Thesis_Rowena Final Version

The EFPIA Disclosure Code on Transfers of Value from
Pharmaceutical Companies to Healthcare Professionals and
Healthcare Organisations: Awareness and Attitude of Irish
Doctors
A Dissertation
By
Rowena Hughes MB BCh BAO, PGDip Health Econ
Department of Pharmacology and Therapeutics,
University of Dublin, Trinity College
Submitted in partial fulfilment of the requirements
for the degree of
Master of Science, Pharmaceutical Medicine.
August 2016

Declaration
This dissertation has not been submitted as an exercise for any other degree at this or
any other university. It is entirely my own work and I agree that the Library may lend
or copy the dissertation upon request. This permission covers only single copies made
for study purposes, subject to normal conditions of acknowledgement.
Rowena Hughes
August 2016, Dublin
ii

Summary
Past transgressions mean that the working relationship between the pharmaceutical
industry and healthcare professionals (HCPs) or healthcare organisations (HCOs) is
under close public scrutiny. There have been several efforts to increase transparency
in order to reassure patients that treatment decisions are not adversely influenced by
this relationship. The latest is the EFPIA Disclosure Code on Transfers of Value from
Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations.
This code was established by the European Federation of Pharmaceutical Industries
and Associations (EFPIA) in 2013.
This EFPIA Disclosure Code requires all pharmaceutical companies that are members
of EFPIA to disclose transfers of value made to HCPs and HCOs. Transfers of value
for research and development, donations and grants, consultancy fees, registration
fees, travel and accommodation costs to attend congresses must be disclosed. The first
publication of transfer of value data (financial transactions) occurred on the 30th
of
June 2016.
The key objectives of this research were to ascertain Irish doctors’ awareness and
attitudes towards the EFPIA Disclosure Code during the final month before first ever
public disclosure.
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An anonymous online survey of all the specialist doctors with email addresses in the
Irish Medical Directory 2015-2016 was undertaken in the beginning of May 2016.
Participants were given 30 days to complete the survey following an initial email. Out
of the 1,111 potential participants who were contacted, a total of 169 (16%)
responded to the survey.
The results suggested that there had been an increase in awareness and likelihood to
disclose on an individual basis compared to an earlier survey performed by the Irish
Pharmaceutical Healthcare Association (IPHA) in 2014. The increase in likelihood to
disclose on an individual basis found in this research was closely mirrored by the
percentage individually consenting on the day of disclosure, 30th
June 2016. Most
doctors completing the survey claimed to have received no education about the
Disclosure Code and didn’t know about consent requirements. The majority of
doctors perceived that disclosure would have no effect on the level of their
interactions with the pharmaceutical industry. Although they supported transparency,
some doctors had concerns about how the public might interpret the information.
In conclusion, the results show an overall welcoming but cautious view of the
Disclosure Code. This research uncovered a need for more education of HCPs about
the provisions of the new code. Further research is needed to determine how
awareness and attitudes of Irish doctors to the Disclosure Code and other transparency
measures unfold over time.
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Acknowledgements
I wish to express my gratitude to my supervisor, Dr. Anne Marie Liddy of the
Department of Pharmacology and Therapeutics, Trinity Centre for Health Sciences
who provided guidance, counselling, and patience throughout. I found her advice and
calm support invaluable.
I would like to thank all the specialist doctors who responded to the survey as without
your input there would be no dissertation.
Thank you to Dr. Mary Teeling, Dr. Mary Jo MacAvin and the Masters classmates for
your moral support and friendship.
Lastly, I would like to acknowledge Rebecca and Ryan, my two children for their
consideration and patience while I was researching and writing this thesis. Thank you,
both.
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Table of Contents
Declaration………………………………………………………………………….…ii
Summary…………………………………………………………………………...…iii
Acknowledgements……………………………………………………………………v
Table of Contents………………………………………………………...………...…vi
List of
Abbreviations………………………………………………………………….ix
List of Tables……………………………………………………………………..…....x
List of Figures…………………………………………………………………..….....xi
Chapter 1. Introduction and Background………………………………………1
1.1 A brief history of the pharmaceutical industry……………………………….2
1.2 Pharmaceutical trade associations………………………………………....…9
1.2.1 EFPIA………………………………………………………………….12
1.2.2 IPHA……………………………………………………………………12
1.3 Regulation of the pharmaceutical industry…………………………………13
1.4 The industry relationship………………………………………….………..16
1.5 Reputational damage and mistrust………………………………………….26
1.6 Rebuilding integrity and trust……………………………………………....35
1.6.1 The IFPMA Code…………………………………………………….…35
1.6.2 The EPFIA HCP Code…………………………………………….…….38
1.6.3 Patientcentricity………………………………………………………...45
1.6.4 Value and pricing……………………………………………………….46
1.6.5 Clinical trial data……………………………………………………..…47
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1.6.6 Corporate culture and corporate social responsibility……………….…47
1.7 The EFPIA Disclosure Code……………………………………………..…49
1.7.1 The introduction of a Disclosure Code……………….……………...…49
1.7.2 Definition of the terms used in the Disclosure Code………………......51
1.7.3 Reporting categories in the Disclosure Code……………………….….52
1.7.4 Individual and aggregate disclosure…………………..………………..52
1.7.5 Application of the Disclosure Code in Ireland………………………....53
1.7.6 Communications and education about the Disclosure Code…………...56
1.7.7 Publication of disclosure data……………………………………….….58
1.8 The transparency movement - a global phenomenon……………….……....59
1.9 ‘The Sunshine Act’…………………………………………………………..61
1.10 Literature search for similar surveys……………………………………..…61
1.11 Rationale for study………………………………………………………….65
Chapter 2. Methodology……………………………………………………..….67
2.1 Ethical approval……………………………………………………….……68
2.2 Study design…………………………………………………………...……68
2.3 Study demographics and sample size……………………………………….69
2.4 Piloting of questionnaire and information leaflet………………………..….70
2.5 Questionnaire design…………………………………………………….….70
2.6 Data collection……………………………………………………………....73
2.7 Analysis of data……………………………………………………………..74
Chapter 3. Results and Findings………………………………………………..75
3.1 Response rate…………………………………………………………….….76
3.2 Section 1: Demographic information……………………………………….77
3.2.1 Question 1…………………………………………………………..…..77
3.2.2 Question 2………………………………………………………...…….78
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3.3 Section 2: Awareness of Disclosure Code…………………………...……..80
3.3.1 Question 3…………………………………………………...………….80
3.3.2 Question 4………………………………………………………...……83
3.3.3 Question 5………………………………………………………..…….84
3.3.4 Question 6…………………………………………………………...…85
3.4 Section 3: Attitude towards the Disclosure Code…………………………..88
3.4.1 Question 7……………………………………………………………...88
3.4.2 Question 8……………………………………………………..……….90
3.4.3 Question 9………………………………………………………….......91
3.4.4 Question 10………………………………………………………..…...92
3.4.5 Question 11……………………………………………………...…..…94
Chapter 4. Discussion and Analysis……………………………………...…......95
4.1 Analysis of Section 1: Demographic information…………………...….….96
4.2 Analysis of Section 2: Awareness…………………………………….…....99
4.3 Analysis of Section 3: Attitudes………………………………………..…101
4.4 A critique of the research methodology and study limitations………….…104
Chapter 5. Conclusion…………………………………………………………108
References……………………………………………………………………….…112
Appendix I Ethics approval letter…………………………………………....…
131
Appendix II Questionnaire………………………………………….…………..132
Appendix III Participant information leaflet…………………………………….136
Appendix IV Reminder email……………………………………………...……137
Appendix V Search terms………………………………………………………138
Appendix VI Additional comments from Question 11……………………….…139
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List of Abbreviations
ABPI Association of the British Pharmaceutical Industry
CPD Continuing Professional Development
CME Continuing Medical Education
EFPIA European Federation of Pharmaceutical Industries’
Associations
GP General Practitioner
HCO Healthcare Organisation
HCP Healthcare Professional
IFPMA International Federation of Pharmaceutical
Manufacturers and Associations
IMD Irish Medical Directory
IPHA Irish Pharmaceutical Healthcare Association
KOL Key Opinion Leader
R&D Research and Development
PhRMA Pharmaceutical Research and Manufacturers of
America
ToV Transfers of Value
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List of Tables
Table 1-1 Public expenditure on health, 1913-94. (Percent GDP)………………...4
Table 3-1 Specialty disposition of respondents………………………………......79
Table 3-2 Specialties with the highest rates of awareness……………………..…81
Table 3-3 Specialties with highest rates of agreement for disclosure………….…89
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List of Figures
Figure 1-1 Attrition rates during drug development projects…………………...….7
Figure 1-2 Template for Disclosure of Transfers of Value……………………….55
Figure 3-1 Number of years in practice………………………………………..…77
Figure 3-2 Awareness of the Disclosure Code…………………………………....80
Figure 3-3 Awareness versus number of years in practice……………………..…82
Figure 3-4 Length of time aware of the Disclosure Code…………………..…….83
Figure 3-5 Types of education about the Disclosure Code…………………….....84
Figure 3-6 Are you aware that your Consent is needed…………………………..85
Figure 3-7 Comparison based on type of education…………………………...….86
Figure 3-8 Comparison based on years in practice…………………………….…87
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Figure 3-9 Opinions about individual disclosure………………………...……….88
Figure 3-10 Level of educational support from pharma………………….....……..90
Figure 3-11 Effect of disclosure on likelihood to request support………..………..91
Figure 3-12 Effect of disclosure on participation in paid consultancies………..….92
Figure 3-13 Participation in paid consultancies – Subgroup (c), Q.9……...………93
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Chapter 1 Introduction and Background
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Chapter 1 Introduction and Background
This research investigates awareness and attitudes of Irish hospital specialists
regarding the EFPIA Disclosure Code during the month before the first ever
publication of transfers of value (ToV). The Disclosure Code is relatively new, but the
events leading to its instigation span many decades. This introductory chapter will
contextualise the research by outlining the background in which transparency codes
such as the EFPIA code have arisen and examines the literature on transparency in the
pharmaceutical industry.
1.1 A brief history of the pharmaceutical industry
The development of medicines is as old as humankind itself, with the earliest known
written record of medical concoctions, the Ebers papyrus dating back to around 1550
BC.1
It was not until the mid-19th
century though that our knowledge of chemistry
and biology was advanced enough to manufacture synthetic chemicals with medicinal
qualities.2
At this time, some of the traditional apothecary businesses moved into
large scale production, the first being Merck in 1827.3
Simultaneously, many
chemical dyestuffs manufacturers such as Bayer, Sandoz and Geigy began plying
their knowledge of chemistry to pharmaceuticals.4
Post World War II: the ‘Golden Age of Pharma'
It is often remarked that ‘war is the mother of invention’ and thus the next major
phase of development in the pharmaceutical industry occurred during the two world
wars. War provided the stimulus for improving manufacturing capabilities and
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research to produce new anti-infectives, analgesics, and performance-enhancing
drugs. It was observed that the war-time invention of mustard gas could destroy bone
marrow and lymphatic tissue and this led to the development of the first
chemotherapies.5
In the aftermath of the world wars, radical decisions were taken in many countries
around the world to change the way healthcare was delivered. The prime example of
this type of policy change was the National Health Service Act of 1946,6
which
provided every citizen in the United Kingdom with universal healthcare coverage
from a central government budget. Thus, began a time of economic expansion for the
industry, because for the first time there was structured, collective funding for
pharmaceuticals at a national level. In the pre-war era, patients paid for prescriptions
out of their own pocket, which meant cost–benefit decisions about treatments
happened at the individual doctor–patient level. The introduction of welfare state
politics changed the ‘agency’ relationship between doctor and patient. It was no
longer just the patient as the principal delegating decisions about health to their
Agent, the doctor, as now there was also a third party in the agency relationship,
which was the government health service as financial provider.7
This new tripartite agency arrangement gave rise to a complicated trilogy of decision
making in which the ‘one who decides neither pays nor consumes, the one who pays
neither decides nor consumes, and the one who consumes neither decides nor pays’.8
The imperfect agency arrangement, together with a steady flow of therapeutic
innovations, public funding, a growing population and higher patient expectations
combined to ensure that the second half of the 20th
century was a period of burgeoning
growth for the pharmaceutical industry.
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Table 1-1 illustrates how healthcare spending relative to gross domestic product,
(GDP) grew during the 20th
century, in most cases doubling between 1960 and 1994.9
Table 1-1 Public expenditure on health, 1913 – 94. (Percent GDP)
Adapted from Public spending in the 20th
century: a global perspective, (p. 38). By
Tanzi V. and Schnuknecht L, 2000, Cambridge: Cambridge University Press.
Copyright (2000) by Vito Tanzi, Ludger Schnuknecht.
In tandem with these favourable economic developments was a remarkably fertile
playing field for drug discovery. The prevailing research style in the chemistry-
driven postwar era was to synthesise and test a large number of chemicals in a
laborious trial and error manner in the hope that there would be a desirable biological
response to one of these compounds. In spite of this unproductive approach several
broad-spectrum antibiotics, corticosteroids, beta blockers, diuretics, anti-depressants
and the first oral contraceptives were discovered in the first few decades after World
War II.10
The pharmaceutical industry was revered for bringing therapeutic
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About 1910 About 1930 1960 1980 1994
Australia 0.4 0.6 2.4 4.7 5.8
Austria … 0.2 3.1 4.5 6.2
Belgium 0.2 0.1 2.1 5.1 7.2
France 0.3 0.3 2.5 6.1 7.6
Germany 0.5 0.7 3.2 6.5 7.0
Ireland … 0.6 3.0 8.4 6.0
Italy … … 3.0 6.0 5.9
Japan 0.1 0.1 1.8 4.6 5.5
Netherlands … … 1.3 6.5 6.9
Norway 0.4 0.6 2.6 6.5 6.9
Spain … … 0.9 … 5.8
Sweden 0.3 0.9 3.4 8.8 6.4
Switzerland … 0.3 2.0 5.4 6.9
United Kingdom 0.3 0.6 3.3 5.2 5.8
United States 0.3 0.3 1.3 4.1 6.3
Total Average 0.3 0.4 2.4 5.8 6.4

