The latest insights from our Health Law team.

In this edition:

$10 Million fine for breach of TGA advertising rules

Cosmetic service provider under investigation after allegedly treating clients in the back of jewellery store

New guide to help patients understand fees and out of pocket expenses

VPA highlights privacy

Chinese trained doctor’s racial discrimination win overturned on appeal

Therapeutic Goods Amendment (Excluded Goods) Determination (No. 2) 2019

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$10 Million fine for breach of TGA advertising rules

Peptide Clinics Australia (PCA) has been handed a $10 million fine by the Federal Court for breaches of the Therapeutic Goods Administration (TGA) medicine advertising rules. His Honour Jude Jagot found in Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107 that PCA had engaged in nine contraventions of the Therapeutic Goods Act 1989 (Cth) (Act), Therapeutic Goods Advertising Code 2015 (2015 Advertising Code) and Therapeutic Goods Advertising Code (No 2) 2018 (2018 Advertising Code).

Beginning in March 2018, PCA published advertisements about its peptide products which encouraged inappropriate use of the products. These are amino acids which can be used to stimulate growth hormones in the body. The Therapeutic Goods Act 1989 (Cth) (Act) and the TGA govern the use and advertisement of therapeutic goods. The advertised peptide products were all listed in Schedule 4 of the Poisons Standard, and are prescription only medicines.

The Court found that every day for over a year, PCA published advertisements on its website and social media which were in breach of the Act. These advertisements misled or were likely to mislead and, in particular the advertisements presented scientific information in an inaccurate, imbalanced and misleading manner. They contained claims, statements and implications that the advertised products were safe, or could not cause harm, and could be used for uses which were inappropriate for those products.

The Court accepted the claims made by the Secretary that PCA was ‘obstructionist’ and refused to make any amendments to its advertisements when put on notice by the TGA. The $10 million fine handed down was intended to 'secure the objective of general deterrence by making it clear message that companies will not be able to profit from their wrongdoing' (Secretary, Department of Health v Peptide Clinics Australia Pty Ltd [2019] FCA 1107, 46).

You can read the full judgement here.

Cosmetic service provider under investigation after allegedly treating clients in the back of jewellery store

There is always an element of risk when undergoing a medical procedure, however a recent case has highlighted the need to ensure the service provider is qualified and registered.

A cosmetic service provider in Springvale has been temporarily prohibited from providing medical services, storing medical products and even advertising services after their salon was allegedly found to be unregistered. The Springvale woman, who is now the centre of the Health Commissioners investigation, was administering cosmetic injections and procedures, such as Botox and dermal filler, from the back of a jewellery store in a Springvale shopping mall.

The same service provider is also under investigation by the Department of Health and Human Services (DHHS) for separate reasons. The investigations began after the Dandenong City Council informed the DHHS of concerns that the health procedures in place at the salon were not adequate. The DHHS is now urging previous clients of this salon to get themselves tested for Hepatitis B, Hepatitis C and HIV.

Furthermore, the Department of Health has recently released an alert regarding cosmetic injections, urging people to be cautious when considering treatments.

The alert outlines the risks that are involved and the importance of engaging a safe and qualified service provider. The alert notes that side effects of using the wrong product, or injecting product into the wrong location can cause discolouration and skin tissue dying.

The government has urged people to report any illegal or questionable practitioners to the Therapeutic Goods Administration.

This provides a reminder for service providers to ensure that their premises and procedures are up to standards and that their staff are all adequately qualified. It also provides a warning to potential clients to ensure they are receiving treatments safely.

To find out more about the case click here and to read the governments alert click here.

New guide to help patients understand fees and out of pocket expenses

The Federal Government and the Australian Medical Association (AMA) recently launched a joint guide that aims to assist Australian consumers when making medical and health decisions.

The guide, AMA’s Informed Financial Consent Guide; A Collaboration Between Doctors and Patients (Guide), aims to help patients better understand medical treatment fees and out of pocket costs. The Guide is intended to support patients to be more engaged in conversations with the doctors, health insurers and hospitals.

