1 Short title This regulation may be cited as the Health (Drugs and Poisons) Amendment Regulation (No. 2) 2016 . 2 Commencement This regulation commences on 1 June 2016. 3 Regulation amended This regulation amends the Health (Drugs and Poisons) Regulation 1996 . 4 Insertion of new ch 2, pt 3A After chapter 2, part 3— insert— Part 3A Medicinal cannabis Division 1 Preliminary 78B Definitions for part In this part— approved good means a registered good or a listed good within the meaning of the Therapeutic Goods Act 1989 (Cwlth). cannabis product means any product—

(a) that is or was any part of a plant of the genus Cannabis, whether living or dead; or

(b) otherwise derived, wholly or in part, from any part of a plant of the genus Cannabis, whether living or dead; or

(c) that has, or is intended by the manufacturer of the product to have, a pharmacological effect that is substantially similar to the pharmacological effect of a product mentioned in paragraph (a) or (b).

carer, for a patient, means an adult who has responsibility for the immediate care and safety of the patient. compliant, for medicinal cannabis, means the medicinal cannabis has been—

(a) prescribed, for the treatment of, or use by, a patient, in accordance with this part; and

(b) dispensed in accordance with this regulation, including a prescription under this regulation; and

(c) if the medicinal cannabis is the subject of a medicinal cannabis approval—prescribed and dispensed in accordance with the approval; and

(d) manufactured or imported in accordance with the applicable law of the Commonwealth; and

(e) approved, or authorised to be supplied, for the purpose of treating the patient, in accordance with the applicable law of the Commonwealth.

medicinal cannabis means a cannabis product that is—

(a) not an approved good; and

(b) used, or is intended by the manufacturer of the product to be used, for human therapeutic purposes; and

(c) is a controlled drug, other than a regulated controlled drug.

medicinal cannabis approval see section (1). patient-class prescriber means—

(a) a specialist health practitioner in the specialty of medical oncology, paediatric neurology or palliative care medicine; or

(b) a registrar in medical oncology, paediatric neurology or palliative care medicine working under the supervision of a specialist health practitioner in the specialty of medical oncology, paediatric neurology or palliative care medicine.

single-patient prescriber means a doctor who is the holder of a medicinal cannabis approval. 78C Purpose of part The purpose of this part is to provide for regulated access to medicinal cannabis in Queensland—

(a) through—

(i) the prescription of medicinal cannabis, under a system of medicinal cannabis approvals, by single-patient prescribers; and

(ii) the prescription of medicinal cannabis, without medicinal cannabis approvals, by patient-class prescribers; and

(b) until the expiry of this part under section .

78D Application of part (1) To the extent of any inconsistency between a provision of this part, and another provision of this regulation, the provision of this part prevails. (2) The following provisions do not apply to medicinal cannabis—

(a) sections 52 and 54;

(b) section 56;

(c) section 58;

(d) section 58A(3) and (4);

(e) section 58B;

(f) section 59A;

(g) sections 61 and 62;

(h) sections 64 to 64A;

(i) section 66;

(j) section 69;

(k) sections 70A and 71;

(l) section 74(3);

(m) section 81.

(3) Nothing in part 2 is taken to authorise—

(a) a person, other than a patient-class prescriber or a single-patient prescriber, to prescribe medicinal cannabis; or

(b) a person to administer medicinal cannabis otherwise than in accordance with a prescription written by a patient-class prescriber or a single-patient prescriber.

Division 2 Medicinal cannabis approvals 78E Grant of medicinal cannabis approval (1) The chief executive may grant an approval (a medicinal cannabis approval) to a doctor to facilitate the treatment of a particular patient of the doctor with medicinal cannabis. (2) A medicinal cannabis approval is an endorsement. Note— See chapter 1, parts 5 and 6 for provisions relating to endorsements. Division 3 Dealing with medicinal cannabis 78F Patient-class prescribers (1) If a patient-class prescriber is satisfied a patient the patient-class prescriber is treating (the patient) needs medicinal cannabis for therapeutic use as a part of the patient’s medical treatment, the patient-class prescriber is authorised to write a prescription for the—

(a) issue or supply of medicinal cannabis for the purpose of treating the patient; or

(b) administration of medicinal cannabis to the patient.

(2) The patient-class prescriber is authorised to obtain and possess compliant medicinal cannabis if the patient-class prescriber is temporarily possessing the medicinal cannabis—

(a) until the patient can be treated with, or use, the medicinal cannabis; and

(b) only for the purpose of treating the patient.

(3) The patient-class prescriber is authorised to do the following in accordance with the prescription—

(a) supply the medicinal cannabis to the patient;

(b) issue the medicinal cannabis to a carer for the patient;

(c) administer the medicinal cannabis to the patient.

78G Single-patient prescribers (1) A single-patient prescriber, for a medicinal cannabis approval, is authorised to write a prescription for the—

(a) issue or supply of the medicinal cannabis for the purpose of treating the patient to whom the medicinal cannabis approval applies (the approved patient); and

(b) administration of the medicinal cannabis to the approved patient.

(2) The single-patient prescriber is authorised to obtain and possess compliant medicinal cannabis if the single-patient prescriber is temporarily possessing the medicinal cannabis—

(a) until the approved patient can be treated with, or use, the medicinal cannabis; and

(b) only for the purpose of treating the approved patient.

