TGA to expand quality audits for medicinal cannabis…

Industry Breakthough as Australian Senate Committee pushes for legalisation and increased patient access to medicinal cannabis in Australia!

The Australian Senate Committee has revealed their recommendations from the inquiry ‘Current barriers to patient access to medicinal cannabis in Australia’.

In its 118-page long document, some of its recommendations include:

Recommendation 1 2.56

The committee recommends that the Department of Health, in collaboration with the Australian Medical Association, the Royal Australian College of General Practitioners and other specialist colleges and health professional bodies, develop targeted education and public awareness campaigns to reduce the stigma around medicinal cannabis within the community.
Recommendation 2 2.59

The committee recommends that the Department of Health allocate funds to relevant medical colleges and peak bodies to support the development and delivery of accredited face-to-face and online training programs on medicinal cannabis for medical practitioners.

Recommendation 3 2.61

The committee recommends that the Australian Medical Council, as part of its role in the accreditation of Australian medical education providers, make mandatory the inclusion of modules on the endocannabinoid system and medicinal cannabis in curriculums delivered by primary medical programs (medical schools).

Recommendation 4 2.64

The committee recommends that the Department of Health commission the development of a suite of printed and online resources for patients, aimed at explaining the regulatory framework and process to access medicinal cannabis.

Recommendation 5 3.94

The committee recommends that, if after 12 months from the tabling of this report the Commonwealth Government through the Therapeutic Goods Administration has failed to address the barriers to appropriate, regulated patient access to medicinal cannabis in Australia, a new Independent Regulator be considered, using the Regulator of Medicinal Cannabis Bill 2014 as a basis.

Recommendation 6 3.105

The committee recommends that the Therapeutic Goods Administration review and improve its online resources for health professionals relating to the regulations and processes for prescribing medicinal cannabis through the Special Access Scheme and Authorised Prescriber pathways.

Recommendation 7 3.107

The committee recommends that the Therapeutic Goods Administration immediately clarify the clinical justification requirements of Special Access Scheme Category B in its instructions to prescribers.

Recommendation 8 3.109

The committee recommends that the Department of Health make amendments to the Special Access Scheme Category B pathway to allow for approval of:

• multiple medicinal cannabis products in a single application
• and/or medicinal cannabis as a class of drug for the treatment of a patient for a particular indication.

Recommendation 9 3.113

The committee recommends that the Department of Health modify the operation of the Authorised Prescriber scheme for health professionals seeking to prescribe medicinal cannabis to ensure that:
completion of an accredited medicinal cannabis course be a requirement to obtain Authorised Prescriber status;
relevant specialist colleges be resourced to grant Authorised Prescriber status to their members;
the pathway to authorised prescriber status through the National Institute of Integrative Medicine be clarified and communicated to doctors; and
authority be granted to prescribe all medicinal cannabis products, rather than on a product-by-product basis.
Recommendation 10 3.156

The committee recommends that the COAG Health Council develop a National Framework for Medicinal Cannabis Access to set out goals for further harmonisation of Commonwealth, state and territory legislation to ensure that there are appropriate, clear and consistent regulatory pathways for accessing medicinal cannabis in Australian into the future.

Recommendation 11 3.158

The committee recommends that the Tasmanian Government immediately join all other jurisdictions in participating in the Therapeutic Goods Administration’s single national online application pathway for accessing unregistered medicinal cannabis and reducing state-based requirements for medicinal cannabis approval.

Recommendation 12 4.55

The committee recommends that the Therapeutic Goods Administration, as a matter of priority, conduct broad public consultation on the future scheduling of cannabidiol and other non-psychoactive cannabinoids.

Recommendation 13 4.58

The committee further recommends that, as soon as practicable after a safety review and public consultation process is completed, the Department of Health make any appropriate application to the Advisory Committee on Medicines Scheduling in relation to the down-scheduling or de-scheduling of cannabidiol and other non-psychoactive cannabinoids.

Recommendation 14 4.112

The committee recommends the Australian Government immediately review the resourcing and staffing levels of the Office of Drug Control to ensure licence applications are processed without delays.

Recommendation 15 4.115

The committee recommends the Australian Government support the World Health Organization Expert Committee on Drug Dependence’s recommendations for changes to the scheduling of cannabis and cannabis related substances in international drug control conventions.

Recommendation 16 4.116

The committee recommends the Department of Health, through the Therapeutic Goods Administration and the Office of Drug Control, continue to monitor how any future changes to Australia’s obligations under international drug control conventions can facilitate streamlining regulations relating to the scheduling, approval, manufacture and handling of cannabis.

Recommendation 17 5.92

The committee recommends that the Medicare Benefits Scheme Review Taskforce accept the General Practice and Primary Care Clinical Committee’s recommendation to introduce a ‘Level E’ consultation item for general practice consultations of 60 minutes or longer, and includes this item in recommendations to the Australian Government relating to changes to Medicare Benefits Scheme items for primary care.

Recommendation 18 5.100

The committee recommends that medicinal cannabis industry peak bodies, such as Medicinal Cannabis Industry Australia and the Medical Cannabis Council, work with their members to implement compassionate pricing models for patients facing significant financial hardship in accessing medicinal cannabis products to treat their health conditions.

Recommendation 19 5.103

The committee recommends that, until medicinal cannabis products are subsidised through the Pharmaceutical Benefits Scheme, the Australian Government:

• investigate the establishment of a Commonwealth Compassionate Access Subsidy Scheme for medicinal cannabis, in consultation with industry and based on the best available evidence of efficacy for certain conditions; and

• encourage all states and territories, through the COAG Health Council, to expand the provision of their own Compassionate Access Schemes to patients requiring treatment with medicinal cannabis.
• Recommendation 20 5.107

The committee recommends that the Australian Government, through COAG, encourage a review of state and territory criminal legislation in relation to:

• amnesties for the possession and/or cultivation of cannabis for genuine self-medication purposes; and
• current drug driving laws and their implications for patients with legal medicinal cannabis prescriptions