innovations, which caused significant improvements in both quality of life and
longevity. According to Fuchs, as cited in Lichtenberg, ‘since World War
II[…]biomedical innovations (new drugs, devices, and procedures) have been the
primary source of increases in longevity’. 11 (p2)
Up to the mid-1980s, drug discovery had been chemistry-driven rather than target-
driven. Then, during the 1990s high throughput screening (HTS) came into vogue.
This entailed screening tens of thousands of compounds a day to understand their
affinity of binding and functional effect on the target protein to find a lead
compound.12
Gefitinib, erlotinib, and sorafenib are examples of cancer drugs that
were HTS hits.13
Another major scientific advance was the discovery of recombinant
DNA technology in 1973, from which emerged the biotechnology industry. The
biotechs were usually founded by academic scientists partnering with venture
capitalists as in the example of Genentech, which was established in 1976.14
Despite progress in science and technology, the tide was beginning to turn for the
pharmaceutical industry. Research and development (R&D) were becoming less
productive regarding the number of approved compounds generated, regulatory
agencies were increasing their requirements, governments were introducing stricter
cost containment measures, and many blockbusters were facing the ‘patent cliff’.
Large pharmaceutical companies started to scout for biotechs with promising
products, because generic competition was slashing revenues on their flagship drugs.
Mergers and acquisitions, licensing deals, takeovers and asset swaps became the norm
for the industry with Pfizer being a notable example: Pfizer bought Warner-Lambert
in 1999, Pharmacia in 2002, Wyeth in 2009, Hospira in 2015 and attempted an
Allergan acquisition in 2016.15
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An industry that is changing rapidly in the 21st
century
The pharmaceutical industry is constantly evolving, but arguably more changes have
been foisted on it during the last two decades than ever before. The ‘blockbuster’
business model behind ‘Big Pharma’s’ healthy profits is almost obsolete. The
common illnesses already have multiple pharmaceuticals on the market, and many of
these mass-market drugs are now off-patent. The majority of new drugs entering the
market are either ‘me-too drugs’, medicines for rare diseases (orphan drugs) or drugs
to be used in combination (add-on drugs) with other established medicines for an
incremental benefit. The number of genuinely innovative products launching has
declined.16
Over recent years, the global pharmaceutical industry has been continuously
challenged by government policies seeking pricing reform due to the economic
downturn in 2008 and rising demands from aging populations.17
New drugs must go
through complex health economic evaluations before they get reimbursement
approval. Notwithstanding this, there is some evidence to suggest that further
confidential discounts and rebates are commonplace. In her survey of public authority
staff, Vogler found that secret price cuts were given by pharmaceutical manufacturers
to public payers in 25 out of the 31 European countries she studied.18
Therefore, profit
margins are vastly reduced in comparison to before.
Meanwhile, the cost of developing drugs has increased considerably.19
Di Masi’s most
recent survey collected data on the R&D costs for 106 randomly selected drugs,
xviii

which were approved during the 2000s and early 2010s and found that the average
out-of-pocket cost per approved compound was $1,395 million.20
The increasing cost
is due to many factors, including but not limited to stricter regulatory requirements,
expensive research technology, and higher attrition rates. Figure 1-1 shows the growth
in the attrition rate during all phases of development from 1990 to 2004.21, (p.430)
Thus, the pharmaceutical industry finds itself in an unpredictable, stochastic
environment and is pondering its business strategy. Some companies are deciding to
keep with the old business model of developing and selling branded innovative
pharmaceuticals, surmising that the current situation is just a temporary blip due to
global recession. Other companies are diversifying into generics, biosimilars,
consumer health, diagnostics, vaccines, nutrition or services as well of or instead of
branded drugs.
Between the end of World War II until the 1980s the predominant business model
was research and development, manufacturing and marketing all taking place within
xix
Figure 1-1 Attrition rates during drug development projects
Reprinted from The productivity crisis in pharmaceutical R & D (p. 430). By Pammolli
F, Magazzini L and Riccaboni M. 2011;10(6),p.430. Macmillan Publishers Ltd.

one integrated structure.10
Nowadays, large pharmaceutical companies are much more
likely to collaborate with academic institutions and development-stage companies to
broaden the portfolio of R&D activities and increase the chance of successful hits.22
Pharmaceutical companies are also more likely to outsource their R&D and
manufacturing to contract research organisations (CROs) and contract manufacturing
organisations (CMOs).
In most cases, the new business areas that pharmaceutical companies are exploring do
not have the same lucrative profit margins as for branded drugs. Even for branded
drugs economic analysis has shown that financial returns from new launches have
fallen sharply from the year 2000 onwards.23
The disappearance of ‘blockbuster’
business amidst profit pressure from investors is at least partly responsible for quite
alarming numbers of mergers and acquisitions in the pharmaceutical industry. Fisher
and Liebman describe this transformation:
‘The spike in mergers and acquisitions in pharma is beginning to make the
industry look more like a pyramid where more companies develop drug
molecules at the bottom than commercialize drug products at the top’. 24
In 2015, the pharmaceutical industry in Europe was worth €192bn, invested €31.5bn
in R&D and directly employed 725,000 people.25
Ireland is the largest net exporter of
pharmaceuticals in Europe and the industry directly employs over 24,500 Irish
people.26
Market research conducted by MarketLine in 2015 projected that the
European pharmaceutical market would grow to €223bn by 2019.27
In contrast to this
buoyant outlook, a more recent report points out the decline in valuations of pharma
and biotech companies in the first quarter of 2016 due to the adverse publicity
produced by drug pricing campaigns.28
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In summary, the pharmaceutical industry is a global research-based industry that must
continuously assess and adapt its operations in order to remain a sustainable producer
of innovative medicines. The next section will describe the trade associations related
to the pharmaceutical industry and their roles.
1.2 Pharmaceutical trade associations
Trade associations are non-profit organisations that exist to represent the collective
view and position of their members. They have a crucial role to play in promoting the
economic activities of their industry while maintaining ethical practices to safeguard
its reputation.29
Trade bodies for the pharmaceutical industry exist on the global level, regional level
and at a national level in countries with a notable pharmaceutical sector.
International associations
The International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA) is a global trade organisation founded in 1968 for the research-based
pharmaceutical industry. It is headquartered in Geneva and represents the views of the
pharmaceutical industry in global policy discussions. An IFPMA code of practice was
first introduced in 1981 and following this code of practice is a binding requirement
for membership.30
IFPMA has partnered with the International Alliance of Patients
xxi