(3) The single-patient prescriber is authorised to do the following in accordance with the prescription—

(a) supply the medicinal cannabis to the approved patient;

(b) issue the medicinal cannabis to a carer for the approved patient;

(c) administer the medicinal cannabis to the approved patient.

78H Patients (1) This section applies if a single-patient prescriber or a patient-class prescriber has, in accordance with this regulation, written a prescription for the administration, issue or supply of medicinal cannabis for the treatment of a patient. (2) The patient is authorised to obtain, possess or self-administer compliant medicinal cannabis in accordance with the prescription. (3) The patient is also authorised to issue the medicinal cannabis to the following persons—

(a) the doctor who wrote the prescription for the purpose of administering the medicinal cannabis to the patient;

(b) a carer for the patient.

78I Pharmacists (1) A pharmacist is authorised to obtain medicinal cannabis and possess the medicinal cannabis at the pharmacist’s dispensary if the pharmacist is possessing the medicinal cannabis for the purpose of—

(a) selling or supplying the medicinal cannabis to patients to whom section applies; or

(b) selling or issuing the medicinal cannabis to carers for patients to whom section applies or other persons authorised to obtain and possess the medicinal cannabis.

(2) The pharmacist, when at the dispensary, is authorised to do the following in accordance with a prescription for medicinal cannabis—

(a) sell or supply medicinal cannabis to patients to whom section applies;

(b) sell or issue medicinal cannabis to carers for patients to whom section applies or other persons authorised to obtain and possess the medicinal cannabis.

(3) In this section— prescription means a prescription of a patient-class prescriber or a single-patient prescriber that complies with this regulation. 78J Carers (1) A carer, for a patient to whom section applies, is authorised to obtain and possess compliant medicinal cannabis if the carer is temporarily possessing the medicinal cannabis—

(a) until the patient can be treated with, or use, the medicinal cannabis in accordance with this part; and

(b) only for the purpose of treating the patient.

(2) The carer is authorised to—

(a) if the patient is able to self-administer the medicinal cannabis—supply the medicinal cannabis to the patient; or

(b) administer the medicinal cannabis to the patient in accordance with a prescription for the medicinal cannabis; or

(c) issue the medicinal cannabis to a single-patient prescriber or patient-class prescriber treating the patient, for administration to the patient.

(3) In this section— prescription means a prescription of a patient-class prescriber or a single-patient prescriber that complies with this regulation. 78K Clinical trials The chief executive may grant an approval to a person to administer, dispense, manufacture, obtain, possess, prescribe, supply or use medicinal cannabis if the approval is for or connected with an approved clinical trial. Division 4 Obligations of prescribers and pharmacists 78L Requirement for prescribers to notify chief executive (1) A patient-class prescriber or a single-patient prescriber (each the prescriber) must notify the chief executive in writing when the prescriber prescribes, supplies, issues or administers medicinal cannabis to a patient. (2) The notice must state—

(a) the name and date of birth of the patient; and

(b) the medical condition, or associated symptoms, of the patient;

(c) the pharmacy from which the patient intends to obtain medicinal cannabis prescribed by the prescriber.

78M Conditions applying to prescribers (1) The chief executive may, by written notice to a patient-class prescriber, or a single-patient prescriber, (each the prescriber) impose conditions on the prescriber’s authority to deal with medicinal cannabis under this part. (2) A condition under subsection (1) may, for example—

(a) impose requirements relating to the prescription of medicinal cannabis; or

(b) impose requirements relating to the monitoring or reporting of the condition, or associated symptoms, of patients being treated with medicinal cannabis by the prescriber; or

(c) require the prescriber to comply with a stated code, guideline, protocol or standard.

(3) For single-patient prescribers, the chief executive’s power to impose conditions under subsection (1) is in addition to the chief executive’s power to impose conditions on a medicinal cannabis approval under chapter 1, part 5. 78N Requirement for pharmacists to notify chief executive (1) A pharmacist must notify the chief executive in writing when the pharmacist dispenses, sells, issues or supplies (each a relevant activity) medicinal cannabis to a patient within 24 hours of carrying out the relevant activity. (2) The notice must state—

(a) the following for the patient—

(i) the name of the patient;

(ii) the medical condition, or associated symptoms, of the patient; and

(b) the type of medicinal cannabis that is the subject of the relevant activity.

78O Conditions applying to pharmacists (1) The chief executive may, by written notice to a pharmacist, impose conditions on the pharmacist’s authority to deal with medicinal cannabis under this part. (2) A condition under subsection (1) may, for example—

(a) impose requirements, in addition to requirements under this regulation, relating to the storage and dispensing of medicinal cannabis; or Note— For storage of controlled drugs, see part 8.

(b) require the pharmacist to comply with a stated code, guideline, protocol or standard.

Division 5 Expiry 78P Expiry of part This part expires on the earlier of the following—

(a) the commencement of the Public Health (Medicinal Cannabis) Act 2016 ; or

(b) 1 January 2017.

5 Amendment of appendix 9 (Dictionary) Appendix 9, definition approved clinical trial, after ‘a clinical trial’— insert— , or another use of medicinal cannabis solely for experimental purposes in humans,