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![Page 1: PHAP Code of Pharmaceutical Marketing Practices CODE OF MKTG ETHICS Dr. Quintin Kintanar Vice-chairman Dr. Benito Teehankee Member Ethics Committee Pharmaceutical.](https://reader035.fdocuments.net/reader035/viewer/2022062421/56649db55503460f94aa6f9a/html5/thumbnails/1.jpg)
PHAP Code of Pharmaceutical
Marketing Practices
CODE
OF MKTG
ETHICS
Dr. Quintin Kintanar Vice-chairman
Dr. Benito TeehankeeMember
Ethics CommitteePharmaceutical and HealthcareAssociation of the Philippines (PHAP)
PHAP
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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.
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CORE PRINCIPLESAll educational and promotional activities conducted/supported by pharmaceutical companies should:
• Benefit patients• Enhance medical practice
through accurate information for appropriate use
• Preserve the independenceof healthcare professionals
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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.
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Conflict of Interest
PRIMARY INTEREST:PATIENT CARE
Patient HealthcareProfessional
“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/Agentof a Pharma Company
SECONDARY INTEREST:PERSONAL MATERIAL BENEFIT
IndependentJudgment
Compromised
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UNETHICAL PRACTICES IN THE MEDICINES CHAIN
Italics fall under PHAP/Ethics Committee Concerns
R&D and clinical trials
Patent
Manufacturing
Registration
Pricing
Selection
Procurement & Import
Distribution
Promotion
Inspection
Evergreening
Overinvoicing
CollusionBribery
Fraud
Cartels
Counterfeit/substandards
Unethical donations
Falsification of safety/Efficacy data
ConfIictof
Interest
State/regulatorycapture
Unethicalpromotion
TaxevasionPressure
TheftsAdapted from WHO
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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
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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.
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OUTLINE OF THE CODEPreamble1. Scope, Interpretation, Responsibility and Exclusions2. Medical Information and Claims3. Product Information4. All Promotional/Educational
Material5. Mailings, faxes, emails,
text messages6. Competitions and raffles7. The use of the Internet for
Pharmaceutical Information8. Medical representatives9. Product samples10.Exhibit Booths11.Continuing Medical EducationAppendix I: Guidelines on communication of prescription products to
the general publicAppendix II: Post-marketing surveillanceAppendix III: Types of breaches and corresponding penalties and
fines
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SCOPE OF THE CODE
• Medical information and claims
• Product information
• Promotional/educational materials
• Medical representatives
• Product Samples
• Booths
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SCOPE OF CODE
• Continuing Medical Education (CME)
• Relationship Building
• Gifts to Healthcare Professionals
• Communications with the General Public
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CAN PHAP MEMBERS SUBSIDIZE DOCTORS’ EXPENSES FOR CME?
• YES, provided:
Scientific objectives should be the primary focus of meetings
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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.
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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
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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
• LOCALMust be in appropriate business centers, not resort locations. Participants to pay for registration fees.
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RELATIONSHIP BUILDING
• Simple/inexpensive business meals/ cocktails
• Only before or following scientific meetings/discussion.
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RELATIONSHIP BUILDING
• No sports activities are allowed.
• NOT EVEN in connection with scientific meetings or CME
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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
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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
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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)
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ETHICS CODE
• SUPPORT TO THE ACTIVITIES OF THE HEALTHCARE PROFESSIONALS WILL CONTINUE FOR AS LONG AS IT IS CONSISTENT WITH THE CODE
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ADMINISTRATION OF THE CODE
• Supervised by the
Ethics Committee of
PHAP
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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
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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.
MEMBERS
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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
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SANCTIONS
• 1st Time Violation of a Provision
Written commitment to discontinue/ modify practice PLUS P100,000 FINE
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SANCTIONS
• 2nd Time Violation of Same Provision
BFAD, Scrip and Company HQ will be advised of affiliate’s offense
PLUS
P250,000 FINE
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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
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SANCTIONS
• Willful disregard for sanctions imposed
Expulsion from PHAP
A public announcement will be made in major daily newspapers
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WE ARE COMMITTED
• TO USE PROFESSIONALISM IN DEALING WITH HEALTHCARE PROFESSIONALS, PUBLIC HEALTH OFFICIALS AND THE GENERAL PUBLIC.
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FOR THE CODE TO BE MEANINGFUL, WE NEED
YOUR SUPPORT