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Pharmaceutical Medicine: History, Global Status, Evolution and Development

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2007, Vol. 21, No. 4 (pp. 253-262)

ISSN: 1364-9027

Current Opinion
Global Status of Pharmaceutical Medicine

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 Int J Pharm Med 2007; 21 (4): 253-262
CURRENT OPINION 1364-9027/07/0004-0253/$44.95/0

 2007 Adis Data Information BV. All rights reserved.

Pharmaceutical Medicine
History, Global Status, Evolution and Development
Peter D. Stonier,1 Honorio Silva2 and Herman Lahon3
1 Faculty of Pharmaceutical Medicine of the Royal Colleges of Physicians of the UK, London, UK
2 Science & Medical Professional Development, Pfizer Inc., New York, New York, USA
3 International Federation of Associations of Pharmaceutical Physicians, Brussels, Belgium

Abstract For over 30 years pharmaceutical medicine has developed as a medical scientific discipline for the discovery,
development, evaluation, registration, monitoring and medical marketing of medicines for the benefit of patients

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and community health. Pharmaceutical medicine occupies common ground between the clinical and healthcare
professions, pharmaceutical industry and government. While the boundaries of pharmaceutical medicine are
indistinct, at its centre is the clinical testing of medicines, translation of drugs into new medicines, safety and
well-being of research subjects in clinical trials, and understanding the safety profile of medicines and their

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benefit-risk balance. Pharmaceutical medicine is a discipline that takes its place alongside other medical
specialties; it has developed its own professional ethos; it has established a distinct body of knowledge based
primarily on clinical science; and its practitioners represent a cohesive group of specialists with common goals
and aspirations. Pharmaceutical physicians work in industry, drug regulatory authorities and clinical research
organisations, but have a close affinity with their medical colleagues in primary and secondary healthcare and at

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universities.
As a postgraduate medical discipline, pharmaceutical medicine has a recognised international syllabus,
training courses with examinations and qualifications, its own research methodologies, professional bodies and
academic societies, journals and texts, and embraces new technologies and regulations in pursuit of proof of

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efficacy, safety and effectiveness of medicines. Pharmaceutical medicine is a listed medical specialty in the UK,
Ireland, Switzerland and Mexico. This official recognition is underlined by the availability of accredited
education and training of specialist pharmaceutical physicians and the establishment and maintenance of
standards of practice and professionalism in the competency, care and conduct applied to their work and of

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growing public recognition and accountability.

Pharmaceutical medicine is the medical scientific discipline The emergence of pharmaceutical medicine, as a discrete medi-

