Public health alert – Bondi Westfield

Source: New South Wales Health – State Government

NSW Health has been notified of a number of new venues in Sydney’s eastern suburbs which have been visited by confirmed cases of COVID-19.
NSW Health is also now advising anyone who visited Westfield Bondi Junction (including the car park) at the following times is asked to get a COVID-19 test, even if they do not have any symptoms. People with no symptoms do not need to isolate while waiting for their test result.
Those times are:
Bondi Junction
Westfield Bondi Junction
500 Oxford Street
Saturday 12 June11am to 12pm
Bondi Junction
Westfield Bondi Junction
500 Oxford Street
Sunday 13 June1pm to 2pm and 4pm to 4:30pm
Anyone who visited Westfield Bondi Junction between Friday 11 June and Friday 18 June should monitor closely for symptoms and get tested if they become unwell.
Anyone who attended any of the following venues at the times listed is a close contact and must immediately get tested and self-isolate for 14 days regardless of the result:
Bondi Junction
Tea Gardens Hotel Bondi Junction – Gaming room
2-4 Bronte Rd
Sunday, 13 June5pm-5:15pm
Anyone who attended any of the following venues at the times listed is a casual contact and must immediately get tested and self-isolate until a negative result is received. Please continue to monitor for symptoms and immediately isolate and get tested if they develop:
Bondi Junction
Myer Bondi JunctionLevel 2 (includes women’s sleepwear, shoes, lingerie, handbags, accessories, watches and cosmetics)
500 Oxford Street
Sunday, 13 June10am to 10:30am
Bondi Junction
Tea Gardens Hotel Bondi Junction – rest of venue excluding gaming room
2-4 Bronte Rd
Sunday 13 June5pm to 5:15pm
Bondi Junction
Woolworths, Westfield Bondi Junction
500 Oxford Street
Sunday 13 June4:00pm to 4:20pm
Bondi Junction
Woolworths, Westfield Bondi Junction
500 Oxford Street
Monday 14 June2:15pm to 2:40pm
Bondi Junction
Eastgate Bondi Junction – Ground floor food court
71-91 Spring St
Monday 14 June11:15am to 11:25am
Bondi Junction
Aldi, Eastgate Bondi Junction           
71-91 Spring St
Monday 14 June11:20am to 11:50am
Bondi Junction
Bondi Junction Interchange Food Court
422 Oxford St
Tuesday 15 June3:05pm to 3:15pm
Bondi Junction
Ichiban Boshi, Bondi Junction
1/171-173 Oxford St
Wednesday 16 June11:40am to 12:15pm
Bondi Junction
Daiso, Oxford St Mall
430 Oxford St
Wednesday 16 June12:00pm to 12:30pm
Bondi Junction
Mitre 10, Oxford St Mall
452 Oxford St
Wednesday 16 June12:15pm to 12:45pm
NSW Health always alerts the community as soon as possible when there is any risk to public health, including exposure venues related to confirmed cases of COVID-19.
As announced this morning, given the latest cases of community transmission, NSW Health has today introduced temporary COVID safe measures.
NSW Health is asking people in the Sydney and Blue Mountains (excluding the Central Coast, and Wollongong and the Illawarra) area to follow updated health advice from 4pm today until 12:01am Thursday 24 June 2021:
avoid non-essential visits to aged care and disability facilities, but if visiting, wear a mask and limit visits to two people per day
masks are mandatory on public transport
masks are strongly encouraged in all public indoor venues, such as retail, theatres, hospitals, aged care facilities and for front-of-house hospitality staff.
Please check the NSW Health website regularly, as the list of venues of concern and relevant health advice will be updated as investigations continue.
Anyone with even the mildest of cold-like symptoms is urged to immediately come forward for testing and isolate until a negative result is received.
There are more than 300 COVID-19 testing locations across NSW, many of which are open seven days a week. To find your nearest clinic visit COVID-19 clinics  or contact your GP.

Philips recall action for CPAP, Bi-Level PAP devices and mechanical ventilators

Source: Australian Department of Health

Safety hazard caused by foam degradation and emissions

The TGA is working with Philips on its global recall action for Continuous Positive Airway Pressure (CPAP), Bi-Level Positive Airway Pressure (Bi-Level PAP) devices and mechanical ventilators due to risks posed by the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices.

The majority of the affected devices are in the first-generation DreamStation product family.