Organisations (IAPO), the International Council of Nurses (ICN), the International
Pharmaceutical Federation (FIP) and the World Medical Association (WMA) to draw
up a consensus framework for ethical collaboration. There are four overarching
principles endorsed in this policy: put patients first, support ethical research and
innovation, ensure independence and ethical conduct and promote transparency and
accountability.31
Regional associations
The main regional trade groups are the following: the European Federation of
Pharmaceutical Industries and Associations (EFPIA), the Pharmaceutical Research
and Manufacturers of America (PhRMA), Medicines Australia, the Japan
Pharmaceutical Manufacturers Association (JPMA), the Organisation of
Pharmaceutical Producers of India (OPPI) and the R&D-based Pharmaceutical
Association in China (RDPAC). Most of these are members of the IFPMA umbrella
organisation and have adopted and regionalised the IFPMA Code of Conduct. There
is, for instance, the PhRMA ‘Code on Interactions with Healthcare Practitioners’32
and the ‘JPMA Code of Practice’.33
EFPIA, JPMA and the PhRMA are on the
steering committee of the International Conference on Harmonisation.34
National associations
National trade associations for research-based pharmaceutical companies offer
information and have an advisory role. Membership typically consists of full
members, who hold marketing authorisation for manufacture and or supply of
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prescription medicines and affiliate members who provide products or services to the
industry, but don’t market drugs. Typically, they work collaboratively with their
members on topics of interest to the industry like value and access, productivity in
R&D, self-regulation and new legislation. National codes of conduct must contain
the requirements specified by the IFPMA code at a minimum. Usually, they will
reflect additional requirements from national laws and regulations and the prevailing
business culture as well and are therefore more detailed than the international
standards. In Europe, national codes must follow the provisions laid down in the
EFPIA code at a minimum.35
The penalties for code violation are variable depending
on the country’s complaint procedure and the nature of the breach. Sanctions may
include fines, a requirement to cease the non-compliant activity, publication of the
outcome of a complaint, a commitment to issue a corrective communication or even
suspension or expulsion from the local trade association.30
1.2.1 EFPIA
The European Federation of Pharmaceutical Industries and Associations (EFPIA) was
founded in 1978 and represents the research-based pharmaceutical industry in Europe.
EFPIA has its headquarters in Brussels and represents 33 national trade associations
and 42 leading companies, which means it actually has over 1900 individual
companies in its membership.36
The following European countries are members of EFPIA: Austria, Belgium,
Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Malta, Netherlands,
xxiii

Norway, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, Spain,
Sweden, Switzerland, Turkey, Ukraine and United Kingdom.37
EFPIA promulgates codes of conduct to guide its members on interactions with
HCPs: the ‘EFPIA Code on Promotion of Prescription-only medicines to, and
Interactions with Healthcare Professionals’,37
and on interactions with patient
organisations: the ‘EFPIA Code of Practice’ on Relationships between the
Pharmaceutical Industry and Patient Organisations.38
1.2.2 IPHA
The Irish Pharmaceutical Healthcare Association (IPHA) is the Irish trade association
of the research-based pharmaceutical industry in Ireland. It has its offices in Dublin
and represents over 50 member companies based in Ireland.
The mission of IPHA is ‘to create a favourable economic, regulatory and political
environment, which will enable the research-based pharmaceutical industry in Ireland
to meet the growing healthcare needs and expectations of patients’.39
IPHA represents the industry in negotiations with the government, the regulatory
authorities, and HCP professional bodies and is the conduit for information from
EFPIA, IFPMA and the Association of the European Self-Medication Industry
(AESGP).
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IPHA oversees adherence of the Irish industry members to its two codes of practice,
which are the ‘Code of Standards of Advertising Practice for the Consumer
Healthcare Industry’40
and the ‘IPHA Code of Practice’.41
These codes embed IFPMA
and EFPIA requirements as well as taking account of Irish Regulation, SI No. 541 of
2007 Medicinal products (control of advertising regulations) 2007 42
and the local
business environment.
1.3 Regulation of the pharmaceutical industry
A comprehensive legislative system for human medicines is in place in both the US 43
and Europe.44
In Europe, the competent legal authority is the European Medicines
Agency (EMA), which is responsible for advising the European Commission. There is
detailed legislation governing, but not limited to, the following: clinical trials,
authorisation of new medicines, variations to marketing authorisation, promotion,
manufacturing, pharmacovigilance, orphan drugs and wholesale distribution and
pricing.45
Many regulations have been born out of tragedy as in the sulphanilamide exilir
tragedy in 193746
where 105 people died of diethylene glycol poisoning and the
thalidomide disaster in 1961, whereby a tranquiliser caused severe birth defects.47
It
came to be recognised that legislation was necessary to protect public health and over
time many directives, regulations, and guidelines have been developed that ensure all
new drugs undergo stringent testing for quality, efficacy, and safety. A host of
scandals revolving around missing safety data, skewed reporting of clinical trial
results, unpublished negative clinical trial results and undeclared conflicts of interest
have culminated in tighter regulations to enforce increased transparency.
xxv

Pharmacovigilance transparency
EMA’s new pharmacovigilance directive; Directive 2010/84/EU 48
entered into force
on July 2012. This new directive demanded a more pro-active approach to safety
reporting with requirements for risk management plans, post-authorisation safety
studies, improved signal detection and overall increased transparency and
communication. In spite of this, there were several new safety scandals in 2012,
which meant the new safety legislation already needed to be amended by October
2012. In 2012, 80,000 uninvestigated adverse event reports had been found in a
computer system during a regulatory inspection of Roche 49
and more than 1,300
deaths associated with off-label use of Mediator (benfluorex) in France.50
Clinical trial data transparency
A call for greater clinical trials transparency came from concerns that trials with
negative results were less likely to be made public.51
Dr. Ben Goldacre’s book ‘Bad
Pharma’ 52
published in 2012 sparked a furore about unpublished trial results.
AllTrials 53
became established with Dr. Goldacre as a co-founder to campaign for the
release of all data within a year of a study ending. In 2015, the World Health
Organisation issued a statement on public disclosure of clinical trial results declaring
that researchers have an ethical imperative to make the results from all clinical trials
public.54
EMA has also pursued a path towards transparency by introducing two new
xxvi

