early as next year.  As laid out in the initial proposal, made in April 2020, inhaled products, such as vapes, and topical products like creams, will not be included.  Cassandra Hunt, managing director at Fresh Leaf Analytics, said it is critical to note that making CBD an S3 medicine does not automatically mean that products will be available for purchase. “In order to get a product registered, companies will need to demonstrate quality, safety and efficacy of their product. While the quality and safety should be achievable for CBD, proving the efficacy of CBD  at the low dose specified by the TGA (60 mg per day and 1800 mg per pack) is not a certainty,” she told Inside Retail.  Hunt expects anxiety, pain and insomnia to be the most likely conditions that companies will seek to register products for. According to the Australian Bureau of Statistics (ABS) in 2017-18, 3.2 million Australians (13.1 per cent) had an anxiety-related condition, a considerable increase from the 2014-15 figure of 2.6 million people, or 11.2 per cent. Females were found to have had an anxiety-related condition at one and a half times the rate of males (15.7 per cent compared with 10.6 per cent). So what will this decision mean for consumers? Earlier access to CBD in a nutshell, Hunt explained.  “Under the current regulatory framework, which first requires patients to try conventional therapies, there are many patients who are not able to access CBD. Over the counter access would open up opportunities for patients to try CBD simply by talking to their pharmacist,” she said. There are currently 17 low-dose CBD products available through the SAS-B and Authorised Prescriber pathways in Australia, with CBD products currently making up about 40 per cent of all medicinal cannabis prescriptions, she explained.  Across the Tasman, medicinal cannabis is legal under the Medicinal Cannabis Scheme, but a prescription from a doctor is still required to obtain any medicinal cannabis products.  However, New Zealand will hold a referendum on the legalisation of cannabis for recreational use next month on October 17. Hunt believes that allowing CBD products to be available for consumers over the counter and after consultation with a pharmacist will actually result in a decrease in recreational use.  “This will be the biggest thing to happen in the industry since legalisation of medicinal cannabis. We expect it will result in more Australians benefiting from the healing properties of cannabis and will reduce the number of people seeking products through unregulated illicit channels,” she said.  Industry concerns over effectiveness  However, the Pharmaceutical Society of Australia (PSA) is not convinced that there is enough clinical data to support the effectiveness of CBD products.  “It’s important to note that this was a delegate initiated submission, the pharmacy profession did not ask for this down scheduling of cannabidiol,” said PSA National President Associate Professor Chris Freeman. “Should the TGA decide to downschedule low dose cannabidiol, pharmacists will need to be supported with the right information to ensure that patients are accessing these medicines appropriately.” Freeman is cautious about putting the industry’s reputation at risk by selling a product that is purported to be therapeutic albeit with little evidence.  “Whilst low dose cannabidiol may be relatively safe at low doses, it is important that it has a therapeutic purpose, and [there is] evidence behind the claims,” he said.  “We would not want the pharmacy profession being set up to fail, by allowing the availability of products through the Schedule 3 appendix M category that has little or no therapeutic benefit.” In the same announcement, TGA made an interim decision not to accept a private scheduling application which would have made CBD freely available as an unscheduled medicine in stores.  A final decision on the matter is expected on November 25.