A full risk assessment is underway including numbers supplied in Australia and on potential particulate and chemical exposure risks which will inform further advice to health professionals and consumers.

As a precautionary measure, pharmacies are advised to quarantine and remove from sale any unsold units of the affected devices.

We will continue to work with Phillips to ensure that comprehensive information is made available as quickly as possible through formal published announcements on the TGA website and from Phillips directly to customers.

Information for consumers

For devices currently in use in critical or lifesaving situations, patients or caregivers should continue using the devices until an alternative becomes available.

Information for health professionals

Please be aware of the above issue and advise patients accordingly if they seek advice.

Reporting problems

Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA’s monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).

The TGA cannot give advice about an individual’s medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.

Public health alert – Additional venues

Source: New South Wales Health – State Government

NSW Health has upgraded the health advice for anyone who attended certain levels of the Myer and David Jones in Bondi Junction on Saturday 12 June, following a confirmed COVID-19 transmission event.
NSW Health’s investigations have confirmed transmission occurred between two patrons at the Myer store.
Anyone, including staff and patrons, who attended Myer Bondi Junction, Level 2 and Level 4 on Saturday 12 June from 11:15am to 11:50am is considered a close contact  and must immediately call NSW Health on 1800 943 553, get tested and self-isolate for 14 days from the date they were at the venue, regardless of the result.
Level 2 includes women’s sleepwear, shoes, lingerie, handbags, accessories, watches and cosmetics. Level 4 includes homewares, toys and kidswear.
Anyone who attended during these times but did not go to level 2 or 4 is not a contact.
Anyone, including staff and patrons, who attended David Jones Bondi Junction, Level 1 on Saturday 12 June from 10.55am to 11.15am is now considered a close contact and must immediately call NSW Health on 1800 943 553, get tested and self-isolate for 14 days from the date they were at the venue, regardless of the result.
Level 1 includes bedding, manchester, homewares and small appliances.
Anyone who attended during these times, on either the food court of level 1, or any other floors of David Jones is not a contact.
NSW Health has also identified a number of additional venues of concern associated with confirmed COVID-19 cases.
Anyone who attended the following venue at the listed time is a casual contact and must immediately get tested and self-isolate until a negative result is received. Please continue to monitor for symptoms and immediately isolate and get tested if they develop:
Bondi Junction
Westfield Bondi Junction, Level 5 Food Court
500 Oxford Street, Bondi Junction
Sunday 13 June1:15pm to 1:45pm
Macquarie Park
Eden Gardens
307 Lane Cove Road
Sunday 13 June12:30pm to 1pm
Anyone who visited the following venues at the listed times should monitor for symptoms and if they occur get tested immediately and self-isolate until you receive a negative result:
Bondi Junction
Westfield Bondi Junction,  Level 4
500 Oxford Street, Bondi Junction
Friday 11 June12:30pm to 1pm
Bondi Junction Interchange
Bondi Junction Interchange Stand J
Bondi Junction
Tuesday 15 June4:10pm to 4:30pm
Sydney International Airport
Limousine car park at Sydney International Airport
Arrival Circuit, Mascot
Tuesday 15 June6am to 7:30am
As announced this morning, given the latest cases of community transmission, NSW Health has today introduced temporary COVID safe measures.
NSW Health is asking people in the Sydney and Blue Mountains (excluding the Central Coast and Wollongong and the Illawarra) area to follow updated health advice from 4pm today until 12.01 am Thursday 24 June 2021:
avoid non-essential visits to aged care and disability facilities, but if visiting, wear a mask and limit visits to two people per day.
masks will be mandatory on public transport from 4pm today
masks are strongly encouraged in all public indoor venues, such as retail, theatres, hospitals, aged care facilities and for front-of-house hospitality staff.
Please check the NSW Health website regularly, as the list of venues of concern and relevant health advice will be updated as investigations continue.
Anyone with even the mildest of cold-like symptoms is urged to immediately come forward for testing and isolate until a negative result is received.
There are more than 300 COVID-19 testing locations across NSW, many of which are open seven days a week. To find your nearest clinic visit COVID-19 clinics  or contact your GP.

