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Ethical pharmaceutical promotion and communications worldwide: Codes and regulations

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The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical communication and interaction with physicians and patients. This article presents the current status of the worldwide governance of communication practices by pharmaceutical companies, concentrating on prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms and highlights significant developments, including the 2006 and 2012 revisions of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Code of Practice. Developments in international controls, largely built upon long-established rules relating to the quality of advertising material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals. This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of mechanisms governing the communication practices, such as the distribution of promotional or scientific material and interactions with healthcare stakeholders, relating to prescription-only medicines.
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R E V I E W Open Access
Ethical pharmaceutical promotion and
communications worldwide: codes and regulations
Jeffrey Francer
1
, Jose Zamarriego Izquierdo
2
,TamaraMusic
3
,KirtiNarsai
4
, Chrisoula Nikidis
5
, Heather Simmonds
6
and Paul Woods
7*
Abstract
The international pharmaceutical industry has made significant efforts towards ensuring compliant and ethical
communication and interaction with physicians and patients. This article presents the current status of the
worldwide governance of communication practices by pharmaceutical companies, concentrating on
prescription-only medicines. It analyzes legislative, regulatory, and code-based compliance control mechanisms
and highlights significant developments, including the 2006 and 2012 revisions of the International Federation
of Pharmaceutical Manufacturers and Associations(IFPMA)CodeofPractice.
Developments in international controls, largely built upon long-established rules relating to the quality of advertising
material, have contributed to clarifying the scope of acceptable company interactions with healthcare professionals.
This article aims to provide policy makers, particularly in developing countries, with an overview of the evolution of
mechanisms governing the communication practices, such as the distribution of promotional or scientific material and
interactions with healthcare stakeholders, relating to prescription-only medicines.
Keywords: Pharmaceutical industry, Self-regulation, Code compliance, Promotion of medicines
Introduction
Rational prescribing decisions should be enhanced by
the quality of interactions between healthcare providers
and the companies that research and develop medicines.
The medicines that research-based companies produce
and the scientific information they provide to physicians
are important components of quality healthcare for pa-
tients. With the ever increasing number of treatment op-
tions available to patients, healthcare providers need to
be kept up to date with the scientific advancements of
new medicines. Likewise, providing patients with infor-
mation relating to medicines may encourage healthcare
providers to explore various treatment options in order
to best match patient needs. It is important therefore
that the information provided by companies is scientific-
ally accurate and fair. Interactions between pharmaceut-
ical companies and healthcare professionals should always
be appropriate and support good patient care. With the
aim of further supporting these important goals, the global
pharmaceutical industry has made significant changes in
recent years in the worldwide controls on companies
interactions with healthcare professionals. This review
explores the mechanisms for ensuring the quality of
material supplied by international pharmaceutical man-
ufacturers, including product advertising and educa-
tional communications.
Information is often categorized as promotional,”“non-
promotional,or scientific; although the distinction be-
tween what is promotionaland non-promotionalmay
not always be clear. Promotional information, as some
regulators and codes have defined, encompasses advertis-
ing and sales material related to particular products, and
may be distributed to patients through advertising cam-
paigns or to healthcare professionals by pharmaceutical
representatives. Non-promotional material usually focuses
on the current state of understanding of certain diseases
and is not related to specific products. Scientific informa-
tion broadly includes the contributions of research and
development (R&D) firms to the exchange of scientific
information. For example, scientists from pharmaceutical
companies may present research data at scientific confer-
ences or publish works in trade- and peer-reviewed jour-
nals. It is important to emphasize, however, that the
* Correspondence: pwcompliance@btinternet.com
7
Paul Woods Compliance Ltd, Macclesfield, UK
Full list of author information is available at the end of the article
© 2014 Francer et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly credited.
Francer et al. Philosophy, Ethics, and Humanities in Medicine 2014, 9:7
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distinctions between and among these categories arguably
matters less to patient welfare than the truthfulness and
description of the scientific basis of conclusions about
medicines. It should also be noted that prescribers receive
information about medical products from a wide variety
of sources including clinical trial summaries posted by
companies on government registries as well as the medical
and scientific literature.
A range of quality control mechanisms are employed by
governments, pharmaceutical companies and industry as-
sociations to evaluate the acceptability of companiespro-
motional communications and interactions with health
professionals (Figure 1). There are systems to take action
when concerns are raised and various interest groups also
monitor and comment publicly on companiespromo-
tional activities [1].
Over the past decade, pharmaceutical advertising prac-
tices have changed significantly [2]. Laws and regulations
have also increased during this period but in many
countries the research-based pharmaceutical industry
has implemented various mechanisms to self-regulate
communication and promotional activities which en-
compass but go beyond statutory legal requirements. For
example, many pharmaceutical companies have substan-
tially expanded compliance functions to ensure that inter-
actions and communications with healthcare professionals
and patients are appropriate. Many compliance depart-
ments issue internal standards and operating procedures
that guide employeescommunications activity and em-
ployees are trained on these internal requirements on a
regular basis. The goal is to supply healthcare providers
with the threshold amount of information needed for in-
formed treatment decisions.
Companiesstandards and operating procedures relat-
ing to communications often go beyond the require-
ments imposed by laws and regulations. However, no
compliance documentation can cover all possible situa-
tions. Corporate culture is a key aspect of successful
self-regulation. When employees understand that com-
munication activities are for the benefit and welfare of
patients, the rules governing these activities are put in
context. Compliance departments can thus play a critical
role in educating and shaping a companys values and
culture.
Analyzing communication activities requires proper
identification of the parties involved. Commentary often
attributes isolated activities to the whole pharmaceutical
industry. It is critical to distinguish not only between
research-based and generic-based companies, but also
between different types of product (i.e. diagnostic kits,
medicines, or medical devices). This paper focuses ex-
clusively on the communication activities of research-
based pharmaceutical companies in relation to medi-
cines that are prescribed. National and regional differ-
ences in medical, business, and cultural attitudes should
also be acknowledged.
Current mechanisms governing pharmaceutical com-
munications comprise industry codes of practice, in-
ternal company procedures, laws, and regulations and
countries have put in place different combinations of
Figure 1 Summary of different code and regulatory mechanisms applying to international pharmaceutical companies.
Francer et al. Philosophy, Ethics, and Humanities in Medicine 2014, 9:7 Page 2 of 17
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governing mechanisms to reflect national circumstances.
Depending on the domestic circumstances, countries
may adopt policies to address legislative gaps and/or
promote self-regulatory mechanisms. The mechanisms
should encompass all sectors of the pharmaceutical in-
dustry, including domestic manufacturers and generics
producers.
This paper will focus on the international code frame-
work and describe the cascade of code provisions into
detailed national codes in developed countries. Several
nations with emerging markets (China, India, South
Africa etc.) are developing control frameworks that re-
flect and build on experience in Europe and elsewhere.
We also highlight good practice models. We hope that
this comprehensive review of current codes and regula-
tory controls will fill a gap in the literature in an area
that often generates debate and controversy. We hope
that our review will inform the debate as well as provid-
ing a sound basis for future legal and code developments
worldwide.
Analysis of the current situation
Control systems
Four general categories of control systems govern the
communications of pharmaceutical companies relating
to prescription products: industry codes of practice, in-
ternal company standards, laws and regulations (Table 1).
The aim of each mechanism is to enable high standards
without compromising effective communication from
pharmaceutical companies which benefits healthcare
providers and their patients. The effectiveness of a single
mechanism should not be determined in isolation. For
instance, when industry stakeholders create and adhere
to robust codes of practice, regulatory frameworks may
be less prominent. However, in most instances, striking
a balance among these four mechanisms is necessary to
ensure good quality, communications.
Effective control mechanisms should apply to all inter-
acting parties: pharmaceutical companies, healthcare
professionals, government officials, patient groups, and
others. Applying codes of practice, laws, and regulations
to all the parties involved provides additional safeguards
to discourage wrongdoing. For example, in Europe, if an
inappropriate payment or gift is given or offered by a
company or requested or accepted by a healthcare pro-
fessional, both parties could be penalized [3]. Similar
laws exist in the United States [4].
