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.
