Physician – Pharma

Relationship:
Should we stand
united or divided?

Roland M. Panaligan, MD, FPCCP

UST-FMS Department of Bioethics
 Relationship Realities

 Financial ties between the doctor and the

pharmaceutical industry has been at scrutiny and
received public attention

 NEJM (2014)reports that 94% of doctors report

some type of relationship between the
pharmaceutical industry
In the last 5 years alone, pharma companies
agreed to pay a total of $13Billion to resolve
DOJ allegations of fraudulent marketing
practices
Do doctors take
bribes?
Public perception on various blog
sites do not paint a pretty picture.

Social media messes up the public

perception of a noble profession.

We don’t pay taxes and we get

“funded” by the industry.
Ethical interactions help ensure
that medical decisions are made
in the best interests of patients
STANDARD OF THE MEXICO CITY PRINCIPLEs
Principles that biopharmaceutical
pharmacies must be guided
 1. Healthcare and patient focus

 2. Integrity

 3. Independence

 4. Legitimate intent

 5. Transparency

 6. Accountability
Principles that biopharmaceutical
pharmacies must be guided
 1. Healthcare and patient focus –
everything we do is intended to benefit
patients
 2. Integrity – dealing ethically, honestly and
respectfully in everything we do
 3. Independence – respect the need of
autonomous decision making of all parties,
free from improper influence
Principles that biopharmaceutical
pharmacies must be guided
 4. Legitimate intent – everything we do is for
the right reasons, is lawful, and aligns with the
spirit and the values of these principles
 5. Transparency – general willingness to be
open about our actions while respecting
legitimate commercial sensitivities and
intellectual property rights
 6. Accountability – willingness to be
responsible for our actions and interactions
 Preamble
 1. Companies engage in the development,
manufacturing, research, marketing,
distribution and/or sale of medicine to benefit
patients.
 2. Ethical relationships with healthcare
professionals, government officials, patients,
and other stakeholders are critical to the
mission of Companies to help patients by
developing and making medicines available.
 Preamble
 3. In interacting with all stakeholders,
Companies are committed to following the
highest ethical standards as well as all
applicable laws and regulations.
Companies encourage healthcare
professionals, government officials, and
others who work with Companies to respect
these Principles and adopt consistent
standards if applicable.
 Preamble

 4. These principles are to reinforce our intention

that Companies’ interactions are professional
exchanges designed to benefit patients and to
enhance the practice of medicine. These
Principles are based on the foundation that a
healthcare professional’s care of patients should
be based solely on each patient’s medical need
and the healthcare professional’s medical
knowledge and experience.
 Preamble

 5. Companies have an obligation and

responsibility to provide objective, accurate,
balanced information about their medicines to
healthcare professionals in order to establish a
clear understanding of the appropriate use of
these medicines. Industry relationships with
healthcare professionals must support, and be
consistent with, the professional responsibilities
healthcare professionals have towards their
patients.
 Preamble

 6. Companies should promote, sell and distribute

their medicines in a manner that is ethical, objective,
balanced and accountable, and in accordance with all
relevant and applicable laws and regulations.
Information on promotional materials must support
proper assessment of the benefits and risks of the
product and its proper use.
 7. Companies are committed to education and
training on the safe, appropriate and effective use of
their medicines.
 Preamble

 8. Companies are accountable for complying with relevant

codes of ethical business practices. They should also ensure
that internal structures and procedures (including adequate
training of employees) are created to ensure responsible and
ethical activities.
 9. Companies will comply with relevant standards regarding the
development, production, processing, distribution,
commercialization and safety of medicines.
 10. Companies undertake to adhere to relevant local, national,
and regional industry ethics codes in both the spirit and the
letter.
 Preamble

 11. Companies will respect the independence of patient

organizations.
 12. Companies should ensure that all relevant personnel and
agents acting on their behalf are appropriately trained in the
requirements of local, national, and regional industry ethics
codes.
 13. Companies will respect patient privacy.

 14. Companies will ensure that all personnel and third parties
working on their behalf comply with these Principles and all
applicable laws and regulations.
Through the promotion of these
Principles, Companies and APEC
economies seek to ensure that
ethical practices are established.
THE PHILIPPINES IS A MEMBER OF APEC.
HENCE, THIS HAS TO BE IMPLEMENTED.
 There are 17 principles
Each of them are explained with corresponding recommendations of the
Philippine FDA under the DOH on the PROPOSED policies and guidelines
for these principles (IRR)
 Interactions with health care professionals
(and medical societies)

 A. Interactions between companies and healthcare

professionals provide valuable scientific, clinical, product,
and policy information about medicines that may lead to
improved patient care

 B. Appropriate marketing helps ensure that medicines are

used correctly for maximum patient benefit. Company
relationships are critical to achieving these goals.