policies that will allow greater public access to clinical trial data: Policy/0043 on
access to agency documents and policy/ 0070 on proactive sharing of clinical study
data.55, 56
Clinical study reports will be proactively published by EMA for the first
time in mid-2016 for all marketing authorisation applications that have been
submitted since January 2015. The publishing of individual-level patient data will be
implemented at a later date. These two policies supplement the new European clinical
trials regulation no536/2014,57
which mandates increased transparency regarding the
authorisation, conduct and results of clinical trials.
Publications transparency
In 2001 in recognition of a lack of transparency in study publications the International
Committee of Medical Journal Editors (ICMJE) revised their ethics requirements.58
They demanded that all personal and financial relationships that could represent a
conflict of interest be disclosed by authors when submitting a manuscript.
Researchers were not to enter into contracts with sponsors in which their access to the
individual patient-level data would be curtailed or whereby they had no rights to
analyse the data independently and independently publish. Guidelines on good
publication practice for the sponsoring companies were subsequently published in
2003.59
These guidelines encouraged publication of all results from trials, described
methods to hinder publication bias and gave recommendations on the appropriate use
of professional medical writers.
1.4 The industry relationship
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There is a long history of close working collaborations between commercial life-
sciences organisations and HCPs. Some would say these collaborative working
arrangements have been a positive force for advancements in medicine and patient
care.60
Others take a different view of such interchanges and argue that any
entanglement with industry creates a conflict of interest and undermines HCP’s
rational prescribing decisions.61
Traditionally both commercial and clinical stakeholders have worked together, during
early scientific research, clinical trials, medical education and patient support
programs to share knowledge and shape research programs that will yield tomorrow’s
treatments.62
The relationship between the industry and health professionals is governed by EU
Directive 2001/83/EC63
, the European Federation of Pharmaceutical Industries’
Associations (EFPIA) Code on the Promotion of Prescription-Only Medicines to, and
Interactions with, Health Professionals,37
and EFPIA member codes such as the Irish
Pharmaceutical and Healthcare Associations (IPHA) code41
for the Irish
pharmaceutical industry. Guidance documents have also been written by many of the
HCP organisations. However, they have a tendency to be difficult to locate and are
infrequently updated. The Royal College of Physicians in Ireland differs here in that it
has two sets of recently published comprehensive guidelines for HCP-industry
relations; one for general sponsorship64
and the other for industry support of
education.65
Other examples of guidelines for the pursuit of ethical relationships with
the industry are those provided by An Bord Altranais,66
the American College of
Clinical Pharmacy,67
the Association of American Medical Colleges,68
and the
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American College of Physicians.69
The guidance defining ethical boundaries varies
considerably in these documents, ranging from vague and lenient to extremely
restrictive.
There are many ways that the industry works with HCPs, such as advisory boards,
medical education, clinical research, consultancy, donations and grants, joint
partnerships as well as media activity. What follows is a description of these
collaborations.
Advisory boards
HCPs are invited to attend advisory boards because a pharmaceutical company needs
their professional advice on a particular topic; for instance treatment pathways or the
most appropriate use of a new drug within a treatment landscape. The medical
profession is the closest to the patient and offers invaluable information on patient
outcomes and the management of the disease.70
Gaining access to this information
helps steer the pharmaceutical industry’s research and development to improve its
products and services, and therefore improve patient care, treatment options, and
patient outcomes.71
Sharing knowledge is the chief purpose of an advisory board with
the objective of benefiting patients from the exchange. Companies compensate HCPs
for their time and expert knowledge at an advisory board based on market value
hourly rates.72
Research collaborations
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The development of a drug that is truly valuable to the end user—the patient—
depends on a close relationship between industry, academic researchers, clinicians,
and patients. HCPs interact with industry by participating in clinical trial steering
committees to help design studies for the company’s pipeline products, participating
as investigators in company-sponsored studies and also by developing stand-alone
investigator sponsored studies that have funding support from industry. Real-world
data is becoming more and more a requirement from regulatory authorities and
reimbursement agencies and the industry relies on strong partnerships with HCPs to
collect this information through observational studies, audits and registries.
Often public research grants have been made conditional on private co-funding or
endorsement. Horizon 2020 is an EU initiative, which provides innovation funding to
promote research collaborations between industry and academic institutes.73
Closer to
home, Science Foundation Ireland’s 2020 strategy is to build partnerships between
public and private interests that will deliver research that is economically and socially
beneficial.74
It has been shown that patients participating in clinical trials tend to have better
outcomes than those being treated with the standard of care.75
There is also a
secondary financial benefit for the State hospital system as participation in industry
trials saves the state money. Recent research conducted by DKM Economic
Consultants on behalf of Clinical Trials Ireland showed that cancer trials save the
exchequer at least €6.7 million per annum in drugs costs savings.76
Grants and donations
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The industry often responds to requests for support for independent medical
educational programs, fellowships and institutional subscriptions to medical journals
by giving grants. Sometimes donations of equipment, free products or funding are
provided to improve the quality of healthcare in areas of need. All grants and
donations must be documented and recorded by both parties.77
Digital media
The digital revolution’s expansion into healthcare has struggled somewhat due to
concerns about security and privacy breaches,78
unreliable information79
and fears
about managing an online reputation.80
It will be important to overcome these
challenges, because using social media could potentially improve the experience of
healthcare delivery for patients, caregivers and providers. So far, pharma’s foray into
digital health has mostly been limited to ‘opt-in’ email newsletters, ‘on-demand’
webcasts to HCPs with the occasional app.81
The industry is increasing its emphasis
on digital offerings partly due to the recognition that doctor demographics and the
system they work in have changed. For instance, there are proportionally more female
doctors than ever before, and many of these are working mothers. Doctors still want
information but have less time for a face to face meeting with a pharmaceutical
representative or attending an evening meeting.82, 83
In pharma websites the flow of
information is usually one way towards HCPs and patients and two-way interactions
don’t really exist, because of perceived regulatory risks.84, 85
From this perspective,
pharma is behind the curve compared to other industries.86
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The use of social media by HCPs is increasing, but similar to the pharmaceutical
industry they have many concerns and uncertainties about using it for professional
interactions.87
In a survey of doctors and nurses in the UK in early 2015, 98.9% of
physicians and 95.1% of nurses owned a smartphone.88
Another survey conducted by
Moore,89
found that HCPs used smartphone applications or ‘apps’ as an adjunct to
medical practice because they believed they improve access to information,
efficiency, and decision making. There is a broad range of apps available for
formularies, textbooks, clinical decision tools and calculators.90
A study performed in
2013 found there were 100,000 health apps in 2013 91
and according to report by
IMShealth™, this number had grown to 165,000 by 2015.92
Thus far, social media
platforms for HCPs have mainly concentrated on education or the facilitation of
private, peer to peer discussion forums such as those on doctors.net.uk 93
and
Sermo.94
There is a growing minority of HCPs using social media to interact with patients, but
overall the idea is viewed with trepidation.95, 96
This is due to possible implications for
patient confidentiality, overstepping of professional boundaries, and misinterpretation
of information by a patient.97
Doctors are using social media for personal use, but not
with patients. A survey in 2013 found that 75% of Australian doctors used social
media websites, but this was for personal use only.98
In today’s world, the internet is often the first port of call for health information
because it is fast, accessible and does not cost anything.99
In a systematic review of
the literature Skype, WhatsApp, Twitter, YouTube, Facebook, PatientsLikeMe,
emails and texting were all found to be beneficial in engaging and empowering
patients.100
With time it may transpire that social media ‘mature’ patients will
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demand, expect and direct engagement with HCPs and other healthcare stakeholders
via this medium. The consulting firms Deloitte and PricewaterhouseCoopers forecast
that virtual consultation over smartphone technology will eventually become the
norm.101
Epatients like Michael Seres, (a patient suffering from Crohn’s disease) are
expressing a desire to have open virtual conversations about medications between the
doctor, patient and pharmaceutical industry; a form of virtual transparency or virtual
empowerment perhaps. Seres in ‘Digital Doctors’ states that “Pharma is a vital part of
any healthcare conversation. To me, I would like them to be in the room when I talk
about my medications with my doctor”.102, (p.4)
Joint working and partnerships
Recently there has been a trend for the pharmaceutical industry to partner with
healthcare providers and institutions to develop or improve patient services.103
There
is a move away from sponsorship and grants, in which industry provides funding, but
has no active role. Pharma is seeking to integrate fully with other stakeholders in
developing patient solutions. The rationale behind is that Pharma has much more to
offer other than just finance. The industry holds a wealth of experience in business
and financial management as well as in-depth knowledge of the disease areas related
to medicines it develops.104
These skills and knowledge can be constructively
combined with those of clinicians, healthcare managers and patient advisors to
improve patient outcomes.
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Arguably the most developed partnering between industry and state healthcare
providers is in the United Kingdom, where a joint working framework has existed for
at least a decade.105
According to guidance documentation provided by the
Association of the British Pharmaceutical Industry (ABPI): ‘Joint working describes
situations where, for the benefit of patients, NHS and industry organisations pool
skills, experience and/or resources for the joint development and implementation of
patient centred projects and share a commitment to successful delivery.’106
Past
examples of joint working collaborations are a personalised acute coronary syndrome
patient support programme between AstraZeneca and Bristol Heart Institute and the
development of an integrated Parkinson’s care pathway between Sunderland Trust
and Lundbeck.105
There are strict conditions for joint working to ensure that patient
benefit remains at the heart of each programme. The feedback from the industry
partners involved in ‘joint working’ projects is that it has enhanced credibility and
trust for their company.107
Consultancy arrangements
The word consultancy derives from the Latin: consultare ‘to discuss with someone in
an advisory manner’108
and consulting in a business sense is offering expert advice to
a third party for a fee. The pharmaceutical industry pays consultancy fees when it
needs an outside expert opinion from an HCP on various topics such as what
constitutes best practice, what to expect from patients when new drugs are introduced
and how to design trials that are patient-friendly. Consultancy is entered into as a
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contract and HCPs are paid in line with fair market value rates for their time and
expertise.109
Medical education
It could be argued that the pharmaceutical industry has a legitimate role to play in
educating HCPs about its medicines. Pharma has researched and developed these
medicines and is the owner of all the proprietary information. Indeed, it is mandatory
for companies to provide information on the medications they market. 37, 41
Typically
though, the industry tends to provide broader support for HCP educational needs than
just information on its products. Notable examples are disease state education,
organising and/or funding of educational meetings for a particular therapy area,
supporting HCPs to attend congresses and organisation of preceptorships and
bursaries to enable training in centers of excellence. It is in everybody's interest, not
least the patients, that experts from the companies developing the latest innovative
treatments provide education about their drugs and how to apply them in clinical
practice. For many medicines, where there is a need for patient education, there are
patient support programs provided by the industry. Patients are informed about these
programs by their clinician and decide if they want to consent to partake.
The issue of industry involvement in HCP education has been a controversial and
much-disputed subject. Krumholz reported how many doctors believe that it ‘must
stop because it diminishes credibility regardless of its quality’110, (p.326)
There is
abundant empirical research on whether or not information received from industry has
an undue influence on prescribing habits. In these studies, doctors display mixed
xxxv

