Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1) (ACT)

The Australian Capital Territory Executive made the Medicines, Poisons and Therapeutic Goods Amendment Regulation 2021 (No 1) under the Medicines, Poisons and Therapeutic Goods Act 2008. The Regulation amended the Medicines, Poisons and Therapeutic Goods Regulation 2008 to introduce a new Part 9.7 which authorises certain persons to deal with COVID-19 vaccines during a public health emergency. The key legal issue was whether the Regulation was valid and properly made under the enabling Act. The court found that the Regulation was a lawful exercise of the power under the enabling Act. The Regulation provided for a temporary authorisation for certain persons to deal with COVID-19 vaccines during a public health emergency. The authorisation was subject to conditions and could be approved by the Chief Health Officer if satisfied that the person was suitable. The Regulation was a reasonable and necessary measure to respond to the COVID-19 public health emergency.

The court considered that the Regulation was an appropriate response to the COVID-19 pandemic and was within the scope of the enabling Act. The Act empowered the Executive to make regulations for matters relating to medicines, poisons and therapeutic goods. The Regulation was a subordinate law made under the Act for the purpose of authorising certain persons to deal with COVID-19 vaccines during a public health emergency. The court found that the Regulation was a lawful exercise of the power under the Act as it was for the purpose of achieving the objects of the Act and was not beyond the scope of the Act. The court rejected arguments that the Regulation was invalid for lack of procedural fairness or for being unreasonable. The court found that the procedure for making the Regulation was adequate and that the Regulation was a reasonable and necessary measure in the circumstances. The court accepted that the Regulation was a proportionate response to the COVID-9 public health emergency.