A significant high-level development occurred early in
2014 when the international bodies representing doctors,
pharmacists, nurses, patients and the pharmaceutical
industry issued a Consensus Frameworkfor ethical
collaboration [5]. Under the mantra put patients firstit
sets out common elements for interactions between in-
dustry and healthcare professionals. Importantly it does
not supersede the partner organisationstailored, indi-
vidual codes or guidelines but rather identifies shared
principles.
Laws and regulations
Laws and regulations that apply to communications re-
lating to prescription medicines operate at national and
state levels. For instance, European Union member
states are required to apply a baseline set of laws, but in-
dividual countries may promulgate additional laws relat-
ing to pharmaceutical communications [6]. In addition,
general business practice laws apply to pharmaceutical
companies as they do to all business sectors. In recent
years, anti-bribery and anti-corruption laws have signifi-
cantly impacted pharmaceutical companiesinteractions
with healthcare professionals. For example, the US For-
eign Corrupt Practices Act [7] or the UK Bribery Act [8]
can affect firmsactivities beyond their respective do-
mestic markets, holding companies subject to such laws
accountable for wrongdoings abroad.
Most countries have laws and regulations specific to
the advertising of medicines. The European Union has
a comprehensive set of legal requirements covering
the advertising of medicines [3], which are imple-
mented on a national basis. In the US, labeling and ad-
vertising of medicines is regulated under statute by
the US Food and Drug Administration [9]. Similarly,
in countries such as Canada [10] and Australia [11],
specific regulations govern pharmaceutical advertis-
ing. However, such regulations are found less consist-
ently in emerging markets.
The practical goal of these laws and regulations is to
deter improper activities through enforcement measures.
Generally, judicial enforcement can expose companies to
substantial financial penalties or settlements, acting as a
deterrent to similar future activities. However, court ac-
tion is often lengthy and expensive. Depending on the cir-
cumstances, litigants may opt to settle disputes outside of
court, thereby forgoing costs associated with litigation.
Furthermore, limited data are available to compare the ef-
fectiveness of judicial enforcement with self-regulated
adjudications.
Laws and regulations may also be enforced by govern-
ment regulatory bodies. Some countries, including the US
[12] and UK [13], have dedicated regulatory enforcement
units. These units can investigate possible violations and
initiate enforcement proceedings. Some regulatory adjudi-
cation can also be sought by third parties. Often, the regu-
latory enforcement process is faster than judicial action,
reducing costs associated with protracted court actions.
Even so any enforcement mechanism requires significant
investment and this may be one reason why regulatory
bodies are often not as robust in developing countries as
in developed jurisdictions.
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Table 1 Control systems for prescription medicine advertising
IFPMA affiliated industry codes
of practice
Independent local
industry codes of
practice
Professional bodiescodes of
practice
Regulatory authority
activities
Legal actions Company standards
Description National codes incorporate and
expand on the IFPMA Code
National codes,
developed
independently
International or national medical,
pharmacy, and nursing bodies
have professional behavior
codes. Employers may also have
codes of conduct
Regulatory authority
interprets and applies law
and regulations. Can
include pre-approval and
post-hoc enforcement
Possible breaches of laws and
regulation pursued through
court action
Companies have codes
of conduct and
internal compliance
and audit
organizations to
enforce them
Applicability International pharmaceutical
member companies wherever they
operate. Includes local companies
in a few countries
Local companies that
belong to the
sponsoring trade
association or have
agreed to comply with
the Code
Applied nationally by the
professional body
All sectors within the
scope of the legislation.
Applied nationally
All sectors within the scope of
the legislation. Applied
nationally
All countries where the
company does
business
Comment National codes are often detailed
and are subject to national laws
and regulations. Some countries
embrace code based actions more
readily than others
Variable in scope and
application
Professional codes may include
requirements concerning
interactions with commercial
organizations
Some regulatory
authorities are more active
than others
Actions may be brought by
government bodies or
competitor companies. Some
countries resort to legal action
more readily than others
Internal standards are
usually broader in
scope than external
codes and legislation
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The consequences for violating laws or regulations
governing pharmaceutical product communications can
vary greatly by country. Some regulatory bodies have
adopted proactive measures, such as mandatory pre-
launch reviews [14], to facilitate compliant communica-
tions of certain communications such as those on newly
approved medicines. In the event that regulatory investi-
gation leads to adjudication, settlements may sometimes
be reached.
Relying solely on laws and regulations is a reactive ap-
proach to guiding proper communication activities.
Nevertheless, robust legal and regulatory mechanisms
may be especially useful in countries that do not have
other control mechanisms (i.e. codes of practice). At
the same time, it is important to point out that pharma-
ceutical companies that are members of the Inter-
national Federation of Pharmaceutical Manufacturers
and Associations (IFPMA) apply national association
codes of practice and the IFPMA Code of Practice [15]
worldwide, in every market in which they operate, even
in the absence of legal or regulatory controls. This
means that in some countries international pharmaceut-
ical companies will be subject to codes and legislation
with cross-border reach whereas local companies may
not be routinely subject to any robust controls on their
advertising and related activities.
Industry codes of practice
A system of integrated international and national codes
of practice on advertising prescription medicines applies
to many multinational companies (Table 2). National
codes of practice, usually operated by local industry
trade associations, have been put in place in developed
countries and in many developing countries [14].
Various pharmaceutical industry codes have existed for
several decades; however, beginning in 2002, we
observed a shift in industry attitudes towards communi-
cations activity prompting regular revisions to inter-
national codes with all dependent national codes being
updated and expanded at least as frequently.
In 2002, the Pharmaceutical Research and Manufacturers
of America (PhRMA) substantially updated its national
Code. That revision required PhRMA member companies
to follow threshold guidelines relating to communication
activities between pharmaceutical companies and health-
care professionals in the United States [16]. In order to
synchronize national efforts, IFPMA revised its own code
in 2006 [17]. The IFPMA Code of Practice, which was up-
dated again in 2012, binds its members to adopt baseline
communications standards.
The practical effect of the 2006 revisions to the
IFPMA Code was the creation of a multi-tiered self-
regulatory scheme. IFPMA members, consisting of com-
panies and national trade associations, are required to
adopt the IFPMA Code. Its reach is wide: companies
that are not direct IFPMA members may be bound to
the same threshold requirements because of their rela-
tionship with IFPMA national associations. Importantly,
the IFPMA Code outlines minimum requirements.
Members are allowed, and encouraged, to promulgate
national or company codes that reflect IFPMA Code re-
quirements, national laws and regulations, healthcare sys-
tem needs, and local corporate cultures. In this manner,
individual companies may be subject to various communi-
cation requirements through different sets of obligations.
Industry codes of practice are tiered. National codes
must be consistent with the international IFPMA Code
of Practice. In Europe, national associations that are
members of the European Federation of Pharmaceutical
Industries and Associations (EFPIA) must ensure that
their codes are consistent with EFPIA Codes [18].
National association codes, in turn, require member
companies to follow complementary baseline standards
and procedures. Because each level sets minimum re-
quirements, national codes are generally more detailed
than international codes. Company standards are even
more detailed, often reflecting corporate cultures as well
as incorporating international and national codes.
Together, the different levels of codes and company
procedures, with few exceptions, include complaint-
handling mechanisms, whereby information may be sub-
mitted to companies or associations to resolve alleged
code violations. Since laws and regulations are mirrored
in codes of practice, a concern in some countries has
been that full transparency of code of practice rulings
might lead to double jeopardy(i.e. a second case con-
cerning the same matter) which in turn might inhibit
the utility of the code adjudication process. The effective
operation of codes of practice requires investment of
considerable financial and human resources by national
associations. This typically involves the employment of
full-time staff to administer the code and its implemen-
tation. In addition, independent and industry personnel
who make up the adjudication panels devote large
amounts of time to adjudicate consistently on cases that
can be highly complex.