 C. All interactions with healthcare professionals are to be

conducted in a professional and ethical manner.
 Scenario 1

 Your hospital decided to revive the Asthma

clinic to service the patients in your area. A
pharmaceutical company, Hingalaway,
which produces beta agonists and inhaled
steroids ask you how they can help. As the
program director, you think about how they
can participate ethically and promote their
products.
 Scenario 1

 Issue: Can the company participate or help

out?
 Promotional information and activities

 Promotional content shall be consistent with the labeling

materials and its product inserts as approved by the FDA
 No healthcare professional or health worker shall
promote, advertise or endorse any drugs and medicines in
mass media, in print or visual display. (Rule 40, IRR of the
Universally Accessible Cheaper and Quality Medicines Act
of 2008)
 All claims must be true and substantiated/referenced from
sources that can be made available upon request.
 Promotional information and activities

 One sided information, or any conclusive statement based on

inadequate or truncated evidence is not permitted.
 Superlatives, exaggerations, and hanging comparatives without
unequivocal supporting data, which merely claim that a product is
better etc., must not be used.
 “Drug of first choice”, “No. 1” claims and the like, must be supported
by current, adequate and relevant clinical evidence.
 Scenario 1

 The following items come up for consideration:

 A 32 inch LED screen on which you will show
your asthma video materials
 Action plan for asthma management leaflets
with the company’s logo included
 Discount cards for medication purchases limited
to members of the club
 Free sample medications for every receipted
purchase of one inhaler
 Scenario 1

 Issue: What are the allowable

contributions?
 Companies may provide promotional aids to HCPs
provided these:
 (a) are of modest value;
 (b) are relevant to the practice of medicine or education
of the patients; and
 (c) do not subsidize normal routine operation of a
medical practice.
Promotional aids may contain the company name and
logo and/ the generic name of the product, and shall be
consistent with the Generics Law and its Implementing
Rules and Regulations.
 Scenario 2

 Your institution is planning an outreach

postgraduate course in Palawan on
Comprehensive TB care. The venue you have
decided upon is a resort in the outskirts to
ensure that the attendees stay in the venue.
 Some of your colleagues in Manila find out
about the conference ask if they can attend.
They will ask for sponsorship from some of the
pharma companies .
 Scenario 2

 Issue :Are there any restrictions where

conferences can be held?
 Issue: In outreach programs like this, which
will most likely be available in the urban
areas too, can doctors request for
sponsorship?
 Scenario 3

 You were invited by a Salaksak Technologies,

an interventional pulmonology company, for a
dinner meeting to explore the needs in the
area. While having your dinner in Bupey 100
KG, your spouse and daughter come in. Upon
seeing you, they come over to greet you and
you ask them to sit with you for dinner. After
dinner, the waiter inquires who will settle the
bill.
 Scenario 3

 Issue: What are the guidelines regarding

accompanying persons for dinners or
conferences?
 Issue: How can the pharm company go
about this situation? Or What should the
physician do in this instance?
 Symposia and Congresses

 All events should be held in an appropriate venue that is

conducive to the scientific or educational objectives and the
purpose of the Event or meeting. Companies should avoid using
extravagant venues or resorts.
 Hospitality should be limited to refreshments and/or meals
incidental to the main purpose of the Event and should only be
provided:
 1. to participants of the Event and not their guests; and
 2. is moderate and reasonable as judged by local standards

 Companies should not pay any costs associated with individuals

accompanying invited HCPs.
 Scenario 4

 A conference on Asthma will be held in

Ecuador. You are interested to attend but
the pharma company you ask for
assistance, Ediwaw, says that they have
filled up their quota of 10 doctors already.
You find out from a colleague that in the
group, there are three surgeons and two
obstetricians. What do you do?
 Scenario 4

 Issue : Can physicians ask for sponsorships?

What are the guidelines on foreign
conferences?
 Issue: Are there restrictions regarding
sponsorships for specialty conferences?
 Local or foreign travels

 1. Industry sponsorship of HCPs to events involving foreign/local travel

shall be allowed subject to the following conditions:

1 1. The main purpose of the event is to provide scientific or

educational information.

