• Chronic illness: a growing problem as the population ages. 33% of residents aged 50+ years (2004). This is projected to be up to 48% by 2050.
• Obesity poses a major risk by increasing the risk of chronic illnesses such as Diabetes, Cardiovascular disease and some Cancers. 68% of adult males and 55% of adult females are overweight / obese and this trend is rising. Increasing Diabetes, much of it still undiagnosed. Prevalence increased from
• 2.4% of population in 1995 to 3.5% in 2005.
• Cardiovascular disease - approx 35% of deaths. Cardiovascular disease is the most expensive health condition, costing over 5.5 billion dollars (approx 11% of health system expenditure).
• Cigarette smoking is the largest preventable cause of death and disease and has one of the highest proportions of overweight citizens in the developed nations in the world.
• Approx 3.5 million Australians (18%) have a Cardiovascular condition with Hypertension being most common (11%).
• Cancer - approx 25% of deaths. Prostate, colon and breast most common cancers. Australia has the highest rate of Melanoma in the world.
• One of the highest rates of Asthma in the world, affecting 10% of the population. Most frequent cause for hospitalisation in children.
• 15% Australians (3.1 million) have some form of arthritis. Largest cause of chronic pain.
• High standard of medical care in line with USA /Europe.
• Government subsidised:

-Pharmaceutical Benefits Scheme (PBS) - for drug therapies.
- Medicare - hospitalisation costs, tests and procedures.

• Internationally recognised for its science, highly trained workforce and quality of health economic data.
• Intellectual property regime compares favourably to the EU and US.
• Proof of concept trials may be conducted in Australia without EU CTA or US IND.
• Comparative Phase III data generated in Australia also of significant value for local pricing and reimbursement activities.
• Government incentives to perform local R&D.
• Highly trained, experienced Principal Investigators and study coordinators.
• Clinical research can take place within the public and private hospital systems and General Practitioner’s rooms.
• ICH/GCP compliant centres and well equipped medical centres.
• Data acceptable for FDA and EMEA submissions.
• Expertise in using EDC, IVRS, Central Laboratories and Imaging.
• Fewer competing studies than in US and Central Europe. Investigator and patient availability for clinical trials facilitates fast enrollment - cost effective.
• Good for seasonal dependent studies as patients can be recruited during quiet times in Northern hemisphere.
• Good where there is high disease prevalence such as Melanoma and Asthma.
• 85% of patients live within 2 hours of a major coastal city.
• Approx 12-16 weeks for EC trial approval.
• Notification only to regulatory authority in Australia on EC approval - acknowledgement recieved within a few days.
• Moving to a centralised approach in Australia to streamline process, framework based on EU system.