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 Foreword
PHAP Code of Practice aligns with the PhRMA, EFPIA and IFPMA Joint Guidance
on Virtual International Medical Congresses Impacted by COVID-19, the 2020
2019 Amended Code of Practice of the International Federation of Pharmaceutical
Manufacturers & Associations (IFPMA) and adopts in full and with Administrative
Order No. 2015-0053 Implementing Guidelines on the Promotion and Marketing
of Prescription Pharmaceutical Products and Medical Devices, and the Mexico City
Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector. It
incorporates local requirements and practices in relation to registration; labeling and
scientific claims approved by the Philippine Food and Drug Administration (FDA).
PHAP and its members are committed to educational and promotional efforts that
benefit patients as well as programs and collaborations that enhance the practice of
medicine. PHAP through its Code of Practice seeks to preserve the independence of
the decisions taken by healthcare professionals (HCPs) in prescribing medicines to
patients.
The ethical promotion of prescription medicines is vital to the pharmaceutical
industry’s mission of helping patients through research and development of new and
innovative medicines. Ethical promotion helps to ensure that HCPs have access to the
right information they need and that right patients have access to the right medicines
at the right time.
Industry relationships with HCPs must support, and be consistent with the
professional responsibilities they have with their patients. Pharmaceutical companies
must maintain high ethical standards in the conduct of promotional activities to
HCPs, Patient Groups and Patient Organizations and comply with applicable legal,
regulatory, professional requirements and international guidelines on face-to-face
and virtual interactions.
Through the promotion of this Code, PHAP seeks to ensure that ethical promotional
practices are established and be at par with International Standards worldwide.

TEODORO PADILLA
Executive Director

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 September 2020

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 The PHAP Board of Trustees (BOT) sets the policies for the PHAP Code of Practice.
It has the responsibilty of ensuring that all member companies abide by the code.

President: Dr. Beaver Tamesis

(Managing Director, Merck Sharp & Dohme,
(I.A) LLC)

Vice President: Mr. Ramonito Tampos

(President and Managing Director,
Merck Inc. Philippines)

Treasurer: Mr. Raymund Azurin

(Senior Vice President Sustainability &
Government Affairs, Zuellig Pharma
Asia Pacific)

Trustees: Mr. Teodoro B. Padilla (Executive Director)

Ms. Kara Brotemarkle

(General Manager, Roche (Philippines), Inc.)

Mr. Yee Kok Cheong

(General Manager, Boehringer Ingelheim)

Ms. Jannette Jakosalem

(Chief Executive Officer, Metro Drug, Inc.)

Ms. Amal Makloufi Benchouk

(General Manager, Sanofi)

Mr. Andreas Riedel

(Country Manager, Pfizer Inc.)

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 Chairman Ernesto O. Domingo, MD
Professor Emeritus, UP College of Medicine
Ramon Magsaysay Awardee

Vice Chairman Reiner W. Gloor

PHAP Adviser

Members

Cristobal C. Dumo, Jr., MD Yolanda Robles, MD

Chief of Section of Infectious Diseases, Dean, University of the Philippines
Department of Medicine College of Pharmacy
Victor R. Potenciano Medical Center Executive Vice President, Philippine
Assistant Professor 3 Pharmacists Association
St. Luke’s College of Medicine

Manuel M. Dayrit MD. MSc Benito L. Teehankee, Ph.D

Dean, Ateneo School of Medicine Chairman, Management & Organization
and Public Health Department, College of Business,
Former Department of Health Secretary De La Salle University

Madeleine Valera, MD, MScIH

Former Department of Health
Undersecretary for Health Policy,
Finance & Research Development

Technical Adviser on Ethics Matters

Francisco P. Tranqulino, MD
Associate Professor 7, UP College of Medicine

Teodoro B. Padilla
Executive Director
Pharmaceutical and Healthcare Association of the Philippines (PHAP)

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 September 2020

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 version

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 Table of Contents

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 Table of Contents

Ethos 15

Guiding Principles 18

Code of Pharmaceutical Marketing Practices 19

2.0 Medical Information and Promotional Claims 23

3.0 Product Information 25

4.0 Content of Promotional Materials 25

5.0 Educational Items 30

6.0 Items of Medical Utility 30

7.0 Promotional Aid 31

8.0 Other Communication Channels 32

9.0 Medical Representatives/Professional Service Representative (PSR) 32

10.0 Product Samples 34

11.0 Events and Meetings 34

11.12 Virtual Egagements 42

12.0 Independence of Healthcare Professionals 44

13.0 Clinical Studies 44

14.0 Post-Marketing Surveillances 46

15.0 Honoraria 47

15.2 Virtual Honoraria 48

16.0 Patient Organization, Patients, Patient Support Programs 48

16.4.1 Virtual Patient Support Programs 51

17.0 Communications With The General Public 51

18.0 Access Program Guidelines 53

19.0 Administration of the Code 54

20.0 Publication of the Outcomes 58

21.0 Compliance Procedures 58

22.0 Amendments 58

Appendix 59
FAQ 66

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 Code of Practice

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 PHAP Code of Practice (Proposed Amended Version- 2018)
Proposed Amendment/ Alignment with PHAP Code
PHAP Code Explanatory Notes

PHAP Ethos Source:

The Pharmaceutical and Healthcare Association of the International Federation of Pharmaceutical

Philippines (PHAP) as a member of the International Manufacturers (IFPMA). Code of Practice, 2018,
Federation of Pharmaceutical Manufacturers and p.4-8 

Associations (IFPMA) fully subscribes to the IFPMA
Ethos that serves as foundation of the PHAP Code of
Practice. 


The Ethos sets out the foundation to inform the 2019

IFPMA Code of Practice which applies to the conduct of
IFPMA member companies and anyone acting on their
behalf. The overarching values of trust, care, fairness,
respect and honesty guide their actions. This set of core
values and principles helps ensure that their interactions
with healthcare professionals and the broader health
community are appropriate and in line with ever-
changing society’s expectations. The Ethos is the baseline
from which IFPMA members work: It underpins the rules
and provides a framework to behave with integrity no
matter how testing the circumstances. 


Trust

Act with integrity and honesty to improve

Trust patient care and build trust with those we
serve and to respect the independence of
healthcare providers, patients and other
stakeholders
Care

Protect the safety of those who use our

products- from the conduct of clinical trials
and throughout the product life cycle.

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 nnovation
Care at

uality mprove global health through innovative

products and services, upholding the highest
ethical, scientific and medical standards.

ua t

ommit to providing high uality products that

have proven clinical efficacy and have a
reliable safety profile.

a r ess

ntegrity
upport and respect fair trade practices and
open competition.
a r ess
Accountability
te r t

Act responsibly, ethically, and professionally.

o not offer promise, provide or accept
anything of value in order to inappropriately
influence a decision, gain an unfair advantage.

u ta t

e accountable for our actions and decisions,

including the appropriate oversight of
e ternal third parties that act on our behalf.

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 espect

es e t
espect all people and embrace a culture of
diversity and inclusion. Protect the
environment. reat animals under our care
responsibly.

Privacy

espect data privacy rights and appropriately

manage and protect personal information.

ducation

upport the advancement of the scientific and

medical education for the ultimate benefit of the
patients.

est onesty

nsure truthful and balanced communication

with governmental authorities, healthcare
professionals, patients and other stakeholders

peaking p

oster a culture in our respective organi ations

where concerns are shared openly and honestly
so that we learn from mistakes and continuously
improve.

ransparency

Advance science and patient care by sharing

industry-sponsored clinical trial data in a
responsible, accurate and appropriate manner.

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 PHAP Guiding Principles On Ethical Conduct and
Promotions
The following Guiding Principles set out basic
standards that apply to the conduct of PHAP Member
Companies and their agents. This helps ensure that
their interactions with stakeholders are appropriate.
The healthcare and well-being of patients are the
first priority for pharmaceutical products and
medical devices companies.
Pharmaceutical and medical devices companies will
conform to high standards of quality, safety and
efficacy as determined by regulatory authorities.
Pharmaceutical and medical devices companies’
interactions with stakeholders must at all times be
ethical, appropriate and professional. Nothing
should be offered or provided by a company in a
manner or on conditions that would have an
inappropriate influence to ensure the
independence of the Healthcare Professional (HCP).
Pharmaceutical and medical devices companies are
responsible for providing accurate, balanced, and
scientifically valid data on products.
Promotion must be ethical, accurate, balanced and
must not be misleading. Information in promotional
materials must support proper assessment of the
risks and benefits of the product and its
appropriate use.
Pharmaceutical and medical devices companies will
respect the privacy of healthcare professionals and
patients’ personal information obtained during
face-to-face and virtual engagements.
All clinical trials and scientific research sponsored
or supported by companies will be conducted with
the intent to develop knowledge that will benefit
patients and advance science and medicine.
Pharmaceutical and medical devices companies are
committed to the transparency of industry
sponsored clinical trials in patients.
PHAP Member Companies should adhere to both the
spirit and the letter of this Code and ensure that all
relevant personnel are appropriately trained.
The PHAP Code of Practice covers not only member
companies but also local subsidiaries of IFPMA
member companies.

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 1.0 Code of Pharmaceutical Marketing Practices

1.1 Scope of Coverage

The face-to-face and virtual promotion and . The Code also covers promotion and
advertisement of pharmaceutical products and advertisement of over the counter medicines
medical devices directed to HCPs are deemed to fall and medical devices to healthcare
within the scope of the Code. professionals.

1.2 Public Sector Relationships and Procurement

The decision-making process by Companies and
Governments during and including the government
procurement process, through bidding or any other
procedure of government procurement, must be.
professional and ethical. There should be no attempt
to exert inappropriate influence.

Companies must provide accurate and balanced

information to the Government.

Companies and government officials should ensure

that their relationships and fee-for- service
arrangements comply with government ethics rules or
procedures.

Adherence to Principles

All Companies that interact with healthcare

professionals, government officials, and other
stakeholders should adopt procedures to assure
adherence to these principles and local, national, and
regional industry codes of ethics. Healthcare
professionals, government officials, and other
stakeholders should respect these principles and
adopt consistent standards if applicable.

1.3 Definition of terms

PPMD Prescription Pharmaceutical Products and

Medical Devices

"Agents and Third Party Agents" are external sales

force such as CROs, CSOs, Promotion, Co-promotion
agreements.

Company initiated events are activities Examples of company-initiated events

independently organized by companies, either on its Product presentation
own or through a third party on behalf of the Round table discussion
Company that provide product, disease awareness, or Focus Group Discussion
other product-related information to HCPs for

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 promotion or non-promotional reasons. The Company Product aunch
has control over the agenda, location, HCP selection, Advisory board
speakers, or management of the meeting and event. Symposium
Clinical trial meetings
Conflict of Interest (COI) - shall mean a situation Congresses
created when persons or entities in the public and/or Investigator meetings
private sectors that have personal, financial, or any
other interest in the pharmaceutical and/or medical
device industry, such as but not limited to, having
existing ownership or investment therein, being an
officer or member of the Board of Directors of a
corporation (including its subsidiaries, affiliates and
branches) or a partner in a partnership engaged
therein and receiving any contribution there from.
This includes receiving or accepting any offer or
contribution there from.

