In this week’s AltMed Podcast, Andrew and Mitch talks about the regulatory processes to be aware of when having access to medicinal cannabis in Australia. 

Australian regulatory bodies take a conservative and cautious approach when issuing access to medicinal CBD. As there isn’t a great level of clinical research to warrant the prescription of those products, cannabis is often only justified as a last resort avenue when conventional treatment has proven to be ineffective. 

In most states and territories in Australia, approval or permission is required by a medical practitioner in order to prescribe cannabis products to their patients. Products are listed differently under  Schedule of Medicines and Poisons (SUSMP).

Additionally, medicinal CBD is an unapproved therapeutic good that is only prescribed at a health professional’s discretion. A doctor will therefore need to weigh in a number of considerations concerning the patient’s condition and health history in order to recommend medicinal CBD. Otherwise, patients can submit an application under the Special Access Scheme. This will vary according to each state or territory health department and issued by Therapeutic Goods Act 1989 (TG Act).

Since many in the medical field have little or no clinical experience with this alternative treatment, it’s advisable to consult a specialist clinic for a second opinion. For import substances, medicinal CBD can submit application form to apply for a licence prior to importing. 

Every application is different, answers to questions and supporting material provided should be tailored to the specific circumstances of the applicant. Users cannot submit a single application for both a medicinal cannabis licence and cannabis research licence. Separate applications will need to be lodged if both selections are needed.

While Andrew and Mitch are not healthcare professionals, this podcast offers an insight into the steps that should be taken when exploring medicinal CBD as a viable alternative to conventional treatments.   

Key Points

 1:33 – Andrew is a lawyer by profession. After observing the recreational side of medicinal cannabis in US, he registered a company in Australia and has been working in this field since last 3 years. In 2017, he decided to use get more vocal about this industry and got involved with Altmed channel on YouTube.

3:03 – With a background in Psychology and commerce, Mitch got involved in passion project of medicinal cannabis owing to his work in a cannabis farm in US where he was directly involved in genetic seeds research, cannabis plants growth and secrets of trade.

5:05 – Mitch described in detail about his work in the farm growing and cloning cannabis. He explained that enhancing the quality as well as growth rate of plants was a part of his job.

6:11 – Mitch was of the view that he implemented the commerce practically in farm. He asserted that in Australia, the access is more regulated as compared to US.

7:43 – Andrew delved into the history of legalisation of medicinal cannabis in Australia. He iterated that after Victoria legalised the use of cannabis as the last line of therapy, many states followed the suite. He believed that Australia follows a very conservative framework along with cautious regulatory approach as compared to other countries.

12:49 – Mitch spelled out that due to the discretionary status given to such drugs, doctors were rarely keen for prescribing medicinal cannabis.

13:42 – Andrew iterated that the level of information in public is parallel to the level of knowledge among doctors. He believed that in the absence of clinical trials, doctors would never feel comfortable with the prescription of medicinal cannabis. Therefore, patients must visit specialist cannabis doctors.

15:13 – Andrew believed that the specialists know more about medicinal cannabis as compared to GP. He also informed the audience that there has been a push for some CBD drugs to be available as over-the-counter medicines.

16:47 – Mitch explained the Step by step process of getting medicinal cannabis prescription. He explained that the first step was to consult with regular GP.

17:38 – Andrew clarified that since most of the cannabis products are considered as illegal therapeutic drugs, doctors would require detailed information about treatment history and medical condition of patients.

18:56 – Andrew elucidated the scenario in which a doctor denied the prescription and advised the patients to consult with the doctor to direct you towards a specialist. He expounded upon the usage of Google to reach out to these doctors as well. However, he asserted that the specialists may need to interact with regular GP to get medical history.

19:45 – Mitch disagreed with Andrew since he believed that the regular doctor may be denying access so as to avoid any particular risks to health condition. In this case, he asserted that patients do not seek any consult.

20:39 – Andrew recommended cannabis clinics to patients for getting an informed opinion.

21:16 – Mitch did not agree with his opinion and was of the view that regular GPs have risk profile along with previous medical history to make more informed decision.

21:43 – Andrew explained in detail the two streams of access under TGA. Among them, he believed that special access stream was more time consuming for doctors as it was done on per patient basis.

22:57 – Andrew threw light on the faster approach of authorised prescriber stream in which doctors could become authorised prescriber by demonstrating that they have sufficient knowledge and understanding of medicinal cannabis. He explained the process through which doctors would share prescription with pharmacists.

25:16 – Mitch clarified that any doctor can prescribe the cannabis to a terminal patient without getting approval from TGA.

25:46 – Andrew explained two categories of Special access scheme. He explained that majority of the patients fell under the category B where TGA’s approval was mandatory where Category A, a compassionate access, necessitates merely notifying TGA.

27:08 – Mitch iterated that category C is for research purposes.

27:29 – While explaining the whole process at pharmacy, Andrew accepted that this is a lengthy process. However, he believed that such intricate system was necessary to ensures quality of the product being consumed.

28:43 – Andrew explained that after prescription, pharmacy would contact the patients and provide the medicine provided it was available. He stressed on the need of regular checkups to monitor the progress of using such unconventional medicines.

32:14 – Mitch believed that the pharmacy part was interesting as different companies were involved in different capacities with pharmacies around Australia. He believed that pharmacies have largely moved to online delivery during the Covid time which has actually increased convenience of customers.

33:21 – Andrew thought that it will still take some regulatory changes to make online deliveries more frequent.

34:32 – Andrew informed that TGA regularly published the conditions which could be cured readily through medicinal cannabis.

For more information about medicinal CBD application:

https://forms.business.gov.au/smartforms/servlet/SmartForm.html?formCode=application-for-a-ca