PHAP Code
of Pharmaceutical
Marketing Practices
Dr. Quintin Kintanar
CODE
PHAP
OF MKTG
ETHICS
Vice-chairman
Dr. Benito Teehankee
Member
Ethics Committee
Pharmaceutical and
Healthcare
Association of the
Philippines (PHAP)
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.
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
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.
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
PRIMARY INTEREST: Compromised
PATIENT CARE
Patient
Healthcare
Professional
UNETHICAL PRACTICES IN
THE MEDICINES CHAIN
Italics fall under PHAP/Ethics Committee Concerns
Collusion
R&D and clinical trials
Evergreening
Bribery
Patent
Manufacturing
Registration
Falsification of
safety/Efficacy data
Cartels
Counterfeit/
substandards
Pricing
ConfIict
of
Interest
State/regulatory
capture
Overinvoicing
Fraud
Selection
Procurement & Import
Distribution
Unethical
promotion
Pressure
Unethical
donations
Promotion
Tax
evasion
Inspection
Thefts
Adapted from WHO
Important Points in R&D
• Clinical trial of a new drug by trained clinicians; wellplanned 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
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.
OUTLINE OF THE CODE
Preamble
1. Scope, Interpretation, Responsibility and Exclusions
2. Medical Information and Claims
3. Product Information
4. All Promotional/Educational
Material
5. Mailings, faxes, emails,
text messages
6. Competitions and raffles
7. The use of the Internet for
Pharmaceutical Information
8. Medical representatives
9. Product samples
10.Exhibit Booths
11.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
SCOPE OF THE CODE
• Medical information and claims
• Product information
• Promotional/
educational materials
• Medical representatives
• Product Samples
• Booths
SCOPE OF CODE
• Continuing Medical Education (CME)
• Relationship Building
• Gifts to Healthcare
Professionals
• Communications
with the General
Public
CAN PHAP MEMBERS SUBSIDIZE
DOCTORS’ EXPENSES FOR CME?
• YES, provided:
Scientific objectives
should be the
primary focus of
meetings
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.
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
CME
• 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.
RELATIONSHIP BUILDING
• Simple/inexpensive
business meals/
cocktails
• Only before or
following scientific
meetings/discussion.
RELATIONSHIP BUILDING
• No sports activities
are allowed.
• NOT EVEN in
connection with
scientific meetings
or CME
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
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
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)
ETHICS CODE
• SUPPORT TO THE ACTIVITIES OF
THE HEALTHCARE PROFESSIONALS
WILL CONTINUE FOR AS
LONG AS IT IS CONSISTENT
WITH THE CODE
ADMINISTRATION OF THE CODE
• Supervised by the
Ethics Committee of
PHAP
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
MEMBERS
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.
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
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
SANCTIONS
• 1st Time Violation of a Provision
Written commitment to discontinue/
modify practice PLUS
P100,000 FINE
SANCTIONS
• 2nd Time Violation of Same Provision
 BFAD, Scrip and Company HQ will
be advised of affiliate’s offense
PLUS
 P250,000 FINE
SANCTIONS
• Repeated Violation of Same Provision
 BFAD will be
advised.
BFAD
 Suspension from
PHAP
 FINE with an amount to be determined
by the Ethics Committee
SANCTIONS
• Willful disregard for sanctions imposed
 Expulsion from PHAP
 A public announcement
will be made in major
daily newspapers
WE ARE COMMITTED
• TO USE PROFESSIONALISM IN
DEALING WITH HEALTHCARE
PROFESSIONALS,
PUBLIC HEALTH
OFFICIALS AND
THE GENERAL
PUBLIC.
FOR THE CODE TO BE
MEANINGFUL, WE NEED
YOUR SUPPORT