2022-2023

 

 

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

 

SENATE

 

 

 

 

 

IMPROVING ACCESS TO MEDICINAL CANNABIS BILL 2023

 

 

 

 

 

EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

 

(Circulated by authority of Senator Hanson)

 

IMPROVING ACCESS TO MEDICINAL CANNABIS BILL 2023

 

OUTLINE

 

The Improving Access to Medicinal Cannabis Bill 2023 (the Bill) restores the primacy of the doctor/patient relationship and removes the need for the Approved Prescriber Scheme and Special Access Scheme for medicinal cannabis.

 

The Bill amends the Therapeutic Goods (Poisons Standard—February 2023) Instrument 2023 (the Poisons Standard) to improve availability of medicinal cannabis for all Australians and their pets, by:

·          re-scheduling medicinal cannabis to schedule 4, allowing prescription by any medical practitioner;

·          adopting a definition for cannabis that allows a higher level of tetrahydrocannabinol (THC), up from 0.1% to 1%, which is below the recognised level for any hallucinogenic response and harmonises Commonwealth law with state law (all states are currently 1%);

·          allowing whole plant cannabis products with a limit of 1% THC and 10% cannabidiol (CBD) to be sold over the counter at a chemist or veterinarian to persons over 18; and

·          retains the listing for hemp as a food product with existing limits unchanged.

 

The Bill provides for any medical practitioner to be allowed to prescribe medicinal cannabis, for human and animal applications, with supply made through any chemist for humans and veterinarians for animals.

 

Re-scheduling cannabis to Schedule 4 of the Poisons Standard will allow for inclusion on the Pharmaceutical Benefits Scheme (PBS) as a separate process.

 

The fundamental principle of this Bill is as follows: The cannabis plant works best when presented as a whole plant, with all 520 known compounds in the plant presented together, each working with others in an entourage effect to provide the safest and most effective uptake by the human body.

 

The Bill offers three categories of cannabis regulation:

1.                   If the product is hemp seeds and hemp seed oil containing 75 mg/kg or less of cannabidiol and 10 mg/kg or less of THC, it is a food product and excluded from the Schedule. This maintains the current arrangement.

2.                   If the product is above the allowable levels for food, and below 1% THC and 10% CBD it is a chemist/vet only product (Schedule 3).

3.                   If the product is above 1% THC or above 10% CBD the product is a prescription only product (Schedule 4).

 

The Bill allows the following forms of cannabis to be sold under Schedule 3 (chemist/vets) - oral, oromucosal, topical and sublingual preparations. This allows oils and tinctures, capsules, creams, topicals, bath bombs, patches, nasal sprays, powders, most likely protein supplements with higher CBD than is allowed for a food product in the supermarket.

 

For prescription cannabis the Bill does not make a stipulation as to product. The Therapeutic Goods Administration (TGA) have done a good job of approving a wide range of products under the pathways scheme, including herb and vaping options. The Bill allows those arrangements to continue.

 

The Bill also makes redundant the application of the Special Access Scheme A and Special Access Scheme B to medicinal cannabis.

 

Legacy listings

 

The Bill has moved the Schedule 8 entry for nabiximols to Schedule 4, as it is a cannabis product.

 

The entry for cannabidiol was also retained to provide continuity for the one animal product that uses this listing.

 

Hemp food listing

 

The Bill does not change the allowed concentrations of CBD and THC of 75 mg/kg or less of cannabidiol and 10 mg/kg or less of tetrahydrocannabinols. The food industry is doing nicely with this low limit.

 

The Bill does make a small change to the wording. Previously the Poisons Standard only included a single line allowing the use of hemp in food products, the listing was under cannabidiol, and the definition only mentioned hemp oil.

 

The Food Standards Australia New Zealand (FSANZ) hemp standard allows not only hemp oil, but also hemp seeds and hemp seed flour to be sold in retail products.

 

The Bill adds hemp seed (also covers hemp seed flour) to the definition and locates the exemption in all the places the wider definition requires, to harmonise the listing with the FSANZ standard.

 

Definition of cannabis

 

The definition of cannabis is tied to the THC level of the plant. Currently the Poisons Standard specifies a plant is a regulated cannabis plant if the THC level is above 0.1%.

 

All States now specify a limit of 1% THC, below which the plant is referred to as hemp.

 

The Bill harmonises Commonwealth law with the states and by increasing the THC limit above which the plant is regulated as a narcotics drug to 1%.