Continuing Medical Education - Any action designed

for or performed by a physician for the purpose of
acquiring, maintaining, or upgrading knowledge,
skills, or attitudes to improve the quality of the health
care that the physician dispenses to the patient.

Events means all promotional, scientific, or

professional meetings, congresses, conferences,
symposia and other similar events, (including, but not
limited to advisory board meetings, visits to research
or manufacturing facilities and planning or
investigator meetings for clinical trials and non-
intervention studies (each an Event ) organized or
sponsored by or on behalf of a company.

Exhibition Stands are areas where pharmaceutical

companies (and other organizations) can display their
product material to delegates in the commercial booth
and their scientific material in the medical exhibition
area.

Healthcare professional (HCP) means any member

of the medical, dental, pharmacy or nursing profession
or any other person who, in the course of his or her
professional activities, may prescribe, recommend,
purchase, supply or administer a pharmaceutical
product.

Healthcare Organization (HCO) means either a

health care, medical or scientific associations, or
organizations such as a hospital, clinic, university or
other institutions or learned society whose business
address, place of incorporation or primary place of
operation is in the Philippines or an organization

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 through which one or more health professionals or
other relevant decision-makers provide services.

tems of edical tility means items that can be offered

to Healthcare Professionals that should not offset routine
business practices and are beneficial to enhancing the
provision of medical services and patient care. These are
medical items or devices that provides benefits to patient
care. These are non-promotional items.

"Medical Representatives/ Professional Service

Representatives (PSR) means company
representatives whose regular duties comprise or
include interaction with or conducting business calls
to healthcare professionals to provide them with
information and/or any other purpose concerning the
company s products/ services.

Medical Congress is a scientific meeting organized by

a medical association/society etc. for their members
with the opportunity for industry to participate in the
form of exhibition (medical and commercial), satellite
symposia etc.
o The medical association/society is the
owner of the congress and responsible for
attendee management, access, and other
relevant criteria, e.g. the scientific agenda.
o The Congress gathers a multinational
group of medical experts and professionals
with the objective to increase the
knowledge about and expertise in a disease
state and treatment, to facilitate exchange
and ultimately to advance patient care.
o The delegates usually comprise of HCPs,
researchers and other individuals who
work in the healthcare and/or research
environment.

"Pharmaceutical product" means any

pharmaceutical or biological product (irrespective of
patent status and/or whether the product is branded
or not) which is intended to be used on the
prescription of, or under the supervision of, an HCP,
and which is intended for use in the prevention,
diagnosis and treatment of disease in humans, or to
affect the structure or any function of the human
body.

"Promotion and advertisement" means any activity

undertaken, organized or sponsored by a member
company, which is directed at HCPs to promote the

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 prescription, recommendation, supply, administration
or consumption of its pharmaceutical product(s)
through any medium, including the internet.

Promotion means the practice of giving value to a

brand, product, or service to achieve specific
marketing objectives. It includes the distribution of
free/sample pharmaceutical products. It shall also
refer to tall informational and persuasive activities by
manufacturers and distributors, the effect of which is
to induce the prescription, supply, purchase and/or
use of medicinal drugs.

Patient Organization means any formally organized

and reputable not-for-profit institution that primarily
represents the interests and needs of patients, their
families and/ or caregivers.

Satellite symposium is a Company activity which

occurs immediately prior, during or immediately after
the main scientific program in the context of a
congress.

Promotional Aid means a non-monetary item given for a

promotional purpose and should be relevant to the
practice of the Healthcare Professional and not for
personal benefit.

hird Party Conference means a conference sponsored

or conducted by or on behalf of a professional associate
that is independent, of an educational or scientific or
policy -making nature and for the purpose of promoting
scientific knowledge, medical advancement or delivery of
effective health care.

Virtual engagements are activities that use virtual or Examples of virtual platforms Emails, SMS,
digital platform in lieu of face-to-face interactions. Viber, Whatsapp, Telegram, Googlemeets,
These virtual platforms may include but not limited to Webex, oom, Facebook, outube, Microsoft
emails, text messages, messenger applications, virtual Teams, etc.
meeting applications, social media and webinar
facilities. Virtual engagements include both 3rd party
and company-sponsored events

Virtual (Medical) Congress is a congress where all

activities are virtual/digital without an in-person
event linked to it. Companies have the opportunity to
participate in the form of virtual exhibition stands as
well as virtual satellite symposia.

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 1.4 Interpretation of the Code

In case of doubt, the interpretation consistent with the

guiding principles shall be adopted. In case of
conflicting rules or provisions (within the PHAP Code
or involving other laws and government regulations),
the more stringent rule or provision shall apply.

1.5 Responsibility for Implementation

The General Manager/President/Managing Director is
responsible for the proper implementation of the
Code and its implementing guidelines within his/ her
company.

1.6 Agents and Third Party Partners

"Organization" shall extend to agents, third party
partners interacting with healthcare professionals on
behalf of the member company.

1.7 Exclusions of the Code

This Code does not seek to regulate the following
activities

Promotion / advertising of over the-counter

medicines to the general public.

Pricing or other trade terms for the supply of

pharmaceutical products and medical device.

2.0 Medical Information and Promotional Claims Pharmaceutical advertising commonly

contains comparisons with other products,
All promotional content (in printed/ electronic form, and such comparisons are usually made to
or communicated orally) must be accurate, show the advantages of the advertised
scientifically sound and objective, reflect the current product over those of its competitor(s).
state of knowledge and must be consistent with the
FDA approved labeling. Provided that such comparisons with other
products are factual, fair and can be
All promotional claims must be substantiated and substantiated, they are acceptable under the
referenced (indicated by a footnote or endnote on the Code.
same material that the claim is made).
The intention of this clause is to prohibit
Data on file may be used as reference and made unfair and unjustified comparisons with the
available upon request. products or activities of competitors.

ou can use the word new in your detail materials

only when it has been made available to the market Where a claim of comparative efficacy or
for not more than 2 months. safety is made, it must not be based solely on a
comparison of Product Information
2.1 Accurate and Not Misleading (IFPMA p. 5) documents that do not reflect the general

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 literature, as those documents are based on
Promotional information should be clear, legible, different databases and are not directly
accurate, balanced, fair, and sufficiently complete to comparable. This applies to Philippine as well
enable the recipient to form his or her own opinion of as overseas Product Information documents.
the therapeutic value of the pharmaceutical product
concerned. Promotional information should be based Claims of comparative efficacy or safety
on an up-to-date evaluation of all relevant evidence should be based on data from adequate and
and reflect that evidence clearly. It should not mislead well-controlled clinical trials, and if they are
by distortion, exaggeration, and undue emphasis, consistent with the body of other clinical data.
omission or in any other way. Every effort should be
made to avoid ambiguity. Absolute or all- embracing The accepted level of statistical significance is
claims should be used with caution and only with P . . If comparative data that are not
adequate qualification and substantiation. statistically significant are used, such data
Descriptions such as safe and no side effects must comply with the following conditions
should generally be avoided and should always be
adequately qualified. ack of significance must be stated explicitly
it is insufficient to state the p value and
nqualified superlatives must not be used.
The data must not be used to generalize or to
Comparison of products must be factual, fair and indicate superiority or inferiority.
capable of substantiation and referenced to its source.
The statement that the claim is not statistically
2.2 Pre Approval Communications and Off Label significant needs to be linked in some manner
Use (IFPMA p. 5) to the original claim, made on the same page
and within a reasonable proximity to the
No pharmaceutical product shall be promoted for use original claim in a manner that is not obscured
until the requisite approval for marketing for such use by other material, and using a type size of not
has been given. less than 2mm. Care should be taken to
distinguish between mathematically
This provision is not intended to prevent the right of determined statistical significance on one
the scientific community and the public to be fully hand and clinical significance on the other
informed concerning scientific and medical progress. hand.
It is not intended to restrict a full and proper
exchange of scientific information concerning a
pharmaceutical product, including appropriate
dissemination of investigational findings in scientific
or lay communications media and at scientific
conferences. Nor should it restrict public disclosure of
information to stockholders and others concerning
any pharmaceutical product, as may be required or
desirable under law, rule or regulation.

2.3 Substantiation (IFPMA p. 5)

Promotional claims should be capable of
substantiation either by reference to the approved
labeling or by scientific evidence. Such evidence
should be made
available on request to healthcare professionals.
Companies should deal objectively with requests for
information made in good faith and should provide

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 data, which are appropriate to the source of the
inquiry.

Any information or quotation derived from

publications must mention the complete source (at
least in a footnote), i.e., name of the author, title of the
publication, name of the journal, volume and page
number, and year of publication.

2.4 New Products

The word new can be used only to refer to product

presentation, or therapeutic indication that has been
available and generally promoted for not more than
2 months.

2.5 Medical Ethics

o PPPM company shall employ or contract any HCP

or health worker to promote, advertise or endorse any
pharmaceutical product or medical device in mass media,
print, audio visual display or social media. ( H A
201 -00 ec 2 etter E)
3.0 Product Information

The PHAP is committed to the rational use of

medicines, and central to this goal is the provision of
relevant information to HCPs. Such information
should include knowledge gained from the research
and development of
medicines as well as from their clinical use. HCPs in
the Philippines should have access to similar data as
those being communicated in developed countries.

4.0 Content of Promotional Materials (DOH AO

2015 0053)

4.1 Promotional content shall be consistent with

the indications in the Certificate of Product
Registration (CPR) and labeling materials as
approved by the FDA.

4.2 General requirements of promotional

material:

a. Any promotional material of
pharmaceutical products (in any form of
mass media) shall comply with the
provisions set forth by Administrative

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 Order 6 s. , specifically under Section
3 on Guidelines on advertisement and
promotions to implement the Generics Act
, including any amendment thereto.
b. Name and address of the Market
Authorization Holder (MAH or product
owner), importer, and/or distributor
marketing the product.
c. A brief profile of the essential product
characteristics or succinct statement.
d. Date of production (month/year) of the
materials.

4.3 Abbreviated advertisements that contain only

no more than a simple statement of indications
and/or pharmacologic class to indicate the
therapeutic category of the product shall
include:

a. Brand name and generic name of the product,
consistent to the Generics aw of and the
provisions set forth by Administrative Order No. 6 s.
on guidelines on advertisement and promotions
including any amendment thereto
b. Name, logo and address of the Market
Authorization Holder (MAH or product owner),
distributor, and/or importer marketing the
product
c. With a note starting with the phrase “Full
prescribing information available from
d. Suggested Retail Price (SRP) and
e. Related adverse events

4.4 Quotations

a. Direct quotes shall be with the written

permission from the original author and shall be
used verbatim and in the context intended by the
author.
b. All claims shall represent the content of the
substantiating sources accurately.
c. Any information or quotation derived from
publications shall properly cite the complete
source using the following format Name of the
author, title of publication, name, volume and
page of the journal, year of publication. The
citation may be indicated as a footnote.