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concerned with the discovery, development, evaluation, registra-
tion, monitoring and medical aspects of marketing of medicines
for the benefit of patients and public health.[1,2] Implicit in this
definition are vaccines, medicinal components of medical devices,
diagnostics and all forms of available medicines. Overall the
description of pharmaceutical medicine depicts an ethical, medical
and scientific endeavour to provide effective and safe medically
active agents for patients across the spectrum of diseases. Doctors
working in this medical discipline, while not dealing with individ-
ual patients, influence the health and well-being of populations,
cohorts and groups of patients, and place the safety and interests of
those patients uppermost in their activities and decisions.
cal discipline, has established channels for communication and
opportunities for development and advancement for medical pro-
fessionals in the pharmaceutical, biotechnology, clinical research
and medical device industries, as well as those in academia,
regulatory or government agencies. Notwithstanding, most bi-
omedical professionals are not fully aware of the mission and
vision of the pharmaceutical industry, and the complexities and
regulations associated with drug discovery, development and com-
mercialisation.
Pharmaceutical medicine is a broad medical specialty that
requires pharmaceutical physicians to have a wide range of experi-
ence, including training and expertise in basic research, drug
254
development and evaluation, clinical trials and registration as well
as a thorough understanding of pharmacoeconomics, medical as-
pects of the marketing of medicines, business administration and
the social impact of healthcare on patients and public health.[3] The
basics of pharmaceutical medicine are founded on the knowledge
and understanding of how drugs work, the limitations and variabil-
ity of response to therapies, and how therapies can be used
optimally in clinical practice.
1. Historical Aspects
The discipline of pharmaceutical medicine has evolved over a
period of two millennia, developing from the use of herbs and
natural medicaments to relieve pain and aid the sick in coping with
their ailments. The scientific basis of medicine, developed over the
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last 100–150 years, resulted in an exponential growth of knowl-
edge and a shift in society’s approach to pharmaceuticals, moving
from unregulated sale and use to government intervention and
professional regulation, and the requirements to demonstrate safe-
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ty and, later, efficacy before medicines were marketed. These legal
requirements reflected changes in social attitudes and expectations
of medicines based around questions posed by biological and basic
sciences.[4]
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The medical profession has always been concerned about the
quality and safety of medicines, because drugs are so central to the
practice of medicine and treatment of the sick, with surgery and
advice being the other treatment interventions by doctors. The
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emergence of pharmaceutical medicine as a medical scientific
discipline and the role of doctors within it have been described,
and the history traced, by a number of authors who have used the
milestones along this path to fix turning points, accelerated devel-
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opment or increased recognition of pharmaceutical medicine as a
medical discipline.[4-6]
Examples of pivotal events from which pharmaceutical
medicine has sprung include: the foundation of the Royal College
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of Physicians (England) in 1518; the appointment of inspectors to
search apothecaries’ shops and destroy defective medicines; the
introduction of the London Pharmacopoeia in 1618; the arrival of
scientific medicine and, at the turn of the 20th century, the emer-
gence of drug manufacturers as the forerunners of the modern
pharmaceutical industry; the introduction of anaesthetics, antipy-
retics and hypnotics; the emergence of statistical methodology and
the development of randomised controlled clinical trials; and the
tragedy of thalidomide and growth of drug regulation.
In the modern era of the last 50 years, the employment, in
increasing numbers, of physicians by companies and the growth of
medical departments and research and development operations,
the need to be involved in the ethical marketing of medicines, the
 2007 Adis Data Information BV. All rights reserved.
Stonier et al.
increased influence of payer-providers and of patients themselves
in their treatment, the acceptance of the need to consider clinical
and cost-effectiveness in addition to the traditional proof of effica-
cy, safety and quality in making medicines available to the public,
have all increased the intimate involvement of the medical profes-
sion in the development, introduction and maintenance of
medicines.[4,6]
Throughout this period the specialty of pharmaceutical
medicine and its medical practitioners have developed hand-in-
hand with regulations, in what must now be considered one of the
most regulated of industries.[7]
2. The Role of the Physician in the Discipline of
Pharmaceutical Medicine
Fifty years ago, the life of physicians in the pharmaceutical
industry was not particularly enviable because there were not
many doctors employed in each company and jobs in the industry
came to be regarded as having a low status by others in the
profession.[6] It was possible for pharmaceutical physicians to
become quite isolated from the mainstream of the medical profes-
sion and recognising this, they joined together in 1957 to form the
Association of Medical Advisers in the Pharmaceutical Industry
(AMAPI; later called the British Association of Pharmaceutical
Physicians [BrAPP]) as a vehicle for mutual support.
Decades later, the pharmaceutical industry has become an
interesting employment opportunity for physicians since an in-
creasing number of professionals with medical degrees are needed
by the pharmaceutical industry to support many tasks requiring
medical training and expertise. These physicians and professionals
report satisfaction with the pharmaceutical industry because:
• the work is never repetitive, dull or boring;
• they encounter a new set of challenges and problems every
working day;
• there is a strong sense of accomplishment, team work and
collaboration in their job environment.[8]
However, the opportunity for advancement in pharmaceutical,
biotechnology and medical device companies may be limited due
to an incomplete understanding of, or insufficient skills in, phar-
maceutical medicine.
Pharmaceutical medicine was initially considered outside the
conventionally respected medical and scientific professions. This
was despite the ultimate responsibility of pharmaceutical physi-
cians for interpreting clinical data to determine whether or not
drugs should be, or should continue to be, marketed. These consid-
erable responsibilities extended nationally, and for some regulato-
ry and pharmaceutical physicians, internationally. The responsi-
bility could be likened to signing prescriptions for whole coun-
Int J Pharm Med 2007; 21 (4)
Global Status of Pharmaceutical Medicine
tries, with some pharmaceutical physicians responsible for the
actual signing, many for providing information to ensure the
prescription was correct, and others, through government regulato-
ry departments and committees, for scrutinising the prescription
once it was written.[5]
Pharmaceutical medicine is a multidisciplinary and global
field, involving scientists and a wide range of professional and
technical groups, both medical and nonmedical, in its work togeth-
er with support from legal, financial and administrative profes-
sions. As a medical specialty, it is also very broad, encompassing:
physicians working in basic research to identify targets for drug
action; experimental medicine to identify potentially useful bi-
omarkers; clinical development, running and managing phase I, II
and III clinical trials; pharmacoeconomics; and supporting
medicines in the healthcare marketplace.[9] In their work, these
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doctors undertake an enormously wide range of jobs in the fields
of drug development, medical affairs, drug safety, regulatory
affairs, and information, education and communication.
A group of pharmaceutical physicians and their teams deserv-
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ing of special recognition are clinical pharmacologists, whose task
embraces the critical bridge between preclinical and clinical stud-
ies and the close evaluation of pharmacokinetics and pharmacody-
namics, tolerability and dosage in phase I studies, often early
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clinical studies in the patient population with the target disease and
also in special populations such as the elderly and children. It is
through the work of these pharmaceutical physicians that drugs
reach humans for the first time, and with that comes the attendant
subjects.
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responsibilities to safeguard the well-being of their volunteer
However, the roles of physicians practising pharmaceutical
medicine must be distinguished from the day-to-day jobs they do,
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and it is these roles that define the relationship of pharmaceutical
physicians to their specialty, whether they are clinical pharmacolo-
gists, clinical toxicologists, clinical research physicians, medical
advisers, regulatory physicians, pharmacoepidemiologists or drug
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safety specialists, not only in the pharmaceutical industry but also
in regulatory authorities and academia.
In contributing to the field of drug development and mainte-
nance, doctors bring to bear an extensive education and clinical
training that in itself is sufficient for some commentators to justify
their place at the table.[10] However, to be more explicit, the roles
and responsibilities of all practising pharmaceutical physicians in
the specialty of pharmaceutical medicine are 4-fold.
1. To be involved in the development, introduction and mainte-
nance of medicines for the treatment and benefit of patients. In
short, to work throughout their careers towards ensuring that the
right patient receives the right medicine by the right route in the
right dose at the right time.
 2007 Adis Data Information BV. All rights reserved.
255
2. To assess the benefits and risks of medicines; to manage those
risks and arrive at a benefit-harm balance that supports, or not, the
continued availability of a medicine on the market. To strive in the
interests of patients’ safety and well-being to provide access to
effective and appropriate medicines for their condition.
3. To maintain the viability of the medicines industry so that it
continues to produce innovative medicines for unmet medical
needs. Pharmaceutical physicians must be able to temper the
natural desire of commercial companies to make profit with the
need to ensure that medicines are of a high standard so that
patients’ interests are safeguarded. Similarly, regulatory physi-
cians need to be able to temper the natural desire of governments
to avoid all risk of injury due to drugs with the need to make
available new medicines for patients in the fight against disease.
4. To operate in a professional manner, adopting values,
behaviours and relationships that underpin the trust the public has
in doctors; to abide by the ethical codes for pharmaceutical physi-
cians;[11-13] to set and maintain standards of practice and of compe-
tency and care in work that is in the interests of patients and public
health.
3. International Pharmaceutical Medicine
In 1970, three British ‘medical advisers’ (as pharmaceutical
physicians were known at the time) conceived the idea of holding
an international meeting of global pharmaceutical physicians.
While drafting a constitution for the international federation, med-
ical advisers became aware that their function and responsibilities
were quite different from those practised by their colleagues in the
clinic. The need for specific professional national associations
became obvious and by 1975 national associations had been
formed in 12 countries: Argentina, Belgium, Brazil, France, Ger-
many, India, Italy, Japan, South Africa, Sweden, The Netherlands
and the UK.
The federation was formed and named the International Federa-
tion of Associations of Pharmaceutical Physicians (IFAPP) to
reflect its global perspective and the movement to no-longer refer
to industry physicians as medical advisers but as specialists.
Today, the IFAPP continues to grow steadily in size and scope,
and to fulfil its objective to support the development of associa-
tions at a national level (table I).
The IFAPP is a nonprofit organisation with the mission to
“promote Pharmaceutical Medicine by enhancing the knowledge,
expertise, and skills of pharmaceutical physicians worldwide, thus
leading to the availability and appropriate use of medicines for the
benefit of patients and society.”[2] The aims and objectives of the
IFAPP are to:
1. act as an international forum;
Int J Pharm Med 2007; 21 (4)
256 Stonier et al.

