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IFPMA Code of Practice2012
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 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
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 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
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 15
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
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