PHAP Code of Pharmaceutical Marketing Practices

1. PHAP Code of PharmaceuticalMarketing Practices Dr. Quintin Kintanar Vice-chairman Dr. Benito Teehankee Member Ethics Committee Pharmaceutical and Healthcare Association of the Philippines (PHAP) CODE OF MKTG ETHICS PHAP

2. WHAT IS IT? • Also referred to as the ETHICS CODE, it sets the standards for the ethical marketing and promotion of prescription products directed to the healthcare professions.

3. CORE PRINCIPLES • All educational and promotional activities conducted/supported by pharmaceutical companies should: • Benefit patients • Enhance medical practicethrough accurate information for appropriate use • Preserve the independenceof healthcare professionals

4. Independence of Healthcare Professionals • Independence means objectivity and impartiality in the exercise of medical judgment. This means the absence of a conflict of interest, whether potential, apparent or actual. • A conflict of interest is any situation in which a healthcare professional is in a position to exploit his/her professional or official capacity in some way for personal benefit. (Adapted from Wikipedia) • Thus, anything that would be of personal benefit to the healthcare professional is not to be offered or given.

5. Employee/Agentof a Pharma Company HealthcareProfessional Patient Conflict of Interest “A conflict of interest occurs in a situation in which professional judgment regarding a primary interest, such as research, education or patient care, may be unduly influenced by a secondary interest, such as financial [material/personal] gain or personal prestige.” --Adapted from “Conflict of interest in research, education and patient care” by T Lemmens and P A Singer SECONDARY INTEREST: PERSONAL MATERIAL BENEFIT IndependentJudgment Compromised PRIMARY INTEREST: PATIENT CARE

6. UNETHICAL PRACTICES IN THE MEDICINES CHAINItalics fall under PHAP/Ethics Committee Concerns Collusion R&D and clinical trials Evergreening Bribery Patent Fraud Manufacturing Overinvoicing Cartels Falsification of safety/Efficacy data Registration Counterfeit/substandards Pricing ConfIictofInterest Selection Procurement & Import Unethical donations State/regulatorycapture Unethicalpromotion Distribution Promotion Taxevasion Pressure Inspection Thefts Adapted from WHO

7. Important Points in R&D • Clinical trial of a new drug by trained clinicians; well-planned and documented • In the Philippines, post-marketing surveillance study: • may be viewed as similar to a clinical trial requiring a research protocol and a reporting form • should be limited to products under BFAD monitored release certificate of product registration • applicable to new products within 3 years of BFAD approval for marketing

8. TO WHOM DOES THE CODE APPLY? • Mandatory for all PHAP members who are also accountable for the actions of all their agents. • Direct PHAP Member/Indirect Members • Local subsidiaries of IFPMA member companies. • Non-member companies also expected to respect the Code.

9. OUTLINE OF THE CODE Preamble • Scope, Interpretation, Responsibility and Exclusions • Medical Information and Claims • Product Information • All Promotional/Educational Material • Mailings, faxes, emails, text messages • Competitions and raffles • The use of the Internet for Pharmaceutical Information • Medical representatives • Product samples • Exhibit Booths • Continuing Medical Education Appendix I: Guidelines on communication of prescription products to the general public Appendix II: Post-marketing surveillance Appendix III: Types of breaches and corresponding penalties and fines

10. SCOPE OF THE CODE • Medical information and claims • Product information • Promotional/educational materials • Medical representatives • Product Samples • Booths

11. SCOPE OF CODE • Continuing Medical Education (CME) • Relationship Building • Gifts to Healthcare Professionals • Communications with the General Public

12. CAN PHAP MEMBERS SUBSIDIZE DOCTORS’ EXPENSES FOR CME? • YES, provided:Scientific objectives should be the primary focus of meetings

13. CAN PHAP MEMBERS SUBSIDIZE DOCTORS’ EXPENSES FOR CME? • Sponsorship not conditional upon any obligation to prescribe or promote any product • Sponsorship limited to economy travel to and from venue. NO SIDE TRIPS. • Company can subsidize meals, registration and accommodation for the duration of CME with maximum additional of 2 days only(EX: if CME runs for 5 nights, company may pay for up to 7 nights). Arrival/departure dates are considered.

