GUIDELINES

ON ETHICAL
PHYSICIAN-PHARMA
RELATIONSHIP

A document of Pakistan Islamic Medical Association (PIMA)

PIMA PUBLICATIONS
Prepared on behalf of
PIMA Central Executive Council
By a core group comprising of:

Prof. Muhammad Iqbal Khan

Dr. Zakiuddin Ahmad

Prof. Sohail Akhtar

Text completed: October 2015

Reviewed: Nov 2015-Jan 2016
First Published: March 2016

Quantity: 3000

PAKISTAN ISLAMIC MEDICAL ASSOCIATION

12, Shalimar Centre, F-8 Markaz, Islamabad

Tel: +92 – 51 - 2261943; Fax: +92 - 51 - 2857132
www.pima.org.pk; facebook.com/pima.org.pk
[email protected], [email protected]
Contents

Preface 02

Background:

 Objectives 03

 Definitions 03

 General principles 04

Guidelines:

 Gifts, inducements or promotional aids 05

 Physicians Samples 05

 CME Meetings, Conferences, and Hospitality 06

 Sponsorship of CME events organized by

Institutions, organizations 08

 Endorsement 09

 Medical Research 09

 Miscellaneous 10

 References 11

01
Preface

In health care delivery, the tripartite relationship between doctors, patients

and pharmaceutical industry is inevitable. Doctors treat patients; both
need medicines produced after research by pharmaceutical companies;
who are in turn dependant for their sales and success on convincing
doctors and patients.

The relationship between doctors and pharmaceuticals has experienced

lots of undesired and often embarrassing situations over the years. Doctors
have been proven to be heavily influenced and accepted financial gains by
the companies against irrational and exuberant prescribing. The compa-
nies’ expenditure to retain their clients’ interest often translates into raise in
medicine prices, in addition to unethical marketing, favor of expensive
medicines over equal and cheaper alternatives and above all, losing
credibility among masses. As Muslim doctors we believe that the worst
consequence of all this would be gaining displeasure of Allah (swt).

Several guidelines have been issued in the last decade or so by associations

across the world on this relationship. PIMA has also realized the need to
educate its members in particular and health care professionals in general,
on this sensitive topic. We believe that while there are some undesirable
elements in our community tainting the name of the profession, many may
not have thought about it seriously or be unclear in some areas. After
discussing in most of its conferences, PIMA now brings its guidelines on
ethical physician-pharma relationship. This has come after review by a
dedicated group, of several guidelines and consultation with senior
members of the profession and religious scholars. We understand that this
is a stepping stone in the thought process and likely to have differing
opinions; however is the best possible draft that can be offered. We pray to
Allah swt to guide us to the best path that is favorable to Him for the benefit
of humanity. Ameen.

Central executive council of PIMA is indebted to the efforts of the core

group; we want to thank members of CEC who gave their valuable sugges-
tions. We are also grateful for review and suggestions from Prof Najeebul
Haq, Dean Peshawar Medical College; Prof Dr Ismatullah, PhD Islamic
jurisprudence, Prof of Shariah and law Islamic International University,
Islamabad; and Prof Hafiz Habib ur Rehman, Prof of Fiqah and Islamic
ideology, Islamic International University, Islamabad

02
Objectives:

To assist members of PIMA & medical community, to understand and abide

by the guidelines for Ethical Physician – Pharma Relationship

Scope of the Guidelines:

Ethical relationship between Doctors and Pharma industry.

Outcome:

To present unequivocal guidelines (clear “Do’s and Don’ts” and not

discussion points which are ambiguous) especially for the issues in the grey
areas
.

Definitions:

Ethics: is the science of morality; a branch of philosophy that is concerned with

human character and conduct. It is a moral system with rules of behavior.

Medical Ethics: comprise a set of moral rules and principles which guide
govern a member of the medical profession in discharging his professional
responsibilities in general.

Industry: any company/organization which provides medicines, medical

equipments, supplies, tools to be used in the delivery of health care

Physician: a doctor, from any field of medicine, involved in patient’s care

and/or related decision making

CME (Continuing medical education): the term includes any activity

undertaken to update or improve knowledge and/or skill of health care
professionals. Terms used in this document as synonymous include
lectures, seminars, symposia, workshops, conferences, discussion, on-line
meetings, etc.

