Court action

19 September 2017

Section 61(5A) of the Therapeutic Goods Act 1989 provides that the Secretary may release to the public therapeutic goods information relating to any decision or action taken under this Act or the regulations. It is TGA practice to publish details of regulatory compliance decisions and actions on its website.

The TGA collects intelligence in relation to alleged breaches of the Therapeutic Goods Act 1989 and Regulations and undertakes:

  • criminal prosecutions (in association with the Commonwealth Director of Public Prosecutions) and
  • civil litigation for the recovery of civil penalties where appropriate.

2017 2016 2015 2014 2013

2017

Conviction for criminal charges for dealing with unapproved therapeutic goods

On 12 July 2017 the Devonport (Petty) Court sentenced a man and woman in relation to 2 criminal charges each surrounding the manufacture and supply of unapproved therapeutic goods under section 19B(4) of the Therapeutic Goods Act 1989. The product, known as Black Salve, is not approved for marketing in Australia and has been the subject of TGA alerts (See Black and red salves in treating cancer and Black salve, red salve and cansema). The man and woman were convicted under the provisions of section 20(1) of the Crimes Act 1914 and fined $750 each. The court ordered that the goods seized as evidential material be forfeited to the Commonwealth under section 54 of the Therapeutic Goods Act 1989.

2016

Conviction for criminal charges for dealing with unapproved and counterfeit medicines

Following investigations by the Therapeutic Goods Administration (TGA), a Sydney based company and its sole director, a man from Sans Souci, appeared in the Downing Centre Local Court (Sydney) on 8 November 2016. The Director entered pleas of guilty to two offences relating to the manufacture and supply of counterfeit medicines contrary to s. 42E(1) of the Therapeutic Goods Act 1989. The unapproved medicines in question were not TGA approved and are considered counterfeit as the label did not disclose the presence of a prescription-only ingredient. The company was fined $10,000 and the Director was placed on a two year good behaviour bond with $1,000 security by the Court. All therapeutic goods seized as evidential material by TGA Investigators were forfeited to the Commonwealth.

2015

Conviction for criminal charges for dealing with unapproved therapeutic goods

On 3 December 2015, a Melbourne man appeared in the Ringwood Magistrates Court, Victoria on 8 criminal charges relating to dealing with unapproved therapeutic goods:

  • 6 counts of importing therapeutic goods not included in the Australian Register of Therapeutic Goods (ARTG) contrary to section 19B(4) of the Therapeutic Goods Act 1989 (Cth) (the Act)
  • 1 count of supplying therapeutic goods not included in the ARTG contrary to section 19B(4) of the Act
  • 1 count of supplying counterfeit therapeutic goods contrary to section 42E of the Act.

The Magistrate ordered that in relation to the import charges and supply charges under section 19B, a single penalty be imposed - the man was convicted and fined $1,500.

In relation to the charge of supplying counterfeit therapeutic goods, the man was convicted and fined $500.

The man who now resides overseas voluntarily returned to finalise these matters. He had no previous convictions and entered a guilty plea.

The man was ordered to pay $117 in court costs and he was allowed 3 months to pay. The Magistrate also ordered that all of the imported goods seized by TGA investigators were forfeited.

Conviction for importation of counterfeit erectile dysfunction medicines

On 22 May 2015 the Adelaide Magistrates Court sentenced a 69 year old Adelaide man in relation to the importation of counterfeit erectile dysfunction medicines. The man pleaded guilty to one criminal charge under section 42E (1)(a)(iii) of the Therapeutic Goods Act 1989. The man was convicted and fined $4,000.

The goods seized as evidential material were forfeited to the Commonwealth under section 54 of the Therapeutic Goods Act 1989.

Conviction for criminal charges surrounding the manufacture, export and supply of unapproved therapeutic goods

On 13 February 2015 the Southport Magistrates Court sentenced a man in relation to 24 criminal charges surrounding the manufacture, export and supply of unapproved therapeutic goods under section 19B(4) of the Therapeutic Goods Act 1989. The product, known as Black Salve, is not approved for marketing in Australia and has been the subject of TGA alerts (See Black and red salves in treating cancer and Black salve, red salve and cansema). The man was convicted under the provisions of section 20(1) of the Crimes Act 1914 and released on security of $5,000 and by recognizance that he be of good behaviour for two years. The court ordered the man not to be in possession of restricted chemicals, not to manufacture, promote, advertise or supply Black Salve and that the goods seized as evidential material be forfeited to the Commonwealth under section 54 of the Therapeutic Goods Act 1989.

2014

Conviction for criminal charges for dealing with unapproved and counterfeit medicines

Following an appeal by the Commonwealth Director of Public Prosecutions, two men were convicted the County Court of Victoria in Melbourne on 13 June 2014. Both respondents had been charged with eight criminal charges relating to their dealing with unapproved, and counterfeit medicines contrary the Therapeutic Goods Act 1989 (Cth) namely:

  • 2 charges contrary to section 19B (1)(a)(i) (import of unapproved therapeutic goods); and
  • 2 charges contrary to section 19B (1)(a)(iv) (supply of unapproved therapeutic goods); and
  • 1 charge contrary to section 35 (1) (carrying out step in manufacture of therapeutic goods while not licensed to do so); and
  • 1 charge contrary to section 42E (1)(a)(ii) (supply of counterfeit therapeutic goods); and
  • 1 charge contrary to section 42E (1)(a)(i) (manufacture of counterfeit therapeutic goods); and
  • 1 charge contrary to section 42E (1)(a)(iii) (import of counterfeit therapeutic goods).

Both men were released conditionally under paragraph 20 (1)(a) of the Crimes Act 1914 (Cth), that each respondent give security by recognisance of $ 750 and to be of good behaviour for two years.

2013

Outcome of criminal prosecutions, from 1 August 2013

  • 13 November 2013 - a company pleaded guilty in the Melbourne Magistrate's Court to the importation and supply of unapproved therapeutic goods contrary to subsection 19B(4) of the Act following an investigation by the Therapeutic Goods Administration. The company entered into an order and recognisance under Subsection 19B(1) of the Crimes Act 1914 with a recognisance of $25,000 on condition the company is to be of good behaviour for 12 months and to pay costs of the prosecution for the offences of $25,000 stayed until 11 February 2014.
  • 7 November 2013 - a man was sentenced at the Downing Centre Local Court (Sydney) in relation to supplying counterfeit medicines contrary to section 42E of the Act following an investigation by the Therapeutic Goods Administration. The man was convicted and ordered to perform 350 hours of community service.
  • 27 August 2013 - a man pleaded guilty at the Downing Centre Local Court (Sydney) to one count of importing unapproved weight loss medicines contrary to section 19B of the Act following an investigation by the Therapeutic Goods Administration. The man was ordered to pay a fine of $2,000 and to be of good behaviour for 2 years. The medicines seized by the TGA as evidence in the case were forfeited to the Commonwealth for destruction.