Shehabi v Attorney General (NSW) [2016] NSWCATAP 137

Shehabi v Attorney General (NSW) [2016] NSWCATAP 137

A 'clinical trial' under Part 5 of the Guardianship Act 1987 (NSW) is limited to a trial of drugs or techniques that necessarily involves the carrying out of new medical treatment that has not yet gained the support of a substantial number of medical practitioners specialising in the relevant area. The SPICE III study, involving accepted sedation methods, is not a clinical trial for these purposes, even if randomised or requiring TGA notification for off-label use.

Jurisdiction
Australia
Judgment Date
24 June 2016
Procedural Posture
Internal Appeal / Appeal Panel Decision
Outcome
Appeal allowed
Legal Topics
['clinical Trials' 'statutory Interpretation' 'consent to Medical Treatment' 'substitute Decision Making']
['guardianship' 'administrative Law'] ['clinical Trials' 'statutory Interpretation' 'consent to Medical Treatment' 'substitute Decision Making']

Case Brief

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Procedural Posture

Internal Appeal / Appeal Panel Decision

Legal Issues

  1. 1 ["Proper construction of 'clinical trial' under Guardianship Act 1987 (NSW), Pt 5" 'Whether SPICE III study constitutes a clinical trial for purposes of s 45AA of the Guardianship Act']

Ratio Decidendi

A 'clinical trial' under Part 5 of the Guardianship Act 1987 (NSW) is limited to a trial of drugs or techniques that necessarily involves the carrying out of new medical treatment that has not yet gained the support of a substantial number of medical practitioners specialising in the relevant area. The SPICE III study, involving accepted sedation methods, is not a clinical trial for these purposes, even if randomised or requiring TGA notification for off-label use.

Court Disposition

Appeal allowed

Orders

  • ['The Appeal is allowed.' 'The orders made in proceedings CT 10/2013 on 23 December 2014 and in proceedings CT 7/2015 on 19 June 2015 are set aside.' 'The application in proceedings CT 10/2013 is dismissed.' 'The application in proceedings CT 7/2015 is dismissed.']