1. PHAP Code of Pharmaceutical Marketing 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 practice through accurate information for appropriate use
Preserve the independence of 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. PERSONAL MATERIAL BENEFIT
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
Employee/Agent of a Pharma Company
SECONDARY INTEREST:
PERSONAL MATERIAL BENEFIT
Independent Judgment
Compromised
Patient
PRIMARY INTEREST:
PATIENT CARE
Healthcare Professional

6. Falsification of safety/Efficacy data Counterfeit/ substandards
UNETHICAL PRACTICES IN THE MEDICINES CHAIN Italics 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
ConfIict of Interest
Selection
Procurement & Import
Unethical donations
State/regulatory capture
Unethical promotion
Distribution
Promotion
Tax evasion
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, s, 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
OVERSEAS Max 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
LOCAL Must 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 P 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 allowed fax, 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 the Ethics Committee of PHAP

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 DR. GODOFREDA DALMACION
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. SANCTIONS FOR 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 Provision Written 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. WE ARE COMMITTED
TO USE PROFESSIONALISM IN DEALING WITH HEALTHCARE PROFESSIONALS, PUBLIC HEALTH OFFICIALS AND THE GENERAL PUBLIC.

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