The influence of the Consumer Protection Act 68 of 2008 and the plain language requirement of pharmaceutical product labelling

Abstract

The dissertation deals with the influence of the plain language requirement provided for in section 22 of the Consumer Protection Act 68 of 2008 (CPA) on the current practice of pharmaceutical product labelling. The introduction in Chapter 1 sets the scene by providing an overview of the dissertation: It includes a brief description and layout of the chapters; a discussion of the research problem and aims; a demarcation of the methodology used; and an explanation of the scope, limitations and delineations of the study. The focus in chapter 2 is on prescription medication and the legislation applicable thereto. The focus is on the Medicines and Related Substances Act 101 of 1965, specifically regulations 8 to 10 promulgated in terms thereof. Furthermore, the relevant provisions of both the abovementioned Acts are critically discussed and analysed. An overview of the appropriate supply chain in this specific context is provided with reference to medical practitioners, pharmacists and suppliers. Section 61 of the CPA concerning damaged goods is also examined. The development, meaning and importance of plain language as well as the application and definition of an ?educated consumer? are discussed in chapter 3. As this study concerns product labelling, section 24 of the CPA as well as the terms ?product labelling? and ?package inserts? are examined in chapter 4. At the same time, section 22 and the meaning of ?document?, ?notice? and ?visual representation? are kept in mind. The dissertation is concluded in chapter 5. Here the final part of the golden thread is completed ? the aims described in chapter 1 are confirmed through a brief summation of the information provided and investigated in chapters 2 to 4.