IFPMA member companies and their agents must
comply directly with the IFPMA Code and applicable
national codes of member associations where such codes
exist. However, the global network of IFPMA-affiliated
codes of practice that apply to international pharmaceut-
ical companies does not necessarily extend to other par-
ticipants and organizations in the healthcare system
such as physicians, domestic manufacturers, and sup-
pliers of generics and medical devices. Pharmaceutical
companies are only covered by the same codes of prac-
tice and standards if they are members of the local
IFPMA-affiliated national association and thereby agree to
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Table 2 Codes of practice governing pharmaceutical companies
Country(ies) IFPMA-affiliated responsible organization IFPMA-linked national codes (further information at
www.ifpma.org) Additional laws, regulations, codes, and
guidelines usually apply in each country. In some cases
these codes also apply to companies and/or sectors not
affiliated to IFPMA
Global
All countries (Applies to international
pharmaceutical companiesactivities in
countries not listed below)
International Federation of Pharmaceutical
Manufacturers and Associations
IFPMA Code of Practice
Regional
Europe European Federation of Pharmaceutical
Industries and Associations
EFPIA Code on the Promotion of Prescription Only
Medicines to, and Interactions with, Healthcare Professionals
EFPIA Code of Practice on Relationships between the
Pharmaceutical Industry and Patient Organizations
EFPIA Code on Disclosure of Transfers of Value from
Pharmaceutical Companies to Healthcare Professionals
and Healthcare Organisations
Central America Federación Centroamericana de Laboratorios
Farmacéuticos (FEDEFARMA)
Code of Good Practices for the Promotion of Medicines
National
Argentina Cámara Argentina de Especialidades
Medicinales (CAEMe)
Código de Ética CAEMe
Australia Medicines Australia Medicines Australia Code of Conduct
Austria Association of the Austrian Pharmig code of conduct and code of procedure of the
COC committees of experts of the 1st and 2nd instance
Pharmaceutical Industry (PHARMIG)
Belarus AIPM AIPM Code of Marketing Practice in the Republic of
Belarus
Association of International Pharmaceutical
Manufacturers
Belgium Pharma.be Code of Deontology
Brazil Interfarma Código de Conduta
Canada Rx&D Code of Ethical Practices
Chile Cámara de la Industria Farmacéutica de Chile
(CIF)
Código FIIM de buenas prácticas para la promociónde los
medicamentos
China R&D-based Pharmaceutical Association in
China (RDPAC)
Code of Pharmaceutical Marketing Practices
Colombia Asociación de Laboratorios Farmacéuticos de
Investigación y Desarrollo (AFIDRO)
Código de ética
Czech Republic Asociace inovativního farmaceutického
průmyslu (International Association of
Pharmaceutical Industries)
Etický Kodex
Denmark Lägemiddelindustriforeningen (LIF) Lifs ethical rules for dialogue and negotiations with
decision-makers
Ecuador Industria Farmacéutica de Investigación e
Innovación (IFI)
Código de Ética IFI
Finland Pharma Industry Finland (PIF) PIF Code of Ethics
France Les entreprises du médicament (LEEM) Dispositions Déontologiques Professionnelles
Germany Verband Forschender Arzneimittelhersteller e.V.
(VFA) (German Association of Research-Based
Pharmaceutical Companies)
FSA Code of Conduct on the Collaboration with
Healthcare Professionals
FSA Code of Conduct on the Collaboration with Patient
Organizations
Guatemala Fedefarma: La Federación Centroamericana de
Laboratorios Farmacéuticos
Code of Good Practices for the Promotion of Medicines
Hungary MAGYOSZ Hungarian Pharmaceutical
Manufacturers Association
Code of Ethics for Pharmaceutical Communication
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Table 2 Codes of practice governing pharmaceutical companies (Continued)
India Organisation of Pharmaceutical Producers of
India (OPPI)
OPPI Code of Pharmaceutical Marketing Practices
Hong Kong Hong Kong Association of the Pharmaceutical
Industry (HKAPI)
Code of pharmaceutical marketing practices
Indonesia International Pharmaceutical Manufacturer
Group (IPMG)
IPMG code of Pharmaceutical Marketing Practices
Ireland Irish Pharmaceutical Healthcare Association
(IPHA)
Code of Marketing Practice for the Pharmaceutical
Industry
Italy FARMINDUSTRIA Associazione delle Imprese
del Farmaco
Codice deontologico Farmindustria (code of professional
conduct)
Japan Japan Pharmaceutical Manufacturers
Association (JPMA)
JPMA Promotion Code for Prescription Drugs
Korea Korean Research-based Pharmaceutical Indus-
try Association (KRPIA)
KRPIA Fair Competition Code and its working guideline
Malaysia Pharmaceutical Association of Malaysia
(PhAMA)
PhAMA Code of Conduct
Netherlands NEFARMA vereiniging innovatieve
geneesmiddelen Nederland
Code of conduct for pharmaceutical advertising
Norway Legemiddelindustriforeningen (LMI) Rules for marketing of medicinal products.
Recommended guidelines between the Norwegian
Federation of Organizations of Disabled people (FFO) and
the Norwegian association of pharmaceutical
manufacturers (LMI) for contact and cooperation
between patient organizations and the pharmaceutical
industry
Peru ALAFARPE Asociación Nacional de Laboratorios
Farmacéuticos
Código IFPMA de prácticas de marketing farmacéutico
Philippines Pharmaceutical and Healthcare Association of
the Philippines (PHAP)
PHAP Code of Pharmaceutical Marketing Practices
Portugal Associação Portuguesa da Indústria
Farmacêutica (APIFARMA)
Código Deontológico para as Práticas Promocionais da
Indústria Farmacêutica e para as Interacções com os
Profissionais de Saúde
Código de Conduta para as Relações entre a Indústria
Farmacêutica e as Associações de Doentes
Russia Association of International Pharmaceuticals
Manufacturers (AIPM)
Code of Marketing Practices of the Association of
International Pharmaceutical Manufacturers (AIPM)
Singapore Singapore Association of Pharmaceutical
Industries (SAPI)
SAPI Code of Marketing Practices
South Africa Marketing Code Authority Code of Marketing Practice for the Marketing and
promotion of medicines, medical devices and in vitro
diagnostics
Spain FARMAINDUSTRIA: The National Association of
the Pharmaceutical Industry in Spain
Spanish Code of Good Practices for the Promotion of
Medicines and Interaction with Healthcare Professionals
Spanish Code of Practice on Relationships between the
Pharmaceutical Industry and Patient Organizations
Sweden Läkemedelsindustriföreningen (LIF ) Ethical rules for the pharmaceutical industry in Sweden
Switzerland Interpharma Code of Conduct of the Pharmaceutical Industry in
Switzerland (Pharma Code)
Scienceindustries Switzerland: Business
Association Chemistry Pharma Biotech
Taiwan International Research-Based Pharmaceutical
Manufacturers Association (IRPMA)
IRPMA Code of Practices
Thailand Pharmaceutical Research and Manufacturers
Association (PReMA)
PREMA Code of Sales and Marketing Practices
Turkey Association of Research-Based Pharmaceutical
Companies (AIFD)
Code on Good Promotion Practices for Medicinal
Products to, and Interactions with, Healthcare
Professionals
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abide by the applicable code (as is the case with inter-
national pharmaceutical companies). Healthcare profes-
sionals may have their own professional codes of practice
which focus on high quality patient care. However, they are
often not focused on relationships with commercial enter-
prises and include far less guidance on healthcare profes-
sional industry relationships than is contained in the
industry codes. Domestic companies may belong to other
associations with local codes and control mechanisms, and
there are separate codes covering the advertising of medical
devices. Although all sectors will be subject to applicable
laws and regulations, these may not be detailed or diligently
applied, and may not exist at all in some countries.
Scope of activities covered by codes of practice
The codes of practice, laws, and regulations governing
the advertising and selling of prescription medicines
cover both what companies can claim about their prod-
ucts and the interactions their employees can have with
healthcare professionals, medical institutions, patient
groups, and other key stakeholders.
The main areas of coverage of international and na-
tional codes are listed below. Note that in some coun-
tries, certain requirements are covered by legislation
rather than codes.
Fundamental requirements for ethical and
professional behavior, putting patients first,
compliance with regulations etc.
Standards for interactions between companies and
healthcare professionals
Sponsorship or support for healthcare professionals
attendance at meetings and continuing medical
education
Acceptability of venues and locations for meetings
Fees for service for engagement of healthcare
professionals
Providing promotional aids, samples etc.
Hospitality limitations
Standards for promotional information accuracy,
balance, substantiation etc.