03
General principles:

 Patients’ rights are of prime importance; there should be no relation-

ship or activity that leads to patients being overburdened or provided
wrong information. (ref 9)
 Avoid unnecessary burden or personal favors that may lead to
indulgence in unethical activities. (ref 3)
 Clear violation of Islamic principles is understandably wrong; one should
try to avoid even those activities that may lead to such acts. (ref 7)
 Keep faith in Allah swt that it is only Him that gives rizq (food, money)
and fame.
 Support of Pharma companies for doctors should not be

1. Personalized ( self serving )

2. Conditional ( deal based )

 Doctors should not enter into a written or verbal deal or agreement,

conditional & reciprocal support of any kind with Pharma industry
against their service or support for personal gains or for the benefit to
organization, hospital, institute or the patient.
 It is difficult to determine a price of a gift which may not oblige the
receiver; hence it is better to avoid gifts altogether. If receiving them, a
useful criterion may be ‘those item(s) which are purely for promotional
use, and for general distribution rather than for a selected few.

The “Ethics Check” Questions

Is it legal?
 Will I be violating either civil law or company policy?
 For a Muslim: Is it in accordance with the teachings of Quran and
Sunnah, or against?

Is it balanced?
 Is it fair to all concerned in the short term as well as the long term?
Does it promote win-win relationships?

How will it make me feel about myself?

 Will it make me proud?
 Would I feel good if my decision was published in the newspaper?
 Would I feel good if my family knew about it?

04
 GUIDELINES
Gifts, inducements or promotional aids

 It is common practice that pharmaceutical companies give promo-

tional items or gifts to doctors either as product reminders or to
oblige them. Such items may be cheap like pen, writing pads, paper
weight, or expensive like air conditioner, mobile phones etc.
 Doctor may accept insignificant promotional items for general use
e.g. mug, pen, table clock etc. if they bear a company or product
name, whose value is nominal, and he doesn’t feel influenced by it.
 Doctor should not accept items for personalized use of expensive
value eg mobile phone, computers, air conditioner etc, even if it
bears a product’s name as reminder.
 Doctor should not accept a gift as an inducement in order to
prescribe, supply, administer, recommend, buy or sell any medicine /
product.
 Doctor may accept promotional aid items that primarily benefit
patients, eg weighing scale, BP apparatus etc, so long as the items are
not of substantial value and are only occasionally offered.
 Doctor may accept text or reference-books, medical journals, CDs or
similar material if they serve a genuine educational function.

Physicians Samples

 Samples of a product/ drug may be accepted by the doctor for

patient use only and ideally used for poor patients
 Although there is no legal/ moral restriction for using drug samples
for doctor’s personal use, it is best avoided, being against the spirit.
 Drug samples should also not be accepted as a deal to prescribe
them more.
 Similarly such samples are clearly not for sale purpose.

05
CME Meetings, Conferences, and Hospitality

Objective of a CME

 The primary purpose of an educational meeting must be enhance-

ment of knowledge, share views or acquire a skill. Doctors should be
encouraged to participate in CMEs for this purpose with the objective
of gaining current, accurate and balanced medical education.
 One should be clear that attending such meeting a) outweighs the
acquisition of same knowledge through conventional means like
journals, audio visual aids and internet, and b) the opportunity is
taken for knowledge sake rather than simply an outing.
 Such CMEs should be held in an ethical and professional manner and
focus on education. Lavish expenditure on meals, unnecessary hospi-
tality and grand social events should not be the spirit of such events

Participation in a CME

 During participation in a CME, almost all of the time should be spent

on its educational component. Participation in social and promotion-
al activities should be discouraged, or if opted, be minimal (less than
20 per cent of the time) and not during prime educational time.
 Such meetings, wherever possible, should be held in the same city to
avoid out of station traveling
 Doctor should avoid participation in a scientific event in other city or
country when equally effective activity(ies) are held in his home town
 Doctors may accept hospitality and meals during/ for the meetings,
but it should always be secondary to the main purpose of the meeting.
 When attending academic conferences, doctors should not indulge in:
 Lucky draws, dart board game or similar recreational activities
during the period of scientific sessions.
 Social events like musical concert etc. of lavish and expensive
nature