14. CAN PHAP MEMBERS SUBSIDIZE DOCTORS’ EXPENSES FOR CME? • NO CASH ASSISTANCE • Family/spouses not allowed unless medically qualified and practicing in a therapeutic area relevant to the CME • Honoraria/compensation not allowed unless healthcare professional attending as speaker

15. C M E • OVERSEASMax of 7 doctors per company. More than this no., rationale of overseas vs. in-country meeting becomes questionable. • REGIONAL (ASEAN countries, Hong Kong, Taipei and China)Max of 12 doctors per company • LOCALMust be in appropriate business centers, not resort locations. Participants to pay for registration fees.

16. RELATIONSHIP BUILDING • Simple/inexpensive business meals/ cocktails • Only before or following scientific meetings/discussion.

17. RELATIONSHIP BUILDING • No sports activities are allowed. • NOT EVEN in connection with scientific meetings or CME

18. COMPETITIONS • Must be based on medical knowledge • Prizes must be relevant and specific to the practice of medicine • Prizes offered are to be of low monetary value

19. RAFFLES / GIFTS • Support of raffles with high value items is inappropriate • Gifts allowed provided- it is less than P1000- it benefits patients- it is specific to the practice of medicine • Cultural gifts (Christmas and other religious holidays) are allowed • Birthday gifts are not allowed

20. DONATIONS • Donations are to institutions, not individuals • Items must have direct use in medical care and diagnosis (ECG, stethoscopes, x-rays) • Business machines/appliances not allowedfax, pagers, cellphones, furniture, AC)

21. ETHICS CODE • SUPPORT TO THE ACTIVITIES OF THE HEALTHCARE PROFESSIONALS WILL CONTINUE FOR AS LONG AS IT IS CONSISTENT WITH THE CODE

22. ADMINISTRATION OF THE CODE • Supervised by theEthics Committee ofPHAP

23. 2007 ETHICS COMMITTEE MEMBERS • REINER W. GLOOR – CHAIRMAN Non-executive Chairman- Zuellig Pharma Vice-Chairman – Zuellig Foundation • DR. QUINTIN KINTANAR – VICE CHAIRMAN Former BFAD Head

24. MEMBERS • PROF. JACINTO GAVINO • ASIAN INSITUTE OF MGMT • HOLDER OF FR. JAMES • DONELAN, S.J. CHAIR IN • BUSINESS ETHICS • DR. ANTONETTE PALMA-ANGELES • ATENEO DE MANILA UNIVERSITY, VICE PRESIDENT FOR ACADEMICS • ETHICS PROFESSOR • DR. BENITO TEEHANKEE • HOLDER OF SEN. BENIGNO AQUINO, JR CHAIR IN CORPORATE SOCIAL RESPONSIBILITY AND GOVERNANCE • ETHICS ASSOCIATE PROFESSOR DR. GODOFREDA DALMACION • UP – MANILA DEPT. OF CLINICAL EPIDEMIOLOGY MR. PAUL KLEINER • FORMER PRESIDENT OF ZUELLIG PHARMA DR. SANTIAGO GUZMAN • MEDICAL CONSULTANT DR. KENNETH HARTIGAN-GO • EXECUTIVE DIRECTOR ZUELLIG FOUNDATION, INC.

25. SANCTIONSFOR NON-PHAP MEMBERS FOR VIOLATIONS BROUGHT TO THE ATTENTION OF THE ETHICS COMMITTEE INVOLVING NON-PHAP MEMBERS, THE COMPLAINANT WILL BE ADVISED TO REFER THE MATTER TO BFAD AND/OR APPROPRIATE CONCERNED BODIES

26. SANCTIONS • 1st Time Violation of a ProvisionWritten commitment to discontinue/ modify practice PLUS P100,000 FINE

27. SANCTIONS • 2nd Time Violation of Same Provision BFAD, Scrip and Company HQ will be advised of affiliate’s offense PLUS P250,000 FINE

28. SANCTIONS • Repeated Violation of Same Provision BFAD will be advised. Suspension from PHAP FINE with an amount to be determined by the Ethics Committee BFAD

29. SANCTIONS • Willful disregard for sanctions imposed Expulsion from PHAP A public announcement will be made in major daily newspapers

30. TO USE PROFESSIONALISM IN DEALING WITH HEALTHCARE PROFESSIONALS, PUBLIC HEALTH OFFICIALS AND THE GENERAL PUBLIC. WE ARE COMMITTED

31. FOR THE CODE TO BE MEANINGFUL, WE NEED YOUR SUPPORT