In brief - Interim supply from international sources allowed to meet short-term demand
Federal Health Minister Greg Hunt announced on 22 February 2017 that the Federal Government would move to facilitate faster access to medicinal cannabis for patients with the pre-existing Special Access Scheme or Authorised Prescriber Scheme approvals.
Under the new import scheme, the Office of Drug Control
will authorise controlled importation of medicinal cannabis products by approved companies (called "sponsors") from approved international sources for interim supply in Australia, until domestic production meets local needs.
Amendments aim to speed up and facilitate access for approved patients under the Narcotic Drugs Act
Amendments to the Narcotic Drugs Act 1967 (Cth)
in November 2016 provided for the legal cultivation, production and manufacture of medicinal cannabis in Australia. While some production and cultivation licenses have been granted to Australian companies, the domestic supply is still some months away.
The delay in domestic supply has meant that patients with approval through the Federal Government's Special Access Scheme or the Authorised Prescriber Scheme, and the relevant state access schemes, have been sourcing medicinal cannabis from overseas suppliers with approval from the Therapeutic Goods Administration
. This is a case-by-case approval process which is reportedly slow, costly and difficult to comply with.
As a result, many patients have been forced to go without medication or source medicinal cannabis on the black market. The new amendments seek to prevent this.
Sponsors of medicinal cannabis must comply with regulations and statutory conditions
Sponsors who intend to import medicinal cannabis products will need to be able to demonstrate a potential supply chain through the Special Access Scheme and Authorised Prescriber Scheme, and meet any state or territory requirements. They will also have statutory conditions imposed upon them in respect of the supply, storage and recording of the medicinal cannabis products.
This is commentary published by Colin Biggers & Paisley for general information purposes only. This should not be relied on as specific advice. You should seek your own legal and other advice for any question, or for any specific situation or proposal, before making any final decision. The content also is subject to change. A person listed may not be admitted as a lawyer in all States and Territories. © Colin Biggers & Paisley, Australia 2019.