ATO Interpretative Decision

ATO ID 2001/485

Goods and Services Tax

GST and the supply of a drug imported under the Special Access Scheme to a patient
FOI status: may be released

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If you reasonably apply this decision in good faith to your own circumstances (which are not materially different from those described in the decision), and the decision is later found to be incorrect you will not be liable to pay any penalty or interest. However, you will be required to pay any underpaid tax (or repay any over-claimed credit, grant or benefit), provided the time limits under the law allow it. If you do intend to apply this decision to your own circumstances, you will need to ensure that the relevant provisions referred to in the decision have not been amended or repealed. You may wish to obtain further advice from the Tax Office or from a professional adviser.

Issue

Is the entity, a medical practitioner, making a GST-free supply under section 38-50 of the A New Tax System (Goods and Services Tax) Act 1999 (GST Act), when it supplies a drug, which it has imported under the Special Access Scheme, to a patient?

Decision

Yes, the entity is making a GST-free supply under section 38-50 of the GST Act when it supplies a drug, which it has imported under the Special Access Scheme, to a patient.

Facts

The entity is a medical practitioner. The entity supplies a drug, which it has imported under the Special Access Scheme, to a patient. The patient uses the drug for their own personal benefit in the treatment of a serious illness.

The drug is subject to an approval under paragraph 19(1)(a) of the Therapeutic Goods Act 1989 (this is commonly known as the Special Access Scheme).

The entity is registered for goods and services tax (GST).

Reasons for Decision

Section 38-50 of the GST Act outlines the circumstances in which the supply of a drug or medicinal preparation is GST-free. Subsection 38-50(7) of the GST Act, provides that section 38-50 of the GST Act will only apply if:

the drug or medicinal preparation is for human use or consumption; and
the supply is to an individual for private or domestic use or consumption.

As the drug is being supplied to an individual for private use and consumption, the supply satisfies subsection 38-50(7) of the GST Act.

Subsection 38-50(6) of the GST Act provides that a supply of a drug or medicinal preparation is GST-free if it is subject to an approval under paragraph 19(1)(a) of the Therapeutic Goods Act and any conditions to which the approval is subject have been complied with.

In this case, the entity has an approval under paragraph 19(1)(a) of the Therapeutic Goods Act to import the drug. Therefore, the entity is making a GST-free supply under section 38-50 of the GST Act when it supplies a drug, which it has imported under the Special Access Scheme, to a patient.

Date of decision:  14 September 2001

Legislative References:
A New Tax System (Goods and Services Tax) Act 1999
   section 38-50
   subsection 38-50(6)
   subsection 38-50 (7)

Therapeutic Goods Act 1989
   paragraph 19(1)(a)

Related ATO Interpretative Decisions
ATO ID 2001/484

Keywords
Goods & services tax
GST-free
GST health
Section 38-50 - drugs & medicinal preparations

Business Line:  GST

Date of publication:  19 October 2001

ISSN: 1445-2782

history
  Date: Version:
You are here 14 September 2001 Original statement
  18 May 2007 Archived

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