Australia has one of the world's best-performing health systems, but to improve patient outcomes and increase national wealth it must strengthen intellectual property (IP) protection and implement clinical trial reforms "as an urgent national priority," experts have said.The newly-published landmark Strategic Review of Health and Medical Research (HMR) in Australia says that embedding HMR in the health system over the next 10 years "will help deliver a wealthy and prosperous Australia that boasts the world's best and most efficient health system." The review panel is led by Simon McKeon, chair of the Commonwealth Scientific and Industrial Research Organisation (CSIRO), the national government body for scientific research in Australia.
Australia's health system costs about A$135 billion a year and delivers a life expectancy of around 82 years and a high quality of life. The nation has created a good health system at a reasonable cost, with only Japan, Italy and Spain achieving higher life expectancy at lower per capita cost, and simply increasing healthcare expenditure will not necessarily lead to improved health outcomes, the panel notes.
The authors call for a 10-year strategy, making 21 recommendations across the following eight themes: - establishing a vision for "better health through research;" - embedding research in the health system; - supporting priority-driven research; - maintaining research excellence; - enhancing the non-commercial pathway to impact; - enhancing the commercial pathway to impact; - attracting philanthropy and new funding sources; and - investment and implementation.
Initiatives to enhance commercial pathways should include providing funding to address the twin preclinical and early clinical-stage "valleys of death,” including the establishment of a A$250 million Translational Biotech Fund for early-state development, funded 50/50 by the government and the private sector, the review panel advises.
The recommendations also call for: a culture of commercialisation to be fostered through freer interchange between researchers and industry, and the recognition of commercialisation achievements through institutional rankings and industry awards; - strengthening Australia's IP system and encouraging researchers to "seek sound advice" on the commercial value of their IP before filing patent applications; and - implementing clinical trial reforms as an urgent national priority.
"IP is clearly a valuable commodity in Australia's knowledge-based economy, and skilful IP protection is necessary to ensure inventions are safeguarded," but at present, “Australia’s IP system is weak and not harmonised with international best practice,” the panel says.
The recommendations have been welcomed by research-based industry group Medicines Australia, which says they will encourage global investment in R&D and lead to a better and more efficient healthcare system.In particular, the report "reinforces the importance of a strong, stable and globally-harmonised IP system. It exposes the short-sightedness of calls from other quarters to dismantle Australia's patent system," said the group's chief executive, Dr Brendan Shaw.
Medicines Australia also strongly supports the recommendations not to ban patents on biological materials or make it easier to obtain compulsory licenses, and that the term of data exclusivity in Australia should align with best global practice, he added.
And Dr Shaw particularly welcomes the report's call to urgently speed up implementation of key reforms that will make Australia a more attractive location for clinical trials."There is an urgent need for far greater political resolve both at federal and state level to implement these key regulatory reforms," he said. There has been "minimal progress" since they were announced two years ago, and "in the meantime, we have been losing trials to other countries."
New figures from the Therapeutic Goods Administration (TGA) show that the number of clinical trials undertaken in Australia has fallen for the fourth time in five years. 602 new trials were begun in 2012, down 5% from the 635 begun in 2011, and total numbers have dropped 30% from their 2007 high of 865, says the TGA's latest Half-Yearly Performance Report.
Releasing the McKeon Review, Australian Health Minister Tanya Plibersek welcomed its focus on "maximising Australia's capacity to produce world-class health and medical research across the research spectrum, from discovery through the translation," and said the government will "engage with relevant parties in formulating its response."