Table I. National member associations of the International Federation of Associations of Pharmaceutical Physicians in 2007
Organisation Member name Country
American APPI Academy of Pharmaceutical Physicians and Investigators USA
AMEIFAC Mexican Pharmaceutical Physicians Associations Mexico
AMIFE Asociacion de Medicina de la Industria Farmaceutica Espanola Spain
AMIPS Association of Physicians from the Health Products Industry France
AMPIF Associacao dos Medicos Portugueses da Industria Farmaceutica Portugal
APPA Australian Pharmaceutical Physicians Association Australia
APPI Association of Pharmaceutical Physicians of Ireland Ireland
APPS Association of Pharmaceutical Physicians of Singapore Singapore
BeAPP Belgian Association of Pharmaceutical Physicians Belgium
BrAPP British Association of Pharmaceutical Physicians UK
DAPP Danish Association of Pharmaceutical Physicians Denmark
DGPharMed Deutsche Gesellschaft fur Pharmazeutische Medizin Germany

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ELEFI Hellenic Society of Pharmaceutical Medicine Greece
FiAPP Finnish Association of Pharmaceutical Physicians Finland
GPMed Gesellschaft fur Pharmazeutische Medizin Austria
HCTMS Hungarian Clinical Trial Management Society Hungary

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IPPA Indonesian Pharmaceutical Physicians Association Indonesia
ISMED Turkish Association of Medical Profession Members in the Pharmaceutical Industry Turkey
JAPhMed Japanese Association of Pharmaceutical Medicine Japan
KSPM Korean Society of Pharmaceutical Medicine South Korea

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NAPP Netherlands Association of Pharmaceutical Physicians Holland
PAPP Pakistan Association of Pharmaceutical Physicians Pakistan
SAAPP South African Association of Pharmaceutical Physicians South Africa
SAMEFA Argentinean Society of Pharmaceutical Medicine Argentina