attitudes, and whilst aware of the potential influence on the prescribing habits of other
doctors, they do not believe their own prescribing choices to be adversely affected.111-
114
To this end, it is important that clinicians receive training in critical appraisal and
biostatistics to that they can be effective critical thinkers.115
There are also those who
advocate strengthening the relationship, as in the case of the UK government, which
decided to formalise educational sponsorships into ‘joint working partnerships’
between the industry and government.116
In Ireland doctors are legally obliged to enroll in a professional competence scheme
and gather at least 45 continuing professional development (CPD) credits per year.117
There is financial support for education available from the Health Services Executive
(HSE) which equates to up to €500 for a specialist trainee doctor and up to €3000 for
a Consultant per year.118
However, the cost of availing of international education and
research opportunities usually exceeds the amounts available from these central
government funds and support from Pharma has helped to fill the gap.
Criticism and restrictions have contributed to a decline the levels of industry support
for HCP education. There are differences in opinion about the impact of this on
continuing medical education (CME). Oncologists in America were surveyed in 2014
about what they thought would be the consequences of diminishing industry support
for their CME. Interestingly, the majority felt that it would lower the quality and
availability of CME and have an adverse impact on the application of new
therapies.119
A prospective study by Segovis that showed a 38.4% increase in
attendance at Grand Rounds when complimentary food was provided by the
pharmaceutical industry.120
On the other hand, Dorr Goold’s review showed case
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studies in which attendance at internal CME events in hospitals is not reduced by lack
of industry sponsorship.121
In summary, interactions between industry and healthcare professionals enable the
development and effective use of new medicines through sharing best clinical
practice, exchanging information on how new drugs fit into the patient pathway and
shaping clinical research. However, the fashion in which these collaborations occur
has not always been entirely savoury, indeed Wager has likened it to ‘a dance with
porcupines.’122, (p.1196)
The next two sections attempt to explain the origin of the
‘porcupine’ analogy and outline some of the transparency measures that have been
taken to repair this image.
1.5 Reputational damage and mistrust
Over the last decade, the pharmaceutical industry has continuously shown up as one
of the least trusted sectors in public opinion polls.123
The opposite is true for
physicians, who are generally held in high moral esteem. An example of this positive
public sentiment towards doctors is evident in the Irish Medical Council’s annual trust
survey. In the 2015 survey, physicians were voted once again the most trusted
profession in Ireland with 91% of the 1000 adults surveyed trusting doctors to ‘tell the
truth.’124
This section will examine why pharma is viewed with so much distrust.
It is important to recall that the pharmaceutical industry didn’t always suffer from a
poor reputation. Merck had been a mainstay at the top of Fortune’s list as America’s
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most admired company between 1987 and 1993.125
Unfortunately this perception
started to be eroded when the business model changed dramatically with the dawn of
the blockbuster drug era. The definition of a blockbuster drug is a medicine that
generates global sales of at least $1 billion annually.126
It is estimated that more than
half of all revenues from the large pharmaceutical companies came from blockbusters
alone before the patent cliff in circa 2010.127
During this period companies deviated from their core mission of discovering and
manufacturing drugs to become blockbuster marketing machines. High-octane growth
and profits fueled the development of unethical practices. Jürgen Drews, former head
of Roche R&D, stated in 2003 that the
‘ethics of successful business have replaced those of medicine. The supreme
loyalty of today’s companies is not primarily directed at patients and their
physicians but at shareholders. Consequently, the most influential figures in
today’s pharmaceutical companies are no longer the heads of R&D but the
heads of marketing and finance.’128 (p.411)
The once-esteemed industry became dogged by government investigations, billion
dollar fines, forced withdrawal of medicines, unflattering exposes in the media,
suppressed drug-safety data, off-label promotion and mistrust about high pricing to
name but a few.129
Some of pharma’s reputational problems may stem from the fact that it sells health
products. Public backlash for may be more harsh for pharma than other industries,
because there are sensitivities around selling health commodities. Often there is a
perception that pharmaceutical companies have a moral obligation to society to give
equity of access to their drugs.130
This concept of health being an inalienable right
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means that some people find it unconscionable that a pharmaceutical company
wouldn’t provide medicines free to those who cannot afford them and makes it
difficult to define the value of its drugs in term of monetary value. Therefore,
although people acknowledge that the drugs produced by pharma are valuable they
still expect to receive them for free. Mc Graw, for instance, provides empirical
evidence, finding that consumers were incensed by pharmaceutical market pricing
strategies, but not by similar profit-based pricing strategies for software companies.131
However, the reality is that the costs and risks of drug development are too high for
governments or non-profits to consider. The pharmaceutical industry is a high-stakes
business. While the mission is to develop medicines to improve health, its foremost
objective is to increase shareholder value just like any other publically traded
company.132
Despite being an R&D industry, pharma is regularly accused of ‘predatory pricing’.133
Price denunciations don't happen at the same intensity to other research or resource-
intensive industries such as smartphone manufacturers, car manufacturers or the film
industry. It could be hypothesised that people find it difficult to accept profit
generation from health products. Health insurance companies are another business in
the anomalous position of delivering a health commodity and interestingly their
reputation was only slightly better than pharma’s in a public sentiment survey.123
The
following subsections examine some of the main criticisms that have been levelled at
pharma.
Fraud: Off-label promotion & bribery
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There have been several high-profile court cases for fraud, the largest of which was a
$3 billion fine for GlaxoSmithKline (GSK) by the US government in 2012 for off-
label promotion and failure to report safety data.134
The same company was caught
again two years later for bribery in China, where it is claimed that doctors were bribed
with cash and sexual favours135, 136
Another infamous settlement was the $2.2 billion
fine in 2013 for Johnson & Johnson for off-label promotion of Risperdal, Invega and
Natrecor and kick-backs to doctors and pharmacists.137
There are many others, where
perhaps the fines were smaller, but the offences none the less casting a pall over the
industry.129
Bias in independent medical education & journals
Industry critic, Ray Moynihan has decried the invisible influence of pharma at
supposedly independent sponsored medical education meetings.138
The criticism has
been that attending doctors are not informed of the fact that sponsoring companies
sometimes suggest speakers for these accredited medical, educational events.
Moynihan’s view is that an educational event cannot be legitimately defined as
‘independent’ unless it is completely free from pharmaceutical industry input into
agenda or speaker choice. Richard Smith, the former editor of the BMJ, wrote about
bias in scientific journals, implying that journals were functioning like extensions of
pharma marketing departments.139
xl

Dubious opinion leaders
The industry has recognised the value of expert clinician advocates since the
beginning of the 20th
century.140
HCPs, who can influence their peers, have come to be
known as ‘key opinion leaders’ and ‘thought leaders’ or KOLs and TLs for short.
Sales representatives and medical scientific liaisons can identify influencers suitable
to be included in the company’s speaker bureau. Companies have even sprung up
with the sole purpose of identifying potential KOLs, mapping their influence,
managing communications, engagements and analysing return on investment.141
KOLs usually receive extensive training on data and slide delivery from industry.141
Criticisms have arisen about the speaker payments and conflicts of interest. Moynihan
launched an attack on KOL speaker fees, questioning whether they were in fact drug
reps in disguise.142
Former rep, Oldani, echoed this sentiment when he recounted KOL
development as the grooming of doctors ‘into speakers and consultants who know the
rules of the game and are quite adept at negotiating a stipend.’143, (p.334)
Krumholz
hinted that some US opinion leaders had leveraged funding from companies by
favouring the company’s products or silencing critics.110
Spelsberg, complained that
many doctors with extensive ties to industry, with disclosed conflicts of interest, were
still sitting on medical expert committees and public policy boards.144
There was
rarely any attempt to exclude them from these positions by the medical fraternity.
More stringent transparency regulations for KOLs has been called for so that other
doctors can make informed judgements about accepting their guidance or not.145
Buying doctors with gifts
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By the late 1990s, the corporate gift culture was a well-established phenomenon and
compromised the integrity of industry employees and HCPs alike. Sales
representatives were indoctrinated into the gifting philosophy during their inductions
with prizes handed out during training competitions. Then over their entire career
sales representatives have been gifted with bonuses, salary rises, points systems for
rewards, holidays and ‘circle of excellence’ awards in return for hitting their sales
targets. Strategic gifting became especially important to differentiate one ‘me-too’
product over another and win a larger slice of the blockbuster pie. High prescribers
were lavished with attention, gifts and unrestricted grants.146
Companies tried to outdo
each other on how elaborate, niche and expensive their gifts were. In this pervasive
gift economy, doctors were brought to wine tastings, dinner cruises, helicopter rides,
rugby matches and given corporate seats at stadiums.
Numerous studies have shown that receipt of gifts and honorarium can shift the
opinion of HCPs to favour the company and its products.147, 148
Empirical evidence
generated by cognitive psychologists proved that even inexpensive gifts, such as pens
and notebooks have outsized influence.149
Indeed, pharma would not have continued
the practice of gifting if it wasn’t producing a good return on investment. Blumenthal
referred to estimates of between $12 to $15 billion spent annually on gifts and money
payments to doctors.150
From a social science perspective, there is ‘a conflict of
interest when a primary ethical or professional interest clashes with financial self-
interest’.151, (p. 252)
Perhaps tellingly, patients were never a party to these gift exchanges. One of the most
influential accounts of the gifting culture comes from Oldani, who was a sales
representative himself during this time. He described what happened as a ‘paradoxical
xlii

health-care economy, one that was all about the patient, while simultaneously not
about the patient at all’.143 (p.343)
Congress ‘junkets’
The all-expenses paid medical conference ‘junket culture’152
was closely intertwined
with the ubiquitous gift culture. Both conspired to increase enmeshment and
obligation.61
Sharma claimed in 2010 that congresses organised on the premise of
providing education had turned into entertainment extravaganzas with doctors
queuing at pharma stalls for ‘freebies’ instead of attending scientific sessions.153
Angell imputes that doctors abdicated their responsibility on medical education to
pharma because it paid – ‘in CME credits, perks, and free lunches’. 154, (p.1452)
Disease mongering
There has been a constant stream of publications suggesting that pharma discovers a
drug that works on a particular biological pathway and then fabricates a medical
condition based on the drug’s mode of action.155-158
The term ‘disease mongering’ was
coined by Lyn Payner, when she wrote the book, ‘How Doctors, Drug Companies,
and Insurers are making you feel sick’.159
Companies have been criticised for running
disease awareness campaigns ostensibly to help patients, but in reality to create or
expand a market for their drug.156
Elliott has classified the types of conditions suitable for disease mongering as ‘the
shameful condition that can be destigmatised’ and ‘a condition that can be plausibly
portrayed as under-diagnosed’.160
A classic example is Detrol, a product launched by
Pharmacia in the late 1990s. Patients who had urge incontinence were embarrassed by
xliii

