Read the full judgment text of FACC 7/2009 on BabelCite. This Court of Final Appeal judgment was delivered on 26 March 2010 before Bokhary PJ, Chan PJ, Ribeiro PJ, Litton NPJ, Hoffmann NPJ.
Criminal law – statutory interpretation – mens rea – presumption of mens rea – absolute liability – strict liability – halfway house – common law defence of honest and reasonable belief – safety legislation – statutory defences – sale of unfit drugs – agent liability – pharmaceutical regulation – appeal after death of appellant – Court of Final Appeal – s.54(1) of the Public Health and Municipal Services Ordinance (Cap 132) – ss.70, 71 and 73 of the Public Health and Municipal Services Ordinance – regulation 36(1) and 36(1C) of the Pharmacy and Poisons Regulations (Cap 138) – the 1st appellant is a medical practitioner and the 2nd appellant was his assistant at a clinic in Tung Chung – on four occasions medicine labelled as Piriton containing Chloropheniramine was sold to child patients and was found to be contaminated with isopropyl alcohol – contamination occurred during the decanting process at the clinic – the medicine was traced to four 3.6 litre bottles of CM 10mg/5ml that were not registered with the Pharmacies and Poisons Board – the 1st appellant was convicted on four s.54(1) summonses and one regulation 36(1) summons and fined a total of $80,000 reduced to $45,000 on appeal – the 2nd appellant was convicted on one s.54(1) summons and fined $3,000 reduced to $1,500 – the Court of Appeal certified the question whether common law defences to s.54(1)(a) exist – the 2nd appellant died after lodging her appeal – whether the common law defence of honest and reasonable belief applies to s.54(1) PHMSO offences – whether s.54(1) creates an absolute offence – the Court of Final Appeal held that the starting point is the presumption of mens rea which may be displaced expressly or by necessary implication – the Court surveyed the development of the law in England and Wales, Australia, Canada and New Zealand and identified five possible alternatives for the mental element of a statutory offence – the Court held that Hong Kong recognises the first alternative (full mens rea), the third alternative (defence approach, where accused proves honest and reasonable belief on a balance of probabilities), the fourth alternative (statutory defences excluding common law), and the fifth alternative (absolute liability) – the Court held that the second alternative (mens rea constituent approach) is not favoured – the Court rejected the broad holding in HKSAR v Shun Tak Properties Ltd that the common law defence has no application to safety legislation, but held that the result in that case was correct on its own facts – on the true construction of s.54(1) PHMSO, the presumption of mens rea is displaced, and the only defences available are the statutory defences in ss.70 and 71 which by necessary implication exclude the common law intermediate defence – the 1st appellant could not bring himself within s.70 (no third party proven responsible and no due diligence shown) or s.71 (no Christo invoice covering the CM 10mg/5ml was produced) – the 2nd appellant fell within s.73 as a servant or agent deemed to sell, but the majority held her conviction could not stand because there were insufficient primary findings to support a sure conclusion that she sold within the statutory meaning and imposing criminal liability on a morally blameless agent without deterrent effect would be arbitrary – Bokhary PJ would have upheld her conviction on the basis of s.73 and the public health objectives of the legislation – the 1st appellant's regulation 36(1) conviction was upheld because he could not show that he could not with reasonable diligence have discovered that the CM 10mg/5ml was unregistered – the 1st appellant's appeal unanimously dismissed and the 2nd appellant's appeal dismissed by majority
Legal issues: Whether the common law defence of honest and reasonable belief is available to a s.54(1) PHMSO offence involving sale of unfit drugs · Whether the Court may entertain the 2nd appellant's appeal after her death · Whether the 2nd appellant 'sold' contaminated medicine within s.54(1) PHMSO read with s.73 · Whether the 1st appellant can rely on the regulation 36(1C) defence for possession of unregistered pharmaceutical products · Whether HKSAR v Shun Tak Properties Ltd correctly held that the common law defence has no application to safety legislation
Outcome: Doctor's (1st appellant's) appeal unanimously dismissed with convictions affirmed. Assistant's (2nd appellant's) appeal dismissed by majority, with Bokhary PJ dissenting, so her conviction was affirmed by majority. The 2nd appellant had died after lodging her appeal, but the Court entertained it on the basis of the interests of her reputation, the feelings of the living, and the purity of the law.
Cited by 15 cases · Cites 1 case