In this edition: 2020-21 Federal Budget Update, Regulation of Prescription Opioids, ACCC sanctions Live Life Alarms, New drugs and novel technologies in Australia, and Amendments to the COVID-19 Commercial Tenancy Relief Scheme.
The latest insights from our Health Law team:
2020-21 Federal Budget Update
Changes to Regulation of Prescription Opioids
ACCC sanctions Live Life Alarms for allegedly misleading statements on its website
New drugs and novel technologies in Australia
Amendments to the COVID-19 Commercial Tenancy Relief Scheme as of 29 September 2020
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2020-21 Federal Budget Update
The 2020-21 Federal Budget (Budget) was released on 6 October 2020, providing over $115.5 billion in 2020-21 and $467 billion over the forward estimates to deliver essential health services to Australians under the Long Term National Health Plan.
The Budget addresses and supports a number of health initiatives such as the Australian Health Sector Emergency Response Plan, mental health support, implementation of the COVID-19 Vaccine and Treatment Strategy, Pharmaceutical Benefits Scheme (PBS) New Medicines Funding Guarantee, improving Medicare and health and aged care workforce capacity, and delivering improvements to health infrastructure and systems, primary care and medical research.
The Government’s record investment in health includes:
- a four-year investment of $467 billion, up $32 billion over last year’s Budget;
- $115.5 billion in health investment in 2020–21, up $11.5 billion on last year’s Budget;
- Medicare investment of $119.3 billion over the forward estimates, up $6 billion;
- $41.5 billion for medicines funding over four years, including the creation of the PBS New Medicines Funding Guarantee;
- ensuring hospital capacity with a $133.6 billion investment over five years, and 2020–21 funding of $23.6 billion;
- $5.7 billion for mental health, including doubling of support under Better Access, from 10 to 20 Medicare-funded psychological services;
- $2.3 billion investment in COVID-19 treatments and vaccines;
- funding for aged care boosted to $23.9 billion, up $2.2 billion; and
- a $230.8 million injection into sport and preventive health.
To read more about the Budget and funding for health, click here. To read the media announcement of the Hon Greg Hunt MP, Minister for Health, click here.
Changes to Regulation of Prescription Opioids
In response to rising statistics in harm and fatalities associated with prescription opioids, the Department of Health and Therapeutic Goods Administration (TGA) are implementing a number of regulatory changes, intended to:
- minimise the harm caused by prescription opioid medicines;
- ensure safe and effective prescribing and use of opioids; and
- maintain access to prescription opioids.
According to the TGA, every day there are nearly 150 hospitalisations and 14 emergency department admissions relating to prescription opioid use, three of which result in death.
Following public consultation conducted on the matter in 2018 in which 98 submissions were received, it was evident that stakeholders were consistently in favour of a regulatory response to the issue. In consultation with an established advisory group of independent health professionals and consumer organisations called the Opioid Regulatory Advisory Group, the TGA determined a number of regulatory changes to be implemented. These changes relate only to certain prescription opioid products and have either commenced or are in the process of being phased in.
In summary, the changes include requiring pharmaceutical companies to:
- register smaller packaging for immediate release opioids, providing a more appropriate option for short-term pain relief;
- add additional warning statements to the approved Product Information for all opioids, including details surrounding circumstances warranting prescription and potential adverse effects;
- improve information available surrounding risks associated with use, minimising those risks and encouraging best-practice prescribing; and
- updating the prescription indications to ensure patients are prescribed opioids only where the benefits outweigh the risks.
For further information on the changes, including a list of the affected prescription opioids, click here. For more information regarding the consultation process and reasoning for the changes, click here.
ACCC sanctions Live Life Alarms for allegedly misleading statements on its website
The Australian Competition and Consumer Commission (ACCC) has fined Live Life Alarms $25,200 for alleged false or misleading representations on its website. Live Life Alarms is an online seller of personal ‘SOS’ alarms used by the elderly and people with disabilities to contact emergency services if they require urgent assistance.
The ACCC alleges that the company posted a testimonial on its website, representing that it was from a customer of Live Life Alarms when, in fact, the testimonial related to a competitor’s product.
The alleged conduct was of particular concern to the ACCC because it “…may have influenced potentially vulnerable consumers to purchase a personal alarm from Live Life Alarms,” ACCC Commissioner Sarah Court said.
The ACCC also alleges that when providing refunds to dissatisfied customers under a 14-day money back guarantee, the company deducted fees for postage, packing and credit card transactions, amounting to almost 20 percent of the purchase price.
Live Life Alarms no longer deducts any amount when providing refunds under its refund policy, and it has removed the testimonial from its website.
Live Life Alarms operates its mobile alarm business online and began trading in Australia in January 2015.
See here for the full ACCC publication.
New drugs and novel technologies in Australia
The House of Representatives Standing Committee on Health, Aged Care and Sport (Committee) is holding an inquiry into the approval processes for new drugs and novel medical technologies in Australia, with a particular focus on treating rare diseases.
In accordance with the Terms of Reference (available here), the Committee will consider the following:
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The development of new drugs in Australia and globally;
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Incentives to research, develop and commercialise new and existing drugs, including where existing drugs could be repurposed and used to treat new conditions;
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Measures that could make Australia a more attractive location for clinical trials for new drugs and novel medical technologies; and
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Whether the approval processes could be made more efficient.
The Committee is accepting submissions for this inquiry until 3 November 2020. To lodge a submission or review submissions already made, click here. You can find information about making a submission here.
Amendments to the COVID-19 Commercial Tenancy Relief Scheme as of 29 September 2020
On 29 September 2020, the COVID-19 Omnibus (Emergency Measures) (Commercial Leases and Licences) Miscellaneous Amendments Regulations 2020 (Amending Regulations) came into force. This followed the passing of the enabling Act, the COVID-19 Commercial and Residential Tenancies Legislation Amendment (Extension) Act 2020.
The Amending Regulations officially extend the Commercial Tenancy Relief Scheme (CTRS) until 31 December 2020. They amend the existing rent relief provisions contained in the COVID-19 Omnibus (Emergency Measures) (Commercial Leases and Licences) Regulations 2020 (Existing Regulations) which applied to the period 29 March 2020 to 29 September 2020. The Amending Regulations amend the Existing Regulations, but the Amending Regulations take effect from 29 September 2020 and do not apply retrospectively.
Read the full Alert for a summary of the changes to the CTRS as a result of the Amending Regulations, here.
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