You have been lucky enough to secure a competitive Business Cadetship with Edu3D ('E3D'). E3D is a large and reputable 3D printing company, which partners with over 50 schools and universities across NSW to provide a variety of models or prototypes that enhance interactive learning. To diversify business revenue during a period of mandated online education, E3D has recently commenced manufacturing and distributing 3D medical supplies to a number of hospitals throughout regional Australia. This new service stream is branded as Medi3D ('M3D').

Dear Intern,

Edu3D is facing a couple of legal problems in connection with our new initiative, Medi3D. Before we make the decision to retain lawyers, we are trying to get a better grasp of the legal issues at hand. We understand that you are currently studying law at University and might be in a position to assist us with some preliminary questions we have about these matters.

The first issue is that we have received a letter from one of our competitors, ProtoHealth ('PH'), alleging that aspects of our advertising campaign are deceptive. The second issue is that a hospital based in regional South Australia (SA) has informed us that our manufacturing processes may be in breach of orders made by the SA Minister of Health.

In relation to the first issue, PH allege that we are engaging in deceptive conduct, in breach of s 7 of the Consumer Protection Act 2011 (Cth),* by advertising that: 'Medi3D products are made from tried and tested sterilisable materials'. They state that since our oxygen mask valves are made from new, largely experimental materials, they will be forced to lodge a complaint with the regulator, the Australian Consumer Protection Commissioner ('ACPC'),* if we do not modify statements made in our current advertising campaign immediately.

In relation to the second issue, the SA Hospital states that our current manufacturing practices fail to comply with part 5 of the Public Health and Safety (Therapeutic Goods) Order 2020 (SA),* which states that 'prior to the supply of new medical devices all manufacturers must complete CrossContamination and Infection Control Training'. Since this hospital has reason to believe that we have not provided such training for all employees involved in printing and scanning processes, they are threatening to report us to the police.

As you know, we have spent a significant amount of time and money developing M3D and, since business has been going well during our first month of operations, we really want to resolve these legal issues fast.

6. Lastly, the SA hospital has alleged that we are in breach of part 5 of the SA Order;* however, we are unsure whether M3D engages in the 'supply of new medical devices', for the purposes of this Order. We cannot find a definition of 'medical devices' or 'new medical devices' within the Order itself. Could you please: (a) Explain the general approach that a Court would take to the statutory interpretation of 'new medical devices'; (b) Discuss whether you think this approach to statutory interpretation is consistent with the doctrine of the separation of powers? (8 marks - 32 minutes)