Phap

Code of Practice
Code of Practice
Philippine Copyright 2013
by Pharmaceutical and Healthcare Association of the Philippines
Foreword
Foreword
Foreword
The PHAP Code of Practice adopts in full and aligns with the Expanded Code of
Practice of the International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA) 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 and professional requirements.
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
June 1, 2013 version
3
Foreword
patients.

TEODORO PADILLA
Executive Director
4
Member’s Pledge
Foreword
As a PHAP Member, I acknowledge our company’s responsibility to adhere to
the Code of Practice in our commitment to operate our businesses ethically
and with
The PHAP integrity.
Code of Practice adopts in full and aligns with the Expanded Code of
Practice of the
I pledge International
to uphold Federation
the Guiding of Pharmaceutical
Principles Manufacturers
of the Code of Practice such as &
Associations
integrity,(IFPMA) and the
transparency, Mexico Cityaccountability
independence, Principles forandVoluntary Codes
patient focus to of
Business Ethics
ensure thatinall
theour
Biopharmaceutical
interactions withSector,.
publicItand
incorporates local requirements
private sectors, healthcare
and practices in relation
professionals, to registration;
medical labeling
institutions and patientand scientific claims
organizations, are atapproved
all times by
the Philippine Food and Drug
ethical, appropriate Administration (FDA).
and professional.
As Delegate, I recognize my role in leading the promotion of the Code of
Practice among company employees through information and education and
benefitthorough
patientstraining.
as well as programs and collaborations that enhance the practice of
patients.
_________________________
Company
_________________________
and innovative medicines. Ethical promotion helps__________________
to ensure that HCPs have access
to the Print
rightName of Delegate
information they need and that right Date
patients have access to the right
Signature
-------------------------------------------------------------------------------------------------------
professional responsibilities they have PLEDGE
MEMBER’S with their patients. Pharmaceutical
As a to
activities PHAP Member,
HCPs, I acknowledge
Patient groups andourPatient
company’s responsibility
Organizations and tocomply
adhere to
with
the Code of Practice in our commitment to operate our businesses ethically
and with integrity.
Through the promotion
I pledge to upholdof this
the Code, Principles
Guiding PHAP seeks of to
theensure that
Code of ethicalsuch
Practice promotional
as
practices are established
integrity, and be
transparency, at par with International
independence, accountability Standards
and worldwide.
patient focus to
ensure that all our interactions with public and private sectors, healthcare
professionals, medical institutions and patient organizations, are at all times
ethical, appropriate and professional.
As Delegate, I recognize my role in leadin g the promotion of the Code of
Practice among company employees through information and education and
TEODORO PADILLA
thorough training.
Executive Director
_________________________
Company
_________________________ __________________
Print Name of Delegate Date
Signature
(Please send this portion of the signed Member’s Pledge to PHAP )
5
Foreword
patients.

TEODORO PADILLA
Executive Director
6
PHAP Board
PHAP ofTrustees
Board of Trustees
Foreword
The PHAP Board of Trustees (BOT) sets the policies for the PHAP Code of Practice. It
has the responsibility of ensuring that all member companies abide by the Code.
patients.


TEODORO PADILLA
Executive Director
7
PHAP Board of Trustees
(2013)
Foreword
patients.

TEODORO PADILLA
Executive Director
8
Ethics Committee/
Appeals Board
Ethics Commitee
Ethics Committee
Foreword
While the Board of Trustees sets policies and rules, it appoints an independent body
composed of experts from the academe, business ethics, and the healthcare sector.
To
Theadjudicate
PHAP Codeoverofpossible
Practiceinfractions
adopts intofull
theand
PHAP Codewith
aligns of Practice and dealsCode
the Expanded with of
complaints
Practice offrom
thewhatever source Federation
International they may come.of Pharmaceutical Manufacturers &
In the context
Business Ethics of transparency,
in the rulings Sector,.
Biopharmaceutical deliberated upon by the
It incorporates localPHAP Ethics
requirements
Committee (EC)
and practices inare madetopublic
relation as theylabeling
registration; are posted in the PHAP
and scientific website.
claims The by
approved
information includes
the Philippine Food andthe Drug
précisAdministration
of the cases and inquiries it handled, the nature of
(FDA).
the complaints, infringements and the corresponding rulings.
patients.

TEODORO PADILLA
Executive Director

9
Ethics Commitee
Foreword
patients.

TEODORO PADILLA
Executive Director
10
Appeals Board
Appeals Board
Foreword
In the instance that either the complainant or the accused contests the ruling of the
EC, the issue may then be elevated to the Appeals Board (AB). Decisions by the AB
are absolutely
The PHAP Code final
of and executory.
Practice adopts in full and aligns with the Expanded Code of
Associations (IFPMA)
The composition of the and the be
AB shall Mexico
drawnCity
fromPrinciples for Voluntary
an independent Codes of
pool of experts.
patients.

TEODORO PADILLA
Executive Director
11
Foreword
patients.

TEODORO PADILLA
Executive Director
12
User’s Guide
User’s Guide
Foreword
The Code o f Practice enumerates the rules falling on the 8 Guiding Principles with
explanatory notes as guides whenever necessary. This copy incorporates all
released
The PHAPcirculars
Code of and the latest
Practice adoptsamendments and modi�ications
in full and aligns and therefore
with the Expanded Code of
supersedes
Practice of allthe
prior rules.
International Federation of Pharmaceutical Manufacturers &
For ease and
Business convenience,
Ethics the Code is rendered
in the Biopharmaceutical Sector,. Itinincorporates
a ring binder format.
local Amended
requirements
sections shall in
and practices be relation
replacedtowith the new guidelines
registration; labeling and and the old claims
scientific ones transferred
approved byto
latter portion
the Philippine Food ofand
the Drug
CodeAdministration
Book. This shall(FDA).
serve as a reference for tracking the
Code of Practice amendment history.
An expanded
benefit patients“Index”
as wellportion containing
as programs keywords/ phrases
and collaborations that enable
that enhance easier and
the practice of
faster access
medicine. to speci�ic
PHAP throughprovisions
its Code ofofPractice
the Codeseeks
is provided.
to preserve the independence of
patients.

TEODORO PADILLA
Executive Director June 1, 2013 version
13
Foreword
patients.

TEODORO PADILLA
Executive Director
14
Table of Contents
Table of Contents
Foreword
TABLE OF CONTENTS PAGE PAGE
TABLEfrom
8 Key Principles (As Adopted OF the
CONTENTS
IFPMA) 19 PAGE
8 Key Principles (As Adopted from the IFPMA)
1.0 Code of Pharmaceutical Marketing Practices
The 1.0
PHAP
CodeCode of Practice
of Pharmaceutical adoptsPractices
Marketing in full and aligns with the Expanded
20 Code of
2.0 Medical
Practice of the Information and Claims Federation of Pharmaceutical Manufacturers &
International
2.0 Medical Information and Claims 21
Associations
3.0 Product (IFPMA)
Information and the Mexico City Principles for Voluntary Codes of
Business Ethics
3.0 Product in the Biopharmaceutical Sector,. It incorporates local
Information 27 requirements
4.0 All Promotional/Educational Materials
and 4.0
practices in relation to registration;
All Promotional/Educational Materials labeling and scientific claims
28 approved by
5.0 Mail, Faxes,
the Philippine FoodEmail
andand Text Administration
Drug Messages (FDA).
5.0 Mail, Faxes, Email and Text Messages 31
6.0 Competitions and Raffles
PHAP 6.0 Competitions and Raffles
and its members are committed to educational and promotional 32 efforts that
7.0 The Use of the Internet for Pharmaceutical Information
benefit patients as well as programs and collaborations
7.0 The Use of the Internet for Pharmaceutical Information that enhance
32 the practice of
8.0 Medical Representatives/ Professional Service Representatives
medicine. PHAP through its Code of Practice seeks to preserve the33 independence of
8.0 Medical Representatives/ Professional Service Representatives
the decisions
9.0 Product taken
Samplesby healthcare professionals (HCPs) in prescribing medicines to
9.0 Product Samples
patients. 33
10.0 Exhibit Booths
10.0 Exhibit Booths 34
The 11.0 Continuing Medical Education
ethical promotion of
11.0 Continuing Medical Education
prescription medicines is vital to the34pharmaceutical
industry’s mission
12.0 Medical of helping Activities
Society-Sponsored patients through research and development of new
12.0
and 13.0 Medical Society-Sponsored
innovative medicines. Activities
Ethical promotion helps to ensure that HCPs 38 have access
Independence of Healthcare Professionals
to the right
13.0 information
Independence they need
of Healthcare and that right patients have access
Professionals 39 to the right
14.0 Clinical Studies and Related Activities
14.0 Clinical Studies and Related Activities 41
15.0 Patient Organizations
15.0 Patient Organizations
Industry relationships with HCPs must support, and be consistent 43 with the
16.0 Communications with the General Public
professional responsibilities they
16.0 Communications with the General Public have with their patients.45Pharmaceutical
companies mustCard
17.0 Discount maintain high ethical standards in the conduct of promotional
Guidelines
17.0 Discount
activities to HCPs, Card Patient
Guidelines 47
18.0 Administration of the Codegroups and Patient Organizations and comply with
applicable legal, regulatory
18.0 Administration and professional requirements.
of the Code 48
19.0 Complaints and Handling Procedures
19.0 Complaints and Handling Procedures 48
20.0 Compliance of this Code, PHAP seeks to ensure that ethical promotional
Procedures
20.0 Compliance
practices are Procedures
established and be at par with International Standards 52
worldwide.
21.0 Amendments
21.0 Amendments 52
TEODORO PADILLA
Executive Director
15
Foreword
patients.

TEODORO PADILLA
Executive Director
16
Index
Index
Foreword
patients.

TEODORO PADILLA
Executive Director
17
Foreword
patients.