Public health alert – additional venue

Source: New South Wales Health – State Government

NSW Health has been notified of additional venue of concern associated visited by confirmed cases of COVID-19.
If you were at the following venue at the time listed, you must immediately call NSW Health on 1800 943 553, get tested and self-isolate until you receive further information from NSW Health:

Leichhardt

Harris Farm

Shop B1, 51-57 Norton Street

Tuesday 15 June9.50am to 10.05am

Please continue to check the NSW Health website regularly, as the list of venues of concern will be updated as investigations continue.
Anyone with even the mildest of cold-like symptoms is urged to immediately come forward for testing and isolate until a negative result is received.
There are more than 300 COVID-19 testing locations across NSW, many of which are open seven days a week. To find your nearest clinic visit https://www.nsw.gov.au/covid-19/how-to-protect-yourself-and-others/clinics or contact your GP.

Promotion of COVID-19 vaccinations: further information for healthcare practitioners and other advertisers

Source: Australian Department of Health

Joint statement from the TGA and Ahpra

The Therapeutic Goods Administration (TGA), National Boards and the Australian Health Practitioner Regulation Agency (Ahpra) support vaccination as a crucial part of the public health response to the COVID-19 pandemic.

Recent TGA regulatory changes regarding the promotion of approved COVID-19 vaccines clarify the way healthcare professionals can communicate to the public about COVID-19 vaccines and gives greater flexibility to openly discuss vaccination. On 7 June 2021, the TGA issued updated guidance on the lawful communication and promotion of COVID-19 vaccines which explain these changes.

A number of healthcare professionals and their peak bodies have asked for clarification about the relationship between these changes, and the responsibilities that registered health practitioners and others who advertise regulated health services have under the National Law, as outlined in the National Boards’ “Guidelines for advertising a regulated health service” (the National Boards’ advertising guidelines).[1],[2]

Not all statements about COVID-19 vaccines will involve advertising of regulated health services. Where promoting COVID-19 vaccines does involve advertising of regulated health services, it must comply with both the TGA’s guidance and advertising requirements of the National Law.

The updated TGA regulations and guidance permits health practitioners, and others, to develop their own materials to communicate publicly about COVID-19 vaccines, within particular bounds. The TGA’s guidance states that the materials must not make statements that are misleading or deceptive, claim that vaccination is totally safe, or compare the different types of COVID-19 vaccines. While more specific, this is consistent with the National Boards’ advertising guidelines and position statement on COVID-19 vaccination.

Offer of rewards

Under the National Law, offers of gifts, discounts or other inducements are permitted in advertising of regulated health services so long as the terms and conditions of the offer are stated. The TGA’s guidance explains that the offer of certain rewards to people who have been fully vaccinated against COVID-19 is now permitted under therapeutic goods regulations provided the offer complies with certain conditions (such as not offering alcohol, tobacco or registered medicines). While offers of a reward for being fully vaccinated are most likely to be provided by businesses who are not providing health services, it is possible that healthcare professionals such as GPs or pharmacists may also offer a reward. Advertising that seeks to attract a person to a specific regulated health service provider for the purpose of COVID-19 vaccination must comply with both the TGA’s guidance and advertising requirements of the National Law.[3]

Importantly, the TGA’s guidance on promotion of COVID-19 vaccines does NOT change responsibilities that health practitioners and other advertisers have under the National Law when advertising a regulated health service. Both sets of regulations and guidance operate in parallel, including the requirements under section 133(1) of the National Law about the advertising of regulated health services. In particular, the prohibition on advertising that is false, misleading or deceptive continues to apply.[4]

Additionally, where the offer of a reward for being fully vaccinated involves advertising a regulated health service, the advertisement must comply with both the TGA’s guidance and the advertising requirements of the National Law, including stating the terms and conditions of the offer.[5]

Providing information as part of a consultation or treatment

The TGA guidance notes that information shared between a doctor, pharmacist or nurse and their patient during consultation or treatment is not subject to the therapeutic goods advertising rules. For example, if a patient asks their doctor during a consultation about the relative merits of each vaccine and which one is suitable for them, the doctor can advise the patient without risk of breaching the TGA’s advertising laws. This is consistent with the National Boards’ advertising guidelines which explain that a practitioner providing information about treatment in a consultation is not considered to be advertising a regulated health service. National Boards expect all health practitioners to use their professional judgement and the best available evidence in practice, including when providing information to their patients and the public about public health issues such as COVID-19 and vaccination.[6]

Further information

Further information on the advertising requirements of the National Law is available on the Ahpra website at www.ahpra.gov.au/publications/advertising-hub.aspx

The 15 National Health Practitioner Boards work in partnership with Ahpra to regulate Australia’s 800,000+ registered health practitioners. The primary role is to protect the public. National Boards’ registration standards, codes and guidelines form part of the regulatory framework for each profession and guide the professional practice of registered health practitioners in Australia.