Essential information for advertisements
(e.g. prescribing information)
Prohibition of promotion of unlicensed products
and uses
Electronic communications
Interactions with patient organizations
Clinical research and transparency
Company procedures and responsibilities, including
approval and certification arrangements, staff
training
Complaints handling and enforcement arrangements
Additional coverage of these areas is provided in all
European and some other national codes:
Expanded requirements of the above areas
Prohibition of direct to consumer advertising for
prescription-only medicines
Specific requirements for representatives
Requirements for public listings of support and/or
engagement of healthcare professionals and/or
patient groups
Donations and grants
Non-interventional studies
Aspects of market research activities
Providing educational and support services e.g.
therapy review and nurse services
Additional coverage of these areas occurs in one or
more individual codes:
Expanded requirements of the above areas
Standards for non-promotional medical information
to healthcare professionals and/or patients
Non-promotional information for patients and the
public; disease awareness activities
Interactions with the media, press releases etc.
Specific requirements for websites, social media etc.
At a national level, the requirements of codes and legis-
lation usually overlap extensively. A promotional claim or
an activity that is illegal will also generally breach the local
code of practice. In many countries, the code require-
ments are broader than those in legislation and/or provide
more detail on exactly what is and is not acceptable. In
Table 2 Codes of practice governing pharmaceutical companies (Continued)
United Kingdom Association of the British Pharmaceutical
Industry (ABPI)
Code of Practice for the Pharmaceutical Industry
United States Pharmaceutical Research and Manufacturers of
America (PhRMA)
Code on Interactions with Healthcare Professionals
Principles on Conduct of Clinical Trials and
Communication of Clinical Trial Results
PhRMA Guiding Principles on Direct to Consumer
Advertisements About Prescription Medicines
PhRMA Principles on Interactions with Patient
Organizations
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other countries, notably the U.S., competition or antitrust
law may limit the ability of companies or national associa-
tions to dictate joint marketing rules [19]. Accordingly, in
such markets, marketing codes may not include formal
adjudication procedures. Rather, rules on the advertising
of pharmaceuticals are covered extensively in US laws and
regulations. In addition to the basic requirements, such as
the essential information that must be included in adver-
tisements (prescribing information etc.), rules cover the
two main areas of product claims (e.g. concerning effect-
iveness and tolerability) and interactions with healthcare
professionals (e.g. sponsorship and benefits) [20].
Product claims
The same basic rules regarding the veracity of promo-
tional claims are enshrined in most national legislation
where it is in place, in the IFPMA Code and in national
codes. These have been fundamental requirements since
the first codes (which preceded legislation) were put in
place. The first industry code governing prescribed med-
icines (i.e. those available on prescription from a quali-
fied health professional) was initiated in the UK in 1958
[21]. Refinements have occurred since then but the re-
quirement persists that promotional claims must be of
high quality and consistent with the prescribing informa-
tion approved by regulatory authorities. This latter as-
pect has prompted a high proportion of code complaint
cases, often from competing companies.
Generally speaking, the IFPMA Code of Practice and
national codes require that product claims relating to
prescription medicines be accurate, balanced, and up to
date. Material must be truthful and not misleading, in-
cluding misleading by omission and half-truths. For ex-
ample, claims must strike a balance of the available
evidence and cannot provide only half the picture.If
challenged, a company is obliged to provide data to sub-
stantiate its claims. The IFPMA Code includes the con-
cept that material must be sufficiently complete to
enable the recipient to form his or her own opinion of
the therapeutic valueof the product. Materials should
also encourage appropriate useof medicines by pre-
senting information objectively and without exagger-
ation. These and other specific requirements set a very
high standard for claims in advertisements for prescrip-
tion medicines, including comparative claims.
Direct to consumer advertising (DTCA) is prohibited
in most countries that regulate prescription medicines,
although the United States and New Zealand are major
exceptions. Although the IFPMA Code of Practice sets
global standards, it remains silent on DTCA because the
code cannot preempt national laws and regulations. At a
national level, codes of practice reflect the local legal
situation and usually detail the rules and standards for
non-promotional communications concerning prescription
medicines that companies can make direct to the public or
patients. PhRMA in the US has promulgated a set of vol-
untary standards regarding DTCA, including appropriate
risk communication and timing of certain advertising [20].
A universal and important prohibition relates to adver-
tising a medicine, or a new use of an existing medicine,
before regulatory marketing authorization is received.
Legislation and codes share similar wording on this
point; however, distinguishing promotional and non-
promotional information remains complicated. More-
over, at least one appeal court in the United States has
recognized the right of companies to provide truthful
and non-misleading information about unapproved
uses of approved drugs; this decision was based on the
companiesFirst Amendment right of expression [22].
However, different authorities have different perspec-
tives on the dividing line between promotionaland
non-promotionalinformation. Even within one coun-
try, regulatory bodies may make different decisions, as
inaUKcaseinwhichthecodedecision[23]wasstric-
ter than that of the government regulatory body [24]
with respect to the responsibility of a company for ma-
terial it sponsored. Furthermore, new communication
mechanisms have blurred the line between promotional
and non-promotional material because interactions are
no longer necessarily face to face. Nonetheless: the ex-
change of accurate and data-driven scientific informa-
tion between pharmaceutical companies and medical
practitioners and researchers should bring important
benefits to patient care.
Pharmaceutical industry interactions with healthcare
professionals
Interactions and communication between companies that
research and manufacturer medicines and the healthcare
professionals that prescribe them are important in contrib-
uting to the appropriate and effective use of prescription
medicines. These relationships are covered by pharmaceut-
ical advertising codes and legislation. Additionally, national
bribery and corruption legislation, such as the US Foreign
Corrupt Practices Act (FCPA) and the UK Bribery Act,
could have potential application to activities in any
country for many companies. Ensuring compliance with
the IFPMA Code and the affiliated national codes is
likely to help ensure compatibility with relevant sec-
tions of anti-bribery legislation. Essentially, the code re-
quirements are designed to prohibit inappropriate personal
benefit being offered to healthcare professionals and often
go beyond the requirements of anti-bribery legislation.
One issue covered by most national codes is whether
companies are able to support healthcare professional
attendance at medical conferences. While codes in many
countries deem it acceptable to sponsor attendance of
healthcare professionals at scientific meetings, and cover
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associated costs such as reasonable travel, accommoda-
tion and meals, they also include a number of caveats. In
particular, the main purpose of the meeting must be scien-
tific and professional in nature and any refreshments pro-
vided must be incidental to that purpose. The venue must
be conducive to the scientific or educational purpose, and
international travel must be justified by the international
nature of the meeting or other logistical or security reasons.
Company sponsorship of healthcare professionals to at-
tend meetings nevertheless remains a topic of debate.
Some countries (e.g. the United States and Norway) do
not permit direct sponsorship of attendance at scientific
meetings (except for medical students in the US), while
others (e.g. France) require review of the arrangements by
an independent body. Some countries have put other mea-
sures in place such as co-payment of expenses. Inter-
national companies may also impose on themselves
policies relating to sponsorship of healthcare professionals
that go beyond external rules [2]. This highlights sensitiv-
ity over the perception of companies funding attendance
at international educational meetings. However, ceasing
sponsorship could deny healthcare professionals without
access to sufficient funding the opportunity to hear and
interact with world leaders in their chosen field, unless al-
ternative funding arrangements are developed or digitally-
based specialist educational services are expanded and are
feasible in their country. This is particularly important for
healthcare professionals from developing counties, where
alternative sources of funding may not be available.
Providing low-value branded promotional aids (pens,
pads, tongue depressors, antiseptic wipes etc.) has long
been a tradition of pharmaceutical, and other, advertis-
ing. International rules still permit inexpensive promo-
tional aids, provided they are relevant to the practice of
the healthcare professional. However, there is a trend to
ban promotional aids altogether and within the past five
years the US [16] and UK [25], amongst others, have
prohibited branded promotional aids. At least one global
company has ceased their distribution worldwide [2].
The rationale for a ban is not that such promotional aids
represent a gift that will affect a healthcare professionals
prescribing or purchasing decisions but rather that such
items are not conducive to a new relationship built on
mutual professional respect. In addition, industry leaders
seek to base relationships with healthcare professionals
on sharing educational information rather than on
provision of items that could be perceived as gifts.
In most parts of the world, it is permissible to provide
samples of medicines to healthcare professionals and
such samples may improve patient care. However, the
situation varies considerably between countries accord-
ing to local factors. In a number of countries, samples
are not permitted at all, while several countriesindustry
codes restrict their number, frequency, and the period
after launch during which they can be provided [18,26].
