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Final decisions and reasons for NCEs, medicines and chemicals, November 2018

Scheduling medicines and poisons

26 April 2019

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1.1. Nabiximols

Part A - Final decisions on matters referred to an expert advisory committee (November 2018)

1. Advisory Committee on Medicines Scheduling (ACMS #25)

1.1. Nabiximols

Delegate's final decision
Final decision

The delegate's final decision under regulation 42ZCZR of the Therapeutic Goods Regulations 1990 (the Regulations) is not to amend the current Poisons Standard in relation to nabiximols.

Reasons

The delegate has confirmed that the reasons for the final decision align with those for the interim decision.

Additional reasons, including consideration of the public submission on the interim decision:

The delegate acknowledges that the WHO Expert Committee on Drug Dependence has recently made a recommendation to ease the international restrictions on preparations containing delta-9-tetrahydrocannabinol (dronabinol) by down scheduling it to Schedule III in the United Nations Single Convention on Narcotic Drugs of 1961. Should this occur it would mean that one of the scheduling factors under the Scheduling Policy Framework for Schedule 8 would not be met. However it would not automatically mean that Schedule 4 is appropriate. However, the United Nations Commission on Narcotic Drugs (CND) has postponed their vote on the WHO recommendations to reschedule delta-9-tetrahydrocannabinol-containing preparations. This means that, under the current Scheduling Policy Framework, [REDACTED] is still required to be classified as a Schedule 8 poison. Not only is the current scheduling of nabiximols consistent with international restrictions on narcotics, but I believe that the current scheduling controls for nabiximols in Australia are comparable to those overseas countries, as evidenced by the information provided by the applicant.

Overall conclusions

On balance, the delegate considers that the risk of misuse and abuse of nabiximols cannot be accurately quantified based of the current level of clinical evidence. In addition, amending the scheduling of nabiximols as proposed would be inconsistent with current scheduling policy and with the Schedule 8 status of other THC/CBD combinations for therapeutic use. As the United Nations Commission on Narcotic Drugs (CND) has postponed their vote on the WHO's recommendation to reschedule delta-9-tetrahydrocannabinol-containing preparations, the delegate considers that the loss of the current Schedule 8 regulatory controls over the prescribing of nabiximols would be premature, and therefore has made the final decision not to amend its current scheduling.

Public submissions on the interim decision

One (1) public submission was received before the second closing date in response to an invitation published on 7 February 2019 under regulation 42ZCZP of the Regulations. The submission opposed the interim decision.

The main points provided in opposition of the amendment were:

  • on the balance of risks, the benefit to those limited numbers of Australian patients in medical need of a prescription medicine containing nabiximols such as [REDACTED] is far outweighed by the perceived risks intended to be controlled by retaining this specific pharmaceutical product in S8 and Appendix D.
  • the proposed change is specifically only applicable to nabiximols as contained in prescription medicines on the ARTG. This means that the attendant regulatory controls of a registered prescription medicine apply now, and would continue to apply regardless of whether it is down scheduled to Schedule 4 or removed from Appendix D
  • post‐marketing experience internationally and within Australia demonstrate that [REDACTED] as a nabiximols registered medicine is not associated with problems of abuse, dependence or diversion
  • [REDACTED] is available as a prescription-only medicine in major European countries, with scheduling similar to the proposed Australian Schedule 4
  • The World Health Organisation (WHO) Expert Committee on Drug Dependence made a recommendation to ease the international restrictions on preparations containing delta-9-tetrahydrocannabinol (dronabinol) by down scheduling it to Schedule III in the U.N. Single Convention on Narcotic Drugs of 1961. This would potentially remove the requirement for the inclusion of [REDACTED] in the SUSMP Schedule 8 under the Scheduling Policy Framework.
Interim decision

The interim decision was published on the TGA website on 7 February 2019 at Scheduling delegates' interim decisions and invitation for further comment: ACMS #25, November 2018 – 1.1. Nabiximols.

Scheduling proposal

The pre-meeting scheduling proposal was published on the TGA website on 31 August 2018 at Consultation: Proposed amendments to the Poisons Standard - ACCS, ACMS and Joint ACCS-ACMS meetings, November 2018.

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