Public health alert – new case and additional venues

Source: New South Wales Health – State Government

NSW Health has been notified that a household contact of a locally acquired case reported earlier this evening has also tested positive, and further venues of concern have been identified.
If you were at the following venue of concern at the time listed, you must immediately call NSW Health on 1800 943 553, get tested and self-isolate until you receive further information from NSW Health:
Bondi Junction
Harry’s Coffee and Kitchen

500 Oxford Street

Tuesday 15 June3pm to 3.40pm
Bondi Junction
NAB in Westfield
500 Oxford Street
Tuesday 15 June2.45pm to 3.10pm
Bondi Junction
David Jones in Westfield
500 Oxford Street
Tuesday 15 June3.30pm to 4.15pm
Vaucluse
Field to Fork
101 New South Head Road
Friday 11 June12pm to 4pm
Anyone on the following public transport service is a close contact and must immediately call NSW Health on 1800 943 553, get tested and self-isolate for 14 days from the date they were on the bus, regardless of the result:
Bondi Junction to North Sydney
200 Bus
From Bondi Junction interchange to Blue St, North Sydney (near North Sydney Station)
Tuesday 15 JuneDeparted approx. 4.25pm, arrived approx. 5pm
Anyone who attended the following venue at the listed time is a casual contact and must immediately get tested and self-isolate until a negative result is received. Please continue to monitor for symptoms and immediately isolate and get tested if they develop:
Bondi
Fruitologist
151 Bondi Rd, Bondi NSW 2026
Tuesday 15 June1pm to 2pm
These venues are in addition to those announced earlier today. Please check the NSW Health website regularly, as the list of venues of concern will be updated as investigations continue: https://www.health.nsw.gov.au/Infectious/covid-19/Pages/case-locations-and-alerts.aspx
Anyone with even the mildest of cold-like symptoms is urged to immediately come forward for testing and isolate until a negative result is received.
A new pop-up testing clinic will open tomorrow morning (17 June) at 8am at the Albion Street Centre Laverty Pathology, 150 Albion Street (Crown Street entrance), Surry Hills, and will then be open 8am to 6pm, seven days a week.
A number of other clinics have had their opening hours extended:
Bondi Beach drive-through, Parks Drive, North Bondi (enter on the junction of Campbell Parade and Beach Road) – open 7.30am to 10pm, seven days a week
Prince of Wales Hospital, enter via Building 14B, Avoca Street, Randwick – open 9am-8pm until Friday initially
Bondi Junction Laverty drive-through, Level 2, car park, 38 Waverley Street, Bondi Junction – open  8am to 8pm, seven days a week
Rose Bay Laverty drive-through, Lyne Park, Vickery Avenue car park, Rose Bay – open 8am to 10pm, seven days a week
St Vincent’s Hospital, East Sydney Arts Centre, 34-40 Burton Street, Darlinghurst (access from Palmer Street entrance) – open 8am to 10pm, seven days a week
North Ryde Laverty drive-through, 60 Waterloo Road, North Ryde – open 7.30am to 8pm, seven days (from 17 June)
There are more than 300 COVID-19 testing locations across NSW, many of which are open seven days a week. To find your nearest clinic visit https://www.nsw.gov.au/covid-19/how-to-protect-yourself-and-others/clinics or contact your GP.

Reporting medicine shortages and discontinuations in Australia – Guidance for sponsors

Source: Australian Department of Health

This guidance is for sponsors of reportable medicines, which include:

‘Reportable medicines’ are defined in the Therapeutic Goods Act 1989 (the Act), see section 30EH.

This guidance describes the mandatory requirements for reporting current and anticipated reportable medicine shortages and discontinuations in Australia.

  • About this guidance
  • Reporting a shortage to the TGA
  • Medicine shortages and discontinuations
  • Mandatory reporting timeframes
  • Impact ratings
  • Completing the shortage notification form
  • Submitting a shortage notification
  • Publication of shortages on the TGA website
  • Communication of shortages
  • Case studies
  • Version history

We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.

