Acta Pharm. 61 (2011) 15-23

full paper

Mini review

International pharmaceutical social risk regulation: An ethical perspective

CAMERON GORDON

Cameron.gordon@canberra.edu.au

Faculty of Business and Government, University of Canberra, Bruce, ACT 2601 Australia

Accepted February 25, 2011

Pharmaceutical production and distribution constitute big business. For the companies the rewards can be substantial. Rates of return on drug company investments tend to be higher than many other manufacturing enterprises. But reward is only one side of the story. There is also the issue of social risk, the focus of this article. Social risk for pharmaceutical production is especially pronounced. An ineffective or, worse, dangerous drug, can have dire consequences for the population at large. For this reason, there is elaborate government regulation and oversight of drug safety and risk. These systems, especially in the US and Europe, will be the main focus of this paper. The two systems will be described, and then compared and contrasted in terms of their framing of social risk and actions governments take to limit it. Systems elsewhere, especially in the developing world, are increasing in relative importance and these will be briefly discussed as well. Ethical issues that have arisen in these various systems will be surfaced and analysed. The paper will close with some conclusions and suggestions for further research.

Keywords: risk, externality, pharmaceutical industry, drug regulation, social risk, drug policy, ethics, corporate social responsibility