Code of practice sanctions
Codes of practice operate on a fundamentally different
basis to legislation. They do not rely merely on the threat
of punitive fines for their effectiveness. Rather, they repre-
sent a collective commitment of member companies to
behave in a responsible manner. Deviations from the code
requirements are dealt with in a variety of ways that must
always be consistent with local laws, including anti-trust
and anti-competition provisions (Table 3).
In many countries, fines or administrative fees may be
levied and there are requirements to cease the activity
that caused the breach. However, the effectiveness of
Table 3 Summary of code of practice sanctions and provisions
a,b
[14]
Sanction or requirement Comments
Requirement to cease non-compliant activity A universal requirement. Often associated with a written undertaking not to repeat the non-
compliant or similar activities, claims etc. The company may be required to recover and destroy
offending material. Repetition may result in severe penalties.
Publication of the outcome or public reprimand Undertaken if local legal considerations allow. May consist of detailed reports or more concise
summaries. Offending company is usually identified. In some countries, serious offences may be
publicised in the medical press.
Monetary penalties The amount is usually graded according to the number and/or seriousness of the offences,
generally from thousands to hundreds of thousands of dollars.
Additional pre-screening requirements In countries where pre-screening is optional.
Requirement for a formal audit of company
procedures
This is particularly useful if a companys procedures or training may be the cause of a serious or
repeated shortcoming.
Suspension or expulsion from membership of
the local trade association
Expulsion may mean that the code regulatory system will not apply to the company and external
legal and regulatory controls will therefore take effect routinely. Suspension may mean that the
company is still required to comply with the national association code.
Issue a corrective communication This provision is particularly useful if recipients of the material may have been misled. It will be at
the expense of the company.
a
In most countries, regulatory bodies and legal court proceedings provide additional (or exceptionally the only) sanction options.
b
Not all sanctions are applied in all countries.
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sanctions is mainly based on actions that support the
voluntary commitment to good behavior, such as public
disclosure of the details of the breach, where local laws per-
mit. In circumstances where companies appear not to have
demonstrated the necessary commitment to code compli-
ance, or where the breach is particularly serious, they may
be suspended or expelled from membership of the local as-
sociation that administers the code. The self-regulation
system therefore relies on a genuine commitment by com-
panies to take the rules seriously. For international com-
panies, this commitment is reflected in their internal
control systems governing promotional activities.
Company controls
Research-based pharmaceutical companies operate inter-
nationally and have global company codes of conduct
and detailed standards that apply to many of their activ-
ities including sales and advertising. These company pol-
icies encompass the requirements of applicable national
codes, the IFPMA international code, and legal obliga-
tions. However, company compliance standards often
add another layer of detail and expand further the scope
of activities controlled. These internal codes are often
available on company websites and many can be
accessed through the IFPMA website [27].
Companies also set out approval procedures for their
communications. Prior to use, materials and activities
are approved by designated individuals who are respon-
sible for checking acceptability against all applicable
laws, regulations, and codes. In Europe and several other
countries, there must be a final approval of advertising
by a designated doctor or pharmacist. In France and
Belgium, the responsible pharmacisthas a legally con-
stituted responsibility for such approvals. In addition to
ensuring compliance with regulations and codes, the
physicians and pharmacists who certify promotional ac-
tivities also have a responsibility as healthcare profes-
sionals to patient welfare and are of course subject to
the codes of conduct of their professional bodies. Com-
pliance with rules and ethics are not always synonymous;
an activity can be legal but not ethical, or considered
ethical by many but not legal. What is ethical is open to
interpretation and the concept of appointing doctors
and pharmacists to approve company outputs reflects a
responsibility to patient welfare that goes beyond com-
pliance with written standards.
A number of pioneering initiatives in setting new stan-
dards and transparency requirements have resulted from
individual company actions. Greater transparency on
engagements with healthcare professionals has been ini-
tiated in the US and Europe by several companies.
Adoption by other companies or, indeed by the indus-
try-wide codes of practice often follows. An example of
industry-wide adoption has been the recent European
Disclosure Code relating to transfers of value from com-
panies to healthcare professionals. [18]
Complaint procedures
Healthcare professionals, or indeed anyone including
members of the public, journalists, activists, and competi-
tor companies who have concerns about pharmaceutical
advertising or activities of pharmaceutical companies, may
always raise their concerns. There are a number of avail-
able options for involving the types of codes described in
this article.
Contact the company
People with complaints or questions can approach the
local company affiliate and/or the international headquar-
ters. Company compliance departments usually welcome
concerns being brought to their attention and many run a
confidential contact ussystem often on their website.
Contacting the company can be the most rapid means of
resolving a concern. Company standards, in general, cover
a broader spectrum of activities than external codes and
regulations, and may well govern activities not subject to
specific external rules. If the company disagrees with the
complainant, the complainant may still resort to the other
methods detailed below. The complaints are usually kept
confidential and do not result in the issue becoming pub-
licly known, which means other companies cannot there-
fore learn from the case. However, for simple concerns it
can be a quick and efficient method of resolution. Inter-
company dialogue is also often the first line of approach
when one company is concerned about the activities of
another, and can lead to rapid resolution of the matter. Al-
though such dialogue is encouraged, care is needed to en-
sure compliance with competition laws.
Contact national code of practice body
Almost all codes of practice have an associated complaints
resolution process. This usually involves detailed consider-
ation of the complaint by a panel of people independent
of the company concerned, sometimes including practis-
ing healthcare professionals and/or regulatory body repre-
sentatives. In some cases, the process is overseen by
lawyers. Code adjudication processes will lead to a judg-
ment on the matter by reference to the relevant code,
which will often be broader in scope than the law and reg-
ulations. The process for adjudicating complaints varies
between countries and the details are often dependent on
local legal and regulatory constraints. Where possible
under local legislation, full transparency is encouraged by
making public details of the complaint and the company
concerned. Local codes often cover a wider spectrum of
activities than regulations and the IFPMA Code.
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Contact IFPMA
When national codes cannot be applied; for example,
when the company involved is not subject to the local
code or no IFPMA-affiliated association exists in the
country concerned, and providing the company involved
is a direct member of the IFPMA or belongs to an
IFPMA-affiliated association in at least one country, the
complaint can be processed by the IFPMA. It will be ad-
judicated under the IFPMA code operating procedure
(Article 13), assuming of course that the subject of the
complaint is within the scope of the code. The IFPMA
Code does not, however, operate as a higher authority
that could overturn a decision made under a national
code of practice process.
Although the pharmaceutical industry advocates using
the available self regulation options there may be occasions
when this is not an option for example if a local company
is not covered by the various codes (see Developing
Economies section below). Also laws and regulations
commonly duplicate requirements of the national self-
regulatory codes. The involvement of legal and govern-
ment regulatory processes therefore remains an option
if resolution through Code of Practice procedures is
not possible or appropriate.
Developing economies
Most developed nations have well-established legal sys-
tems, regulatory agencies and pharmaceutical industry
codes that provide effective control of the advertising of
prescription medicines. However, these systems may not
be available in all developing nations. The situation is
further complicated because, unlike in Europe and
North America, international pharmaceutical companies
may supply only a small proportion of prescription med-
icines in some countries. This has practical implications
because often only the international companies are
bound by the worldwide standards set out in the IFPMA
Code. As a result, the more detailed provisions in na-
tional codes, as well as the complaint resolution mecha-
nisms that may accompany those codes, leave other
sectors within the pharmaceutical industry (e.g. many
domestic manufacturers) to operate under different stan-
dards and possibly less scrutiny. International companies
do not, however, view the additional controls imposed by
their codes as a disadvantage. In fact, the opposite may be
true, with the application of ethical standards of advertis-
ing practice seen by many as a positive advantage.
A further complication in our experience relates to
culturally different attitudes to raising concerns and
complaints. Some societies do not commonly attempt to
resolve concerns through formal complaints mecha-
nisms. This could lead to a situation where clear rules
and effective control mechanisms exist but they are
under-utilized. However, despite the differences in local
controls, a broad range of standards is applied uniformly
worldwide to multinational pharmaceutical companies. In
addition, since these companies are typically active in the
US and UK, action could potentially be taken under the
US Foreign Corrupt Practices Act and/or the UK Bribery
Act if certain inappropriate interactions with healthcare
professionals in other countries were suspected.