4.5. Data from clinical studies

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 a. Research data, including those from clinical studies
being used in promotional material, shall reflect fair
and balanced information regarding risks and benefits
of the product.

b. Clearly mark in-vitro and animal tests data as such.

c. The following information to where the data can be
shall include

. Total number of subjects or patients

involved (N values)
2. Dosage regimen
3. Treatment period
4. Trial design
. Clinical endpoints
6, Statistical significance and
. Reference to related publications

4.6. Visuals, graphics and tables

a. Visuals, such as graphics and tables, shall be

consistent with the text to convey the information
accurately.

b. Graphs, tables and other visuals used shall be

adequately cited. Copyright permission shall be
obtained from the original authors, if the company
cites these data in their promotional materials.

4.7. Unpublished data

a. npublished data may be allowed if cited as data

on file . Such data shall be available to HCPs on
request. Before the promotional material is published,
it must be available on hand and shall be kept for
future reference.

b. Prior to printing of promotional material, the

complete length of publications and manuscripts for
publication or in press shall be available on hand.

4.8. Claims

a. All claims shall be accurate and substantiated from

legitimate sources and be made available upon
request.

b. The use of phrases such as Drug of first choice or

The number drug shall be supported by up to date,
sufficient and appropriate clinical evidence.

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 c. Requirements for Comparative Claims

c. Claims properly supported by scientific data

and in accordance with local regulations may
be allowed

c.2. The use of adverse drug reaction data to

compare two (2) drug products in promotional
materials may be allowed to demonstrate a full,
fair, and balanced comparison

c.3. Superiority claims may be allowed if

supported by competent (measuring up to all
requirements) and well-controlled clinical
trials and

c.4 Claims related to difference in efficacy

between drugs may be allowed if it is clinically
relevant and statistically significant (p . ).

Pursuant to Section 2 of DOH AO 2015 0053:

4.9 Promotional Information and Activities

a. Information provided by (PPPMD) manufacturers

and distributors to health professionals regarding
their products shall be restricted to evidence-based
scientific data.

b. Promotional materials provided by industry to any

HCP shall ensure the following

. Demonstrate the balance between risks and

benefits
2. Comply with existing FDA and other
pertinent regulations
3. Substantiate claims with up-to-date scientific
evidence

c. Informational and educational materials, whether

written, audio, or visual, dealing with the use of
PPPMDs, shall include clear information on all the
following points

( ) benefits and risks of the drug or device

(2) pharmacodynamics and pharmacokinetics
of the drug
(3) indications and contraindications to use of
the drug or device
(4) adverse effects and drug interactions.

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 d. Promotional or marketing materials of PPPMD
companies using citations, quotes or statements lifted
from medical literature, lectures, presentations, or
similar sources of information shall not be changed,
distorted or taken out of context.

The following claims and/or comments shall be

prohibited:

. One-sided information and any decisive statement

based on inadequate or truncated evidence

2. Superlatives, exaggerations and lines with hanging

comparatives, without supporting data. e.g., This
product is better (e.g. safety, efficacy, quality, and
price) because....

3. nsupported comments about competitors and

their products

4. nspecified, unreferenced claims about side effects,

safety and efficacy.

Other Prohibited Words and Phrases are:

. The word new , unless the product or

indication has been available and generally
promoted for less than twelve ( 2) months

2. Non-toxic , and no side effects and

3. nspecified, unreferenced claims about safety,

and efficacy without proper qualification (DOH
AO 2 - 3, Sec 2, A to D)

4.10 Virtual Promotional Materials

Virtual promotional materials must be Sample Explanatory Statements/ Disclaimer

accompanied by a statement indicating the “ ou are viewing an International
countries in which the medicinal product is Virtual Congress run by society name
registered, and by an explanatory statement and provided to international HCPs
indicating that registration conditions differ from around the world. Please note
internationally. that prescribing information provided
here may vary depending on local
Additionally, the statement should be approval in each country. For purposes
prominently displayed (e.g. via a pop-up box or of congress name , best efforts were
alternative display) informing delegates to undertaken by society name and
refer to prescribing information from their congress sponsors to ensure
home country as information may be different compliance with relevant code ,
for each country however, you should review your local

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 Companies should ensure that a process is in prescribing information and consult
place to c n irm participants stat s as directly the local affiliate of the
C s n C s (patient advocates, relevant Company to address any
journalists, industry representatives, etc.). questions.
o Make reasonable efforts to restrict “The materials for PROD CT(S)
access to promotional material to HCPs contained in this virtual exhibition are
only, where required by applicable rules approved for use only in CO NTR .
and regulations. Prescribing information may vary
o Where the medical association’s depending on local approval in each
platform does not have a categorization country. Therefore, before prescribing
capability, Companies should consider any product, always refer to local
alternative mechanisms to enable materials such as the prescribing
attendee classification for their information and/or the Summary of
promotional events. Product Characteristics (SPC).

5.0 Educational Items

PPPMD companies may occasionally provide

textbooks and journal subscriptions to Healthcare
Organizations (HCOs) to benefit patients or serve a
genuine educational function for the HCO.

Guidance on values

One ournal subscription may be provided to HCOs

per year provided that it is of reasonable value.

A medical or scientific book may be given per

clinical department, hospital or HCO department
per year and should not exceed Php , .

6.0 Items of Medical Utility to enhance the

Provision of Medical Services and Patient
Materials

Items of medical utility may be offered or

provided by member companies if such items
are of modest value, do not offset routine
business practices and are beneficial to
enhancing the provision of medical services
and patient care.

They should not be offered more than twice a

calendar year, even if each individual item is
appropriate.
. hat are examples of items of medical utility
Guidance on values which offset business practices

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 Maximum value for items of medical utility
should not exceed Php , . A. Items such as stethoscopes, surgical gloves,
blood pressure monitors and needles are
Materials provided to HCPs for their education examples of routine business expenses, and they
or for the education of patients on disease and are expected to be supplied by the HCPs
its treatments may be offered by member themselves or their employers.
companies provided that the items are
primarily for educational purposes and do not
have independent value.

Informational and educational items provided

to HCPs for patient use can include the
company name, but must not be product
branded, unless the product’s name is essential
for the correct use of the item by the patient.

As a general rule, items of medical utility and

patient materials can only include the company
name, unless the product’s name is essential
for the correct use of the item by the patient.

7.0 Promotional Aid . ection .0 prohibits promotional aids for

A promotional aid is a non-monetary item prescription-only medicines. oes this also apply
given for a promotional purpose, which does to the provision of pens and notepads in the
not include printed promotional materials. context of CMEs conference set-up
Providing or offering them to HCPs in relation
to the promotion of prescription-only A. o, pens and notepads can be provided to
medicines and medical device is prohibited. HCPs in the context of CMEs conference set-up
as long as they are company branded only, of
minimal value and only the necessary uantity
for the purpose of the CME are distributed as
part of conference table arrangement. Pens and
notepads will not be allowed in prescription
medicine and medical device booths.

Guidance on values

Promotional aids of minimal value and uantity

may be provided or offered to HCPs solely for the
promotion of over-the-counter medicines if
relevant to the practice of the HCP.

Maximum value for promotional aid should not

exceed Php , .

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 8.0 Other Communication Channels Examples of virtual channels/ platforms
Emails, SMS, Viber, Whatsapp, Telegram,
. These channels include all non-face-to-face or Google Meet, Global Meet, Hangout, Webex,
virtual engagements/ interactions like social media, oom, Facebook, outube, Microsoft Teams,
digital meeting applications, email, fax, SMS (Text etc.
messages), and webinars.

These forms of communications must comply with all

relevant provisions of the Code and data privacy
protection measures as prescribed by the Data
Privacy Act, and applicable rules and regulations
issued by the National Privacy Commission.

PHAP members are requested to review and evaluate

the privacy notices and agreements of these virtual
platforms or applications and evaluate if these meet
data privacy protection standards to safeguard
healthcare professionals and patients’ personal and
sensitive information.

.2 These communications should be sent only to

those categories of healthcare professionals whose
need for, or interest in, the particular information can
be reasonably assumed. Requests to be removed from
promotional mailing or any virtual / digital platform
lists must be complied with promptly, and no name
should be restored except upon specific request or
with written permission.

.3. Mailing or virtual / digital platform lists should be

kept up-to-date.

.4 Exposed mail, including postcards, envelopes,

wrappers, emails and any digital form must not carry
matter that might be regarded as advertising to the
general public or that could be considered unsuitable
for public view.

9.0 Medical Representatives/ Professional Service 9.0 Medical Representatives/ Professional

Representatives (PSR) Service Representatives (PSR)

. Medical representatives/ Professional Service Company representatives whose regular duties
Representatives should possess sufficient medical and comprise or include interacting with or
technical knowledge to present information on the conducting business calls to healthcare
company s products in an accurate, current, and professionals to provide them with information
balanced manner, and should be cognizant of all and or any other purpose concerning the
provisions of this Code. company s products services.

.2 Members have a responsibility to maintain high

standards of continuing competency training for
representatives and shall be required to conduct the

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 mandatory courses under the Integrity and
Proficiency Program in the Pharmaceutical Sector
(IPPS) or its equivalent.

.3 Medical representatives/ Professional Service

Representatives should, at all times, maintain a high
standard of ethical conduct in discharging their duties.

.4 Medical Representatives/Professional Service

Representatives should complete the training and
pass the assessment under the IPPS.

. Medical representatives/Professional Service

Representatives must ensure that calls do not
inconvenience or hinder the HCPs performance of
their duties. Medical representatives should conform
to institutional regulations governing their calls.

9.6 Conduct of Training of PPPMD Company

Representatives

a. Personnel employed as medical or sales

representatives shall comply with existing Philippine
aws

. Be registered with the Professional

Regulation Commission (Board of Pharmacy)

2. Be trained according to the standard training

curriculum accredited by the Board of
Pharmacy for all medical representatives, and
as provided by law.

3. Have adequate training and sufficient

scientific knowledge about their products to be
able to give complete and accurate information
in a responsible manner

4. Report all current relevant safety

information to the HCP regarding proper use of
the product and

. Provide feedback to their office on reports

submitted by the HCP on their experience with
the product.

b. The practice of looking through prescriptions made

by doctors is a violation of patient confidentiality.
ikewise, the offer and provision of financial rebates
to doctors who make a specified quantity of
prescriptions is unethical. Direct marketing of medical

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 representatives with patients are strictly prohibited.
(DOH AO 2 - 3 Sec 2).
Compliance with the ata Privacy Act of 2012 should be
observed at all times.

10.0 Product Samples F A Memo 2018-00 and epublic Act 10918

(Pharmacy aw) ection 4:
. In accordance with FDA regulations, free samples
of a pharmaceutical product may be supplied to
healthcare professionals, and only with their consent, Pharmaceutical products classified as antimicrobials,
in order to enhance patient care or to gain clinical including anti-T medicines and other classifications
experience. Samples should not be sold or otherwise of medicines, as may be prescribed by the F A, shall
not be given or distributed as physician’s samples.
misused by medical representatives and employees.

