Recommendations

Regulatory objectives

  1. 1 Law reform to allow people to be treated with medicinal cannabis in exceptional circumstances should be designed so as to be compatible with the following objectives:
  2. (a) Allow compassionately for exceptional circumstances of medical need.
  3. (b) Integrate the use of medicinal cannabis products into the patient’s medical treatment.
  4. (c) Ensure that patients are informed of clinical uncertainty about the safety and efficacy of medicinal cannabis products they use.
  5. (d) Ensure that medicinal cannabis products are of reliable quality and known composition.
  6. (e) Foster, and be responsive to, clinical research and developments in technology.
  7. (f) Preserve the prohibition of unlawful trafficking, cultivation, supply and use of cannabis.
  8. (g) Provide an equitable and accessible scheme.

Patient eligibility

  1. 2 Eligibility to be treated with medicinal cannabis in exceptional circumstances should be:
  2. (a) determined by the patient’s medical condition and symptoms arising from that condition or its treatment
  3. (b) specified in regulations.
  4. 3 Eligibility for any Victorian medicinal cannabis scheme should be based initially on the following conditions and corresponding symptoms:
  5. (a) severe muscle spasms or severe pain resulting from multiple sclerosis
  6. (b) severe pain arising from cancer, HIV or AIDS
  7. (c) severe nausea, severe vomiting or severe wasting resulting from cancer, HIV or AIDS (or the treatment thereof)
  8. (d) severe seizures resulting from epileptic conditions where other treatment options have not proved effective or have generated side effects that are intolerable for the patient
  9. (e) severe chronic pain where, in the view of two specialist medical practitioners, medicinal cannabis may in all the circumstances provide pain management that is superior to what can be provided by other options.
  10. 4 The Secretary of the Department of Health and Human Services, or a committee constituted by the Secretary under delegation, should be given power to permit patients on a case-by-case basis to be treated with medicinal cannabis in exceptional circumstances that do not otherwise fall within the eligibility criteria of the scheme.
  11. 5 The Minister for Health should constitute an independent medical advisory committee on medicinal cannabis to provide ongoing advice about the conditions and corresponding symptoms on which eligibility to be treated with medicinal cannabis is based. Such advice should include reference to:
  12. (a) the responsiveness by patients to medicinal cannabis provided under the scheme and any side effects experienced by them
  13. (b) the state of the clinical literature in relation to the efficacy or potential efficacy of medicinal cannabis for particular medical conditions and symptoms
  14. (c) the state of the clinical literature in relation to the risks or potential risks posed by medical cannabis for patients with particular medical conditions
  15. (d) the seriousness of the medical conditions, including patients’ prognoses and the extent of the disability caused by their conditions
  16. (e) the extent to which symptoms of the conditions interfere with patients’ ability to derive enjoyment and fulfilment in their lives
  17. (f) the extent to which medicinal cannabis can reasonably be anticipated to improve patients’ quality of life
  18. (g) the availability of standard treatments that may assist, how effective they are, and what side effects they cause.
  19. 6 Any medicinal cannabis scheme in Victoria should be applicable only to persons who ordinarily reside in Victoria.

