In the medical and pharmaceutical industries, Australia is notable as a place to conduct clinical trials. In fact, the country is among the most welcoming places to conduct medical research, even for companies in other countries.
There are many reasons Australia presents an enticing platform for clinical trials, but perhaps the most notable is the country’s R&D tax incentives.
Indeed, tax rebates in Australia far surpass most other countries. Companies conducting R&D research can receive a 43.5% tax credit from the government. Few other nations can compete with this rate. For example, the tax rebate offered by the United States government is 6%.
Because of this generous tax credit, companies view Australia as a haven for clinical trials. For every 100,000 AUD spent on research, the government will pay 43,000 AUD back in a rebate.
Trial Requirements in Australia
While conducting a clinical trial in Australia has some clear benefits, there are also requirements in place for companies and the research the conduct. Before looking at requirements organisations must fulfil, let’s look at the requirements clinical trials must adhere to in Australia.
When conducting R&D in the country, pharmaceutical and biotech firms must meet certain stipulations. For example, organisations must show that the research is being conducted to find new information about medicine or therapy being investigated. Furthermore, the purpose of the trial should be to to try to discover new knowledge, and further scientific discovery.
There are also limitations regarding to the type of study that can be conducted. Specifically, a company should base a study on existing knowledge and as a scientific endeavour across data collection, experimentation, hypothesis, and analysis. Finally, to be eligible for rebates, a company must hold the study in Australia.
While the above appears a long list of hoops to jump through, the truth is structuring a clinical trial to meet the requirements of Australian R&D regulations is easy. In fact, if you are running a trial built on a solid foundation, it should inherently meet the requirements. This is true of Phase I, II, III, and even Phase IV research.
Company Requirements for R&D in Australia
As mentioned, there are some requirements the organisation or entity conducting the clinical trial must meet. For a start, the corporation must have a global turnover of 20m AUD or less. Larger companies won’t be eligible to receive R&D tax rebates in the country. It is also worth noting that current exchange rates are in play when assessing a company’s global turnover.
Perhaps the most important requirement for a company wishing to do R&D in Australia is that the organisation must be a legal entity within the country. This basically means the corporation must have staff and engage in contracts in Australia, either wholly or through a subsidiary.
Obviously, this can be a stumbling block for some companies that don’t have such a presence in the country. In these instances, it is possible to hire an Australia-based Contract Research Organisation (CRO) that can assume the responsibilities of conducting the clinical trial and meet the legal requirements.