the condition and hesitant to seek help.161
Pharmacia rebranded the condition as
‘overactive bladder’ to make it more palatable to potential patients and worked with
physicians to broaden the diagnostic criteria. The former vice president, Neil Wolf,
gave a presentation called ‘Positioning Detrol: Creating a Disease’ at the
Pharmaceutical Marketing Research (PMRG) Group Conference in October 2002 in
which he openly extolled the virtues of Pharmacia’s marketing campaign. Slides from
this presentation are freely available on the internet and detail the plan to transform ‘a
niche product into a mass-market opportunity’.162
Doubtless many patients who had
been suffering in silence benefited from Pharmacia’s campaign, but in the same vein,
many countless others may have taken medication unnecessarily.163
Another example
of pharma widening diagnostic boundaries is the condition of ‘social phobia’.164
The
uncovering of this ‘hidden’ epidemic was heralded by Pharmaceutical Marketing as
‘best practice in shaping medical and public opinion about a disease’. 165
Thwarted R&D
Research has shown that during the 1990s, the top ten drug companies in the world
were spending approximately 35% on marketing and only 11-14% on R&D.166
Much
of this limited investment was dedicated to pseudo-clinical trials, otherwise known as
‘seeding studies'.167
The primary intention of seeding studies was to facilitate rapid
uptake of a new agent which would create familiarity and advocacy.168
Merck’s
ADVANTAGE trial (Assessment of Differences between Vioxx and Naproxen to
Ascertain Gastrointestinal Tolerability and Effectiveness) has often been cited as an
example of such a trial.169
An internal marketing slide set is purported to have shown
that the ‘behind the scene’ orchestrators of the trial were the marketing team. In this
slide-set the marketing objective is stated as ‘gain[ing] experience with Vioxx prior
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to and during the critical launch phase.’170
The study was designed by the marketers in
the spirit of Merck marketing principles and the sales force were tasked with
nominating potential investigators.169
Court evidence revealed that the marketing team
responsible for ADVANTAGE had been nominated for an internal prize called the
‘Best Physician Program’ award.171
Vioxx® was withdrawn from the market in 2004,
but litigation continues even twelve years later in 2016. It is estimated that payouts
from the Vioxx® disaster come to at least $6 billion already.172
The Vioxx® case
study illustrates the need for transparency in the way clinical studies are conceived
and executed.
The industry has also been criticised for its focus on developing lucrative drugs for
developed economies instead of drugs for communicable diseases, especially tropical
diseases.173
In 2001, Médecins Sans Frontières highlighted that the development
pipeline for sleeping sickness, leishmaniasis, Chagas disease, malaria, and
tuberculosis was nearly empty.174
When studies were conducted in developing
countries, standards were often compromised. In the 1990s, in particular, there were
many examples of anti-retroviral and vaccine trials in developing countries lacking
ethical oversight. Fatalities and life-threatening adverse events were underreported,
consent wasn’t always obtained, and sometimes patients didn’t even know they were
on a trial. Often patients were placed on a placebo arm for a life-threatening disease
when there was a licensed alternative on the market.175
LeCarre’s book “the Constant
Gardener,” tells a fictional story of a pharmaceutical company forcing unknowing
Africans to take unapproved tuberculosis drugs in exchange for desperately needed
antiretrovirals.176
It has been alleged that the story draws close parallels to the Pfizer
Trovan case, where an antibiotic for meningitis was tested in 200 Nigerian children
causing 11 deaths. 177
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In conclusion, it is evident that for the pharmaceutical industry to reclaim its
reputation, the culture of covert deals and hidden facts needed to end. As Weber
stated:
“The message of critics is clear: In the search for corporate profits, the drug
industry, often with the complicity of medical professionals, engages in
practices that can and frequently do lead to treatment that is unnecessarily
costly”. 178, (pp.3-4)
The following section presents some of the measures taken by pharma to resurrect its
standing in the public eye.
1.6 Rebuilding integrity and trust
Given the litany of indictments described above, it was imperative for the industry to
make some drastic changes to restore trust. Many reforms have already taken place
and compliance in the industry is an actively growing and evolving field. There has
been an incremental tightening of industry codes and companies are gradually
transforming from the product-driven model of the blockbuster era to a ‘patient-
centric’ model.179
The corporate dogma of financial goals surmounting everything else
has conceded to the notion that profits and ethics need not be mutually exclusive.
In the past, the industry had behaved reactively to findings or even just shrugged off
fines as the ‘cost of doing business’.180
However, in the 21st
century a corporation’s
reputation is considered its most valuable asset. It is estimated that intangible assets
such as brand equity, intellectual capital and goodwill are responsible for 70% to 80%
of market value.181
Pharma can no longer be complacent about reputation.
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1.6.1 The IFPMA Code
Almost all of the recent reforms by the industry relate to transparency. A series of
revisions to industry codes of practice setting new thresholds on communications and
interactions with HCPs began in 2002 when PhRMA substantially updated its code.35
The global IFPMA Code of Practice was first established in 1981. As already
discussed, all regional and national codes must follow the IFPMA code as a bare
minimum, but local codes are more detailed in scope. The IFPMA Code underwent
major revisions in 2006182
and 201230
in recognition of the fact that profound
alterations needed to take place in practices such as sampling, gifts, hospitality, HCP
consultancies, clinical trial transparency and support for continuing medical education
(CME).
IFPMA Code: 2006 revision
In the 2006 review of the IFPMA Code,182
the following rules were introduced for
hospitality arrangements:
Clause 7.5.1
‘All events should be held at an appropriate venue that is conducive to the
scientific or educational objectives and the purpose of the event or meeting.
Companies should avoid using renowned or extravagant venues'.
Clause 7.5.4
‘No stand-alone entertainment or other leisure or social activities should be
provided or paid for by member companies'.
Stipulations were also applied to the practice of gifting in the 2006 revised IFPMA
code:
Article 7.6.1
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‘Payments in cash or cash equivalents (such as gift certificate) must not be
offered to healthcare professionals'.
Article 7.6.2
‘Gifts for the personal benefit of healthcare professionals (including, but not
limited to, music, CDs, DVDs, sporting or entertainment tickets, electronic
items) must not be provided or offered’.
However, items of medical utility could still be provided if they were of modest
value.
IFPMA Code: 2012 revision
The current version of the IPMA Code of Practice has been in implementation since
September 2012.183
Before this; the code had focused mainly on promotional
activities. In the new version, the scope of the code broadened to encompass
interactions with HCPs and patient organisations with the aim of ensuring high
quality, ethical interactions.184
The new code also presented mandatory standards for
clinical trial transparency and industry support of CME.
New minimum criteria were delineated for engaging HCPs as paid consultants for
services such as speaking or chairing at meetings, participating in advisory boards or
market research. The IFPMA Code of Practice 2012 criteria for paid HCP
consultancies are as follows:
Article 7.4 – Fees for Services30
• A written contract or agreement must be agreed in advance of the
commencement of the services which specifies the nature of the services to
xlviii

be provided and the basis for payment of those services
• A legitimate need for the services must be clearly identified and documented
in advance
• The criteria for selecting consultants must be directly related to the identified
need and the consultants must have the expertise necessary to provide the
service
• The number of consultants retained must not be greater than the number
reasonably necessary to achieve the identified need
• The hiring of the consultant to provide the relevant service must not be an
inducement to prescribe, recommend, purchase, supply, and/or administer
any medicine
• The compensation for the services must be reasonable and reflect the fair
market value of the services provided.
In Article 9.1, IFPMA’s commitment to disclosing clinical trial data is officially
expressed, with the caveat that this transparency has to be balanced by the duty to
protect patient confidentiality, intellectual property, and contract rights. Article 9.2
states that ‘All human subject research must have a legitimate scientific purpose.
Human subject research, including clinical trials and observational studies, must not
be disguised promotion’.30
Minimal expectations were declared for industry support of continuing medical
education (CME) in Article 10:
‘The primary purpose of an educational meeting must be the enhancement of
medical knowledge, and therefore financial support from companies is
appropriate. When companies provide content to CME activities and
programs, such material must be fair, balanced and objective, and designed to
allow the expression of diverse theories and recognised opinions. Content
must consist of medical, scientific or other information that can contribute to
enhancing patient care’.30
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1.6.2 The EFPIA HCP Code
The European Federation of Pharmaceutical Industries’ Association's code is broadly
similar to the IFPMA code, but with slight modifications to tailor it for European
uses. The EFPIA Code on the Promotion of Prescription-Only Medicines to, and
Interactions with, Healthcare Professionals (the ‘EFPIA HCP code’)37
was adopted by
the EFPIA Board in 2007 and has been amended three times since then. The final
consolidated version 2013 is the version currently in use. All national trade
associations in Europe must adopt at a minimum the standards set out by EFPIA and
are encouraged to supplement these provisions further to comply with local laws,
regulations, and requirements.
Transparency has been an integral part of the EFPIA HCP Code since its first
adoption in 2007. Article 7 on the transparency of promotion has remained the same
through all revisions of this code.185
The original version in 2007 contains the
following wording in Article 7 in regards to transparency of promotion:
Section 7.01. Promotion must not be disguised.
Section 7.02. Clinical assessments, post-marketing surveillance and
experience programmes and post-authorisation studies (including those that
are retrospective in nature) must not be disguised promotion. Such
assessments, programmes, and studies must be conducted with a primarily
scientific or educational purpose.185, (p.10)
l