The Guide provides basic information about how the Australian health care system is funded, the types of fees that may be incurred depending on the treatment type and when fees may change throughout the process. It also provides a sample list of questions for patients to ask their medical practitioner regarding fees.

The Guide is one aspect of the AMA’s position on Informed Financial Consent, which encourages medical practitioners, insurers and hospitals to work together to provide detailed information to patients about the costs associated with medical treatment.

Access the Guide here and the AMA’s page on Informed Financial Consent here.

VPA highlights privacy

In a recent Communique, the Victorian Pharmacy Association has reminded licensees of the requirement under clause 9(h) of the Pharmacy Regulation Act 2010 (Regulation) to put in place adequate arrangements “to ensure that the identity of a medicine being supplied or dispensed to a client…cannot be known by another person present in the pharmacy…

The reminder comes after a Western Australian man was robbed at knifepoint after filling a prescription for alprazolam.

The Communique reminds pharmacies that the provision of medication in open baskets is a breach of the Regulation and to be aware of the potential public safety risks that could arise from any breach of privacy.

To read the Communique, please click here.

Chinese trained doctor’s racial discrimination win overturned on appeal

The ACT Government has successfully appealed a decision of ACT Civil and Administrative Tribunal (Tribunal) that it discriminated against a Chinese-born doctor, after he missed out on a medical internship at Canberra Hospital on the basis that he was trained overseas.

Dr Qinglin Wang is a former director of neurology at Tianjin Medical University, he moved to Australia in 2001 and became a citizen in 2006. Between 2006 and 2014, Dr Wang undertook relevant studies, completed relevant courses and passed relevant examinations. He has satisfied all the requirements for registration as a health practitioner in Australia, except that he needs to complete a one-year internship in an Australian hospital.

In 2013, Dr Wang applied for an internship and the position of Resident Medical Officer at the Canberra Hospital and other states and territories, he was unsuccessful in all of his applications.

In 2013-2014, the ACT implemented a policy which contained Categories 1 to 8 to prioritise grant of medical internship to graduates of the Australian National University (ANU) Medical School and graduates of interstate universities over overseas trained doctors. Under the policy, Dr Wang was placed in Category 8, internationally trained graduates.

Dr Wang lodged a complaint and argued that the policy amounted to racial discrimination because it disadvantaged graduates of foreign universities, which the Tribunal upheld in 2016. The ACT Government appealed, and the Tribunal overturned the decision on 15 July 2019.

The Tribunal found there is no evidence to find that the administration of the policy had the effect of disadvantaging people of Chinese national origin or non-Australian national origin. The Tribunal also found the ACT Government had not discriminated against Dr Wang, either directly or indirectly, on the basis of his nationality.

Read more about the decision here.

Therapeutic Goods Amendment (Excluded Goods) Determination (No. 2) 2019

A recent amendment to the Therapeutic Goods Act 1989 (Act) confirms that fluoridated tap water is not classified as a ‘therapeutic good’ under the Act.

Given the Act was previously silent on the status of fluoridated tap water, the Therapeutic Goods Amendment (Excluded Goods) Determination (No. 2) 2019 is significant in clarifying that adjusting the level of fluoride in drinking water is not subject to regulation under the Act and is to remain the responsibility of state and territory governments.

Adjusting the level of fluoride in drinking water is generally accepted as an equitable and effective way of improving communities’ dental health, and the National Health and Medical Research Council indicates that there is no proven connection between fluoridated water and any adverse public health outcomes. Indeed, since the connection between fluoridated drinking water and improved dental health was confirmed in the 1940s and 1950s, water authorities on both a domestic and global scale have adjusted levels of fluoride with demonstrated benefits to public health.

In confirming that the state and territories retain regulatory power within this space, the amendment appears illustrative of the Commonwealth’s view that a national approach to the regulation of fluoridated drinking water is not needed.

For more information on the impact of this amendment, click here.