New CTH Regulation To Permit Export of Medicinal Cannabis Products

Thursday 15 February 2018 @ 10.02 a.m. | Legal Research | Trade & Commerce

On Tuesday, 13 February 2018, the Australian Government released the Narcotic Drugs Amendment (Cannabis) Regulations 2018 (Cth) (the “Regulations”). The object of these regulations, as outlined in the explanatory statement accompanying the Regulations (p 1):

“is to give effect to certain of Australia’s obligations under the Single Convention on Narcotic Drugs, 1961, as in force from time to time. The Act implements a licensing and permit scheme that regulates the cultivation of cannabis plants and cannabis resin, the production of cannabis or cannabis resin and the manufacture of drugs.”

Background

In June 2017, the Office of Drug Control sought comments from various stakeholders in order to discover whether Australia should allow the export of medicinal cannabis products. With submissions closing on 21 July 2017, the results of the consultation were overwhelmingly positive. Some key arguments from stakeholders for justifying the export of medicinal cannabis, as found in the media release of 8 August 2017, were:

Australia is an ideal supply source (well regulated, low domestic consumption, ideal and consistent growing conditions and low cost).
There is a current global shortage
Ability to tap into larger markets compared with what can be offered in Australia
Australia has ethical farming practices and a well-governed image to become a major player internationally
Foreign investment opportunities
Australia's competitive edge through geographic location (e.g. growing conditions, amount of annual sunlight)
Economic growth, tax benefits, creation of new jobs
Will facilitate the growth of an emerging industry
Opportunity to invest in research.

Conversely the concerns raised by the consultation process included: ensuring that the domestic market has priority access to medicinal cannabis products; building the Australian market of medicinal cannabis products through the education of General Physicians; and improving the harmony between state, territory and federal regulatory frameworks with regard to medicinal cannabis.

The Regulations

The purpose of the Regulations is to permit exports of medicinal cannabis products by amending the Narcotic Drugs Regulation 2016 (Cth). These amendments in turn allow for medicinal cannabis products to be supplied directly to holders of a manufacture licence under the Therapeutic Goods Act 1989 (Cth). The creation of this license ensures the regulation and direct supply of these products to both Australian patients and the export market.

The minor amendments implemented by the Regulations are outlined in the explanatory statement (p 1):

The minor and technical amendments support the streamlined operation of the Act [Narcotics Drug Act 1967 (Cth)], provide support to the amendments to the Act made by the Narcotic Drugs Legislation Amendment Act 2016 on November 2016, and provide consistency in relation to the requirements applying to the different licences under the Act. The amendments include the following:

non-disclosure of sensitive law enforcement information in the provision of a notice to a licence holder stating the reasons for the proposed suspension of a licence;
prescribing the periods for the provision of specified information;
prescribing general grounds for the refusal of a licence under the Act;
additional information requirements in relation to the supply of cannabis plants or parts of the cannabis plant by the cannabis research licence holder;
additional information requirements in relation to the business associates of the applicant that are bodies corporate;
prescribing of substances for the purposes of the definition of a “drug” under the Act; and
waiving the “fit and proper person” requirement where the applicant or a licence holder is an agency of a State or Territory.

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