COVID-19 and recent developments in the health regulatory space

8 minute read 08.04.2020 Alix Friedman, Linda Kevorkian, Natasha Simonds, Jonathan Kelp

The outbreak of the COVID-19 pandemic has led to a dramatic increase in the promotion and sale of various products which may be used to combat the virus. By stepping up to manufacture, advertise and supply products such as hand sanitiser and disinfectants, companies are also stepping into the regulatory framework for therapeutic goods.

We explore some of these regulatory requirements, and some of the concessions made by the national regulator to facilitate wider participation in the industry.

The outbreak of the COVID-19 pandemic has resulted in a dramatic increase in the promotion and sale of various health-related products. Consumers are stocking up on prescription medicines, vitamins and supplements, and purchasing large quantities of hand sanitisers and disinfectants in an effort to both combat the coronavirus and be prepared for a potentially prolonged lockdown. Many manufacturers and suppliers have taken the opportunity to participate in these expanding markets, however not all are familiar with the strict regulatory regime which applies to all products which can be used for a therapeutic purpose, including preventing, treating and diagnosing COVID-19. It is critical that businesses are aware of, and comply with, any regulations that apply to them, and are aware of the specific requirements that relate to COVID-19-related products.

Role of the therapeutic goods regulatory regime

The Therapeutic Goods Administration (TGA) is the authority responsible for regulating therapeutic goods, such as medicines (including vaccines and complementary medicines) and medical devices. Therapeutic goods, including all products about which therapeutic use claims are made, are in most cases required to be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be imported into, supplied or manufactured in, or exported from, Australia. Examples of therapeutic use claims include claims that a product can:

Prevent, diagnose, cure or alleviate a disease or injury;
Influence a physiological process in a person; or
Test the susceptibility of a person to a disease or ailment.

In addition, representations about therapeutic goods that refer to a serious form of disease, condition, ailment or defect, are characterised as 'restricted representations'. TGA approval is required before any restricted representation can be made in an advertisement about a therapeutic good.

Any claim about the treatment of or protection against COVID-19 requires express TGA approval before it can be made.

Before approving a restricted representation, the TGA will likely require evidence to support the claim (for example, results of clinical trials).

Advertising of COVID-19 related products

A supplier must comply with the strict requirements under the Therapeutic Goods Act 1989, Therapeutic Goods Regulations 1990 and Therapeutic Goods Advertising Code (No. 2) 2018 (Therapeutic Goods Advertising Code) when advertising therapeutic goods. If a supplier makes a claim about a product that relates to the cure or alleviation of a disease, it may be considered therapeutic in nature and subject to the therapeutic goods regulatory regime.

For example, while a claim that a hand sanitiser 'kills 99.9% of germs' would likely not constitute a therapeutic use claim, an additional claim that the sanitiser has a health benefit, such as alleviating symptoms of a disease, would render it a therapeutic good.

The therapeutic goods legislation provides for a range of criminal offences (including up to five years' imprisonment) and civil penalties (including up to $1.05 million for an individual or $10.5 million for a company) as consequences of a breach. Despite these severe penalties and stringent advertising requirements, some businesses have taken advantage of the current period of uncertainty and engaged in advertising that is false and misleading, or otherwise unlawful. For example, there have been claims that certain unregistered products 'kill COVID-19' and that other medicines and medical devices can help fight or prevent the virus.

On 27 March 2020, the TGA announced that it had issued Oxymed Australia Pty Ltd (Oxymed) five infringement notices with penalties of $63,000 for alleged advertising contraventions, relating to the advertising of hyperbaric oxygen therapy chambers. The advertisements made therapeutic use claims that the hyperbaric oxygen therapy chambers could be used to treat serious ailments, diseases and conditions, including COVID-19. However, the hyperbaric oxygen therapy chambers were not included in the ARTG and Oxymed had not received TGA approval to make these restricted representations.

The TGA is also investigating advertisements funded by Clive Palmer, which promote a malaria drug (hydroxychloroquine) combined with another medication as a potential cure for COVID-19. Although a clinical trial for the drug has not yet begun or received ethics approval, and the TGA has warned that the drug poses serious risks to patients, the advertisements claimed that this is a 'cure' for the virus. The TGA is investigating whether the advertisement breaches the therapeutic goods advertising rules, for which serious penalties could apply.