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SBMF Sociedade Brasileira de Medicina Farmaceutica Brazil
SFM Serbian Association of Pharmaceutical Physicians Serbia
SGPM Swiss Society of Pharmaceutical Medicine Switzerland
SOMFAR Romanian Society of Pharmaceutical Medicine Romania

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SSFA Society for Applied Pharmaceutical Sciences Italy
SSPM Swedish Society of Pharmaceutical Medicine Sweden

2. foster the development and international recognition of phar- 3.1 Pharmaceutical Medicine in the USA

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maceutical medicine as a separate medical specialty;
3. foster development of training and continuing educational
programme;
4. promote a closer relationship and understanding between na-
tional member associations and medical and allied professions,
regulatory authorities and international organisations;
5. disseminate information on developments in pharmaceutical
medicine to health professionals worldwide; and
6. organise international conferences on pharmaceutical
medicine.
Membership of the IFAPP is open to all national organisations
of pharmaceutical physicians.
In the early 1990s, a formal pharmaceutical medicine society
did not exist in the US. Although the idea had been explored for
many years, it had only been the subject of debate and not of
implementation.[14] In the early stages, the Pharmaceutical Manu-
facturers Association (PMA) was involved in many of the over-
arching concerns in pharmaceutical medicine and had a specialist
group termed the ‘Medical section’, which was responsible for
human ethics and regulatory affairs. In 1981 the PMA Medical
section and the IFAPP fostered the concept of an independent
association of American pharmaceutical physicians. In 1989, the
core founders lobbied PMA members and the American Academy
of Pharmaceutical Physicians (AAPP) was finally formed in 1993.