.2 The quantity of samples given should be

appropriate for HCPs to

.2. Initiate therapy and/or

.2.2 Gain clinical experience with the
product.

.3 Product samples may be given for humanitarian

reasons, but dispensing must be under the
supervision of a qualified HCP
.4 Product samples must be accompanied by
product inserts
. Product samples must comply with the labeling
requirements of FDA, and must be clearly marked
Physician s Sample - Not For Sale.
.6 Companies should have adequate systems of
control and accountability for samples provided to
healthcare professionals including how to look after
such samples whilst they are in possession of medical
representatives. ( .2 of IFPMA)
. Samples should not be used as payment for
services, return for favorable treatment, or other
inappropriate inducements. (MCP, p. )
. Samples are duly acknowledged by the HCP and
HCO
(DOH AO 2 - 3 Sec , etter A)

11.0 Events and Meetings

11.1 General Guidelines

These requirements shall apply to face-to-face and

virtual meetings thus require that support and
attendance be based on the event’s educational value,
considering the educational program, overall cost,
nature of the audience, and cybersecurity and privacy
arrangements, with attention paid to the overall

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 impression given by all the various arrangements.

Virtual engagement guidelines are specified in Section

. 2.

11.1.1 Scientific and Educational Objectives

The purpose and focus of all symposia, congresses and
other promotional, scientific or professional meetings
(an Event ) for healthcare professionals organized or
sponsored by a company should be to provide
scientific or educational information and/or inform
healthcare professionals about products.

11.1.2 Sponsorship

Sponsorship of the HCP must be limited to travel to

and from the venue (and meals and accommodations) “Recreational for the purposes of this Code is
for the duration of the Event with possibility of understood to mean that the establishment
extending one ( ) day before and one ( ) day after the primarily offers or markets itself as a venue
Event if warranted by logistical considerations (e.g., for sports and/or leisure, such as country
flight schedule). Sponsorship of entertainment or side clubs, golf clubs, sports clubs.
trips of the HCP within or outside of the duration of
the Event is not allowed. For example, since ohn Hay is considered a
leisure area, the PHAP Board of Trustees
Decision dated 3 March 2 is upheld such
11.2. Appropriate Venue that “For CME events that are to be held in
Baguio xxx, the Baguio Convention Center and
All Events organized or sponsored must be held in an the CAP Convention Center are considered
appropriate venue that is conducive to the scientific acceptable as venues for holding such
or educational objectives and the purpose of the Event activities.
or meeting. The meeting facilities including exhibition
should only be accessible to the intended audience. Guidelines on venue appropriateness shall
also apply to sponsorship of hotel
Hotels and establishments which are located at accommodation of participants who will be
beachfronts and considered as beach resorts as well as attending the scientific or educational events.
those that primarily offer spa, sports, entertainment,
leisure or other recreational facilities, as well as those that
operate casino casino facilities, and or golf courses within
their premises are considered inappropriate venues.

ikewise, hotels and establishments that operate, or have

a third party-operated recreational, entertainment or
leisure facility such as country clubs, golf clubs, sports
clubs as well as resorts and casino or is attached to such
facilities are considered inappropriate.

In case of change of classification of appropriateness

of a venue, PHAP should give at least six months prior
notice to its members. The members will be strongly
advised on alternative solutions to the extent possible

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 under the circumstances and likewise taking into
consideration the time constraints.

The geographical location is in or near a city or town,

which is a recognized scientific or business center and
is easily accessible for the intended audience. The
location and venue should not be the main attraction
of the event or to be perceived as such. The time of the
event should preferably not coincide with local or
internationally recognized sporting or cultural events
taking place in the same location, at the same time and
preferably not just before or just after the meeting.

The location is appropriate in respect to the

geographical scope of the event.

11.3 Events

1. Symposium and Congress

General Guidelines:

Companies may support seminars, scientific meetings

and third party conferences provided

a. The meals provided are modest

b. No entertainment that would incur expenses is

provided during the entire duration of the activity

c. Conference Organizers shall make a written request

to the PPPMD Company containing relevant
information such as scientific content, attendees,
duration and cost

d. The support provided is consistent with relevant

guidelines set by this Code

e. The venue is appropriate and conducive to the

scientific/educational objectives of the event. No
extravagant venues are allowed, unless there is no
other suitable venue in the locality where the event is
to be held

f. All forms of support and activities are well

documented

g. Attendees to such conference are legitimate or

authorized and

h. Speakers shall disclose any potential or actual

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 conflict of interest prior to topic presentation during
the event.

A. Company Organized

Product presentation
The following are examples of company
organized events.
Product presentation
Round table discussion
Focus Group Discussion
Product aunch
Advisory board
Symposium
Clinical trial meetings
Investigator meetings
Tactical activities

B. Third Party

B.1 HCP/Medical Societies Member companies
should not specifically support

• Sports events, such as fun runs, golf

tournaments, etc.

• Fund-raising activities, such as movie premieres,

dinners, chorales, concerts, etc.

• Fellowship nights during congresses,

conventions and the like.

B.2 Patient Organizations Companies may provide

financial support for patient organization meetings
provided that the primary purpose of the meeting is
professional, educational, and scientific in nature, or
otherwise supports the mission of the patient
organization. When companies hold meetings for
patient organizations, companies must ensure that the
venue and location is appropriate and conducive to
informational communication. In addition, any meals
or refreshments provided by a company must be
modest as judged by local standards.

B.3. Hospitals No government agency/facility shall

be used for the purpose of promoting pharmaceutical
or medical device products, nor be used for the
display of products not within the scope of the DOH
AO 2 - 3 or for placards or posters concerning
such products except during scientific conventions

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 when their facility is used as its venue. (Adopted from
DOH AO 2 - 3)

B.4. Pharmacists/Pharmacy clerks in their

capacity as HCPs.
11.4 Exhibit Booths

Exhibit booths of prescription medicines and medical
device must be directed only to HCPs. The display
must clearly identify the exhibitor and must comply
with all the requirements of the organizer and the
relevant provisions of this Code

.4. Raffle activities will not be allowed

.4.2 Educational activities may be conducted in

booths.

11.5 Support for Continuing Professional

Development (CPD)

General Guidelines:

The purpose of any continuing professional

development activity shall be to provide additional
and updated information to HCPs that can contribute
to the improvement of patient care. PPPMD
companies shall develop objective criteria for making
CPD grants to ensure that programs funded are bona
fide and quality educational programs. The financial
support provided shall not be an inducement to
prescribe to recommend a particular pharmaceutical
product or medical device or any course treatment.

a. Industry sponsorship of HCPs to events involving

foreign/local travel shall be allowed but subject to the
following conditions

. The purpose of the event is to provide scientific or Adapted DOH AO 2 - 3 Sec , etters A,
educational information C, D, E

2. The travel is justified because

(a) the event is held outside of the sponsored

HCP s place/country of practice, and/or it
makes greater logistical or security sense to
hold the event in another location/country or
(b) in the exceptional circumstances where 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 or

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 practice.

3. The venue for such event is appropriate and

conducive to the educational or scientific objectives of
the conference and Subject to clarification with FDA. In the event
that FDA will issue clarification on the rates
4. The selection of the HCPs should be unrelated to pertaining to UNDP and Daily Subsistence
prescribing and sale of the PPPMD company s Allowance, PHAP will issue a Memorandum
products. Circular to the members.

. The sponsorship for travel of HCPs attending events For overseas venues, PPPM companies may
as legitimate participants shall only be for economy sponsor seven ( ) HCPs for the Americas,
class. This particular restriction on the travel Europe, and Australia.
arrangement, however, shall not apply to HCPs who
are traveling under a specific and legitimate service For regional or ASEAN countries, Hong ong,
agreement with the PPPMD Company. Taiwan, India, China, apan orea and Middle
East, companies may sponsor up to twelve
b. PPPM companies shall act responsibly in terms of ( 2) HCPs.
numbers of HCPs sponsored for international and or local
events and appropriateness of the cost based on Adopt the more stringent interpretation. This
prevailing government regulations for local travel or section will apply to both third party-
P ( aily ubsistence Allowance) rate for organized or company-organized events.
international travel. A PPPM company may sponsor to
legitimate overseas scientific educational events, a
maximum of seven ( ) HCPs (for Europe, Americas and
Australia) and twelve (12) HCPs (for A EA countries,
Hongkong, Taiwan, India, apan, orea, China and
Middle East. The sponsorship to these events must
consider e uitable distribution of training opportunities to
HCPs. Family members or guests of the HCPs are not
allowed to be sponsored.

c. HCPs sponsored to overseas and local symposia,

conventions or CP events have the obligation to transfer
knowledge in the medical community. An agreement to
this effect should be made between the sponsoring
PPPM company and the HCP.

d. A PPPM company, however, may sponsor an HCP as

mere participant or delegate to a medical congress or
convention involving international travel CE
(1x) in any calendar year. Excluded from the scope of
this provision are speakers, presenters, meeting officers
(e.g., chairs, rapporteurs, organi ers), clinical
investigators, consultants or advisory board members
provided the travel is ustified in accordance with this
rder and that there is a service agreement between the
HCP and company in the case of contracted speakers,
consultants, advisory board members, etc.

.6 A pharmaceutical company is allowed to sponsor

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 only HCPs accommodations, meals, transportation
and registration fees for participating in programs of
scientific meetings for recognized medical societies
(CME meetings), except for local meetings where
HCPs should shoulder registration fees to encourage
attendance. Cash assistance or check vouchers are not
acceptable under any circumstances. Neither is
payment of expenses for accompanying guests.

. International and Regional Conventions Held in

the Philippines

In order to allow more local delegates to participate in

international and regional conventions, all
international or regional CMEs conducted in the
Philippines shall be treated as local events, and hence
the following provisions shall apply

Companies can send more than 2 delegates to

the conventions but sponsorship will be
limited to meals and accommodations

Delegates must pay for their own registrations

fees

11.8 Service Provider

a. Speaker Consultants
b. Adboards
c. Others

General Guidelines: Table on Rates of Honorarium was increased

11.8.1 PHAP recommends the amounts in Table 1 as the based on annual inflationary rate. Added a
maximum rates for HCP honoraria for common events category for moderator, reactor, etc.
conducted within the Philippines. These
recommendations are not intended to restrict member Travel outside of Metro Manila is considered
companies from providing different rates as long as they outbase if within the province, travel time
are not excessive and they reflect the fair market value of consisting of kilometers is still considered
the services provided, taking into consideration such as outbase.
factors as the nature of the services, therapeutic area of
expertise, experience level ualification of the HCP
engaged, number of HCPs in the same level of expertise,
complexity of the sub ect matter, duration of the event
and the number of event participants

. .2 Consultant and Speaker Arrangements

The engagement of consultant/s in medical

conferences or scientific studies may be allowed
provided there is a written contract which specifies

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 the nature of services rendered and payment for such

a. Criteria for consultant selection is based on

identified need and expertise

b. Contracting PPPMD company keeps a record of all

transactions

c. Compensation for said services is reasonable and

reflect the fair market value for said services

d. Disclosure of any potential or actual conflict of

interest (Annex B) by the consultant or speaker must
be made and

e. Information is to be made public, if and when

requested for legitimate purposes

HCPs who conduct lectures for international event

held in the Philippines are entitled to an honoraria
based on the prevailing fair market value relative to
the same measures used for non-Filipino HCPs in the
same event.

f. A healthcare professional may be a lecturer, moderator, or

speaker during CME activities and shall use only generic names
when referring to pharmaceutical products during his
presentation. nly the names of the pharmaceutical or health
product company may be posted in the main session for medical
society or third party organi ed events. The posters, pamphlets,
brochures, stickers, advertisements or other similar character
containing the names of the medicines or devices shall be posted
only in designated areas.