Authorisation

  1. 7 Specialist medical practitioners should determine which eligible patients should receive treatment with medicinal cannabis, while general practitioners should have principal responsibility for monitoring the efficacy and side effects of the treatment.
  2. 8 A specialist medical practitioner who is registered with the Medical Board of Australia within a prescribed category for the medical condition on which their patient’s eligibility is based should be able to apply to the Secretary of the Department of Health and Human Services for a permit to issue an Authority to Dispense Medicinal Cannabis in respect of that patient. The application should state that:
  3. (a) The patient’s condition and associated symptoms meet the eligibility criteria of the scheme.
  4. (b) It is appropriate in all the circumstances that the patient be treated with medicinal cannabis.
  5. (c) The patient has been informed and accepts that the medicinal cannabis product they will receive will not have been tested for efficacy and side effects by the Therapeutic Goods Administration, and has been informed of other treatments which have been so tested, along with the risks, potential benefits and side effects, including long-term effects, of each.
  6. (d) The patient has been informed that information about their treatment will be collected and used for scheme evaluation and research purposes.
  7. 9 The Secretary of the Department of Health and Human Services should have the power to issue a permit to a specialist medical practitioner if satisfied that:
  8. (a) the specialist medical practitioner is registered as a specialist with the Medical Board of Australia within a prescribed category for the medical condition on which patient eligibility is based
  9. (b) the patient ordinarily resides in Victoria
  10. (c) there is not an unacceptable risk that the patient will abuse the terms of the permit.
  11. 10 A valid permit should entitle the specialist medical practitioner, or a general practitioner identified on the permit, to issue an Authority to Dispense Medicinal Cannabis. An Authority to Dispense Medicinal Cannabis would:
  12. (a) authorise a pharmacy or pharmacy department identified on the permit to dispense medicinal cannabis in accordance with specified instructions
  13. (b) enable no more than three months’ supply of the medicinal cannabis products to be dispensed to the patient or carer at a time.
  14. 11 The permit issued to a specialist medical practitioner by the Secretary of the Department of Health and Human Services should specify:
  15. (a) the duration of the permit, not to exceed 12 months
  16. (b) the name and address of the patient
  17. (c) the name of the general practitioner or clinic with principal responsibility for monitoring the efficacy and side effects of the treatment
  18. (d) the pharmacy at which the patient or carer will obtain medicinal cannabis
  19. (e) the names of any carers who will collect or administer the medicinal cannabis
  20. 12 An Authority to Dispense Medicinal Cannabis issued by a specialist medical practitioner or a general practitioner should specify:
  21. (a) the product and dosage
  22. (b) the name and address of the patient
  23. (c) the pharmacy at which the patient or carer will be dispensed medicinal cannabis
  24. (d) the names of any carers who may collect or administer the medicinal cannabis.
  25. 13 New offences should be created, or existing offences expanded, proscribing dishonest conduct in relation to obtaining a permit or issuing or obtaining an Authority to Dispense Medicinal Cannabis.
  26. 14 The Drugs, Poisons and Controlled Substances Act 1981 (Vic), and the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) should be amended to allow patients and carers nominated in a valid Authority to Dispense Medicinal Cannabis, as appropriate, to obtain, possess and use the medicinal cannabis products designated in the Authority.
  27. 15 The Drugs, Poisons and Controlled Substances Act 1981 (Vic), and the Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) should be amended to allow medical practitioners, registered nurses and pharmacists who participate in any Victorian medicinal cannabis scheme to obtain, have in their possession, administer, sell and supply medicinal cannabis products, as appropriate, for the purposes of the scheme.
  28. 16 The Secretary of the Department of Health and Human Services should provide suitable training and information materials to medical practitioners, pharmacists, patients and others with responsibilities under the scheme.

Commonwealth/State cooperation

  1. 17 The Victorian Government should seek to work in collaboration with the Commonwealth Government in establishing any medicinal cannabis scheme in Victoria.

Recommended option

  1. 18 The Victorian Government should create a scheme to regulate the production of medicinal cannabis by:
  2. (a) licensing private entities to cultivate and manufacture medicinal cannabis products under regulatory arrangements that are based on those that apply to the cultivation of alkaloid poppies, the processing of poppy straw and the manufacture of therapeutic goods
  3. (b) establishing a process for approving medicinal cannabis products and ensuring that they are of appropriate quality
  4. (c) providing the Secretary of the Department of Health and Human Services with the power to administer the scheme and the authority to take possession of medicinal cannabis products, account to the Commonwealth for those products, and arrange their transfer to pharmacies.

