Updated on 4 September 2012
Australia has a favorable environment and regulatory system for clinical research
As everyone already knows, the international pharmaceutical industry is currently undergoing a number of significant changes brought on by pressures caused by the weakening financial situation in the US and Europe.
Big pharma are continually being forced to streamline their operations by narrowing their focus and specializing on one or two main areas. They are also deciding to cut costs at all points along the concept-to-market chain by opting to outsource virtually all of their development processes. Despite the considerable pressures on the industry, Australia is well positioned to emerge as the new ‘hot spot' for clinical research due to two important factors.
Unlike other parts of the world the Australian therapeutic product development environment has always been relatively cash starved, and therefore well versed with restricted budgets, and outsourcing services to CROs and other niche services providers in order to develop their products and to move them along the development pipeline. So this "paradigm shift" that is taking place in other regions is for Australia, merely an alignment to the offering (and strengths) of its product development pipeline.
Coupled with a favourable clinical research environment, and the Australian regulatory system, which is headed by the robust yet relatively simple Clinical Trial Notification (CTN) Scheme, Australia becomes a key option for global product development. This becomes exceptionally evident when compared to the US Investigational New Drug (IND) and EU Clinical Trial Application (CTA) procedures. The CTN has enabled Australia to become increasingly attractive to time and money-sensitive sponsors and their financial backers, eager to generate timely, reliable and cost-effective early proof-of-principle clinical trial data. The efficient regulatory approval process also enables companies to commence trials in weeks, rather than months.
Now, with the advent of the R&D Tax Credit Scheme, that enables eligible applicants to receive a 45 percent reimbursement of R&D expenditure, Australia is an even more attractive option.