Sponsorships offered by pharmaceutical companies

 Wherever possible, particularly when such expenses are in doctor’s

reach, travel, accommodation and registration of scientific meetings
should be borne by the doctor himself. Resources may be generated
from doctor’s personal funds, their institutions, or through grants
offered by some conference organizers to presenters of scientific
papers/ lectures.
06
 Doctor can accept hospitality of a journey from companies to another
city or to a foreign country if:

 it is purely for an academic activity, and

 he is presenting a scientific paper/lecture, and
 the presenters/speakers are from the local city or country, where
the trip is being organized.
 Air travel for attending an educational meeting, if needed to be
provided by the sponsors, must be by economy class only.
 Any doctor other than presenter, who wishes to participate in an
educational meeting through sponsorship, should route it through
his institution/organization i.e. a committee of peers rather than
individually.

Non academic activities

 Doctor should not attend company sponsored pleasure trips, not

associated with or part of academic activities, including passes or
tickets to attend expensive outings or music concerts etc. just for the
sake of entertainment.
 Doctor should not accept invitations/coupons to company
sponsored meals, Iftar dinners or similar invitations which are not
associated with any academic activity.

Others:

 Medical students, residents and others in training may accept

scholarships or sponsorships to attend CMEs if the selection of the
attendee is made by the academic/ training institution; such
selection should be based on participant’s contribution in academ-
ics/ research.
 Doctor should not demand or accept, from pharmaceutical compa-
nies, hospitality of a trip for his accompanying spouse or other family
member or friend to another city or to a foreign country.

07
 Sponsorship of CME events organized
by institutions/ organizations

 Continuing medical education (CME) meetings eg conferences

contribute to the improvement of patient care through enhance-
ment of knowledge of participants. Institutions/ organizations should
be satisfied that such meetings are not just for the sake of an activity,
and serves a genuine educational need.
 Such CME meetings should budget expenses to the minimum and
ideally be held in educational institutions. Hotels, holiday resorts or
recreational places should be avoided where non academic focus
overrides the educational objectives and lavish meals add on to
unnecessary spending.
 Keeping above in perspective, and to meet the expenses of such
events, financial support from companies is permissible. However,
meetings for organization’s administrative needs eg half yearly
review meetings, should be held on their own expenses. Similarly
companies should not sponsor non academic activities eg recreation-
al outings, musical evenings, which are not part of CME.
 Stalls, banners, advertisements or other promotional display items of
participating companies may be allowed against their sponsorship,
outside the main conference halls.
 There should be no written or verbal agreement by organizers or on
a personal level, of conditional & reciprocal support with participat-
ing companies against such service.
 A prior agreement may be done with sponsors on the fate of leftover
amount whether it should be returned to the sponsors or can be utilized
by the organization/ institution for their development or welfare.

08
Endorsement

 Doctors should not promote a product/company during their

scientific presentations by:
 Placing the name of the brand, or logo, in the slides. (Only gener-
ic names to be displayed)
 Placing the name of the company or logo in the slides.
 When briefing the audience about a drug or product, doctors should
be fair in explaining its benefits and adverse effects both, as well as
objective comparison with alternatives.
 Any study conducted on the efficacy or safety of a product should be
presented to and/ or through appropriate scientific bodies after
approval from an Institutional Review Board (IRB)/ Ethical Review
Board (ERB).
 Doctor may participate in health awareness programs to improve
knowledge amongst public on preventive and therapeutic aspects of
a disease. Product names should be in generics, in display material or
presentation. Presenters should be fair in explaining all aspects of a
drug, and not just highlight its benefits only. Doctors participation in
advertisement of a product is however to be avoided.

Medical Research
 Doctor, while participating in a drug trial, must meet the current
scientific, ethical and legal requirements/regulations and must
conform to the internationally recognized principles of Good Clinical
Practice.
 Funding for medical research or study can only be received through
IRBs by modalities laid down by law and guidelines adopted by such
approved institutions, in a transparent manner. It shall always be fully
disclosed.
 Investigators taking part in a trial should not take part in marketing
promotions for the product or procedure investigated.
 Doctor can accept an honorarium against the time of their involve-
ment in a clinical trial/research study, in Industry initiated trials, or
Investigator/ doctor initiated trials/ studies. It should be disclosed to
the IRB, and should be without any conflict of interest.

