​19. Public Health

D.  Medicines, Vaccines & Therapeutic Goods

i.  Legislation

​Commonwealth:
Made under the Therapeutic Goods Act 1989 (Cth):

• Poisons Standard February 2020 amended by the following instruments principally to ensure the continued availability of medicines containing these substances in Australia during the public health emergency caused by the outbreak of COVID-19:
  • Poisons Standard Amendment (Hydroxychloroquine and Salbutamol) Instrument 2020 (23 March 2020) – no longer in force.
  • Poisons Standard Amendment (Hydroxychloroquine) Instrument 2020 (2 April 2020) – no longer in force.
• Therapeutic Goods (Excluded Goods) Determination 2018, amended by:
  • Therapeutic Goods Amendment (Excluded Goods) Determination (No. 1) 2020: excludes from the operation of the Therapeutic Goods Act 1989 (Cth) all non-sterile personal protective equipment and safety apparel other than articles specified in item 1 of Sch 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020.
• Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020: specifies a particular class of non-sterile personal protective equipment and safety apparel to be medical devices.
• Therapeutic Goods (Declared Goods) Order 2019, amended by:
  • Therapeutic Goods Amendment (Declared Goods) Order (No. 1) 2020.
• Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 amended by:
  • Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination (No 2) 2020:  to clarify certain matters relating to the specification of hand sanitisers that are excluded goods for the purposes of the Therapeutic Goods Act 1989 (Cth), and to introduce minor safety measures.

 
Made under National Health Act 1953 (Cth):

• National Health (COVID-19 Supply of Pharmaceutical Benefits) Special Arrangement 2020: makes a special arrangement to make the supply of pharmaceutical benefits to patients who have been prescribed a pharmaceutical benefit, as the result of a Medicare telehealth attendance or telephone attendance, more convenient and effective. Medicare telehealth and telephone attendances have been introduced as a temporary measure in response to the impact of COVID-19. The instrument modifies arrangements for the supply of a pharmaceutical benefit on a paper-based prescription to enable certain supplies to be made based on an image of the prescription provided to the approved supplier by the PBS prescriber (s 5).
• National Health (Listing of Pharmaceutical Benefits) Instrument 2012 (PB 71 of 2012), amended by:
  • National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020; and
  • National Health (Listing of Pharmaceutical Benefits) Amendment Instrument 2020 (No. 5): replaces the table at Schedule 6 which sets out pharmaceutical items with modified prescription circumstances during COVID-19 pandemic.
• National Health (Highly specialised drugs program) Special Arrangement 2010 (PB 116 of 2010), amended by:
  • National Health (Pharmaceutical Benefits) Legislation Amendment (Continuing Treatment during Coronavirus Pandemic) Instrument 2020.
• National Health (Continued Dispensing – Emergency Measures) Determination 2020 as amended from time to time.

We also note that notifiable instruments have been used in the area of therapeutic goods. For example:

• Therapeutic Goods (Medical Devices—Novel Coronavirus) (Emergency) Exemption 2020.
• Therapeutic Goods (Medical Devices—Accredited Pathology Laboratories) (COVID-19 Emergency) Exemption 2020.
• Therapeutic Goods (Medical Devices—Face Masks and Other Articles) (COVID-19 Emergency) Exemption 2020.
• Therapeutic Goods (Medicines—Hydroxychloroquine and Chloroquine) (COVID-19 Emergency) Exemption 2020.
• Therapeutic Goods (Medicines—Lopinavir and Ritonavir) (COVID-19 Emergency) Exemption 2020.
• Therapeutic Goods (Medicines—Remdesivir) (COVID-19 Emergency) Exemption 2020.
• Therapeutic Goods (Medical Devices—Ventilators) (COVID-19 Emergency) Exemption 2020.