11.9 Informational Presentations by Company . Tactical activities refer to the day-to-day

Representatives activities of Medical Representatives, which
include
General Guidelines: Meetings with HCPs
• Small group presentations
When presenting product information, PPPMD • Focus group discussions
company representatives must provide scientific • Product group discussions
information of educational value to the HCP. • Other hospital-based activities.

a. Detailing, Product Presentation What is the meal cap for tactical activities
b. Focus Group Discussion by Medical Representatives?
c. Others
The meal cap is P /person, inclusive of
11.10 Hospitality & Meals gratuity and tax.

Meals with HCPs Hospitality & Meals

Member-companies are required to establish cap Can medical representatives exceed the meal

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 amounts for hospitality and meals. A robust cap r tactical activities t nl e
monitoring and control system must be in place to reim rsed the maxim m all a le am nt
ensure the implementation and adherence to the said
cap. This may be viewed as a circumvention of the
cap imposed by PHAP. Thus, PHAP encourages
For tactical activities carried out by Medical companies to set up policies and processes
Representatives, the amount spent should not exceed that will not allow the use of private funds by
the cap set in the Code. This amount is subject to employees to engage in activities that are not
periodic review by member companies. allowed under the Code.

11.10.1 Provision of Meals for Virtual Meetings/

Company organized meetings

Meals may only be provided under the following

condition
o At least 5 healthcare professionals are
gathered in same hospital-setting or venue
for meetings, continuing medical education,
etc.

o It is imperative for member companies to

establish monitoring and control in
ensuring that HCPs provided with
hospitality attended the event.
A Company should consider the policies
and guidelines of healthcare institutions or
facilities regarding utilization of contactless
delivery services, food handling and other
limitations on food sharing.

o However, meals should not be provided

where prohibited by the policies of the
healthcare institution or facility.

Delivery of meals to individual healthcare

professionals, especially in their residence will not
be allowed

11.12 Virtual Engagements

The following are guidelines on local, national, and
international meetings, organized by third parties,
providing funding to assist in the medical education of
HCPs, sponsorships to medical societies organizing
events, hiring of exhibition space, support of speakers.

Companies should also ensure that they are aware of

and comply with the guidance issued by medical
associations/societies etc. for organizing Virtual

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 Congresses.

. 2. Virtual CME/ Scientific Congress Access and
Promotion

Congress attendees should sign a di ital

c nsent indicating a areness/acknowledging
Virtual Congress terms and conditions, such as
speci ic permissi n t access di erent virt al
areas (lectures, commercial expositions, social
engagement sites, the basis of promotional
material development, etc.).
Even if this is the responsibility of the medical
association/society, companies need to be
aware of the content of these kinds of
Explanatory Statements/ Disclaimers.
Companies should explore putting in place
s stems t appr priatel address the sit ati n
here C s vie materials r m c ntries ther
than their n.
Of particular concern is p tential pr m ti n
directed t pe ple n t ali ied t receive s ch
c ntent and pr m ti n nlicensed medicines
and r indicati ns
A Company sponsoring/collaborating with a
booth at the virtual exhibition area should be The use of outube live and Facebook live
able to identi th se ishin t vie its th are discouraged for CMEs since these risk
C r n C and therefore determine an exposure to unintended audience
what information will be appropriate. (public). Access to CMEs should be limited
Companies and medical associations/ societies to healthcare professionals.
(congress owners) are strongly encouraged to
work together to share experiences and where
possible intl devel p standards for all to
follow.
Only company logos will be allowed in virtual
CMEs/ Scientific meetings interface.
Add virtual booth system including specific
time slots to enable access of participants only
during breaks.

11.12.3 Support for Virtual Continuing
Professional Development/ Sponsorships

Sponsorship of HCP in virtual platforms will
allow registration of unlimited number of
participants with company internal guidelines
and 2x a year limit for both
international/regional.

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 11.12.4 Sponsorship of Virtual Webinars

Sponsorship of virtual conference/meeting platforms

(i.e. subscription fees) for a particular event, such as
hosting a webinar for
institution/hospital/department will be allowed.
Paying for personal/individual, medical society and Similar to face-to-face local CMES, HCPs
hospital department virtual platform monthly or year- should shoulder registration fees.
round subscription fees will not be allowed.

12.0 Independence of Healthcare Professionals

Member companies relationships with healthcare

professionals and other stakeholders are intended to
benefit patients and to enhance the practice of
medicine. Interactions should be focused on informing
healthcare professionals about medicines, providing
scientific and educational information and supporting
medical research and education. (Sec. 2. of IFPMA
Code)

No financial benefit or benefit-in-kind (including

grants, scholarships, subsidies, support, consulting
contracts or educational or practice- related items)
may be provided or offered to a healthcare
professional in exchange for prescribing,
recommending, purchasing, supplying or
administering products or for a commitment to
continue to do so. Nothing may be offered or provided
in a manner or on conditions that would
inappropriately influence on a healthcare
professional s prescribing practices. Gifts of any kind
for the personal benefit of healthcare professionals
are not allowed, irrespective of value, kind or
occasion.
12.1 Gifts . In particular, cash gifts or equivalents are
completely not acceptable. Considered cash
a. Any item, which does not have any direct patient equivalents are gift certificates, prepaid cell
benefit or is not related to the work of the HCP shall phone loads, gasoline-cards, and the like.
not be permitted.
b. Gifts or personal services and benefits unrelated to Subject to clarification with FDA. In the event
the work of the HCP shall not be provided by any that FDA will issue clarification on this matter,
PPPMD company representative to a healthcare PHAP will issue a Memorandum Circular to
professional or members of their families. the members.

13.0 Clinical Studies and Related Activities

How does one ensure transparency in the
This section covers the conduct of investigators conduct of Clinical trials
meetings and presentations related to clinical trials
and sponsored by pharmaceutical companies held As stated in FDA Circular (2 2- ) which

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 locally or outside the country. discusses
the role of ethical boards on the conduct of
3. Clinical trials are scientific investigations using Clinical Trials
valid study designs conducted according to protocols on Investigational research on Medicinal
or study descriptions approved by the FDA and a duly products. The General Objectives section, as
established independent institutional review board or well as in item of its Implementing
Ethics Committee. Guidelines mandate the registration of all
research activities to a national registry to wit
3.2 Any type of clinical study or research program
involving humans (pre- and post-authorization, • C. Mandatory Inclusion of Clinical Trials in
interventional and non-interventional) must be the Philippine Trial Registry. All Clinical Trials
conducted in compliance with the principles of Good are to be uploaded in the Philippine Clinical
Clinical Practice as laid down in the Declaration of Trial Registry.
Helsinki.
• It is the responsibility of the Study sponsor
3.3 All such studies must address meaningful to upload information related to the clinical
medical or scientific topics, e.g. the clinical profile of a trial it is conducting to the registry
product such as safety, efficacy, modes of action or (http //registry.healthresearch.ph ) 3 days
performance related to other treatments. after the application to conduct the clinical
trial has been granted.
3.4 The well-being, personal integrity and privacy of
participants must always be of highest priority. The • Specific provisions in the publication of
informed consent document must appropriately Clinical
convey all relevant aspects of the study to potential trial results are indicated from items to 2 ,
subjects. pages 2 - 3 of the PNHRS National Ethical
Guidelines for Health Research 2
3. Studies in humans must not have the promotion
of products as their purpose. Its implementation Published data derived from clinical
cannot be used as disguised promotions. trials/studies may subsequently be
translated into tools for marketing or
promotional activities.

3.6 The details of conducting and financing studies

must be set out in a written contract. Sponsor
Company will only pay remuneration to HCPs, which
reflect fair market value for study-related activities.

3. All clinical trials, once approved for

implementation by the FDA, shall be uploaded into the
Philippine Clinical Trial Registry as required under
local regulations.

3. All study data must be statistically evaluated.

Investigators have in principle the right to publish
their data consistent with the pre-agreed study
protocol. Authors should have access to all relevant
data and statistical assessments to support
publications.

3. Sponsorship to clinical trial investigators

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 meetings and presentations is allowed subject to the
following provisions Section . A D, and .6.

3. . For investigators meetings or

presentations held outside the country, the
limits set forth in this code apply prior to the
approval of the study protocol or description.

Invitations should be extended only to

healthcare professionals in relevant
therapeutic areas related to the scientific
content, research associate and
administrative/ technical personnel who are
involved in the conduct of clinical trials.

3. .2 Once the protocol or study description

has been approved, the maximum number of
sponsored healthcare professionals will be
limited to two per participating investigational
site.

3. .3 For clinical trials conducted solely in the

Philippines, investigators meetings held
outside the country are not allowed. However,
the principal investigator from each
participating investigational site may be
sponsored to attend if the clinical trial results
are presented outside the country, and if the
number of sponsored investigators does not
exceed limits prescribed under Section . ,
etter A.

1 0 Post- ar eting Sur eillances F A Circular o. 2018-012 rescinds Circular

F A uidelines (Circular o. 2018-012): . 201 -004 and provides new guidance in the
conduct of PM of all drug products, especially
All Marketing Authori ation Holder (MAH) shall for drug products classified as monitored release.
establish a PM system for every product in the market
which shall be translated into a product isk
Management Plan ( MP) to be submitted to F A. The
product MP shall be a re uirement for the approval of
new applications of new products classified as monitored
released (i.e., new chemical entities ( CEs)) and
biological products, and shall be based on the latest
version of the following guidelines:

International Conference on Ha moni ation (ICH)

Harmoni ed Tripartite uideline- Pharmacovigilance
Planning- E2E
The European Medicines Agency’s (EMA) uideline on
isk Management ystems for Medicinal Products on
Human se

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 EMA’s uideline on ood Pharmacovigilance Practices
( P) Module - isk Management ystems
EMA’s olume 9A of the ules overning Medicinal
Products for Human se and
The . Food and rug Administration Amendment Act of
200 (F AAA) and the F A’s uidance for Industry
Format and Content for isk Evaluation and Mitigation
trategies ( EM ), EM Assessments and Proposed
EM Modifications.

ocal Phase I clinical trials for drug products that are

classified as monitored release shall be conducted
following the F A-approved protocol, consistent with the
guidelines provided under A. no s 198 as
supplemented by A. o. 200 -0021.

pon submission of the complete and correct

re uirements, review and approval of the clinical trial
protocol and product dossier, the F A shall grant a
Marketing Authori ation (MA) distinctly indicating that
it is classified under monitored release, which shall valid
for three years, unless sooner revoked, but for revision
with single extension.