Consumers must also be cautious about the increased risk of scammers seeking to exploit fear and uncertainty about the virus to sell products claiming to prevent or cure coronavirus or encourage investment. Consumers should be wary about any anonymous emails and texts relating to COVID-19 and submit a report to the Australian Competition and Consumer Competition's Scamwatch if they think they have been the target of an attempted scam.

Hand sanitisers and disinfectants – regulatory requirements

The outbreak of the COVID-19 pandemic has led to a dramatic rise in the sale of hand sanitiser and disinfectant products which consumers are using to quell the spread of germs and bacteria. Certain hand sanitisers and disinfectants are regulated as therapeutic goods and, importantly, the TGA has recently made various determinations to clarify suppliers' obligations in relation to the sale and advertising of these products.

Hand sanitisers

The TGA's guidance states that hand sanitisers fall into one of three classes for regulatory purposes – general consumer products, which are not regulated by the TGA, therapeutic goods, which are, and products with one of two specific formulations, which are excluded from regulation for the duration of the COVID-19 pandemic.

Hand sanitisers are general consumer products (and therefore classified as 'cosmetics') if:

They are for personal or domestic use and not used in a health care setting;
Any claims are limited to general low level activity against bacteria and germs (e.g. 'kills 99.9% of germs');
They have no claims against viruses; and
They contain only low-risk ingredients.

These cosmetics are regulated under the National Industrial Notification and Assessment Scheme rather than by the TGA.

By contrast, antibacterial hand hygiene products that claim to kill specific organisms (such as viruses) and/or that are to be used in clinics or hospitals are therapeutic goods and must be entered in the ARTG. Claims that are permitted to be made on the labels of these products include 'antiseptic hand wash/rub' and 'hygienic hand wash/rub'.

On 28 March 2020, in an attempt to enable the urgent and continued supply of hand sanitiser in Australia, the Federal Minister for Health made an Excluded Goods Determination excluding specific hand sanitiser formulations from TGA regulation. To fall within the scope of this exclusion, a hand sanitiser must contain particular ingredients in particular quantities, comply with manufacturing regulations, and comply with advertising and labelling conditions.

Importantly, regardless of whether a hand sanitiser is covered under the Excluded Goods Determination, a person cannot make a claim that a product can be used to prevent or treat COVID-19 without express TGA approval.

Disinfectants

In light of the coronavirus outbreak, there is significant interest from potential suppliers of disinfectants. Certain disinfectants are 'therapeutic goods' and must be entered in the ARTG, depending on the intended purpose of the disinfectant and what claim/s are made about it. Under the therapeutic goods regime, hospital grade or household/commercial grade disinfectants that make 'specific claims' (such as claims that the product kills, or is active against, viruses) and that are:

not intended for use internally or on skin;
not intended for use on a medical device; and
intended for use on hard or soft surfaces (for example curtains, floors, bench tops),
must be entered in the ARTG prior to supply in Australia.

Disinfectants of the kind described above that do not make 'specific claims' are exempt from inclusion in the ARTG, but must still meet other regulatory requirements for exempt disinfectants as set out in the therapeutic goods legislation.

Further, under the therapeutic goods regime:

liquids, sprays, wipes and aerosols that are intended to be used on medical devices; and
other cleaners intended to be used on medical devices and that do not make disinfectant or sterilant claims,

are regulated as medical devices and must be entered in the ARTG.
Otherwise, general cleaners and sanitisers that do not make disinfectant claims are not regulated by the TGA. Read more about the regulation of disinfectants under the TGA.

Safety advisories

In light of the current COVID-19 pandemic, certain health-related claims and advice that are not supported by robust clinical evidence have been widely circulated both on social media and in traditional media platforms. The TGA has actively refuted some of these claims, such as reports that ibuprofen worsens COVID-19 symptoms, or that treatment with intravenous high-dose vitamin C can assist in the management of COVID-19. Consumers and businesses alike should exercise caution when considering health claims that are not accompanied by supporting scientific evidence, even if they originate from typically reliable sources.

Further, it is important that businesses do not perpetuate these claims without substantiation. If businesses rely on or repeat unsubstantiated claims to promote or sell any products, there is a risk that they could be engaging in misleading or deceptive conduct in breach of the Australian Consumer Law and/or breaching the Therapeutic Goods Advertising Code.

Our specialists are assisting clients with navigating their obligations under the therapeutic goods regulatory framework, including considering advertising and marketing campaigns, and advising on therapeutic claims, in light of COVID-19. Please feel free to contact us to see how we can assist.