The provisions of the EFPIA HCP Code are the industry’s moral compass and define
the exemplary standards of behaviour that are expected of all member organisations.
In concordance with the IFPMA code, the European code’s scope has broadened from
governing the pure promotional elements of the industry to encompass industry-HCP
interactions. Most updates to these industry codes have been reactionary; in response
to scandals and criticisms such as those detailed in section 1.5. However, the
‘Disclosure Code’, which is the subject matter of this dissertation, marks a departure
from passivity. The pro-active decision by EFPIA to oblige its members to declare
HCP payments shows active commitment to its ethical ideals of transparency.186
The EFPIA HCP code clarifies standards that differentiate appropriate from
inappropriate relationships to avoid suspect interactions. Herein follows a description
of some of these standards.
Events and hospitality
The code has placed restrictions on the hospitality that can be afforded at events to
protect against any excesses that would bring discredit on the industry.
Article 10 denotes the criteria that must be followed for ‘Events and Hospitality’:
Section 10.01: Company events must be held in an “appropriate” venue that is
conducive to the main purpose of the event.'
Section 10.04: Hospitality extended in connection with events shall be limited
to travel, meals, accommodation and genuine registration fees.37, (p.11)
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Section 10.05 was added to Article 10 in the 2013 update of the Code to place
limitations on the amount of the money pharma could spend on HCP meals and make
it transparent.
Section 10.05.
Member Companies shall not provide or offer any meal (food and beverages)
to healthcare professionals, unless, in each case, the value of such meal (food
and beverages) does not exceed the monetary threshold set by the relevant
Member Association in its national code. Each Member Association shall set
such monetary threshold in its national code by 31 December 2013, failing
which EFPIA will set such threshold in lieu of such Member Association. The
monetary threshold set in the country where the event takes place (i.e. the
“host country”) shall prevail, as an exception to the provision of Article 13.01
and deviating from the general principle where the strictest prevails.37, (p.12)
The monetary threshold for meals, (food and beverages) to HCPs taking place in
Ireland is €80 (including VAT and excluding any gratuity) as set forth in Clause 16.3
of the IPHA Code of Practice for the Pharmaceutical Industry. 41, (p.23)
The amount
allowed in the UK is £75 per person, excluding VAT and gratuities, as dictated in
Clause 22.2 of the Association of the British Pharmaceutical Association (ABPI)
Code of Practice. 187, (p.32)
Gifts
EFPIA’s curtailments on gifts became stricter over time until they were banned
altogether in the most recent amendment. As a result of this, low-cost promotional
aids like pens, pads, USB keys, etc. have been phased out.35
The ban on gifting is
important because it allows the relationship between industry representatives and
HCPs to be redefined to one based on integrity and mutual respect.188
lii

In older versions of the EFPIA Code no gift for personal benefit was permitted, but
gifts could be given to HCPs as long as they were ‘inexpensive and relevant to the
practice of medicine or pharmacy’. 185, (p.11)
In the 2012 revision, Section 9.02 of
Article 9 states that ‘items of medical utility can still be provided as long as they are
“inexpensive” and do not offset routine business practices of the recipient’. Section
9.03 clarifies and tightens the ruling on items of medical utility to ensure it could not
be used as a loophole for providing gifts:
Section 9.03
The scope of Informational or educational materials and items of medical
utility considered may not constitute a circumvention of the prohibition on
gifts defined under Article 17 of this Code.37, (p.11)
The use of consultants
As pointed out in section 1.4 of this introduction, the industry values and needs the
expert clinical knowledge that HCPs possess. The practice has been to pay
consultancy fees, (sometimes known as ‘fee per service’) for sharing this expertise.
The EFPIA HCP Code, Section 14.01 specifies criteria that must be fulfilled in order
to ensure that all consultancies are legitimate:
Section 14.01. 37, (p.13)
a. A written contract or agreement is agreed in advance of the
commencement of the services which specifies the nature of the services
to be provided and, subject to clause (g) below, the basis for payment of
those services
b. A legitimate need for the services has been clearly identified in advance
of requesting the services and entering into arrangements with the
prospective consultants
c. The criteria for selecting consultants are directly related to the identified
need and the persons responsible for selecting the consultants have the
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expertise necessary to evaluate whether the particular healthcare
professionals meet those criteria
d. The number of healthcare professionals retained is not greater than the
number reasonably necessary to achieve the identified need
e. The contracting company maintains records concerning, and makes
appropriate use of, the services provided by consultants
f. The hiring of the healthcare professional to provide the relevant service is
not an inducement to recommend, prescribe, purchase, supply, sell or
administer a particular medicinal product
g. The compensation for the services is reasonable and reflects the fair
market value of the services provided. In this regard, token consultancy
arrangements should not be used to justify compensating healthcare
professionals
Section 14.02 encourages companies to promote disclosure of any conflict of interest
including provisions in written contracts with consultants ‘regarding the obligation
of the consultant to declare that he/she is a consultant to the company whenever
he/she writes or speaks in public about a matter that is the subject of the agreement or
any other issue relating to that company’.37, (p.14)
Non-interventional studies
In order to eradicate any proclivity for ‘seeding studies’, the EFPIA HCP Code sets
out quite detailed criteria for company sponsored non-interventional studies of
marketed medicines:
Article 15 – Non-interventional studies of marketed medicines37, (p.14)
Section 15.02.
a. The study is conducted with a scientific purpose
b. (i) There is a written study plan (protocol) and (ii) there are written
contracts between healthcare professionals and/or the institutes at which the
study will take place, on the one hand, and the company sponsoring the study,
liv

on the other hand, which specify the nature of the services to be provided and,
subject to clause (c) immediately below, the basis for payment of those
services
c. Any remuneration provided is reasonable and reflects the fair market value
of the work performed
d. In countries where ethics committees are prepared to review such studies,
the study protocol should be submitted to the ethics committee for review
e. Local laws, rules and regulation on personal data privacy (including the
collection and use of personal data) must be respected
f. The study must not constitute an inducement to recommend, prescribe,
purchase, supply, sell or administer a particular medicinal product
g. The study protocol must be approved by the company’s scientific service
and the conduct of the study must be supervised by the company’s scientific
service as described in Section 18.02.a
h. The study results must be analysed by or on behalf of the contracting
company and summaries thereof must be made available within a reasonable
period of time to the company’s scientific service (as described in Section
18.02.a, which service shall maintain records of such reports for a reasonable
period of time. The company should send the summary report to all healthcare
professionals that participated in the study and should make the summary
report available to industry self-regulatory bodies and/or committees that are
in charge of supervising or enforcing Applicable Codes upon their request. If
the study shows results that are important for the assessment of benefit-risk,
the summary report should be immediately forwarded to the relevant
competent authority
i. Medical Sales Representatives may only be involved in an administrative
capacity, and such involvement must be under the supervision of the
company’s scientific service that will also ensure that the representatives are
adequately trained. Such participation must not be linked to the promotion of
any medicinal product. Section 15.03. To the extent applicable, companies are
encouraged to comply with Section 15.02 for all other types of studies covered
by Section 15.01, including epidemiological studies and registries and other
studies that are retrospective in nature.
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Medical samples
Article 16 clarifies when sampling is allowed and sets limitations on the number of
samples that can be given and the time-scale for sampling. Section 16.01 37, (p.15-16)
states that ‘medical samples must not be given as an inducement to recommend,
prescribe, purchase, supply, sell or administer specific medicinal products’ and are
only to be used to help HCPs ‘familiarise themselves with the medicines and acquire
experience in dealing with them.’ The maximum amount of free samples that can be
provided is ‘4 medical samples of a particular medicine he/she is qualified to
prescribe for 2 years after he/she first requested samples of each particular medicine’.
Financial disclosure
Neither the IFPMA Code nor the EFPIA HCP Code include financial transparency
reporting requirements. IFPMA released a position paper in 2014 titled, "Interactions
in the Healthcare Sector: Disclosure of Transfers of Value" expressing support for
disclosure of payments to HCPs, but didn’t attempt to introduce a global transparency
code.189
In some countries, governments have introduced transparency laws and in
others, transparency is governed by a industry self-regulatory code. The ‘EFPIA Code
on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare
Professionals and Healthcare Organisations’ (‘Disclosure Code’) was adopted by
EFPIA in 2013 as a blanket transparency code for EFPIA members. The ‘Disclosure
Code’ is discussed in more detail in section 1.7.
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1.6.3 Patientcentricity
In the new paradigm, the strategic emphasis has shifted from products to patients,
from mass-marketing to tailored, holistic offerings with the aim of optimising patient
outcomes. Companies are eager to initiate a two-way dialogue with patients and
patient associations to listen and learn in the hopes of co-creating value based
healthcare solutions.179, 190
It would be hoped that such worthy collaborations would
foster trust and support for pharma within the patient community. The voice of the
patient would always be more meaningful and convincing than any amount of ‘spin’
from even the most sophisticated pharma PR outfit. 129
Patients too are expressing a
desire for action and feel that there is too much reliance on lobbying and public
relations.191
1.6.4 Value and pricing
It would help the industry if it reached out to the public to educate about the costs of
drug development and to explain the proposed price of a new drug by describing the
benefit to patients and any potential cost-saving to the health service.129
The
Association of the British Pharmaceutical Industry (ABPI) plans to lead a ‘Value
Story’ multi-media campaign to explain to the public about scientific advances
brought about by the industry and the impact they’ve had for patients and their
families.192
Several states in America have submitted bills for a ‘pharmaceutical cost
transparency act'.193
They are requesting that pharmaceutical manufacturers be forced
to submit a report outlining the total costs for developing any drugs costing more than
$10,000 a year.193
The value society places on individual health outcomes and the
total cost of developing a successful medicine factoring in pipeline failures is a
complex debate. Instead of vacuous slogans on company websites about caring for
patients, scientifically qualified industry executives should proactively engage in
lvii

