SECTION VI
Medical Services
Introduction
This section covers the area that is typically termed
‘Medical Affairs’ in pharmaceutical companies.
The specific areas of knowledge and capability
are described in the following chapters, but a few
words on the less tangible aspects of this subspeci-
alty might be offered here.
Firstly, the term is somewhat of a misnomer:
many different professions contribute toaneffective
Medical Affairs department. The tasks of such
departments are diverse and include everything
that has any, even tangential, clinical implication.
These may include developing old drugs for new
indications, post-marketing commitments fornewly
approved products, pharmacovigilance, marketing,
promotion, price negotiations and so on.
Secondly, these diverse tasks bring diverse
responsibilities. Very often, those working in Med-
ical Affairs departments will find themselves in the
role of an in-house ombudsman. It is here that
ebullience in the Marketing department must be
tempered with realities of labeling, where pharma-
covigilance signals are sifted and corporate
responses to them are designed, and the clinical
impact of manufacturing deviations must be
assessed. If the Company must defend itself in
litigation, then it will be the medical affairs spe-
cialists who will have to ensure that the lawyers are
properly educated. These can sometimes be lonely
roles, because insistence on their performance is
often counter to short-term financial aspirations
elsewhere in the Company.
The best medical affairs specialists are those
with long experience. Although these chapters
contain a useful knowledge base, nothing can
replace several years’ experience ‘in the trenches’
of a vigorous Medical Affairs department. The role
can be the most stimulating of any in the industry,
and it suits well the versatile generalist.