Description
Bloomsbury Publishing PLC Law and the Regulation of Medicines by Emily Jackson
The principal purpose of this book is to tell the story of a medicines journey through the regulatory system in the UK from the definition of a medicine through clinical trials licensing pharmacovigilance litigation marketing and funding. While the UKs regulatory regime is the principal focus the question of global access to medicines is addressed not only because of its political importance but also because it is an issue which places the question of whether medicines are a private or a public good in particularly stark focus. Two further specific challenges to the future of medicines regulation are examined separately: pharmacogenetics or the genetic targeting of medicines to subgroups of patients and the possibility of using medicines to enhance wellbeing or performance rather than treat disease. Throughout the emphasis is upon the role of regulation in shaping and influencing the operation of the medicines industry an issue which is of central importance to the promotion of public health and the fair and equitable distribution of healthcare resources.