Pertinent fees shall adhere to A. . o. 0 s.2001

chedule of Fees and Charges for the Corresponding
ervices endered by the F A.

15. Honoraria

. HCPs may be engaged as consultants and

advisors for services such as speaking at and/or
chairing meetings and events, involvement in
medical/scientific studies, clinical trials or training
services, participation at advisory board meetings,
and participation in market research where such
participation involves remuneration.

The arrangements that cover these genuine

consultancies or other services must, to the extent
relevant to the particular arrangement, fulfill all the
following criteria

(a) A contract or agreement must be in place that

specifies the nature of the services to be provided and
the basis for payment of those services.

(b) A legitimate need for the services must be clearly

identified and documented.

(c) The criteria for selecting consultants must be

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 directly related to the identified need and the
consultants must have the expertise necessary to
provide the service.

(d) The number of consultants engaged must not be

greater than the number reasonably necessary to
achieve the identified need.

(e) The hiring of the consultant to provide the

relevant service must not be an inducement to
prescribe, recommend, purchase, supply, and/or
administer any medicine.

(f) The compensation for the services must be

reasonable and reflect the fair market value of the
services provided. For honorarium paid for services to
be rendered locally, member companies should take
into consideration certain criteria, including but not
limited to

Nature of services (speaker, chair, moderator,

etc.)
Therapeutic area of expertise
Experience level/qualification of HCP engaged
Number of HCPs in same level of expertise
Complexity of the subject matter
Duration of event
Number of event participants

15. 2 Virtual Honoraria

For recordings of virtual lectures that are expected

for multiple usage to different group of audiences,
a company may pay the speaker an additional
premium, in addition to the applicable regular in-
base lecture rates.

The service agreement should indicate the

applicable regular in-base lecture rates plus the
additional premium amount.

The additional premium amount should not be

more than the applicable regular in-base
lecture rate.

16.0 Patient Organization, Patients, Patient 3. How do we determine a formally

Support Programs organized and reputable not-for-profit
institution
16.1 Definition
The engaging company must do due diligence

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 16.1.1 Patient Organizations to establish the reputation and constitution of
the organization, e.g., check if there is formal
Typically, a formally organized and reputable not-for- structure (e.g., set of officers, regular
profit institution that primarily represents the meetings, etc.), examine the constitutive
interests and needs of patients, their families and/or documents (articles of incorporation,
caregivers declaration of membership, credo or similar
documents.), on organizational objectives,
16.1.2 Patients financial statements, etc.

Refers to individuals on therapy of a product, or those Companies may impose as an additional

that are not on therapy but could benefit by such (e.g. requirement registration with a government
vaccines, or those at risk but not yet on therapy) agency (e.g., Securities and Exchange
Commission) or recognition by another formal
16.1.3 Patient Support Programs group like the Philippine Medical Association.

Programs that involve interaction with patients, This section shall apply to cases where OTC
including patient education, or programs to ensure products and medical devices are involved
patient compliance and adherence except to the extent allowed by law. For
example, promotional interactions with
patients and patient organizations involving
16. 2 Interactions with Patient Organizations OTC products may be allowed to the extent
provided by law.
16.2.1 Scope

The pharmaceutical industry has many common

interests with patient organizations. All interactions
with patient organizations must be ethical. The
independence of patient organizations must be
respected.

16.2.2 Declaration of Involvement

When working with patient organizations, companies
must ensure that the involvement of the company and
the nature of that involvement are clear from the
outset.

No company may require that it be the sole funder of

the patient organization or any of its programs.

16.2.3 Written Documentation

Companies that provide financial support or in-kind

contribution to patient organizations must have in
place written documentation setting out the nature of
support, including the purpose of any activity and its
funding.

16.2.4 Events for Patient Organizations

Companies may provide financial support for patient

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 organization meetings provided that the primary
purpose of the meeting is professional, educational,
and scientific in nature, or otherwise supports the
mission of the patient organization. When companies
hold meetings for patient organizations, companies
must ensure that the venue and location is
appropriate and conducive to informational
communication. In addition, any meals or
refreshments provided by a company must be modest
as judged by local standards.

16.2.5 Communication to Patients

Communication with patients should aim at

supporting better healthcare and not for purposes of
promotion.

Careful consideration needs to be made about the

appropriateness, language and style of
communication. Therapeutic decisions must be made
by HCPs only.

16.3 Disease awareness programs

Any disease awareness programs must be accurate,
balanced and materials should be written in
appropriate language for the public. The purpose of
such programs is to enhance public awareness of
diseases, to encourage members of the public to seek
treatment for their symptoms and thereby save
and/or improve the lives of patients while not
promoting the use of any specific product.

16.3.1 Virtual Disease Awareness Program

Disease awareness programs are focused on

encouraging patients to seek appropriate
treatment and management for their symptoms
while not promoting the use of any specific
product thus, only company logos of sponsoring
companies will be allowed.
A privacy notice should always be employed in
getting consent of participants for the sole purpose
of registration and access to virtual platforms.
Personal data collected should be protected based
on the Privacy Act provisions.

16.4 Patient Support Programs

Patient Support Programs ( PSPs ) should have clear
objectives, and should maintain HCP independence

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 and protect the rights and privacy of the participants.
PSPs must not be designed or used to encourage the
use of products in a manner that is inconsistent with
the approved product labeling (e.g., no targeting of
patient populations outside of the approved product
label). All PSPs must comply with applicable laws and
regulations (including laws relating to data privacy,
drug safety reporting, drug advertising laws, etc.).

16.4.1 Virtual Patient Support Programs

A privacy notice should always be employed in

getting consent of patients for the sole purpose of
registration and access to the virtual applications/
tools. Personal data collected should be protected
based on the Privacy Act provisions. Companies
are not to access these patient personal data.

Companies are not recommended to participate in

telemedicine interactions that should be limited
between the HCP and the patient.

16.5 Patient Information

All safety data processing and reporting obligations
must be fulfilled. Patient or caregiver data must only
be collected and used and disclosed in accordance
with applicable privacy laws and all notice and other
privacy requirements must be met. Companies must
be transparent, clear and unambiguous with patients
or patient caregivers about the collection of the data
and how it will be used. All required consents must be
obtained and only the minimum amount of data
needed for the disclosed purposes should be collected
and retained for only as long as needed to achieve the
disclosed purpose.

17.0 Communications With The General Public

(Refer to Guidelines On Communication Of

Prescription Products To The General Public
Appendix .)

. Inquiries regarding the use of pharmaceutical

products may be construed as practice of medicine
hence, appropriately qualified personnel such as the
Product Manager or Medical Director must handle
this. Request for advice on diagnosis and treatment
must always be referred to a healthcare professional.

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 .2 The current trend is the rapid transfer of
information, awareness and education on the health
risks of certain diseases, such as coronary heart
disease, diabetes, smoking, respiratory diseases, HIV,
tuberculosis, gastrointestinal infection, obesity,
influenza, cancer, osteoporosis, menopause, stress and
depression. Infomercials covering medical and
healthcare topics and treatment options are permitted
as long as their content is medically sound, does not
encourage self-medication, and directs the readers to
consult a doctor, and as long as treatment options are
balanced with information on contraindications,
precautions, warnings and side effects.

.3 General media articles may be initiated by

manufacturers to announce the holding of a scientific
event.

.4 Any activity directed to the general public that

encourages a patient to consult a healthcare
professional for a specific illness is allowed as long as
no specific brand is mentioned.

. For public service announcements on product

withdrawals, batch problems, batch mix-ups, and new
warnings about a product that may have serious
public health implications, brand names together with
their corresponding generic names may be used.

.6 Patient education should encourage patients to

seek further information or explanation from the
appropriate healthcare professional.

. The educational material should be current,

accurate, and balanced, and should not focus on a
particular product unless it is to be given after a
particular product has been prescribed.

. The educational material must contain a

statement directing the patient to seek further
information from his or her healthcare professional.

. Patient Aids

Once a decision to prescribe a product has been made,

patient aids that are solely intended to provide
information for the patient may be product-specific.
The content of such material must be designed to
assist patient compliance by providing information
that clarifies the method of the administration,
precautions and special instructions. Patient aid must

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 not make comparisons or include promotional claims.
To ensure compliance, patient aids must be
administered by the appropriate healthcare
professional.

. The tone of material must not cost unnecessary

alarm or misunderstanding nor must it cause
unfounded hopes of successful treatment to stimulate
demand for prescription of a particular product.

18.0 Access Program Guidelines

PHAP recognizes that patients benefit from access This Section is based on PHAP Memorandum
programs and patient care initiatives that allow access Circular -2
to cheaper medicines for Filipino patients. On the Amendments on the PHAP Code as Ratified
other hand, the independence of healthcare During the February 26, 2 GMM
professionals must be maintained such that no
financial benefit or benefit-in-kind may be provided or
offered to a healthcare professional in exchange for
prescribing or recommending the product. Also, such
programs must encourage appropriate use for
pharmaceutical products by supporting the qualified
oversight by healthcare professionals over the
prescribing and medication process. To ensure that
these programs comply with existing and applicable
legal and regulatory frameworks, the following should
be observed

. Access programs or patient care initiatives may

include a discount feature, whether through coupons
or e-cards.

2.Such discounts through coupons or e-cards must be

channeled through the physician and backed by a
prescription. No such discount card or coupon can be
given directly to patients.

3. nder no circumstances should the physician be

compensated nor benefit from such discounts.

4.Access programs and patient care initiatives,

particularly in implementing discount features, should
be non-discriminatory. It must be made available to
any or all physicians who may wish to pass them to
patients.

.The discount feature or scheme under any access

program or patient care initiative should not be
advertised to the patient in any form at the doctor s
clinic, including the display of posters and/or leaflets.

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 6.The discount feature or scheme cannot be tied to
sales promotion, raffles or promise of reward that
may encourage self-prescription.

.For purposes of accountability, access programs or

patient care initiatives, with or without a discount
feature and whether through coupons, cards or
electronic versions thereof, must clearly identify the
responsible company and relevant participating
health product.

19.0 Administration of the Code

The administration of the Code shall be supervised by

the Ethics Committee of the Association. The
Committee in reaching a decision as to whether or not
a breach has occurred may seek expert advice
externally.

Complaints Handling Procedure

19.1 Intercompany Discussions First

Member companies are encouraged to settle matters
among themselves before elevating the issue to the
PHAP Ethics Committee.

19.2 Submission of Complaints

Complaints must be in writing or by e mail and must

include

Complainant details:

•The true identity of the complainant with a

full mailing address (including fax number and
email, if possible) for correspondence.

A private person or entity who lodges a

complaint may request for anonymity.
Industry complaints must be signed by the
General Manager or a senior officer of the
Company in violation For each case, the
identity of the company which is alleged to be
in breach of the PHAP Code and the name of
any product or products which are specifically
involved.

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 •Summary For each case, a brief description
of the complaint with reference to the portion
of the PHAP Code under which the complaint is
being made (section and paragraph number).

•Reference material: For each case, a specific

reference to the source of the
advertisement/activity, which is the subject of
the complaint, or printed material or other
evidence. A copy of the material in question
must be provided.

•Date(s) and place(s): The date and place of

the alleged breach of the PHAP Code.

All communications should be addressed to:

The Executive Director

Pharmaceutical Healthcare Association of the

Philippines
Rm. 2 One Corporate Plaza, A. Arnaiz Avenue,
Makati City

The PHAP Secretariat shall stamp and acknowledge

receipt of the complaint.

The PHAP Secretariat who shall also determine if such

merit the attention of the EC may entertain inquiries
and clarifications pertaining to the Code.

19.3 Validation

When a complaint alleging a breach of the PHAP Code

is received by the PHAP Secretariat, it shall first
validate the complaint within five ( ) working days to
ensure that

It appears to be genuine, submitted in good

faith
There is sufficient information to enable the
complaint to be processed (Based on the
requirements for the submission of
complaints).

If the information provided in the complaint is

inadequate, the complainant must provide additional
information within the working days allocated for
Secretariat validation.

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 Finally, if a complaint cannot be validated, it shall not
be processed and the complainant must be notified
accordingly.

19.4 Notice

Within five ( ) working days from receipt by PHAP of

the valid complaint, a copy, including any supporting
evidence (e.g. a copy of the advertisement alleged to
be in breach of the PHAP Code), shall be sent to the
General Manager and the Compliance Officer of the
Respondent Company .

19.5 Response

The etter to Respondent shall indicate the time
within which a response must be made which shall be
no more than fifteen ( ) working days from
Respondent s receipt of the document. No extension of
time shall be granted.

If Respondent fails to respond within the prescribed

period, the complaint shall be submitted for
resolution by the EC based on the evidence submitted
by the complainant.

19.6 Resolution

Cases shall be decided within thirty (3 ) working days

from receipt of Respondent s reply, or if Respondent
fails to submit a written response, from the lapse of
the period for submitting such response.

If necessary, the PHAP EC may convene an experts

panel to provide medical or technical advice and may
therefore extend the timelines.

However, for all cases, the PHAP Ethics Committee

must resolve the case and transmit its ruling to both
the complainant and Respondent within sixty (6 )
working days from receipt of Respondent s reply, or if
Respondent fails to submit a written response, from
the lapse of the period for submitting such response.

19.7 Appeal

The PHAP Ethics Committee shall not entertain any

motions for reconsideration. The decision of the
Ethics Committee shall be immediately enforceable. In
the instance that either the complainant or the

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 accused contests the decision, it may file an appeal
within fifteen ( ) working days to the PHAP Board of
Trustees from receipt of the decision that in turn
constitutes an Appeals Board.

19.7.1 Appeals Board (AB)

Decisions by the AB are absolutely final and

executory.

The composition of the AB shall be drawn from an

independent pool of experts.

An administration fee shall be charged to the party

who files the appeal.

All appeals shall be decided within thirty (3 )

working days from receipt of the appeal.

19.8 Sanctions How much is the administration fee for

appeals
If a company is found in breach of the PHAP Code,
company has ten ( ) working days to provide The administration fee for appeals is P4 ,
written details of the action taken to comply with the if the decision is reversed on appeal, this
ruling ( the Compliance Statement ). amount will be returned to the appealing
party.
At the very least, the company will be asked to
confirm that the activity or use of the material or
program in question, and any similar material/
program if not already discontinued or no longer in
use, will cease immediately and that all possible steps
will be taken to avoid a similar breach of the Code in
the future.

The Compliance Statement must be signed or

authorized by the General Manager and must include
the date on which the material was finally used or
appeared and/or the last date on which the activity
took place.

19.9 Penalty Scheme

First offense shall be meted a fine of PHP

2 , . .

Succeeding offenses of the same nature (e.g.,

interfering with HCP independence) or within
the same section of the Code within a twelve
month period shall be meted a fine of PHP
, . per offense and company name will

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 be published on the PHAP website.

Clean slate if no violations of the same offense

are committed within a 2-month period.
Reckoning date for all violations is the date
when a decision was issued by the PHAP Ethics
Committee.

20.0 Publication of the Outcome

A summary of the cases will be published on the PHAP

website. The information disclosed will include a brief
summary of the key facts and the results of the EC
ruling and/ or the Appeals Committee. The
respondent company, the complaina . nt, and
product(s) shall not be named.

However, for companies with multiple violations

involving any provision of the Code, the information
on the identity of the company in breach, the name of
any product, and other relevant information shall be
disclosed.

Moreover, the Headquarters of the company in breach

shall be notified of the violation.

A copy of the material to be published is provided to

the respondent company for information only.

21.0 Compliance Procedures

It is the responsibility of PHAP members to ensure

that an internal compliance procedure exists that
strives for compliance with all provisions of the Code
and the spirit it embodies. This procedure should be
documented and provided to relevant employees to
further enhance COP compliance.

22.0 Amendments

This Code may be amended by a simple majority vote

of all the members present in a General Membership
Meeting provided the meeting was announced at least
two weeks in advance and the proposed amendments
are included in the agenda.

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 a le 1: PHAP recommends the amounts in ta le as the maximum rates for HCP honoraria for common
e ents conducted within the Philippines

hese rec mmendati ns are n t intended t restrict mem er c mpanies r m pr vidin C s in the
same level expertise c mplexit the s ect matter d rati n the event and the n m er
event participants

HCPS who conduct lectures for international event held in and outside the Philippines are
entitled to an honoraria based on the prevailing fair market value relative to the same measures
used for non-Filipino HCPs in the same event. 


It is acceptable for virtual lectures to have an additional exact amount or no more than 100%
original in base amount of lecture fee with the expectation for lecture to be used repeatedly as
needed.

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72827 - CT.indd 60 29/09/2020 10:51:05 AM
 Appendix

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 APPENDIX 1
GUIDELINES ON COMMUNICATION OF PRESCRIPTION PRODUCTS TO THE
GENERAL PUBLIC

DEFINITION OF TERMS

Advertisement:
Promotion of a product, service, advocacy or institution by way of paid placement through
media (print, broadcast, billboards, collaterals) at a guaranteed target date or time. This
includes any representation by any means whatever for the purpose of promoting directly
or indirectly the sale or disposal of any pharmaceutical product.

Advertorial:
A paid advertising material in editorial format. An advertorial can be distinguished from
a news release or feature article in that most of the time an advertorial material would
contain at the bottom of the material the word “ADVT,” which means advertising.

By-lined articles:
News articles, feature stories or health columns with the name of the writer displayed after
the title of the story.

Infomercials:
Dissemination of information of a product, disease, clinical study or advocacy through non-
paid media.

Locally generated news:

Press materials prepared and issued by the Philippine-based pharmaceutical company.

Mass Media:
Any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print
medium, radio, television, cinema, mobile audiovisual unit or widespread medium of
information directed at the lay public.

Press Release:
An official announcement or account of a news item circulated to the media without
assurance
that it will come out in a newspaper or magazine.

Prescription products:
BFAD-registered medicines or drugs dispensed by drugstores and pharmacies to patients
with prescriptions. These are also known as “Ethical Drugs.”

Promotion:
The practice of giving temporary additional value to a brand, product or service to achieve
specific marketing objectives. This includes the distribution of free/sample pharmaceutical
products.

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 Tri-media advertisement:
Paid advertising placement using print, TV and radio.

Wire News:
Press articles generated by a wire agency.

THE GUIDELINES

1. Conform to FDA and local industry regulations.

2. Per DOH AO 65 Sec. 2.4, the pharmaceutical company that owns the pharmaceutical
product and its Medical Director shall be responsible and accountable for the content
of its advertisement and promotional materials. To be consistent, all materials and
press releases should have the approval of at least the Medical Director.

3. Observe self-regulation in the following channels of communication and news trigger

points:

a. Any form of tri-media advertisement is strictly not allowed per Section No. 3 of BFAD
Regulation No.5 s. 1989. The only allowable channels of communication are press
releases, editorials, health columns and features, and public service announcements
per Section 4 of BFAD Regulation No.5 s. 1987.

b. For multi-national and foreign-owned companies: news coming from company

headquarters,
• The local subsidiary should filter or adapt International Headquarters
news to local requirements.
• Press information shall follow the company approval process
Consistent with DOH AO 65 Sec. 2.4, the Medical Director should approve
all outgoing press information.
• It is advisable to also secure legal approval either through in-house
legal counsel, a legal retainer or PHAP legal counsel.

c. Locally generated news.

• This is allowable if consistent with PHAP Code.
• However, this should go through medical approval or the appropriate
company approval process. The company’s Medical Director should
approve all outgoing press information.
• It is advisable to also secure legal approval either through in-house
legal counsel, a legal retainer or PHAP legal counsel.

d. By-lined articles
•PHAP does not have jurisdiction over third-party writers, health
columnists and media spokes- persons.
•Please refer to #4 below on ethics related to industry interactions.

e. Statements of Employees
•Attributions, quotations and statements lifted out of an interview, lecture
or media briefing are allowed as long as employee statements, whether
direct or indirect, conform to ALL the prescribed guidelines.

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 f. Media briefing (press conference, media RTD’s, exclusive one-on-one
interview)
• Press kits shall have the necessary medical approval. The Medical
Director should approve all outgoing press information.
• It is advisable to also secure legal approval either through in-house
legal counsel, a legal retainer or PHAP legal counsel.
• No product photos and product backdrops are allowed
• PHAP Guidelines on “Communications with the General Public’’ shall
be part of the press kit.

g. Global and Regional Media Conference

• The invited journalist/s shall be issued press materials complying

with Section 5 (Accept- able and Recommended News Content/Format.
Since this is an international event, it is the responsibility of the Philippine-
based pharmaceutical company to ensure compliance with the guidelines.
(Refer to the Philippine Journalists Code of Ethics)

h. “Online” (internet) news and promotion

• This should apply to local broadsheets with online versions (e.g.,
inquirer.net,mb.com.ph.,philstar. net, bworldonline.com, etc.). Guidelines
a,b, and c are to be applied for online news.

i. Wire news
• Wire news is acceptable. PHAP has no jurisdiction over wire news
independently picked up by media. However, to be legitimate, wire news
articles should have been properly sourced from the news agency (e.g., AP,
Reuters).
• Feeding of news on competitive products is considered unethical.

j. Pre-arranged interviews and guesting (TV, radio and print)

• The Medical Director should approve script guides and proposed
scripts.
• It is also advisable to secure legal approval either through in-house
legal counsel, a legal retainer or PHAP legal counsel.
• Backdrops with brand mention for TV, and sound bites with brand
mention for radio are not allowed.

Please refer to Guideline #4 (Ethics on Industry Interactions).

4. Ethics on Industry Interactions with Media and Third-Party Spokespersons

• It is unethical to pay physicians and media to influence professional

or public opinion. Specifically, no commissions or payments shall be given
for articles, editorials or medical journal re- views that are actually written
by industry or public relations firms in an attempt to manage the press on
certain products and services.

