1.3. Final decision in relation to sanguinarine

1. Advisory Committee on Medicines Schedule (ACMS #27) - Final decisions made pursuant to regulation 42ZCZR

1.3. Final decision in relation to sanguinarine

Final decision

Pursuant to regulation 42ZCZR of the Regulations, a Delegate of the Secretary has made a final decision to confirm the interim decision and amend the current Poisons Standard in relation to sanguinarine as follows:

Date of effect of the decision

1 February 2020.

Reasons for the final decision (including findings on material questions of fact)

I have made a final decision to confirm my interim decision to schedule Sanguinaria canadensis (bloodroot) in Schedule 10 of the Poisons Standard. In making my final decision, I have taken into account the three public submissions received before the second closing date in response to the call for further submissions published on 12 September 2019 under regulation 42ZCZP of the Regulations.

I have taken into account the views expressed in the public submission regarding the cross reference to sanguinarine in the index. However, I am not persuaded that the index entry for sanguinarine impacts or restricts the extracts of other plants containing sanguinarine. Sanguinarine itself is not specifically scheduled in the Poisons Standard and therefore has no restrictions placed on it outside of the Schedule 10 entry for Sanguinaria canadensis (bloodroot). The inclusion of sanguinarine in the index is simply to offer clarity and direct an observer to the scheduled plant, Sanguinaria canadensis (bloodroot).

I have taken into consideration the views expressed in the public submission that the Schedule 10 entry for Sanguinaria canadensis (bloodroot) provides restriction on the use of Sanguinaria canadensis for research purposes. The Schedule 10 entry only restricts use of Sanguinaria canadensis in preparations for human use. It does not prevent the use of Sanguinaria canadensis in laboratory or research settings not involving humans. If it were to be demonstrated that Sanguinaria canadensis has the capability to provide a significant public health benefit, then re-consideration may be required and a future application for rescheduled may be submitted with the appropriate evidence. However, at present I am of the opinion that there is insufficient data to justify a lower schedule for Sanguinaria canadensis. On balance, I find that the current risks to public health outweigh any potential human health benefits.

I have taken into account the views expressed in the public submission over the use of the term 'human use' as opposed to 'therapeutic use' in the schedule entry for Sanguinaria canadensis. Given the potential for Sanguinaria canadensis to cause significant harm to members of the public and that there is insufficient evidence to support the therapeutic potential of Sanguinaria canadensis, I am of the opinion that using the term 'human use' is more appropriate in this context.

Summary of public submissions on the interim decision

Three (3) public submissions were received in response to the call for further submissions published on 12 September 2019 under regulation 42ZCZP of the Regulations. One (1) submission was in support of the interim decision with amendments, one (1) submission was in opposition of the interim decision and one (1) suggested a less restrictive schedule to the one proposed in the interim decision.

The main points in support with amendments of the proposed amendment were:

• The scheduling entry will address the concerns raised by the Applicant and will not inadvertently impact the existing complementary medicines containing C. majus.
• The broadening of the entry to capture "human use" as opposed to the "therapeutic use" consulted on, raises concerns as to the process given that the application, the submissions, the background information, the ACMS recommendation and the interim decision itself only considered the narrower field of "therapeutic use".

The main points in opposition of the proposed amendment were:

• The public submission does not fully support the Delegate's interim decision regarding sanguinarine, most especially the inclusion of sanguinarine in the index, with a cross reference to Sanguinaria canadensis.
• The proposed cross reference of sanguinarine in the index could impact the extracts of other plants and place needless restrictions on other herbal medicines.
• The public submission supports the ACMS recommendation, but not the Delegate's interim decision.

Main points of a suggested less restrictive schedule to the one proposed in the interim decision:

• The interim decision to replace scheduling of sanguinarine with that of S. canadensis (unless less than 0.01% sanguinarine) is an appropriate measure to prevent unintended consequences on other commonly available preparations.
• The proposed removal of community access to S. canadensis is consistent with the literature recommendations on safety and identified risk with community use.
• The scheduling entry could be reviewed for an alternative entry that provides a similarly strict restriction of public access but one that also permits further approved research under State and Territory permit (something that appears generally unavailable for Schedule 10). Further areas of research include anti-inflammatory, antimicrobial, antimycobacterial and anticancer capabilities of S. canadensis.