Chloropheniramine unfit for human use because it was contaminated with isopropyl alcohol.
The 1st appellant was convicted under four summonses for having, on four separate occasions, prescribed for children who were his patients, and accordingly sold to their respective parents or guardians, a medicine which was unfit for human use because it was contaminated to varying degrees. The 2nd appellant’s conviction was based on the contention that she had engaged in selling the contaminated medicine on one of those four occasions.
The first appellant, on four separate occasions, prescribed and accordingly sold medicine that was unfit for human use because it was contaminated to varying degrees with isopropyl alcohol. When the contamination was reported, the first appellant’s clinic was inspected by officers of the Department of Health.
Magistrates' Court
The 1st appellant was convicted under four summonses for selling a drug intended for use by man but unfit for that purpose, contrary to section 54(1) of the Public Health and Municipal Services Ordinance. He was also convicted under one summons for possessing for sale a drug which had not been registered by the manufacturer with the Pharmacies and Poisons Board, contrary to regulation 36(1) of the Pharmacy and Poisons Regulations.
The section 54(1) convictions related to the 1st appellant having, on four separate occasions, prescribed for children who were his patients, and accordingly sold to their respective parents or guardians, a medicine labelled as “Piriton” containing a drug called Chloropheniramine (“the medicine”) which was unfit for human use because it was contaminated to varying degrees with isopropyl alcohol (“the contaminant”). The 2nd appellant’s conviction was based on the contention that she had engaged in selling the contaminated medicine on one of those four occasions.
The Magistrate convicted the appellants of the section 54(1) offences after making detailed findings regarding the contamination. He discounted the possibility of contamination by the patients. He also found that the four 3.6 litre bottles, including the opened bottle from which the 1st appellant claimed to have dispensed the prescribed medicine, had not been supplied by Christo and that, in any event, the contaminant was not present in any of the 3.6 litre bottles nor in the 500 ml container used for decanting the medicine into the small bottles provided to the patients. This accorded with the prosecution’s case which was that the contaminant had somehow been introduced in the decanting process at the clinic and not higher up in the supply chain.
The 1st appellant was fined a total of $80,000. The 2nd appellant was fined $3,000.
The High Court of the Hong Kong Special Administrative Region
The High Court held that the Magistrate’s verdict could not stand. The Magistrate purported impermissibly to draw highly damaging inferences on the basis of his findings, namely, that the 1st appellant (and the 2nd appellant on his instructions) had deliberately caused the contaminant to be introduced into the children’s medicines and that he had destroyed similarly contaminated bottles to avoid being incriminated. The High Court judge nevertheless held that the convictions should be sustained in relation to the section 54(1) offences. He also confirmed the conviction under regulation 36(1) holding (as the Magistrate had done) that on the evidence, the 1st appellant could not bring himself within the reasonable diligence defence under regulation 36(1C) referred to below.
The 1st appellant’s fines were reduced on appeal to a total of $45,000. The 2nd appellant’s fines were reduced to $1,500.
The Court of Final Appeal of the Hong Kong Special Administrative Region
The main issue on appeal in the present case regarded the mental element in statutory offences.
In summary, Hin Lin Yee was charged under the Public Health and Municipal Services Ordinance, “Subject to the provisions of this section, any person who – sells…any drug intended for use by man but unfit for that purpose, shall be guilty of an offence”. Defences for having been given a warranty as to the quality of the items are in subsequent provisions, although they did not apply to Hin Lin Yee’s particular case (his defence was simply that he had not known the medicines had been contaminated).
The question became whether, under Hong Kong law, performing an act prohibited by statute in the mistaken but honest and reasonable belief that the circumstances associated with that act are such that, if true, no liability would attach, constitutes a common law defence to that offence.
The Court of Final Appeal concluded that the proper starting-point for ascertaining the mental requirements of any statutory offence or any external element of such an offence is to presume that the prosecution must prove mens rea in respect thereof. That presumption may be displaced expressly (eg. “wilfully”, “knowingly”, “negligently”, “without due care and attention” and the like) or by necessary implication.