NSW maintains strong elective surgery performance

Source: New South Wales Health – State Government

NSW has achieved a five-year record performance in the number of elective surgeries performed in any first quarter, according to the latest Bureau of Health Information (BHI) Healthcare Quarterly report.
The number of elective surgical procedures performed in NSW public hospitals increased by 7,065 (13.9 per cent) to 58,044 in the January to March 2021 quarter, compared with the same quarter in 2020.
NSW Health Deputy Secretary Susan Pearce said the system has remained focused on fast-tracking surgeries which were unavoidably delayed following the National Cabinet decision to suspend all non-urgent and most semi-urgent surgery in March 2020 due to the COVID-19 pandemic.
“Our public hospitals recorded the highest number of elective surgeries performed for any first quarter over the past five years – this is an extraordinary result and reflects the tremendous efforts of our staff to ensure people receive their elective surgeries on time,” Ms Pearce said.
“Almost all (99.6 per cent) urgent elective surgical procedures were performed on time and we continue to ensure that those who need surgery most receive it quickly.”
Ms Pearce said it is also important to note the BHI report does not include unplanned emergency surgery, including many critical life-saving procedures, which is a major component of the provision of surgical services for the people of NSW, and often more complex and surgically challenging than other elective surgical procedures.
People who receive emergency surgery are not included on the elective surgery wait list, which was down to 88,908 at the end of March from 90,456 at the end of December.
“Though we still have work to do, it is positive that the number of people waiting for their elective procedures has been reduced again,” Ms Pearce said.
Between January and March 2021, there were 759,157 emergency department attendances, which was slightly down by 5,272 (0.7 per cent) compared with the same quarter in 2020.
However, triage category 2 (emergency) presentations were up 5,808 (6.2 per cent) to 99,816. The median time to treatment for patients in this category was nine minutes, unchanged from the same quarter in 2020 and within the 10-minute target.
Triage category 1 patients are the most urgent and almost all are treated within two minutes.
Triage category 5 (non-urgent) presentations were down 9,678 (10.8 per cent) to 80,229, compared with January to March 2020. This drop was mainly due to the subsequent establishment of dedicated COVID-19 testing clinics across the state, reducing testing within emergency departments.
Since March 2020, the NSW Government has committed more than $3 billion to increase the capacity of the health system and ensure it is well placed to manage the ongoing impacts of COVID-19, including $458.5 million to fast-track elective surgeries. This boost in funding has helped bring the 2020-21 Health budget to a record $29.3 billion, or 27 per cent of the total NSW Budget. 
Since 2011, the NSW Government has built or upgraded more than 130 hospitals and health facilities across the State. A further 80 projects are currently underway and more than two-thirds of those are in rural and regional areas. Since 2011, the NSW Government has increased the health workforce by 24,614 Full Time Equivalent (FTE) or 25 per cent. A further 8,300 frontline staff are being added over this term, with 45 per cent going to the regions.

Communicating about COVID-19 vaccines

Source: Australian Department of Health

As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates the advertising of therapeutic goods in Australia. The following guidance explains how any party can lawfully provide communications about COVID-19 vaccines to support the Government’s COVID-19 vaccine roll-out.

These arrangements cease on 31 December 2022.

The information set out in this guidance does not extinguish responsibilities that any party has under other relevant laws, including but not limited to, the Australian Consumer Law. Additionally, health professionals also have responsibility to comply with the requirements of the Health Practitioner Regulation National Law.

Patient consultations are exempt from the advertising requirements

The information contained in this guidance does not apply to information shared between a doctor, pharmacist or nurse and their patient during consultation or treatment. For example, if a patient asks their doctor during a consultation about the relative merits of each vaccine and which one is suitable for them, the doctor can advise the patient without risk of breaching the advertising laws.

Lawful communications about COVID-19 vaccines

Any party (including health professionals, corporate entities and media outlets) can use the following mechanisms, individually or in any combination, to communicate information publicly about COVID-19 vaccines.

It is important to note that this guidance, and the corresponding legal instrument, only apply to COVID-19 vaccines registered on the Australian Register of Therapeutic Goods. The promotion of unregistered vaccine products or of any other registered or unregistered medicines for the prevention or treatment of COVID-19 is not permitted.

