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

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 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

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

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

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

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

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 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

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

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.

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 allowedfax, 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

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

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

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.

Suspension from PHAP

FINE with an amount to be determined by the Ethics Committee

BFAD

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