STRIKING A BALANCE

ETHICS & TRANSPARENCY IN THE HEALTHCARE SECTOR:

FRANCISCO P. TRANQUILINO, M.D., FPCPSpecial Assistant to the Dean and College Secretary, UP College of Medicine

Member, APEC Expert Working Group on Business Ethics in the Biopharmaceutical Sector(The Mexico City Declaration)

Technical Adviser/Expert Consultant, Pharmaceutical & Healthcare Association of the Philippines (PHAP)Chairman, Ethics Committee, Philippine College of Physicians (PCP)

PROFESSIONAL AFFILIATIONS:Technical Adviser/Expert Consultant, Pharmaceutical & Healthcare Association

of the Philippines (PHAP)

Member, APEC Expert Working Group on Business Ethics in the Biopharmaceutical Sector

PHAP Representative, International Federation of Pharmaceutical Manufacturers and

Associations – Code Compliance Network (IFPMA-CCN)

Chairman, Philippine College of Physicians Committee on Ethics

Member, Philippine College of Physicians Committee on Advocacy

Member, Research Implementation and Development Office (RIDO), UP College of Medicine

EDUCATION/TRAINING:•Certificate on Flagship Course of Pharmaceutical Policy Reform, UK Department of International

Development, World Bank and Harvard School of Public Health

•National University of Singapore Outcomes Research and Pharmacoeconomics Training

•Asian Institute of Management Business Leadership Program

•UP-PGH Department of Medicine Section of Cardiology Fellowship Training in Cardiology

•Epworth Hospital Victorian Heart Centre Melbourne, Australia

Advance course in Cardiology sponsored by the Asian-Pacific Society of Cardiology

•UP-PGH Department of Medicine Residency Training in Internal Medicine

•University of the East Ramon Magsaysay Memorial Medical Center Doctor of Medicine

FRANCISCO PASCUAL TRANQUILINO, M.D., FPCP

DISCLOSURESPHAP Representative to the International Federation of Pharmaceutical Manufacturers and Associations – Code Compliance Network (IFPMA-CCN)

Cluster Physician, Cardiovascular, Pfizer Philippines (2002-2008)

Consultant, Therapharma (2009-2011)

Consultant, Takeda (2011-2012)

Advisory Board Member, Speaker, Lecturer, Clinical Trialist: Pfizer, Therapharma, Novartis, AstraZeneca, MSD, GSK, Glenmark Pharma, InnoGen Pharma, Sel-J Pharma Corp.

Basic Principles• In the treatment of their patients, physicians use

drugs, instruments, diagnostic tools, equipment and materials developed and produced by commercial enterprises

• Industry possesses resources to finance expensive research and development programmes, for which the knowledge and experience of physicians are essential. Moreover, industry support enables the furtherance of medical research, scientific conferences and continuing medical education that can be of benefit to patients and the entire health care system

Basic Principles• Conflicts of interest between commercial

enterprises and physicians occur that can affect the care of patients and the reputation of the medical profession

• An inherent conflict of interest between the legitimate business goals of manufacturers and the social, medical and economic needs of providers and the public to select and use drugs in the most rational way (WHO Europe, 1993)

Basic Principles• The duty of the physician is to objectively

evaluate what is best for the patient, while commercial enterprises are expected to bring profit to owners by selling their own products and competing for customers

• Commercial considerations can affect the physician's objectivity, especially if the physician is in any way dependent on the enterprise

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

THE INVERSE BENEFIT LAW

How Drug Marketing Undermines Patient Safety and Public Health

by Howard Brody, MD, PhD and Donald W. Light, PhD

It is manifested thru 6 basic marketing strategies:• Reducing thresholds for diagnosing disease• Relying on surrogate endpoints• Exaggerating safety claims• Exaggerating efficacy claims• Creating new diseases• Encouraging unapproved uses

The law highlights the need for comparative effectiveness research and other reforms to improve evidence-based prescribing

..states that the ratio of benefits to harms amongpatients taking new drugs tends to vary inversely withhow extensively the drugs are marketed.

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SURPRISE!