TEODORO PADILLA
Executive Director
18
Code of Practice
PHAP CODE Explanatory Notes
Foreword
PHAP Guiding Principles On Ethical Conduct
and Promotions
The following
The PHAP CodeGuiding Principlesadopts
of Practice set outinbasic
full and aligns with the Expanded Code of
standards of
Practice thatthe
applyInternational
to the conductFederation
of PHAP of Pharmaceutical Manufacturers &
Member Companies and their agents. This helps
ensure that their andwith
interactions thestakeholders
Mexico City Principles for Voluntary Codes of
are appropriate.
The healthcare
the Philippine Food andand Drug
well being of patients (FDA).
Administration
are the first priority for pharmaceutical
companies.
benefit patients as well
 Pharmaceutical as programs
companies and collaborations that enhance the practice of
will conform
medicine. PHAP
to high throughofitsquality,
standards Code safety
of Practice
and seeks to preserve the independence of
efficacytaken
the decisions as determined
by healthcare by regulatory
professionals (HCPs) in prescribing medicines to
authorities.
patients.
 Pharmaceutical companies’ interactions
The ethical promotion must
with stakeholders of prescription
at all times bemedicines is vital to the pharmaceutical
ethical,
industry’s appropriate
mission and patients
of helping professional.
through research and development of new
Nothing should
and innovative be offered
medicines. or provided
Ethical by helps to ensure that HCPs have access
promotion
a company in a manner or on conditions
to the right
that would have an inappropriate right patients have access to the right
information they need and that
medicines at thetoright
influence time.
ensure the independence of
the Healthcare Professional (HCP).
 Pharmaceutical companies are
responsible for providing accurate,
companies must maintain high ethical standards
balanced, and scientifically valid data on in the conduct of promotional
products.
 Promotion must be ethical, accurate,
balanced and must not be misleading.
Information in promotional materials must
support and be at
proper assessment of par
the with
risks International Standards worldwide.
and benefits of the product and its
appropriate use.
 Pharmaceutical companies will respect

the privacy and personal information of
patients.
TEODORO PADILLA
 All Director
Executive 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 companies are
19
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 With respect to membership, the Code
that all  relevant personnel are appropriately considers the following types:
trained. a) A company that is a member of the IFPMA
(referred to as a “direct member”)
The PHAP Code Of Practice covers not only b) A company that is a member of PHAP but
member companies but also local subsidiaries of is not a member of IFPMA (referred to as
IFPMA member companies. “indirect member” of IFPMA)
c) “Company” refers to a wholly local
company, a local subsidiary company and/or
its worldwide parent company.
1.0 CODE OF PHARMACEUTICAL

MARKETING PRACTICES
1.1 Scope of Coverage 1.1

The promotion and advertisement of The Code covers promotion of over-the-
pharmaceutical products directed to HCPs are counter products to healthcare
deemed to fall within the scope of the Code. professionals in hospitals and drugstores.
“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 prescription, recommendation,
supply, administration or consumption of its
pharmaceutical product(s) through any medium,
including the internet.
“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.
1.2 Interpretation of the Code

All matters of interpretation of any section of the
PHAP Code must be consistent with the 8
Guiding Principles.
1.3 Responsibility for Implementation

The General Manager/President/Managing
Director is responsible for the proper
20
implementation of the Code and its implementing
guidelines. He or she shall ensure that all
company employees and the company’s external
advertising and/or public relations and
Foreword
promotional/ detailing agencies are conversant
with the PHAP Code. Press releases fall under
this provision. (Refer to GUIDELINES ON
COMMUNICATION OF PRESCRIPTION
The PHAP Code
PRODUCTS of Practice
TO THE GENERALadopts in full- and aligns with the Expanded Code of
PUBLIC
Practice 1.)of the International Federation of Pharmaceutical Manufacturers &
Appendix
1.4 Exclusions
Business Ethics inofthe
theBiopharmaceutical
Code Sector,. It incorporates local requirements
This Code does not seek to regulate the following
activities:
Promotion
PHAP and/ its
advertising
members / detailing of over - the-
are committed to educational and promotional efforts that
counter products astowell
benefit patients theastrade and and
programs public.
collaborations that enhance the practice of
However, PROVISIONS OF THIS CODE APPLY
medicine.
TO HCPs. PHAP through its Code of Practice seeks to preserve the independence of
patients.or other trade terms for the supply of
*Pricing
pharmaceuticals products.
2.0 MEDICAL INFORMATION AND
CLAIMS
to the
2.1 right information they need and that 2.1
Responsibility right patients have access to the right
medicines at the right time. This responsibility relates not only to the
It is the responsibility of companies, their product being promoted but also to any
employees and their medical/technical advisers information given or claims made about other
Industry
to ensure thatrelationships
the contents ofwith HCPs must
all promotional and support,
products orand be consistent
disease with theIt
states or conditions.
professional
medical responsibilities
claims are they correct
balanced, accurate, have with theirto patients.
also applies tag lines andPharmaceutical
their ability to be
and fully supported
companies by the Product
must maintain high Information, substantiated.
ethical standards in the conduct of promotional
literature
activitiesor to “Data on File”
HCPs, or appropriate
Patient groupsindustry
and Patient Organizations and comply with
source, where these do not conflict with the It is fundamental that any claim made must
applicable
Product legal, regulatory and professional requirements.
Information. be consistent with the FDA approved
information sheet (package inserts) and
Through the
Activities of promotion of this Code, PHAP
company representatives and seeks to ensure
recognized that
current ethical
scientific promotional
papers.
company
practices are advertising and and
established PR be / at
Detailing
par with/ International Standards worldwide.
Promotional agencies shall comply with the
PHAP Code at all times. (a) All data to substantiate claims must
be easily retrievable so that they can be
2.2 Provision of Additional Information supplied upon request within 10 working
days.
Upon written request, the member company will
provide additional accurate and relevant (b) Evaluated data contained in an
TEODORO PADILLA
information about products being marketed to application for marketing may be used to
Executive Director
HCPs. substantiate claims. Such data must be
made available when the company is
All data cited in promotional materials in support requested to substantiate a claim. A
of a claim must be provided within 10 working statement that the data are “Confidential” will
days upon request. Substantiating information not be accepted.
must not rely solely on “data on file”; the
company must have it available upon request. (c) If the information on which a claim is
based may not be released (e.g., an “in

21
2.2.1.Provision of Substantiating Data press” article which is subject to
confidentiality provisions), then that
In addition to the information supplied or information MAY NOT BE USED TO
generally available, a company will, upon SUBSTANTIATE A CLAIM for purposes of
reasonable request, provide healthcare satisfying this section.
professionals with additional accurate and
relevant information about the products, which it (d) Papers cited as “in press” must have
markets, and about the company itself. been accepted for publication and are
available as final approved manuscripts or in
Data in support of a claim, including “data on file” proof form. Papers submitted for publication
or “in press,” MUST BE MADE AVAILABLE and not yet accepted by a journal may be
without delay upon reasonable request even identified only as “unpublished data”,
though the material is not generally available to “personal communication”, “unreferenced
the medical community. data “or similar terms.
2.2.2 Level of Substantiating Data (e) Data relating the cost effectiveness of a
product may be used to substantiate
Any information used to support a medical or promotional claims; however, these data
promotional claim must include sufficient detail must conform with Sections 2.1.2.2., 2.3, 2.5
and be of adequate quality to allow evaluation of and 2.7 of this Code.
the validity of results and hence the claim. Such
substantiating information must not rely solely on In determining whether sufficient evidence is
“data on file” but must be supported by a available to support a claim, companies
Recognized scientific published article. should have regard to issues such as, but not
limited to, the study design, the number of
patients, the location of any trial or study, its
primary purposes and end points, the results,
the reputation and qualifications of the
people involved in the study or trial, the
study’s consistency with the current body of
evidence and where (e.g., peer-reviewed
journal or professional journal) or if it has
been published.
For example, to satisfy the requirements of

this section, the evidence to support any
major claim that will have a significant impact
on the prescribing of a product must be
unequivocal and of the highest quality. It
should not rely upon evidence from sources
such as poster presentations or abstracts
that do not provide sufficient information to
assess the veracity of the claim. Used
appropriately, these information sources may
be used to support lesser or minor claims.
22
2.3 Accurate Scientific Claims
All information, claims and Foreword

graphical
representations provided to healthcare
professionals and members of the general public
must be current, accurate, balanced and must
ThebePHAP
not Codeeither
misleading of Practice adopts
directly, by in full
implication or and aligns with the Expanded Code of
Practice
by of Every
omission. the effort
International
must be made Federation
to avoid of Pharmaceutical Manufacturers &
ambiguity.
Claims must be referenced where there is a
possibility that a reader may be misled if the
the Philippine
source Food and
of the reference Drug
is not Administration (FDA).
disclosed.
2.3.1
PHAPUnapproved productsare
and its members andcommitted
indicationsto educational
2.3.1 and promotional efforts that
Products that have not been approved for The majority of breaches of the Code found
medicine. PHAP
registration by thethrough its Code
FDA cannot be of Practice concern
promoted. seeks to preserve the independence
this section. The following areof
the decisions
However, taken
samples by healthcare
of unapproved professionals
products may examples(HCPs) of in prescribing
situations medicines
wherein to
materials
patients.
be displayed and educational material made may breach the Code. This list is not all-
available at International Congresses and inclusive and is based on the experience of
Regional Congresses in accordance with Section the Ethics Committee.
9. This restriction also applies to unapproved
industry’sformission
indications of products.
registered helping patients through(a) research
Literature and development
references of new
or quotations
and innovative medicines. Ethical promotionderived helps to ensure
from a study that HCPs have
or studies access
and citations
to the right information they need and that of individual
right patients opinions,
have which
accessaretosignificantly
the right
medicines at the right time. more favorable or unfavorable than have
been demonstrated either within the study,
or more likely from the body of experience.
Industry relationships with HCPs must support, and be toconsistent
It is unreasonable with ofthe
cite the results an
professional responsibilities they have with their favorable
excessively patients. Pharmaceutical
(or excessively
companies must maintain high ethical standards unfavorable to aconduct
in the comparative product) study
of promotional
activities to HCPs, Patient groups and Patient in a manner that
Organizations misleadingly
and comply suggests
with
that those results are typical.
(b) Information or conclusions from a study
Through the promotion of this Code, PHAP seeksthat istoclearly
ensure that ethical
inadequate promotional
in design, scope or
conduct to furnish
practices are established and be at par with International Standards port for such
sup-worldwide.
information and conclusions.
(c) Citation of data previously valid but made

obsolete or false by the evaluation of new
data.
(d) Suggestions or representations of uses,

TEODORO PADILLA dosages, indications or any other aspect of
Executive Director the Product.
(e) Shortening an approved indication (e.g.,

in a by-line) so as to remove a qualification or
limitation to the indication.
(f) Use of animal or laboratory data as sole

evidence to support a promotional claim. It
should be noted that if animal or laboratory
23
data are used a prominent statement
identifying this type of data and
acknowledging that such data do not
necessarily predict clinical effects must be
made on the same page and within
reasonable proximity to the data in a
manner that is not obscured by other
material.
(g) Presentation of information in such a

manner (e.g., type size and layout) which, to
the casual reader, could produce an incorrect
perspective. The type size used for qualifying
statements must not be less than 2 mm. The
qualifying statement must not be included
with other reference material but must be on
the same page as the original statement. The
original statement and the qualifying
statement must be linked by use of a readily
identifiable asterisk or a similar symbol.
(h) Statements made about a competitive

product, particularly negative statements, not
balanced with corresponding information
about the product being promoted.
(i) Shortening the title’s graphical

representations reproduced from literature,
which alters the original author’s meaning.
Use of overseas Product Information to

support a claim where that information is
inconsistent with the Philippines Approved
Product Information.
(k) Literal or implied claims that a parameter,

contraindication, precautionary statement,
adverse reaction or limitation on a claim in
the Product Information, is not cause for
concern.
(l) Lack of substantiation of claims

not of a medical or scientific nature. This
includes information or claims relating to
marketing factors such as pricing and market
share. Care should be taken when
extrapolating from sales data.
24
2.4 Good Taste
All promotional and educational material Foreword