meaningful discussion to explain the industry’s merits and counter with education any
misinformation.129
1.6.5 Clinical trial data
EFPIA and the American Association, PhRMA jointly launched a document titled
‘Principles for Clinical Trial Data Sharing’194
in July 2014. Here certain commitments
were made regarding the disclosure of clinical trial data to increase transparency.
Amongst others, promises were made to share patient-level data, study-level data, and
protocols, if they were requested by qualified scientific researchers. The commitment
to publish all research whether positive or not was reaffirmed in this document.
Furthermore, some companies such as GlaxoSmithKline signed up to the campaign
on Alltrials.net by agreeing to publish all their clinical study reports (CSRs) on the
clinical trials register. 195
Bioethics International, a US-based non-profit organisation, launched a ranking
system called the Good Pharma Scorecard (GPS) in 2016.196
This ranking system
scores every drug and sponsor for trial transparency, ethics, human rights and public
health criteria. The aim is to drive change by incentivising and recognising companies
who are transparent. A pilot ranking was performed in 2015 with two companies,
GlaxoSmithKline and Johnson & Johnson scoring 100% for clinical trials
transparency.197
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1.6.6 Corporate culture & corporate social responsibility
Corporate culture can be defined as the deep, underlying assumptions and beliefs that
are shared by organisational members.198
It is the foundation of the social order at an
organisation and the rules employees abide by. Mission statements, visions, and
espoused ethical values are merely lip service to compliance if they are not embedded
in a culture based on integrity. An LRN survey of 104 ethics and compliance
professionals found that building a values and ethics-based culture instead of just an
organisation of ‘box-tickers’ inspired staff to ‘live their company’s values’. 199
In the
new world order, pharma has recognised that ‘competitive advantage in the future will
come by distinguishing a company through integrity’.200
There is a trend now for
companies to allocate a proportion of employees’ compensation based on how well
they have demonstrated company values. An example is Novartis, where ‘company
values and behaviors set the expectations for how our targets should be achieved. We
then reward our associates based on how and the extent to which we achieve our
targets’. 201
Companies must align their internal policies and procedures with the industry codes
of conduct, ensuring these are applied both in letter and in spirit. However, most
companies also have their own internal codes of conduct, compliance standards and
operating procedures which go beyond legal and regulatory requirements.35
Pharmaceutical employees are trained on compliance from the day they enter a
company, and there are internal audit systems to deal with infringements with
compliance policies. 202
lix

Pharma has embraced corporate social responsibility (CSR) over the last two decades
opening up many ‘access to medicines’ initiatives in developing nations.203, 204
Droppert and Bennett conducted interviews with representatives from selected firms
in their exploratory study about corporate responsibility strategy in the
pharmaceutical sector. They reported that all subjects saw CSR and reputation as
inextricably linked. One interviewee said, “being socially responsible and engaging in
activities that both advance our business objectives as well as social objectives really
will help the company be sustainable over the longer term”. 205
Pharma’s CSR
activities have evolved, becoming sustainable corporate partnerships with local
communities rather than charitable donations. An example is the Amgen Foundation’s
programs for science teachers across Europe, which provides free training sessions on
hands-on, inquiry-based experiential learning to ‘inspire the next generation of
innovators’.206
It would appear that the perception of the industry has started to recover because
recent polls performed in 2015 by PatientView, Edelman and the Center for
Information and Study on Clinical Research Participation (CISCRP) have all shown
an improvement in trust levels.207
The moves towards transparency and ethical
dealings are of paramount importance. Even the staunch industry critic, Marcia
Angell conceded that “despite all its excesses, this is an important industry that should
be saved—mainly from itself”. 208, (p.237)
Ultimately, the industry and HCPs need to
work together with mutual transparency and respect for the sake of patients and
innovation. The next section describes the latest venture to drive transparency and
respect: The EFPIA Disclosure Code.
lx

1.7 The EFPIA Disclosure Code
1.7.1 The introduction of a Disclosure Code
The pharmaceutical industry decided to be proactive in bringing greater transparency
to relationships that it considers vital in order to strengthen the basis for collaboration
in the future. This was in recognition of the fact that society has increasingly high
expectations for transparency, especially in healthcare.
The EFPIA General Assembly of 24 June 2013 adopted the ‘EFPIA Code on
Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare
Professionals and Healthcare Organisations’ (‘Disclosure Code’) to provide an
additional level of transparency to industry-HCP relationships.209
It was expected that
all European national industry associations would incorporate the disclosure code into
their national codes by the end of 2013. Adaptations were permissible only if the
provisions of the disclosure code conflicted with national laws or regulations.210, (p.4)
Companies have to publicly disclose all transfers of value to HCPs on an annual basis.
The first report was due by the 30th
June 2016 for transfers during 2015. 211
The
information can be published on the EFPIA member company’s own website or a
central online platform (hosted by the industry association or other professional
organisation). In France, Denmark and Portugal the national legislation requires
disclosure on a central government platform. Ireland, the UK, Belgium, Czech
Republic, Sweden and the Netherlands can make disclosures on a central, online
platform in each country in a self-regulatory capacity.212
Disclosure must occur
annually within six months of each year’s end. The information is public for three
years.
lxi

There had been a call from some sources and working groups for greater transparency
due to the suspicion that some companies had been offering and some HCPs are
accepting, inappropriate and ethically questionable payments and gifts.150
The Royal
College of Physicians in the UK had requested that the relationship between medicine
and the pharmaceutical industry be rewritten to become ‘a more balanced and
mutually respectful partnership’.213, (Section 3.41)
EFPIA believes healthcare professionals deserve to be fairly compensated for the
legitimate expertise and services they provide to the industry.71
The EFPIA disclosure
code aims to satisfy public scrutiny and demonstrate that industry-HCP relationships
are entirely valid, and for the purpose of scientific exchange and improving patient
outcomes. EFPIA anticipates that bringing greater transparency to this, already
highly-regulated, vital relationship will strengthen the basis for collaboration in the
future.212
Perhaps, financial transparency would even help move industry-HCP
relations from a conflict of interest to a confluence of interest.214
1.7.2 Definitions of the terms used in the Disclosure Code
EFPIA’s definition of HCPs for the purposes of disclosure is,
‘any member of the medical, dental, pharmacy or nursing professions or any
other person who, in the course of his or her professional activities, may
prescribe, purchase, supply or administer a medicinal product.’ 210, (p.11)
A healthcare organisation (HCO) is defined as,
lxii

‘any legal person (i) that is a healthcare, medical or scientific association or
organisation (irrespective of the legal or organisational form) such as a
hospital, clinic, foundation, university or other teaching institution or learned
society (except for patient organisations within the scope of the EFPIA PO
Code) whose business address, place of incorporation or primary place of
operation is in Europe or (ii) through which one or more HCPs provide
services.’210, (p.11)
Transfers of value to be included were defined by EFPIA as,
‘Transfers of Value Direct and indirect transfers of value, whether in cash, in
kind or otherwise, made, whether for promotional purposes or otherwise, in
connection with the development and sale of prescription-only Medicinal
Products exclusively for human use. Direct transfers of value are those made
directly by a Member Company for the benefit of a Recipient. Indirect
transfers of value are those made on behalf of a Member Company for the
benefit of a Recipient, or transfers of value made through an intermediate and
where the Member Company knows or can identify the HCP/HCO that will
benefit from the Transfer of Value.’ 210,(p. 12)
1.7.3 Reporting categories in the Disclosure Code
Transfers of value are to be reported in three categories: research and development,
healthcare organisations (HCOs) and HCPs using a template based on the structure of
the template provided in Schedule 2 of the EFPIA disclosure code.210, (p.6)
• Research and Development to be disclosed on an aggregate basis, (Section
3.04):
- Transfers of Value to HCPs/HCOs related to the planning and conduct
of:
Non-clinical studies (as defined in the OECD Principles of GLP)
- Clinical trials (as defined in Directive 2001/20/EC)
- Non-interventional studies that are prospective in nature and that
involve the collection of patient data from or on behalf of individual, or
groups of, HCPs specifically for the study (cfr Section 15.02 of the
EFPIA HCP Code)
lxiii

• Individual Healthcare Organisations:
- Contribution to Costs of Events (Sponsorship agreements with
HCOs/third parties appointed by HCOs to manage an event, including
registration fee, travel, accommodation).
- Grants & Donations to HCOs
- Fee for Service & Consultancy fees
• Individual Healthcare Professionals:
- Contribution to costs related to events (including registration fee, travel,
accommodation).
- Fees for Service & Consultancy (fees, related expenses agreed in the fee
for service or consultancy contract).
Section 1.02 of the Disclosure Code excludes the following transfers of value from
disclosure: 1) transfers that are solely related to over-the-counter medicines; 2)
transfers that are not explicitly identified in the Code, including, for example, items of
medical utility, meals/drinks, and medical samples; or 3) transfers that are part of
ordinary course purchases and sales of medicinal products by and between a member
company and a HCP or healthcare organisation.210, (p.5)
1.7.4 Individual and aggregate disclosure
It is clearly stated in Section 3.01 of the Code that transfers of value should be
disclosed on an individual basis, except when prohibited by national law or
regulations. In cases where individual disclosure cannot occur the member company
should disclose on an aggregate basis, including detail on the number and percentage
of recipients within the aggregate amount for each reporting category.210, (p.7)
Research
and Development ToVs shall be disclosed on an aggregate basis.210, (p.8)
lxiv

1.7.5 Application of the Disclosure Code in Ireland
The Irish Pharmaceutical and Healthcare Association amended its Code of Practice
during 2014 by including its interpretation of the disclosure code in Annex V: ‘IPHA
Code on Disclosure of Transfers of Value from companies to Healthcare
Professionals and Healthcare Organisations.’41
The IPHA interpretation of the EFPIA
Disclosure Code required that each member company document and publicly disclose
Transfers of Value (ToV) it made, directly or indirectly and that except as expressly
provided in the revised IPHA Code, ToVs should be disclosed on an individual basis.
Consent is required for this individual level disclosure.41, (p.76)
IPHA identified that the location of disclosure could be on the company's website or
on an IPHA central report at www.transferofvalue.ie. The revised IPHA Code
mandates referral to provisions relating to the recipients’ consent to disclose ToVs
and in their written contracts with HCPs and HCOs in accordance with the provisions
of this disclosure code. The governing language states:
‘When making a Transfer of Value to an healthcare professional or healthcare
organisation, and in their written contracts with healthcare professionals or
healthcare organisations, companies must include, or refer to, provisions
relating to the Recipients' consent to disclose Transfers of Value in accordance
with the provisions of this Disclosure Code’.41, (p.79)
Each company has to load data into a defined Template for Disclosure of ToV
including a methodological note summarising the methodologies used in preparing
lxv

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