Cultivation

  1. 19 Cannabis should be grown for medicinal purposes by cultivators licensed by the Secretary
    of the Department of Economic Development, Jobs, Transport and Resources.
  2. 20 The licensing and regulation of medicinal cannabis cultivators should be modelled on
    Part IVB of the Drugs, Poisons and Controlled Substances Act 1981 (Vic) as it applies to alkaloid poppy cultivation. Key features of the scheme should be as follows:
  3. (a) Applicants for a cultivation licence would be subject to a fit and proper person test and be required to satisfy the Secretary of their intended commercial activities and pay a prescribed fee.
  4. (b) The Chief Commissioner of Victoria Police would be able to oppose the issuing or renewal of a licence to an applicant, in which case the Secretary would be unable to issue or renew it.
  5. (c) Licensees would be required to ensure that their employees are of suitable character.
  6. (d) Licensees would be required to prepare and submit a risk management plan addressing safety and diversion risks associated with cultivation and how they would be addressed.
  7. (e) Licensees would be required to comply with appropriate quality control measures.
  8. (f) All cannabis grown would be required to be delivered to a licensed manufacturer or destroyed.
  9. (g) Licensees would be required to have a contract with a licensed manufacturer at all relevant times.
  10. (h) The Secretary would have the power to suspend or cancel a licence, including at the request of the Chief Commissioner of Police.
  11. (i) Applications would be able to be made to the Victorian Civil and Administrative Review Tribunal for review of a decision by the Secretary to refuse to issue or renew a licence, or to suspend, cancel or amend it.
  12. 21 The Secretary of the Department of Economic Development, Jobs, Transport and Resources should:
  13. (a) monitor and enforce compliance by licensed cultivators with licence conditions and risk management plans
  14. (b) be empowered to appoint inspectors for this purpose
  15. (c) be resourced accordingly.

Manufacture

  1. 22 Medicinal cannabis products should be made by manufacturers licensed by the Secretary of the Department of Health and Human Services.
  2. 23 Medicinal cannabis products should be made by manufacturers licensed by the Secretary of the Department of Health and Human Services under arrangements modelled on those for licensing manufacturers under the Therapeutic Goods Act 1989 (Cth) and processors of poppy straw under the Drugs, Poisons and Controlled Substances Act 1981 (Vic). Key features of the scheme should be as follows:
  3. (a) Applicants for a manufacturing licence would be subject to a fit and proper person test, required to satisfy the Secretary of their intended commercial activities, and required to pay a prescribed fee.
  4. (b) Applicants for a manufacturing licence should be required to demonstrate to the Secretary their capability to comply with quality standards.
  5. (c) The Chief Commissioner of Victoria Police would be able to oppose the issuing or renewal of a licence to an applicant, in which case the Secretary would be unable to issue or renew it.
  6. (d) Licensees would be required to hold a manufacturing licence under the Narcotic Drugs Act 1967 (Cth) at all relevant times.
  7. (e) Licensees would be required to ensure that their employees are of suitable character.
  8. (f) Licensees would be required to prepare and submit a risk management plan addressing safety and diversion risks associated with cultivation and how they will be addressed.
  9. (g) Licensees would be required to comply with appropriate quality control measures.
  10. (h) Licensees would be required to deliver all medicinal cannabis products to the Secretary within four months of the harvest date and destroy any unused material.
  11. (i) The Secretary would have the power to suspend or cancel a licence, including at the request of the Chief Commissioner of Police.
  12. (j) Applications would be able to be made to the Victorian Civil and Administrative Tribunal for review of a decision by the Secretary to refuse to issue or renew a licence, or to suspend, cancel or amend it.
  13. 24 The Secretary of the Department of Health and Human Services should:
  14. (a) monitor and enforce compliance by licensed manufacturers with licence conditions and risk management plans
  15. (b) be empowered to appoint inspectors for this purpose
  16. (c) be resourced accordingly.
  17. 25 All medicinal cannabis products made by licensed manufacturers should be purchased by the Secretary of the Department of Health and Human Services.