(including graphics and other visual
representations) must conform to generally
accepted standards of good taste and recognize
The PHAP Code
the professional of Practice
standing adopts in full and aligns with the Expanded Code of
of the recipients.
These materials(IFPMA)
Associations must not and
contain
theanything
MexicothatCity Principles for Voluntary Codes of
would likely cause serious or widespread offense
Business Ethics in the Biopharmaceutical
against prevailing community standards. Sector,. It incorporates local requirements
the Philippine Food
2.5 Unqualified and Drug Administration 2.5
Superlatives (FDA).
Unqualified superlatives must not be used. All Although in some circumstances “unique”
claims must not imply that a product or an active may be used to describe some clearly
benefit patients
ingredient as well
is “unique” assome
or has programs
specialand collaborations
merit, that feature
defined special enhanceofthea practice
medicine, ofin
medicine. PHAP through
quality or property, its Code
unless the of Practice
claim(s) seeksinstances
can be many to preserve
it maythe
beindependence
taken as implyingofa
the decisions The
substantiated. takenword
by healthcare
“safe,” for professionals (HCPs)
example, general in prescribing
superiority. medicines
In such instance, thistois
must not be used without qualification.
patients. unacceptable unless the claim can be
supported in every respect.
The ethical promotion of prescription medicines
Use of a is definite
vital toarticle
the topharmaceutical
imply a special
industry’s mission of helping patients through research
merit, and
quality or development
property of newis
for a medicine
and innovative medicines. Ethical promotion unacceptable
helps to ensure underthat
this HCPs
clausehave
if it cannot
accessbe
substantiated.
to the right information they need and that right patientsFor example,
have accessatoclaim that a
the right
product is “The analgesic” implies that it is in
medicines at the right time. effect the best, and might not be acceptable
under this clause.
2.6 New Products
activities to HCPs,
The word “new” must notPatient
be usedgroups andanyPatient Organizations and comply with
to describe
applicable legal, regulatory
product, presentation, and professional
or therapeutic indication requirements.
that has been available and generally promoted
for more than
Through the12 months in the
promotion Philippines.
of this Code, PHAP seeks to ensure that ethical promotional
2.7 Comparative Statements
and be at par with International Standards worldwide.
2.7.1 Comparison of products must not be 2.7.1

disparaging, but must be factual, fair and capable
of substantiation and referenced to its source. Pharmaceutical advertising commonly
Care must be taken to ensure that it does not contains comparisons with other products,
mislead by distortion, by undue emphasis or by and such comparisons are usually made to
TEODORO PADILLA
any other way. Clinical terminology, rather than show the advantages of the advertised
Executive
mere claimsDirector
that a product is better, stronger or product over those of its competitor(s).
more widely prescribed, should be used to Provided that such comparisons with other
describe improved benefits. products are factual, fair and can be
substantiated, they are acceptable under the
“Data on file”, when used to substantiate Code.
comparative statements, must comply with the
requirements of Section 2.2. The intention of this clause is to prohibit
unfair and unjustified comparisons with the
products or activities of competitors.
June 1,
June 1, 2013
2013 version
version
25
Where a claim of comparative efficacy or
safety is made, it must not be based solely
on a comparison of Product Information
documents that do not reflect the general
literature, as those documents are based on
different databases and are not directly
comparable. This applies to Philippine as
well as overseas Product Information
documents.
Claims of comparative efficacy or safety

should be substantiated with respect to all
aspects of efficacy or safety. Where a
comparative claim relates to a specific
parameter, any claim must be clearly identified
as pertaining to that parameter.
The accepted level of statistical significance is

P < 0.05. If comparative data that are not
statistically significant are used, such data must
comply with the following conditions:
• Lack of significance must be stated

explicitly; it is insufficient to state the p value; and
• The data must not be used to generalize or to

indicate superiority or inferiority.
The statement that the claim is not statistically

significant needs to be linked in some manner to
the original claim, made on the same page and
within a reasonable proximity to the original claim
in a manner that is not obscured by other material,
and using a type size of not less than 2mm. Care
should be taken to distinguish between
mathematically determined statistical significance
on one hand and clinical significance on the other
hand.
2.8 Imitation
Promotional information should not imitate the

devices, copy, slogans or general layout adopted
by other manufacturers in a way that is likely to
mislead or confuse.
2.9 Medical Ethics

2.9
HCPs’ names or photographs must not be used Wherever a HCP’s name is specified in any
in any way that is contrary to professional ethics. kind of promotional material, other than by
citation of a published reference, the
Company should ensure that the individual
specified is aware of and has provided
written approval for the use of his/her name
in the context of the entire promotional
material. For example, if a doctor agrees to
introduce an educational video, he/ she
should be fully aware of the final content of
26
that video, since such as a situation would
imply endorsement.
The company should also obtain written

Foreword
approval from the individual if his/her name is
used in sub- sequent promotion material.
2.10 Distinction
Practice of theof Promotional Material
International Federation 2.10
of Pharmaceutical Manufacturers &
Promotional material and advertisement must be Advertisement in a journal should not be
Business Ethics
identified as such.in the Biopharmaceutical Sector,. It incorporates
designed local requirements
to resemble editorial matter unless
and practices in relation to registration; labeling
clearlyand scientific
identified claims
as an approvedSee
advertisement. by
the
3.0 Philippine Food and Drug Administration also
PRODUCT INFORMATION (FDA).Section 4.3.
The PHAP is committed to the rational use of

medicines, and central to this goal is the
benefit
provisionpatients as well
of relevant as programs
information to HCPs.and collaborations that enhance the practice of
Such
medicine.
informationPHAP
shouldthrough
include its Code of Practice
knowledge gained seeks to preserve the independence of
fromdecisions
the the research and by
taken development
healthcareof medicines
professionals (HCPs) in prescribing medicines to
as well as from their clinical use. HCPs in the
patients.
Philippines should have access to similar data as
those being communicated in developed
The ethical promotion of prescription medicines
countries. is vital to the pharmaceutical
3.1 Full
and Disclosure
innovative Product Information
medicines. Ethical promotion helps to ensure that HCPs have access
to
A full disclosure Productthey
the right information need andmust
Information that right patients have access to the right
medicines
accompany atallthe right time.
promotional materials for at least
twelve (12) months from the date of product
launch.
Exceptions to the full disclosure rule are items
companies
and materialsmust maintain
that serve only ashigh ethical
reminders standards in the conduct of promotional
of the
activities to HCPs,without
product’s existence Patient groups
making and Patient Organizations and comply with
promotional
claims. Thislegal,
applicable full disclosure rule and
regulatory shallprofessional
apply also to requirements.
reformulated products as approved by FDA.
Where the material only indicates the brand
name, generic name andofpreparation,
this Code, PHAP
no full seeks to ensure that ethical promotional
practices
disclosure are
of established and be at par
product information shallwith
be International Standards worldwide.
required.
The Product Information should include:
3.1.1 The Brand name of the product and the

generic name (INN) of each active substance;
3.1.2 Pharmacological
TEODORO PADILLA data–a brief description of
pharmacologic effects and mechanism of action;
Executive Director
3.1.3 Clinical information, including indications,
dosage regimen and relevant pharmacokinetic
data, contraindications, precautions and
warnings, adverse effects, drug interactions, and
over dosage precautions.
3.1.4 Pharmaceutical information, including:
dosage forms, strength of dosage forms, storage
conditions and description of the product and the

27
name and address of manufacturer(s) and
importer(s).
3.2 Abridged Disclosure Product Information
3.2.1 Brand name of the product and the

generic name (INN) of each active substance;
3.2.2 Approved indications for use;
3.2.3 Contraindications;
3.2.4 Precautions for use;
3.2.5 Adverse effects and drug interactions;
3.2.6 Available dosage forms and dosage
regimens;
3.2.7 Routes of administration; and
3.2.8 Reference to special groups of patients.
4.0 ALL PROMOTIONAL/ EDUCATIONAL

MATERIALS
4.1 Advertising in Healthcare Professional

Journals
An advertisement must contain at least the
following:
4.1.1 Brand name of the product;

4.1.2 Generic name of the active substance(s);
4.1.3 Name and address of the supplier;
4.1.4 Full disclosure Product Information in
advertisements appearing within 12 months after
product launch. Abridged Product Information
may be used 12 months after the product launch.
4.1.5 The clause “Please review Product
Information before prescribing”; and
4.1.6 Date of production of the advertisement.
If the advertisement makes no promotional

claims, the following minimum information
should be supplied:
4.1.7 Brand name of the product;

4.1.8 Generic name of active substances;
4.1.9 Name and address of the supplier; and
4.1.10 The statement “Additional information is
available upon request.”
4.2 MIMS Advertising

The requirements for journal advertising also
apply to advertisements in MIMS and other
similar references.
4.3 Company Commissioned Articles - (Refer

to Guidelines on Communication of
Prescription Products to the General Public -
28
Appendix 1.)
4.3.1 Company-commissioned articles must be

identified as such in a type size not less Foreword
than 2
mm.
4.3.2 The PHAP member that is responsible for

The PHAP Code
the insertion of Practice
of the Company adopts in full and aligns with the Expanded Code of
Commissioned
Practice
Article mustofbethe International
clearly Federation
identified at either the top of Pharmaceutical Manufacturers &
Associations
or the bottom (IFPMA) and the Mexico City Principles for Voluntary Codes of
of the Company-Commissioned
Article, in aEthics
Business type size
in not
theless than 2 mm.
Biopharmaceutical Sector,. It incorporates local requirements
4.3.3 Company-Commissioned Articles must
the Philippine
conform Food and
to all relevant Drug Administration
provisions of Section 1 of (FDA).
this Code.
4.3.4 Commissioned
benefit Articles
patients as well as shall also conform
programs and collaborations that enhance the practice of
to the requirements of Section 3.1.1 of the Code
medicine.
of Conduct. PHAP through its Code of Practice seeks to preserve the independence of
patients.
4.4 Short Advertisement - Reference Manuals
Short advertisements in reference manuals shall

correspond to the requirements of Section 3.1.3
industry’s
of the Code. mission of helping patients through research and development of new
4.5the Materials
to for
right information use by
they need Medical
and that right patients have access to the right
Representatives
4.5.1 Covered in this section are detailed aids,
Industry relationships
leaflets, and with HCPs
posters containing must support, and be consistent with the
promotional
professional
claims intendedresponsibilities
for distribution orthey have
display to with their patients. Pharmaceutical
healthcare professionals.
activities
4.5.2
to HCPs, Patient groups and Patient Organizations and comply with
All promotional claims must be
applicable
accompaniedlegal,
by regulatory and professional requirements.
4.5.3 Printed
practices promotional material
are established and be atand
paraudio-
with International Standards worldwide.
visual material must contain the following
information: brand name of the product; generic
name of the active ingredients; name and
address of the supplier; and full or abridged
4.5. 4 Promotional Giveaways 4.5.4

TEODORO
Promotional PADILLA
giveaway items, such as pens, Taglines and other short promotional claims
Executive
notepads, Director
t-shirts and mugs, where no are not allowed in promotional giveaways.
promotional claims are made do not require
Product Information. However, these items
should not be of a nature of economic value (i.e., Only company logos may be printed on
valued at less than PI000.00), which would bring clothing materials, such as polo shirts, t-
discredit upon the industry or the recipient. Items shirts, barongs, coats, and jackets.
of higher cost may be donated to institutions
(such as medical societies, professional
organizations, and hospital departments) but
June 1,
June 1, 2013
2013 version
version
29
never to individuals.
4.5.5 If promotional claims are made, these items

must be accompanied by a document containing
the required information.
4.5.6 Medical literature and reprints must be

consistent with the Product Information.
4.5.7 Quotations from medical literature,

conferences or from personal communication
must accurately reflect the meaning of the author
and the significance of the study.
4.6 Electronic Promo Materials, including

audiovisuals such as PowerPoint
presentations, CD’s and DVD’s
4.6.1 All previously discussed rules apply to

these materials. In case of pharmaceutical
product related websites, the following
guidelines should be observed:
• The identity of the pharmaceutical company and
of
the intended audience should be readily
apparent;
• The presentation (content, links, etc.) should be
appropriate and clear to the intended audience;
• Country-specific information should comply with
local laws and regulations.
4.6.2 Where an individual product is being

promoted, the appropriate Product Information
must be offered to an individual reviewing the
promotional material, readily accessible via the
computer-based material or offered to an
audience in a group situation upon completion of
the presentation.
4.6.3 Where the Product Information is included
in an interactive data system, instructions for
accessing it must be clearly displayed.
4.6.4 Where promotional or medical claims are

included in the computer-based promotional
material, details of the substantiating references
must be readily accessible via the computer-
based promotional material.
4.6.5 The type size and graphics used in all

promotional material must be clear and easy to
read.
4.6.6 Where an audiovisual item is demonstrated,

the Product Information document must be given
to the individual reviewing the promotional
material, or offered to the audience in a group
30
situation upon completion of the presentation.
4.7 Brand Name Reminders Foreword

