1. International Federation
of Pharmaceutical
Manufacturers & Associations
IFPMA Code of Practice
2012
© IFPMA 20131

2. Our Role and Commitment
© IFPMA 20132

3. 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.
© IFPMA 20133

4. 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
4 © IFPMA 2013

5. 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

6. 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
6 © IFPMA 2013

7. 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)
7 © IFPMA 2013

8. 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.
8 © IFPMA 2013

9. 9
2012 Revision: Key changes
© IFPMA 2013

10. 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

11. • 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
11 © IFPMA 2013

12. Compliance is not a program. It is a way of doing business
Promoting an Ethical Climate
Global Code:
IFPMA
Regional &
National Codes
12 © IFPMA 2013

13. 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?
13 © IFPMA 2013

14. 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
14 © IFPMA 2013

15. Code Operating Procedure
May 11, 2012 © IFPMA 201215
http://www.ifpma.org/ethics/ifpma-code-of-practice/operating-procedure.html
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16. http://www.ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-practice.html
IFPMA Code Website
16 © IFPMA 2013

17. IFPMA Code e-learning Tool
http://www.ifpma.org/ethics/ifpma-code-of-practice/ ifpma-online-code-training.html
© IFPMA 201317