The quick pace of legal and regulatory change in response to COVID-19
Partner Ben Miller and Lawyer Sophie Vo discuss the immediate legal and regulatory measures implemented by the Australian government and regulatory agencies for access to pharmaceuticals, testing kits and medical devices in light of the Coronavirus (COVID-19).
The law is rapidly changing in an attempt to keep up with the epidemiology of the coronavirus disease (COVID-19) outbreak, and its direct and indirect consequences on people and organisations. The World Health Organisation declared it a Public Health Emergency of International Concern on 30 January 2020, and a pandemic on 11 March 2020. We have since seen responses from government and regulatory bodies to myriad issues associated with testing, the supply of medication and essential equipment, and advertising regarding treatments for COVID-19.
We outline a number of measures taken within the last month in Australia.
Access to COVID-19 testing kits
TGA fast-tracking the approval and access to COVID-19 testing kits
The Therapeutic Goods Administration (TGA) has announced a series of measures to support efforts in managing the COVID-19 emergency, with a focus on ensuring that Australia has laboratory and point of care tests available that are able to accurately detect COVID-19 infections. Under the new measures, there are two pathways to legally supply these types of tests in Australia:
- Undergoing an expedited TGA assessment of the COVID-19 test for inclusion on the Australian Register of Therapeutic Goods (ARTG). Once approved for inclusion on the ARTG, the COVID-19 test can be legally supplied in Australia.
- Supply of COVID-19 tests under the new Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020 (Cth). This exemption permits importation, manufacture and supply of COVID-19 tests (that have not yet undergone TGA assessment) to accredited pathology laboratories.
New Medicare item numbers for COVID-19 tests
To support access to COVID-19 tests, the Health Insurance (Section 3C Pathology Services – COVID-19) Determination 2020 enables the payment of Medicare benefits for a pathology service to test for SARS-CoV-2 under new items numbers in the pathology services table. The Determination, made on 12 March 2020, began with one item number, but was amended on 31 March 2020 to increase the Medicare rebate with 2 item numbers – one for private patients in a recognised (public) hospital or by a prescribed laboratory, and the other for any other patient.
Supply and distribution of essential goods
There has been an ongoing concern that protective gear and disinfectants are not being made available to those at greatest risk, particularly health professionals and law enforcement officers. Measures to address this issue include a determination by the Minister for Health (using powers made available from the Governor General’s declaration of a human biosecurity emergency) under the Biosecurity Act 2015 (Cth), regulations made under the Customs Act 1901 (Cth), and exceptions and declarations made under the Therapeutic Goods Act 1989 (Cth).
Since 30 March 2020, the exportation and price gouging of particular goods, including face masks and hand sanitiser, have become prohibited. The goods are required to be surrendered to a law enforcement or customs officer, which is then given to the National Medical Stockpile (unless defective) for deployment to those in need.
TGA exemptions and exclusions
The Secretary, as a delegate of the Minister for Health, has the capacity to make exemptions and exclusions under the Therapeutic Goods Act 1989 (Therapeutic Goods Act) to effectively enable devices and goods to be made available urgently to deal with public health emergencies. This includes:
- The exemption of certain kinds of personal protective equipment (including disposable face masks) from conformity assessment and registration, to facilitate access to equipment that is intended to assist in reducing the transmission of infection between individuals, particularly patients and health care professionals.
- The exclusion, from the operation of the Therapeutic Goods Act, of hand sanitisers that are made to one of the 2 formulations specified, under particular conditions and practices, and advertised and presented for supply with the prescribed labels. This is to facilitate the urgent and continued supply of hand sanitisers in Australia during the COVID-19 outbreak, especially for medical and health services.
- The exemption of relevant kinds of medical devices for diagnosis, confirmatory testing, preventing, monitoring, treatment or alleviation of COVID-19 from the operation of parts of the Therapeutic Goods Act.
- The exemption, from the requirements for conformity assessment and registration under the Therapeutic Goods Act, of ventilators that are manufactured in Australia in accordance with the features specified in the Ventilator for COVID-19 use in Australia (version 1.0) document published by the TGA on 7 April 2020, as a response to the anticipated demand for ventilators to treat patients requiring respiratory support as a result of COVID-19.
Continued access to medicines during the COVID-19 pandemic
To support equitable access to medicines whilst reducing public health risk, new measures have been put in place to limit dispensing and sales of medicines and support distribution of available medicine.
A new arrangement has been implemented to provide for the use of a digital image of a paper-based prescription and/or an authority code for certain prescriptions, thus making the supply and distribution of pharmaceuticals easier and safer for both patients and healthcare professionals at risk of COVID-19.
Limits on dispensing and sales of medicines
To avoid supply interruption at a national level, community pharmacists are required to enforce new limits regarding dispensing certain prescription products to one months’ supply at the prescribed dose, and sales of over-the-counter medicines (including Ventolin, insulins and anti-epileptics) to a maximum of one unit per purchase. Pharmacists are also strongly encouraged to apply these limits to all other medicines.
ACCC authorises co-ordination by pharmaceutical wholesalers
On 31 March 2020, wholesalers of medicines were granted interim authorisation by the ACCC to co-operate to facilitate distribution of essential medication and pharmacy products. The announcement follows an application by the National Pharmaceutical Services Association to enable businesses to coordinate the supply, inventory management, distribution, logistics and import of pharmaceuticals needed by consumers and hospitals.
ACCC authorisation provides statutory protection from court action for conduct that might otherwise raise concerns under the competition provisions of the Competition and Consumer Act 2010 (Cth). The co-ordination by pharmaceutical wholesalers will be subject to oversight from government and other regulatory bodies, and price fixing behaviour remains prohibited. The ACCC can review the authorisation at any time.
Supporting COVID-19 treatment
TGA exemptions for promising COVID-19 treatments
To support urgent availability of treatment for COVID-19, compounds identified as most promising have been exempted from registration and listing under the Therapeutic Goods Act, including:
- hydroxychloroquine and chloroquine (malaria medications)
- remdesivir (an experimental antiviral)
- lopinavir and ritonavir (HIV drugs).
TGA warns of illegal advertising
The TGA has issued a variety of warnings to advertisers and consumers in response to products that have been claiming to test for, treat, prevent or kill COVID-19. The TGA recently issued Oxymed Australia Pty Ltd with 5 infringement notices, carrying penalties of $63,000, for allegedly breaching advertising requirements under the Therapeutic Goods Act. The company was said to have made claims in advertisements for hyperbaric oxygen therapy chambers, not included in the ARTG, regarding the treatment of serious ailments, diseases and conditions, including representations in relation to COVID-19.
The TGA has reminded advertisers that claims of preventing or curing COVID-19 are considered therapeutic claims which are subject to requirements under the Therapeutic Goods Act, such as the legal prerequisite that they are included in the ARTG before being supplied in Australia. Similarly, disinfectants are also required to comply with the Therapeutic Goods Act, some of which must also be included in the ARTG. If the disinfectant overtly claims to kill the coronavirus or SARS-CoV-2 then it must have undergone tests to demonstrate efficacy.
Misleading claims in advertising are also an area of focus for the ACCC. Its greater focus on competition and consumer issues stemming from COVID-19, including scams, were highlighted in a recent media release.These measures to regulate the availability of medicines, medical devices and protective equipment were all implemented within one month of the declaration of a pandemic.
Given the rapid developments facing this sector, we have prepared a range of practical guides to assist our clients, which will be updated regularly to accommodate for the rapidly changing legal and regulatory landscape.
This article appeared in Edition 1 of The Prescription.