ifpma code of practice2012
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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.
© IFPMA 2013 3
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
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
5
• 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
6 © IFPMA 2013
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
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
2012 Revision: Key changes
© IFPMA 2013
2012 Revision: New Provisions
10
*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
11 © IFPMA 2013
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
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
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
Code Operating Procedure
May 11, 2012 © IFPMA 2012 15 http://www.ifpma.org/ethics/ifpma-code-of-practice/operating-procedure.html
15
http://www.ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-practice.html
IFPMA Code Website
16 © IFPMA 2013
IFPMA Code e-learning Tool
http://www.ifpma.org/ethics/ifpma-code-of-practice/ ifpma-online-code-training.html © IFPMA 2013 17