Health Law and Cannabis in Queensland

In Queensland the main pieces of Commonwealth and State health legislation governing cannabis for medical purposes are: 

 

• Narcotic Drugs Act 1967 (Cth)

• Narcotic Drugs Regulations - the Commonwealth is still in the process of making the regulations for the NDA. 

• Therapeutic Goods Act 1989 (Cth)

• Poisons Standard  (Standards for Scheduling of Medicines and Poisons or the "SUSMP")

• Customs Act 1901 and Customs (Prohibited Import) Regulations 1956 (Cth)

• Health Act 1937 (QLD) 

• Health (Drugs and Poisons) Regulation 1996 (QLD)

 

Queensland Bills

 

• Public Health (Medicinal Cannabis) Bill 2016 

• Medicines, Poisons and Therapeutic Goods Bill 2015

 

Queensland and Western Australia are the only two states in Australia that did not adopt the Commonwealth Therapeutic Goods Act 1989 into state law. Queensland still has in place the Health Act 1937 and Regulations which contain provisions to regulate and control medicines and drugs, and cannabis for medical purposes in Queensland.  

 

In November 2015 Cabinet made amendments to the Health (Drugs and Poisons) Regulations to include provisions for approvals to be granted for the use of Schedule 8 nabiximols, and in December 2015 further changes were made to include approvals to be granted for the use of Schedule 9 botancial cannabis. 

 

Queensland is the only state to change it's laws to allow for Schedule 9 cannabis to be prescribed by doctors and dispensed by pharmacists in Queensland, however the changes were restricted to supply via the SAS and research trials.  

 

Brisbane teenager Lindsay Carter is the first patient in Australia and Queensland to be able to lawfully access medical cannabis treatment after his Queensland doctor was given federal TGA, and state approval to treat Lindsay with a 4:1 medical cannabis oil and dried indica bud. Lindsay's pharmacist was given state approval to obtain and dispense the medical cannabis in Queensland. The Drug Control Section of the TGA issued the pharmacist with an import licence and a permit for each product to import the medical cannabis products from Canada.

 

Health Act 1937

 

The Health Act 1937 contains a range of regulation-making powers that cover the regulation and control of medicines, drugs, poisons and cannabis for medical purposes in Queensland from cultivation and manufacturing licences and practices to possession, supply, prescribing, dispensing, investigation, monitoring, and enforcement. 

 

The Health Act does however adopt the Commonwealth Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) or the Poisons Standard.  The SUSMP is not law but comprises of recommendations to the states and territories regarding the classification of medicines and poisons into Schedules and provisions about containers and labels. 

 

Head Regulating Power

 

Section 180 (1) of the Health Act provides that the Governor in Council (Premier and Cabinet) may make regulations under the Act. Regulations are far more flexible than provisiions under an act as they can be made or amended by the Premier and Cabinet rather than the need for an amending Bill to go before Parliament for debate and passed by both houses of Queensland Parliament. 

 

Part 4 - Drugs and other articles

 

Section 101 to 133 contains provisions for regulations to be made about manufacturing, packaging and labeling requirements and advertising. [29]  

 

Section 132 provides for a number of Regulations to be made about about drugs, articles, substances and appliances including the following: 

 

• Section 132(a) provides for regulations to be made about standards for the composition, strength, weight, quantity, purity, or quality of any drug or article, or of any ingredient or component part thereof, or for the nature or proportion of any substance which may be mixed with or used in the preparation or preservation thereof, or prohibiting the addition of any article to any drug or article.  

• Section 132(t) provides for regulations to be made about prescribing poisons, restricted drugs, controlled drugs and biological preparations. 

• Section 132(u) provides for regulations to be made about controlling and, as deemed necessary, prohibiting or restricting the ownership, possession, manufacture, cultivation, sale, distribution, supply, use, lending, dispensing, prescribing, or giving away of, or forging and uttering of prescriptions for or any other dealing with poisons, restricted drugs, controlled drugs, biological preparations  …… or goods for therapeutic use under and within the meaning of the Therapeutic Goods Act 1989 (Cth). 

 

Part 4 A - Monitoring, Investigation and Enforcement Powers

 

Sections 134 - 153 contain a raft of provisions for regulations to be made about monitoring, investigation and enforcement including the appointment of inspectors, appointment conditions and limits on power, identity cards, powers of inspections including entry of places, search and seizure, stopping motor vehicles, power to seize, and power to obtain information and warrants. 