09
Miscellaneous

 Doctors should not request fee from the industry representative for
the grant of a meeting for product briefing.
 Such meetings should not be held in hospital/clinic prime (active)
timings at the cost of patient dealing or official work
 In the conferences and presentations, drugs are, in principle, to be
referred to by their internationally recognized generic name.
 Doctor can accept an honorarium against the time of their involve-
ment, in a presentation on invitation, ensuring complete disclosure
and without any conflict of interest.
 Doctors can purchase a product from company at low price, as
compared to market price, to benefit the patient by selling him at the
cost price without any profit.
 Doctors should avoid purchasing pharmaceutical company shares to
avoid conflict of interest in prescribing.

Dua at the end:

10
Reference Sources

Some references, guidance from Quran and Hadith:

11
 Code of Ethics-2001, Pakistan Medical and Dental Council (PMDC)
 Medical Ethics: an Islamic perspective. Prof Mohammad Iqbal Khan (2013)
 Guidelines for Doctors-Pharmaceutical Industry Relationship, Pakistan Medical
Association-PMA (October 2006)
 Pakistan National Code of Pharmaceutical Marketing Practices by Pakistan
Association of Pharmaceutical Physicians (PAPP)
 Guidelines on physician-pharmaceutical relationships: consensus of sharia
advisory board of Peshawar Medical College (2015)

(2011 ) 


(2010 )

 Islamic Medical Association of North America (IMANA) Islamic Medical Ethics

 Guidelines of the American College of Physicians (1990)
 Managing Ethical Behavior - American College of Physician Executives (ACPE-
March 2005)
 Medicine Australia, Code of Conduct: 16th Version (2010)
 Professional Conduct, Etiquette and Ethics – Amended Regulations 2009, Ethics
Regulations of Indian Medical Council (2002)
 Medical Ethics Manual: World Medical Association (WMA)
 International Federation of Pharmaceutical Manufacturers and Associations
(IFPMA) Code of Pharmaceutical Marketing Practices (2006 Revision)
 European Federation of Pharmaceutical Industries and Associations (Epfia)
Code of Practice on the Promotion of Medicines (2004 Edition)
 Irish Pharmaceutical Healthcare Association (IPHA) Code of Pharmaceutical
Marketing Practices (September 2006)
 Canadian Marketing Association (CMA) Code of Ethics and Standards of
Practice (CMA)
 Code of Conduct of the Pharmaceutical Industry in Switzerland (Pharma Code)
(December 4, 2003)
 Singapore Association of Pharmaceutical Industries (SAPI) Code of Marketing
Practices
 Pharmaceutical Research and Manufacturers of America (PhRMA) Pharma Code
on Interaction with Healthcare Professionals (Revised January 2009)
 Food and Drug Administration (FDA) Final Guidance on Industry Supported
Scientific and Educational Activities (December 3, 1997)
 Pharmaceutical Research and Manufacturers of America (PhRMA) Pharma
Code on Interaction with Healthcare Professionals (Revised July 2008)
 GSK European Promotion of Medicines Code of Practice (2nd Edition 2007)
 Abbot Laboratories Code of Business Conduct
 Ethical Marketing and Use (Lilly)
 Novartis Code of Conduct (Revised June 2001)
 Ethics and Pharmaceutical Marketing – The Pfizer way
 ABPI Code of Practice for the Pharmaceutical Industry (2008)
 The Kuwait Document
 Jeddah Declaration
12
PAKISTAN ISLAMIC MEDICAL ASSOCIATION (PIMA)

Mission Statement

To seek the pleasure of Almighty Allah through character

building and service to mankind.

Aims and Objectives

To motivate doctors to trail the tenets of Islam, adopt Islamic way of life and
organize doctors, agreed to the goal of PIMA, at an effective platform.

To provide opportunities for ideological, ethical and professional

training of doctors at large scale particularly for its members and associates.

To strive for provision of medical assistance to those in dire need,

in disasters or in less privileged areas within the country and abroad.

To use the doctor–patient relationships in the best

concern of the society for dissemination of Islam ideology.

To strive for holistic National Health Policy and Medical

Education in line with the Islamic teachings.

Solving problems of health care professionals and

professional organizations on ethical lines.