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 5. Acceptable and Recommended News Content/Format

• Infomercials covering medical and healthcare topics and treatment

options are permitted as long as its content: (a) is medically sound; (b) does
not encourage self-medication; (c) directs readers to consult a doctor;
and (d) includes treatment options that are balanced with information on
contraindications, precautions, warnings, and/or side effects.
• Information material should encourage patients to seek further
information or explanation from the appropriate healthcare professional.
• The material should be current, accurate, and balanced.
• The material must contain a statement directing the patient to seek
further information from his or her doctor.
• BFAD Sec. 4 Press releases, editorials, health columns and features
and public service announcements on health and medicines shall not
specify brand/trade names. Generic names, however, are permissible.
For prescription drugs, it should be clearly stated that this product can
be bought only with a prescription and that a doctor’s advice should be
sought.

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 Frequently Asked Questions on PHAP Code Virtual Engagement Guidelines

Introduction

This FAQ document is developed to further guide PHAP Member companies in interpreting
the PHAP Code of Practice Virtual Engagement Guidelines. Member companies should
adhere to the requirements established by applicable laws, regulations, PHAP Code of
practice and internal company guidelines. In the event of a conflict between the provisions
of the applicable laws, regulations, and codes, the more restrictive of the conflicting
provisions should apply.

The Scope of the PHAP Code of Practice Virtual Engagement Guidelines

1.Does the guidance also relate to hybrid meetings?

This guidance is specifically released for purely virtual meetings. Hybrid meetings should
follow the principles of face-to-face meetings. If there is a virtual element to the congress,
the guidance principles should be adhered to. Please note that for Hybrid meetings, the
‘host-country’ code (as per face-to-face congress) and label is applicable. Therefore,
companies can apply them in the development of materials or communications.
(IFPMA, EFPIA, PhRMA Joint Guidance Q&A document)

2. What are obligations with respect to ensuring privacy within the medical society is
maintained? A number of medical societies are selling their detailed delegate list to
sponsors. What happens if companies sponsor HCPs and register the HCPs on their
behalf?

The obligations around privacy do not differ between virtual meetings and face-to-
face meetings. Companies need to ensure that when registering HCPs themselves, they
counsel HCPs of the terms and conditions. Companies also have an obligation to check
that information around privacy will be included on the congress website so that HCPs
are aware of the privacy implications upon entering the site. It is the medical society’s
ultimate responsibility that they are adhering to the privacy obligations of the country they
are operating in and that they are clear to the HCP as to what they are doing with their
personal information.
(IFPMA, EFPIA, PhRMA Joint Guidance Q&A document)

3. Are company organized virtual meetings covered by the PHAP Code of Practice
Virtual Engagement Guidelines?

Data privacy principles provided by the National Privacy Act of 2012, as reiterated in
the PHAP Code of Practice Virtual Engagement Guidelines should always be applied to
company-organized virtual meetings.

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 The frequency and limit to the number of participants provided to virtual CMEs are not
applicable to company organized meetings. Companies should refer to their internal
processes for organizing such virtual meetings.
Guidance on provision of meals to participants is applicable to company organized events.
Sending of meals to individual doctors especially in their residence is prohibited.
The product logos or names are allowed for company events like product launches.

4. What are company organized meetings/ events?

Company initiated events are activities independently organized by companies, either

on its own or through a third party on behalf of the Company that provide product,
disease awareness, or other product-related information to HCPs for promotion or non-
promotional reasons. The Company has control over the agenda, location, HCP selection,
speakers, or management of the meeting and event.

The following are examples of company organized events.

o Product presentation
o Round table discussion
o Focus Group Discussion
o Product Launch
o Advisory board
o Symposium
o Clinical trial meetings
o Investigator meetings
o Tactical activities

5. What type of information can be shared via SMS, WhatsApp, Viber, etc.?

It depends on the consent obtained by the company and the terms and conditions of the
platforms.

PHAP Code provisions on promotional materials shall apply.

Virtual Exhibit Booths

6. What are Virtual Exhibit Booths?

Similar to regular exhibit booths at scientific conferences, the virtual booths are spaces/ ads
or links where companies share information about their products and services, showcase
their latest innovations.

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 7. The PHAP Code Guidelines specify “Add virtual booth system including specific
time slots to enable access of participants only during breaks.”

Does this mean that companies can present/show product logos after or before the CME?
Or this is solely for booth sponsorship?

Presentation of products/ logos are allowed only for virtual booth spaces. The main lecture
session should be purely for Continuing Medical Education (CME). There should be no
promotions of any kind. Product presentations should have a specific time slot and not
as a part of CME program.

8. How should the virtual platform separate investigational and disease inquiries
from marketed product inquiries?

A minimum disclaimer should be applied. Where possible, you can ask the HCP to
categorize the query (e.g. through selection of a dropdown menu) prior to responding to
the question. Please note: this is no different from face-to-face meetings.

(IFPMA, EFPIA, PhRMA Joint Guidance Q&A document)

9. Can brands be mentioned before each session begins if there is no segregation for
promo like a virtual booth area?

It is important to clearly indicate to the delegate what information is promotional and what
is non-promotional. A medical/scientific session should not be associated with promotion
of any product. When discussing brand information, you must follow the relevant code
provisions for promotion.

(IFPMA, EFPIA, PhRMA Joint Guidance Q&A document)

10. Can we use brand colors in virtual scientific/promotional/’social area’?

The use of color branding should follow the relevant country code’s provision for
promotional activities. For non-promotional sites/areas, branding colors should not be
used to avoid the perceived promotion.

(IFPMA, EFPIA, PhRMA Joint Guidance Q&A document)

11. If an international medical society holds a congress with many delegates being
from outside of host country, would it be acceptable to share information about a
product indication which is not approved in in the host country, but is approved in,
for example, North America and Japan?

It is critical that the company clearly indicates which label has been used for the development
of promotional material and has a disclaimer indicating that registration conditions differ
internationally and that HCPs should refer to prescribing information from their country of
practice as information may be different for each country.

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 (IFPMA, EFPIA, PhRMA Joint Guidance Q&A document)

12. Is it sufficient to have delegate click a check-box confirming he/she is an HCP, or

should there be additional validation (name, country, professional affiliation, etc.)?

When a delegate enters a company area where promotional information is provided, there
should be a clear disclaimer of what is presented. It is sufficient to have the HCP indicate
through a check-box or validation mechanism confirming their status as a HCP and they
accept the shared responsibility that they will only access what they are supposed to see.

Conduct of Virtual Meetings

13. Why are we limiting provision of meals to a minimum of 5 HCP participants

gathered in one venue.

Meals are only provided as incidental to the meeting. In order to be construed that the
meals is not the main purpose of the virtual CME or meetings, a minimum of 5 participants is
the approved recommendation from the PHAP Governance and Compliance subcommittee
members and PHAP Board members. Sending of meals to individual HCPs especially in
their residence can be construed as provision of gift.

14. What if a webinar meeting will run simultaneously nationwide where HCP’s are
in different venues or location, should we still follow minimum limits in providing
meals in each venue?

We can provide meals to a gathering of 5 in different appropriate locations/ meeting

venues.
Internal company controls should be in place.

15. Why are we limiting sponsorship to twice a year limit per participant for
international/ regional CMEs?

This recommendation by the PHAP Governance and Compliance subcommittee is based on

the goal to help give equitable opportunities to all HCPs.
16. We are allowed to sponsor doctors to foreign virtual congresses twice each year. If face-
to-face international congress will already be allowed, can we still sponsor a doctor to this
face-to-face congress once each year on top of the 2 virtual foreign congresses?

No.

17. How about 1 virtual and 1 face-to-face sponsorship?

In the event that face-to-face meetings resume, HCPs can only be sponsored either 1 face-
to-face or 2 virtual sponsorships per year.

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 18. Does DOH AO 2015- 0053 Implementing Guidelines on the Promotion and
Marketing of Prescription Pharmaceutical Products and Medical Device (also
known as MCP AO) limit of 20 participants still apply in virtual international CME
sponsorships?

The limit does not apply to virtual CME sponsorships. The AO guidelines on limit of 20
HCPS was specifically for CME sponsorships involving international travel. For face-to-
face sponsorships, the PHAP Code limits sponsorship to 7 (International/ Regional) and
12 (Asia).

Virtual Lectures Honoraria

19. In relation to Virtual Honoraria, if the role of the HCP consultant is moderator
only, and the virtual session of the moderator was recorded for post-viewing/video
highlights for subsequent virtual events/required by the medical society, do we
consider paying additional honoraria for the moderator recording?

Provision on additional premium is not applicable to moderators.

20. Does Virtual Honoraria also cover recording/reuse of “live” Q&As? We noted
some events (even third party conventions) where there is a live Q&A, and they
record the session with this Q&A segment, and make it accessible/available for a
certain period in the website. Should this be paid separately to the speaker (on top
of honoraria for speaker + recording/reuse of lecture + live Q&A) or would it already
be covered by the recording/reuse fee?

There should be no additional premium for Q&As.

21. Can the companies sponsor the virtual platform subscription for Medical
Societies?

No.

22. In relation to Virtual Patient Support Programs which states “Companies are
not recommended to participate in telemedicine interactions that should be limited
between the HCP and the patient,” if the Company were to provide a telemedicine
platform through a program but not participate in the interactions between HCP and
patient, will this be allowed?

This provision refers to the MD-patient virtual consultations only where the companies are
not allowed to get involved (e.g. promotional products appearing on screen, drop-down list
of products in the Rx generation page).

23. Can companies sponsor telemedicine apps?

No.

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 PHAP Members

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 1. Abbott Laboratories
2. Astellas Pharma Philippines, Inc.
3. AstraZeneca Pharmaceuticals
4. Ayala Healthcare
5. Bayer Philippines
6. Blue Sky Pharma
7. Boehringer Ingelheim
8. Calmoseptine
9. Champion Biotech
10. Ferring Pharmaceuticals
11. Galderma
12. GlaxoSmithKline Philippines
13. Glenmark Philippines, Inc.
14. Hi-Eisai Pharmaceutical
15. IQVIA
16. Johnson and Johnson
17. Merck, Inc.
18. Merck Sharp and Dohme
19. Mercury Drug Corporation
20. Metro Drug, Inc.
21. Mundipharma Distribution GmbH
22. Novartis Healthcare
23. Novo Nordisk Pharmaceuticals
24. Otsuka (Philippines) Pharmaceuticals
25. Panpharma-Meinz Healthcare and Pharmaceuticals Inc.
26. Pfizer, Inc.
27. PhilUSA Corporation
28. PharmAsia-Cuvest
29. Qualimed
30. Roche (Philippines), Inc.
31. Rudolf Lietz
32. Sanofi-aventis
33. Swiss Pharma
34. Taisho Pharmaceutical
35. Takeda Healthcare Philippines Inc.
36. TGP Pharma Inc.
37. Vizcarra Pharmaceutical
38. Watsons Personal Care Store
39. Zuellig Pharma Corp

*Members list updated as of reprint in February 2018.

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