4.7.1 Brand name reminders must include the
following information:
Practice
(a) of the
The brand nameInternational Federation
of the product and generic of Pharmaceutical Manufacturers &
name of active substances;
(b) Other FDA-approved name(s) of the active
ingredient(s), wherever applicable;
andWhere
(c) practices in relation
applicable, to registration;
the annotation “See Boxedlabeling and scientific claims approved by
the Philippine
Warning” to drawFood and to
attention Drug
the Administration
boxed warning (FDA).
in the Product Information
4.7.2 Brand Name Reminders are not to contain
benefit
any patients
promotional as well
claim as programs and collaborations that enhance the practice of
or statement.
theLay
4.8 decisions taken by healthcare professionals
Media Advertising 4.8 (HCPs) in prescribing
Advertisement of medicines to
Prescription
patients. Medicines guidelines
Lay media advertising shall not be allowed for
prescription products. Provisions of Section 16 Advertisements of prescription drugs on H&L
TheAppendix
and ethical 1promotion of prescription medicines is vital to
and DiabetEASE the pharmaceutical
magazines and all other
-industry’s
Guidelinesmission of helpingofpatients
on Communication through
Prescription researchofand
publications development
similar nature are of new
allowed
and innovative
Products medicines.
to the General Public Ethical promotionunder
shall apply. helpsthe
to following
ensure that HCPs have access
conditions:
5.0 MAIL, FAXES, EMAIL AND TEXT 1. The following phrase shall be printed
MESSAGES along with the advertisement:
Industry
5.1 relationships with
These communications HCPs with
must comply mustall support, anddoctors
“Consult your be consistent with
regarding the use the
and
relevant provisions
professional of the Code.
responsibilities they have with benefitstheir
and patients.
risk of thisPharmaceutical
drug for your
companies must maintain high ethical standards condition”
in the conduct of promotional
5.2 These communications should be sent only to
activities to HCPs, Patient groups
those categories of healthcare professionals and Patient Organizations
2. Abridged product and comply
information with
must be
applicable
whose needlegal,
for, regulatory
or interest and professional
in, the particular requirements.
printed in the Ad or a package insert
information can be reason- ably assumed. included in the publication. In the US,
Requests
Through the to promotion
be removedof this
from Code,
promotional
PHAP seeks to some prescription
ensure drug promotional
that ethical products are
mailing lists must be complied with promptly, and advertised in mass-circulated
practices are established and be at par
no name should be restored except upon specific
with International Standards
magazines like VOGUE
worldwide.
request or with written permission.
The package insert is included in the
5.3 Mailing lists should be kept up-to-date. advertisement. Also, no. 1 statement is
included.
5.4 Exposed mail, including postcards,
envelopes, and wrappers, must not carry matter 3. Limit the circulation to doctors and
TEODORO
that might bePADILLA
regarded as advertising to the healthcare providers.
Executive
general Director
public or that could be considered
unsuitable for public view.
5.5 Document Transfer Media

Unsolicited electronic transmissions or replicas
thereof must not be used for promotional
purposes.

31
6.0 COMPETITIONS AND RAFFLES
Competitions must fulfill all of the following
criteria:
6.1 Raffles and competitions are permitted only

during official conventions organized by the PMA
or its affiliates. They should not conflict with any
of the official convention activities.
6.2 Competitions must be based on medical

knowledge or on the acquisition of it. The contest
may involve answering simple questions or
preparing elaborate reports or presentations.
Hence, the prizes must be proportionate to the
complexity of the contest.
6.3 The prizes must be relevant and specific to

the practice of medicine. Prizes may include
stethoscopes and other medical equipment.
6.4 Individual prizes offered are to be of low

monetary value (i.e., less than P1000.00) or be
items of educational material.
6.5 Entry into a competition must not depend on

prescribing, ordering or recommending a
product, and no such condition shall be made or
implied.
6.6 The conduct of competitions shall comply in

all respects with relevant government regulations.
7.0 THE USE OF THE INTERNET FOR

PHARMACEUTICAL INFORMATION
PHAP supports the right of its Members to use

the Internet as a means of providing accurate
and scientifically reliable information on
medicines in a responsible manner for the benefit
of both patients and HCPs.
Local websites have to follow all rules of the

Code on promotion and advertising. For example,
the promotion and advertising of products
covered by the Code to the general public via the
internet would breach Section
16.0 of the Code.
The following provisions are applicable to

information generated for use via Philippine
Internet sites.
7.1 HCPs should be provided with access codes

for information that is not intended for access by
32
the general public.
7.2 Should a Member company link its website to

PHAP’s website, this does not constitute Foreword
PHAP
endorsement of the company’s site nor its
content.
Practice MEDICAL
8.0 of the International Federation 8.0
REPRESENTATIVES of Definition
Pharmaceutical
- Manufacturers &
PROFESSIONAL
Associations (IFPMA) and the Mexico SERVICECity Principles for Voluntary Codes of
REPRESENTATIVES
Business Ethics in the (PSR)
Biopharmaceutical Sector,. Medical Representatives/
It incorporates Professional
local requirements
Service Representatives (PSR)
and practices in relation to registration;
8.1 Medical representatives/ Professional Service labeling and scientific claims approved by
the Philippine Food
Representatives and Drug
should Administration
possess (FDA). representatives whose regular
sufficient Company
medical and technical knowledge to present duties comprise or include interacting with or
information
PHAP and on the company’s
its members products in to
are committed aneducational
conducting andbusiness calls toefforts
promotional healthcare
that
accurate, current, as
benefit patients and
wellbalanced manner,
as programs andand professionalsthattoenhance
collaborations providethe practice
them with
of
should be cognizant of all provisions of this Code. information and/or any other purpose
medicine. PHAP through its Code of Practice concerning seeks to preserve the independence
the company’s products/services of
the Members
8.2 decisionshave
takena by healthcareto professionals
responsibility maintain (e.g.(HCPs) in prescribing
Field Force, medicinesKey
Product Managers, to
patients.
high standards of continuing competency training Account Managers (KAM), Outsourced Sales
for representatives and shall be required to Force, etc.).
conduct the mandatory courses under the
Integrity and Proficiency Program in the
industry’s mission
Pharmaceutical Sectorof(IPPS).
helping patients through research and development of new
8.3 Medical
to the rightrepresentatives/
information Professional Service
they need and that right patients have access to the right
Representatives
medicines at the should,
right at all times, maintain a
time.
high standard of ethical conduct in discharging
their duties.
professional
8.4 responsibilities
Medical representatives/ they Service
Professional have with their patients. Pharmaceutical
Representatives
companies must must ensure that
maintain highcalls do not
ethical standards in the conduct of promotional
inconvenience or hinder the HCPs’ performance
of their duties. Medical representatives should
applicable
conform to legal, regulatory
institutional and professional
regulations governing requirements.
their calls.
8.5 Whenever
practices are aestablished
promotionaland
claim
beisatmade, the International Standards worldwide.
par with
medical representative/ professional service
representative must provide the Product
Information, as approved for the Philippines.
9.0 PRODUCT SAMPLES
9.1 In accordance with BFAD regulations, free

TEODORO
samples of PADILLA
a pharmaceutical product may be
Executive
supplied to Director
healthcare professionals, and only
with their consent, in order to enhance patient
care or to gain clinical experience. Samples
should not be sold or otherwise misused by
medical representatives and employees.
9.2 The quantity of samples given should

be appropriate for HCPs to:
33
9.2.1 Initiate therapy; and/or
9.2.2 Gain clinical experience with the product.
9.3 Product samples may be given for

humanitarian reasons, but dispensing must be
under the supervision of a qualified HCP.
9.4 Product samples must be accompanied by

product inserts
9.5 Product samples must comply with the

labeling requirements of BFAD, and must be
clearly marked “Physician’s Sample - Not For
Sale.”
10.0 EXHIBIT BOOTHS
10.1 The main objective of congresses and

symposia is medical education. Hospitality
attendant to such events is always secondary.
10.2 Exhibit booths 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.
10.3 Product samples may be given to HCPs

attending congresses or symposia, but
Product Information must always accompany
these samples.
10.4 Contests, raffles, and other similar activities

conducted in the booths are allowed, provided
prizes are limited to stethoscopes, medical
books, medical journals and tokens described in
Section 4.5.4. Such contests, raffles, and similar
activities may not be conducted at times that will
conflict with any existing scientific event or that
will draw symposium participants away from
scientific events and satellite symposia.
10.5 Video presentations must be scientific or

related
to the products promoted.
11.0 CONTINUING MEDICAL EDUCATION
The purpose and focus of all symposia,

congresses and other promotional, scientific or
professional meetings (an “Event”) for HCPs
organized or sponsored by a company should be
to inform healthcare professionals about products
34
and/or to provide scientific or educational
information.
11.1 Conventions, Symposia, Foreword

Scientific
Programs and
Post-Graduate Courses
This section covers participation in and
sponsorship of continuing medical education
Associations
(CME) and other(IFPMA) and theorganized
medical activities MexicobyCity Principles for Voluntary Codes of
Businessmedical
various Ethics inspecialty
the Biopharmaceutical
societies or by Sector,. It incorporates local requirements
pharmaceutical
and practices in companies,
relation towhether expenses
registration; labeling and scientific claims approved by
are
the paid for by the
Philippine Foodlocal
andPharma company or its (FDA).
Drug Administration
affiliate or headquarters, and whether held locally
or outside the country.
benefit
No patients
company may as well asorprograms
organize sponsor anand collaborations that enhance the practice of
event
for HCPs (including
medicine. PHAP throughsponsoring individuals
its Code to seeks to preserve the independence of
of Practice
attend such events as described in 11.5.1 and
11.9.1) that takes place outside of their home
patients.
country unless it is appropriate and justified to do
so from the logistical or security point of view.
International
The ethicalscientific
promotioncongresses and symposia
of prescription medicines is vital to the pharmaceutical
that derive participants
industry’s mission offrom many patients
helping countries through
are research and development of new
therefore justified and permitted. Travel should
and innovative
be by economy class.medicines. Ethical promotion helps to ensure that HCPs have access
medicines
11.2 at the right
The scientific agendatime.
must be the primary
basis for the company’s sponsorship of or
participation in the event, and any support to
individual doctors should not be conditional upon
professional
any responsibilities
obligation to they
prescribe or pro- motehave
any with their patients. Pharmaceutical
companies
medicinal must maintain high ethical standards in the conduct of promotional
product.
11.3 Multi-Companies/Products
In instances when an umbrella organization has
Through
two the promotion
or more companiesof handling
this Code,different
PHAP seeks to ensure that ethical promotional
practices aretoestablished
compounds and be
be represented in atthe
parsame
congress, the organization may be allowed to
sponsor up to seven (7) doctors per company or
up to twelve (12) for regional scientific meetings,
subject to the approval of the EC. Such
organization must obtain clearance from the
Committee at least two (2) months prior to the
event.
TEODORO PADILLA
Executive Director
11.4 While pharmaceutical companies may
support continuing medical education, they
should not conduct tours, socials, games,
contests, sports and other activities that draw
participants away from the official CME activities.
Activities before and after the CME program are
considered acceptable if in line with the PHAP
Code of Ethics guidelines.
35
Sponsorship of the HCP must be limited to travel
to and from the venue and accommodation for
the duration of the scientific event with a
maximum of an additional two (2) days only.
Sponsorship of side trips of the HCP is
unacceptable.
11.5 Pharmaceutical companies are strongly

encouraged to observe reasonable restraint in
expenditures related to CME. Member
companies may sponsor HCPs to attend CME
events. Invitations should be extended only to
HCPs in their area of activity or interest.
Furthermore, such sponsorships must be in
accordance with the following requirements:
11.5.1 A pharmaceutical company is allowed to

sponsor 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 spouses or
other family members.
11.5.2 In addition to the Philippines, the venue of