The nature and subject-matter of the offence were said to be of great importance in deciding whether mens rea is required. The more serious the offence in terms of penalty and social obloquy, the less likely it is that the presumption will be held to have been supplanted. Where the declared object of the statute is the protection of public health and safety, the court would be much more ready to come to the conclusion that the presumption of mens rea had been displaced.
If the presumption is not displaced, the mens rea requirement persists. If the presumption is displaced, three possible alternatives arise under Hong Kong law, namely whether the legislative intent is:
(i) to allow a defence if the defendant can prove on the balance of probabilities that the prohibited act was done in the honest and reasonable belief that the circumstances were such that, if true, he would not be guilty of the offence; or
(ii) to confine the defences open to the accused in relation to his mental state to the statutory defences expressly provided for in relation to the offence charged; or,
(iii) to make the offence one of absolute liability so that the prosecution succeeds if the accused is proved to have performed or brought about the actus reus, regardless of his state of mind.
In the present case, the presumption of mens rea is displaced in relation the offences requirement that the medicine sold be unfit for human use. The offence comes within (ii) since the legislative intent is to confine the defences available to those regarding warranties.
Ultimately, the Court unanimously dismissed the appeal of the first defendant and in majority dismissed the appeal of the second defendant.
In his dissenting opinion, Justice Bokhary PJ discussed the liability of agents and found the following:
The 2nd appellant was charged for sale by an agent: “every person shall be deemed to sell…..any…..drug for use by man, who sells…..such…..drug either on his own account or as the servant or agent of some other person, and, where such person is the servant or agent of some other person, such other person shall…..be under the same liability as if he had himself sold…..such…..drug”.
The question was whether there was a proper basis for treating the 2nd appellant as someone who had “sold” the contaminated medicine. There was de facto a separation between the provision of the 1st appellant’s medical services and the provision and sale of the medicines prescribed (after the patient’s consultation, the 1st appellant would write a prescription and, in a separate part of the clinic, the 2nd appellant would fill the prescription and transfer the medicine to the patient for payment). He found that there were insufficient findings of primary fact to support a sure conclusion that the assistant sold within the meaning of the provision under which she was charged, but that she had sold the medicine as the servant or agent of the 1st appellant. This was not the majority opinion of the Court.
The 1st appellant, a medical doctor, was convicted under four summonses for selling a drug intended for use by man but unfit for that purpose, contrary to section 54(1) of the Public Health and Municipal Services Ordinance. He was also convicted under one summons for possessing for sale a drug which had not been registered by the manufacturer with the Pharmacies and Poisons Board, contrary to regulation 36(1) of the Pharmacy and Poisons Regulations.
The 2nd appellant, who died before the trial but after her appeal had been lodged, was the 1st appellant’s assistant. She was convicted under one summons for an offence against section 54(1).
The Court of Final Appeal of the Hong Kong Special Administrative Region
The Court of Final Appeal gave a definitive judgment on the common law approach to the presumption of mens rea. The decision canvasses how mens rea was interpreted for statutory offences in several other jurisdictions (UK, Australia, Canada, New Zealand).
The decision also highlights difficulties in assessing the level of involvement of various actors in fraudulent medicine crimes. The following was noted: “There was some discussion as to whether there is any social utility in imposing liability on a person in the 2nd appellant’s position, acting as an assistant in a doctor’s clinic. In my view such utility clearly exists. The self-evident policy is to promote public health and safety by imposing a regime of diligence and care to avoid supplying medicines which are unfit for use. Doctors will commonly rely on their nurses or clinical assistants to place orders for medicines kept in stock, to prepare them for use and to dispense them to patients. Doctors are seldom if ever likely to be concerned in ensuring that the medicines delivered properly match those ordered; that they come from reputable sources and are properly prepared for use by patients. The imposition of such liability promotes careful handling of the medicines by the assistant and diligent supervision by the doctor.”