All books in this flagship series contain carefully selected substantial extracts from key cases, legislation, and academic debate; providing students with a stand-alone resource. This chapter examines the regulation of medicines. It first explains what a medicine is and the need for it to have a marketing authorization before it can be put into circulation. It covers the importance not only of establishing safety and efficacy before licensing, but afterwards as well, through pharmacovigilance mechanisms. The chapter covers the increasing European harmonization of the rules covering the licensing and marketing of medicines, and briefly discusses the implications of Brexit. Finally, it looks at liability for defective medicines, and the strict liability regime under the Consumer Protection Act.
Chapter
This chapter discusses various aspects of ethics and medical law. It begins with a definition of medical law. It then covers the nature of illness, the scope of medicine, the sociological impact of being ill, UK health statistics, and general ethical principles. This is followed by discussions of the notion of rights; patients’ obligations; principlism; hermeneutics; casuistry; feminist medical ethics; care ethics; virtue ethics; and communitarian ethics. It also explains the role of theology, relativism, and pragmatism in medical ethics. The chapter also explores the links between ethics and law. It cannot be assumed that because something is unethical it must be unlawful, nor that everything unlawful is necessarily unethical.
Chapter
This chapter discusses various aspects of ethics and medical law. It begins with a definition of medical law. It then covers the nature of illness, the scope of medicine, the sociological impact of being ill, UK health statistics, and general ethical principles. This is followed by discussions of the notion of rights; patients’ obligations; principlism; hermeneutics; casuistry; feminist medical ethics; care ethics; virtue ethics; and communitarian ethics. It also explains the role of theology, relativism, and pragmatism in medical ethics. The chapter also explores the links between ethics and law. It cannot be assumed that because something is unethical it must be unlawful, nor that everything unlawful is necessarily unethical.
Chapter
This chapter examines the regulation of medicines. It covers the importance of establishing safety and efficacy before licensing, and afterwards as well, through pharmacovigilance mechanisms. European harmonization of medicines regulation means that Brexit has had a significant impact on how medicines are licensed for use in the UK. It also looks at liability for defective medicines, and the strict liability regime under the Consumer Protection Act.
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G. T. Laurie, S. H. E. Harmon, and E. S. Dove
This chapter discusses the following: the ethical basis for the practice of medicine; the organisation of modern medicine; the importance of the relationship between the medical profession and the public; legal intervention in medicine; and the doctor’s position.