Communicating about COVID-19 vaccines

Any party can create their own content to promote COVID-19 vaccines, provided:

  • the content is consistent with current Commonwealth health messaging regarding the national COVID-19 vaccination program, including content found on the Australian Government Department of Health website; and
  • the content does not contain:
    • any reference to the trade name, sponsor name or active ingredient or any other information that would identify the vaccine (e.g. Pfizer or AstraZeneca)
    • any statement, or implication comparing different COVID-19 vaccines (or comparing vaccines with treatments such as medicines)
    • statements to the effect that COVID-19 vaccines cannot cause harm or have no side effects
    • any statement regarding COVID-19 vaccines that is false or misleading

Commonwealth health messaging means material that is published on Australian Government websites (including social media). This material is updated in accordance with changes to Government policy about the vaccine program. The onus is on the party preparing the communications to ensure the message is based on current Government messaging. The use of promotional materials produced by the Australian Government or an Australian state or territory government for use by others is the safest way to be compliant.

Commonwealth messaging about the COVID-19 vaccines is crafted to both facilitate optimal uptake and to ensure the public receives accurate information about safety and efficacy. References to the safety and efficacy of COVID-19 vaccines must be in alignment with Commonwealth health messaging.

Compliant examples

Doctor’s practice

Dr Smith posts on the clinic’s Facebook page a statement indicating that they support the Government’s vaccine roll-out and encourages their eligible patients to be vaccinated. Their post includes a link to information from the Australian Government Department of Health website, along with logistical information, including the opening hours of their COVID-19 vaccination clinic.

Employers

Happy Workers Co sends an email to their staff, using their own branding, indicating they encourage all eligible staff to receive the COVID-19 vaccine as recommended by the Government, and on the advice of a health practitioner. In the email they offer additional paid leave and an Uber ride to attend a vaccination appointment.

Offering rewards

Any party can offer valuable consideration (cash or other rewards) to people who have been fully vaccinated under the Government’s national COVID-19 vaccination program, subject to the following conditions:

  • the offer can only be made to people who have been fully vaccinated, which for the current approved COVID-19 vaccines, means two vaccinations. The TGA does not prescribe the means by which full vaccination is to be verified
  • the offer must contain a statement to the effect that the vaccination must be undertaken on the advice of a health practitioner
  • rewards must not include alcohol, tobacco or medicines (other than listed medicines)
  • the offer must only refer to COVID-19 vaccines generically (i.e. not by trade name or another reference to a particular vaccine, such as ‘the mRNA vaccine’)
  • the offer must be made to all eligible people who have been vaccinated i.e. the offer cannot be made to only those people vaccinated from the date of the offer, it must also apply retrospectively (i.e. to those who have commenced or completed their vaccination schedule prior to an offer being announced).

The offer can be made to a certain group, for example the employees of the business, or the members of the organisation, or to all members of the public.

The ‘advice of a health practitioner‘ means that the health practitioner has consulted with the prospective recipient and advised them of their suitability to receive a vaccination having regard to the individual’s health circumstances.

The Health Practitioner Regulation National Law

The arrangements set out in this guidance do not affect the responsibility health practitioners have to comply with the requirements set out in the National Law, in particular section 133(1), regarding the advertising of regulated health services.

For example the National Law prohibits:

  • advertising that is false, misleading or deceptive or is likely to be misleading or deceptive; and
  • offers a gift, discount or other inducement to attract a person to use the service or the business, unless the advertisement also states the terms and conditions of the offer.

It is the responsibility of the heath practitioner to determine and communicate the applicable terms and conditions of any offer. For further information, refer to AHPRA’s ‘Guidelines for advertising a regulated health service‘.

‘Valuable consideration’ includes any offer of value. Simply stated, valuable consideration occurs when a person receives goods, services or some other benefit (except for alcohol, tobacco, or medicines other than listed medicines), in exchange for being fully vaccinated under the national COVID-19 vaccination program.

Compliant examples

Business

Fly Away offers a 10% discount on flights to all ‘Fly Away Club’ members who have been fully vaccinated under the Government’s national COVID-19 vaccination program. The offer is open to any club member on the provision of validated vaccination status. The offer includes a statement that it is only valid for vaccinations undertaken on the advice of a health practitioner.

Business

Dramatic Days theatre company publicly offers a chance to win a years’ worth of free theatre tickets to anyone who is fully vaccinated under the national COVID-19 vaccination program. The offer includes a statement that it is only valid for vaccinations undertaken on the advice of a health practitioner.

Clinic and pharmacy

Uptown Medical Centre and Pharmacy publishes a Facebook post offering a free health check to anyone who has been fully vaccinated under the national COVID-19 vaccination program. The offer includes a statement that it is only valid for vaccinations undertaken on the advice of a health practitioner.

While businesses can limit the offer of the reward to particular persons, (i.e. members of an organisation or program, their staff etc.) the offer of the reward must not be conditional on the vaccination occurring after the offer is made.

For example, Fly Away announces the 10% discount to its club members on 8 June 2021. Club member Sam, was fully vaccinated on 1 April 2021 and therefore must be eligible to receive the reward.

Using government materials

Any party can use materials produced by the Australian Government or an Australian state or territory government to promote COVID-19 vaccines (see Further information below for links to these materials).

It would be helpful for advertising parties to make reference to the Vaccine Eligibility Checker for their staff, patients, customers, or stakeholders, to find out whether they are eligible to receive a vaccine, which vaccine they are eligible for and where it can be obtained.

Factual and balanced information that does not constitute advertising

Any party can publicly present factual and balanced information, that is not promotional and therefore not subject to the advertising rules, about the COVID-19 vaccines. Some examples of factual and balanced information include:

  • technical information relating to how the vaccines were developed and manufactured
  • sharing scientific reports from reputable sources (like the World Health Organization) about vaccination, without including promotional material or language
  • re-tweeting or sharing valuable news-worthy information from reputable sources about the COVID-19 vaccines; or
  • presenting comprehensive information that doesn’t emphasise the benefits over, for example, the risks and limitations.

Health professional endorsements

Ordinarily, health professionals are not allowed to endorse a medicine or other therapeutic good. However in the context of the pandemic, and under the legal instrument referenced below, this prohibition does not apply to registered COVID-19 vaccines.

Further information

  • The Australian Government materials on COVID-19 vaccines are available from:
  • The arrangements described in this guidance are enabled by:
  • The arrangements described in this guidance are enabled by:
  • If you have questions about the legal requirements regarding advertising of therapeutic goods including vaccines, please lodge an advertising enquiry online with the TGA.
  • You can also contact the TGA by phone on 1800 020 653 (free call within Australia) or 02 6289 4124 (for mobiles that do not allow 1800 calls).

Novartis-Bio Somatropin Human Growth Hormone (HGH)

Source: Australian Department of Health

The Therapeutic Goods Administration (TGA), in conjunction with Sandoz Pty Ltd and Novartis Australia, has investigated reports of counterfeit Somatropin HGH vials in community circulation.

From this investigation the TGA has established that Novartis-Bio Somatropin HGH (191 amino acid sequence rDNA origin for injection) 3.7mg per Vial (10x10IU Vials of Somatropin) as presented in the photographs below is not marketed in Australia by either Sandoz Pty Ltd or Novartis Australia.

The manufacturer of the original product, Novartis-Bio, confirmed that the product in question is not a commercial product of Novartis Australia and is a suspected counterfeit based on the packaging and invalid batch number present on the product.

Counterfeit Somatropin Human Growth Hormone (HGH) vials pose a serious risk to your health and should not be taken.

The supply of counterfeit Somatropin Human Growth Hormone (HGH) vials in Australia is illegal.

Information for consumers

  • Stop using Somatropin Human Growth Hormone (HGH) vials and take any remaining vials to your local pharmacy for safe disposal.
  • If you have any concerns arising from your use of this product, consult your health care practitioner.
  • If you suspect you have had a side effect (also known as an adverse event) to this product, please report it to the TGA. In addition, if you have concerns about this or other products, you can make a report to the TGA on 1800 020 653 or through our website.

Action the TGA is taking

The TGA is working with the Australian Border Force (ABF) to help stop shipments of Somatropin Human Growth Hormone (HGH) vials from entering Australia.

The TGA will notify ABF to seize and destroy any of these products intercepted at the border.

The TGA is advising consumers to exercise extreme caution when purchasing medicines from unknown overseas Internet sites and has produced a short video on the risks associated with buying medicines and medical devices online.

Products purchased over the Internet:

  • may contain undisclosed and potentially harmful ingredients
  • may not meet the same standards of quality, safety and efficacy as those approved by the TGA for supply in Australia.