1.2. The travel is justified because:

(a) a significant proportion of the invited attendees (HCPs) is from

outside of the sponsored HCP’s place/country of practice, and it makes
greater logistical or security sense to hold the event in another
location/country; or

(b) the relevant resource or expertise that is the object or subject

matter of the event is located outside of the sponsored HCP’s
place/country of practice
 Local or foreign travels
 The venue for such event is appropriate and conducive to the
educational or scientific objectives of the conference. No posh venues
or resorts are allowed
 The selection of the HCP should be unrelated to prescribing and sale of
the company’s products. The following criteria shall apply for HCP
sponsorship:
1.4.1. The event for which the HCP will participate must be
scientific in nature.
1.4.2. The HCP’s area of practice/expertise must be consistent
with the therapeutic field covered at the meeting or event.
 No entertainment, side trips or other social/leisure activities are
offered or paid for by the company
 Local or foreign travels
 The sponsoring company shall submit through FDA website
(details of submission and focal person to be determined) and
post travel report two weeks after the travel date on the
sponsorship of HCPs to Events involving local and foreign travel
containing the following information:
 1. The purpose/objectives of the travel, including the name,
description and date of the event;
 2. The names of the sponsored HCPs and their specialty/field of
practice, the travel dates of the HCPs;
 3. The scope and estimated value of sponsorship shouldered by the
company (e.g., travel, accommodations, meals, registration fee,
etc.);
 4. If the recipient is employed by the government, the sponsored
HCP shall make a post travel report to his respective agency,
including appropriate recommendations
Travel restrictions

Can I travel on business class?

How many trips can I travel each

year?

How many times can I get

sponsored by Company X?

Who can I bring with me in the

next trip?
 Local or foreign travels
 The sponsorship for travel of HCPs attending events as
mere participants shall only be for Economy class.

 A company may sponsor an unlimited number of HCPs for

local events, including company sponsored events and a
maximum of 7-10 HCPs for events involving international
travel at one time, provided that the event is related to
the HCPs area of expertise. Accompanying guests or
family members of the HCP shall not be entitled to any
travel sponsorship, meals or other expenses
 Local or foreign travels
 A company may sponsor an HCP as a mere participant or
delegate to a medical congress or convention involving
international travel only twice in any calendar year.
Excluded from the scope of this provision are Company-
organized events such as investigator’s or advisory board
meetings provided the travel is justified in accordance with
this Order and provided further that there is a service
agreement between the investigator and the Company.

 Any sponsorship given to a HCP shall not be conditional

upon an obligation nor an inappropriate inducement to
prescribe, recommend, or promote any product.
 Symposia and Congresses

 The purpose and focus of all symposia, congresses and other

promotional or non-promotional, scientific or professional
meetings (an “EVENT”) for healthcare professionals organized
by a Company should be to inform healthcare professionals
about products and/or to provide scientific or educational
information.
 Company relationships with HCPs are regulated by multiple
entities and intended to benefit patients and to enhance the
practice of medicine. Interactions should be focused on
informing HCPs about products, providing scientific and
educational information, and supporting medical education.
 Any sponsorship provided to individual HCPs must not be
conditional upon an obligation to prescribe, recommend or
promote any medicine.
 Scenario 5

 While attending a conference in France, the

group goes for dinner. As the orders are taken,
one of the doctors, Dr. Epales, orders foie gras
with gold leaf shavings with the dish alone
costing 200 Euros. This doctor is notorious for
having expensive taste when he will not bear
the cost and is known for banning products
from companies who refuse him. What can be
done?
 Scenario 5

 Issue: Are there safeguards in the guidelines

to prevent events like this from happening?
 Scenario 6

 During one of the conferences, a show, Perya

de Pinas, was being held simultaneously at the
venue featuring renowned local acrobats and
illusionists. The tickets, inclusive of the show
and dinner, cost PhP1000. You ask the
sponsoring company if you can have your
dinner there instead of a restaurant they were
considering.
 Scenario 6

 Issue : Can entertainment be provided or

sponsored by the pharmaceutical company?
 Companies should not provide any form of entertainment or
recreational items, such as tickets to the theater or sporting events,
sporting equipment, or leisure or vacation trips, to any healthcare
professional. Such entertainment or recreational benefits should not be
offered, regardless of:
 (1) the value of the items;
 (2) whether the Company engages the healthcare professional as a speaker
or consultant, or
 (3) whether the entertainment or recreation is secondary to an educational
purpose.
 No stand-alone entertainment or other leisure or social activities should
be provided or paid for by Companies. At events, entertainment of
modest nature which is secondary to refreshments or meals, is allowed.
 Scenario 7

