By
M.N.G. Dukes, Oslo, Norway
Description
As one of the most massive and successful business sectors, the pharmaceutical industry is a potent force for good in the community, yet
its behaviour is frequently questioned: could it serve society at large better than it has done in the recent past? Its own internal
ethics, both in business and science, may need a careful reappraisal, as may the extent to which the law - administrative, civil and
criminal - succeeds in guiding (and where neccessary contraining) it.
The rules of behavior that may be considered to apply to today's
pharmaceutical industry have emerged over a very long period and the process goes on. Even the immensely detailed standards for quality,
safety and efficacy laid down in drug law and regulation during the second half of the twentieth century have their limitations as tools
for ensuring that the public interest is well served. In particular, national and regional regulatory agencies are heavily dependent
on industrial data for their decision-making, their standards and competence vary, and even the existing network of agencies does not
cover the entire world. What is more there are many areas of law and regulation affecting the industry, concerning for example the pricing
of medicines, the conduct of clinical studies, the health protection of workers and concern for the environment. In some fields it is
indeed hardly possible to maintain standards through regulation.
Professor N.M. Graham Dukes, a physician and lawyer with long term
experience in industrial research management, academic study and international drug policy, provides here a powerfully documented analysis
into the way this industry thinks, acts, and is viewed, and examines the current trends pointing to change.
Audience:
Pharmaceutical Industry, Government policy makers, Academic Health policy researchers