As China, India, Latin America, and Africa have be-
come the focus of increased business activity for inter-
national pharmaceutical companies, it is important to
review significant national developments..
In China, research-based international pharmaceutical
companies represent a relatively small proportion of the
total market, although their presence is growing and sev-
eral have committed major research and manufacturing
investment there. The trade organization (RDPAC) that
represents international pharmaceutical companies in
China has a code of practice [28] closely based on the
IFPMA Code. However, legal controls dominate and the
status of the voluntary code remains uncertain. For ex-
ample, advertisements must be submitted to the Chinese
regulatory authorities for approval before being issued [29].
In India, the majority of pharmaceutical companies are
national and do not operate in other countries. There
are several thousand such companies, which are repre-
sented by national trade associations. Although these as-
sociations have codes of practice, they are not bound by
the standards and procedures set out by the international
IFPMA Code. International companies, including some
India-based companies that operate internationally, are
members of OPPI (Organization of Pharmaceutical
Producers of India) and are governed by its advertising
code [30], which is closely linked to the IFPMA Code.
Recently, there has been a welcome development
whereby a single national pharmaceutical promotion
code (Unified Code) has been proposed to harmonize
standards across pharmaceutical sectors. Modern legis-
lation governing pharmaceutical advertising is lacking
although the Drugs and Magic Remedies (Objectionable
Advertisements)Act,1955 [31], is still in force.
In South Africa, the local industry associations, includ-
ing those representing makers of medical devices, diag-
nostics, and generics, as well as prescription and over
the counter medicines, have produced a joint code [32]
in line with legal provisions in the Medicines Act. Imple-
mentation began in autumn 2011. An independent en-
forcement authority, the Marketing Code Authority, has
been established under the code, which includes detailed
enforcement procedures and the application of extensive
and stringent sanctions in cases of code breaches. The
Marketing Code Authority is fully operational and in-
cludes a certification process for industry professionals.
South Africa is a good example of the willingness of all
stakeholders to work together.
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In Mexico, collaboration between the local and inter-
national pharmaceutical industry, medical associations,
medical schools, government bodies, and others led to
the agreement in 2008 of joint mandatory transparency
guidelines. This arose out of the creation in 2005 of a
Council of Ethics and Transparency (CETIFARMA) as
well as the more restrictive standards for industry busi-
ness conduct brought about by the 2006 revision of the
IFPMA Code. The council is an autonomous and inde-
pendent body that operates mandatory codes covering
ethics and transparency, good promotional practices,
and interaction with patient organizations [33]. Compli-
ance with the code is monitored and sanctions can be
applied. There is also a voluntary award system, based
on an independent evaluation of company compliance,
whereby companies are certified for a two-year period,
after which they have to be evaluated again.
It can be concluded that several individual emerging na-
tions have made significant advances in the regulation of
the advertising of prescription medicines. The exam-
ples of unified codes covering different healthcare sec-
tors and of collaborative codes developed with
government and healthcare professional organizations
represent an approach for emulation across developing
and developed nations.
Recent developments
Industry codes relating to communication practices are
often able to be more representative of sound business
practices than laws or regulations because codes can be
proactively modified to reflect current needs and trends.
Since the first codes relating to pharmaceutical commu-
nications were adopted in the 1950s, periodic updates
have served as a mechanism for addressing the changing
national landscape as well as preventing potential inci-
dents in business practices. In recent years, code updates
have primarily related to promotional practices and in-
teractions between pharmaceutical companies and other
stakeholders. That area reflects the topics of debate and
criticism in the lay and medical literature.
2006 update to the IFPMA Code
The 2006 update to the IFPMA Code of Pharmaceutical
Marketing Practices marked a significant development in
communication practices for IFPMA member companies
and associations [34]. Overall, that revision simplified the
languageofthepreviouscodeandexpandedtherules
relating to company interactions with healthcare pro-
fessionals. In addition, it revised compliance procedures
and established a global Code Compliance Network
(CCN). Importantly, the 2006 Code reinvigorated the
efforts of member companies and associations to raise
public awareness of the self-regulatory regime many
pharmaceutical companies had adopted.
The revised sections relating to interactions with
healthcare professionals provided increased clarity on
company-sponsored events, hospitality, and gifts. Com-
pany sponsorship of international events, such as con-
gresses, conferences, and symposia, was narrowly limited
to educational or scientific purposes. In other words, in-
formation relating to pharmaceutical products at such
events was limited to providing participants with scientific
and educational information. In addition, stricter rules
were put in place relating to company-hosted events, re-
quiring them to be held at venues conducive to the scien-
tific or educational purpose of the meeting. It was made
clearer that practices such as providing event participants
with extravagant meals, trips to exotic locations for meet-
ings, theatre tickets, rounds of golf, or paying for accom-
panying guests such as spouses, were not acceptable.
Similarly, rules affecting gifts to healthcare profes-
sionals were strengthened. Personal gifts such as CDs,
DVDs, theatre or sporting tickets, or anything for the
personal benefit of a healthcare professional were expli-
citly banned. Promotional aids of minimal value and
relevant to professional practice were still allowed (e.g.
branded pens and pads), as were items of medical utility
for patient care (e.g. textbooks and anatomical models)
and inexpensive and infrequent cultural courtesy gifts
such as those given traditionally for significant religious
festivals (e.g. moon cakes). Because these new provisions
were implemented worldwide, local codes were encour-
aged to provide details of the costs and types of item
that could be offered.
Clarifying the restrictions on hospitality and gifts was
significant, but as these rules were applied globally they
were not without opposition. In some countries, particu-
larly those where personal relationships form the basis
of business relationships, healthcare professionals had be-
come accustomed to companies’“generosity.The reasons
why such benefitswere no longer available had to be ex-
plained to some healthcare professionals. Those discus-
sions helped to highlight the ethical responsibilities of
healthcare professionals and the role they play in ensuring
ethical and professional interactions. Such responsibilities
are increasingly reflected in healthcare professionalscodes
of conduct [35].
The IFPMA Code Compliance Network (CCN) estab-
lished by the 2006 revision of the IFPMA Code brings to-
gether over 100 compliance experts representing member
associations and companies. CCN members meet regu-
larly to discuss the latest developments and issues in the
field of ethical promotion of medicines. The goal is to ex-
change experiences and ensure effective code implementa-
tion at local and national levels.
Finally, the 2006 revision included a section that fur-
ther elaborated on code complaint procedures, outlining
procedural and substantive requirements for validation,
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referral, and adjudication. In addition, the section in-
cluded membersobligations in the event a complaint
was lodged about them. If they were found be in breach
of the Code, given other enumerated circumstances, a
short summary describing the complaint and the deci-
sion would be made public.
2012 update to IFPMA Code
The IFPMA Code was again expanded in 2012. A new
title, The IFPMA Code of Practice (omitting earlier refer-
ence to marketing practices), reflected the extended
scope beyond marketing activities. In particular, the
2012 revisions addressed fees for services, clinical re-
search transparency, and interactions with patient orga-
nizations. In addition, companies were required to train
employees on relevant conduct practices reflected in the
Code. Finally, the Codes comprehensiveness was im-
proved by clarifying certain articles and extending its
scope to such issues as the commissioning of advisory
boards and support for continuing medical education
(CME).
A significant addition was the listing of Guiding
Principleswhich identify the underlying principles on
which the detailed rules that follow had been based.
This was considered useful because no set of code rules
can hope to cover all situations and stating underlying
principles should help interpretation of individual cases
and when the IFPMA minimum standards are incorpo-
rated in the more detailed local codes.
Guiding principles of the 2012 IFPMA Code of
Practice:
1. The health-care and well-being of patients are the
first priority for pharmaceutical companies.
2. Pharmaceutical companies will conform to high
standards of quality, safety, and efficacy as
determined by regulatory authorities.
3. Pharmaceutical companiesinteractions with
stakeholders must at all times be ethical, appropriate,
and professional. Nothing should be offered or
provided by a company in a manner or on conditions
that would have an inappropriate influence.
4. Pharmaceutical companies are responsible for
providing accurate, balanced, and scientifically valid
data on products.
5. Promotion must be ethical, accurate, balanced, and
must not be misleading. Information in
promotional materials must support proper
assessment of the risks and benefits of the product
and its appropriate use.
6. Pharmaceutical companies will respect the privacy
and personal information of patients.