Victoria:
Made under the Drugs, Poisons and Controlled Substances Act 1981 (Vic):

• Drugs, Poisons and Controlled Substances Regulations 2017:
  • Approval under Regulation 162 concerning electronic prescriptions.
• Public Health Emergency Orders:
  • Public Health Emergency Order under Section 22D (PHEO #4): Pharmacist Supply on a Digital Image.
  • Public Health Emergency Order under Section 22D (p 3), authorising registered pharmacists to sell or supply a Schedule 4 poison without a prescription to a person in an emergency.
  • Public Health Emergency Order under Section 22D (p 4), removing the requirement for a registered medical practitioner or nurse practitioner to apply to for a Schedule 8 permit in certain circumstances, amended by:
    • Public Health Emergency Order under Section 22G (PHEO #6)
  • Public Health Emergency Order under Section 22D (PHEO #7): to enable pharmacists to supply Metformin in Victoria consistent with a Therapeutic Goods Administration Serious Shortage Medicine Substitution Notice (SSN).

New South Wales:
Health Practitioner Regulation (Adoption of National Law) Act 2009 (NSW) amended by the COVID-19 Legislation Amendment (Emergency Measures) Act 2020 (NSW).
 
Health Practitioner Regulation National Law (NSW) amended by the COVID-19 Legislation Amendment (Emergency Measures) Act 2020 (NSW).
 
Made under the Poisons and Therapeutic Goods Act 1966 (NSW):

• Poisons and Therapeutic Goods Regulation 2008 amended by:
  • Poisons and Therapeutic Goods Amendment (Prescriptions) Regulation 2020.
  • Poisons and Therapeutic Goods Amendment (Restricted Substances) Regulation 2020.
  • Poisons and Therapeutic Goods Amendment (Supply and Administration by Pharmacists) Regulation 2020.
• Note: Subordinate Legislation Act 1989 (NSW) amended by the COVID-19 Legislation Amendment (Emergency Measures—Attorney General) Act 2020 (NSW) keeps the Poisons and Therapeutic Goods Regulation 2008 in force for a further 12 months.

 
Queensland:
Made under the Health Act 1937 (Qld):

• Health (Drugs and Poisons) Regulation 1996 amended by the Health (Drugs and Poisons) Amendment Regulation 2020: to implement telehealth arrangements.

Made under the Public Health Act 2005 (Qld):

• Prescribing, Dispensing or Supply of Hydroxychloroquine Direction.

Made under the Medicines and Poisons Act 2019 (Qld):

• Medicines and Poisons (Monitored Medicines Database Testing) Regulation 2020.

South Australia:
Made under the Controlled Substances Act 1984 (SA):

• Controlled Substances (Poisons) Regulations 2011 amended by:
  • Controlled Substances (Poisons) (Emergency Supply – Human Coronavirus Disease (COVID-19)) Notice 2020
  • Modification of Controlled Substances (Poisons) Regulations 2011 (p 2759)

Western Australia:
Made under Public Health Act 2016 (WA):

• Authorisation to prescribe or supply a poison
• Authorisation to supply a poison without a prescription
  

Australian Capital Territory:
Made under the Medicines, Poisons and Therapeutic Goods Act 2008 (ACT):

• Medicines, Poisons and Therapeutic Goods Regulation 2008, amended by:
  • Medicines, Poisons and Therapeutic Goods Amendment Regulation 2020 (No 1) – now repealed; and
  • COVID-19 Emergency Response Act 2020 (ACT).

 
Made under the Medicines, Poisons and Therapeutic Goods Regulation 2008:

• Medicines, Poisons and Therapeutic Goods (Vaccinations by Pharmacists) Direction 2020 (No 2).

Drugs of Dependence Act 1989 (ACT) amended by the COVID-19 Emergency Response Legislation Amendment Act 2020 (ACT).

Northern Territory: 
Made under the Medicines, Poisons and Therapeutic Goods Act 2012 (NT):

• Medicines, Poisons and Therapeutic Goods Regulations 2014 amended by the Medicines, Poisons and Therapeutic Goods Amendment Regulations 2020.

 
ii.  Case law

This is an area of substantive law that is very likely to result in case law. As of the last update, we are not aware of any relevant decision of a superior court in this area.

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