 

Health Regulations - Currently used to prescribe and dispense cannabis

 

Under the Health Act 1937 there are two pieces of subordinate legislation that provide for a range of controls over cannabis, for medical use and drugs and poisons in Queensland.

 

• The Heath (Drugs and Poisons) Regulation 1996 (QLD) imposes a wide range of controls over substances listed in the Standard for the Uniform Scheduling of Medicines and sets out requirements for approvals and endorsement holders and obligations around the manufacture, supply, prescription, storage, record keeping and sale and use of medicines, drugs and poisons in Queensland. In November 2015, Cabinet made changes to the Health (Drugs and Poisons) Regulations to include approval provisions for Schedule 8 nabiximols; and in December further amendments were made to include approval provisions for Schedule 9 cannabis via the SAS and research trials.     

 

• The Health Regulation 1996 (QLD) sets out standard operating procedures for dispensing and dispensaries and imposes controls over the advertising, promotion and labelling of therapeutic substances in Queensland.

 

Approved drug dronabinol (synthetic delta-9-tetrahydrocannabinol (THC)

 

Section 77 provides that a person must not dispense, prescribe, sell or use dronabinol unless the person is (a) is a doctor, or a member of a class of doctors, approved for the purpose and dispenses, prescribes, sells or uses the drug under the approval; or (b) is a pharmacist and dispenses dronabinol on the prescription of a doctor who has an approval to prescribe it. Prior to the Premier and Cabinet making amendments to the Health (Drugs and Poisons) Regulation 1996, dronabinol was the only cannabis type susbtance with approval provisions for prescription and supply in Queensland.

  

Medical Cannabis Approvals 2015 and 2016 - Queensland only 

In November 2015, Cabinet made changes to the Health (Drugs and Poisons) Regulations to include approval provisions for Schedule 8 nabiximols; and in December further amendments were made to include approval provisions for Schedule 9 cannabis via the SAS and research trials.  

 

Before these changes Regulation 270A of the Health (Drugs and Poisons) Regulation prohibited the granting of approvals for the use of botanical cannabis for therapeutic use in Queensland as follows: the “the Chief Executive Officer must not grant an approval to a person to manufacture, obtain, possess or use a S9 poison for human therapeutic use.”

 

Queensland is the only state to change it's laws to allow for Schedule 9 cannabis to be prescribed by doctors and dispensed by pharmacists in Queensland, however the changes were restricted to supply via the SAS and research trials.

 

Note: In june 2015 the TGA Scheduled Cannabidiol (CBD - less than 2% THC content) as a s4 prescription medicine - state approval is not required for doctors and pharmacists.

 

Section 78A - Schedule 8 Approved drug nabiximols: Specialist doctors only

 

A person must not dispense, prescribe, sell or use nabiximols unless the person is specialist health practitioner in the speciality of neurology or rehabilitation medicine; or a registrar in the speciality of neurology or rehabilitation medicine working under the direction of a specialist health practitioner in the speciality of neurology or rehabilitation medicine. 

 

Prior to the changes Queensland patients could not be prescribed Sativex a Schedule 8 product. GW Pharmaceuticals have a form of nabiximols marketed under the trade name Sativex. Sativex is the only cannabis product registered on the Australian Register of Therapeutic Goods (ARTG). 

 

Section 270B - Schedule 9 Cannabis for Human Therapeutic Use: Special Acces Scheme (SAS case by case) and research trials  

 

The chief executive may grant an approval to a person to administer, dispense, manufacture, obtain, possess, prescribe, supply or use an S9 poison if (a)  the S9 poison is cannabis; and (b)  the approval is for or connected with (i)  an approved clinical trial; or (ii)  an approval, for the supply of cannabis for use in the treatment of a person, given under the Therapeutic Goods Act 1989 (Cwlth), section 19(1). 

 

View: Further Amendments 1 June 2016

 

On 1 June 2016 further amendments were made ahead of the re-scheduling of the Commonwealth SUSMP of some cannabis from Schedule 9 to Schedule 8. This will enable Queensland patients to take immediate advantage of the TGA re-scheduling as the new Bill is not expected to be debated until the end of 2016. These changes create a new category of controlled drugs for when the rescheduled S8 medical cannabis products become available, and will give an as-of-right authority to a nationally-agreed list of specialists to prescribe, supply or use the re-scheduled S8 medicinal cannabis products.

