Australia is home to hundreds of companies in the life sciences industries (including pharmaceuticals, veterinary pharmaceuticals, medical devices and technology, biologicals, biotechnology, and agricultural biotechnology). It is also home to numerous world-class universities, major medical research institutes and teaching hospitals. It has a long-established reputation for excellence in life sciences research, drug discovery, diagnostics, clinical trials and pharmaceutical manufacturing.
Australia's reputation as a centre of excellence for research in the life sciences is built on its wide availability of internationally recognised researchers and a full range of services and facilities to support active drug discovery programs.
Australia is also the premier location for clinical trials in the Asia Pacific. The number of clinical trials conducted locally has grown significantly in recent years; a trend that is expected to continue.
The importance of reaping the commercial and social benefits of research is recognised by the Australian medical and business communities. The commercialisation of research in the medical, pharmaceutical, veterinary and biotechnology industries in Australia is increasing rapidly and is likely to play a key role in the country's future prosperity. Hundreds of life sciences companies, including many of the world's largest pharmaceutical companies, already operate in Australia to commercialise their research. This number continues to grow each year.
Australia has a strong but flexible regulatory environment.
Therapeutic goods, which include pharmaceuticals, medical devices and technology and biologicals, are all regulated in Australia by the Therapeutic Goods Administration (TGA), a body administered by the Commonwealth Department of Health and Ageing.
The Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act) provides sponsors, manufacturers and importers of therapeutic goods with a national framework of regulation, as well as a system to control the quality, safety, efficacy, and timely availability of therapeutic goods.
Clinical trials in Australia are conducted under either the Clinical Trial Notification or Clinical Trial Exemption Scheme, which are administered by the TGA.
Australian practice and standards frameworks are recognised by the US Food and Drug Administration and the European Medicines Agency. This ensures products successfully trialled in Australia have immediate transferability to European Union and US markets.
IMPORTING, MANUFACTURING, SUPPLYING AND EXPORTING THERAPEUTIC GOODS
Before a therapeutic good can be imported into, manufactured in, supplied in, or exported from Australia, it must be granted regulatory approval by the TGA under the Therapeutic Goods Act and entered on the Australian Register of Therapeutic Goods (ARTG).
Although therapeutic goods may be supplied in Australia once granted regulatory approval and entered on the ARTG, prescription medicines are generally not supplied in Australia until they are also listed on the Schedule of Pharmaceutical Benefits. This Schedule lists all prescription medicines available to Australian residents under Australia's Pharmaceutical Benefits Scheme (PBS). Under the PBS, listed medicines are available to Australian residents at prices subsidised by the Federal Government, resulting in a lower cost to consumers than would otherwise be the case. The PBS is governed by the National Health Act 1953 (Cth).
KEY LEGAL ISSUES - REGULATORY COMPLIANCES AND PATENT PROTECTION AND ENFORECMENT
Key legal issues that exist for life sciences companies in Australia include regulation and compliance, intellectual property protection and enforcement, corporations law requirements, consumer law compliance, privacy, taxation, and workplace and employment issues.
From a regulatory perspective, compliance with the Therapeutic Goods Act and regulations, as well as the Medicines Australia Code of Conduct and the Medical Technology Association of Australia Code of Practice, are mandatory for applicable life sciences companies. The legislation and Codes cover a number of issues, including advertising and promotion, interactions with health care professionals and the regulatory approval of therapeutic goods.
From an intellectual property perspective, the primary issues for life sciences companies in Australia relate to patents. Two types of patents are available in Australia - standard patents, which are equivalent to patents granted around the world, and innovation patents, which are unique to Australia. In general, the term of a standard patent is 20 years, although the term of particular types of standard patents relating to pharmaceuticals may be extended by up to five years. The term of an innovation patent is eight years and cannot be extended.
Life sciences companies regularly commence litigation in Australia to enforce their patents so as to protect their products from competition in Australia. As part of that litigation, companies generally seek interlocutory (preliminary) injunctive relief to prevent the launch of competing products. Such litigation also generally involves a challenge to the validity of the asserted patent by the defendant, usually a generic pharmaceutical company. Australian courts are very experienced in handling patent litigation, and are able to move very quickly to address the often urgent issues that arise in the context of that litigation. Moreover, in recent years, these courts have exhibited a trend of granting interlocutory injunctions in life sciences patent cases; doing so in a significant majority of such cases during this period.
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