Chapter 10 Commonwealth medicine registration and regulation
Upon completion of this chapter you should be able to:
INTRODUCTION
Concern regarding the safety of medicines was heightened in the early 1960s with the thalidomide disaster which resulted in approximately 10000 children, predominantly in Africa and Europe, being born with severe birth defects.[1] The drug, whose safety had not been adequately assessed before its release, was aggressively promoted as an antiemetic to combat morning sickness in pregnant women. The outcome of the thalidomide experience was a recognition of the need for regulatory authorities to ensure whether the effect of a medicine on humans had been researched adequately prior to marketing. In Australia, clinical trials, which are a critical component of drug regulation, have been subject to a formal process of regulation since the 1970s.[2]
A survey undertaken by the Welcome Trust in South-East Asia in 1999 also found that 38% of 104 anti-malarial drugs on sale in pharmacies did not contain any active ingredients.[7]
Counterfeit medicines represent an enormous public health challenge with the risks being greater in those countries where regulatory oversight is weak. The World Health Organization (WHO) noted that the USA-based Center for Medicines in the Public Interest had predicted that the worldwide sales of counterfeit drugs will reach US$75 billion by 2010, an increase of more than 90% on the estimated 2005 figures.[7]
AUSTRALIAN CONSTITUTIONAL COMPLEXITIES
As outlined in Chapter 1, Australia is an independent nation with its own constitution and a federal system of democratic government. The federal government came into existence on 1 January 1901 as a result of the Commonwealth of Australia Constitution Act 1900 (UK). The Constitution sets out the parameters under which the state and federal governments operate and the relationships that exist between them. The constitutional complexities following federation arose from the fact that prior to federation Australia was a collection of separate colonies; while after federation (following two constitutional conventions and extensive negotiation between each of the six Australian states and the newly formed Commonwealth Government) each state was governed by its own (existing) constitution and the Commonwealth Constitution.
The Commonwealth can only pass laws where it believes it has a constitutional head of power to do so. For example, it could be argued that the Therapeutic Goods Act 1989 (Cth) which imposes quality controls for the preparation, packaging and labelling of therapeutic goods imported into Australia is based in part on its quarantine power (section 51(ix)). Likewise, the trade and commerce power (section 51(i)) provides for the control of medicines being imported or exported under the Customs Act 1901 (Cth). Also the external affairs power has considerable potential for being the basis for Commonwealth legislation. Through a series of decisions the High Court has shown that the external affairs powers can be invoked through the mere signing of an international agreement.[8] It is worthy of note that Australia became a signatory to the WHO in 1947. The terms of the agreement were incorporated into the World Health Organization Act 1947 (Cth) and appear to be able to support considerable Commonwealth health care legislation.
However, historically it has not always been straightforward in regard to federal legislative power. In 1944 the Commonwealth Government attempted to set up a national scheme to provide health services including pharmaceutical benefits. The scheme was thwarted by a decision of the High Court where the scheme was held to be unconstitutional.[9] As a result of a 1946 referendum the Commonwealth Government was given constitutional power to provide a range of services under section 51(xxiiiA). The section states:
THERAPEUTIC GOODS ADMINISTRATION (TGA)
Therapeutic goods are defined within the Therapeutic Goods Act 1989 (Cth) (s3) as goods:
The Therapeutic Goods Act 1989 also defines (s3) ‘therapeutic use’ as use in or in connection with:
The regulation of therapeutic goods in Australia is based ‘… on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden’.[10] The risk management process identifies, assesses and evaluates the risks posed by a therapeutic good, applies any measure necessary for treating the risks posed, and monitors and reviews the risks over time. The Act also sets out the legal requirements for the import, export, manufacture and supply of medicines in Australia. The TGA further states:
It [the Act] details the requirements for listing or registering all medicines on the Australian Register of Therapeutic Goods (ARTG), as well as many other aspects of the law including advertising, labelling, and product appearance. The Act is supported by the Regulations, and various Orders and Determinations, which provide further details of matters covered in the Act. The Act is a Commonwealth Act that provides a substantially uniform national system of controls over therapeutic goods, facilitating trade between the states/territories and benefiting both consumers and industry.
AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG)
There has been recent criticism by Harvey et al of the AUST L scheme with concerns being expressed over inadequacies and abuses of the listing mechanism as well as complicated and ineffectual complaint processes.[11]
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