Extract

This chapter outlines the key economic and governance issues surrounding regulatory approvals for new health food products, the regulation of health claims and the protection of intellectual property rights (IPR). It begins by outlining how these issues arise and why they are important, drawing upon the economic concepts of market and non-market failure. A major theme of the chapter is the challenges facing regulators in developing new policy frameworks and insights from the literature are used to examine the state of flux within policy environments. Three case studies are then used to illustrate different aspects of regulatory development. Canada is used as one of the case studies to examine the gradual process of regulatory adaptation in response to the relatively new category of health food products. An example of regulatory harmonization is provided within the context of the development of EU regulations that supersede previously disparate individual country regulatory approaches. The issues explored in this chapter serve as a backdrop for Chapters 4 and 5, which provide a detailed examination of the regulations pertaining to health claims and new product approvals in selected developed and emerging markets, respectively. The emergence of the health foods sector has raised a number of policy issues for governments.