With the Royal Commission into Defence and Veteran Suicide. established on 8 July 2021, AMCA continues to work with veteran groups and advocates to ensure that medicinal cannabis is included and recognised by the Commission as a valuable treatment for veterans wo still need improved access and funding.
To read more about the Royal Commission into Defence and Veteran Suicide, click the image above.
The Royal Commissioners, Mr Nick Kaldas APM, the Hon James Douglas QC, and Dr Peggy Brown AO are required to produce an interim report by 11 August 2022 and a final report by 15 June 2023.
AMCA will be making a submission to the Royal Commission. Submissions are invited until at least end-March 2022.
On 7th September, members of the AMCA had a Zoom meeting with Avi Rebera, the new Assistant Secretary of the Regulatory Engagement, Education & Planning Branch, Regulatory Practice and Support Division | Health Products Regulation Group of the Department of Health.
Avi replaces George Masri in overseeing the ODC/MCS. Danielle Chifley, Director of the MCS, also joined the call.
AMCA discussed concerns it had with regard to significant delays in members obtaining licences and / or permits and the economic impact this was causing.
Specific examples from AMCA members were outlined to Avi and Danielle who gave their commitment to continued improvement of the processes and timelines involved.
AMCA will continue to meet regularly with Avi and Danielle and members are encouraged to continue to provide examples of concern for which AMCA can provide ongoing support and advocacy.
The CDA Express website that sparked an investigation by the TGA earlier this year is currently suspended for "improvements".
Industry concerns about the site were raised and published in the original article by Cannabiz on April 29th. CDA Health had, until then, been a member of AMCA but left the Association soon after AMCA expressed its concerns at the site.
AMCA is committed to respond to complaints about alleged or actual breaches of TGA guidelines and has addressed such breaches by other members and non-member companies.
But AMCA can only address breaches of TGA guidelines if its members report them, so we encourage you to do so to AMCA or directly to the TGA. Your confidentiality will always be respected.
Please help us to keep this industry safe and compliant.
Frequently asked questions on Schedule 3 cannabidiol:
What is medicinal cannabis?
Medicinal cannabis is any product (flower, oil, etc) that has been derived from the plant Cannabis Sativa.
What is in medicinal cannabis?
Extracts of medicinal cannabis usually contain many hundreds of different types of chemicals. The most important are the cannabinoids and the terpenes.
Which chemical in cannabis is responsible for the “high” effect?
The chemical responsible for the high of cannabis is called delta-9-cannabinol and it is commonly abbreviated as THC. Not all medicinal cannabis products contain THC.
How do I access medicinal cannabis in Australia?
Cannabis is available in Australia via a prescription from your health care provider (medical doctor and in some states a nurse practitioner).
Can any doctor prescribe cannabis?
Currently no. To do so, a doctor must either be an Authorised Prescriber OR apply to the Australian government for approval for you via the Special Access Scheme – B pathway.
Are there some types of cannabis that can be purchased without a prescription?
A medicinal cannabis product that meets Schedule 3 requirements can be purchased in pharmacies without a prescription. To meet the criteria of Schedule 3 they must be 98% cannabidiol (CBD) at a maximum dose of 150 mg per day. It can contain other cannabinoids to make up the other 2% of which no more than 1% can be THC.
Are there any schedule 3 – CBD medicines available in Australia?
Not yet. To be available they must be on the Australian Register of Therapeutic Goods (ARTG) which requires clinical trials data to demonstrate safety and efficacy. No manufacturer has yet been able to supply to data for their product to be in the ARTG as a Schedule 3 medicine.
AMCA is behind a new Veterans’ campaign to improve access, especially for those with PTSD not supported by DVA.
Chair and long-time cannabis campaigner Lucy Haslam spearheaded an initial fact-finding discussion on Tuesday 13th April with support groups, doctors, veterans and legal experts. There was an enthusiastic attendance with more than 25 people on the call.
This initiative will be a joint project with the Australian chapter of the Society of Cannabis Clinicians (SCCAC) to address the lack of access or funding for veterans.
