In this edition: New national clinical guidelines for diagnosis and treatment of Endometriosis, ACCC releases guidance for button / coin batteries and Mosaic Brands pays $630,000 in penalties over COVID-related 'health essentials'
The latest insights from our Health Law team:
New national clinical guidelines for diagnosis and treatment of Endometriosis
ACCC releases guidance for button / coin batteries
Mosaic Brands pays $630,000 in penalties over COVID-related 'health essentials'
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The Royal Australian and New Zealand College of Obstetricians and Gynaecologists, along with a team of endometriosis experts, has developed and released new national clinical practice guidelines for the diagnosis and treatment of endometriosis, which were commissioned by the Australian Government. Endometriosis is a chronic inflammatory condition which affects one in nine women and girls (an estimated 700,000 Australians) and involves the endometrium growing in locations outside the uterus. In addition, the guidelines also provide evidence-based guidance in relation to adenomyosis, which is a related condition which can occur independently or in conjunction with endometriosis.
The guidelines align with the National Action Plan for Endometriosis which launched in 2018, and since which, the Australian Government has committed $21.13 million to improve awareness, clinical management, case and research into endometriosis. The action plan has three priority areas, including:
- Education and awareness;
- Clinical care; and
It aims to improve awareness of endometriosis, patient’s understanding of the condition, treatment options and research programs into endometriosis and chronic pelvic pain. The newly released guidelines, which fall under the priority area of ‘clinical care’ aim to provide up-to-date and evidence based guidance to assist health practitioners in providing care to people with endometriosis and to ensure earlier detection.
To read more about the guidelines, click here.To read more about the National Action Plan for Endometriosis, click here.
Australia's consumer watchdog, the Australian Competition & Consumer Commission (ACCC) has released guidance for the new, mandatory standards relating to button/coin batteries introduced in December 2020.
Button/coin batteries are small, single cell batteries that enjoy wide application in small, portable electronic devices. However, they also present the risk of injury and even death to children if swallowed or inserted into the body. In response to this risk, the ACCC introduced the following four mandatory standards in late 2020:
- Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020.
- Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020.
- Consumer Goods (Button/Coin Batteries) Safety Standard 2020.
- Consumer Goods (Button/Coin Batteries) Information Standard 2020.
These standards cover new requirements for secure battery compartments, child resistant packaging, and warnings and information. While they do include an 18 month transition period intended to allow suppliers time to implement changes necessary for compliance, this period ends on 21 June 2022. Non-compliant batteries sold thereafter may attract penalties.
Healthcare providers, hospitals, medical colleges, aged care providers and other businesses are encouraged to review their buying arrangements to ensure compliance from 22 June 2022 onwards.
You can read a summary of the guidance here, while a more comprehensive version is available here.
It has been reported by the Australian Competition and Consumer Commission (ACCC) that Mosaic Brands Limited (Mosaic Brands), an ASX listed company, has paid $630,000 as a penalty for its breach of the Australia Consumer Law. The breach arises from its promotion of pandemic-related ‘Health Essential Products’.
Mosaic Brands operates about 1210 stores nationally, including fashion brands Noni B, Autograph, BeMe, Crossroads, Katies, Millers, Rivers, Rockmans and W.Lane.
Five infringement notices were issued to Mosaic Brands for alleged false or misleading representations relating to hand sanitiser and face masks advertised on their websites and through direct marketing between March and June 2020. The key offending conduct by Mosaic Brands includes:
- Air Clean hand sanitiser sold on the Noni B website purporting to contain 70 per cent alcohol, when a sample tested by the ACCC was found to contain 17 per cent alcohol;
- Miaoyue hand sanitiser sold by Millers purporting to contain 75 per cent alcohol, contained only 58 per cent alcohol;
- Velcare-branded hand sanitiser products sold on its websites as ‘WHO-approved’, when they were not. The World Health Organisation does not approve or certify hand sanitiser products;
- KN95 Kids Safety Face Masks sold on its websites as ‘CE/FDA certified’, when they were not; and
- KN95 Adult Face Masks as “non-refundable”, when in fact consumers have a statutory right to a refund under the consumer guarantee remedies.
Mosaic Brands admitted to false or misleading statements regarding their products. As a result, Mosaic Brands must, under a court-enforceable undertaking, refund customers under a redress program, implement a three-year compliance program and properly substantiate its claims with respect to hand sanitisers and face masks, including independent product testing.
A copy of the enforceable undertaking can be found here.
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