 

These amendments replicate the specialist pathway in the new Bill and will be automatically repealed once the Bill is enacted. The Bill was also been amended to become the vehicle for the rescheduling changes. Queensland is the only state to change it's laws and to put in place a process for doctors and pharmacists to use Schedule 9 cannabis ahead of the Commonwealth rescheduling of some cannabis. Some of the other states have provisions for access to Schedule 8 Sativex, and discretionary access to Schedule  9 medicines.

 

Access to Cannabis via the Special Acces Scheme (SAS)

 

As there are no local supplies of cannabis products available, they must be imported in the interim.

 

 

Queensland Bills

 

There are currently two new health Bills in Queensland that will impact on patients who use cannabis for medical purposes in the future.

 

• Public Health (Medicinal Cannabis) Bill 2016

 

On 10 May 2016 the Bill was introduced into the Queensland Parliament and proposes to replace the current approval provisions for doctors and pharmacists in the Health (Drugs and Poisons) Regulations.  The Bill will create a new regulatory framework under which medicinal cannabis products may be prescribed and dispensed to patients in Queensland and provides a formalised process for doctors to follow if they want approval to prescribe medicinal cannabis as part of their patient’s overall treatment. Approval via the SAS and other TGA regimes as well as state approval will still be required when locally made cannabis becomes available.

 

 

 

• Medicines, Poisons and Therapeutic Goods Bill 2015

 

The Medicines, Poisons and Therapeutic Goods Act and  Medicines, Poisons and Therapeutic Goods Regulation proposes to adopt the Therapeutic Goods Act 1989 as a law of Queensland, and will replace the Health Act 1937, Health (Drugs and Poisons) Regulation 1996 and the Health Regulation 1996. The Department of Health have finalised its public consultations in preparation for the introduction of the Bill into the Legislative Assembly.  

 

 

Medical Defences and Legal Exemptions: from Prosecution under the Drugs Misuse Act

 

An approval under Regulation 78A or Regulation 270B allows for the principle of authorisation to be used as the underlying legal concept for an eligible person to be authorised to ‘lawfully’ undertake activities which would otherwise be a criminal offence under the Drugs Misuse Act. As long as the person does not act outside the scope of the approval, authorisation provides the person with a defence or exemption from criminal prosecution under the Drugs Misuse Act.

 

The use of this concept under the Health (Drugs and Poisons) Regulations has avoided the need for enacting new legislation or making amendments to the offences, penalties schedules in the Drugs Misuse Act, as well as changes to other substantive legislation.  The changes also bring the regulation and control of cannabis for medical purposes rightly under the health legislation and the responsibility of the Health Minister, rather than remaining in the criminal legislation and the Minister for Police, and also avoids confusion with existing provisions in the Drugs Misuse Act that provide for the commercial cultivation and production of industrial cannabis. 

 

The recent changes and provisions in the new Bill do not go far enough. Research trials are restrictive and importing through the SAS is not viable for most patients.  There were no provisions made for cultivation, not for profit cooperatives or legal protection for patients in Queensland who are growing their own cannabis or sourcing it from the illicit market. Patients and carers are still at risk of criminal prosecution and will need to rely on the defences available under the Drugs Misuse Act and Criminal Code.

 

 

Medical Cannabis Law Reform Proposal 2015

 

In May 2015 our group submitted a comprehensive proposal to the Queensland Government requesting the Premier and Cabinet to make an amendment to Regulation 270A to remove the prohibition on the use of cannabis for “human therapeutic use” and to make new regulations for the regulation and control of cannabis for medical purposes in Queensland. 

 

As mentioned above the recent changes and provisions in the new Bill do not go far enough. Research trials are restrictive and importing through the SAS is not viable for most patients.  Our proposal requested that provisions be made for a state medical cannabis program with approvals for commercial cultivation,as well as provisions for not for profit cooperatives and legal protection for patients in Queensland who are growing their own cannabis or sourcing it from the illicit market. Patients and carers are still at risk of criminal prosecution and will need to rely on the defences available under the Drugs Misuse Act and Criminal Code.

 

You can read our full proposal here.