CME events may be the Americas, Europe,
Australia, Japan, or the ASEAN countries, Hong
Kong, Taiwan, China, Korea, and India.
11.5.3 For overseas venues, pharmaceutical

companies may sponsor seven (7) HCPs for the
Americas, Europe, Australia and Japan. For
ASEAN countries, Hong Kong, Taiwan, India,
and Korea, companies may sponsor up to twelve
(12) HCPs.
11.5.4 For CME events in the Philippines,

pharmaceutical companies may sponsor any
number of HCPs, provided the professionals will
pay the registration fee. The scientific program
must constitute a minimum of 66% of the time in
the given location(s) before or after the scientific
agenda, outside of reasonable travel time, and
must be held in business accommodation
locations, and not primarily resort locations.
11.6 No honorarium or compensation will be

given to the HCP for attending the convention,
symposium or CME event. This provision does
not apply to HCPs sponsored as speakers in a
CME event.
36
11.7 Limits of Hospitality 11.7
Hospitality should be limited to refreshments Sponsorship of stand-alone meetings or

and/or meals incidental to the main purpose of social events is not allowed.
Foreword Therefore,
the event. No stand alone entertainment or other sponsorship of any sports activity such as
leisure or social activities should be provided or golf, badminton and bowling, after a
paid for by member companies. CME meeting is not allowed. This ruling
The PHAP Code of Practice adopts in full and aligns
applies with before
to both the Expanded
and after Code
a CME of
At events, entertainment
Practice of modest nature,
of the International which meeting.
Federation of Pharmaceutical Manufacturers &
isAssociations
secondary to(IFPMA)refreshments andand/or meals, isCity Principles for Voluntary Codes of
the Mexico
allowed.
Business Ethics in the Biopharmaceutical Sector,. It incorporates
For example, a karaokelocal requirements
session would be
and practices
Hospitality shouldinonlyrelation to registration;
be provided if it: labeling andonly
allowable scientific
if held claims approved
in the same venuebyof
the Philippine Food and Drug Administrationthe (FDA).
CME event during meals. If the karaoke
• Is for participants of the event and not their session were held in a different venue,
guests; sponsorship of the event would not be
• Is moderate and reasonable as judged by local allowable.
benefit
standards; patients as well as programs and collaborations that enhance the practice of
•medicine.
Does not use PHAPstar through
talent; andits Code of Practice seeks to preserve the independence of
•the decisions
Is held takenvenues
in business by healthcare venues International
and not inprofessionals (HCPs) in and Regional Conventions
prescribing medicines to
such as discos, nightclubs, resorts or other Held in the Philippines
patients.
places where refreshments and/or meals are
incidentally available. In order to allow more local delegates to
The ethical promotion of prescription medicines is vital
participate to the pharmaceutical
in international and regional
industry’s
11.8 mission oftohelping
HCPs sponsored foreign patients
and regionalthrough research all
conventions, andinternational
development or of new
regional
symposia, conventions
and innovative or CMEEthical
medicines. events should be CMEs
promotion helpsconducted
to ensureinthatthe HCPs
Philippines
have shall be
access
able andright
to the willing to lecture orthey
information shareneed
highlights of treated
and that as localhave
right patients events,
accessandto hence the
the right
topics at local CME’s. An agreement to this effect following provisions shall apply:
medicines
should be atmadethe right time. the sponsoring
between
company and the healthcare professional. PHAP • Companies can send more than 12
Industryshould
sponsors relationships with HCPs
assist their sponsored must
doctors in support,delegates
and be toconsistent with the
the conventions but
sharing their newresponsibilities
professional knowledge at local events.
they have with their sponsorship will bePharmaceutical
patients. limited to meals
companies must maintain high ethical standards and accommodations
in the conduct of promotional
11.8.1 Pharmaceutical companies are expected • Delegates must pay for their own
activities to HCPs, Patient groups
to act responsibly in terms of numbers of HCPs and Patient Organizations
registrations fees andor comply
the ruleswith
as
applicabletolegal,
sponsored regulatory
meetings overseas.andThe professional
maximum requirements. stated in 11.5.4
number is seven (7) per overseas event, and
twelve
Through(12)the per regional event
promotion of thisasCode,defined
PHAP in seeks to ensure that ethical promotional
11.5.2, and should be working in a specialty
practices are established and be at
related to the event. Recognition of specialty is
par with International Standards worldwide.
based on the HCPs’ qualifications and/or
current practice specialties.
Events
11.9 Company-Sponsored CME
TEODORO
11.9.1 PADILLA
Overseas
Executive Director
Pharmaceutical companies sponsoring doctors
overseas (Central America, USA, Australia,
Japan and Europe) company meetings may
sponsor no more than seven (7) doctors per
event. At a level above this, the rationale of an
overseas meeting vs. an in-country meeting is
highly questionable.
June
June 1,
1, 2013
2013 version
version
37
11.9.2 Regional
Pharmaceutical companies may sponsor no
more than twelve (12) HCPs to regional company
scientific meetings. Regional events are
described as those held in ASEAN countries,
Hong Kong, Taiwan, China, and Korea.
11.9.3 Local
Local company-sponsored CME events must be
held in business accommodation locations, and
not in primarily resort locations.
Hotels and establishments, which are primarily

located at beachfront resorts as well as those
that primarily offer and provide recreational
facilities/ activities such spas, golf, casinos etc.
are also not considered as appropriate venue for
scientific meetings and CME events.
The scientific program must constitute a

minimum of 66% of the time in the given location
and/or locations before or after the scientific
agenda, outside of reasonable travel time.
Invitations should be extended only to healthcare
professionals in relevant therapeutic areas
related to the scientific content.
Under no circumstances is a pharmaceutical

company allowed to pay expenses for spouses or
other family members. The only exception is if
the spouse is medically qualified and practices in
a therapeutic area relevant to the scientific
meeting or society.
Support of raffles with high-value items (i.e., over

P1000.00) is totally inappropriate. Star talents
should not be used to attract participants to
meetings, symposia, conventions and the like.
11.9.4.Pharmaceutical companies must

encourage their sponsored HCPs to attend a
major part of the CME event.
12.0 MEDICAL SOCIETY-SPONSORED

ACTIVITIES
12.1 Member companies should not specifically

support sports events, such as golf tournaments,
or charity or fund-raising activities, such as movie
premieres.
12.2 Sponsorship of events, such as fellowship

night, if the event is clearly part of a scientific
meeting, is acceptable as long as such
38
sponsorship is on a modest scale and does not
involve star talent that would attract public
attention.
Foreword
13.0 INDEPENDENCE OF HEALTHCARE 13.0
PROFESSIONALS
The PHAP Code of Practice adopts in full and aligns with
Sponsorship the Expanded
of employees of a Code
Memberof
Practice
No financialofbenefit
the International
or benefit-in-kindFederation of Pharmaceutical
(including company Manufacturers
in any sports activity &
is not allowed.
Associations
grants, (IFPMA) and
scholarships, the Mexico
subsidies, support,City Principles for Voluntary Codes of
consulting contracts
Business Ethics or educational
in the or practice-
Biopharmaceutical Sector,. It incorporates local requirements
related items) may be provided or offered to a
and practices in relation to
healthcare professional in exchange for
registration; labeling and scientific claims approved by
the Philippine Food
prescribing, and Drug Administration
recommending, purchasing, (FDA).
supplying or administering products or for a
commitment
PHAP and its to continue
members to are
do so. Nothing may
committed to educational and promotional efforts that
be offered
benefit or provided
patients as well in a manner and
as programs or on
conditions that would inappropriately influence on
a healthcare professional’s prescribing practices. seeks to preserve the independence of
medicine. PHAP through its Code of Practice
the decisions
Gifts of any kindtakenfor by
thehealthcare professionals
personal benefit of (HCPs) in prescribing medicines to
patients. professionals are not allowed,
healthcare
irrespective of value, kind or occasion. The only
exceptions are as follows:
industry’s
13.1 mission
Equipment, tools,ofdevices,
helpingcomputers
patients andthrough research and development of new
and innovative
educational medicines.
materials Ethical promotion
may be donated or loaned helps to ensure that HCPs have access
to
to medical training
the right institutions
information andneed
they hospitals,
and but
that right patients have access to the right
not to individuals.
medicines Clinics
at the right of doctors are not
time.
considered institutions. Items for donation must
have direct use in medical care and diagnosis.
Industry relationships
Examples of these arewith ECGHCPs must support, and be consistent with the
machines,
professional x-ray
stethoscopes, responsibilities
machines/films, they have with their patients. Pharmaceutical
scanners,
and other diagnostic
companies must maintain equipment. Business
high ethical standards in the conduct of promotional
machines
activities toandHCPs,appliances,
Patient communications
groups and Patient Organizations and comply with
equipment (such as fax machines, pagers and
applicable
cellular legal,furniture,
phones), regulatory andand
air professional
conditioners requirements.
are not allowed as donations.
Items of medical
practices utility may and
are established be offered for with
be at par free International Standards worldwide.
provided that such items are of modest value and
are beneficial to the provision of the medical
services and for patient care. Medical books as
well as subscriptions to medical journals may
also be offered free of charge. Medical books
must be given directly to the healthcare
professional, and subscriptions to journals must
TEODORO
be PADILLA
in the name of the healthcare professional.
Executive Director
GIFTS
13.2 On Christmas, gifts of moderate value may 13.2 Flowers for funerals can only be
be given to HCPs even if these gifts are allowed in the death of a healthcare
unrelated to the practice of medicine, as long as professional.
the retail price is not more than P1500.00. (to be
39
removed) A fundamental principle guiding the Code is
the preservation of the independence of the
Cultural Gifts, including gifts during Christmas decisions taken by HCPs in prescribing
shall not be allowed. medicines to patients. This is particularly
important in light of the need to assure the
Flowers for funerals can only be allowed on the public that company resources are not, in
death of an HCP. They are not allowed on any way, being used to influence HCPs’
occasions of death of any family member of a prescribing practices.
healthcare professional.
Therefore, pharmaceutical companies should
not offer any thing of value to HCP’s that may
be construed by the HCP or the public as
exerting undue influence or otherwise
reducing the HCP’s independence.
This prohibition, of course, applies to the

