Legal concepts for health professionals

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Chapter 1 Legal concepts for health professionals


The delivery of pharmacy services, as with any health care service, takes place within a legally regulated environment. The law therefore plays a significant role in the day-to-day activities of a pharmacist, whether the practice is conducted in the private or public sectors of health care delivery, whether it is a sole practice, part of a pharmacy group or whether it is within the institutional setting. The very nature of pharmacy practice places the pharmacist in situations where legal issues need to be considered when making decisions about a patient’s or client’s clinical management and care. The provision of services by a pharmacist are therefore based on a framework of common law principles, legislative provisions and professional guidelines and policies which regulate and determine not only the standard of the care but also the rights and obligations of both the pharmacist and their patients or clients. This area of law, referred to as ‘health law’, operates as one of the mechanisms by which pharmacy practice and the provision of individual services by pharmacists is controlled and regulated.

It is fundamental to the provision of a safe and competent service that the pharmacist has an understanding of the relevance of the law to the provision of that service. Within Australia, health law is made up of a range of legal concepts that derive from the common law, civil and criminal law, contract law, the regulation of industrial relations and agreements as well as the statutory arrangements between state, territory and federal governments. The obligations and responsibilities imposed through the federal government’s commitment to international treaties and declarations also impact significantly on the provision of pharmacy services within the Australian context.

As stated, health law is only one area of the law that governs the conduct of pharmacy practice. It is therefore important for the reader to have an understanding of the Australian legal system as a whole. This chapter will provide an outline of the structures of the Australian legal system, including sources of the law and an overview of the hierarchy of the courts and their processes.


The law is reflective of the values and attitudes of the particular society in which it exists and, as such, evolves over time. This evolution can be seen if one considers the laws which applied to the provision of pharmacy services in Australia a decade ago and compares them with the current laws under which pharmacists in Australia now practise. The law may be prescriptive, in setting out what is required from a pharmacist in relation to registering to practise, providing a service, managing a business or working as part of a health care team within a health care facility. Simultaneously, the law defines what the pharmacist is prohibited from doing in exactly the same situations and circumstances.

The law also determines the consequences that will follow when a pharmacist fails to comply with the requisite legal obligations and requirements. It can confer powers on individuals and groups, such as the power of the pharmacist to legally dispense or supply medications and poisons. The law can also remove or place limits on the powers of individuals or groups. It is evident that the law provides a framework that imposes obligations and bestows rights on individuals, institutions and entities such as corporations. In Australia, the sources of these obligations, responsibilities and rights are to be found in the decisions of the courts, the legislation passed by state, territory or federal parliaments and the provisions of applicable international laws. From these sources the behaviour and standards of practice for health professionals, including pharmacists, are determined and maintained.

There are several different legal systems which operate throughout various countries around the world. As an example, there are countries which function under Islamic law, socialist law or Asian legal systems. Many European countries have a civil system, which was inherited from French or Roman cultures and is based on codes. One of the characteristics of a civil legal system is the inquisitorial nature of the trial process. This means the judge, rather than remaining impartial and making a decision based on the merits of a case argued before the court, will take an active role in investigating the facts and evidence. Unlike many European and Middle Eastern countries, Australia is described as a common law country (See Figure 1.1). This resulted from the colonisation of New South Wales by the British, who also operated under a common law system. The Australian legal system, and system of government, were thereby inherited as a function of British colonisation and have continued to develop post-federation into the systems as they exist today. As a common law country there are two sources of law under the Australian system. The first is legislation passed by the parliaments at both the state and federal levels. The second source is the common law that has developed from judicial decisions handed down by the courts.

Legislation — parliamentary law

Prior to the formation of the Commonwealth of Australia on 1 January 1901 the self-governing colonies operated independently and passed legislation through their own individual parliaments and, for some, under their own Constitution. The passage of the Commonwealth of Australia Constitution Act 1900 (the Constitution) by the British government established the Commonwealth of Australia. The Constitution gave the Commonwealth Parliament the power to make laws either exclusively or concurrently with the states. Under the Constitution, the state parliaments retained their power to make laws as they had done prior to federation, unless the power to make laws about a specific matter had been given exclusively to the Commonwealth. Section 107 of the Constitution states:

The Commonwealth Constitution thereby limits and controls the power of the states to pass legislation. Section 52 of the Constitution identifies the matters over which the Commonwealth Parliament has exclusive power to pass legislation whereas section 51 grants powers over matters which are not exclusive to the Commonwealth and are thereby shared with the states. These are referred to as ‘concurrent powers’. Under section 51 of the Constitution both the state and Commonwealth parliaments are empowered to pass laws on matters such as trade and commerce with other countries, tax, postal and telegraphic services and under placita 51 xxiiiA ‘… the provision of … pharmaceutical, sickness and hospital benefits, medical and dental services …’.

Each of the federal, state and territory parliaments, through their individual constitutions, may pass laws for the ‘peace, and good government’[1] of the jurisdiction.

The federal, state and territory parliaments are therefore empowered to enact legislation, also known as Acts or statutes, for the purpose of regulating certain aspects of society. An Act, passed by the parliament elected by the people, is a primary source of the law and has priority over the common law, which is derived from court decisions. That is, legislation takes precedence over judge-made law (case law) and while it is not the role of the court to make laws where the same subject matter is covered by an Act, it is the role of the court to interpret legislation that is relevant to the determination of the case that is before it. Some states and territories will also have codes which are a complete statement of the law in a particular area. Legislation can be accessed online through the state, territory or Commonwealth government websites.

Prior to a draft Act (statute) being approved by the parliament it is called a Bill. A Bill must be passed by parliament before it is sent to the Governor-General, or Governor, for signature, also known as assent, which generally results in it becoming an Act and having legal force. This will be the case unless the Bill identifies its own procedure of enactment. That is, it may stipulate that it will not become effective until there is a notice placed by the government in the Government Gazette. The process for enacting legislation is the same in each jurisdiction where a Bill must pass through both the Lower and Upper Houses of parliament. However, in Queensland, there is only one house of parliament through which a Bill must pass.

At Commonwealth, state and territory levels legislation prescribes many of the activities of individual health professionals, professional regulatory authorities, health care facilities and institutions. The legislative provisions that apply to all aspects of the health care industry are therefore regularly amended and updated to keep pace with the current demands and constraints. There are many Acts of parliament at both the state and federal levels which regulate and control the practices of pharmacists and the services provided by them. To give some examples, at the state level, there are statutes that control the registration and regulation of pharmacists, legislation controlling workplace health and safety within a pharmacy practice, and legislation providing avenues for complaints by consumers of pharmacy services. At the federal level the legislation is primarily directed to issues of funding and regulating Commonwealth health care agencies and services.


When reading legislation the focus must be on the actual language used. Examples of words that mandate a particular activity or status include will, shall or must. However, the use of a word such as may indicates a discretionary power. It is important when attempting to interpret an Act that the legislation is read as a whole so as to obtain the context of the words used. Explanatory notes, that sometimes accompany the Act and associated regulations, may also assist in resolving any ambiguity or clarifying the intention of the law. Statutory interpretation is now governed by various state, territory and Commonwealth Interpretation Acts.[2] Section 15AA (1) of the Acts Interpretation Act 1901 (Cth) states: