SECTION VII
Legal and Ethical Aspects
of Pharmaceutical Medicine
Introduction
Ethical conduct in both drug development and
ordinary clinical practice is obviouslysine qua
non. This section brings together aspects of this
essential prerequisitewith some of the mechanisms
that are used to enforce it.
In drug development, the rare clinical disasters
that are well publicized almost always turn out to
have an ethical component during the investiga-
tions that follow. Although neither academic insti-
tutions nor governments are entirely free of ethical
lapses during clinical trials, it is the pharmaceutical
industry that usually garners most negative press,
perhaps disproportionately.
Although, on its face, this book would not
seem to be about clinical practice, let us not
forget that pharmaceutical companies, disease
management enterprises, economists, third-
party payers, regulators of formularies, whether
local committees or national bodies such as the
National Institute for Health and Clinical Excel-
lence (NICE) in England and the Scottish Med-
icines Consortium, and politicians, among many
others, all have an indirect hand in shaping that
ultimate clinical activity: prescribing. Arm’s-
length influence over clinical practice is no
excuse for ignoring the ethical implications of
one’s indirect actions.
The law, it can be argued, is the enforcement
aspect of ethics, among other things. Respect for
intellectual property (seen especially in Japan
where patent litigation is almost unknown), appro-
priate prescribing, and the detection and punish-
ment of those who unethically invent ‘paper’
patients or alter research data are the subjects of
other chapters in this section. This may seem pes-
simistic. However, there is a yet stronger argument
to be made: the law can be a rather blunt tool for
dissecting ethical issues, and may not be able to
right a wrong when it is somebody’s personal
health that has been damaged. Moreover, if we
did not exercise our best ethical judgment at all
times, then the law, in any case, could only ever
address a small minority of cases that would arise.
Clearly, other chapters in this book could have
appeared in this section. An early chapter in this
book is on ‘informed consent’; its location is
designed to indicate the supervening importance
of that particular application of autonomy, benefi-
cence and equipoise. Ethical behavior is also at the
very centre of ‘good clinical practices’. The chap-
ter on ‘publishing clinical trials’ also examines
some of the ethical aspects of that activity.
Dr Belsey also enters into this area with his chapter
on ‘advertising and marketing’.
Ethics and the law are thus presented in conjunc-
tion in this section.