INTRODUCTION

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.

SOURCES OF THE LAW

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.

Figure 1.1 Sources of the law

STATUTORY INTERPRETATION

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: