Posted 08 September 2020
In March 2019, Natasha Bolognesi wrote an article for GroundUp, making the point: “But practitioners of so-called mild hyperbaric oxygen therapy (mHBOT) are fraudulently cashing in on the science that supports medically-approved HBOT”.
She also wrote: “Former chiropractor Malcolm Hooper, who owned the hyperbaric treatment clinic Oxymed Australia, is to stand trial for unsafe practice following the death of a former client who was undergoing treatment for multiple sclerosis at Hooper’s facility.”
TGA initiates court proceedings against Oxymed Australia and director Malcolm Hooper
3 September 2020
The Therapeutic Goods Administration (TGA), part of the Department of Health, has initiated proceedings in the Federal Court of Australia (Federal Court) in response to Oxymed Australia Pty Ltd and its sole director, Mr Malcolm Hooper’s alleged unlawful advertising of hyperbaric oxygen therapy chambers.
The TGA alleges the advertising promoted the devices for the treatment of serious diseases and medical conditions, including coronavirus (COVID-19), cancer, post-traumatic stress disorder and autism spectrum disorders.
The TGA recently issued Oxymed Australia with five infringement notices totalling $63,000 in relation to alleged unlawful advertising.
At that time, the TGA also informed Oxymed Australia that it must immediately remove all advertisements in breach of the Therapeutic Goods Act 1989 (the Act) and warned court action may be initiated if the advertisements were not removed and the notices were not paid.
Oxymed Australia did not pay the infringement notices, and the alleged unlawful advertising continued to be present on the Oxymed Australia website after the notices were issued.
The TGA therefore initiated court proceedings to obtain an injunction restraining Oxymed Australia and Mr Hooper (the Respondents) from advertising hyperbaric oxygen therapy chambers. The TGA further seeks orders that the Respondents pay penalties for alleged contraventions of the Act.
“The TGA continues to actively pursue those responsible for unlawful advertising in order to protect some of the most vulnerable Australians-those people living with serious diseases and conditions,” Adj. Professor John Skerritt, Deputy Secretary of the Department of Health, said.
“We will not tolerate the actions of any business which tries to take advantage of people, particularly during these very stressful times, and the TGA will continue to ensure the health and wellbeing of Australians is its highest priority.”
Following the commencement of proceedings, the website which is the subject of the proceedings was taken down by the Respondents, without any admission of liability.
The Federal Court has also made orders, by consent of the parties, that the website is not to be reinstated without the prior written consent of the TGA. The Federal Court’s orders can be accessed on the Commonwealth Courts Portal.
References to such diseases and medical conditions are prohibited and restricted representations under the Act. References to COVID-19 are of particular concern to the TGA given the current pandemic, and the TGA has recently published a warning to advertisers and consumers about illegal advertising relating to COVID-19.
Further information about the alleged advertising breaches is available in the following document:
Originating Application – https://www.tga.gov.au/sites/default/files/tga-initiates-court-proceedings-against-oxymed-australia-and-director-malcolm-hooper-alleged-unlawful-advertising-original-application.pdf
The matter is next before the Federal Court on 16 September 2020.
The TGA takes action against advertising breaches
The regulatory scheme is critical to the safety of Australian consumers and the TGA investigates suspected illegal activity in relation to therapeutic goods. A range of compliance and enforcement tools are available and may include criminal or civil court proceedings, which can result in substantial penalties, fines or imprisonment.
In July 2019, the Federal Court of Australia ordered Peptide Clinics Australia to pay $10 million to the Commonwealth for breaches of the mandatory rules for advertising.
In March 2020, the TGA commenced proceedings against Evolution Supplements Australia Pty Ltd and its sole director in relation to alleged advertising contraventions. In that matter, the Federal Court granted, by consent, an interim injunction to prevent the continuation of the alleged unlawful advertising.
In May 2020, the TGA commenced proceedings against MMS Australia and its sole director in relation to alleged advertising contraventions. In that matter, the Federal Court made orders restraining MMS Australia and its director from advertising and supplying goods containing certain potentially dangerous substances, including the main chemical used to make ‘Miracle Mineral Solution’ (MMS).
Any person, including businesses, advertising therapeutic goods to consumers must comply with the requirements for advertising. The TGA encourages people to report suspected non-compliant advertising via its advertising complaints form.
Visit the TGA website for tips about how to spot a dodgy health product.
Contact for members of the media
Email: [email protected]
Phone: 02 6289 7400
Tags: enforcement, advertising