 

The Bill will not affect the decriminalisation of cannabis in the Australian Capital Territory.

 

International Obligations

 

The Commonwealth has responsibility for ensuring that any scheme for the cultivation of cannabis for medicinal purposes is consistent with Australia’s international obligations under the following three international drug control conventions:

1.                   the Single Convention on Narcotic Drugs (1961) (Single Convention), which specifies the obligations of signatory states in relation to narcotic drugs including cannabis;

2.                   the United Nations Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (1988), which is guidance related to controlling illicit traffic in narcotics drugs within the framework of the Single Convention; and

3.                   the Convention on Psychotropic Substances (1971), which aims to limit the use of psychotropic substances to medical and scientific purposes and also to ensure their availability for those purposes.

 

The opening line of the United Nations Convention on Narcotics Drugs (1961) sets out the basic intent of the Convention:

 

“The Parties…recognize that the medical use of narcotic drugs continues to be indispensable for the relief of pain and suffering and that adequate provision must be made to ensure their availability…”

 

The Convention on Psychotropic Substances (1971) sets out both obligations on the Commonwealth to supervise medicinal cannabis and at the same time an obligation to ensure the availability of cannabis preparations for medical purposes.

 

Previous Governments in Australia have concentrated too much on the “control” side of the Conventions to the detriment of the “make available” side of the Conventions. In short the current regulatory system fails in the basic obligation to ensure availability for medical purposes, a problem the Bill addresses.

 

Members of the United Nations worldwide have been left to implement the Conventions in a way that produces the most appropriate medical outcomes for their citizens. This level of regulation in the Bill easily meets the UN Convention on regulation and accounting of cannabis production.

 

Notes on Clauses

Clause 1: Short Title

1.           Clause 1 is a formal provision specifying the short title of the Bill.

Clause 2: Commencement

2.           The Bill commences the day after it receives the Royal Assent.

Clause 3: Schedules

3.                   Legislation that is specified in a Schedule to this Act is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this Act has effect according to its terms.

 

Schedule 1—Amendments

 

Item 1 - Section 6

4.                   This item inserts the definition of ‘total tetrahydrocannabinol content’ into section 6 of the Poisons Standard, consistent with the definition of ‘total tetrahydrocannabinol content’ in the Customs (Prohibited Imports) (Importation of Hemp Seeds and Hemp Derived Products) Approval 2018.

 

Item 2 - Schedule 3 (entry for cannabidiol)

4.                   This item amends the definition of cannabidiol (CBD) to make the definition workable. The current definition specifies a cannabidiol concentration of 98% to 2% of other cannabinoids. In practice this requires a CBD extract. The new wording removes that requirement and places a limit of 10% total CBD including not more than 1% THC. In practice this will be a low strength, natural cannabis product.

5.                   The allowed preparations of oral, oromucosal and sublingual have been retained and topicals added to permit the use of patches, lotions and soaks. All other provisions of this entry were retained. No products have been authorised under this entry since the listing was created.

 

Item 3 - Schedule 4 (entries for cannabidiol and cannabis)

6.                   This item retains the existing wording in Schedule 4 for the cannabidiol entry and adds the word “extract” after the word “Cannabidiol” to clarify this entry does allow cannabidiol extracts. This protects existing extracts and synthetic cannabidiol products already on the market and that may be in the approval process.

7.                   This item also adds ‘(d) separately specified in the CANNABIS entry in this Schedule’ to take account of the new cannabis listing in Schedule 4.

8.                   This item also introduces cannabis into Schedule 4 as a Prescription-only medicine. The wording chosen matches wording already in use in the Poisons Standard to describe products derived from the cannabis plant. The exemptions are also present in other listings for cannabis in the Poisons Standard:

·          Nabiximols and cannabidiol are dealt with in separate listings.

·          Items 4, 8, 10, 11 or 12 of Schedule 5A to the Therapeutic Goods Regulations 1990 deal with visitors, sportsman and dignitaries bringing cannabis products into Australia while visiting.

·          Hemp seed oil matches the wording from the original Schedule 8 entry for cannabis, with the addition of hemp seeds to take into account products already publicly available in supermarkets.

 

Item 4 - Schedule 4, after the entry for mycophenolic acid

9.                   This item moves nabiximols into Schedule 4 from Schedule 8. This is a natural cannabis-derived nasal spray with a broad spectrum of cannabinoids that is currently available alongside other cannabis products under the ‘pathways’ scheme.

