Regulatory framework and intellectual property (IP) protection

The efficiency and transparency of our regulatory system is highlighted by Australia’s ranking as the easiest place in the world to start a business, with registration procedures taking just two days. Australia's intellectual property regime, in terms of protection, ranks in the top 12 countries in the world and top 3 in the Asia-Pacific Region (Source: World Competitiveness Yearbook 2007).

Australia has a robust regulatory system for biotechnology and has developed customised information about biotechnology regulation in Australia, available at www.bioregs.gov.au

Biotechnology products intended for human therapeutic use are regulated by the Therapeutic Goods Administration (TGA) as therapeutic goods (prescription, over-the-counter and complementary medicines, medical devices, blood and tissues). The TGA undertakes risk-based assessment and monitoring activities to ensure that therapeutic goods available in or exported from Australia meet acceptable standards of quality, safety and efficacy or performance. The regulatory environment is consistent with international best practice.

The TGA adopts international standards, regulatory requirements and guidelines, where relevant and appropriate. For example, the TGA generally adopts the guidelines developed by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has adopted the framework of the Global Harmonisation Task Force (GHTF) for medical device regulation. Product approval timelines vary depending on the nature of the product, and are generally consistent with international practice.

Australia has signed Mutual Recognition Agreements (MRAs) on conformity assessment with the European Community (EU), Singapore ,Canada, Switzerland and the USA. Each MRA provides for Australia to accept the other party’s Good Manufacturing Practice (GMP) inspections of medicinal products manufacturers, and vice versa. Additionally, the EC MRA provides for mutual recognition of medical devices conformity assessment. Such agreements reduce regulatory duplication and facilitate trade between the parties.

The TGA has established cooperative arrangements to facilitate information sharing with other regulators, including with the US Food and Drug Administration.

Australia has a Federal legislative framework to provide access to genetic resources and legal certainty for biodiscovery research and development. Australia has a clear food safety regulatory regime through Food Safety Australia and New Zealand (FSANZ).

Australia has a robust regulatory system for dealing with genetically modified organisms (GMOs) through the Federal Office of the Gene Technology Regulator (OGTR), which examines the health, safety and environmental aspects of GMOs. States are able to impose moratoria based on market and trade issues. Two of the eastern states have ended their moratoria on the commercial cultivation of GM canola resulting in that part of the Australian mainland being able to commercially commence GM canola production.

Australia also provides a transparent and attractive regulatory environment for stem cell research, offering stability and certainty for industry and investors. Amendments made to Australian stem cell laws in 2006 broaden the scope of human embryonic research that can be conducted under licence in Australia, and permit research involving somatic cell nuclear transfer. For information on the licensing system see: www.nhmrc.gov.au/publications/synopses/_files/embryact.pdf.

The Australian Government has made a significant investment in the Australian Stem Cell Centre, with funding committed until 2011. It also supports the Australian Centre for Plant Functional Genomics through the Australian Research Council, with funding committed until 2012.

Programs and assistance

Existing government support for innovation, including the biotechnology sector, comprises a large number of programs that cater for different stages of development and also for some niche interest groups. There are also a number of State government initiatives which support research and development. Key Australian Government programs and assistance include:

• Funding programs for biotech companies:
  • Innovation Investment Fund (IIF)
    • Supports funds to commercialise R&D and develops new fund managers for early stage venture capital investing.
    • In IIF rounds 1 & 2, 4 of the 9 funds announced focused on biotechnology and bioscience.
  • Early Stage Venture Capital Limited Partnerships (ESVCLP)
    • Exempts domestic and foreign investors in early stage venture capital limited partnerships from income and capital gains tax.
    • Supports Investment in Australian entities worth between $10m and $100m.
    • Australia is the top destination for venture funds invested in the Asia Pacific region.
• A premium 175 per cent R&D tax concession to encourage additional R&D in Australia by subsidiaries of multinational enterprises. The tax concession is worth 22.5 cents per dollar (after tax) for additional R&D conducted in Australia.
• The Australian Government's Global Opportunities Program aims to facilitate groups of Australian biotech companies to form alliances and partnerships with global pharmaceutical and biotechnology companies. 

Cooperative Research Centres

The Government’s Cooperative Research Centres (CRC) Program links public and private-sector investment and R&D expertise, establishing formal, strategic seven-year agreements between research providers and users in the public and private sectors. CRCs are major drivers of biotechnology and biomedical innovation in Australia. There are currently 49 CRCs operating across a wide range of industry and public benefit sectors, with over one-third completely or partially involved in biotechnology, biomedical or environmental bioscience research. Over the last few years, approximately 50 per cent of Australia’s biotechnology companies have been spun out of publicly funded research institutes.

For more information please visit www.crc.gov.au

CSIRO

The Commonwealth Scientific and Industrial Research Organisation (CSIRO), is one of the largest and most diverse research organisations in the world, with wide-ranging research interests that include programs in the areas of health, agriculture and the environment. The CSIRO has developed close ties with leading firms in the US, Europe and Japan and is Australia’s leading patenting enterprise with more than 4,000 live or pending patents.

For more information please visit www.csiro.au