The Therapeutic Goods Administration (TGA) are currently consulting with interested parties after it received a proposal to alter the Poisons Standard to down-regulate the rules related to the supply of Cannabidiol (CBD) to Schedule 3 (AUST R). The Department states it is currently undertaking a safety review of CBD at lower doses, to determine whether 'relaxation of the scheduling status of low dose CBD (e.g. to over the counter) could be considered during 2020. If the proposed regulatory changes are accepted, it is expected that from 2021 certain CBD products will have increased consumer access and be able to be purchased without a prescription.
This consultation occurs in conjunction with a private application seeking public access (unscheduled), to cannabidiol where consumers would be able to purchase the preparation across the counter from any retailer or from any health care professional. The two consultations currently open, will result in a final decision as to what form this consumer access may take.
From current consultations it is apparent that rescheduling will result in increased consumer access to cannabidiol products and the CMA Position Statement is in alignment with this and will inform CMA’s submission response.
The due date for both cannabidiol consultations is close of business 22 May 2020.
On 22 October, the TGA released a consultation with a draft of a proposed Declared Therapeutic Goods Order under Section 7 of the Act, which will transform or clarify a high number of products, commonly known as sports supplements, into goods regulated as therapeutic goods. Members and businesses are welcome to view and refer to Complementary Medicine's Australia Position Statement in regards to the consultation on sports supplements.
1. This may affect health products other than sports supplements.
2. Some products on the ARTG may be de-regulated under the proposal
Industry stakeholders have a strong level of concern in respect of the released for sports supplements consultation, as it is expected to have very high anticipated regulatory impacts on Australian businesses, and could worsen, rather than improve safety for consumers. For example, it is estimated to:
A solution is sought that protects both businesses and Australian consumers and provides a coherent framework whereby businesses may succeed and consumers can obtain products from Australian businesses. Therefore broad policy options are sought under principles of best practice regulation.
The consultation closed on 3 December 2019 on the TGA website.
Medical Board of Australia - proposed guidelines for complementary, unconventional and emerging medicine
The Medical Board of Australia (MBA) has commenced a public consultation on new guidelines for medical practitioners related to ‘complementary and unconventional medicine and emerging treatments‘.
In the rationale to these guidelines complementary medicine (CM) and integrative medicine (IM) are specifically mentioned.
The concern is that, if progressed, a new set of guidelines would create a two-tiered system that would be divisive to the practice of CM and IM and could lead to medical and allied healthcare practitioners (under AHPRA) being unfairly and unreasonably targeted (read the guidelines here).
Of additional concern is the rational the MBA have used in their discussion paper, which states the consultation is in response to ‘concerns raised by stakeholders about this area of practice’.
However, no evidence has been provided in the discussion paper that quantifies risk or relative risk in practicing complementary or integrative medicine compared with ‘conventional’ medicine.
CMA and the peak body for integrative medicine in Australia (AIMA), as well as other IM organisations and the research community were not consulted in the lead up to this consultation.
As such we are working together and calling for the Medical Board to retract the consultation.
In the meantime, CMA encourages individuals and organisations to make a response specific to their concerns and field of practice.
You may wish to let the MBA know these guidelines could effect your practice and impact consumers’ freedom of choice and quality use of medicines.
A whole-health system view is necessary as consumers obtain their medicines from a range of sources such as those initiated by themselves, general practitioners, other medical specialists, pharmacists and complementary therapists.
Make a submission to the MBA
Submissions can be made by email marked ‘Consultation on complementary and unconventional medicine and emerging treatments’ should be sent to email@example.com by close of business 30 June 2019.
You can view CMA’s position on the consultation here: CMA Position Statement on the MBA Consultation
FX Medicine - Complementary Medicine Under Siege – Prof. Stephen Myers
FX Medicine – Concerns over Complementary Medicine Suppression – Dr Penny Caldicott
CMA's goal is to achieve a sustainable vibrant, compliant industry that holds its place in consumer health. We support the ethical and responsible promotion of complementary healthcare products and their value to the health of our community.