 2007 Adis Data Information BV. All rights reserved. Int J Pharm Med 2007; 21 (4)
Global Status of Pharmaceutical Medicine
By 1995, the PMA had evolved into the Pharmaceutical Research
and Manufacturers of America (PhRMA) and became concerned
primarily with governmental affairs.[15,16]
The AAPP was modelled after the European organisations with
the membership restricted to physicians only. In 1995 the bylaws
were changed to allow membership of physicians outside the
pharmaceutical industry and, subsequently, the membership grew
rapidly to over 1000 members with diverse places of employment
including: pharmaceutical companies, biotechnology companies,
regulatory authorities, universities, consultant firms and contract
research organisations. In 2005, a new entity with a broad mem-
bership was formed as the Academy of Pharmaceutical Physicians
and Investigators (APPI). Clearly the role of the Physician Investi-
gator (PI) overlaps with that of the pharmaceutical physician, and
this was recognised as an important factor leading to the creation
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of the APPI. The mission of the APPI is “to enhance proficiency of
all physicians engaged whether directly or indirectly, in the dis-
covery and development of ethical new drugs or products and to
vigorously protect the welfare of all subjects participating in
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clinical research”.[16]
In 2005, the APPI applied to the American Medical Association
for a certificate of added qualification in clinical pharmacology
and pharmaceutical medicine. However, they were unsuccessful in
original publisher.
achieving recognition as a subspecialty.
4. The Specialty of Pharmaceutical Medicine
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Organised pharmaceutical medicine is a relatively young spe-
cialty, and whilst physicians have worked with pharmaceutical
companies for many years, it was in 1975 that the first structured
training programme in pharmaceutical medicine was introduced
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for physicians employed in the pharmaceutical industry; from
1978 the course, the Postgraduate Course in Pharmaceutical
Medicine, was jointly organised by the University of Wales (Car-
diff) and the AMAPI.[17] These initiatives paralleled the creation of
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a diploma examination in the discipline in 1976, with the aim of
advancing the specialty, and this was adopted by the Royal Col-
leges of Physicians of the UK as a means of establishing standards
in the discipline.[18-20] These developments in the UK are consid-
ered to be the start of organised pharmaceutical medicine.
Elsewhere many countries followed this lead, with professional
associations, courses of study, and diplomas in pharmaceutical
medicine. The large number of national associations are coordinat-
ed through the IFAPP.
In the mid 1980s, in recognition of the growing acceptance of
the specialty within medicine, the BrAPP proposed that the Royal
Colleges of Physicians set up a Faculty of Pharmaceutical
Medicine (FPM), and this was inaugurated in 1989, in the same
 2007 Adis Data Information BV. All rights reserved.
257
year that the UK Medicines Control Agency was established to
streamline the regulation of drug development and approval of
medicines. [20]
Further developments to advance the specialty included the
establishment of the multidisciplinary Society of Pharmaceutical
Medicine in 1987, with the aim of challenging standards, stimulat-
ing research and helping to solve problems at the interfaces of
academia, industry and regulatory bodies. Together with the
BrAPP (communicating standards and education) and the Faculty
(standard-setting), these three bodies represented the professional
infrastructure for the specialty. [21]
5. Recognising the Specialty of
Pharmaceutical Medicine
Although there are physicians working for pharmaceutical
companies worldwide, there is limited awareness of the discipline
at the level of the academic and national medical associations,
which has contributed to a slow uptake in achieving recognition as
a medical specialty. Pharmaceutical medicine is currently accept-
ed as a medical specialty in the UK, Ireland, Switzerland and
Mexico. This limited recognition substantiates the need for further
awareness and education.
In pursuing its aim to achieve formal specialty recognition for
pharmaceutical medicine, the Faculty within the Royal Colleges of
Physicians of the UK embraced the European legislation establish-
ing pan-European postgraduate medical training. The European
Medical Directive (93/16/EEC) established the free movement of
doctors across Europe, recognition of medical qualifications and
the issue of Certificates of Completion of Specialist Training
(CCSTs) to those who had completed a prescribed programme of
postgraduate training in medical specialties. Working with the
Joint Committee on Higher Medical Training of the Royal Col-
leges of Physicians from 1995, the Faculty developed a postgradu-
ate training programme leading to a CCST, which was submitted
with an application for listing of the specialty to the Specialist
Training Authority (1999) and then to the Department of Health
(2000). It received the signature of the Secretary of State for
Health in April 2002 and the assent of the UK Parliament, when
pharmaceutical medicine was listed as a specialty in Schedule 2 of
the European Specialist Medical Qualifications Order (1995).
In September 2005, under new legislation The General and
Specialist Medical Practice (Education, Training and Qualifica-
tions) Order, 2003,[22] the Postgraduate Medical Education and
Training Board (PMETB) took over the work of the Specialist
Training Authority and Joint Committee for Postgraduate Training
in General Practice. The Certificate of Completion of Training
(CCT) replaced the CCST.
Int J Pharm Med 2007; 21 (4)
258
Specialist recognition and formal listing in the UK followed
that in Mexico and Switzerland (which occurred in 1999), and was
followed by similar moves in Ireland, a second Member State of
the European Union, in 2005.
6. Education and Certification in
Pharmaceutical Medicine
Informal educational programmes were developed as physi-
cians met to share experiences, define best practices and stay
abreast of changes as the pharmaceutical industry experienced
growth.[23] Originally through the efforts of professional societies
and clinical pharmacology meetings, these nonstructured forums
were important first steps in the educational process for medical
doctors entering the pharmaceutical industry.
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As mentioned previously, the first postgraduate course in phar-
maceutical medicine was established in 1975 and transferred to the
University of Wales at Cardiff in 1978 (now called Cardiff Univer-
sity). This programme was introduced to advance graduate educa-
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tion and the status of medical advisors in the pharmaceutical
industry. By 1976, the Royal Colleges of Physicians of the UK had
developed the first Diploma in Pharmaceutical Medicine. The
Diploma examination was conducted by examiners who were
original publisher.
senior physicians working in pharmaceutical companies, regulato-
ry authorities, universities and hospitals with experience in phar-
maceutical medicine and related specialties such as clinical phar-
macology and toxicology.[24]
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In 1994, the Diploma examination was transferred from the
parent Royal Colleges of Physicians of the UK to their FPM,
which had been inaugurated in 1989. The need to spearhead the
development of the Faculty evolved as a result of a transition of
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clinical pharmacologists and specialist physicians to industry and
regulatory positions. From its inception, the FPM has had a strong
association with clinical pharmacology that forms a fundamental
pillar of the Faculty, based on the premise that clinical pharmacol-
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ogy and therapeutics are crucial to the pharmaceutical business of
the discovery, development and registration of medicines.[3] The
Faculty has overarching responsibility for maintaining and raising
the standards of practice in pharmaceutical medicine and has
grown to encompass aspects of an international specialty.
Education is also a major focus of the IFAPP and in 2001 the
federation formed the Council for Education in Pharmaceutical
Medicine (CEPM). The mandate of the CEPM is to harmonise
programmes of postgraduate courses in pharmaceutical medicine
established by various universities, internationally, in collabora-
tion with the local associations of pharmaceutical physicians, as
well as the continuing medical education (CME) and continuing
professional development (CPD) programmes for this specialty.
 2007 Adis Data Information BV. All rights reserved.
Stonier et al.
Since 2003, the CEPM has accredited postgraduate courses at
universities in Barcelona, Basel, Belgrade, Brussels, Cardiff, Dub-
lin, Madrid, Mexico, Stockholm and Surrey (Guildford, UK), with
Sydney and Latin American universities in Buenos Aires and Sao
Paulo, scheduled for accreditation in 2007.
Through this major harmonisation effort, the CEPM will con-
tinue to foster the mutual recognition of diplomas in pharmaceuti-
cal medicine as well as worldwide recognition of pharmaceutical
medicine as a medical specialty.
The CEPM has recently issued Guidance Notes for the Estab-
lishment of Structured National CME/CPD Programmes for Phar-
maceutical Physicians.[25] Today, such structured programmes
only exist in Belgium, Switzerland, the Netherlands and the UK,
but it is hoped that the initiative by the CEPM will assist and
stimulate other national member associations to organise a similar
system. This will contribute to the evolution of pharmaceutical
medicine as a specific medical specialty. Furthermore, a working
group of the CEPM has developed an international computerised
training course for investigators.
Currently, ten European countries offer postgraduate educa-
tional programmes in pharmaceutical medicine (table II) with a
range of levels of accreditation from the IFAPP and other academ-
ic institutions. These programmes include a varied approach in
course delivery including distance learning, in class lectures and
interactive online learning.
Most programmes require 2 years of study with course content
delivered by lecturers from industry, academia, clinical research
organisations and regulatory authorities. Postgraduate courses in
pharmaceutical medicine are taught under the auspices of the
CEPM with a mandate to:
1. assist IFAPP’s national member associations to establish ap-
propriate educational and training programmes in pharmaceutical
medicine;
2. support the development of structured CME and CPD
programmes in pharmaceutical medicine;
3. contribute to the harmonisation of existing postgraduate
courses in pharmaceutical medicine;
4. promote the mutual recognition of equivalent educational
qualifications and CME/CPD requirements between countries;
and
5. stimulate the recognition of pharmaceutical medicine as a
distinct medical specialty.[2]
To address these objectives, the CEPM established a core
curriculum of essential lectures that allows for accreditation by
IFAPP.
Taking advantage of the acceptance and success of e-learning,
internet technologies and distance education[26] a partnership was
Int J Pharm Med 2007; 21 (4)
 2007 Adis Data Information BV. All rights reserved.