actions of the pharmaceutical company and
its agents carried out at the expense of the
company or in a way that may be construed
as being at the expense of the company.
For example, the prohibition in no way

prevents individual company employees,
acting solely a their personal expense,
from giving a funeral wreath with their
own names on the wreath as an
expression of condolence on the
occasion of the death of a HCP’s relative.
In summary, extending sympathy to HCP’s

relatives by way of giving flowers at the
expense of the Member company is not
allowed.
13.3 Hospitality & Meals 13.3 Tactical activities refer to the day-to-
day activities of Medical Representatives,
Meals with HCPs which include:
 Meetings with HCPs
Member-companies are required to establish cap  Small group presentations
amounts for hospitality and meals. A robust  Focus group discussions
monitoring and control system must be in place  Product group discussions
to ensure the implementation and adherence to  Other hospital-based activities.
the said cap.
What is the meal cap for tactical activities
For tactical activities carried out by Medical by Medical Representatives?
Representatives, the amount spent should not
exceed the cap set in the Code. This amount is The meal cap is P1500/person.
subject to periodic review by member companies.
Hospitality & Meals
Can medical representatives exceed the

meal cap for tactical activities but only be
reimbursed the maximum allowable
amount?
40
This may be viewed as a circumvention of
the cap imposed by PHAP. Thus, PHAP
Foreword
encourages companies to set up policies and
processes that will not allow the use of
private funds by employees to engage in
activities
The PHAP Code of Practice adopts in full and alignsthat arethe
with notExpanded
allowed under
Code the
of
Code.
Business
14.0 Ethics
Clinical in the
Studies andBiopharmaceutical
Related Activities Sector,.
14.0 It incorporates local requirements
This section covers
the Philippine theand
Food conduct
DrugofAdministration
investigators’ In particular, cash gifts or equivalents are
(FDA).
meetings and presentations related to clinical completely not acceptable. Considered cash
trials and sponsored by pharmaceutical equivalents are gift certificates, prepaid cell
PHAP andheld
companies its locally
members are committed
or outside the country. to educational and
phone loads, promotional
gasoline cards, andefforts
the like.that
14.1 ClinicalPHAP
medicine. trialsthrough
are scientific
its Code of Practice How
investigations seeksdoes one ensure
to preserve thetransparency
independence in the
of
using valid study designs conducted according to conduct of Clinical trials?
protocols or study descriptions approved by the As stated in FDA Circular (2012-007) which
patients.
FDA and a duly established independent discusses the role of ethical boards on the
institutional review board or Ethics Committee. conduct of Clinical Trials on Investigational
The ethical promotion of prescription medicines researchis on vital
Medicinal products.
to the The General
pharmaceutical
14.1.1 Any mission
industry’s type of clinical studypatients
of helping or research Objectives
through researchsection,
and as well as in itemof5 new
development of its
program involving humans (pre- and post- Implementing Guidelines mandate the
and innovative
authorization,
medicines.
interventional
Ethicaland
promotion helps to ensure that HCPs have
non- registration of all research activities to a
access
to the right information
interventional) they need
must be conducted and that national
in compliance right patients have
registry to wit: access to the right
medicines
with at the right
the principles time.
of Good Clinical Practice as o “C. Mandatory Inclusion of
laid down in the Declaration of Helsinki. Clinical Trials in the
Industry relationships with HCPs must support, and Philippine be consistent Trial with
Registry.
the
14.1.2 All such studies must address meaningful All Clinical Trials are to be
professional responsibilities they have
medical or scientific topics, e.g. the clinical profile with their patients. Pharmaceutical
uploaded in the Philippine
companies
of a product suchmustasmaintain high ethical
safety, efficacy, standards in the Clinical
modes of conduct TrialofRegistry.
promotional
activities
action or toperformance
HCPs, Patient groups
related to and
otherPatient Organizations
o It is theand comply of
responsibility with
the
treatments.
applicable legal, regulatory and professional requirements. Study sponsor to upload
information related to the
14.1.3 The well being, personal integrity and clinical trial it is conducting to
Through
privacy the promotion
of participants must of this Code,
always PHAP seeks to ensurethe
be of highest that ethical promotional registry
practices
priority. Theareinformed
established anddocument
consent be at par must
(http://registry.healthresearc
appropriately convey all relevant aspects of the h.ph) 30 days after the
study to potential subjects. application to conduct the
clinical trial has been
14.1.4 Studies in humans must not have the granted.
promotion of products as their purpose. Its o Specific provisions in the
implementation cannot be used as disguised publication of Clinical trial
promotions.
TEODORO PADILLA results are indicated from
Executive Director items 18 to 20, pages 52 –
14.1.5 The details of conducting and financing 53 of the PNHRS National
studies must be set out in a written contract. Ethical Guidelines for Health
Sponsor Company will only pay remuneration to Research 2011
HCPs, which reflect fair market value for study-
related activities. Published data derived from clinical
trials/studies may subsequently be
14.1.6 All clinical trials, once approved for translated into tools for marketing or
implementation by the FDA, shall be uploaded promotional activities.
into the Philippine Clinical Trial Registry as
June 1,
June 1, 2013
2013 version
version
41
required under local regulations.
14.1.7 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 publication.
14.2 Sponsorship to clinical trial investigators’

meetings and presentations is allowed subject to
the following provisions:
14.3 Sections11.2,11.4,11.6 and 11.9.1, 11.9.2,

11.9.3, and 11.9.4 are deemed to apply.
14.4 For investigators’ meetings or presentations

held outside the country, the limits set forth in
Section 11.8.1 apply prior to the approval of the
study protocol or description.
14.5 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.
14.6 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 11.8.1.
14.7 PMS
Whereas Post Marketing Surveillances ceases to

be an FDA requirement for drug registration, a
member company is not barred from conducting
such activity in conformity with its risk
management strategies. However, HCPs are not
to be compensated for participation to such
activities.
14.8 HONORARIA 1
14.8.1 HCPs may be engaged as consultants 14.8.1 Please refer to Table 1 for a list of
and advisors for services such as speaking at recommended honoraria rates for Philippine-
and/or chairing meetings and events, based HCPs.
involvement in medical/scientific studies, clinical
trials or training services, participation at advisory For foreign HCP speakers, member
board meetings, and participation in market companies must comply with the applicable
research where such participation involves regulations in speaker's home country.
remuneration.
42
The arrangements that cover these genuine
consultancies or other services must, Foreword
to the
extent relevant to the particular arrangement,
fulfill all the following criteria:
TheA PHAP
(a) contractCode of Practice
or agreement must adopts in that
be in place full and aligns with the Expanded Code of
Practice the
specifies of thenatureInternational
of the services Federation
to be of Pharmaceutical Manufacturers &
provided
Associationsand the basis for
(IFPMA) andpayment of thoseCity Principles for Voluntary Codes of
the Mexico
services.
(b) A legitimate need for the services must be
Sector,. It incorporates local requirements
and practices
clearly identified in
andrelation to registration; labeling and scientific claims approved by
documented.
theThe
(c) Philippine Food
criteria for and Drug
selecting Administration
consultants must be (FDA).
directly related to the identified need and the
consultants
PHAP and must have the expertise
its members necessarytotoeducational and promotional efforts that
are committed
provide the service.
benefit patients as well as programs
(d) The number of consultants engaged must andnot
medicine.
be greaterPHAP thanthrough its Codereasonably
the number of Practice seeks to preserve the independence of
the decisions
necessary takenthe
to achieve byidentified
healthcare
need.professionals (HCPs) in prescribing medicines to
(e) The hiring of the consultant to provide the
patients.
relevant service must not be an inducement to
prescribe, recommend, purchase, supply, and/or
The ethical
administer any promotion
medicine. of prescription medicines is vital to the pharmaceutical
industry’s
(f) mission offorhelping
The compensation patients
the services must through
be research and development of new
and innovative
reasonable medicines.
and reflect the fairEthical
marketpromotion
value of helps to ensure that HCPs have access
the services
to the rightprovided.
information For they
honorarium paid that
need and for right patients have access to the right
services to be rendered locally, member
companies should take into consideration certain
criteria, including but not limited to:
 Nature responsibilities
professional of services (speaker, chair, with their patients. Pharmaceutical
they have
moderator,
companies must etc.)
maintain high ethical standards in the conduct of promotional
 therapeutic area of expertise
 Experience level/qualification of HCP
engaged
 number of HCPs in same level of
expertise
 Complexity
practices of the subject
are established and matter
be at par with International Standards worldwide.
 Duration of event
 Number of event participants
15.0 Patient Organization, Patients, Patient

Support Programs
TEODORO PADILLA
15.1 Definition
Executive Director
15.1.1 Patient Organizations 15.1.1 How do we determine a formally
organized and reputable not-for-profit
Typically a formally organized and reputable not-
for-profit institution that primarily represents the institution?
interests and needs of patients, their families
and/or caregivers The engaging company must do due
diligence to establish the reputation and
15.1.2 Patients constitution of the organization, e.g., check if
Refers to individuals on therapy of a product, or there is formal structure (e.g., set of officers,
regular meetings, etc.), examine the

43
those that are not on therapy but could benefit by constitutive documents (articles of
such (e.g. vaccines, or those at risk but not yet incorporation, declaration of membership,
on therapy) credo or similar documents.), on
organizational objectives, financial
15.1.3 Patient Support Programs statements, etc.
Programs that involve interaction with patients, Companies may impose as an additional
including patient education, or programs to requirement registration with a government
ensure patient compliance and adherence agency (e.g., Securities and Exchange
Commission) or recognition by another
formal group like the Philippine Medical
15.2 Interactions with Patient Organizations Association.
15.2.1 Scope This section shall apply to cases where OTC

products and medical devices are involved
The pharmaceutical industry has many common except to the extent allowed by law. For
interests with patient organizations. All example, promotional interactions with
interactions with patient organizations must be patients and patient organizations involving
ethical. The independence of patient OTC products may be allowed to the extent
organizations must be respected. provided by law.
15.2.2 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.
15.2.3 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.
15.2.4 Events
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.
15.2.5 Communication to Patients
Communication with patients should aim at
44
supporting better healthcare and not for purposes
of promotion. Careful consideration needs to be
made about the appropriateness, language and
Foreword
style of communication. Therapeutic decisions
must be made by HCPs only.
15.3 Disease awareness programs
Associations
Any (IFPMA) and
disease awareness the Mexico
programs must beCity Principles for Voluntary Codes of
accurate,
Business balanced and Biopharmaceutical
Ethics in the materials should be Sector,. It incorporates local requirements
written in appropriate
and practices language
in relation for the public.
to registration; labeling and scientific claims approved by
The purpose of such programs is to enhance
the Philippine
public awarenessFood
of and Drug Administration
diseases, to encourage (FDA).
members of the public to seek treatment for their
PHAP andand
symptoms its thereby
members saveare committed
and/or improve to
theeducational and promotional efforts that
lives of patients
benefit patientswhile not as
as well promoting the and
programs use of
any specific product.
the decisions
15.4 takenPrograms
Patient Support by healthcare professionals (HCPs) in prescribing medicines to
patients.
Patient Support Programs (“PSPs”) should have
clear objectives,
The ethical and should
promotion maintain HCP
of prescription medicines is vital to the pharmaceutical
independence and protect the rights and privacy
of the participants. PSPs must not be designed or
and innovative
used to encourage medicines.
the use Ethical promotion
of products in a helps to ensure that HCPs have access
to the right
manner information
that is inconsistent they
with need and that right patients have access to the right
the approved
product
medicines labeling
at the(e.g.,
rightno targeting of patient
time.
populations outside of the approved product
label). All PSPs must comply with applicable laws
Industry
and relationships
regulations withrelating
(including laws HCPs tomust
data support, and be consistent with the
professional
privacy, responsibilities
drug safety reporting, drugthey have with their patients. Pharmaceutical
advertising
companies
laws, etc.). must maintain high ethical standards in the conduct of promotional
15.5 Patient Information
All safety data processing and reporting
Through the
obligations mustpromotion
be fulfilled.ofPatient
this Code, PHAP seeks to ensure that ethical promotional
or caregiver
data must are
practices only be collected
established andandbe atused and International Standards worldwide.
par with
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
TEODOROmust be obtained and only the
PADILLA
minimum amount of data needed for the
Executivepurposes
disclosed Director should be collected and
retained for only as long as needed to achieve
the disclosed purpose.
16.0 COMMUNICATIONS WITH THE GENERAL

