By Dr Teresa Nicoletti, Partner and Helaena Short, Law Graduate and Sarah Martin, Law Graduate.
Yesterday, the Senate majority voted in favour of the Medicinal Cannabis Legislation Amendment (Importation and Manufacture) Bill 2017 (Greens Bill), which was introduced to Parliament by Senator Richard Di Natale on 12 September 2017 in a bid to improve access to medicinal cannabis under Category A of the Special Access Scheme (SAS). In Parliament yesterday, Senator Di Natale urged members of the House of Representatives to cross the bench and show the Greens Bill the support it deserves when it faces a vote in the Lower House.
The Greens Bill is intended to prevent the government from using import licence and permit conditions to block medicinal cannabis importation for Category A use and to clarify the availability of manufacturing licences for the purpose of manufacturing medicinal cannabis products for Category A use.
As we have previously discussed, Category A of the SAS is designed to ensure that terminally ill patients can obtain immediate access medicines and other therapeutic goods to assist in the management of their condition and/or improve their quality of life.
On 13 June 2017, the Senate disallowed legislation which excluded medicinal cannabis from Category A of the SAS, thereby restoring the ability for doctors to prescribe medicinal cannabis to Category A patients (subject to compliance with State/Territory approval requirements. However, notwithstanding the disallowance, the government adopted a “policy position” which ensured that doctors could not access already imported medicinal cannabis for supply to Category A patients. Further, doctors have been unable to access medicinal cannabis manufactured in Australia for a Category A patient because of provisions in the Narcotic Drugs Act 1967 (ND Act) which restrict access to domestically manufactured medicinal cannabis and to patients under Category B of the SAS, the Authorised Prescriber Scheme or clinical trials (see our further commentary on this below).
Importation of medicinal cannabis
The Customs (Prohibited Imports) Regulations 1956 (Cth) (CPI Regulations) prohibit the importation of a number of drugs, including narcotic drugs (e.g. cannabis), into Australia unless the importer holds both an import licence and permit. An import licence authorises the licensee to apply for an import permit to import a prohibited drug. An import permit authorises the permit holder to import a specified amount of a specified drug in accordance with the permit conditions.
Under the CPI Regulations, the Secretary “shall” (i.e. must) grant an import permit if:
- the application is in the required form;
- the applicant provides all of the information requested by the Secretary; and
- the applicant holds a licence authorising the sale or supply of the drug in the State or Territory in which the applicant’s business premises are situated.
Notably however, pursuant to subregulation 5(13) of the CPI Regulations, an import permit may specify conditions or requirements in relation to, inter alia, the possession, safe custody, transportation, use or disposal of the imported good or substance. This provision appears to have been relied upon by the Office of Drug Control (ODC) to impose conditions which restricted imported medicinal cannabis to supply for:
- patients under Category B of the SAS with pre-approval from the TGA;
- a medical practitioner under the Authorised Prescriber Scheme with pre-approval from the TGA; or
- a clinical trial approved by a Human Research Ethics Committee and the TGA.
Noting that such conditions are inconsistent with the operation of the Therapeutic Goods Act 1989 (TG Act) & Regulations 1990 (Cth) (TG Regulations), the Greens Bill intends to amend the Customs Act 1901 (Cth) to provide that where a prohibited good is intended to be used as a medicinal cannabis product:
- the prohibited good shall be taken to be a drug required for medical purposes; and
- if a permit condition authorises the supply of the imported good for use under Category B of the SAS, the Authorised Prescriber Scheme or a clinical trial, that condition shall be taken to also permit supply under Category A of the SAS.
In this way, it would appear that the Greens Bill, if passed, will effectively override any licence or permit conditions imposed by the ODC to restrict the importation of medicinal cannabis and stifle access for Category A patients.
Manufacture of medicinal cannabis
The ND Act provides that the Secretary may only grant a licence to manufacture medicinal cannabis if the Secretary is satisfied that certain circumstances exist. Relevantly, subparagraph 11K(2)(b)(ii) provides that a licence may be granted where the cultivated cannabis or manufactured medicinal cannabis product (as applicable) is intended to be supplied in accordance with an “approval” or “authority” from the TGA i.e. under Category B of the SAS, the Authorised Prescriber Scheme or for clinical trials.
Because Category A of the SAS does not require an “approval” or “authority” from the TGA – under Category A of the SAS, a doctor must simply notify the TGA within 28 days of the supply of a product to a patient – the technical effect of subparagraph 11K(2)(b)(ii) is that a licence to domestically cultivate cannabis or manufacture a medicinal cannabis product which is intended to be supplied other than in accordance with an “approval” or authority” form the TGA (i.e. under the Category A of the SAS) cannot be granted.
Noting that this provision too is inconsistent with the intention and operation of the TG Act and TG Regulations and the Category A scheme as a whole, the Greens Bill intends to amend the ND Act to clearly authorise the Secretary to grant a licence to manufacture medicinal cannabis which is intended for use under Category A of the SAS.
A message to the government
The government drew considerable criticism in the Senate yesterday for its continuing efforts to restrict access to medicinal cannabis from patients with demonstrated clinical need. It is disappointing on any view that Senator Di Natale has had to go to such great lengths to “stifle the stifler” and put an end to the government’s efforts to deny access to medicinal cannabis for Australia’s most vulnerable patients. On the vote in the House of Representatives, Senator Di Natale made the following remarks to Lower House members:
Have the guts and the decency to stand up when this legislation makes it through to the lower house. Cross the floor if you have to…[S]tand up and have a bit of courage to say you stand with patients and their needs, not your own political self-interest, and we can get this through both houses of parliament.
We applaud Senator Di Natale for taking steps to ensure that critically ill patients are not the casualties of political game-playing and encourage the Lower House to show equal concern.
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