INTRODUCTION

In Australia the regulation and registration of medicines is achieved, at least in part, through the agency of the Therapeutic Goods Administration (TGA) and enabling legislation. Society spends money on medicines because of the benefits that accrue through disease treatment and prevention. In order to maximise such benefits, medicines must meet appropriate standards of quality, safety and efficacy; which means in turn that their development, production and distribution must be regulated to ensure compliance with prescribed standards. It is, however, also important that society achieves a balance, on the one hand facilitating an individual’s access to medicines while on the other ensuring that medicines meet appropriate standards of quality, safety and efficacy.

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]

In regard to an individual’s access to unapproved medicines, therapeutic goods legislation allows such access under the ‘Special Access Scheme’ in certain circumstances such as:

Drug regulation is a component of the public policy framework that restricts or controls private-sector activity to achieve identified social goals. In Australia such goals are given focus by the National Medicines Policy, which has as its core components:

The pharmaceutical industry has flourished since the 1930s and now represents one of the largest globalised industries. Unfortunately, in parallel with this development has been the phenomenon of counterfeit or substandard pharmaceuticals that include toxic, inactive or non-standardised products. Some notable examples of the risks associated with the use of counterfeit pharmaceuticals include:

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]

Before discussing the role of the TGA in regard to the regulation of therapeutic goods it is useful to briefly consider the constitutional complexities that exist in Australia.

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.

Each government in the federal system has law-making functions, with the constitution giving the federal government certain enumerated powers, and the states retaining those general powers necessary to provide peace, order and good government. Some of the powers given to the federal government are exclusive and cannot be exercised by the states and territories. For example, section 90 of the Constitution states:

In other cases the Constitution prohibits states from exercising certain powers. For example, section 114 states:

As both the Commonwealth and the state governments have law-making functions, disputes may arise over the exercise of such powers. This potential for conflict is recognised in the Constitution and is addressed by section 109 that provides that where there is an inconsistency between a state law and a Commonwealth law, the inconsistency is resolved in favour of the Commonwealth. Disputes of this nature are decided by the High Court.

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:

While the Therapeutic Goods Act 1989 (Cth) and the National Health Act 1953 (Cth) are the two pieces of federal legislation most likely to affect practising pharmacists, practitioners should also be aware of the Narcotic Drugs Act 1967 (Cth), the Psychotropic Substances Act 1975 (Cth) and the Customs (Prohibited Imports) Regulations 1956 (Cth). The Narcotics Drugs Act 1967 (Cth) is an act to ‘… regulate the manufacture of narcotic drugs in accordance with the United Nations Single Convention on Narcotic Drugs 1961’. The Psychotropic Substances Act 1975 (Cth) is an Act to:

The Customs (Prohibited Imports) Regulation 1956 (Cth) prohibits the import of a wide range of goods including drugs, unless the person importing the drug holds the appropriate licence. Exceptions include where a person is a passenger on a ship or plane and where the drug was prescribed by a medical practitioner for the purposes of treatment.

THERAPEUTIC GOODS ADMINISTRATION (TGA)

The TGA, a division of the Department of Health and Ageing, conducts a range of assessment and monitoring activities which ensure therapeutic goods available in Australia are of an acceptable standard, and that therapeutic advances are made available to the Australian community within a reasonable time. The overall control of therapeutic goods is maintained predominantly through five processes. These can be characterised as:

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 definition of therapeutic goods does not include those goods declared not to be therapeutic goods under an order in force under section 7 of the Act, or goods for which there is a prescribed standard in the Australia New Zealand Food Standards Code as defined in subsection 3(1) of the Australian New Zealand Food Authority Act 1991, or goods which have a tradition of use in Australia and/or New Zealand as foods for humans in the form in which they are presented. The differences between a ‘medicine’ and a ‘cosmetic’ should be noted. The main determining factors are the claims made about the product. For example, moisturisers containing sunscreens and therefore having a stated therapeutic purpose are classified as medicines, whereas moisturises without a specific therapeutic ingredient are classified as cosmetics. When a product is classified the ingredients, route of administration and therapeutic claims are taken into consideration.

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:

From 1 July 1998, the TGA has been required by the government to fully recover its operating costs for all activities that fall within the scope of the Act, including regulation of the industry and the TGA’s public health responsibilities.

In terms of the Therapeutic Goods Regulations 1990, Regulation 9A, a sponsor must supply written information for consumers as specified in Schedule 12 or 13 for all prescription products and Pharmacist Only medicines. This written information is referred to as Consumer Medicine Information (CMI) and can be in various formats; for example, electronic, pads, and package inserts.

In is also worthy of note that a Trans-Tasman Harmonisation Agreement was signed between Australia and New Zealand to implement a joint regulatory scheme for therapeutic products. However this process has been deferred indefinitely due to New Zealand not passing enabling legislation.

AUSTRALIAN REGISTER OF THERAPEUTIC GOODS (ARTG)

All medicines marketed in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) unless they are specifically exempt or excluded. The ARTG, established under Part 3 of the Act, is divided into two parts; the first part is for ‘Listed Goods’, the second part for ‘Registered Goods’. Some goods otherwise captured by the Act are classified as ‘Exempt Goods’ and include homoeopathic preparations, extemporaneously prepared medicines, dandruff shampoos, fluoride toothpastes and antiperspirants. It is important to note that although Listed Goods appear in the ARTG (a ‘register’) they are not ‘registered’ as such.

It is intended that Listed Goods contain ingredients that are generally considered to be safe. Such ingredients are usually characterised as being well known, established, and with a long history of use. Examples include most complementary and alternative medicines, vitamin and mineral products, and sunscreens. Prior to listing they are assessed for quality and safety, with the manufacturer being required to comply with the Code of Good Manufacturing Practice and to be licensed by the TGA. However, and this goes to the core of concerns that have been raised about Listed Goods, they are neither independently assessed for efficacy nor stability. Listed Goods are denoted by the symbol ‘AUST L’ followed by an identifying number. They do not contain substances scheduled in the Standards for the Uniform Scheduling of Drugs and Poisons (SUSDP) unless the products are for export only and not marketed in Australia.

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]