PUBLIC
(Refer to GUIDELINES ON COMMUNICATION

OF PRESCRIPTION PRODUCTS TO THE
45
GENERAL PUBLIC: Appendix 1.)
16.1 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.
16.2 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 in-
formation on contraindications, precautions,
warnings and side effects.
16.3 General media articles may be initiated by

manufacturers to announce the holding of a
scientific event.
16.4 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.
16.5 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.
16.6 Patient education should encourage patients

to seek further information or explanation from
the appropriate healthcare professional.
16.7 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.
16.8 The educational material must contain a

statement directing the patient to seek further
information from his or her healthcare
professional.
46
16.9 Patient Aids
Once a decision to prescribe a product has been
made, patient aids that are solely intended to
Foreword
provide information for the patient may be
product-specific. The content of such material
must be designed to assist patient compliance by
The PHAP
providing Code ofthat
information Practice
clarifiesadopts in full
the method of and aligns with the Expanded Code of
Practice
the of the International
administration, precautions, and Federation
special of Pharmaceutical Manufacturers &
instructions.
Associations Patient
(IFPMA) aidsandmustthe not makeCity Principles for Voluntary Codes of
Mexico
comparisons or include promotional claims. To
ensure compliance, patient aids must be
Sector,. It incorporates local requirements
and practicesbyin relation
administered to registration;
the appropriate labeling and scientific claims approved by
healthcare
professional.
16.10
PHAP The tonemembers
and its of material
are must not cause
committed to educational and promotional efforts that
unnecessary alarm or misunderstanding nor must
benefit patients as well as programs
it cause unfounded hopes of successful and collaborations that enhance the practice of
medicine.toPHAP
treatment through
stimulate itsfor
demand Code of Practice
prescription of seeks to preserve the independence of
the
a decisions
particular taken by healthcare professionals (HCPs) in prescribing medicines to
product.
patients.
17.0 Discount Card Guidelines
industry’s
PHAP mission
recognizes that of helping
patients patients
benefit through research and development of new
from cash
and innovative
discounts medicines.
and that discountEthical promotion
programs allow helps to ensure that HCPs have access
access to cheaper
to the right medicines
information for need
they more and
Filipino
that right patients have access to the right
patients. On the other hand, the independence
of healthcare professionals must be maintained
such that no financial benefit or benefit-in-kind
Industry
may relationships
be provided withto HCPs
or offered must support, and be consistent with the
a healthcare
professional
professionalin responsibilities
exchange for prescribing
they have or with their patients. Pharmaceutical
recommending
companies must the product.
maintain high ethical standards in the conduct of promotional
activities
Also, to HCPs,must
such programs Patient groups
encourage and Patient Organizations and comply with
appropriate
applicable
use legal, regulatory
for pharmaceutical andbyprofessional
products supporting requirements.
the qualified oversight by healthcare
professionals over the of prescribing
Through the promotion this Code, PHAPand seeks to ensure that ethical promotional
medication process.
1. Cash discounts through coupons or e-
cards must be channeled through the
physician and backed up by prescription.
No such discount card or coupon can be
given directly to the patients.
2. Under no circumstances should the
TEODORO PADILLA
physician be compensated nor benefit
Executive
fromDirector
the discounts.
3. Discount programs should be non-
discriminatory. It must be made
available to any or all physicians who
may wish to pass them to the patients.
4. Discount schemes should not be
advertised in any form, including the
display of posters and/or leaflets in the
doctor’s clinic.
5. Discount cards cannot be tied to sales

47
promotion, raffles or promise of a reward
that may encourage self-medication,
e.g., requiring a minimum purchase
before the discount can be claimed.
6. Discount card and doctor’s letter to the
patient should only specify generic name
and not brand/trade name.
7. The company name may be featured on
the card.
18.0 ADMINISTRATION OF THE CODE
18.1 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.
19.0 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 e-mail, 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.
- Summary: For each case, a brief

description of the complaint with
reference to the portion of the
PHAP Code under which the
48
complaint is being made (section
and paragraph number).
Reference material: ForForeword

- each
case, a specific reference to the
source of the
advertisement/activity, which is
The PHAP Codethe of Practice
subject adopts
of the in full
complaint, or and aligns with the Expanded Code of
printed
Practice of the material Federation
International or other of Pharmaceutical Manufacturers &
evidence. Aand
Associations (IFPMA) copythe
of the material
Mexico City Principles for Voluntary Codes of
in question must be provided.
and practices
- in relation
Date(s) and to registration;
place(s): labeling and scientific claims approved by
The date
the Philippine and
Foodplace
and of
Drug
the Administration
alleged breach (FDA).
of the PHAP Code.
All communication should be addressed to:
medicine. PHAP
The Executive through its Code of Practice seeks to preserve the independence of
Director
the decisions taken
Pharmaceutical by healthcare
& Healthcare professionals
Association of the (HCPs) in prescribing medicines to
Philippines
patients.
Rm. 502 One Corporate Plaza,
A. Arnaiz Avenue, Makati City
industry’s
The PHAPmission of helping
Secretariat shall patients
stamp through
and research and development of new
acknowledge
and receipt
innovative of the complaint.
medicines. Ethical promotion helps to ensure that HCPs have access
The PHAP Secretariat who shall also determine if
medicines at the
such merit the right of
attention time.
the EC may entertain
inquiries and clarifications pertaining to the Code.
19.3 Validation
activities to HCPs,
When a complaint Patient
alleging groups
a breach of theand
PHAPPatient Organizations and comply with
applicable legal,byregulatory
COP is received and professional
the PHAP Secretariat, it shall requirements.
first validate the complaint within five (5) working
days to ensure
Through that:
the promotion of this Code, PHAP seeks to ensure that ethical promotional
- It appears to be genuine, submitted in
good faith;
and be at par with International Standards worldwide.
- 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

TEODORO
inadequate, PADILLA
the complainant must provide
Executive Director within the 5 working days
additional information
allocated for Secretariat validation.
Finally, if a complaint cannot be validated it shall

not be processed and the complainant must be
notified accordingly.
June 1,
June 1,2013
2013version
version
49
19.4 Notice
Within five (5) 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 Letter to Respondent shall indicate the time
within which a response must be made which
shall be no more than fifteen (15) 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 (30) 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 (60) 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 accused contests the
decision, it may file an appeal within fifteen (15)
working days to the PHAP BOT from receipt of
the decision that in turn constitutes an Appeals
Board.
50
19.7.1 Appeals Board (AB) 19.7.1 How much is the administration fee
for appeals?
Decisions by the AB are absolutely finalForeword
and
executory. The administration fee for appeals is P40,
000.00 If the decision is reversed on appeal,
The composition of the AB shall be drawn from this amount will be returned to the appealing
The PHAP Code
an independent poolofof Practice
experts. adopts in full and aligns with the Expanded Code of
party.
Associations
An administration(IFPMA)
fee shalland
be the Mexico
charged to theCity Principles for Voluntary Codes of
party who files
Business the in
Ethics appeal.
the Biopharmaceutical Sector,. It incorporates local requirements
All appeals shall be decided within thirty (30)
the Philippine
working days from Food andofDrug
receipt Administration (FDA).
the appeal.
19.8 Sanctions
If a company is found in breach of the PHAP
medicine. PHAP through
Code, the company its Code
has ten (10) of Practice
working days to seeks to preserve the independence of
the decisions
provide written taken
detailsbyofhealthcare
the action professionals
taken to (HCPs) in prescribing medicines to
patients.
comply with the ruling (‘the Compliance
Statement’).
At the very least, the company will be asked to
industry’s
confirm that mission oforhelping
the activity patients
use of the materialthrough
or research and development of new
and innovative
program medicines.
in question, and anyEthical
similarpromotion
material/ helps to ensure that HCPs have access
to the right
program if notinformation they need
already discontinued or noand that right patients have access to the right
longer
in use, willat cease
medicines immediately
the right time. and that all
possible steps will be taken to avoid a similar
breach of the Code in the future.
professional
The Complianceresponsibilities
Statement must be they have
signed or with their patients. Pharmaceutical
authorized bymust
companies the General
maintain Manager and must
high ethical standards in the conduct of promotional
include the date
activities on which
to HCPs, the material
Patient groups wasand
finallyPatient Organizations and comply with
used or appeared and/or the last date on which
applicable legal,
the activity took regulatory and professional requirements.
place.
Through theScheme
19.9 Penalty promotion of this Code, PHAP seeks to ensure that ethical promotional
- First
practices areoffense shall be
established andmeted
be at apar
fine of International Standards worldwide.
with
PHP 200,000.00
- 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 750,000.00 per
offense.
TEODORO
- Clean PADILLA
slate if no violations of the same
Executive Director
offense are committed within a 12-month
period
- Reckoning date for all violations is the
date when a decision was issued by the
PHAP Ethics Committee
version
51
19.10 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
complainant, 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.
20.0 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.
21.0 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.
52
provided to relevant employees to further
enhance COP compliance.
21.0 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. Appendix
APPENDIX1
GUIDELINESON
GUIDELINES ONCOMMUNICATION
COMMUNICATION
Foreword
OF PRESCRIPTION PRODUCTS
OF PRESCRIPTION TO THE TO THE
PRODUCTS
GENERALPUBLIC
GENERAL PUBLIC
DEFINITION OFTERMS
The PHAP OF TERMS
Code of Practice adopts in full and aligns with the Expanded Code of
Advertisement:
Promotion of a product, and
service, the Mexico
advocacy City
or institution Principles
by way for Voluntary
of paid placement Codes
through media (print, of
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
and practicesproduct.
pharmaceutical in relation to registration; labeling and scientific claims approved by
Advertorial:
A paid advertising material in editorial format. An advertorial can be distinguished from a news release or
PHAP and its
feature article members
in that are
most of the committed
time an advertorialtomaterial
educational and at
would contain promotional efforts
the bottom of the that
material
benefit patients
the word “ADVT,” as means
which well as programs and collaborations that enhance the practice of
advertising.
By-lined articles:
the
Newsdecisions taken
articles, feature by orhealthcare
stories professionals
health columns (HCPs)
with the name of indisplayed
the writer prescribing
after themedicines
title of the to
patients.
story.
Infomercials:
The ethicalofpromotion
Dissemination information of aofproduct,
prescription medicines
disease, clinical is vitalthrough
study or advocacy to the pharmaceutical
non-paid media.
Locally
and generated news:
innovative medicines. Ethical promotion helps to ensure that HCPs have access
Press materials prepared and issued by the Philippine-based pharmaceutical company.
medicines
Mass Media: at the right time.
Any publication, book, notice, handbill, poster, circular, pamphlet, letter, billboard, print medium, radio,
television, cinema, mobile audio visual unit or widespread medium of information directed at the lay
Industry
public. relationships with HCPs must support, and be consistent with the
Press Release:must maintain high ethical standards in the conduct of promotional
companies
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
Through the
prescriptions. promotion
These of this
are also known Code, Drugs.”
as “Ethical PHAP seeks to ensure that ethical promotional
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.
Tri-media advertisement:
Paid advertising placement using print, TV and radio.
TEODORO
Wire news: PADILLA
Executive
Press articlesDirector
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 Direct or 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. June
Any form of tri-media advertisement 1, 2013
is strictly notversion
allowed per Section No.3 of BFAD Regulation
No.5s.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
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.
Tri-media advertisement:
Paid advertising placement using print, TV and radio.
Wire news:
Press articles generated by a wire agency.
THE GUIDELINES
Foreword
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
The PHAP
Medical Code
Direct of Practice
or shall adopts
be responsible andin full and for
accountable aligns with the
the content of itsExpanded Code
advertisement and of
promotional materials. To be consistent, all materials and press releases should have the approval of at
Practice of the International
least the Medical Director.
Federation of Pharmaceutical Manufacturers &
Business
3. ObserveEthics in the inBiopharmaceutical
self-regulation Sector,.
the following channels of It incorporates
communication localpoints:
and news trigger requirements
a. Any form of tri-media advertisement is strictly not allowed per Section No.3 of BFAD Regulation
theNo.5s.1989.
Philippine TheFood
only and Drugchannels
allowable Administration (FDA).are press releases, editorials, health
of communication
columns and features, and public service announcements per Section 4 of BFAD Regulation No.5 s.
1987.and its members are committed to educational and promotional efforts that
PHAP
benefit patients asand
b. For multi-national well as programs
foreign-owned and collaborations
companies: news coming fromthat enhance
company the practice of
headquarters,
medicine.
 ThePHAP
local through
subsidiaryitsshould
Code filter
of Practice
or adaptseeks to preserve
International the independence
Headquarters news to local of
requirements.
 Press information shall follow the company approval process. Consistent with DOH AO 65
patients.
Sec.2.4, the Medical Director should approve all outgoing press information.
The ethical promotion
retainer or PHAP legal ofcounsel.
prescription medicines is vital to the pharmaceutical
c. Locally generated news.
and innovative
 medicines.
This is allowable Ethical
if consistent withpromotion
PHAP Code. helps to ensure that HCPs have access
to the right information
However, this shouldthey need and
go through thatapproval
medical right patients have access
or the appropriate companyto approval
the right
medicines at theThe
process. right time. Medical Director should approve all outgoing press information.
company’s
retainer or PHAP legal counsel.
d. By-lined articles