Global Status of Pharmaceutical Medicine

Table II. Postgraduate courses in pharmaceutical medicine in Europe

Country Year founded Qualification obtained Level Location Teaching time Language Accreditation
Belgium 1992 Postgraduate programme in Diploma University of Brussels, 280h for 1 or 2 English IFAPP
Pharmacology and Brussels years

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Pharmaceutical Medicine
(PHARMED)

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France 1999 European Diploma in Masters University of Lyons, Lyons 325h for 2 years English

original publisher.
Pharmaceutical Medicine
(EUDIPHARM)

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Germany 2005 Masters of Science in Masters University of Essen, Essen 450h for 2 years English/
Pharmaceutical Medicine German

Ireland 2005
is prohibited.
MSc in Pharmaceutical Masters Hibernia College, Dublin 380h for 18–24 English HETAC
Medicine months

Ireland 2004 Postgraduate Diploma/MSc in Diploma/ University of Dublin, Dublin 200h for 18 English IFAPP
Pharmaceutical Medicine, Masters months
Trinity College

Italy 2007 Masters of Science in Masters University of Rome, Rome 200h for 1 year Italian
Pharmaceutical Medicine

Serbia 2004 Postgraduate Diploma in Diploma University of Belgrade, 359h for 1 year Serbian/ IFAPP
Pharmaceutical Medicine Belgrade English

Spain 1986 Postgraduate Diploma in Diploma Universitat Autonoma de 220h for 2 years Spanish/ IFAPP
Pharmaceutical Medicine Barcelona, Barcelona Catalan

Spain 1986 University Specialist in Diploma Universidad Complutense 300h for 2 years Spanish IFAPP
Pharmaceutical Medicine de Madrid, Madrid

Sweden 2001 Course in Pharmaceutical Diploma Karolinska Institute, 350h for 2 years English IFAPP
Medicine University of Stockholm,
Stockholm

Switzerland 1991 European course in Diploma University of Basle under 169h for 2 years English IFAPP
Pharmaceutical Medicine the auspices of EUCOR;
(ECPM) European Confederation of
the Upper Rhine
Universities of Basle,
Freiburg, Strasbourg

UK 1976 Postgraduate Course in Diploma Cardiff University, Wales 200h for 2 years English IFAPP
Int J Pharm Med 2007; 21 (4)

Pharmaceutical Medicine
(DipPharmMed)

UK 1996 MSc in Pharmaceutical Masters University of Surrey, 288h for 15–18 English IFAPP
Medicine Guildford months

HETAC = Higher Education Training and Awards Council of Ireland; IFAPP = International Federation of Associations of Pharmaceutical Physicians.

