The Therapeutic Goods Administration (TGA) was recently asked by an Australian Senate Committee to consult broadly with you, the public, on making medicinal cannabis products which are not psychoactive, like cannabidiol (“CBD”) – more easily accessible and affordable – due to a strong public plea for legal access.
Instead, the TGA bypassed the Senate’s recommendation and only consulted the public – but in a way that was hard for the public to understand – on its own preferred option that would make little difference to current barriers.
Your Health Your Choice made the options easier to understand and through us, the TGA received 5,399 public submissions that overwhelmingly supported (>95%) options that would make CBD products far easier to access and far more affordable. Less than 5% of respondents supported the TGA option.
The TGA will release its “interim decision” on future access to CBD in September 2020. There is a real risk it will continue to ignore what the public wants, in favour of pushing its own option. This is why the public must now appeal directly to politicians, to hold the TGA to account if decisions are made without consultation with the broader public, which do not result in easier and more affordable access.
Please take a few minutes to let Federal politicians know how you feel about legal access to affordable CBD products in the form below. We have made it easy for you to have your say. Further information is provided in the ‘Background’ section under the form below to assist you.
(*Note: This issue is only about CBD as a product for sale. It is NOT about “THC” or psychoactive cannabis or recreational use. It is not about growing your own, which is decided by your State or Territory. Take care to just focus on CBD products in your response).
Cannabidiol (CBD) is a non-mind-altering (non-psychoactive) extract of cannabis that many people like to try to help mild health issues. To understand the differences between ‘cannabis’, ‘marijuana’, ‘hemp’, ‘CBD’ and ‘THC’, click here.
In Australia, CBD is currently high cost and only available through a special application by a medical practitioner. Many patients find it hard to find doctors who are willing to prescribe CBD. Such barriers mean that most patients cannot afford it or feel the only way they can access it is ‘off-grid’.
People can currently legally purchase an affordable range of CBD products over-the-counter in stores in other countries, including many European countries, several US states, the UK, Canada and South Africa – but not Australia.
In a recent YouGov poll, two thirds (66%) of Australians would support a decision to make it easier for consumers to gain access to safe, high quality, medicinal cannabis (including CBD products), including 41% strongly supporting such a decision.
The recent Senate Inquiry into current barriers to patient access to medicinal cannabis in Australia received submissions from consumers and health groups. These overwhelmingly supported low cost and more easy consumer access to high-quality CBD products.
As a result, the Senate asked the TGA, as a matter of priority, to conduct broad public consultation on the future scheduling of CBD and other non-psychoactive cannabinoids (Recommendation 12).
The TGA conducted a safety review that established that CBD is expected to be relatively safe at a low dose, but they chose the level of limited access that they supported, instead of first broadly consulting the public on if they wanted less limited (and therefore easier and more affordable) access.
Choosing the level of access is a process called “down-scheduling”. Down-scheduling options include:
– Pharmacist Only (‘Schedule 3’). This is where you must speak to a Pharmacist before you buy it from them. However, companies cannot receive marketing approval to sell as a registered product in pharmacies unless they can first prove to the TGA that they have clinical trials ‘proving’ that it works, making it very difficult and more expensive to sell. At the very low dose proposed, it is possible that a product would not become ‘proven’ and therefore approved for years. Special access or exemption schemes may allow limited supply however CBD products in the main would remain difficult and expensive to obtain”.
– Pharmacy Only (‘Schedule 2’). You can only buy CBD from a Pharmacy (without needing to talk to Pharmacist), but all else is the same as above.
– Unscheduled. This is how most vitamins, minerals, herbal tablets, and many throat lozenges, sunscreens, etc are sold in Australia, or even the painkillers and cough syrups that you are allowed to buy in supermarkets. The TGA does not allow high-risk claims, as they do not approve the evidence before the products are allowed to be sold. As long as the company follows TGA requirements for the supply of these types of products, including requirements relating to manufacturing quality and advertising, any company can sell unscheduled medicines, including in retail shops and online stores. This means that many high-quality products can become readily available, making it cheaper and easier for people to access.
The TGA ignored the Senate’s recommendation to broadly consult the public and instead have submitted a narrow application that proposes to only make low-dose CBD a ‘Pharmacist-Only’ medicine, which is unlikely to be of any therapeutic benefit and is unlikely to be more affordable or easily accessible.
The Senate recommended that AFTER the TGA completes a safety review and public consultation process, an application is then submitted to have CBD and other non-psychoactive cannabinoids ‘down-scheduled’ or ‘de-scheduled’ (Recommendation 13). The TGA did not consult the public on its views regarding whether CBD (and other non-psychoactive cannabinoids) should be de-scheduled – as recommended by the Senate.
The TGA also developed its preferred option to only make low-dose CBD a ‘Pharmacist-Only’ medicine BEFORE it consulted the public – even though the Senate asked the TGA to FIRST consult the public on what it wanted.
Further, the approach taken by the TGA includes a consultation process that members of the public would only be aware of if they accessed the TGA’s website and specifically the web pages relating to scheduling decisions.
The information on the TGA’s website is too complex and technical for most members of the public to understand.
The TGA’s approach will not improve access to CBD products and most people will continue to be forced to source CBD products illegally from overseas to gain affordable access, with all the problems this entails – legal issues, shipping delays, the support of overseas products instead of Australian-grown products, dosage concerns, provenance and the lower quality standards required of overseas products compared to Australian-manufactured products.
For these reasons, some have labelled the TGA’s proposed down-scheduling a ‘red herring’.
The TGA conducted a safety review of CBD, which was published alongside its recent public consultation on CBD. The review established that CBD is safe in the low doses proposed for use in medicines. If CBD is safe in the low proposed dose, then why restrict it?
The main reason that the TGA proposal is saying for ‘Pharmacist Only’ is because high doses may interact with other drugs by influencing how your liver metabolises them – but the dose they are proposing is so low that the TGA themselves admit that drug interaction is ‘uncertain’ and ‘unconfirmed’.
Other foods and medicines are well known to interact with drugs via the liver, including foods like grapefruit juice. In the world of packaged vitamins and herbs, a useful comparison is St John’s Wort, which is known to interact with drugs. St John’s Wort and many similar foods and herbs are allowed to be un-scheduled and sold to the public as long as they have a warning statement on the packet – why not CBD?
In places where CBD products are available over-the-counter in stores, there is no evidence to substantiate this theoretical concern: real-world experience in other countries indicates that CBD is as safe or safer than many other substances that are widely available.
The TGA did not do what the Senate asked of them and ask you, the public, whether:
– You want to buy CBD easily and legally.
– You want to buy CBD affordably, including whether you want to buy CBD from a wide range of manufacturers and farmers including Australian made CBD products.
– You want to buy CBD yourself and talk to your own health practitioners about it, without having to buy a very expensive product from a Pharmacist. The low dose proposed by the TGA safety review and the evidence requirements for Pharmacy (registered) products are so high that it is thought unlikely that CBD products would become available at all at some unknown time in the future.
If you would like more information, please see:
ABC news article (March 2020): https://www.abc.net.au/triplej/programs/hack/medicinal-cannabis-inquiry/12090294
Australian Senate Committee List of Recommendations: https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community_Affairs/Medicinalcannabis/Report/section?id=committees%2freportsen%2f024403%2f72394