International Federation

of Pharmaceutical

Manufacturers & Associations

IFPMA Code of Practice

2012

© IFPMA 2013 1

Our Role and Commitment

© IFPMA 2013 2

The Code

The Code is:

• A model of self-regulation for pharmaceutical industry’s

activities in medicines promotion, communication and

interaction with key stakeholders such as healthcare

professionals, medical institutions and patient organizations.

• Although self-regulatory, the IFPMA Code is not voluntary, it is

a condition of membership to the IFPMA for both member

companies and national associations.

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Requirements of the Code

The IFPMA Code is guided by 8 high-level

principles and requires that:

• the primary objective is patient safety and full information to

health care professionals

• promotional activities are carried out in a responsible, ethical and

professional manner

• therapeutic choices of doctors should be based on objective

information and not swayed by nonscientific or non-transparent

considerations

• a balance is sought between the needs of patients, health

professionals and the general public

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IFPMA Code Coverage

• The IFPMA Code DOES

regulate:

– Standards of promotional

information incl.

promotional material

– Pre-approval

communications & off-label

use

– Interactions with key

stakeholders incl

sponsorship to scientific

congresses

– Samples

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• The IFPMA Code DOES NOT

regulate:

– Pricing and terms of trade

– Communication with the

public

– Disclosure of payments to

HCPs, patient

organizations and medical

institutions

© IFPMA 2013

Value of Ethical Promotion

of Medicines

• Ethical promotion helps ensures that:

Healthcare professionals have access to information they require;

Patients have access to the medicines they need;

and

That medicines are prescribed and used to benefit patients worldwide

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IFPMA Code History

1981 The first IFPMA Code established

1982 Complaints procedure announced

1983 Decision to publish breaches to the Code

1988 Code becomes a condition of membership to IFPMA

1989 Three language versions (English, French & Spanish)

1993 Decision to revise the IFPMA Code

1994 Adoption of the 1994 revised edition of the IFPMA Code

1995 Implementation of the 1994 Revised Edition, (1 March)

2000 Minor revision – Addendum 1: Use of the Internet

2006 Decision to revise the IFPMA Code

2007 Implementation of the 2006 Revision, (1 January)

2011 Decision to revise the IFPMA Code

2012 Implementation of 2011 revision (1 September)

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External Requirements & Regulation

• IFPMA respects and recognizes the role of:

– National laws and regulations, national association

codes, pharmaceutical company codes, professional

codes, SOPs, and guidelines;

– + Ethical Criteria for Medicinal Drug Promotion

provided by the World Health Organization in 1988; and

– + Relevant codes and principles of ethics developed by the

World Medical Association, International Council of

Nurses and the International Federation of

Pharmacists.

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2012 Revision: Key changes

© IFPMA 2013

2012 Revision: New Provisions

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*IFPMA/EFPIA/PhRMA/JPMA Joint Position

on the Disclosure of Clinical Trial Information

via Clinical Trial Registries and Databases

(2009) & IFPMA/EFPIA/PhRMA/JPMA Joint

Position on Publication of Clinical Trial

Results in the Scientific Literature (2010)

© IFPMA 2013

• Promotional Aids (strict provision)

• Items of Medical Utility (strict provision)

• Hosting of scientific promotional meetings

• Limited sponsorship to genuine scientific event

• Cultural Courtesy Gifts (i.e. inexpensive gifts not related to medical utility, and only if allowed by local law)

• Meals/Dinners if in connection to an event and secondary

• Monetary Gifts • Personal Gifts (i.e. flowers,

jewelry, cars, etc.) • Recreational Activities (i.e.

golf, tickets to sporting events, concert, vacations, etc.)

• Sponsoring of family events or paying for a guest/companion

• Meals/Dinners if not in connection to an event

• Any form of entertainment (i.e. company paid for musical performance during dinner)

ALLOWED NOT ALLOWED

DOs & DON’Ts

GO

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Compliance is not a program. It is a way of doing business

Promoting an Ethical Climate

Global Code:

IFPMA Regional &

National Codes

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Global implementation: 1 September 2012

• Increased global standard on how research-based pharmaceutical companies conduct business and interact with key stakeholders

• Direct applicability of the IFPMA Code and the operating procedure of the IFPMA Code are in countries where there are no national codes or where a member company may not be a member of the local association

• Requires national and company codes to be revised as necessary to align with new provisions of the IFPMA Code

What does it mean in practice?

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Code Compliance Network (CCN)

• Established in 2006

• Gathers worldwide experts to discuss latest developments and issues in the field of ethical promotion of medicines

• Composed of at least one representative from each IFPMA member association & member company

• Currently the network has over 100 members

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Code Operating Procedure

May 11, 2012 © IFPMA 2012 15 http://www.ifpma.org/ethics/ifpma-code-of-practice/operating-procedure.html

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http://www.ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-practice.html

IFPMA Code Website

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IFPMA Code e-learning Tool

http://www.ifpma.org/ethics/ifpma-code-of-practice/ ifpma-online-code-training.html © IFPMA 2013 17