259
260
formed in 2004 between Hibernia College (Dublin, Ireland) and
Pfizer Inc., with academic support from Harvard University and
the Royal College of Surgeons (Ireland) that resulted in an interna-
tional, online Masters of Science degree in Pharmaceutical
Medicine.[27] This web-based Masters programme in pharmaceuti-
cal medicine offers a standardised core curriculum as well as
training in a broad range of nontraditional disciplines including:
leadership skills, fundamentals of information technology,
eMedicine, business ethics, health economics and finance. Two
groups of 40 Pfizer employees representing 25 countries were
enrolled consecutively in 2005 and 2006. Interim results show
high metrics for academic performance and student satisfaction.
Furthermore, the programme became available to all pharmaceuti-
cal companies in 2007. This innovation in pharmaceutical
medicine education is the initial step in the integration of critical
This material is
knowledge management and performance improvement in a cost-
effective, global manner.[27]
Additionally, a novel approach has been created for pharma-
ceutical physicians and physician investigators in the form of the
the copyright of the
Certified Physician Investigator examination. Accredited by the
American APPI, this examination is offered to qualified physician
investigators (PIs) worldwide. It is a written examination that
certifies that the physician possesses a basic knowledge sufficient
original publisher.
for the safe and ethical conduct of a clinical trial in accordance
with the appropriate ethical, medical, scientific, legal and regulato-
ry standards.[28] A PI is defined as a physician who serves as a
principal investigator that monitors, supervises or designs clinical
Unauthorised copying
trials. PIs are responsible for the safe and ethical conduct of
clinical trials, including systematic experimentation designed to
evaluate pharmacokinetics, pharmacodynamics, pharmacoeco-
nomics, safety, efficacy and effectiveness of a drug, biologic,
and distribution
medical device, procedure or intervention involving human par-
ticipants.
An examination for investigators and scientific personnel for
good clinical practice exists in the UK and is accredited by the
FPM.
is prohibited.
6.1 Specialty Training for Pharmaceutical Physicians
The purpose of training in pharmaceutical medicine is to pro-
duce accredited pharmaceutical physicians who are equipped with
specialist knowledge and comprehensive skills and competencies
to practise to the highest ethical and professional standards, for the
benefit and safety of patients and the public, in the development
and maintenance of medicines.
The specialty training programme for pharmaceutical physi-
cians was introduced in the UK in November 2002. This is a
workplace-centred, competency-based, education and training
 2007 Adis Data Information BV. All rights reserved.
Stonier et al.
programme for registered doctors who have completed a period of
clinical training and secured a position in pharmaceutical medicine
within a pharmaceutical company, clinical research organisation
or drug regulatory authority. This indicative 4-year programme
comprises a specialty knowledge base, leading to the Diploma in
Pharmaceutical Medicine and six practical modules in operational
areas of pharmaceutical medicine: medicines regulation, clinical
pharmacology, statistics and data management, clinical develop-
ment, healthcare marketplace and drug safety surveillance. A
seventh, generic, module requires doctors to practise pharmaceuti-
cal medicine according to the principles and standards of ‘good
medical practice’ laid down by the General Medical Council and
in the Good Pharmaceutical Medical Practice Guidelines[29]
adopted by the FPM, and to acquire and demonstrate interpersonal
and management skills for the practice of pharmaceutical
medicine to the highest expected levels of competency and profes-
sionalism.
The training programme is conducted within a framework of
assessment of competencies, appraisal and annual review. The
outcome for success is the CCT and a place on the General
Medical Council’s specialist register – in pharmaceutical
medicine.[30]
In the UK today there are 70 specialist pharmaceutical physi-
cians who have completed specialty training and gained their
CCST/CCT. There are currently 180 physicians enrolled in the
programme in over 80 establishments approved for training.
6.2 Country Initiatives
The IFAPP has 30 national member associations (table I)
representing over 6600 pharmaceutical physicians. A major objec-
tive of IFAPP’s membership is to obtain formal recognition of
pharmaceutical medicine from the national body responsible for
granting credit to new medical specialties. To reach this objective,
several prerequisites must be fulfilled, including the existence of a
national association of pharmaceutical physicians, a specific sylla-
bus, a university teaching a postgraduate programme according to
this syllabus and awarding a Diploma or Masters in pharmaceuti-
cal medicine, a standard-setting body establishing and maintaining
standards and monitoring the educational programme, and a struc-
tured CME/CPD system.
In Japan the concept of pharmaceutical medicine is relatively
new with just over 100 physicians working in clinical develop-
ment, clinical pharmacology, pharmacovigilance, regulatory af-
fairs and marketing within the pharmaceutical industry. Since
implementation of the International Conference on Harmonisation
of Technical Requirements for Registration of Pharmaceuticals for
Human Use (ICH) guidelines in Japan in 1998, the role for
Int J Pharm Med 2007; 21 (4)
Global Status of Pharmaceutical Medicine
physicians in clinical development have been evolving.[31] The
place of pharmaceutical medicine is becoming increasingly impor-
tant as talented Japanese physicians are recruited to the pharma-
ceutical industry and the quality of clinical trials sponsored by
pharmaceutical companies is leveraged.
In Switzerland, the European Center of Pharmaceutical
Medicine (ECPM) was the first and leading university institute for
pharmaceutical medicine and drug development. In 1990, the
ECPM course was founded with 80 participants, of whom 66%
were physicians and 33% nonphysicians; the course has been
accredited by the IFAPP.[32-34]
In 1993, the University of Surrey in the UK was the first
University to offer a MSc (Masters) programme in Pharmaceutical
