Factual Background

In April 2020 the Federal Minister for Health announced that the drug RU-486 (colloquially known as the 'abortion pill') had been approved for sale throughout Australia under the Therapeutic Goods Act 1989 (Cth). Under s 7 of the Act, the Secretary of the Department of Health classified the drug as 'therapeutic goods' for the purposes of the Act and, thus, made the drug open to use in humans. Previously, in accordance with Regulations (authorised under s 63 of the Act), the public sale of RU-486 was limited to specific regions, and only certain doctors could lawfully prescribe it.

Part 5 of the Act lists certain offences in relation to therapeutic goods including, unauthorised advertising (s 42DL), dealing with counterfeit therapeutic goods (s 42E) and offences related to product tampering (s 42T).

The objects of the Act are set out in section 4, which provides as follows:

1. The objects of this Act are to do the following, so far as the Constitution permits:

(a)provide for the establishment and maintenance of a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods that are:

(i)used in Australia, whether produced in Australia or elsewhere; or

(ii)exported from Australia;

(b)to provide a framework for the States and Territories to adopt a uniform approach to control the availability and accessibility, and ensure the safe handling, of poisons in Australia.

(1A)The reference in paragraph(1)(a) to the efficacy of therapeutic goods is a reference, if the goods are medical devices, to the performance of the devices as the manufacturer intended.

(2)This Act is therefore not intended to apply to the exclusion of a law of a State, of the Australian Capital Territory or of the Northern Territory to the extent that the law is capable of operating concurrently with this Act.

Following the announcement of the Federal Minister, both the Tasmanian Premier and the Minister for Health came under intense pressure to respond, particularly from influential religious groups within the State. Following an intense campaign in the media, the Premier announced an amendment to the Tasmanian Criminal Code Act 1924 (Tas). A new offence of possessing, administering, or ingesting the drug RU-486 was inserted into the Code. A new section - s 167C - was inserted into the Code by an amending Act passed in July 2020. Section 167C provides as follows:

1. Any person who deals with the drug RU-486 by way of -
2. Being in possession of the drug;
3. Administering, or attempting to administer, the drug by way of medical prescription;
4. Dispensing the drug to a person upon presentation of a medical prescription;
5. Ingesting the drug;

is guilty of an offence.

1. For the purposes of sub-section (1)(a), 'possession' includes the following -
2. Having the drug RU-486 on one's physical person;
3. Having the drug RU-486 on premises, in a vehicle, bag or movable item, owned, rented, leased, managed or controlled by the person.

Charge: Unlawful dealing with a prohibited substance.

The charge carries with it a fine of $5000 and possible imprisonment of up to 5 years.

Dr Rae Nelson is a GP located in Sandy Bay, Hobart. She has been charged and convicted with an offence under s 167C of the Code - after it was discovered that a 16 year old female presented a prescription signed by Dr Nelson for the drug RU-486 at a pharmacy in Hobart. Dr Nelson has been fined $5000 and received a 2 year suspended sentence.

The conviction has been appealed and the matter removed to the High Court for consideration. The only issue before the Court concerns the constitutional validity of s 167C of the Code under s 109 of the Constitution.

--> prepare submissions for the RESPONDENT - The State of Tasmania