Influence of the Industry• Links between the health professions and the pharmaceutical

industry have grown enormously in the late 20th and early 21st centuries, leading to a call from physician educators for strong ‘firewalls’ to protect the independence of academic medical centres

8 out of 10 received gifts, usually free food at their workplace

8 out of 10 received free medicine samples4 out of 10 had their expenses paid to attend meetings

and conferences3 out of 10 were paid consultants, on a company

Speakers’ Bureau or Advisory Board

Effects of Free Samples

Effects of PHRs(Illusion of Unique Invulnerability)

Effects of Interactions Between Physicians and Industry

• Most surveyed physicians denied that gifts could influence their practice

• The more gifts physicians received, the less likely they were to believe their prescribing would be affected

• The more frequent the contact with sales representatives, the greater the likelihood that physicians would request addition of sponsors’ products to hospital formularies

Effects of Interactions Between Physicians and Industry

• Payment for conference travel, industry-sponsored meals, research funding and honoraria also increased the likelihood of requests for formulary additions versus other physicians who had not received such payments

• More exposure to talks by sales representatives was associated with less ability to recognise inaccurate claims about medicines

Effects of Interactions Between Physicians and Industry

• CME funding increased the likelihood of prescribing sponsors’ products

• More frequent contact with sales representatives was associated with higher prescribing costs, more rapid prescriptions of new medicines and less prescribing of generics

Non-traditional Forms of Marketing

• Industry-sponsored continuing medical and pharmacy education• Funding of key physician ‘opinion leaders’• Ghost-writing of journal articles• Funding of diagnostic and treatment guideline development• Public relations campaigns including unbranded ‘disease-

oriented’ advertising• Funding of patient groups and medical societies• Market seeding research (‘Phase IV’ studies without clear

scientific objectives)• Internet advertising• Journal supplements and free journals• Pharmacy discounts linked to sales volume

Codes of Ethics

• Code of Ethics of the PMA• Code of Ethics of the PCP, other

Medical Societies• 2010 Revised Guidelines on Ethical

Relationships with Pharmaceutical Companies of the UP-PGH Department of Medicine

Codes of Ethics

• Physician - Patients• Physician - Community• Physician - Physicians, Colleagues, and to

the Profession• Physician - Health Products Industry

Composition of the E.C.

Chairman: Francisco P. Tranquilino, M.D.Regent Coordinator: Maria Gina C. Nazareth, M.D.Members:

Edith C. Miguel, M.D. (Chapter Representative)Jorge G. Ignacio, M.D. (Subspecialty Society)Ma. Bella R. Siasoco, M.D. (Academe)Patrick Gerard L. Moral, M.D. (Academe)Jaime C. Montoya, M.D. (Council of Elders)Oscar Ty Cabahug, M.D. (Immediate Past President)Rudyard A. Avila, M.D. (Legal)

No Representative from the DOH

WEAKNESSES

• Lack of consistent guidelines in addressing ethical issues (e.g. relationship with pharmaceutical companies, etc.)

• Over-reliance on external sponsorhip (e.g. Pharmaceutical Companies)

• Conflicting priorities and disunity with Component Societies and individual members

• Incongruence in Central vis-à-vis Chapter policies

THREATS

• Changing landscape of the local healthcare system (e.g. Disclosure Bill by Sen. Miriam Santiago, PMA-PCP Codes, PHAP Code, institutional Codes/guidelines, etc.)

• Changing global landscape (IFPMA Code, US Sunshine Act, UK Bribery Act 2010, WHO-HAI Guides, The Mexico Declaration by APEC, etc.)

GOALS

• Culture change• Raise awareness on ethical issues

by disseminating the PCP Code of Ethics and other relevant local & international Codes and Guidelines

• Awareness of global trends involving ethical issues (e.g. MD-Pharma relationship)

SPECIFIC OBJECTIVES

• Address specific issues/queries brought before the EC

• Timely resolution of new cases • Conduct consultations with

selected Chapters• Continue to encourage Chapters to

resolve their own ethical issues/concerns

STRATEGY 1

• Raise awareness on ethical issues by disseminating the PCP Code of Ethics and other relevant local and international Codes and Guidelines

TACTIC• Conduct regular Sessions/RTDs on Ethical

Issues • During Annual Convention (May 2014,

2015) involving Training Officers of training institutions who will certify that Residents in-training undergo orientation on ethical issues

• Other opportunities where discussion of ethical issues can be incorporated (e.g. post-graduate courses, etc.)

STRATEGY 2• Ensure timely promulgation of

decisions by the EC

TACTIC• Review and revise existing SOPs

(identify specific timelines in resolution of cases)

• Conduct Committee meetings as often as necessary

STRATEGY 3• Awareness of global trends on

ethical issues (e.g. MD-Pharma interaction)

TACTIC- Networking with government (e.g. DOH, FDA),

societies (e.g. PMA, AMP, etc.), key organizations (e.g. IFPMA, PHAP, PCPI) with stake in ethical issues

- Participation in IFPMA-CCN-MeTA Meeting (February 2014)

THANK YOU!