Why Australia is the best location in the world for medicinal cannabis trials
Australia is emerging as a leading destination for pharmaceutical companies to conduct research into medicinal cannabis. Companies like GW Pharmaceuticals, Zynerba, Tilray, Botanix, Zelda Therapeutics and others have all made announcements in recent years about medicinal cannabis research programs here.
The reasons for this interest varies but it relates to the way Australia has implemented its medicinal cannabis regulations, including reasons such as:
- Products prescribed must be manufactured in a pharmaceutical grade environment
- Product quality must meet the stringent TGO93 standard, ensuring that doctors and patients know exactly what they are getting
- Dosages are highly specific in terms of product type and amount to be taken
- Patients must be tracked and monitored as a standard part of patient care
All of these factors mean that a robust, precise, data-oriented platform exists as part of ‘business as usual’ for Australian patients.
In addition to this, Australia has a long standing reputation for excellence in medical research based on its:
- High-quality research and infrastructure in the academic, government and private sector
- Internationally recognised processes for registering medicines
- Efficient ethics and regulatory frameworks that deliver results in days or weeks, instead of months
- A lower cost base for most activities
- Investment incentives for R&D that can amount to up to 90 cents on the dollar
Let’s explore some of these factors in more detail.
Australia’s Cannabis Industry is thriving
Although medicinal cannabis in Australia is still very new, several major players have already emerged including domestic and international cultivators and manufacturers such as AusCann; Cann Group; Creso Pharma; GD Pharma; LeafCann; Little Green Pharma; MGC Pharmaceuticals; Medifarm; MedLab; MMJ Phytotech; Tasmanian Botanics, PUF Ventures; Tilray; and Zelda Therapeutics.
Some of these businesses are planning on an import-heavy strategy, allowing them to leverage already-established cultivation and manufacturing facilities overseas (mostly Canadian), while others are focusing primarily on domestic production for both local consumption and potential future export.
While they wait for the regulatory green light, several firms are engaged in discussions with major Australian universities to test and develop new treatments and products.
Cannabis regulations are favourable for research
Clinical trials into the efficacy of medicinal cannabis were announced by the New South Wales Government in 2014 and began in 2016 with collaboration from the Queensland, Victorian and Tasmanian Governments.
In June 2015, the Lambert family donated $33.7 million to the University of Sydney, establishing the ‘Lambert Initiative’. This is the largest medicinal cannabis research group in the country, providing an invaluable boost to the development of treatments for childhood epilepsy, cancer, chronic pain, obesity, anorexia and dementia.
Australian regulations have motivated several companies to engage in research partnerships for product and market development purposes. Major research programs have been announced by the University of Melbourne, RMIT, Canberra University, and the University of Newcastle. Most of the cannabis research in Australia currently focuses on pre-clinical drug development, basic biomedical/chemical science, plant science, and early-phase clinical trials.
Large observational studies through companies like Cannabis Access Clinics are also underway which will help evaluate the effects of cannabis in broader populations within a real-world setting and provide valuable information for future clinical trials. Clinics like these often undertake robust patient monitoring and data collection as part of ‘business-as-usual’ operations, allowing them to cost effectively add specific trial protocols to their patient care operations.
High-quality research and infrastructure
Australia has a strong reputation for the quality of its scientific and medical research. Australia is internationally recognised for its highly trained clinical workforce and the high-quality data produced by its experienced, trained (and accredited) research teams. Australian clinical research sites also have high-quality clinical facilities with state-of-the-art equipment for testing, treatment and analysis. These characteristics of the Australian environment ensure high quality research conduct and generate confidence in the findings of clinical trials conducted in Australia.
Internationally recognised processes
International standards of conduct for clinical trials, developed by the International Conference on Harmonisation (ICH) and the International Organization for Standardization (ISO), provide a benchmark of clinical research quality that can be relied upon throughout the world. Under the Therapeutic Goods Act 1989 and associated regulations, ICH or ISO good clinical practice (GCP) standards are mandatory for all Australian clinical trials involving unapproved medicines or medical devices. Many Australian researchers have international experience and are familiar with GCP and other guidelines.
Australia adheres to the highest level of GCP standards, meaning that Australian clinical data and results are accepted by international regulatory agencies, including the US Food and Drug Administration and European Medicines Agency.
The Australian Therapeutic Goods Administration (TGA) has adopted the European Guideline CPMP/ICH/135/95 (and therefore the ICH E6 guidance) with some elements modified according to local regulatory requirements.
The Australian clinical trial process allows flexibility without compromising quality. Data output from studies carried out in Australia meet global standards and can be used to support international regulatory applications, including the US FDA IND submission – making the process more efficient, flexible yet ethical.
Efficient ethics and regulatory frameworks
Australia has a fast and pragmatic regulatory pathway for clinical trials. Under the Clinical Trials Notification (CTN) scheme administered by the TGA, research proposals are submitted directly to Australian human research ethics committees (HRECs) which assume the primary review responsibility for ethical and scientific review. The TGA also administers the Clinical Trials Exemption (CTX) scheme, under which proposals are submitted to the TGA for scientific review followed by ethical review conducted by the HREC.
This effective and efficient process avoids costly preparation of extensive regulatory applications and means that research can start much sooner.
Diverse participant recruitment pool
Australia has an informed and willing population of potential trial participants, resulting in a higher level of research participation than would be expected from a population of our size. Australia is a multicultural country with a diverse population that is capable of meeting recruitment needs.
Australian treatment processes and regimens are often similar to the United States, Canada and some western European countries. Australia’s diverse population enables recruitment of a similar patient population to recruitment in those countries.
The Australian Institute of Health and Welfare collects statistics on Australian risk factors, diseases and death in Australia, and provides links to online data collections, which also provides useful information for sponsors considering placing trials in Australia.
Compared to the United States, Australia is highly cost-competitive for early phase clinical trials. Recent studies indicate that Australia is 28% cheaper than the United States before tax incentives; and a massive 60% cheaper after tax incentives.
The Australian Government’s Research & Development (R&D) Tax Incentive has undergone reform to become globally competitive and encourage more industry investment in R&D.
The Incentive provides businesses investing in eligible R&D with generous tax offsets:
- a 45% refundable tax offset (equivalent to 45c per $1 of eligible R&D) for companies with annual turnover of less than AUD $20 million; and
- a 40% non-refundable tax offset (equivalent to 40c per $1 of eligible R&D) for all other eligible companies.
- Up to an equivalent benefit on amounts spent overseas
Other benefits under the new Incentive:
- Clinical trials can be eligible R&D activities
- Provides for increased access by international companies – since there is no requirement to hold the intellectual property in Australia;
- Certainty and stability of the rate of support – since the rates are no longer linked to the company tax rate;
- Increased level of expenditure that can be claimed on R&D activities
The tangible benefits of this tax can be significant – up to 90 cents on the dollar rebated on the amount of R&D spent in Australia.
It is still early days for medicinal cannabis research and Australia has positioned itself as a leading location to explore the answers to the many questions that doctors, patients and medical scientists have in relation to this exciting and newly legal medicine.