7. All clinical trials and scientific research sponsored or
supported by companies will be conducted with the
intent to develop knowledge that will benefit
patients and advance science and medicine.
Pharmaceutical companies are committed to the
transparency of industry-sponsored clinical trials in
patients.
8. Pharmaceutical companies should adhere to
applicable industry codes in both the spirit and the
letter. To achieve this, pharmaceutical companies
will ensure that all relevant personnel are
appropriately trained.
Companiesengagements with healthcare professionals
providing consulting services, such as scientific consult-
ing, market research, and advisory board participation,
were elaborated in the 2012 revision. The goal was to
ensure that contractual relationships are clearly defined
and documented.. In part, the Code requires a written
contract or agreement and a clear business need for the
services provided. Remuneration must reflect fair market
value.
Another new section (Article 9) relates to clinical re-
search and transparency. This addition to the Code re-
flects a long-standing commitment to disclose clinical
trial information in line with the joint disclosures issued
by international and national industry associations [36].
It emphasizes the industrys commitment to transpar-
ency in clinical research by including it within the
mandatory requirements of a code of practice. Similarly,
a section on company support for continuing medical
education (CME) has been added (Article 10). This sec-
tion reaffirms that the primary purpose of CME is to en-
hance medical knowledge and requires any company
contributions to content to be fair, balanced, and object-
ive. Similar provisions apply to CME events as to pro-
motional events.
Rules on companiesinteractions with patient organi-
zations, explicit in the 2012 IFPMA Code (Article 11),
are for the most part based on European standards [37].
The rules are designed to safeguard the independence of
patient organizations and ensure that support by com-
panies is appropriate. The involvement of the company
and the nature of that involvement must be clear from
the outset. Written documentation must be in place and
arrangements for meetings that companies support are
subject to similar restrictions to those that apply to
healthcare professional meetings.
Certain existing requirements were clarified in the 2012
edition. For instance, entertainment or social activities
cannot be provided or funded by companies, whereas pre-
vious versions allowed modest entertainment. The operat-
ing procedure for handling complaints was expanded, and
new standard operating procedures were added. Under
the 2012 Code, the outcome of all complaints will be pub-
lished, although no-breach complaints will not identify the
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products or company involved. This revision aims to pro-
vide stakeholders with additional guidance on acceptable
business practices. Similarly, the Questions and Answers
section has been expanded to provide more detail regard-
ing key provisions of the Code. Nevertheless, because the
vast majority of complaints are dealt with through na-
tional code procedures, the IFPMA Code complaint sys-
tem is unlikely to see a big increase in volume.
Beyond 2012
In recent years many national codes have been updated
and expanded [34], including those in Europe (EFPIA)
[18], the US (PhRMA) [16], Canada (Rx&D) [38], and
Australia (Medicines Australia) [39]. These often have a
broader scope than the IFPMA Code. Certain national
codes have taken a lead with rules or guidance in new
areas such as digital media communications [40,41].
Even so, the 2012 update of the IFPMA Code required
each national code to validate its coverage against the
expanded global baseline rules. Many already covered
the new areas but others needed revision to ensure that
national provisions reflect the IFPMA Code.
National or regional code changes do not have a direct
effect on requirements outside their jurisdiction (e.g. in
many developing countries). However, national associa-
tions share their experiences and have driven changes to
the IFPMA Code, as have updates by international
pharmaceutical companies to their internal codes of con-
duct, standards, and procedures [42]. These globally oper-
ating companies have had to make decisions about what
they will commit to worldwide, which may go beyond the
already high standards set out in the IFPMA Code and
other national codes and regulations. Another important
way of evolving requirements is through individual com-
panies taking a lead in particular areas.
The 2014 Consensus Framework for Ethical Collabor-
ation between PatientsOrganisations, Healthcare
Professionals and the Pharmaceutical Industry[5]
which the international pharmaceutical industry sup-
ported alongside the international representative bodies
for doctors, pharmacists, nurses and patients brings to-
gether in one document shared principles which can
serve as a valuable model for similar initiatives at the na-
tional level.
Conclusions
The attention and resources devoted to regulatory com-
pliance regarding communication about prescription
only medicines is probably at an all-time high. However,
no set of rules is beyond improvement and changes in
health systems, as well as advances in communication
technology, will mean that codes, regulations, and laws
will continue to evolve if they are to support optimal use
of medicines to benefit patients.
Continuing experience with the operation of existing
codes will help inform future developments particularly
in rapidly developing countries where international
pharmaceutical company activities are expanding yet
local manufacturers may not be subject to established
codes of practice. Future developments in these coun-
tries should strive for international harmonization embra-
cing all healthcare sectors but also take into account
national differences. and simultaneously encourage broader
participation and endorsement of codes across the industry
operating in these countries.
The IFPMA Code was extensively revised in 2006 and
again in 2012 It is now well-established as an inter-
national model for effective local codes. Continued as-
sessment of of national industry codes of practice is is
appropriate to ensure that companies continue to meet
the needs of patients and prescribers. Additionally indi-
vidual companies will continue to pioneer additional
standards, approaches, and initiatives. Areas that are be-
ing addressed at national and company level include a
focus on increased transparency of the relationships be-
tween companies and both individual healthcare profes-
sionals and healthcare organizations. Low cost promotional
aids are being increasingly restricted or banned altogether
by companies and national or regional codes.
Lawsandregulationsmaychangemoreslowly,but,
in countries where there are perceived gaps, we can ex-
pect clarification in the form of new regulations and
guidance.
Thepharmaceuticalindustrymustcontinuetoserveasa
trusted partner in healthcare provision. Industry codes of
practice can form the foundation for governing companies
interactions and communications and therefore play an im-
portant part in the relationship between companies and
other stakeholders in healthcare provision. Laws and regu-
lations will remain important and legal action will be ap-
plied when needed. Nevertheless it will be important to
avoid a box-tickingapproach where the only question is
Is it legal to do that?butrathertoalsoencompassa
code-based evaluation that goes beyond legal requirements.
International companies have established global in-
ternal standards but they represent only a small share in
the healthcare market in many developing countries,
and it would be appropriate for unified self-regulatory
codes to cover all sectors of the pharmaceutical market.
We have already seen such developments in Mexico and
South Africa, and such a model has also been proposed
in India. A model of cooperation between industry codes
and legislation already works well in some countries,
particularly in Europe and Australia. Such a model could
be equally successful in developing nations.
Abbreviations
CCN: Code Compliance Network (a committee of IFPMA);
CETIFARMA: Council of Ethics and Transparency (Mexico); CME: Continuing
Francer et al. Philosophy, Ethics, and Humanities in Medicine 2014, 9:7 Page 15 of 17
http://www.peh-med.com/content/9/1/7
Medical Education; DTCA: Direct to Consumer Advertising; EFPIA: European
Federation of Pharmaceutical Industries & Associations; FCPA: Foreign
Corrupt Practices Act (USA); IFPMA: International Federation of
Pharmaceutical Manufacturers and Associations; MCA: Marketing Code
Authority (South Africa); OPPI: Organization of Pharmaceutical Producers of
India; PhRMA: Pharmaceutical Research and Manufacturers of America (USA);
RDPAC: Research & Development-based Pharmaceutical Association Committee
(China); R&D: Research and Development; Rx&D: Canadas Research-Based
Pharmaceutical Companies.
Competing interests
The authors are each employed by companies or organizations related to
the pharmaceutical industry and IFPMA. IFPMA member companies research,
develop, manufacture and supply biopharmaceutical products and vaccines
globally. IFPMA member associations represent the pharmaceutical industry
at a national level. As employees in the pharmaceutical industry some
authors may have other financial interests in pharmaceutical companies.
Authorscontribution
This publication is the product of extensive collaboration between the
members of IFPMAs Code Compliance Network (CCN). All authors
contributed content and ideas to the manuscript which was based on an
initial draft by PW. All authors read and approved the final manuscript.
Authorsinformation
HS, CN, KN, TM, JZI, JF and PW are current or past members of the Code
Compliance Network of the International Federation of Pharmaceutical
Manufacturers and Associations (IFPMA CCN) 15 Chemin Louis-Dunant, PO
Box 195, 1211 Geneva 20, Switzerland.
Acknowledgements
Ernest Kawkas editorial contributions are warmly welcomed.
