46 Pharmaceutical Medicine

and the Law

Sarah CroftandTimothy Pratt

46.1 Introduction

In this chapter, we introduce basic legal principles
and some of the legal concepts most relevant to the
pharmaceutical physician. The central topics,
touched upon here, are expanded upon elsewhere
in this section.

46.2 Individual or corporate

responsibility?

The circumstances in which a pharmaceutical phy-
sician will personally be sued under the civil law
are relatively infrequent. The individual doctor or
pharmaceutical physician, who is usually an agent
of the company, does not fall within the definition
of a ‘producer’ or ‘manufacturer’, although the
pharmaceutical company usually will. Therefore,
the individual pharmaceutical physician is unlikely
to have proceedings brought against him or her
personally, except in rare circumstances. It is
much more likely that the company will be a
defendant to an action by an individual patient or
by another company, whether in tort or in contract.
The deeper pockets of the company, in comparison
to the individual pharmaceutical physician, practi-

cally guarantee that this is also the case in the

United States. It is possible that criminal sanctions

could be applied to the individual, but such pro-

ceedings are not common. As discussed elsewhere

in this book, both the UK and US regulations make

it an offence for an applicant (i.e. the company) to

give false information in connection with an appli-

cation for a licence for a pharmaceutical product.

Most regulations, however, also provide that where

a company makes a misrepresentation and it can

also be shown that the misrepresentation was com-

mitted with the consent and connivance of, or

attributable to the neglect of any director, manager

or similar officer of the company, those individuals

may also be personally liable. This may obviously

affect the pharmaceutical physician, who is a

director or equivalent in the company, who may

be the signatory to advertising materials, for

example.

It is sometimes the case that the company and the

pharmaceutical physician are sued for negligence,

where the allegations include specific acts for

which the pharmaceutical physician is responsible,

such as the warnings in a data sheet or the reports

from a clinical trial. Regardless of who might be

held legally responsible, an understanding of the

relevant legal framework is essential.

Principles and Practice of Pharmaceutical Medicine, 2nd Edition Edited by L. D. Edwards, A. J. Fletcher, A. W. Fox and P. D. Stonier
#2007 John Wiley & Sons, Ltd ISBN: 978-0-470-09313-9