 Your local pulmonary society decided to hold a

fun run to benefit the victims of flooding. The
local arm of the pharmaceutical company,
Nagoya, offered to provide energy drinks to
the participants. You also ask them to sponsor
some of the participants. In return, the
company asks if they can put banners and
tarpaulins at the finish line.
 Scenario 7

 Issue: For charitable events spearheaded by

doctors, are there limits to the participation
by pharma companies?
 Company donations for
charitable purposes
 As a demonstration of good corporate citizenship, Companies
recognize their responsibility to support worthwhile activities
both within and outside our communities.
 Funding and donation in-kind should be directed to organizations
and documented in a manner that outlines the nature of the
donation provided
 Acknowledgement by the recipient organization of such support
should be restricted to appropriate recognition of support.
 Companies should ensure that there are no incentives to prescribe,
recommend, purchase, supply or administer a product based on
financial support and that nothing should be offered or provided
which would interfere with the independence of a healthcare
professional’s prescribing or dispensing practice.
 Scenario 8

 Dr. Zee Gacia was invited to attend a

pulmonary conference in the USA. She
happens to sit on the therapeutics committee
of a big private hospital and in a bidding
committee in a local government hospital. The
company is introducing a new antimicrobial in
the market and seeks inclusion in the
formularies of various hospitals.
 Scenario 8

 Issue: How should the physician treat this

invitation? Should there be disclosure to
the company or should the company be
responsible for identifying conflicts?
 Scenario 9

 A local pharmaceutical company, Beegtaymna

Inc., is planning to launch a new drug in the
market sourced from a local herb. They want
to do a multicenter, international study and
they have scheduled an investigators meeting
in Shanghai, China which will host two of the
centers. They are sending 10 investigators
from the country for the local arm of the study.
You have a pulmonary fellow who serves as
your sub-investigator.
 Scenario 9

 Issue: What are the rules regarding

researches and investigators meetings? For
local studies, can meetings be held out of
the country?
 Research

 Companies may assist in the conduct of research

activities of health care professionals and/or
healthcare-related institutions, provided, that the
policies and guidelines of the DOH, FDA and the
National Ethical Guidelines for Health Research,
ed. 2011, of the Philippine National Health
Research system (PNHRS), regarding such
activities are strictly followed.
 Research

 Moreover, companies must respect the integrity

of research activities and not fund, conduct, or
use such activities as a means to disguise product
promotion or prescription. All outcomes or results
of researches conducted shall be forwarded to
FDA, regardless of whether the outcomes were
favorable or not.
 Scenario 10

 Your hospital is putting up a fellowship

program in pulmonary medicine. The plan is
to take two fellows but you can only sustain
one. You plan on asking a pharma company,
Azucarpapa to provide the stipend for the
other fellow. The fund they can provide is
lower than what the other fellow will
receive from the hospital.
 Scenario 10

 Issue: How should the process of providing

fundings for scholarships go?
 Educational items and gifts
 Payments in cash or cash equivalents (such as
GCs) or gifts for the personal benefit of the HCPs
should not be provided or offered to HCPs.
 Appropriate to offer items designed primarily for the
education of HCPs or patients if the items are of
modest value and do not have value to HCPs outside
his or her professional responsibilities
 The items should not subsidize normal routine
operations of a medical practice.
 Support for Continuing Medical
Education
 CME helps physicians and other medical professionals to obtain
information and insights that can contribute to the
improvement of patient care and the medical practice.
 Grants, scholarships, subsidies, support, consulting contracts,
educational or practice related items should not be provided or
offered to a HCP in exchange for recommending and prescribing
medicines, or otherwise in a manner that would interfere with
the ethics and the independence of a HCPs prescribing practice.
Companies should have a reasonable expectation that the grant
is for the purpose of supporting legitimate education, scientific
or medical research.
 Informal Presentations by
company representatives
 In order to provide important scientific information and to
respect healthcare professionals’ abilities to manage their
schedules and provide patient care, Company
representatives may take the opportunity to present
information during healthcare professionals’ working day,
including mealtimes, in accordance with applicable laws
and regulations.
 It is appropriate for occasional meals to be offered as a business
necessity to the HCP and members of their staff attending
presentations, as long as the presentations provide scientific or
education value and the meals are modest in nature.
 No take out meals to be eaten without a Company representative is
allowed.
 Samples

