PHAP Code of Pharmaceutical Marketing Practices

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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
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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 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

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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
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
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UNETHICAL PRACTICES IN THE MEDICINES
CHAINItalics fall under PHAP/Ethics Committee
Concerns
Collusion
RD 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
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Important Points in RD

• 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 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

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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, providedScientific 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

• 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.

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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 theEthics Committee ofPHAP

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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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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.

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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 ProvisionWritten
  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
  affiliates 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