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

Civil and Administrative Tribunal New South Wales Medium Neutral Citation: Shehabi v Attorney General (NSW) [2016] NSWCATAP 137 Hearing dates: 27 May 2016 Date of orders: 24 June 2016 Decision date: 24 June 2016 Jurisdiction: Appeal Panel Before: Wright J, President Boland ADCJ, Deputy President Dr J Hollis, Senior Member (Professional) Decision: (1) The Appeal is allowed. (2) 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. (3) The application in proceedings CT 10/2013 is dismissed. (4) The application in proceedings CT 7/2015 is dismissed. Catchwords: CLINICAL TRIAL – whether study's use of a drug outside its approved product information is determinative of whether study is a "clinical trial" under the Guardianship Act 1987 (NSW) – use of drug beyond TGA Product Information not determinative

CLINICAL TRIAL – whether notification of trial under TGA Clinical Trial Notification (CTN) Scheme is determinative of whether it is a "clinical trial" under the Guardianship Act 1987 (NSW) – notification under TGA CTN Scheme is not determinative

WORDS AND PHRASES – "clinical trial" – a trial of drugs or techniques that necessarily involves the carrying out of new medical or dental treatment that has not yet gained the support of a substantial number of medical practitioners or dentists specialising in the area of practice concerned – Guardianship Act 1987 (NSW), s 33(1) Legislation Cited: Civil and Administrative Tribunal Act 2013 (NSW) Guardianship Act 1987 (NSW), Part 5 Interpretation Act 1987 (NSW), ss 33, 34 Cases Cited: Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (ADRENAL Trial) [2015] NSWCATGD 23 Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (AMOUNT Rehabilitation Trial) [2015] NSWCATGD 1 Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (ARISE Study) (5 August 2008, unreported) Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (NICE Study) (8 December 2004, unreported) Application for approval for adults unable to consent to their own treatment to participate in a clinical trial (TRANSFUSE Trial) [2015] NSWCATGD 18 Alcan (NT) Alumina Pty Ltd v Commissioner of Territory Revenue [2009] HCA 41; 239 CLR 27 Bignill v Director of Public Prosecutions [2016] NSWCA 13 Commissioner for Railways (NSW) v Agalianos [1955] HCA 27; 92 CLR 390 Duffy v Da Rin [2014] NSWCA 270; 87 NSWLR 495 Hope v Bathurst City Council [1980] HCA 16; 144 CLR 1 Kelly v The Queen [2004] HCA 12; 218 CLR 216 Project Blue Sky v Australian Broadcasting Authority [1998] HCA 28; 194 CLR 355 Taxation v Consolidated Media Holdings Ltd [2012] HCA 55; 250 CLR 503 Thiess v Collector of Customs [2014] HCA 12; 250 CLR 664 Category: Principal judgment Parties: Professor Yahya Shehabi (Appellant) Attorney General (NSW) (Intervenor) Representation: Counsel: Mr P Dwyer (Appellant) Ms M Kumar (Intervenor)