Dispensing

  1. 26 Medicinal cannabis products purchased by the Secretary of the Department of Health and Human Services should be dispensed to patients through pharmacies and pharmacy departments.
  2. 27 Dispensing of medicinal cannabis products to patients should be through pharmacies and pharmacy departments that elect to participate in the scheme.
  3. 28 Dispensing of cannabis by pharmacies and pharmacy departments should be modelled on the Victorian program for opioid replacement therapy and include the following features:
  4. (a) Patients or carers specified in the Authority to Dispense Medicinal Cannabis would be able to obtain medicinal cannabis products only by attending at the specified pharmacy or pharmacy department.
  5. (b) Pharmacies and pharmacy departments would be able to dispense to patients or carers only the medicinal cannabis product(s) specified in the Authority to Dispense Medicinal Cannabis.
  6. (c) Pharmacies and pharmacy departments would be required to store medicinal cannabis products pursuant to requirements comparable to those that apply to the storage of Schedule 8 and Schedule 9 poisons.
  7. 29 The Secretary of the Department of Health and Human Services should require pharmacists to notify the Secretary about the amount and type of products they dispense to patients under an Authority to Dispense Medicinal Cannabis.
  8. 30 The Secretary of the Department of Health and Human Services should from time to time designate a price above which medicinal products cannot be sold, incorporating the mark-up able to be charged by pharmacists.

Regulation

  1. 31 Licensed cultivators should be required to comply with appropriate Good Agricultural and Collection Practice.
  2. 32 Licensed manufacturers should be required to comply with Good Manufacturing Practice, as reflected in the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.
  3. 33 The Secretary of the Department of Health and Human Services should have the power to determine which medicinal cannabis products may be manufactured under licence and dispensed in Victoria.
  4. 34 The Secretary of the Department of Health and Human Services should establish and publish a register of medicinal cannabis products approved for sale in Victoria. The register should specify, for each product:
  5. (a) its THC and CBD content, as a percentage
  6. (b) its formulation
  7. (c) permitted ingredients
  8. (d) the brand name under which it will be sold
  9. (e) label contents.
  10. 35 The Secretary of the Department of Health and Human Services should have the power to authorise independent testing facilities in Victoria to test medicinal cannabis products.
  11. 36 All medicinal cannabis products manufactured under a Victorian scheme should be subject to testing by an authorised testing facility to confirm whether the cannabinoid content correlates with that specified on the label and to identify the presence of any contaminants.
  12. 37 Medicinal cannabis products supplied under any Victorian scheme should:
  13. (a) not include products that can be smoked
  14. (b) include a variety of delivery systems, such as tinctures, oils, capsules, sprays and vaporisable liquids
  15. (c) provide for variation in cannabinoid content
  16. (d) be kept under review in view of developments in technology and medical knowledge about the medicinal use of cannabis and specific cannabinoids.

Research and evaluation

  1. 38 Any Victorian medicinal cannabis scheme should foster research by providing for:
  2. (a) licensed cultivators to supply cannabis to appropriately licensed manufacturers capable of producing or trialling pharmaceutical-grade cannabis-derived products
  3. (b) researchers and those holding commercial cultivation licences to obtain experimental cultivation licences.
  4. 39 The Secretary of the Department of Health and Human Services should have the power to issue medical practitioners with permits to treat patients other than those who are eligible under the scheme with medicinal cannabis for trials and research.
  5. 40 The Secretary of the Department of Health and Human Services should collaborate with the clinical research community in developing methods and protocols for collecting and sharing information about the incidence and outcomes of treatment with medicinal cannabis products under any Victorian scheme.
  6. 41 The Secretary of the Department of Health and Human Services should:
  7. (a) retain data collected on permit applications and Authorities to Dispense Medicinal Cannabis in a way that enables statistical information about the operation of the scheme to be compiled and used for evaluation purposes, and for non-identifying information to be made available for the purpose of research into the efficacy of medicinal cannabis
  8. (b) ensure that a privacy impact assessment is conducted when designing the data collection and management systems in support of the medicinal cannabis scheme, to safeguard the information privacy of patients, carers, practitioners, pharmacists and other participants in the scheme.
  9. 42 The Minister for Health should cause an independent evaluation of the scheme to take place no later than four years from its date of commencement and should be required to report to Parliament on the findings and recommendations of the evaluation.

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