companies PHAPmustdoes maintain
not have jurisdiction over third-party
high ethical writers,in
standards health
thecolumnists
conductandofmedia spokes-
promotional
persons.
activities
 to HCPs, Patient groups and Patient Organizations
Please refer to #4 below on ethics related to industry interactions. and comply with
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.
 In-house prepared press/news articles containing attributions to doctors, scientists, head medical
researchers of the pharmaceutical company, and quotations/statements from employees (CEO,
country manager, managing director, medical director, etc.) shall be allowed as long as their
content complies with Guideline#5 (Acceptable and Recommended News Content/Format).
f. Media briefing (press conference, media RTD’s, exclusive one-on-one interview)

TEODORO
 PADILLA
Press kits shall have the necessary medical approval. The Medical Director should approve all
outgoing press information.
Executive

Director
It is advisable to also secure legal approval either through in-house legal counsel, a legal
 June 1, are
No product photos and product backdrops 2013 version
allowed
 PHAP Guidelines on “Communications with the General Public’’ shall be part of the press kit.
g. Global and Regional Media Conference

 Invitations to journalists to global and regional media meetings shall be allowed provided that the
media group will pay its own way to cover the event.
 The invited journalist/s shall be issued press materials complying with Section5 (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.
h.“Online” (internet) news and promotion June 1, 2013 version

 This should apply to local broad sheets 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)

 Press kits shall have the necessary medical approval. The Medical Director should approve all
outgoing press information.
 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

 Invitations to journalists to global and Foreword
regional media meetings shall be allowed provided that the
media group will pay its own way to cover the event.
 The invited journalist/s shall be issued press materials complying with Section5 (Accept- able
and Recommended News Content/Format). Since this is an international event, it is the
The PHAP Code ofofPractice
responsibility adopts inpharmaceutical
the Philippine-based full and aligns
companywith the Expanded
to ensure Code
compliance with theof
Practice guidelines.
of the International Federation of Pharmaceutical Manufacturers &
h.“Online” (internet) news and promotion
Business

Ethics in the Biopharmaceutical Sector,. It incorporates local requirements
This should apply to local broad sheets with online versions(e.g.,inquirer.net,mb.com.ph.,philstar.
and practices in relation to
net, bworldonline.com, registration;
etc.). Guidelines a, b,labeling
and c are and
to be scientific claims
applied for online approved by
news.
i. Wire news
 Wire news is acceptable. PHAP has no jurisdiction over wire news independently picked up by
PHAP and its However,
media. members are
to be committed
legitimate, to articles
wire news educational andbeen
should have promotional efforts
properly sourced that
from the
benefit patients as (e.g.,AP,
news agency well asReuters).
programs and collaborations that enhance the practice of

medicine. Feeding
PHAPof through
news on competitive
its Codeproducts is considered
of Practice seeksunethical.
to preserve the independence of
the decisions interviews
j. Pre-arranged taken by andhealthcare
guesting (TV,professionals
radio and print) (HCPs) in prescribing medicines to
patients.
 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
The ethical promotion of prescription medicines is vital to the pharmaceutical
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).
medicines
4. Ethics onat the right
Industry time. with Media and Third-Party Spokespersons
Interactions
 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
professional
re-viewsresponsibilities they
that are actually written haveor public
by industry with relations
their firms
patients. Pharmaceutical
in an attempt to manage the
companiespressmust maintain
on certain products high ethical standards in the conduct of promotional
and services.
5. Acceptable and Recommended News Content/Format
 Infomercials covering medical and healthcare topics and treatment options are permitted as long
Throughastheits content:
promotion(a) is medically sound; PHAP
of this Code, (b) doesseeks
not encourage self-medication;
to ensure (c) directs
that ethical readers
promotional
to consult a doctor; and (d) includes treatment options that are balanced with information on
practicescontraindications,
are established and be at par with International
precautions, warnings, and/or side effects. Standards worldwide.
 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,
TEODORO PADILLA
however, are permissible. For prescription drugs, it should be clearly stated that this product can
Executive
beDirector
bought only with a prescription and that a doctor’s advice should be sought.

TABLE 1
PHAP recommends the amounts in table as the maximum rates for HCP honoraria
for common events conducted within the Philippines.
These recommendations are not intended to restrict member companies from

providing different rates as long as they are not excessive and they reflect the fair
market value of the services provided, taking into consideration such factors as the
nature of the services, therapeutic area of expertise, experience level/qualification
of the HCP engaged, number of HCPs in the same level of expertise, complexity of the
subject matter, duration of the event and the number of event participants.

PHAP Members
1. Abbott Laboratories, Inc. 37. Pfizer
2. Alcon Laboratories Phils., Inc. 38. PharmAsia-Cuvest
3. AstraZeneca Philippines, Inc. 39. Pharsight, Inc.
4. Astellas Pharma Philippines Inc. 40. Philusa Corporation
5. Baxter Healthcare Phils., Inc. 41. Qualimed Pharma. Inc.
6. Bayer Schering Pharma 42. Roche Philippines, Inc.
7. Blue Sky Trading Co., Inc. 43. Sanofi-Aventis Phils., Inc.
8. Boehringer Ingelheim Phils., Inc. 44. Swisspharma Research
9. Buergli Pharma, Inc. Laboratories, Inc.
10. Calmoseptine Phils., Inc. 45. Takeda Pharmaceuticals,
11. Catalent Pharma Solutions Phils., Inc.
12. Eli Lilly Philippines Inc. 46. Vizcarra Pharma
13. Farmacia Oro 47. Zuellig Pharma Corp.
14. First Associated Medical
Distribution Co., Inc.
15. Galderma Philippines
16. GlaxoSmithKline Phils.
17. HI-EISAI Pharmaceuticals, Inc
18. Hizon Laboratories, Inc.
19. IMS Health Philippines, Inc.
20. Interphil Laboratories
21. Janssen Pharmaceuticals
22. Johnson & Johnson Medical
23. Lietz, Inc. Rudolf
24. Medicomm Pacific Inc.
25. Medimarketing
26. Menarini Philippines, Inc.
(formerly Invida)
27. Mercury Drug Corporation
28. Merck Inc. Philippines
29. MSD
30. Metro Drug, Inc.
31. Metro Pharma, Phils., Inc.
32. Mundipharma Distribution
GmbH Philippines
33. Novartis Healthcare, Phils.
34. One Pharma Company
35. Pacific Pharmaceutical Generics,
Inc.
36. Panpharma-Meinz Pharmaceutical
Corp.
PHARMACEUTICAL AND HEALTHCARE
ASSOCIATION OF THE PHILIPPINES
Unit 502 One Corporate Plaza,

845 A. Arnaiz Avenue, Makati City
Tel No.: 8141800
Website: www.phap.org.ph
www.phap.ph
www.phapcares.org.ph

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Code of Practice

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

(Please send this portion of the signed Member’s Pledge to PHAP )

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

The ethical promotion of prescription medicines is vital to the pharmaceutical

June 1, 2013 version

 Pharmaceutical companies will respect

June 1, 2013 version

June 1, 2013 version

PHAP Member Companies should adhere to both

1.0 CODE OF PHARMACEUTICAL

1.1 Scope of Coverage 1.1

“Pharmaceutical product” means any

“Promotion and advertisement” means any

“Healthcare professional (HCP)” means any

1.2 Interpretation of the Code

1.3 Responsibility for Implementation

June 1, 2013 version

June 1, 2013 version

For example, to satisfy the requirements of

June 1, 2013 version

All information, claims and Foreword

(c) Citation of data previously valid but made

(d) Suggestions or representations of uses,

(e) Shortening an approved indication (e.g.,

(f) Use of animal or laboratory data as sole

June 1, 2013 version

(g) Presentation of information in such a

(h) Statements made about a competitive

(i) Shortening the title’s graphical

Use of overseas Product Information to

(k) Literal or implied claims that a parameter,

(l) Lack of substantiation of claims

June 1, 2013 version

All promotional and educational material Foreword