R v Comax-Pharma Pty Ltd [2008] NSWDC 200

Reported Decision : 7 DCLR (NSW) 288

New South Wales District Court

CITATION: R v Comax-Pharma Pty Ltd [2008] NSWDC 200

HEARING DATE(S): 12 September 2008

JUDGMENT DATE: 18 September 2008

JURISDICTION: Criminal

JUDGMENT OF: Goldring DCJ

DECISION: On Count 1 taking into account offence on Crimes Act s 16BA Form the offender is fined $270,000. On Count 2 the offender is fined $252,000.

CATCHWORDS: CRIMINAL LAW - manufacture counterfeit therapeutic goods - penalty

LEGISLATION CITED: Therapeutic Goods Act 1989 Crimes Act 1914 (Cth)

CASES CITED: R v Pan Pharmaceuticals Ltd NSWDC 12 December 2005

PARTIES: Crown Comax-Pharma Pty Ltd (Offender)

FILE NUMBER(S): 08/11/0027

COUNSEL: R J Bromwich (Crown) TG Feerick, solicitor (Offender)

SOLICITORS: Commonwealth DPP Frontier Law Group

SENTENCE

1. Comax-Pharma Pty Ltd (Comax) pleaded guilty to two charges that it manufactured therapeutic goods knowing that those goods were counterfeit, because they contained false representations about the identity of the goods, contrary to the Therapeutic Goods Act 1989, (the Act), section 42E. It also asked me to take into account a further charge that it breached a condition of a licence under that Act by failing to ensure that the person, nominated by it as having control of quality control measures in respect of the goods, maintained that control.

2. The maximum penalty for each of the two charges in the indictment is $220,000 for individuals, but because the offender is a corporation, the maximum pecuniary penalty is five times that sum, $1.1 million.

3. A number of other persons have been charged in relation to this offence, as accessories. Each has now pleaded guilty, having earlier defended the charges, and they will be sentenced later. They are Dr Shahid, Dr Adil, and Mr Jobanputra. Dr Shahid was the quality control manager of the offender, Dr Adil was the quality assurance manager, and Mr Jobanputra, the production manager. In theory, the production and quality control operations of the offender were supposed to be separate, according to the code of good practice for the pharmaceutical industry, but, in fact, Dr Adil was answerable to Dr Shahid, and Dr Shahid appeared to be answerable to Mr Jobanputra. There was a director of the offender, Mr Sohn, but I am told from the Bar table that he knew nothing of these offences until they had been reported. It is the responsibility of the directors and officers of a corporation that they ensure that the corporation obeys the law, and it is that failure on the directors' part that gives rise to the charge on the s 16BA Form.