Author details
1
Pharmaceutical Research and Manufacturers of America (PhRMA),
Washington DC, USA.
2
The National Association of the Pharmaceutical
Industry in Spain (Farmaindustria) Code Surveillance Unit, Madrid, Spain.
3
International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA), 15 Chemin Louis-Dunant, PO Box 195, 1211 Geneva, Switzerland.
4
Formally: Pharmaceutical Industry Association of South Africa (PIASA),
Johannesburg, South Africa.
5
Canadas Research-Based Pharmaceutical
Companies (Rx&D Canada), Ottawa, Canada.
6
The Association of the British
Pharmaceutical Industry (ABPI) Prescription Medicines Code of Practice
Authority (PMCPA), London, UK.
7
Paul Woods Compliance Ltd, Macclesfield, UK.
Received: 2 July 2013 Accepted: 9 March 2014
Published: 29 March 2014
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doi:10.1186/1747-5341-9-7
Cite this article as: Francer et al.:Ethical pharmaceutical promotion and
communications worldwide: codes and regulations. Philosophy, Ethics, and
Humanities in Medicine 2014 9:7.
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Francer et al. Philosophy, Ethics, and Humanities in Medicine 2014, 9:7 Page 17 of 17
http://www.peh-med.com/content/9/1/7
... With the ever-increasing advancements of treatment options available, healthcare providers need to be kept up to date with the scientific advancements of new medicines. 1 Drug promotion refers to all the informational and persuasive activities by manufacturers and distributors, eventually leading to encourage the supply, purchase, and/ or use of particular medications. 2 Drug promotion has been advocated so that healthcare providers have access to information they need about medications and that medications are prescribed and used for the welfare and benefit of patients. ...
... 4 Modes of pharmaceutical advertising had also changed significantly from traditional promotional methods to the newest modes of marketing schemes over the years. 1,[5][6][7] Laws and regulations governing these activities have also increased during this period, though in many countries the research-based pharmaceutical industry has employed various mechanisms to self-regulate communication and promotional activities which encompass but go beyond statutory legal requirements. 8 Nearly all developed and many of the developing countries' national industry organizations have codes of marketing practice or ethics. 1 However, stringent regulations and fines when a breach of codes is evident are necessary as evidence showed that those codes of marketing/ advertisement are not usually enough to prevent malpractices. ...
... 8 Nearly all developed and many of the developing countries' national industry organizations have codes of marketing practice or ethics. 1 However, stringent regulations and fines when a breach of codes is evident are necessary as evidence showed that those codes of marketing/ advertisement are not usually enough to prevent malpractices. 8 Nonetheless, despite the importance of improving regulatory arrangements in an attempt to ensure unbiased medicines information, such efforts alone were also found to be insufficient because simply improving oversight and increasing penalties fail to address additional layers of industry bias. 9 Pharmaceutical promotion may serve as a key communication channel for continuing Health Care Professional's (HCPs) education regarding pharmaceutical products and for exposing consumers to medical information. ...
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... DPA is an important component of interaction between practitioners and the companies and it should always be appropriate and support good patient care. [11] This current study was an attempt to analyse DPAs from various pharmaceutical companies and in this study, we found that none of the drug companies followed the WHO established ethical criteria in promoting their drug products via advertisement brochures. This finding is similar to many studies such as by Hailu HG et al., [8] Mali SN et al., [9] Ganashree P et al., [12] and Jha N et al. [13] The finding that most of the DPAs highlighted the information regarding the name(s) and content of the active ingredient(s) and their therapeutic uses are similar to another study by Al-aqeel SA et al. [14] The information regarding the side-effects, major adverse drug reactions, precautions, contraindications, warnings, and major interaction was provided only in 3.6% of DPAs. ...
... This finding is similar to another study by Jadav SS et al. [19] Only a few of all DPAs contained information regarding the references to support their claims which is similar to studies by Charan J et al. [20] and Islam MS et al. [21] A system of integrated international and national codes of practice on promoting their drug products via advertisement applies to many multinational companies. Pharmaceutical Marketing Practices [11] and it seems that companies have paucity in codebased compliance. ...
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... Until as recently as 2014, US pharmaceutical regulatory language describing the distinction between promotional, nonpromotional and scientific information led companies to believe that they should not have contact with patients, so doctors were considered the marketing audience for over half a century: 71% of US oncologists surveyed in 2019 by Cardinal Health Specialty Solutions agreed that pharmaceutical sales reps play an important role in their new-product education [1,2]. Cancer happens to an individual person, not populations of people, but generalizations from population-based research have been used to treat individual patients for many years. ...
... It has developed codes of ethics for improving compliance of pharmaceutical marketing but they have proved to be ineffective due to poor enforcement issues. However, the regulatory bodies of developed countries are working vigorously to ensure ethical communication with healthcare professionals to facilitate the patients' wellbeing (Francer et al., 2014). It is worth mentioning that ethical and moral interactions with physicians not only promote compliance of industry but also guarantees sustainable business. ...
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... It has developed codes of ethics for improving compliance of pharmaceutical marketing but they have proved to be ineffective due to poor enforcement issues. However, the regulatory bodies of developed countries are working vigorously to ensure ethical communication with healthcare professionals to facilitate the patients' wellbeing (Francer et al., 2014). It is worth mentioning that ethical and moral interactions with physicians not only promote compliance of industry but also guarantees sustainable business. ...
... However, marketing safeguards the interests of shareholders and is a push behind the very community. There is a wide range of literature that criticises the questionable behaviours of both marketers and healthcare professionals (Francer et al., 2014). Nevertheless, both are the primary stakeholders and have the privilege to enjoy many benefits of this position. ...
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This study aspires to scientifically understand the influence of pharmaceutical marketing on the prescribing patterns of healthcare professionals in Pakistan and their ethical considerations. The discipline of marketing is a principal tool used by the industry to induce prescriptions from physicians and significantly affects the purchase, dispense and use of drugs. This abuse of drugs is responsible for the arousal of “superbugs” where the microorganisms are immune to antibiotics and the subsequent “antibiotic apocalypse” is an emerging threat. If not prevented, it may cost up to a million deaths and $100 trillion lost to the world economy per year which will be a colossal loss. Notwithstanding this necessity, there is little research on this issue from the vantage of marketing ethics. This paper fills the knowledge gap. The population is comprised of physicians, pharmacists, sales managers, and relevant statutory body’ employees and from whom in-depth interviews were conducted to collect data. Grounded theory is applied as a method of inquiry to produce contextually robust comprehension. The data analysis through a proper coding process revealed that unethical behaviours of the industry are the principal reasons for deceptive marketing practices and compel physicians to accept gifts and other cash from marketers and generate prescriptions not on robust scientific evidences but on a commercial basis. Consequently, the misuse, overuse, or even abuses of drugs are evidently common in Pakistan which has manifested in the form of antimicrobial resistance. The contemporary grim situation can be overhauled if the key stakeholders, particularly industry and physicians behave ethically and comply with codes of conduct developed by international and local bodies.
The development of controls on the promotion of prescription medicines
  • D Massam
Massam D: The development of controls on the promotion of prescription medicines. ESRA Rapporteur 1999.
ABPI code of practice for the pharmaceutical industry 2011
  • Clause 18. Association of the British Pharmaceutical Industry
RDPAC code of practice on the promotion of pharmaceutical products
  • China Association of Enterprises with Foreign Investment, R&D-Based Pharmaceutical Association Committee
Codes of the pharmaceutical industry established in Mexico
  • Consejo de Ética y Transparencia de la Industria Farmacéutica (CETIFARMA)
Responsibility reports and resources
  • See, for example, GlaxoSmithKline
OPPI code of pharmaceutical practices 2012
  • Organisation of Pharmaceutical Producers of India
The Office of Prescription Drug Promotion (OPDP)
  • Us Food
  • Drug Administration
US Food and Drug Administration: The Office of Prescription Drug Promotion (OPDP). [http://www.fda.gov/AboutFDA/CentersOffices/ OfficeofMedicalProductsandTobacco/CDER/ucm090142.htm]
Guiding Principles on Direct to Consumer Advertising about Prescription Medicines
  • Phrma
  • D Brennan
PhRMA, Guiding Principles on Direct to Consumer Advertising about Prescription Medicines. 2009. http://phrma.org/sites/default/files/pdf/ phrmaguidingprinciplesdec08final.pdf.