Lucy recently joined Cannabiz co-founder, Martin Lane and editor-at-large, Rhys Cohen in the Green Room to discuss the campaign for proper veteran access and plans for this year’s Australian Medicinal Cannabis Symposium (https://www.cannabiz.com.au/the-green-room-the-campaign-for-veteran-access).
The campaign to improve access for veterans-in-need kicked off on 22nd April with a Change.org petition that already has more than 10,000 signatures.
We'll continue to keep our members updated.
We contacted the Office of Medicinal Cannabis in the Victorian Department of Health when we heard it was planning to reimpose the need for state approval for S8 medicines from 29th March.
Last year, the Victorian S8 permit requirements were suspended via a Covid-triggered Public Health Emergency Order #6. For the past 12 months, Victorian GPs have only needed TGA sign-off to prescribe cannabis.
However, the streamlined process came to an end on March 28 when the emergency order expired. Since that date, all registered Victorian medical practitioners and nurse practitioners are required to apply for a Schedule 8 permit when prescribing a Schedule 8 medicinal cannabis product (i.e. a product containing >2% THC), noting existing exemptions for permit requirements when prescribing to some patients.
The Victorian Schedule 8 permit system is currently under review and the department has recently surveyed prescribers (via KPMG) to gain an understanding of their views towards the Schedule 8 permit system. This survey closed on 14 March 2021 and will assist in determining whether there is a role for the S8 Permit System moving forward. However, the Office has advised AMCA that, unfortunately, it is not able to advise on the timeframe for when any decision will be made regarding S8 permits.
29 January 2021
AMCA lodged a submission to the TGA on behalf of our members regarding potential reforms to medicinal cannabis manufacturing, labelling and packaging requirements.
18 December 2020
AMCA lodged a submission to the ODC on behalf of our members regarding Medicinal Cannabis Permit reform.
18 December 2020
AMCA Chair and recently appointed Drive Change Ambassador, Lucy Haslam, attended the inaugural Drive Change Friends & Supporters meeting. We are delighted to see our own AMCA Ambassadors, David Heilpern and Mick Palmer, working alongside Fiona Patten, MP and the rest of the committed Drive Change team, campaigning tirelessly for drug driving law reform for patients using medicinal cannabis.
AMCA and its partner organisation, SCCAC, are proud to continue to support Drive Change in its commitment to help create drug driving law reform that’s fair, equal, and improves public health.
17 December 2020
AMCA Company Secretary and Lawyer, Dr. Teresa Nicoletti provided our opinion for a Cannabiz article on the TGA down-scheduling decision on cannabidiol.
16 December 2020
We held the first of our Interest Groups, as outlined during our AGM, on 16th December. This Industry/Regulatory/Legal Interest Group focused on two topics - 1. GMP requirements for imported medicinal cannabis products to those that are domestically manufactured and 2. ODC Medicinal Cannabis Permit Reform. The meeting was very well attended by 25 members and input from the meeting is being used in submissions from the AMCA for consultations regarding these topics by the TGA and ODC respectively.
Our inaugural AGM was held on 28th October and was extremely well attended. Thanks to the nearly 60 of our members who joined the Zoom meeting and to Rhys Cohen for providing essential technical assistance!
The AGM introduced our members to AMCA's Founders, Board and Ambassadors as well as its Foundation Partners and Collaborative Partners (see our website for more).
Lucy Haslam, the Chair, presented AMCA's Vision, Mission and belief that it is essential to have a broad mix of members to meet the needs of each facet of the complex medicinal cannabis industry. Our current membership of more than 90 individuals and organisations, from patients and their HCPs through to industry and research, reflects this diversity.
The GM, Gail Wiseman, outlined the Association's priorities, actions to date and plans for the future, including a new structure to enable members' voices to be heard, issues raised and action plans and solutions to be produced.
During the meeting, eligible members were invited to vote for an additional Industry Board Director from 6 high calibre nominees. Joel Hardy from Cymra Life Sciences was elected. We congratulate Joel on his appointment and thank all of the nominees who put themselves forward for election.