IFPMA Code of Practice 2012


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IFPMA Code of Practice 2012

  1. 1. International Federationof PharmaceuticalManufacturers & AssociationsIFPMA Code of Practice2012© IFPMA 20131
  2. 2. Our Role and Commitment© IFPMA 20132
  3. 3. The CodeThe Code is:• A model of self-regulation for pharmaceutical industry’sactivities in medicines promotion, communication andinteraction with key stakeholders such as healthcareprofessionals, medical institutions and patient organizations.• Although self-regulatory, the IFPMA Code is not voluntary, it isa condition of membership to the IFPMA for both membercompanies and national associations.© IFPMA 20133
  4. 4. Requirements of the CodeThe IFPMA Code is guided by 8 high-levelprinciples and requires that:• the primary objective is patient safety and full information tohealth care professionals• promotional activities are carried out in a responsible, ethical andprofessional manner• therapeutic choices of doctors should be based on objectiveinformation and not swayed by nonscientific or non-transparentconsiderations• a balance is sought between the needs of patients, healthprofessionals and the general public4 © IFPMA 2013
  5. 5. IFPMA Code Coverage• The IFPMA Code DOESregulate:– Standards of promotionalinformation incl.promotional material– Pre-approvalcommunications & off-labeluse– Interactions with keystakeholders inclsponsorship to scientificcongresses– Samples5• The IFPMA Code DOES NOTregulate:– Pricing and terms of trade– Communication with thepublic– Disclosure of payments toHCPs, patientorganizations and medicalinstitutions© IFPMA 2013
  6. 6. Value of Ethical Promotionof Medicines• Ethical promotion helps ensures that: Healthcare professionals have access toinformation they require; Patients have access to the medicines they need;and That medicines are prescribed and used to benefitpatients worldwide6 © IFPMA 2013
  7. 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. 8. External Requirements & Regulation• IFPMA respects and recognizes the role of:– National laws and regulations, national associationcodes, pharmaceutical company codes, professionalcodes, SOPs, and guidelines;– + Ethical Criteria for Medicinal Drug Promotionprovided by the World Health Organization in 1988; and– + Relevant codes and principles of ethics developed by theWorld Medical Association, International Council ofNurses and the International Federation ofPharmacists.8 © IFPMA 2013
  9. 9. 92012 Revision: Key changes© IFPMA 2013
  10. 10. 2012 Revision: New Provisions10*IFPMA/EFPIA/PhRMA/JPMA Joint Positionon the Disclosure of Clinical Trial Informationvia Clinical Trial Registries and Databases(2009) & IFPMA/EFPIA/PhRMA/JPMA JointPosition on Publication of Clinical TrialResults in the Scientific Literature (2010)© IFPMA 2013
  11. 11. • Promotional Aids (strictprovision)• Items of Medical Utility (strictprovision)• Hosting of scientificpromotional meetings• Limited sponsorship togenuine scientific event• Cultural Courtesy Gifts (i.e.inexpensive gifts not relatedto medical utility, and only ifallowed by local law)• Meals/Dinners if in connectionto an event and secondary• Monetary Gifts• Personal Gifts (i.e. flowers,jewelry, cars, etc.)• Recreational Activities (i.e.golf, tickets to sportingevents, concert, vacations,etc.)• Sponsoring of family eventsor paying for aguest/companion• Meals/Dinners if not inconnection to an event• Any form of entertainment(i.e. company paid for musicalperformance during dinner)ALLOWED NOT ALLOWEDDOs & DON’TsGO11 © IFPMA 2013
  12. 12. Compliance is not a program. It is a way of doing businessPromoting an Ethical ClimateGlobal Code:IFPMARegional &National Codes12 © IFPMA 2013
  13. 13. Global implementation:1 September 2012• Increased global standard on how research-basedpharmaceutical companies conduct business and interact withkey stakeholders• Direct applicability of the IFPMA Code and the operatingprocedure of the IFPMA Code are in countries where thereare no national codes or where a member company maynot be a member of the local association• Requires national and company codes to be revised asnecessary to align with new provisions of the IFPMA CodeWhat does it mean in practice?13 © IFPMA 2013
  14. 14. Code Compliance Network (CCN)• Established in 2006• Gathers worldwide experts to discuss latestdevelopments and issues in the field of ethicalpromotion of medicines• Composed of at least one representative from eachIFPMA member association & member company• Currently the network has over 100 members14 © IFPMA 2013
  15. 15. Code Operating ProcedureMay 11, 2012 © IFPMA 201215http://www.ifpma.org/ethics/ifpma-code-of-practice/operating-procedure.html15
  16. 16. http://www.ifpma.org/ethics/ifpma-code-of-practice/about-ifpma-code-of-practice.htmlIFPMA Code Website16 © IFPMA 2013
  17. 17. IFPMA Code e-learning Toolhttp://www.ifpma.org/ethics/ifpma-code-of-practice/ ifpma-online-code-training.html© IFPMA 201317