 A. When used appropriately, samples can be an important

tool for HCPs and provide benefit to patient health
outcomes

 In accordance with local laws and regulations, samples of

medicines supplied at no charge may be provided to HCPs
in order to enhance patient care. Samples must not be
resold or otherwise misused.
 Consultant and Speaker
arrangements
 A. Consulting arrangements with HCPs allow companies to obtain
information or advice from medical experts on such topics as the
marketplace, products, therapeutic areas and needs of patients.
Companies use this advice to inform their efforts to ensure that the
medicines they develop, produce and/or market are meeting the
needs of the patients.
 1. Companies should continue to ensure that consultant and speaking
arrangements are neither inducements nor rewards for prescribing or
recommending a particular medicine or course of treatment
 2. It is appropriate for consultants and speakers who provide services
to be offered reasonable compensation for those services and
reimbursement for reasonable travel, lodging, and meal expenses
incurred as part of providing those services. Any compensation or
reimbursement made in conjunction with a consulting or speaking
arrangement should be reasonable and based on fair market value.
 3. Consulting or advisory arrangements lacking a bona fide business
purpose should not be used to justify compensating HCPs for their
time or their travel, lodging and other out-of-the pocket expenses.
 Consultant and Speaker
arrangements
 B. The following factors support the existence of a bona
fide consulting or speaking arrangement (not all factors
may be relevant to any particular arrangement):
 1. a written contract specifies the nature of the services to be
provided and the basis for payment of those services;
 2. legitimate need for the services has been clearly identified
in advance of requesting the services & entering into
arrangements with the prospective consultants;
 3. criteria for selecting consultants and speakers are directly
related to the identified purpose, and the persons
responsible for selecting the consultants & speakers have the
expertise necessary to evaluate whether the particular
healthcare professional meet those criteria;
 Consultant and Speaker
arrangements
 B. The following factors support the existence of a bona
fide consulting or speaking arrangement (not all factors
may be relevant to any particular arrangement):
 4. the number of healthcare professionals retained is not
greater than the number reasonably necessary to achieve the
identified purpose;
 5. the retaining Company maintains records concerning, and
makes appropriate use of, the services provided;
 6. the venue and circumstances of any meeting with
consultants or speakers are conducive with the primary focus
of the meeting; specifically, resorts are not appropriate
venues.
 11. Compliance Procedures & Responsibilities

 12. Conduct and training of Company Representatives

 13. Public sector relationships and procurement

 14. Clinical trials

 A. All clinical trials (phases I to IV) and scientific research

involving patients sponsored or supported by companies will be
conducted with the intent to develop bona fide scientific
knowledge that will benefit patients and advance science and
medicine. Companies must ensure transparency and
accountability in the presentation of research and publication of
study results.
 B. Clinical trials should not be used as inappropriate
inducements for past or future sales.
 C. Clinical trials should be undertaken in an ethical manner,
without undue influence by competitors.
 15. Company donations for
charitable purposes
 As a demonstration of good corporate citizenship, Companies
recognize their responsibility to support worthwhile activities
both within and outside our communities.
 1. Donations including donations in kind, may be provided to
organizations and institutions involved in promoting activities such
as artistic, charitable, cultural, community, educational,
humanitarian, health, philanthropic, and sporting activities in
accordance with applicable laws and regulations.
 2. Companies should ensure that such support is not undertaken
solely for product promotional reasons, and is not directed solely
for product promotion purposes.
 Sanctions (for the Company)

 1. First violation – warning letter

 2. Second violation - Fine of not less than fifty thousand pesos (P50,000)
up to five hundred thousand pesos (P500,000) depending on the gravity of
the offense and the additional administrative fine of not more than One
thousand Pesos (Php 1,000) for each of continuing violation.

 3. Third violation- Fine as stated above and suspension of product

registration or license to operate or any authorizations, for a period not to
exceed one (1) year;

 4. Fourth violation- Fine as stated above, depending on the gravity of

the offense and cancellation of product registration or license to operate
or other appropriate authorizations, for a period not to exceed one (1)
year depending on the gravity of the offense.
There is an immediate need to put
back the respect in our profession
But respect is EARNED and is not a gift nor an endowment.