 

Item 5 - Schedule 4, after the entry for tetraethylammonium

10.               This item moves tetrahydrocannabinols into Schedule 4 from Schedule 8. The wording is the same as it was in Schedule 8, with some minor variations to phrasing to the exceptions as they reference entries in Schedules. This move allows tetrahydrocannabinols to be extracted and prescribed separately. This product is currently available under the Pathways Scheme.

 

Items 6 to 8 - Schedule 8 (entries for cannabis, nabiximols and tetrahydrocannabinols)

11.               Items 6 to 8 repeal the entries for cannabis, nabiximols and tetrahydrocannabinols from Schedule 8, following their down-scheduling to Schedule 4 in items 3 to 5 of the Bill.

 

Item 9 - Schedule 9 (entry for cannabis)

12.               This item repeals the existing entry for cannabis in Schedule 9 (prohibited substance) and replaces it with an amended definition of cannabis. Three changes were made to the original definition:

·          the THC level was increased from 0.01 to 1%;

·          the exception now includes the new listing for cannabis in Schedule 4; and

·          hemp seeds were added to the exceptions.

 

Item 10 - Schedule 9 (entry for tetrahydrocannabinols)

13.               This item makes the same change as item 9 to the definition of tetrahydrocannabinols:

·          the THC level was increased from 0.01% to 1%; and

·          the exemption now includes the new listing for tetrahydrocannabinols in Schedule 4.

Item 11 - Index (entries for cannabis, nabiximols and tetrahydrocannabinols)

14.               Item 11 replaces references to Schedule 8 with Schedule 4 for cannabis, nabiximols and tetrahydrocannabinols to reflect the down-scheduling of these substances from Schedule 8 to Schedule 4.

 

STATEMENT OF COMPATIBILITY WITH HUMAN RIGHTS

 

Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

 

The human rights implications of the Improving Access to Medicinal Cannabis Bill2023 (the Bill) are materially the same as those identified in relation to the, which established the current regulatory environment for medicinal cannabis.

 

Any change to the regulatory framework must strike a balance between protecting the Australian community by mitigating the risk of the diversion and adulteration of cannabis, with the need to ensure that medicinal cannabis regulation in Australia facilitates access to this life-saving plant.

 

This Bill strikes such a balance.

 

The Bill is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011 .

 

Overview of the bill

 

The Bill amends the regulatory framework of medicinal cannabis to improve access to this natural plant substance by:

 

1.       allowing prescription by any prescribing medical practitioner, the current system is any approved prescriber;

 

2.       adopting a definition for cannabis as a regulated product that allows a higher level of THC, up from 0.1% to 1%; and

 

3.       allowing whole plant cannabis products with a limit of 1% THC and 10% cannabinoids to be sold over the counter at a chemist for humans and a veterinarian for animals, provided the purchaser is over 18.

 

Human rights implications

 

The Bill will engage the following rights:

 

1.       Right to health - Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR)

 

Which requires: “The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health…and the creation of conditions which would assure to all medical service and medical attention in the event of sickness.”

 

The limitation to access inherent in the current scheme, especially to residents of regional and rural Australia, and those who are physically limited in movement or mental acuity, contravenes this provision, a problem the Bill will correct.

 

2.       The Right to work - Article 6 of the ICESCR

 

Overseas experience and the science shows that a person is more able to attend work, and work safely, while using medicinal cannabis for certain conditions, including pain relief, where that person would otherwise miss work if dosed to their eyeballs on narcotic pain killers.

 

3.       Right to privacy and reputation - Article 7 of the International Covenant on Civil and Political Rights (ICCPR)

 

Article 17 of the ICCPR provides for the right not to be subjected to arbitrary or unlawful interference with privacy. The level of interrogation and personal information required to satisfy the current “pathways” framework, with a system of review by an unknown number of public servants and the retention of private data for an unknown period of time under unknown storage and handling is intrusive and unwarranted given the patient’s own doctor has already conducted adequate inquiry before writing the prescription. The Bill restores the right to privacy of any Australian receiving medicinal cannabis.

 

Conclusio n

 

The Bill is compatible with human rights because it promotes the right to health, the right to work and the right to privacy. Retaining some of the restrictions of the current legislation is necessary to meet Australian obligations under International Conventions. To the extent that it may limit human rights, those limitations are reasonable, necessary and proportionate.

 

Senator Hanson