarly, it is not the place of the Regulator to determine how affordability should be determined in such a context. The role of the Regulator is to determine the safety, efficacy or performance, and quality of therapeutic products. Clause 65(2) and (3) should therefore be deleted.