Medicine, which, as an academic degree, is open to all profession-
al and graduate groups in addition to pharmaceutical physicians.
This material is
In Latin America the Pharmaceutical Medicine Associations
from Argentina, Brazil and Mexico have developed various CPD
activities for their members and maintain close relationships with
the respective government authorities and academic institutions.
the copyright of the
In the US, the Drug Information Association (DIA) has taken a
lead role in providing education pertaining to methodological
knowledge required for the postgraduate education of pharmaceu-
tical medicine specialists. Ongoing courses include: design, con-
original publisher.
duct, monitoring and analysis of clinical trials, pharmacoepidemi-
ology, health economic studies, outcomes research,
pharmacokinetics, pharmacodynamics, as well as drug safety and
surveillance, regulatory, approval, marketing and legal issues. [34]
Unauthorised copying
7. Future of Pharmaceutical Medicine
Pharmaceutical medicine has grown to encompass global
and distribution
dimensions. The principles of pharmaceutical medicine, when
implemented on a global scale, will enhance the timely introduc-
tion of novel, high quality medicines to patients anywhere in the
world regardless of economic status. Change has been attributed to
is prohibited.
growing economies with the increased potential to produce and
deliver products locally; as well as an increased reach of commu-
nications and science across national and cultural borders.[35]
Additionally, unforeseen incremental development in basic phar-
maceutical research (genetics and stem cell research) has contrib-
uted to escalating development of pharmaceuticals.[35]
The pharmaceutical industry and regulatory authorities from
the European Union, US, Canada and Japan have achieved much
in the short history of harmonisation of the interpretation and
application of technical guidelines and requirements for product
registration. In Latin America, regulatory harmonisation and
standardisation has contributed to a better relationship and trans-
parency between the pharmaceutical industry and regulatory au-
 2007 Adis Data Information BV. All rights reserved.
261
thorities. Experts in pharmaceutical medicine recognise that the
next hurdle in harmonisation will be the ‘common technical docu-
ment’ to accelerate registration without sacrificing quality, safety
and efficacy.[36] Future discussions should focus on the paradigm
shift of genome-driven drug discovery and the rising pressures of
high throughput drug development as insurmountable tasks in
light of the changing face of drug development with the addition of
the biotechnology industry to the milieu.
Importantly, the need for multidisciplinary, harmonised educa-
tional programmes will address the need to strive for better
medicines in an integrated drug development environment that
demands better training and education in pharmaceutical
medicine. Specialists in pharmaceutical medicine, as global physi-
cian managers, are expected to accelerate clinical development
and the approval cycle by conducting worldwide clinical research
programmes with effective navigation of the regulatory process. In
addition to these responsibilities, there are critical challenges that
face the pharmaceutical industry over the next several years in-
cluding:
• intellectual property and patent protection;
• industry convergence and globalisation; and
• technology transformation.
Therefore to be effective in today’s employment landscape,
specialists in pharmaceutical medicine must function as global
managers.[37]
Enhanced and improved education through undergraduate,
graduate and postgraduate programmes will continue to be a
significant contributing factor to the acceleration of and improve-
ments to the drug development process by pharmaceutical
medicine specialists. Improving the profile of publications in
pharmaceutical medicine will also significantly contribute to the
development of the discipline. The expectations of pharmaceutical
medicine in emerging markets will be fulfilled with e-learning and
accreditation.
Expansion of pharmaceutical medicine throughout the world is
required with a focus on naive populations and those without ready
access to medical school facilities. The fundamentals of the disci-
pline should be included in the medical curriculum at the under-
graduate and postgraduate levels. However, the education of phar-
maceutical medicine specialists requires innovative educational
partnerships between academia and the pharmaceutical industry,
achieved through incorporation of the fundamentals of experimen-
tal and clinical pharmacology and enhanced with training
programmes including drug discovery and development, clinical
trials and regulatory matters.
As a medical specialty, pharmaceutical medicine is dependent
on the progress of medicine and therapeutics and the diverse
complexity of public health in countries worldwide. Pharmaceuti-
Int J Pharm Med 2007; 21 (4)
262
cal physicians are key to this process as they insure the protection
of patients and the respect of ethics as pharmaceutical companies
are driven by scientific and public health priorities and, most
importantly, public demand.[38] The future of pharmaceutical
medicine is dependent on the accelerated development and educa-
tion of a new generation of innovative, international, multidiscipli-
nary pharmaceutical physicians.
Acknowledgements
Dr Chris Allen (Past President, International Federation of Associations of
Pharmaceutical Physicians) and the Late Dr Louis Sherwood (Immediate Past
President, Academy of Pharmaceutical Physicians and Investigators) made
important contributions to the manuscript. The authors wish to thank Sandra
Kleinstiver for her contributions to and editorial support for this manuscript.
This material is
The opinions expressed in this article are those of the authors and do not
necessarily reflect those of the Faculty of Pharmaceutical Medicine or its
parent colleges or their policies.
The authors have no conflicts of interest relevant to the content of this
review. No sources of funding were used to assist in the preparation of this
the copyright of the
review.
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Correspondence: Professor Peter D. Stonier, Faculty of Pharmaceutical
Medicine, 1 St Andrew’s Place, Regent’s Park, London, NW1 4LB, UK.
E-mail: peterstonier@btinternet.com
Int J Pharm Med 2007; 21 (4)