Dragonfly Biosciences is the first international and UK CBD brand available on prescription in Australia following its acceptance onto the country’s Special Access Scheme. Chief executive Regan Saveall discussed the impact of the approval on the company’s plans for global growth.
One of Europe’s largest seed-to-sale producer of CBD and cannabis-derived extracts, Dragonfly Biosciences, has been approved under Australia’s Special Access Scheme (SAS), making it one of the first brands available on prescription in the country.
When Australia’s Therapeutic Goods Administration (TGA) down scheduled CBD in February 2021 it theoretically enabled the prescription of CBD in Australian pharmacies. To meet the legal requirements for prescription, products need to be included on the Australian Register of Therapeutics Goods. Working with partners Health House International, headed by the first clinician to prescribe medical cannabis in Australia, Paul Mavor, Dragonfly Biosciences was accepted onto the SAS while it waits for full TGA approval.
The move is the latest international business expansion step for the innovative brand, which Saveall says lays the groundwork for movement into international markets such as Asia.
Australian approval
Dragonfly CBD, the first CBD oil to be stocked by Boots, is currently sold in thousands of pharmacies, health food stores and grocery retailers across the globe.
The SAS approval for Dragonfly Biosciences will see greater prescription choice across the CBD sector in Australian pharmacies to help with stress, anxiety, sleep or pain in 1000mg 10ml and 3000mg 300ml CBD oil.
“The TGA approval requires a similar process that the Food Standards Agency (FSA) has whereby you submit a dossier to prove the products are safe. So, we felt that we could meet the compliance of the requirements because we have done so much for the FSA as part of our own novel certification. We worked with Health House International which is a well-respected company in Australia and has access to around 1500 pharmacies there,” said Saveall.
“The SAS allows pharmacists to prescribe the products while we are processing our TGA application and waiting for the full approval. Once we receive that, we can start advertising and compete more widely. We have been approved for two of our products to start with. Settling for a SAS is not a long-term strategy. With a full TGA approval in theory, we could have access to retail and would be able to advertise more widely. So, those two things combined means you can make a real impact on the local market.
“As part of our expansion we are looking for countries that have a definitive way of getting to market that is legal and compliant and that is what we are following.
“We have always been a bit of a trailblazer in the UK. We always felt that the only way you can really demonstrate that you are organically grown is doing it yourself, that you have got organic accredited soil, for example. We felt as a company that it is always really important to have that, so we have been trailblazing about the importance of this from the start and it helped us to be the first brand in stores because of our approach to compliance and transparency. So, having the same kind of thing in Australia is really important and that is quite key for us as a company to be pushing the boundaries.”
Expanding into international markets
Saveall explained that the regulatory hurdles in Australia will give the brand authority in the Asian market as Dragonfly Biosciences looks to expand globally.
“Australia is a bit of a testbed for the Asian market. If you have got through the regulatory hurdles in Australia, Asia will then look at you seriously – as a serious product for their market. That’s where we see our topicals really coming into play because the Asian market is actually much more attuned to using CBD as a topical – so I think there is an opportunity to get Dragonfly branded topical products into that market. So, once you are established in one country, you get noticed by another country. We are having calls with Asian distributors about bringing our products to the market. So, we can really see how this expansion is helping us get our product out and more widely known and accepted in these territories.
“2020 was quite a tough year for us but we have got through it. We have restructured our company and we are in a better position now where we are looking to expand internationally as a stepping stone from Australia to other markets – we are a stronger, more focused company as a result and we are to capitalising on the seed to shelf infrastructure that’s been built over the last few years.
“Once we are a listed company in Australia, we will be taken more seriously, which should be in the next couple of weeks. We will then have a good pitch for those distributors in Asia which will I think will be one of the more transformative agreements that we would have as a company.
“We have a global ambition to bring CBD to the world, and hopefully one day we will be able to tell them about the benefits of it as well.”
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